What exactly drugs fall under the definition of "Total belladonna alkaloids" for the purposes of PKU? Medicinal product: belladonna sum of alkaloids Medicines based on belladonna

PREPARATIONS belladonna leaves (Folia Atropae belladonnae). The leaves of a perennial cultivated herbaceous plant of belladonna (belladonna) - Atropa belladonna L., collected in the phase of the beginning of budding before mass fruiting, fam. nightshade - Solanaseae. The plant contains alkaloids of the atropine group (hyoscyamine, scopolamine, apoatropine, etc.). The content of alkaloids in the leaves (in terms of hyoscyamine) must be at least 0.3% according to the requirements of the State Pharmacopoeia; when the content of alkaloids is more than 0.3% for the preparation of dosage forms, the leaves are taken in a correspondingly smaller amount. The pharmacological properties of belladonna coincide mainly with the properties of atropine. Preparations of belladonna (extracts, tinctures) are used as antispasmodic and analgesic agents for gastric ulcer, cholelithiasis and other diseases accompanied by spasms of smooth muscles of the abdominal organs, with bradycardia due to overexcitation of the vagus nerve, etc. Contraindicated in glaucoma. The belladonna leaf and preparations derived from it (extracts, tinctures) are stored with caution (list B). Belladonna tincture (Tinctura Belladonnae). Transparent liquid of greenish or reddish-brown color with a peculiar smell and bitter taste. Prepared from belladonna leaves (1:10) in 40% alcohol; contains 0.027-0.033% alkaloids. Assign inside: adults 5-10 drops per reception; children 1 - 5 drops per reception, depending on age. Highest doses for adults: single 0.5 ml (23 drops), daily 1.5 ml (70 drops). Release form: in vials of 10 ml. The belladonna tincture is part of the so-called Zelenin Drops (see) and other combined dosage forms. Belladonna (Belladonna) thick extract (Extractum Belladonnae spissum). A dense mass of dark brown color, a peculiar smell. Contains from 1.4 to 1.6% alkaloids. Included in a number of combined dosage forms. Single doses: 0.01 - 0.015 - 0.02 g. Higher doses for adults inside: single 0.05 g, daily 0.15 g. Belladonnae siccum). Brown or light brown powder with a slight odor, a peculiar taste. Hygroscopic. Contains 0.7 - 0.8% alkaloids. Due to the lower content of alkaloids in the manufacture of dosage forms, the dry extract is used in double the amount in relation to the thick extract. Higher doses for adults inside: single 0.1 g, daily 0.3 g. The following medicinal preparations are available containing belladonna leaf powder and extracts from belladonna leaves and roots. Anti-asthma collection (Species antiasthmaticae) (list B). Synonyms: Asthma powder, Pulvis antiasthmaticus. Ingredients: belladonna leaves 2 parts, henbane leaves 1 part, Datura leaves 6 parts, sodium nitrate 1 part. Powder of brownish-green color with a peculiar smell. Contains 0.2 - 0.25% alkaloids. Lit slowly and evenly smolders until completely ashed. It is used for bronchial asthma. Burn half a teaspoon and inhale the smoke or smoke a cigarette containing said powder. Tablets "Becarbonum", (Tabulletae "Becarbonum"). Composition: belladonna extract 0.01 g, sodium bicarbonate 0.3 g. Take 1 tablet 2-3 times a day for intestinal cramps, increased acidity of gastric juice. Tablets "Besalol" (Tabulettae "Besalolum"). Composition: belladonna extract 0.01 g, phenyl salicylate 0.3 g. For use, see Bepasal. Tablets "Bepasal" (Tabulettae "Bepasalum"). Composition: phenyl salicylate (salol) 0.3 g, papaverine hydrochloride 0.03 g, belladonna extract 0.012 g. Spasmodic, anticholinergic and antiseptic agent. Assign for diseases of the gastrointestinal tract on a tablet 2 to 3 times a day. Tablets "Bellalgin" (Tabulettae "Bellalginum"). Composition: analgin and anesthesin 0.25 g each, belladonna extract 0.015 g, sodium bicarbonate 0.1 g. Antispasmodic, antacid and analgesic. Assign mainly for diseases of the gastrointestinal tract, accompanied by high acidity, spasms of smooth muscles, pain. Take orally 1 tablet 2-3 times a day (after meals). The highest dose for adults: single 3 tablets, daily 10 tablets. Storage: list B. In a place protected from light. Bellastezin tablets, see Anestezin. Gastric tablets with belladonna extract (Tabulettae Stomachicae cum extracto Belladonnae). Ingredients: belladonna extract 0.01 g, wormwood extract 0.012 g, valerian extract 0.05 g. Take 1 tablet 2-3 times a day. Storage: list B. Candles "Betiol" (Suppositoria "Vethiolum"). Ingredients: belladonna extract 0.015 g, ichthyol 0.2 g, candle base 1.185 g. Used for hemorrhoids and anal fissures. Release form: in packing on 10 pieces. Candles "Anuzol" (Suppositoria "Anusolum"). Ingredients: belladonna extract 0.02 g, xeroform 0.1 g, zinc sulfate 0.05 g, glycerin 0.12 g, suppository base 2 g. Used for hemorrhoids and anal fissures. Release form: in boxes of 10 pieces, as well as candles containing belladonna extract of 0.015 g. The amount of alkaloids from belladonna roots is part of the Bellataminal, Belloid (Hungary) tablets, the Solutan preparation. Tablets "Bellataminal" (Tabulettae "Bellataminalum"). Coated tablets containing phenobarbital 0.02 g (20 mg), ergotamine tartrate 0.0003 g (0.3 mg), belladonna alkaloids total 0.0001 g (0.1 mg). The composition and action of bellataminal is similar to the drug "Bellaspon" (Bellasron). * The pharmacological properties of bellataminal and its analogues correspond to the action of their constituents: the drugs reduce the excitability of the central and peripheral adrenergic and cholinergic systems of the body, have a calming effect on the central nervous system. Applied with increased irritability, insomnia, menopausal neurosis, neurodermatitis, autonomic dystonia. Assign 1 tablet 2 to 3 times a day (after meals). Due to the content of ergotamine (see), which can cause contraction of the uterus and blood vessels, tablets are contraindicated during pregnancy and during childbirth, with spasms of the vessels of the heart and peripheral vessels, in advanced stages of atherosclerosis. Also contraindicated in glaucoma. Storage: list B. In a place protected from light. Dragee "Belloid" * (Belloid). Composition: 0.3 mg of ergotoxin, 0.1 mg of belladonna (belladonna) alkaloids and 0.03 g of butylethylbarbituric acid. Take with increased irritability, insomnia, vegetative dystonia, Meniere's syndrome, neurogenic disorders associated with menstrual irregularities, hyperthyroidism, etc. 1-2 tablets (pellets) 3 times a day. Contraindications: see Bellataminal tablets. Release form: in packing on 50 tablets. Solutan*. Contains 1 ml of radobelin (Belladonna root alkaloid) 0.1 mg, saponin (Saponinum gipsophillae) 1 mg, dill oil 0.4 mg, novocaine 4 mg, ephedrine hydrochloride 17.5 mg, sodium iodide 0.1 g, tolutan extract balm 25 mg, bitter almond water 30 mg, alcohol and water up to 1 ml. Clear yellow-brown or orange-brown liquid. In the course of time, a fine precipitate, soluble on agitation, may form. The occurrence of sediment does not reduce the effectiveness of the drug. It has a bronchodilator (choline and antispasmodic) and expectorant effect. Used for bronchial asthma and bronchitis. Assign inside adults 10 - 30 drops 3 times a day (after meals). With asthmatic attacks, up to 60 drops are prescribed per reception, they are also used for inhalation. Children are prescribed 5-10 drops 3 times a day (with milk or tea). At high doses, side effects are possible that are characteristic of preparations of the belladonna group (dry mouth, dilated pupils, etc. Contraindicated in glaucoma. Release form: in vials of 50 ml (list B). Rp .: T-rae Belladonnae 10 ml D.S. 5 each - 10 drops 2 - 3 times a day Rp.: T-rae Belladonnae 10 ml T-rae Valerianae 20 ml Mentholi 0.25 D.S. 10 -15 drops 2 - 3 times a day Rp.: T-rae Belladonnae 5 ml T -rae Convallariae T-rae Valerianae aa lO ml Mentholi 0.2 D.S. 10 - 15 drops 2 - 3 times a day Rp.: Extr. Belladonnae 0.015 Natrii hydrocarbonatis 0.25 D.t.d. N. 6 in tab. S. 1 tablet 2 - 3 times a day Rp.: Magnesii oxydi 0.5 Bismuthi subnitratis 0.2 Extr. Belladonnae 0.01 M.f. pulv. D.t.d. N. 10. S. 1 powder 2-3 times a day (with increased acidity of gastric juice)

Medicine Dictionary. 2005 .

See what "Beauty's PREPARATIONS" are in other dictionaries:

Belladonna leaves (Belladonna preparations) is an anticholinergic agent. Atropa belladonna Contents 1 Demoiselle Leaves 2 On ... Wikipedia

Method for obtaining the amount of belladonna alkaloids. Usage: the invention relates to the chemical and pharmaceutical industry, and, specifically, to a method for obtaining drugs from plant materials, and concerns a method for obtaining the amount of belladonna alkaloids. The purpose of the invention is to increase the yield of the target product and simplify the process. The essence of the invention lies in the extraction of belladonna herb with dichloroethane in an alkaline medium, treatment of the dichloroethane extract with a solution of sulfuric acid, subsequent treatment of the sulfuric acid extract with chloroform in an alkaline medium, drying the obtained extract, evaporation, sorption purification of the concentrated chloroform extract using vacuum sequentially on aluminum oxide and activated carbon in ratio of at least 1: 3, elution with chloroform, evaporation of the eluate, precipitation of the total alkaloids with petroleum ether, crystallization, filtration and drying. The positive effect is to increase the yield from 60.4% to 84.9% and simplify the process.

The invention relates to the pharmaceutical industry, namely to a method for obtaining drugs from plant materials, and relates to obtaining the amount of belladonna alkaloids, which, as an antispasmodic, is part of the "Bellataminal" tablets used in neurological practice. The main component in the amount of belladonna alkaloids is hyoscyamine, an alkaloid of the tropane group. Smaller amounts contain alkaloids of the same class - atropine and scopolamine. There are 2 ways to obtain the amount of belladonna alkaloids, which have received industrial use. According to the first method, belladonna cut grass is extracted with dichloroethane at pH = 8-9. Dichloroethane extract is treated with 1% sulfuric acid solution, alkaloids are extracted from sulfuric acid extracts with chloroform at pH = 8-9, the chloroform extract is dried over anhydrous sodium sulfate, and then evaporated to dryness. The residue in the form of tar is boiled several times with sulfuric ether, while extracting the alkaloids into the ether. The ether extracts are concentrated to a small volume, cooled, kept in a refrigerator for a more complete crystallization of the product, which is then filtered off, washed with sulfuric ether and dried. The total yield of alkaloids from raw materials with a content of 0.5% is 54.82% or 148.5 g from 60 kg of raw materials. The disadvantages of the known method are the relatively low yield of the finished product, the frequent inconsistency of the resulting product with the NTD and, as a result, the need for additional purification and reduced yield. In addition, such recrystallization was associated with large (almost complete) losses of ether and increased explosion and fire hazard. The closest in technical essence and the achieved result to the proposed method is a method for obtaining the amount of alkaloids, in which the chloroform extract obtained as described above is evaporated to a small volume, the VAT residue is boiled with activated carbon, cooled to 40-50 o C, into the resulting suspension alumina of the II degree of activity is added, stirred for five minutes, after which the suspension is passed by gravity through a column with alumina of the II degree of activity, then the sorbent is washed with chloroform until a negative reaction to alkaloids. The main eluate and the sorbent obtained after washing are combined and boiled with charcoal, cooled to 40-50 o C, the charcoal is filtered off and then evaporated to a small volume, freon-113 or petroleum ether is added to the distillation residue with stirring, and a precipitate of the total belladonna alkaloids is released , which after aging in the refrigerator is filtered off, washed with a mixture of chloroform - freon-113 (or chloroform - petroleum ether) in a ratio of 1:3 and dried. The output of the total alkaloids from raw materials with a content of 0.5% is 60.4% or 160 g from 60 kg of raw materials. On the basis of this method, an industrial regulation was developed and introduced into the industry: for the production of belladonna alkaloids. To additionally obtain the amount of alkaloids, the mother liquor formed after filtering the finished product is processed. To this end, the mother liquor is concentrated to 8% of the original volume, after which the VAT residue is subjected to sorption purification according to a scheme similar to that for chloroform extraction. The resulting product is added to the main one. The main disadvantages of this method are the irreproducibility of the production technology on some batches of raw materials and the associated sharp decrease in the yield of the drug and the decrease in its quality, as well as the low technology of operations at the stage of purification of the chloroform extract and significant labor intensity. The actual yield of the drug from a number of batches of raw materials was 2-5 times less than expected, in addition, the product could not be isolated from the mother liquor from any batch of raw materials. The purpose of the invention is to increase the yield of the target product and simplify the technology. This goal is achieved by developing a technology for obtaining the amount of belladonna alkaloids based on the use of a new set of operations at the stage of purification of chloroform extract and the optimality of process parameters, in which concentrated chloroform extract is passed under vacuum without preliminary purification through a filter with a combined sorbent alumina - activated carbon, then rinsing sorbent with chloroform, the eluate is evaporated and the amount of alkaloids is precipitated by pouring the VAT residue into petroleum ether. From 60 kg of raw materials with a total alkaloid content of 0.5%, 237 g of the total alkaloids are obtained, which is 84.9% of the content in the raw material. The optimality of the selected parameters is illustrated by the data in Table. 1 and 2. From the data in Table. 1 it follows that at a ratio of distillation residue - alumina - coal 1:3:1 (experiment 6), the highest yield of the total alkaloids is observed and excellent product quality is achieved. An increase in the amount of alumina above the specified leads to a decrease in the yield of the product, and its decrease leads to a product that does not comply with the NTD. A change in the amount of activated carbon leads to a similar effect. From the data in Table. 1 also shows that the use of any one sorbent for sorption purification is inefficient; you need a combined sorbent. In table. Table 2 presents data on the kinetics of elution of the total alkaloids from the combined sorbent. The optimal amount of chloroform for eluting the total amount of alkaloids is its twofold volume relative to the volume of chloroform extract supplied for purification (experiment 2). A further increase in the volume of the eluent is impractical, because does not lead to an increase in output; in addition, an increase in the volume of the eluent above this contributes to the leaching of impurities from the sorbent that impair the solubility of the drug (i.e., control of the end of the elution of the product from the sorbent according to the sample with silicotungstic acid recommended by the authors of the prototype is not effective). Reducing the volume of the eluent to less than 2 volumes relative to the volume of the chloroform extract leads to incomplete desorption of the product and a decrease in yield. Compliance of the proposed method with the criteria of "novelty" and "significant differences" lies in the fact that the chloroform extract is passed under vacuum through a filter with a combined sorbent, then washing the sorbent with chloroform. Below are examples of the proposed method for isolating the amount of alkaloids from belladonna herb with a low and high content of alkaloids in the raw material, as well as from the mother liquor obtained after filtering the finished product. PRI me R 1. Grass belladonna cut (the content of the total alkaloids 0.35%) in the amount of 60 kg is extracted twice with dichloroethane at pH 8 at room temperature and constant stirring in an extractor with a capacity of 1000 liters. To create an alkaline environment in the reaction mass add 19 l of 10% ammonia solution. The time of the first extraction is 4 hours, the second and third 2 hours each. The ratio of raw materials and extractant - dichloroethane at the first contact of the phases is 1: 8. For the second and third extraction, dichloroethane is served in an amount equal to the drained previous extract. Get 390 l of each extract. The third dichloroethane extract is fed to fresh raw materials. The first and second dichloroethane extracts are separately treated with 5% sulfuric acid 3 times in 15 liters, while the time of each extraction is 15 minutes. The second and third sulfuric acid extracts from the first dichloroethane extract are fed to the processing of the second dichloroethane extract, respectively, for the first and second extractions, and a 5% solution of sulfuric acid is supplied to the third extraction. The second and third sulfuric acid extracts obtained by processing II dichloroethane extract are fed to the processing of the first dichloroethane extract of the next boot. Next, the first sulfuric acid extracts from the first and second dichloroethane extracts are combined (30 l are obtained) and alkalized with a 25% ammonia solution to pH 8, this takes 4.2 l of ammonia. An alkaline solution of alkaloids is treated with chloroform 3 times for 20 minutes, applying 12 liters of chloroform to I extraction, 11 liters to II, and 8 liters to III. Chloroform extracts are combined (28 l are obtained), 3 kg of sodium sulfate are added, dried for two hours, after which the chloroform extract is taken to the park, filtering it from sodium sulfate through a fungus seasoned with coarse calico. Sodium sulfate is washed with 1.5 l of chloroform, which is added to the main portion of the chloroform extract. The chloroform extract is evaporated at a temperature of 352 o C and a residual pressure of 0.02 MPa to 2 liters. One stripped off chloroform extract in the amount of 2 l is passed under vacuum through a filter (diameter - 19 cm) with a combined sorbent: aluminum oxide in the amount of 0.6 kg at the bottom, activated carbon - 0.2 kg at the top. The filtrate is collected in a Bunsen flask. Filling the filter with activated carbon is carried out necessarily using a vacuum. After passing the basic solution (2 l), the sorbent is washed with 4 l of chloroform, also using a vacuum. 5.2 liters of eluate are obtained, which is evaporated to 1.5 liters under the same conditions as the chloroform extract. VAT residue is poured with stirring into 4.5 l of petroleum ether (ratio 1:3), kept at a temperature of 4 2 ° C for 8 hours, after which the precipitate of the total alkaloids is filtered off, washed with 1.5 l of petroleum ether, ventilated under draft in for 5 hours and then dried in a vacuum oven at a temperature of 60 about C and a residual pressure of 0.02 MPa for 5 hours Get 120 g of the amount of belladonna alkaloids corresponding to the NTD. Additionally, 7 g of the product is isolated from the mother liquor. The total yield of the product is 127 g or 70.95% of the content in the raw material. Example 2. Cut belladonna grass (content of total alkaloids 0.5%) in an amount of 60 kg is extracted with dichloroethane at pH 8 as in example 1. The whole process until stripped off chloroform extract is obtained as in example 1. Stripped off chloroform extract in the amount of 2 l is passed under vacuum through a filter (diameter - 19 cm) with a combined sorbent: aluminum oxide in the amount of 1.2 kg at the bottom, activated carbon - 0.4 kg at the top. Filling the filter with activated carbon is carried out necessarily using a vacuum. After passing the basic solution, the sorbent is washed with 4 l of chloroform, also using a vacuum. 5 l of the eluate are obtained, which is evaporated to 2 l under the same conditions as the chloroform extraction, the VAT residue is poured with stirring into 6 l of petroleum ether (ratio 1:3), kept at a temperature of 4 + 2 ° C for 8 hours, after which the precipitate of the sum of alkaloids is filtered off, washed with 2 l of petroleum ether, weathered under draft for 5 hours and then dried in a vacuum oven at a temperature of 60 ° C and a residual pressure of 0.02 MPa for 5 hours. Get 230 g of the amount of belladonna alkaloids corresponding to the NTD. Additionally, 7 g of the product is isolated from the mother liquor. The total yield of the product is 237 g or 84.9% of the content in the raw material. PRI mme R 3. The mother liquor in the amount of 7 l from one load in 60 kg of raw material is evaporated at a temperature of 40 2 about C and a residual pressure of 0.02 MPa to 0.7 l (10% of the original volume), VAT residue kept at a temperature of 42 ° C for 8 hours, after which the precipitate is filtered off and dried under the same conditions as the finished product for 2 hours. 10 g of the technical amount of alkaloids is obtained, which is purified according to the scheme described in example 1 for chloroform extraction. For this purpose, 10 g of the technical amount of alkaloids is dissolved in 200 ml of chloroform, the resulting solution is passed under vacuum through a filter (diameter - 5 cm) with a combined sorbent: alumina - 60 g at the bottom, activated carbon - 20 g at the top. After passing the basic solution, the sorbent is washed with 400 ml of chloroform, also using a vacuum. Receive 520 ml of eluate, which is evaporated to 150 ml under the same conditions as the chloroform extraction in example 1; the VAT residue is poured with stirring into 450 ml of petroleum ether (ratio 1:3), kept at a temperature of 42 ° C for 5 hours, after which the precipitate of the total alkaloids is filtered off, washed with 100 ml of petroleum ether, weathered under draft for 1-2 hours and dried at a temperature of 60 about C and a residual pressure of 0.02 MPa for 2 hours Get 7 g of the amount of alkaloids corresponding to the NTD, which is attached to the main product. The use of the proposed method in comparison with the known provides the following advantages: 1. Increasing the yield of the finished product by at least 24.5% of the content of the total alkaloids in the raw material (from 60.4% to 84.9%). 2. Simplification of the technological process: the following operations are excluded from production at the stage of sorption purification: boiling one stripped off chloroform extract with coal, cooling the resulting suspension to a certain temperature, treating it with aluminum oxide of the II degree of activity, boiling the eluate with coal, cooling the eluate, filtering the eluate from coal , preparation of aluminum oxide II degree of activity; 3. By simplifying the process, working conditions are improved and labor costs are reduced; The developed method for purifying chloroform extract was tested on several batches of raw materials* processed under industrial conditions at the Production and Experimental Plant of NPO VILRA and showed reproducible results. On the basis of the proposed method, a PR is currently being drawn up for the production of belladonna alkaloids. * Raw materials used in the phytochemistry area during the industrial production of the drug according to the proposed method.

Claim

METHOD FOR OBTAINING TOTAL BELLADEA ALKALOIDS by extracting the belladonna herb with dichloroethane in an alkaline medium, treating the dichloroethane extract with a solution of sulfuric acid, then treating the sulfuric acid extract with chloroform in an alkaline medium, drying the resulting extract, evaporating, sorption purification of the concentrated extract using chloroform, evaporating the eluate, precipitating the total alkaloids petroleum ether, crystallization, filtration and drying, characterized in that, in order to increase the yield of the target product and simplify the technological process, the sorption purification of the concentrated chloroform extract is carried out using a vacuum on a combined sorbent: alumina and activated carbon, taken in a ratio of not less than 3:1.

DRAWINGS

MM4A Early termination of a patent of the Russian Federation for an invention due to non-payment of the fee for maintaining the patent in force by the due date

Trade name:

belladonna amount of alkaloids

Belladonna leaves (Belladonnae folia)

Antispasmodic

Description of the active substance (INN):

belladonna leaves

tincture, rectal suppositories, raw vegetable powder

Means of plant origin. It has an m-anticholinergic and antispasmodic effect. Interferes with the stimulating action of acetylcholine; reduces the secretion of salivary, gastric, bronchial, lacrimal, sweat glands, exocrine function of the pancreas. Reduces the tone of the muscles of the gastrointestinal tract, bile ducts and gallbladder, but increase the tone of the sphincters; causes tachycardia, improves AV conduction. It dilates the pupils, impedes the outflow of intraocular fluid, increases intraocular pressure, causes accommodation paralysis.

Peptic ulcer of the stomach and duodenum, cholelithiasis, spasm of smooth muscles of the abdominal organs, biliary colic, renal colic; bradycardia, AV blockade; hemorrhoids, anal fissures.

Hypersensitivity, angle-closure glaucoma, prostatic hypertrophy with impaired urine outflow.

Dry mouth, mydriasis, accommodation paresis, intestinal atony, dizziness, tachycardia, urinary retention, hyperemia of the skin of the eyelids, photophobia. Overdose. Symptoms: psychomotor agitation, accommodation paralysis, acute urinary retention.

Inside, adults - 5-10 drops of tincture 3-4 times a day; children - 1-5 drops. The highest dose for adults: single - 0.5 ml (23 caps), daily - 1.5 ml (70 caps). Thick extract is taken at 0.01-0.02 g; the highest single dose - 0.05 g, daily - 0.15 g. Dry extract - 0.02-0.04 g each; the highest single dose - 0.1 g, daily - 0.3 g. Rectally, 1 suppository 2-3 times a day; the maximum dose is 10 suppositories per day.

During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration, speed of psychomotor reactions and good vision.

Description of the drug Belles alkaloids amount is not intended for prescribing treatment without the participation of a doctor.
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Question: What exactly drugs fall under the definition of "Total belladonna alkaloids" for the purposes of PKU?

Answer: According to the clarifications of the Ministry of Health of the Russian Federation, set out in Letter No. 25-4/10/2-26691 dated 03.09.2014 "On the implementation of subject-quantitative accounting of medicines", "... only medicines (pharmaceutical substances) are subject to subject-quantitative accounting and monopreparations) containing belladonna total alkaloids as the main and only pharmacological active substance and having an appropriate international non-proprietary (grouping) or trade name (for example, vegetable raw materials - dry extract, registered under the trade name "Beauty alkaloids sum)". At the same time, in the said Letter of the Ministry of Health, it is concluded that "Thus, the drug "Belladonna extract rectal suppositories" (having the international non-proprietary (grouping) name of Belladonna leaves and containing belladonna dry or thick extract) is not subject to accounting."
In this regard, it should be noted that Belladonna and Belladonna are two names for the same poisonous plant, the roots, leaves, stems, flowers and fruits of which contain atropine group alkaloids, that is, "the sum of belladonna alkaloids."
According to the instructions of Section II of the "List of medicines for medical use subject to subject-quantitative accounting", approved by Order of the Ministry of Health of the Russian Federation of April 22, 2014 N 183n, it includes medicines - pharmaceutical substances and medicines containing potent and toxic substances (their salts , isomers, ethers and esters, mixtures and solutions, regardless of concentration), included in the "Lists of potent and toxic substances for the purposes of Article 234 and other articles of the Criminal Code of the Russian Federation", approved by Decree of the Government of the Russian Federation of December 29, 2007 N 964, in combination with pharmacologically inactive substances. At the same time, neither in Section II, nor in the entire "List of medicines for medical use subject to subject-quantitative accounting", approved by the Order of the Ministry of Health of the Russian Federation of April 22, 2014 N 183n, there is no indication that they contain only international generic drug names. funds.
Therefore, "Beautyne extract rectal suppositories" containing belladonna dry or thick extract, which, in turn, contains "Total belladonna alkaloids", as well as any other medicinal products containing "Total belladonna alkaloids" as the only pharmacologically active substance, as whatever they are called (Belladonna leaves, belladonna extract, etc.), of course, are subject to subject-quantitative accounting.

Manufacturer: PHARMTSENTR VILAR CJSC (Russia)

raw materials plant-extract dry: jars Reg. No.: P N000548/01

Clinico-pharmacological group:

Drug with antispasmodic and analgesic action for local use in proctology

Release form, composition and packaging

Vegetable raw material - dry extract.

amount of belladonna alkaloids (belladonna)

dark glass jars (1) - wrapping paper.

Description of the active components of the preparation "Krasavka"

pharmachologic effect

Means of plant origin. Contains alkaloids atropine, hyoscyamine, scopolamine, which have m-holinolytic activity. It blocks m-cholinergic receptors and prevents the interaction with them of acetylcholine, a mediator of the parasympathetic division of the autonomic nervous system. Reduces the secretion of the digestive, bronchial, lacrimal, sweat glands. It relaxes smooth muscles and causes spasm of the intestinal sphincters, bile and urinary tracts, has a bronchodilator effect, mainly on small bronchi and bronchioles. Causes pupil dilation and accommodation paralysis, increases intraocular pressure. Reduces the cholinergic effect of the vagus nerve on the heart. As a result of the predominance of the adrenergic (sympathetic) effect on the heart, tachycardia occurs, and AV conduction improves. It practically does not affect the blood vessels and the level of blood pressure.

The duration of the resorptive action of alkaloids ranges from 2 to 6 hours. When applied topically to the mucous membrane of the eyes, accommodation is disturbed for 3-4 days, mydriasis persists for up to 7-10 days.

In high doses, it has a stimulating effect on the cerebral cortex, causes motor and speech excitation, hallucinations, activates, and when the dose is increased, it depresses the respiratory center.

Indications

For systemic use: spasms of smooth muscle organs of the gastrointestinal tract, biliary and urinary tract, hypersecretory gastritis, peptic ulcer of the stomach and duodenum, pancreatitis, hypersalivation, poisoning with heavy metal salts, m-cholinomimetics, anticholinesterase agents, obstructive bronchitis, bronchial asthma, premedication before surgery interventions, bradyarrhythmia, AV blockade, prevention of cardiac arrest and bronchospasm during anesthesia.

For local use in ophthalmology: for the study of the fundus, for the treatment of iritis, iridocyclitis, choroiditis, keratitis, embolism and spasm of the central retinal artery, some eye injuries.

Dosing regimen

Individual. The dose, frequency and duration of use depend on the indications, the age of the patient and the dosage form used.

Side effect

With systemic use: headache, nervousness, drowsiness, weakness, dizziness, sleep disorders, ataxia, speech disturbance, agitation (especially in elderly patients), dry mouth, loss of taste, loss of appetite, constipation.

In case of overdose: nausea, vomiting, tachycardia, tachyarrhythmia, myocardial ischemia, impotence, suppression of lactation, idiosyncrasy, urticaria, decreased sweating, hyperthermia.

When applied topically: visual disturbances, mydriasis, accommodation paralysis, increased intraocular pressure, photophobia.

Contraindications

Glaucoma, suspected glaucoma, stenosing diseases of the gastrointestinal tract, intestinal atony, acute ulcerative colitis, mechanical intestinal obstruction, atonic constipation, benign prostatic hyperplasia, pronounced atherosclerosis, acute pulmonary edema, cardiac decompensation, tachyarrhythmia, acute bleeding, myasthenia gravis, lactation, hypersensitivity to belladonna.

Pregnancy and lactation

The use of belladonna during pregnancy is possible only if the intended benefit to the mother outweighs the potential risk to the fetus.

During lactation (breastfeeding), the use of belladonna is contraindicated.

Application for violations of kidney function

Use with caution in patients with kidney disease.

special instructions

Use with caution in patients with polyneuropathy, hyperthyroidism, coronary artery disease, chronic heart failure, hypertension, kidney disease, diaphragmatic hernia, reflux esophagitis. Long-term use is not recommended for cholelithiasis and nephrolithiasis.

At high ambient temperatures, the use of belladonna can lead to heat stroke.

Influence on the ability to drive vehicles and control mechanisms

drug interaction

drug interaction

The belladonna reduces or eliminates the effect of m-cholinomimetics, anticholinesterase agents.

Potentiates the arrhythmogenic effect of MAO inhibitors, cardiac glycosides, clonidine, anticholinergic properties of quinidine, novocainamide, the effects of barbiturates, adrenomimetics, antihistamines, tranquilizers.

With lead acetate, calcium salts, tannin, tincture of lily of the valley forms a precipitate.

BEAUTY PREPARATIONS.

Sheet belladonna (Folium belladonnae). The leaves of a cultivated or wild-growing perennial herbaceous plant of belladonna (Belladonna)-Atropa belladonna L. and belladonna of the Caucasus - Atropa caucasica Kreyer, collected during the summer, fam. nightshade-Solanaceae.

The plant contains alkaloids of the atropine group (hyoscyamine, scopolamine, apoatropine, etc.). The content of alkaloids in the leaves ranges from 0.14 to 1.2%, in the roots - from 0.4 to 1.3%. According to the requirements of the State Pharmacopoeia of the USSR, the content of alkaloids in the leaves must be at least 0.3% with alkaloid content of more than 0.3% for the preparation of dosage forms, the leaves are taken in a correspondingly smaller amount.

The pharmacological properties of belladonna coincide mainly with the properties of atropine.

Preparations of belladonna (extracts, tinctures) are used as antispasmodic and analgesic agents for gastric ulcer, cholelithiasis and other diseases accompanied by spasms of smooth muscles of the abdominal organs, with bradycardia due to overexcitation of the vagus nerve, etc. Contraindicated in glaucoma.

The belladonna leaf and preparations derived from it (extracts, tinctures) are stored with caution (list B).

Tincture belladonna (Tinctura Belladonnae). Transparent liquid of greenish or reddish-brown color with a peculiar smell and bitter taste. Prepared from belladonna leaves (1: 10) in 40% alcohol contains 0.027-0.033% alkaloids.

Assign inside: adults 5-10 drops per reception, children 1-5 drops per reception, depending on age.

Higher doses for adults: single 0.5 ml (23 drops), daily 1.5 ml (70 drops).

Included in the drops of Zelenin.

Extract belladonna (belladonna) thick (Extractum Belladonnae spis-sum). A dense mass of dark brown color, a peculiar smell. Contains from 1.4 to 1.6% alkaloids.

Assign in pills, mixtures, powders and suppositories of 0.01-0.015-0.02 g per reception.

Higher doses for adults inside: single 0.05 g, daily 0.15 g.

belladonna extract(Belladonna) dry (Extractum Belladonnae siccum). Brown or light brown powder with a slight odor, a peculiar taste. Hygroscopic. Contains 0.7-0.8% alkaloids.

Due to the lower content of alkaloids in the manufacture of dosage forms, the dry extract is used in double the amount in relation to the thick extract.

Higher doses for adults inside: single 0.1 g, daily 0.3 g.

The following formulations are available containing belladonna leaf powder and extracts from belladonna leaves and roots.

Tablets "Corbella" coated (Tabulettae ઼orbella "obductae). Contains dry extract of belladonna root. Each tablet contains 0.001 g belladonna root alkaloids in terms of atropine. The use in medical practice is mainly associated with the central anticholinergic effect and the ability to weaken trembling and reduce tone in lesions of the subcortical nodes.

It is used for Parkinson's disease, parkinsonism due to chronic epidemic encephalitis and due to atherosclerosis, chronic manganese poisoning and other intoxications.

Treatment begins with the use of 1 tablet once a day at bedtime and, gradually increasing the dose, bring it to the most effective for this patient. To obtain a lasting effect, it is recommended to prescribe the highest doses that are well tolerated by patients for a long time. Treatment is contraindicated in general exhaustion, kidney disease, cardiac decompensation, severe tuberculous process, glaucoma. During treatment with the drug, dry mouth, paresis of accommodation, dizziness and other complications associated with the atropine-like effect of the drug are possible. In case of poor tolerance, the dose is reduced.

Release form: in banks on 50 tablets.

I Storage: list B. In a dry place.

Juice from belladonna roots. Sucradbelium (Succus radicis Belladonnae Sucradbelium). Contains 0.13-0.15% of the amount of alkaloids.

It is used for parkinsonism, starting with 3 drops per dose 2-3 times a day, the dose can be gradually increased, but not more than 15 drops per dose.

Possible complications and contraindications are the same as when using Corbella tablets.

Release form: in bottles of 30 ml.

Collection antiasthmatic (Species antiasthmaticae) (list B).

Synonyms: Asthmatol, Asthma Powder, Asthmatolum, Pulvis antiasthmaticus.

I Ingredients: belladonna leaves 2 parts, henbane leaves 1 part, Datura leaves 6 parts, sodium nitrate 1 part.

Powder of brownish-green color with a peculiar smell. Contains 0.2-0.25% alkaloids.

Lit, slowly and evenly smolders until completely ashed.

Used for bronchial asthma. Burn half a teaspoon and inhale the smoke or smoke a cigarette or cigarette containing said powder.

Release form: powder (in a package of 80 g), as well as in the form of cigarettes and cigarettes (20 pieces each).

Bellataminal(Bellataminalum). Combined preparation produced in the form of tablets containing phenobarbital 0.02 g (20 mg), ergotamine tartrate 0.0003 g (0.3 mg), the amount of belladonna alkaloids 0.0001 g (0.1 mg) and excipients up to the total weight tablets 0.1 g.

The composition and action is similar to the preparation "Bellaspon" (Bellaspon).

Lenbiren(Lenbiren), produced in the Socialist Republic of Romania, contains phenobarbital 0.03 g, the amount of ergot alkaloids 0.0003 g, the amount of belladonna root alkaloids 0.00025 g. It is similar in action to bellataminal.

Pharmacological properties of bellataminal and its analogs correspond to the action of their constituents: drugs reduce the excitability of the central and peripheral adrenergic and cholinergic systems of the body, have a calming effect on the central nervous system,
Applied with increased irritability, insomnia, menopausal neurosis, neurodermatitis, various autonomic dystonia.

Assign 1 tablet 2-3 times a day.

Storage: list B. In a place protected from light.

D, S. 1 tablet 2-3 times a day

Solutan(Solutan). A complex preparation containing in 1 ml: belladonna extract liquid 0.01 g, Datura extract liquid 0.016 g, primrose extract liquid 0.017 g, ephedrine hydrochloride 0.017 g, sodium iodide 0.1 g, novocaine 0.004 g, glycerin and aqueous alcohol up to 1 ml.

It has a bronchodilator (cholinergic and antispasmodic) and expectorant effect. Used for bronchial asthma and bronchitis.

Assign inside 10-30 drops 3 times a day after meals. With asthmatic attacks, up to 60 drops are prescribed per reception, they are also used for inhalation.

At high doses, side effects characteristic of drugs of the belladonna group (dry mouth, dilated pupils, etc.) are possible. Contraindicated in glaucoma. Produced in bottles of 50 ml (list B).

Becarbon- tablets (Becarbonum). Ingredients: belladonna extract 0.01 g, sodium bicarbonate 0.3 g. Take 1 tablet 2-3 times a day for intestinal cramps, increased acidity of gastric juice.

Besalol- tablets (Besalolum). Composition: belladonna extract 0.01 g, phenyl salicylate 0.3 g. For use, see Bepasal.

Bepasal- tablets (Bepasalum). Composition: phenyl salicylate (salol) 0.3 g, papaverine hydrochloride 0.03 g, belladonna extract 0.012 g. Antispasmodic, anticholinergic and antiseptic agent. Assign for diseases of the gastrointestinal tract, 1 tablet 2-3 times a day.

Bellalgin- Tablets (Bellalginum). Composition: analgin and anestezin 0.25 g each, belladonna extract 0.015 g, sodium bicarbonate 0.1 g. Antispasmodic, antacid and analgesic agent. Assign mainly for diseases of the gastrointestinal tract, accompanied by high acidity, spasms of smooth muscles, pain.

Bellastezin- tablets (see Anestezin).

Gastric tablets with belladonna extract (Tabulettae Stomachicae cum extracto Belladonnae). Contains belladonna extract 0.01 g, wormwood extract 0.012 g, valerian extract 0.015 g. Take 1 tablet 2-3 times a day.

There are also tablets of the following composition: a) belladonna extract 0.015 g, hexamethylenetetramine 0.25 g b) belladonna extract 0.015 g, sodium bicarbonate 0.25 g c) belladonna extract 0.015 g, sodium bicarbonate and phenyl salicylate 0.25 g each d) extract belladonna 0.015 g, phenyl salicylate and bismuth nitrate 0.25 g each e) belladonna extract 0.015 g and phenyl salicylate 0.25 (or 0.5) g.

All of these tablets are stored according to list B.

Candles Betiol (Suppositoria ઻ethiolum). Ingredients: belladonna extract 0.015 g, ichthyol 0.2 g, fatty base 1.185 g, Used for hemorrhoids and anal fissures.

Candles "Anuzol"(Suppositoria ઺nusolum). Ingredients: belladonna extract 0.02 g, xeroform 0.1 g, zinc sulfate 0.05 g, glycerin 0.12 g, fatty base 2 g. Used for hemorrhoids and anal fissures.

Release form: in boxes of 10 pieces.

They also produce suppositories containing belladonna extract, 0.015 g each. The amount of alkaloids from belladonna roots is included in the composition of the tablets (pellets) "Bellataminal", "Belloid" (see pages 191, 417).

Rp.: T-rae Belladonnae 10.0

D.S. 5-10 drops 2-3 times a day

Rep.: Extr. Belladonnae 0.015 Natrii hydrocarbonatis 0.25 D. t. d. No. 6 in tabl.

S. 1 tablet 2-3 times a day

Rp.: Magnesii oxydi 0.5

Bismuthi subnitratis 0.2 Extr. Belladonnae 0.01 M. f. pulv. D.t. d. No. 10