CN1224382C - Method for preparing medicine for relieving cough and reducing sputum - Google Patents
Method for preparing medicine for relieving cough and reducing sputum Download PDFInfo
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- CN1224382C CN1224382C CN 03100532 CN03100532A CN1224382C CN 1224382 C CN1224382 C CN 1224382C CN 03100532 CN03100532 CN 03100532 CN 03100532 A CN03100532 A CN 03100532A CN 1224382 C CN1224382 C CN 1224382C
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Abstract
The present invention relates to a method for preparing a medicine for relieving cough and reducing sputum, particularly to a medicine for relieving cough and reducing sputum, which uses dextromethorphan hydrobromide and guaifenesin as effective ingredients. The cough relieving ingredients in the medicine for relieving cough and eliminating sputum are prepared into sustained release preparations, the medicine effects of which sustain 8 to 12 hours; the sputum eliminating ingredients are prepared into a quick-release preparation which releases within one hour; the cough relieving ingredient in the medicine is dextromethorphan hydrobromide, and the sputum eliminating ingredient is guaifenesin. The medicine for relieving cough and eliminating sputum, which is produced by the method and contains the dextromethorphan hydrobromide and the guaifenesin solves the problems that the treating effects of the existing similar medicines are mutually antagonistic in the treating process.
Description
Technical field: the present invention relates to a kind of manufacture method that contains the antitussive component and the compound recipe eliminating phlegm and stopping cough medicine of the composition that eliminates the phlegm.
Background technology: coughing, coughing up phlegm is two common big symptoms of respiratory system disease, does not develop into emphysema, bronchiectasis, pulmonary heart disease etc. for a long time more possibly.In etiological treatment, use cough medicine timely and reasonably and expectorant is very important.Compound recipe dromethan preparation is to be the compound cough-relieving and phlegm-eliminating medicine of active ingredient with dextromethorphan hydrobromide and guaifenesin.Dextromethorphan hydrobromide is decided to be over-the-counter medications by U.S. FDA, it is the OTC medicine, be decided to be non-narcotic medicine in the anesthesia meeting in 1961, The World Health Organization (WHO) in 1989 thinks that dextromethorphan hydrobromide is a kind of good cough medicine that replaces codeine, compare with the same dose codeine, the antitussive intensity of dextromethorphan hydrobromide is suitable with it, and does not suppress respiratory center, no addiction does not produce toleration.Guaifenesin is the sputum diluent, oral back stimulates the gastric mucosa Vagal Afferent Fibers, biography is to the oblongata vomiting center, cause mild nausea, the vagus nerve efferent fiber of gas-distribution pipe, bronchus body of gland is propped up in the excitement of reflexive ground again, make glandular secretion increase in trachea, the bronchus, sputum is thinning, thereby is easy to expectoration.Guaifenesin also has certain sterilization antisepsis, and sterilization then can play certain inhibitory or killing effect at pathogenic microorganisms such as the antibacterial that grows in a large number in the sputum, viruses; Anticorrosionly then can protect respiratory mucosa, prevent that retention is corrupt and can alleviate the sputum stench at interior sputum, this is concerning the patient; alleviated the danger of inflammation infection and inflammation diffusion; concerning healthy people on every side, discharge pathogenic microorganism minimizing in the sputum, pathophorous chance also decreases.Analyze from antitussive and expectorant physiological reaction, in antitussive, can suppress the discharge of sputum, can cause cough simultaneously at expectorant, therefore the existing compound cough-relieving and phlegm-eliminating medicine that contains hydrobromic acid dextromethorphan and guaifenesin is mutual antagonism in therapeutic process, so its curative effect is not obvious.
Summary of the invention: the objective of the invention is to develop a kind of manufacture method of eliminating phlegm and stopping cough medicine, the eliminating phlegm and stopping cough medicine that this method is produced has solved the problem of the mutual antagonism that existing similar medicine exists in therapeutic process.The manufacture method of eliminating phlegm and stopping cough medicine of the present invention is that the antitussive component in the eliminating phlegm and stopping cough medicine is made the slow releasing preparation that drug effect continues 8-12 hour, the composition that eliminates the phlegm is formed in the quick releasing formulation that discharges in 1 hour, antitussive component in this medicine is a dextromethorphan hydrobromide, and the composition that eliminates the phlegm is a guaifenesin.The ratio of weight and number of dextromethorphan hydrobromide and guaifenesin is in this medicine: 1: (3-20).Its concrete manufacture method is: the raw material of one, getting following weight ratio: (one) dextromethorphan hydrobromide micropill, and its composition is: dextromethorphan hydrobromide 19-21g, the dextrin 5-6g, starch 15.5-17g, polyvinylpyrrolidone K-300.19-0.21g, the Pulvis Talci 1-1.2g that cross 120 mesh sieves; (2) guaifenesin micropill, its composition is: guaifenesin 95-105g, polyvinylpyrrolidone K-30 0.9-1.1g, Pulvis Talci 5-6g, dextrin 25-30g, starch 75-85g; (3) coating solution, its composition is: ethyl cellulose 10-11.5g, polyvinylpyrrolidone K-30 2-2.4g, diethyl phthalate 2-2.4g, Pulvis Talci 5-6g, 95% ethanol 500-600ml; More than all raw materials make 1000 left and right sides capsules altogether, the heavy 260mg of every capsules, every capsules contains hydrobromic acid dextromethorphan 19-21mg, guaifenesin 95-105mg; Two, technological operation: (1), ball core preparation: the appropriate amount of starch dextrin is placed coating pan, make wetting agent with Diluted Alcohol, the general ball of molding, when ball core circle arrives to a certain degree, and size is taken out when the 24-28 order left and right sides, and drying is 3 hours in 60 ℃ of baking ovens, the ball core of screening 30～24 order sizes, standby; (2), dextromethorphan hydrobromide pastille micropill preparation: get an amount of ball core, Diluted Alcohol liquid with 1% polyvinylpyrrolidone K-30 squirts the ball wicking surface, add a small amount of 120 purpose dextromethorphan hydrobromide medicated powder and Pulvis Talci, make it adhere to the ball wicking surface, so repeated multiple times operation all adds until medicated powder, blow to dry tack free with hot blast, drying is 4 hours in 50 ℃ of baking ovens, filters out 22 orders～18 orders size micropill, and is standby behind the mensuration content; (3), guaifenesin pastille micropill preparation: get an amount of ball core, Diluted Alcohol liquid with 1% polyvinylpyrrolidone K-30 squirts the ball wicking surface, add a small amount of 120 purpose guaifenesin medicated powder and Pulvis Talci, make it adhere to the ball wicking surface, so repeated multiple times operation all adds until medicated powder, blow to dry tack free with hot blast, drying is 4 hours in 50 ℃ of baking ovens, filters out 22 orders-18 order size micropill, and is standby behind the mensuration content; (4), the preparation of coating solution: get ethyl cellulose by each component ratio noted earlier, polyvinylpyrrolidone, diethyl phthalate, Pulvis Talci 95% dissolve with ethanol, mixing is made the solution that ethyl cellulose concentration is 1.5%-2.5%, and is standby; (5), the preparation of dextromethorphan hydrobromide sustained-release micropill: a certain amount of dextromethorphan hydrobromide pastille micropill is placed coating pan, carry out spray coating with coating solution, until micropill weightening finish about 8%, drying is standby in 45 ℃ of baking ovens; (6), the preparation of dextromethorphan hydrobromide and guaifenesin slow releasing capsule: the slow-release micro-pill that will contain hydrobromic acid dextromethorphan 19-21mg, guaifenesin pastille micropill 95-105mg and an amount of neutral micropill, pack into behind the mix homogeneously in No. 1 capsule, promptly.The present invention makes slow-release micro-pill and fast release micropill respectively with dextromethorphan hydrobromide and guaifenesin, forms capsule then.Above-mentioned slow-release micro-pill and fast release micropill are microgranule or spheroidal pelle.The biological half-life of dextromethorphan hydrobromide is 3-4 hour, and its duration of efficacy is short, need frequently take medicine.The present invention is designed to day the long-acting slow-release preparation of clothes 2 times with dextromethorphan hydrobromide, and it is particularly useful then to reduce the patient that the trouble that patient repeatedly takes medicine, particularly night take medicine, and takes once before sleeping, can get sleep peacefully whole night in good health.In addition,, make blood drug level steadily lasting, reduced toxicity, make that medication is convenient, effective, safety because control has delayed the speed of release and absorption of dextromethorphan hydrobromide.In addition, the capsule of forming by the dextromethorphan hydrobromide sustained-release micropill, belong to single dose and disperse dosage form, has more outstanding galenic pharmacy meaning with respect to slow releasing tablet, oral back slow-release micro-pill extensively is scattered in the gastrointestinal tract, it is minimum " to collapse and release phenomenon " extent of injury that causes, to the safety coefficient height of human body, and also relatively little to gastrointestinal tract mucous local excitation.In addition, the scientific matching of different rate of release micropills in the capsule can be designed the comparatively ideal plasma concentration curve that meets physiological law more that is better than slow releasing tablet, better brings into play curative effect.The present invention makes guaifenesin the fast release micropill of rapid release, its mechanism is: 1, this medicine has its specific position-stomach that eliminates the phlegm, it is by stimulating the vagus nerve on the gastric mucosa to reach its phlegm-dispelling functions, therefore be unsuitable for and make the slow releasing preparation that all-digestive tract discharges absorption, otherwise will reduce its bioavailability.And according to the literature, and the pharmacological evaluation of guaifenesin proves, excises animal stomach vagus nerve afferent limb or intravenous administration in advance, phlegm-dispelling functions all do not occur.2, analyze from antitussive and expectorant physiological reaction, these two kinds of reactions occur simultaneously, it is mutual antagonism, and allow guaifenesin bring into play drug effect earlier, one eliminating the phlegm of the property crossed then can be avoided this contradiction dexterously, and owing to discharged a kind of stimulating factor-expectorant of cough, then the antitussive to dextromethorphan hydrobromide plays collaborative effect.Therefore, guaifenesin is made the fast release micropill of rapid onset in 1 hour in the present invention, has more rational clinical pharmacology, pharmaceutics meaning.The medicine that the present invention produced is used for the treatment of cough, the abundant expectoration that diseases such as upper respiratory tract infection, acute bronchitis cause, prescription contains the effective cough-relieving of hydrobromic acid dextromethorphan, and its slow releasing preparation of making can make drug effect continue 8-12 hour; Other is furnished with the guaifenesin quick releasing formulation, can remove sticking expectorant fast, makes trachea unobstructed.
The specific embodiment: the ratio of weight and number of dextromethorphan hydrobromide and guaifenesin is 1 in the medicine of present embodiment: (4-6).Dextromethorphan hydrobromide is made the slow-release micro-pill that drug effect continues to continue in 8-12 hour release, and guaifenesin is made the fast release micropill that discharges in 1 hour.
Its manufacture method is: one, get crude drug by following weight ratio: the weight ratio of contained each raw material of (one) dextromethorphan hydrobromide micropill is: dextromethorphan hydrobromide (crossing 120 mesh sieves) 19-21g, dextrin 5-6g, starch 15.5-17g, polyvinylpyrrolidone K-30 (PVP) 0.19-0.21g, Pulvis Talci 1-1.2g; (2) weight ratio of contained each raw material of guaifenesin micropill: guaifenesin 95-105g, polyvinylpyrrolidone K-30 (PVP) 0.9-1.1g, Pulvis Talci 5-6g, dextrin 25-30g, starch 75-85g; (3) weight ratio of the contained raw material of coating solution: ethyl cellulose 10-11.5g, polyvinylpyrrolidone K-30 (PVP) 2-2.4g, diethyl phthalate 2-2.4g, Pulvis Talci 5-6g, 95% ethanol 500-600ml, more than all raw materials make 1000 left and right sides capsules altogether.The heavy 260mg of every capsules, every capsules contains hydrobromic acid dextromethorphan 19-21mg, guaifenesin 95-105mg;
Two, technological operation: 1, ball core preparation: the appropriate amount of starch dextrin is placed coating pan, make wetting agent, the general ball of molding with Diluted Alcohol, arrive to a certain degree when the ball core is round, and size is taken out when the 24-28 order left and right sides, drying is 3 hours in 60 ℃ of baking ovens, and the ball core of screening 30～24 order sizes is standby.2, dextromethorphan hydrobromide pastille micropill preparation: get an amount of ball core, Diluted Alcohol liquid with 1% polyvinylpyrrolidone K-30 squirts the ball wicking surface, add a small amount of 120 purpose dextromethorphan hydrobromide medicated powder and Pulvis Talci, make it adhere to the ball wicking surface, so repeated multiple times operation all adds until medicated powder, blow to dry tack free with hot blast, drying is 4 hours in 50 ℃ of baking ovens, filters out 22 orders～18 orders size micropill, and is standby behind the mensuration content.3, guaifenesin pastille micropill preparation: get an amount of ball core, Diluted Alcohol liquid with 1% polyvinylpyrrolidone K-30 squirts the ball wicking surface, add a small amount of 120 purpose guaifenesin medicated powder and Pulvis Talci, make it adhere to the ball wicking surface, so repeated multiple times operation all adds until medicated powder, blow to dry tack free with hot blast, drying is 4 hours in 50 ℃ of baking ovens, filters out 22 orders-18 order size micropill, and is standby behind the mensuration content.4, the preparation of coating solution: get ethyl cellulose in the prescription ratio, polyvinylpyrrolidone, diethyl phthalate, Pulvis Talci 95% dissolve with ethanol, mixing is made the solution that ethyl cellulose concentration is 1.5%-2.5%, and is standby.5, the preparation of dextromethorphan hydrobromide sustained-release micropill: a certain amount of dextromethorphan hydrobromide pastille micropill is placed coating pan, carry out spray coating with coating solution, until micropill weightening finish about 8%, dry, standby in 45 ℃ of baking ovens.6, the beautiful more preparation of slow releasing capsule: will contain the slow-release micro-pill of hydrobromic acid dextromethorphan 19-21mg, the fast release micropill of guaifenesin 95-105mg and an amount of neutral micropill are in No. 1 capsule of packing into behind the mix homogeneously, promptly.
Utilize certain proportion of starch and dextrin molding, make a certain size ball core, easy-formation, and dry back hardness is good.The ball core that reuse is selected by dry sieve is made mould, and principal agent is adhered on its surface, makes micropill, and the micropill of making like this wraps certain thickness extended release coatings film again, slow-release micro-pill, the clothing film mainly is made up of ethyl cellulose and polyvinylpyrrolidone.Ethyl cellulose is water insoluble, be the extensive filmogen that adopts of film controlling agent, polyvinylpyrrolidone not only can be made coating material, and easily molten in water, so also can make porogen, these two kinds of materials all are dissolved in ethanol, it is become the homogeneous state, by packaging technique, Jiang Qibao invests the micropill surface, promptly forms good release membranes after the drying.The micropill of coating is once run into aqueous solution, and the polyvinylpyrrolidone dissolving in the clothing film forms little duct, and medicine is discharged in the gastro-intestinal Fluid according to certain rules by osmosis, plays slow releasing function.Diethyl phthalate is the suitableeest plasticizer of ethyl cellulose, and concentration can obtain optimum efficiency in 20% of plasticized thing amount.Pulvis Talci is an antitack agent, can improve the adhesion phenomenon between the micropill in the coating process, and its consumption is about 1% of a coating solution volume.The consumption of porogen polyvinylpyrrolidone, we rule of thumb are chosen to be about 20% of filmogen ethyl cellulose.
In the above-mentioned manufacture method, under optimised process prescription condition, the heal drug release determination result of slow releasing capsule of five batches of U.S.As: prepare five batches of dextromethorphan hydrobromide sustained-release micropills and guaifenesin fast release micropill respectively by the optimised process prescription, respectively by labelled amount 100% encapsulated after, measure release, see Table 1, table 2.
Table 1 five batch sample dextromethorphan hydrobromide release results (n=6)
| Criticize and discharge number degree (%) | Time (h) | |||||||
| 1 | 2 | 3 | 4 | 6 | 8 | 10 | 12 | |
| 1 | 21.6 | 41.4 | 54.9 | 62.7 | 72.5 | 82.0 | 90.7 | 96.9 |
| 2 | 20.8 | 40.9 | 54.2 | 62.0 | 71.9 | 81.4 | 90.0 | 96.1 |
| 3 | 22.5 | 42.2 | 55.6 | 63.3 | 73.3 | 82.7 | 91.5 | 97.6 |
| 4 | 21.8 | 41.5 | 54.8 | 62.8 | 72.7 | 82.1 | 90.9 | 97.3 |
| 5 | 22.8 | 42.5 | 56.0 | 63.9 | 73.6 | 83.3 | 92.4 | 98.6 |
| On average | 21.9 | 41.7 | 55.1 | 62.9 | 72.8 | 82.3 | 91.1 | 97.3 |
| ±SD | 0.79 | 0.64 | 0.63 | 0.65 | 0.67 | 0.72 | 0.90 | 0.92 |
The release result (n=6) of table 2 five batch sample guaifenesins
| Put (h) degree between (%) when releasing | Lot number | ||||
| 1 | 2 | 3 | 4 | 5 | |
| 1 | 92.3 | 92.9 | 92.5 | 99.2 | 96.3 |
The pharmacodynamic experiment summary:
1, case standard: have 60 of the upper respiratory tract infection of cough and expectoration symptom and acute and chronic bronochitic's outpatient service or inpatients.
2, administrated method: patient is divided into two groups, and every group 30 people takes medicine of the present invention for one group, each 2 of each 3, placebo, and a twice-daily is oral, the 5-7 day course of treatment.Another group is taken control drug heal each 2 of U.S. sheet, each 3 of placebo, and 3-4 time on the one oral, the 5-7 day course of treatment.
3, drug combination: look the state of an illness and can merge use antibiotics (amoxicillin or Roxithromycin) and antipyretic.
4, observation index: sings and symptoms: write down the character of cough, amount of expectoration, expectorant and complexity and pulmonary rale situation that productive cough goes out every day.Cough symptom classification: do not have cough (-); Slight cough (+): be interrupted cough, do not influence orthobiosis and study; Moderate cough (++): between slight and severe; The severe cough (+++) the frequent or apasm of coughing of cough round the clock, influence work and sleep.Amount of expectoration split pole: no expectorant (-); Amount of expectoration few (+): expectoration 10-50ml round the clock; In the amount of expectoration (++): expectoration 51-100ml round the clock; Amount of expectoration many (+++): round the clock more than the expectoration 100ml.
5, efficacy evaluation: clinic control: finish the course of treatment, the cough and expectoration symptom transfers (-) to by (+++), and sign disappears.Produce effects: finish the course of treatment, the cough and expectoration symptom transfers (+) to by (+++), or transfers (-) to by (++), and sign is improved.Take a turn for the better: finish the course of treatment, and the cough and expectoration symptom transfers (++) to by (+++), or transfers (+) to by (++), or transfers (-) to by (+), and sign is improved not obvious.Invalid: the cough and expectoration sings and symptoms does not have improvement or increases the weight of.
The Comparison of therapeutic table:
| Medicine | The example number | Curative effect (routine number) | Effective percentage | P | |||
| Clinic control | Produce effects | Take a turn for the better | Invalid | ||||
| Medicine of the present invention | 30 | 19 | 10 | 1 | 0 | 96.7％ | ＜0.05 |
| The U.S. sheet of healing | 30 | 17 | 6 | 7 | 0 | 76.7％ | |
Effective percentage=(clinic control+produce effects)/sum
Claims (1)
1, a kind of manufacture method of eliminating phlegm and stopping cough medicine is characterized in that the antitussive component in the eliminating phlegm and stopping cough medicine is made the slow releasing preparation that drug effect continues 8-12 hour, and described antitussive component is a dextromethorphan hydrobromide; The composition that eliminates the phlegm is formed in the quick releasing formulation that discharges in 1 hour, and the described composition that eliminates the phlegm is a guaifenesin; The ratio of weight and number of dextromethorphan hydrobromide and guaifenesin is 1: 3～1: 20 in the medicine noted earlier; Its concrete manufacture method is:
One, get the raw material of following weight ratio:
(1) dextromethorphan hydrobromide micropill, its composition is: dextromethorphan hydrobromide 19-21g, the dextrin 5-6g, starch 15.5-17g, polyvinylpyrrolidone K-30 0.19-0.21g, the Pulvis Talci 1-1.2g that cross 120 mesh sieves;
(2) guaifenesin micropill, its composition is: guaifenesin 95-105g, polyvinylpyrrolidone K-30 0.9-1.1g, Pulvis Talci 5-6g, dextrin 25-30g, starch 75-85g;
(3) coating solution, its composition is: ethyl cellulose 10-11.5g, polyvinylpyrrolidone K-302-2.4g, diethyl phthalate 2-2.4g, Pulvis Talci 5-6g, 95% ethanol 500-600ml;
More than all raw materials make 1000 left and right sides capsules altogether, the heavy 260mg of every capsules, every capsules contains hydrobromic acid dextromethorphan 19-21mg, guaifenesin 95-105mg;
Two, technological operation:
(1), ball core preparation: the appropriate amount of starch dextrin is placed coating pan, make wetting agent, the general ball of molding with Diluted Alcohol, arrive to a certain degree when the ball core is round, and size is taken out when the 24-28 order left and right sides, drying is 3 hours in 60 ℃ of baking ovens, and the ball core of screening 30～24 order sizes is standby;
(2), dextromethorphan hydrobromide pastille micropill preparation: get an amount of ball core, Diluted Alcohol liquid with 1% polyvinylpyrrolidone K-30 squirts the ball wicking surface, add a small amount of 120 purpose dextromethorphan hydrobromide medicated powder and Pulvis Talci, make it adhere to the ball wicking surface, so repeated multiple times operation all adds until medicated powder, blow to dry tack free with hot blast, drying is 4 hours in 50 ℃ of baking ovens, filters out 22 orders～18 orders size micropill, and is standby behind the mensuration content;
(3), guaifenesin pastille micropill preparation: get an amount of ball core, Diluted Alcohol liquid with 1% polyvinylpyrrolidone K-30 squirts the ball wicking surface, add a small amount of 120 purpose guaifenesin medicated powder and Pulvis Talci, make it adhere to the ball wicking surface, so repeated multiple times operation all adds until medicated powder, blow to dry tack free with hot blast, drying is 4 hours in 50 ℃ of baking ovens, filters out 22 orders-18 order size micropill, and is standby behind the mensuration content;
(4), the preparation of coating solution: get ethyl cellulose by each component ratio noted earlier, polyvinylpyrrolidone, diethyl phthalate, Pulvis Talci 95% dissolve with ethanol, mixing is made the solution that ethyl cellulose concentration is 1.5%-2.5%, and is standby;
(5), the preparation of dextromethorphan hydrobromide sustained-release micropill: a certain amount of dextromethorphan hydrobromide pastille micropill is placed coating pan, carry out spray coating with coating solution, until micropill weightening finish about 8%, drying is standby in 45 ℃ of baking ovens;
(6), the preparation of dextromethorphan hydrobromide and guaifenesin slow releasing capsule: the slow-release micro-pill that will contain hydrobromic acid dextromethorphan 19-21mg, guaifenesin pastille micropill 95-105mg and an amount of neutral micropill, pack into behind the mix homogeneously in No. 1 capsule, promptly.
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|---|---|---|---|
| CN 03100532 CN1224382C (en) | 2003-01-20 | 2003-01-20 | Method for preparing medicine for relieving cough and reducing sputum |
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|---|---|---|---|
| CN 03100532 CN1224382C (en) | 2003-01-20 | 2003-01-20 | Method for preparing medicine for relieving cough and reducing sputum |
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| CN1437935A CN1437935A (en) | 2003-08-27 |
| CN1224382C true CN1224382C (en) | 2005-10-26 |
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Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN1315475C (en) * | 2005-11-04 | 2007-05-16 | 浙江万联药业有限公司 | Soft capsule composition of compound cough-relieving and phlegm-eliminating medicine |
| CN1994285B (en) * | 2006-01-04 | 2011-03-16 | 上海医药工业研究院 | Sustained release micro-pellet of guaifenesin and preparation process thereof |
| CN101084898B (en) * | 2006-06-06 | 2011-03-16 | 朱志宏 | Compound chemical medicine with antitussive and phlegm-eliminating action and its preparation technology |
| CN102219737B (en) * | 2011-04-28 | 2012-12-12 | 江苏宝众宝达药业有限公司 | Preparation process for key intermediate 1-(4-methoxyl)benzyl-1,2,3,4,5,6,7,8-octahydro isoquinoline (mixed isomer) of dextromethorphan hydrobromide serving as cough relieving medicine |
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