CN101288658A - Compound ambroxol sustained-release drop pills and preparation method thereof - Google Patents
Compound ambroxol sustained-release drop pills and preparation method thereof Download PDFInfo
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- CN101288658A CN101288658A CNA2008101118664A CN200810111866A CN101288658A CN 101288658 A CN101288658 A CN 101288658A CN A2008101118664 A CNA2008101118664 A CN A2008101118664A CN 200810111866 A CN200810111866 A CN 200810111866A CN 101288658 A CN101288658 A CN 101288658A
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Abstract
The invention discloses a drug combination oral pill preparation which takes Ambroxol hydrochloride and Clenbuterol hydrochloride as drug active ingredients and is used for relieving cough, dissolving phlegm and relieving asthma. The invention aims at overcoming the defects of the present therapeutic drug preparation for relieving cough, dissolving phlegm and relieving asthma and providing the drug combination preparation, namely, a compound Ambroxol sustained-release pill preparation which is characterized by high bioavailability, rapid effect, less times of medicine taking for patients, long acting time, less toxic and side effect and convenient application and carrying for patients and medical workers. The compound Ambroxol sustained-release pill related by the invention uses Ambroxol hydrochloride and Clenbuterol hydrochloride as drug active ingredients and is prepared by mixing the active ingredients with a hydrophilic framework material and a hydrophobic framework material that are used as substrate.
Description
Technical field
The present invention relates to a kind of medicine that is used for cough-relieving, reduces phlegm, relievings asthma, particularly the pharmaceutically suitable carrier that mixes as substrate with hydrophilic framework material and hydrophobicity framework material is a kind of oral formulations that active constituents of medicine is prepared from ambroxol hydrochloride and clenbuterol hydrochloride.
Background technology
Ambroxol is a bromhexine metabolite in vivo, has the phlegm dissolving effect, thereby can make the how sticking fibrous fracture dilution sputum of apoplexy due to phlegm, and reduces expectorant viscosity by suppressing the synthetic of glycoprotein, makes expectorant be convenient to discharge.Be applicable to the thick sputum that acute and chronic respiratory tract disease (as acute and chronic bronchitis, bronchial asthma, bronchiectasis, pulmonary tuberculosis etc.) causes, dys-expectoration etc.
Chronic obstructive pulmonary disease (COPD) is the respiratory system commonly encountered diseases, is principal character with the airway obstruction that can not reverse fully, and Chang Fanfu morbidity and carrying out property increase the weight of.At present still do not have special Therapeutic Method and can contain its development.The main pathological characters of COPD is exactly the flow limitation due to the airway inflammation.Airway inflammation causes the swelling of air flue mucosa, oozes out and increases, and influences patient's ventilatory function.
Ambroxol hydrochloride is a kind of efficient mucolytic agent, also has antiinflammatory, antioxidation and the synthetic effect of promotion alveolar surfactant simultaneously.Tan Lijie etc. discover that ambroxol hydrochloride has protective effect to the decline of PS due to the thoracic surgery.Zhang Lei etc. then find to add immediately puerperal effectively prevention of preterm birth youngster respiratory distress syndrome of usefulness ambroxol hydrochloride (intravenously administrable).Ipratropium bromide can reduce airway secretions by its anticholinergic effect, has the effect of expansion bronchus simultaneously concurrently.The essential drugs of COPD treatment has been classified it as in whole world COPD proposal (GOLD).
At present existing in the world about ambroxol hydrochloride and clenbuterol hydrochloride being formed jointly the report of compound preparation, the compound ambroxol sheet of being formed by expectorant ambroxol hydrochloride of new generation and powerful anti-asthmatic clenbuterol hydrochloride, can bring into play expelling phlegm for arresting cough and antasthmatic effect simultaneously, be used for cough-relieving, reduce phlegm, relieving asthma, can play the effect that mutual coordination is gone forward side by side.
Clenbuterol is the beta 2 receptor agonist, and its lax bronchial smooth muscle effect is strong and lasting.Its bronchiectatic activity is about 100 times of albuterol, so dosage is minimum.Each oral this medicine 30 μ g of asthmatic patient can obviously increase per second vital capacity (FEV1.0) and maximum expiratory flow rate (FEF), reduce airway resistance.This medicine still can increase the bronchus ciliary movement and promote sputum to discharge, and this also helps to improve the curative effect of relievining asthma.This medicine is better than 100 times of salbutamols for bronchial dilating effect, strengthens bronchus cilia activity ability in addition, promotes sputum to discharge, and helps to improve the curative effect of relievining asthma, and has rapid-action, the characteristics such as length, suitable dose is little, toxic and side effects is low of holding time
[1～3]
The existing Korea S Bochringer Ingelheiim Pharma KG company development abroad of compound ambroxol tablet, every ambroxol-hydrochloride-containing 30mg, hydrochloric clenbuterol 20 μ g.Domestic also do not have the manufacturer that gets the Green Light so far, and compound ambroxol sustained-release drop pills was not met any relevant report as yet.
Owing to reasons such as technologies of preparing, after taking, the oral formulations of most drug exists all that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, medicining times is many, blood drug level is not steady, problems such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.Dropping pill formulation is as a kind of new pharmaceutical preparation, the above many disadvantages that can overcome conventional oral formulations to a great extent and had.
Summary of the invention
Purpose of the present invention, be to replenish the deficiency of the existing medicine preparation that is used for cough-relieving, reduces phlegm, relievings asthma, provide a kind of bioavailability height to extensive patients and medical personnel, quick produce effects, patient's medicining times is few, the time of proving effective is long, and toxic and side effects is littler, and uses drug combination preparation easy to carry---the compound ambroxol sustained-release drop pills preparation.
Of the present invention and compound ambroxol sustained-release drop pills be to be active constituents of medicine with ambroxol hydrochloride and clenbuterol hydrochloride, a kind of oral slow-releasing preparation that is prepared from as pharmaceutically suitable carrier of substrate with the mixture of hydrophilic framework material and easypro aqueous framework material.Be prepared by the following technical solutions, can obtain compound ambroxol sustained-release drop pills involved in the present invention:
[preparation method]
1. fill a prescription
1.1 ambroxol hydrochloride
1.1.1 English name---Ambroxol Hydrochloride, Chinese phonetic alphabet Yansuan Anxiusuo;
1.1.2 medicine another name---Mucosolvan, Lanbroxol, NA-872, ammonia bromohydrin, mucosolvan, shellfish Lay sheet, Ambroxol Hydrochloride;
1.1.3 chemical name---chemical name is trans 4-[(2-amino-3,5 two bromo-phenyl) methyl-amino] the Hexalin hydrochlorate;
1.1.4 chemical structural formula
1.2 clenbuterol hydrochloride
1.2.1 English name---Clenbuterol Hydrochloride, the Chinese phonetic alphabet: Yansuan Kelunteluo;
1.2.2 medicine another name---clenbuterol, clenbuterol hydrochloride, Celenbuterol, Clenbuterol, NAB-365;
1.2.3 chemical name---chemistry α by name-[(uncle's fourth amino) methyl]-4-amino-3,5-dichlorbenzyl alcohol hydrochlorate.
1.2.4 chemical structural formula
2. substrate: hydrophilic framework material and hydrophobicity framework material are formed:
2.1 hydrophilic framework material: the mixture of one or more in polyethylene glycol 1500, Macrogol 4000, polyethylene glycol 6000, polyvinylpyrrolidone, the above-mentioned pharmaceutically suitable carrier of microcrystalline Cellulose;
2.2 hydrophobicity framework material: the mixture of one or more in stearic acid, cohune eleostearic acid, glyceryl monostearate and the above-mentioned pharmaceutically suitable carrier of octadecanol;
3. component constitutes: calculate according to percentage by weight, compound ambroxol sustained-release drop pills involved in the present invention is made up of the substrate of 10-40% ambroxol hydrochloride, 0.006-0.026% clenbuterol hydrochloride and 60-90%, and substrate comprises 40-85% hydrophilic framework material and 10-30% hydrophobicity framework material composition.
4. preparation method: take by weighing described hydrophilic framework material and hydrophobicity framework material earlier, place the heating container internal heating and stir and make it to dissolve, the ambroxol hydrochloride and the clenbuterol hydrochloride that add corresponding proportion, fully stir, under heat-retaining condition, the medicinal liquid of fusion or mixing is splashed in the condensation column that fills condensed fluid, and take out the back that is shaped, promptly.
In the above-mentioned preparation method, the temperature during described heating and melting is 55 ℃～80 ℃.
In the above-mentioned preparation method, described condensed fluid is greater than 100
#Dimethicone or liquid paraffin.
In the above-mentioned preparation method, the temperature on described condensed fluid top is 25 ℃～50 ℃, and the temperature of bottom is-2 ℃～10 ℃.
[beneficial effect]
The compound ambroxol tablet that utilizes existing conventional oral formulations technology to obtain can be brought into play expelling phlegm for arresting cough and antasthmatic effect simultaneously, is used for cough-relieving, reduces phlegm, relievings asthma, and can play the effect that mutual coordination is gone forward side by side.The oral formulations that on curative effect, is better than each folk prescription.The development of external existing Korea S Bochringer Ingelheiim Pharma KG company, domestic also do not have the manufacturer who gets the Green Light so far, and compound ambroxol dripping pill was not met any relevant report as yet.
Owing to reasons such as technologies of preparing, after taking, the oral formulations of most drug exists all that dissolve scattered time limit is long, dissolution is low, absorption is relatively poor, medicining times is many, blood drug level is not steady, problems such as liver sausage first pass effect and bioavailability are lower, thereby influence the performance of drug effect, also directly affect therapeutic effect.Dropping pill formulation is as a kind of new pharmaceutical preparation, the above many disadvantages that can overcome conventional oral formulations to a great extent and had.
Compound ambroxol sustained-release drop pills involved in the present invention is compared with the compound ambroxol tablet, and following beneficial effect is arranged:
1. compound ambroxol sustained-release drop pills involved in the present invention; utilize hydrophilic framework material and hydrophobicity framework material as substrate; make solid dispersion with ambroxol hydrochloride and clenbuterol hydrochloride; making medicine be molecule, colloid or microcrystalline state is scattered in the substrate; the total surface area of medicine increases, and because of substrate has the hydrophilic framework material, medicine is had wetting action; can make that medicine is rapidly molten to loose into microgranule or solution, thereby make the dissolving of medicine and absorb and accelerate.Thereby improved bioavailability, brought into play effects such as efficient, quick-acting, had the hydrophobicity framework material because of substrate again, made medicine time of proving effective long, patient's medicining times is few, and medicine has slow release release effect.
Compare with the administering mode of traditional oral formulations, exist essential distinction.Sustained-release dropping pill with the solid dispersion technology preparation can adopt oral and sublingual administration, and effective ingredient is fully contacted with mucomembranous surface, absorbs by mucomembranous epithelial cell, directly enters blood circulation.Owing to directly enter blood circulation without gastrointestinal tract and liver, avoided first pass effect effectively, also avoided gastrointestinal irritation, thereby it is rapid to have an onset, bioavailability height, characteristics such as side effect is little, and medication is convenient.
2. compound ambroxol sustained-release drop pills involved in the present invention, volume is little, and is in light weight, is convenient to carry.After containing entrance cavity, contact promptly with saliva and to dissolve rapidly, and absorb by oral mucosa, and the influence of not taken food, promptly all can containing take after meal ante cibum.
3. production technology, the equipment of preparation drop pill are simple, easy to operate, the automaticity height, and labor intensity is low, the production efficiency height.Workshop does not have dust simultaneously, helps labor protection and environmental protection yet.
The preparation drop pill need adopt high-tech means and equipment, and active constituents of medicine is uniformly dispersed in substrate, and dosage is accurate, and the ball method of double differences is different little than tablet, and production cost is with below 50% of kind tablet.
4. compound ambroxol sustained-release drop pills involved in the present invention is by after the heating of solid drugs active component and substrate, being melt into liquid state, splashes into to make in the not miscible condensed fluid.Therefore, the stability of drug height, not facile hydrolysis, oxidation, and the operation be under liquid state, to carry out, no dust pollution is not subject to the influence of crystal formation, thereby has guaranteed the quality of medicine, has increased stability.
In sum, make compound ambroxol sustained-release drop pills involved in the present invention have the advantage of triple effect (quick-acting, efficient, long-acting), three little (taking dose is little, toxicity is little, side effect little), five convenience (convenient for production, store convenience, convenient transportation, easy to carry, easy to use).
Simultaneously two kinds of active constituents of medicine can play the effect of cooperative compensating in this compound preparation, have saved the trouble of taking two kinds of a kind of symptoms of Drug therapy simultaneously, have not only improved therapeutic effect, also take to the patient and have brought convenience.
The specific embodiment
Now, be further described with several groups of preferred specific embodiments with regard to compound ambroxol sustained-release drop pills of the present invention.
First group:
In gross weight 100g, take by weighing substrate PEG6000 20%, PEG4000 40%, stearic acid 14%, octadecanol 6%, raw material ambroxol hydrochloride 20%, raw material clenbuterol hydrochloride 0.007%; Place heating container internal heating and stirring to make it to dissolve substrate, the ambroxol hydrochloride and the clenbuterol hydrochloride that add corresponding proportion, fully stir, under heat-retaining condition, the medicinal liquid of fusion or mixing is splashed in the condensation column that fills dimethicone, and wherein, the temperature during heating and melting is 55 ℃, the temperature on condensed fluid top is 30 ℃, and the temperature of bottom is-2 ℃; The back taking-up is shaped.
Products obtained therefrom, 2 hours cumulative release percentage rate are that 32～53%, 6 hours cumulative release percentage rate are that 60～77%, 10 hours cumulative release percentage rate are 78～93%, and hardness is better, and roundness is better.
Second group:
In gross weight 100g, take by weighing substrate PEG6000 5%, PEG4000 35%, and PEG1500 15%, stearic acid 20%, glyceryl monostearate 10%, raw material ambroxol hydrochloride 15%, raw material clenbuterol hydrochloride 0.006%; Place heating container internal heating and stirring to make it to dissolve substrate, the ambroxol hydrochloride and the clenbuterol hydrochloride that add corresponding proportion, fully stir, under heat-retaining condition, the medicinal liquid of fusion or mixing is splashed in the condensation column that fills liquid paraffin, and wherein, the temperature during heating and melting is 60 ℃, the temperature on condensed fluid top is 30 ℃, and the temperature of bottom is-1 ℃; The back taking-up is shaped.
Products obtained therefrom, 2 hours cumulative release percentage rate are that 37%～48%, 6 hours cumulative release percentage rate are that 56～79%, 10 hours cumulative release percentage rate are 79～91%, and hardness is better, and roundness is better.
The 3rd group:
In gross weight 100g, take by weighing substrate PEG1500 21%, PEG6000 20%, polyvinylpyrrolidone 9%, glyceryl monostearate 13%, cohune eleostearic acid 7%, raw material ambroxol hydrochloride 30%, raw material clenbuterol hydrochloride 0.026%; Place heating container internal heating and stirring to make it to dissolve substrate, the ambroxol hydrochloride and the clenbuterol hydrochloride that add corresponding proportion, fully stir, under heat-retaining condition, the medicinal liquid of fusion or mixing is splashed in the condensation column that fills liquid paraffin, and wherein, the temperature during heating and melting is 60 ℃, the temperature on condensed fluid top is 45 ℃, and the temperature of bottom is 8 ℃; The back taking-up is shaped.
Products obtained therefrom, 2 hours cumulative release percentage rate are that 41%～59%, 6 hours cumulative release percentage rate are that 65～83%, 10 hours cumulative release percentage rate are 86～95%, and hardness is better, and roundness is better.
The 4th group:
In gross weight 100g, take by weighing substrate PEG4000 40%, PEG6000 10%, stearic acid 20%, octadecanol 5%, raw material ambroxol hydrochloride 25%, raw material clenbuterol hydrochloride 0.010%; Place heating container internal heating and stirring to make it to dissolve substrate, the ambroxol hydrochloride and the clenbuterol hydrochloride that add corresponding proportion, fully stir, under heat-retaining condition, the medicinal liquid of fusion or mixing is splashed in the condensation column that fills dimethicone, and wherein, the temperature during heating and melting is 80 ℃, the temperature on condensed fluid top is 35 ℃, and the temperature of bottom is 5 ℃; The back taking-up is shaped.
Products obtained therefrom, 2h cumulative release percentage rate is 32%～53%, and 6h cumulative release percentage rate is 60～81%, and 10h cumulative release percentage rate is 79～90%,, hardness is better, and roundness is better.
The 5th group:
In gross weight 100g, take by weighing substrate PEG1500 15%, PEG4000 35%, and PEG6000 10%, stearic acid 10%, cohune eleostearic acid 5%, raw material ambroxol hydrochloride 25%, raw material clenbuterol hydrochloride 0.008%; Place heating container internal heating and stirring to make it to dissolve substrate, the ambroxol hydrochloride and the clenbuterol hydrochloride that add corresponding proportion, fully stir, under heat-retaining condition, the medicinal liquid of fusion or mixing is splashed in the condensation column that fills dimethicone, and wherein, the temperature during heating and melting is 55 ℃, the temperature on condensed fluid top is 40 ℃, and the temperature of bottom is 10 ℃; The back taking-up is shaped.
Products obtained therefrom, 2h cumulative release percentage rate is 38%～65%, and 6h cumulative release percentage rate is 64～88%, and 10h cumulative release percentage rate is 79～96%, and hardness is better, and roundness is better.
The 6th group:
In gross weight 100g, take by weighing substrate PEG4000 40%, PEG1500 10%, stearic acid 10%, glyceryl monostearate 10%, cohune eleostearic acid 3%, raw material ambroxol hydrochloride 27%, raw material clenbuterol hydrochloride 0.009%; Place heating container internal heating and stirring to make it to dissolve substrate, the ambroxol hydrochloride and the clenbuterol hydrochloride that add corresponding proportion, fully stir, under heat-retaining condition, the medicinal liquid of fusion or mixing is splashed in the condensation column that fills dimethicone, and wherein, the temperature during heating and melting is 60 ℃, the temperature on condensed fluid top is 25 ℃, and the temperature of bottom is 5 ℃; The back taking-up is shaped.
Products obtained therefrom, 2h cumulative release percentage rate is 33%～56%, and 6h cumulative release percentage rate is 69～83%, and 10h cumulative release percentage rate is 83～92%, and hardness is better, and roundness is better.
The 7th group:
In gross weight 100g, take by weighing substrate PEG4000 30%, polyvinylpyrrolidone 5%, microcrystalline Cellulose 15%, stearic acid 20%, cohune eleostearic acid 7%, octadecanol 3%, raw material ambroxol hydrochloride 20%, raw material clenbuterol hydrochloride 0.02%; Place heating container internal heating and stirring to make it to dissolve substrate, the ambroxol hydrochloride and the clenbuterol hydrochloride that add corresponding proportion, fully stir, under heat-retaining condition, the medicinal liquid of fusion or mixing is splashed in the condensation column that fills dimethicone, and wherein, the temperature during heating and melting is 70 ℃, the temperature on condensed fluid top is 55 ℃, and the temperature of bottom is 8 ℃; The back taking-up is shaped.
Products obtained therefrom, 2h cumulative release percentage rate is 36%～64%, and 6h cumulative release percentage rate is 75～86%, and 10h cumulative release percentage rate is 81～90%, and hardness is better, and roundness is better.
Claims (5)
1. compound ambroxol sustained-release drop pills and preparation method thereof, by active constituents of medicine ambroxol hydrochloride, clenbuterol hydrochloride is raw material, mixes a kind of oral formulations that the pharmaceutically suitable carrier as substrate is prepared from hydrophilic framework material and hydrophobicity framework material.Wherein:
1.1 described hydrophilic framework material: the mixture of one or more in polyethylene glycol 1500, Macrogol 4000, polyethylene glycol 6000, polyvinylpyrrolidone, the above-mentioned pharmaceutically suitable carrier of microcrystalline Cellulose;
1.2 described hydrophobicity framework material: the mixture of one or more in stearic acid, cohune eleostearic acid, glyceryl monostearate and the above-mentioned pharmaceutically suitable carrier of octadecanol.
2. according to the described compound ambroxol sustained-release drop pills preparation method of claim 1, it is characterized in that: be prepared from by following method:
2.1. component constitutes: calculate according to percentage by weight, compound ambroxol sustained-release drop pills involved in the present invention is made up of the substrate of 10-40% ambroxol hydrochloride, 0.006-0.026% clenbuterol hydrochloride and 60-90%, and substrate comprises 40-85% hydrophilic framework material and 10-30% hydrophobicity framework material;
2.2 preparation method: take by weighing described hydrophilic framework material and hydrophobicity framework material earlier, place the heating container internal heating and stir and make it to dissolve, the ambroxol hydrochloride and the clenbuterol hydrochloride that add corresponding proportion, fully stir, under heat-retaining condition, the medicinal liquid of fusion or mixing is splashed in the condensation column that fills condensed fluid, and take out the back that is shaped, promptly.
3. according to the described preparation method of claim 2, it is characterized in that: the temperature during described heating and melting is 55 ℃～80 ℃.
4. according to the described preparation method of claim 2, it is characterized in that: described condensed fluid is greater than 100
#Dimethicone or liquid paraffin.
5. according to the described preparation method of claim 2, it is characterized in that: the temperature on described condensed fluid top is 25 ℃～50 ℃, and the temperature of bottom is-2 ℃～10 ℃.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008101118664A CN101288658A (en) | 2008-05-16 | 2008-05-16 | Compound ambroxol sustained-release drop pills and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008101118664A CN101288658A (en) | 2008-05-16 | 2008-05-16 | Compound ambroxol sustained-release drop pills and preparation method thereof |
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| CN101288658A true CN101288658A (en) | 2008-10-22 |
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| CNA2008101118664A Pending CN101288658A (en) | 2008-05-16 | 2008-05-16 | Compound ambroxol sustained-release drop pills and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102772395A (en) * | 2011-05-09 | 2012-11-14 | 中国人民解放军军事医学科学院毒物药物研究所 | Sustained release preparation containing ambroxol hydrochloride and clenbuterol hydrochloride, and preparation method thereof |
| CN115531337A (en) * | 2022-10-17 | 2022-12-30 | 南京康川济医药科技有限公司 | Compound ambroxol Luo Huanshi tablet and preparation method thereof |
-
2008
- 2008-05-16 CN CNA2008101118664A patent/CN101288658A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102772395A (en) * | 2011-05-09 | 2012-11-14 | 中国人民解放军军事医学科学院毒物药物研究所 | Sustained release preparation containing ambroxol hydrochloride and clenbuterol hydrochloride, and preparation method thereof |
| CN115531337A (en) * | 2022-10-17 | 2022-12-30 | 南京康川济医药科技有限公司 | Compound ambroxol Luo Huanshi tablet and preparation method thereof |
| CN115531337B (en) * | 2022-10-17 | 2024-01-26 | 南京康川济医药科技有限公司 | Compound ambroxol sustained release tablet and preparation method thereof |
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Open date: 20081022 |