CN101978953A - Hygroscopic auxiliary material-based solid preparation - Google Patents
Hygroscopic auxiliary material-based solid preparation Download PDFInfo
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- CN101978953A CN101978953A CN2010105015503A CN201010501550A CN101978953A CN 101978953 A CN101978953 A CN 101978953A CN 2010105015503 A CN2010105015503 A CN 2010105015503A CN 201010501550 A CN201010501550 A CN 201010501550A CN 101978953 A CN101978953 A CN 101978953A
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Abstract
The invention provides a hydroscopic auxiliary material-based solid preparation, which belongs to the technical field of medicament preparation. The solid preparation comprises the following components: 1 to 10 percent of active ingredient, 0.1 to 60 percent of hydroscopic auxiliary material, 0.1 to 2.0 percent of antioxidant, 40 to 75 percent of excipient, 2 to 10 percent of disintegrating agent, 1 to 10 percent of adhesive, and 0.5 to 3 percent of lubricant. The problem can be solved by utilizing a method of adding the hydroscopic auxiliary material, and the contact between a hydroscopic medicament and moisture is reduced so as to reduce the hydrolysis of the hydrolytic medicament in the solid preparation.
Description
Technical field
What the present invention relates to is a kind of preparation of field of medicine preparing technology, specifically is a kind of solid preparation based on easy hygroscopicity adjuvant.
Background technology
The basic demand of pharmaceutical preparation should be a safety, effective, stable.Stability means that medicine is in external stability.Medicine not only can make drug effect reduce if decomposition is rotten, and some medicine even generation toxic and side effects are so pharmaceutical preparation stability is to guaranteeing that preparation safety effectively is very important.Medicine is owing to the difference of chemical constitution, and its degradation reaction is also different, and hydrolysis and oxidation are two main paties of drug degradation.Other are reflected at as isomerization, polymerization, decarboxylation etc. also generation in the some drugs.
Hydrolysis is the main path of drug degradation, and the drug main that belongs to this class degraded will comprise esters (comprising lactone), amide-type (comprising lactams) etc.The hydrolysis of procaine hydrochloride, aspirin, tetracaine hydrochloride, probanthine, atropine sulfate belongs to the hydrolysis of esters medicine; The hydrolysis of simvastatin, pilocarpine nitrate belongs to the hydrolysis of lactone, this class medicine since ester molecule in the oxygen elecrtonegativity bigger than carbon, so acyl group is polarized, nucleophilicity reagent OH
-Reaction takes place in reaction.
The hydrolysis of barbiturates, acetaminophen belongs to the hydrolysis of amide-type medicine, generates acid and amine behind this class drug hydrolysis.
Solid preparation has its characteristics again as pharmaceutical preparation a kind of: system inhomogeneity, and as tablet, capsule, content is incomplete same between every, thereby analysis result is difficult to reappear; These dosage forms are again multiphase systems, often comprise gas phase (empty G﹠W), liquid phase (moisture of absorption) and solid phase, and when experimentizing, the composition of these phases and state can both change.The particularly existence of moisture causes very big difficulty to experiment, because of moisture very big to stability influence.These characteristics are more unfavorable for containing facile hydrolysis medical solid stability of formulation.
Find by prior art documents, the Chinese patent notification number is CN1951501A, the day for announcing is JIUYUE in 2006 29 days, put down in writing a kind of " can prevent the pharmaceutical composition with Meclofenoxate hydrochloride of hydrolysis ", this technology comprises active ingredient hydrochloric acid meclofenoxate, pharmaceutic adjuvant, lubricant and stabilizing agent, and this stabilizing agent can make medicine keep faintly acid.But then there is following problem in the above-mentioned method of meclofenoxate hydrochloride hydrolysis that prevents if extend to other solid preparation: at acid condition, some drugs hydrolysis meeting is quickened, because acid has catalytic action for hydrolysis, just do not have the effect that prevents facile hydrolysis drug hydrolysis in the solid preparation.The Chinese patent notification number is CN 1994296A, the day for announcing is on July 11st, 2007, patent name is: a kind of pharmaceutical preparation that contains simvastatin, this patent is mentioned following content: a kind of pharmaceutical preparation that contains simvastatin, the organic acid that accounts for preparation total amount 9%-12% by interpolation can make the pH of pharmaceutical preparation aqueous solution preferably be in the 2.5-3.2 scope as acidic ph modifier.Use the oxidizing process that can effectively suppress simvastatin by merging, make the existing better pharmaceutical preparation of preparation of stability with other adjuvants such as antioxidant.But still there are 3 deficiencies in the preparation of above-mentioned simvastatin preparation: do not consider that 1. medicine is owing to the content that hydrolysis causes descends; What 2. adopt is wet granulation, tablet forming technique, and this technology mainly need participate in granulating, oven dry, and the simvastatin raw material adopts this technology can cause that content descends to thermally labile; 3. used organic solvent in pelletization in a large number, the volatilization of organic solvent may exert an influence to stability of drug.
Summary of the invention
The present invention is directed to the prior art above shortcomings, a kind of solid preparation based on easy hygroscopicity adjuvant is provided, the method of utilize adding easy hygroscopicity adjuvant can address this problem, and reduces contacting of easy hygroscopicity medicine and moisture, thus the hydrolysis of facile hydrolysis medicine in the reduction solid preparation.
The present invention is achieved by the following technical solutions, and component of the present invention and content are: active component 1～10%, easy hygroscopicity adjuvant 0.1～60%, antioxidant 0.1～2.0%, excipient 40～75%, disintegrating agent 2～10%, binding agent 1～10% and lubricant 0.5～3%.
Described active component comprises: procaine hydrochloride, aspirin, tetracaine hydrochloride, simvastatin, probanthine, atropine sulfate, chloromycetin, penicillin, barbital, acetaminophen, vitamin B or stable etc.
Described easy hygroscopicity adjuvant is one or more in mannitol, sorbitol, crosslinked carboxymethyl fecula sodium, cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, Polyethylene Glycol, polyvidone, sodium alginate or the citric acid; In preferred sorbitol, cross-linking sodium carboxymethyl cellulose or the citric acid one or more.
Described excipient is a kind of or its combination in lactose, white sugar, maltose, mannitol, maltose alcohol, erithritol, corn starch, rice starch, wheaten starch, microcrystalline Cellulose, cellulose powder, cross-linking sodium carboxymethyl cellulose, low degree of substitution hydroxypropyl cellulose, carboxymethyl cellulose, carboxymethylcellulose calcium, Talcum, light silicon anhydride or the calcium phosphate; Optimize a kind of or its combination that is selected from sugar, starch, cellulose, lactose, white sugar, corn starch, crystalline cellulose, cross-linking sodium carboxymethyl cellulose, carboxymethyl cellulose or the low degree of substitution hydroxypropyl cellulose.
Described disintegrating agent is a kind of or its combination in crystalline cellulose, cellulose powder, cross-linking sodium carboxymethyl cellulose, low degree of substitution hydroxypropyl cellulose, hydroxypropyl cellulose calcium, corn starch, alphalysed starch, part alphalysed starch, hydroxypropyl starch, Sodium Hydroxymethyl Stalcs or the crospolyvinylpyrrolidone.
Described binding agent is a kind of or its combination in methylcellulose, carboxymethyl cellulose, carboxy-propyl cellulose, hydroxypropyl cellulose, hydroxypropyl emthylcellulose, crystalline fibers, alphalysed starch, polyvinyl alcohol, polyvinylpyrrolidone, amylopectin, dextrin, arabic gum or the gelatin.
Described lubricant is a kind of or its combination in magnesium stearate, calcium stearate, fixed oil, sucrose fatty acid ester or the Polyethylene Glycol.
Described solid preparation is tablet, powder, granule or capsule.
Under this dosage condition in the easy hygroscopicity adjuvant of interpolation one or more can produce significant protective effect to easy hygroscopicity medicine in the solid preparation, and the hydrolysis of easy hygroscopicity medicine in the solid preparation is obviously reduced.
The specific embodiment
Below embodiments of the invention are elaborated, present embodiment is being to implement under the prerequisite with the technical solution of the present invention, provided detailed embodiment and concrete operating process, but protection scope of the present invention is not limited to following embodiment.
Embodiment 1
Present embodiment component and mass percent thereof are: simvastatin 5%, BHA0.5%, lactose 60.5%, microcrystalline Cellulose 28%, cross-linking sodium carboxymethyl cellulose 5% and magnesium stearate 1%.
Wherein: the amount of simvastatin is 5mg, 10mg, 20mg or 40mg.
The present embodiment preparation method may further comprise the steps:
(1) takes by weighing BHA and put into glass mortar, add the lactose employing gradually and doubly grind the method mix homogeneously, and 1. 60 mesh sieves obtain compound excessively;
(2) simvastatin that takes by weighing recipe quantity is then put into glass mortar, adds above-mentioned compound then and 1. adopts the method for doubly grinding to mix, and obtains compound 2.;
(3) take by weighing and the 2. lactose of equivalent of above-mentioned compound,, and cross 20 mesh sieves and obtain compound 3. with 2. mix homogeneously of compound;
(4) with compound 3. with remaining lactose, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose mix homogeneously in mixer, add the magnesium stearate mix homogeneously again, compacting in flakes.
Embodiment 2
Present embodiment component and mass percent thereof are: simvastatin 5.1%, BHA0.3%, lactose 59.7%, microcrystalline Cellulose 30.8%, sorbitol 5.2% and magnesium stearate 0.9%.
Wherein: the amount of simvastatin is 5mg, 10mg, 20mg or 40mg.
The present embodiment preparation method may further comprise the steps:
(1) takes by weighing BHA and put into glass mortar, add the lactose employing gradually and doubly grind the method mix homogeneously, and 1. 60 mesh sieves obtain compound excessively;
(2) simvastatin that takes by weighing recipe quantity is then put into glass mortar, adds above-mentioned compound then and 1. adopts the method for doubly grinding to mix, and obtains compound 2.;
(3) take by weighing and the 2. lactose of equivalent of above-mentioned compound,, and cross 20 mesh sieves and obtain compound 3. with 2. mix homogeneously of compound;
(4) with compound 3. with remaining lactose, microcrystalline Cellulose, sorbitol mix homogeneously in mixer, add the magnesium stearate mix homogeneously again, compacting in flakes.
Embodiment 3
Present embodiment component and mass percent thereof are: simvastatin 4.8%, BHA0.4%, lactose 58.6%, microcrystalline Cellulose 30%, microcrystalline Cellulose 30%, citric acid 5.2% and magnesium stearate 1%.
Wherein: the amount of simvastatin is 5mg, 10mg, 20mg or 40mg.
The present embodiment preparation method may further comprise the steps:
(1) takes by weighing BHA and put into glass mortar, add the lactose employing gradually and doubly grind the method mix homogeneously, and 1. 60 mesh sieves obtain compound excessively;
(2) simvastatin that takes by weighing recipe quantity is then put into glass mortar, adds above-mentioned compound then and 1. adopts the method for doubly grinding to mix, and obtains compound 2.;
(3) take by weighing and the 2. lactose of equivalent of above-mentioned compound,, and cross 20 mesh sieves and obtain compound 3. with 2. mix homogeneously of compound;
(4) with compound 3. with remaining lactose, microcrystalline Cellulose, citric acid mix homogeneously in mixer, add the magnesium stearate mix homogeneously again, compacting in flakes.
Embodiment 4
Present embodiment component and mass percent thereof are: simvastatin 4.9%, BHA0.5%, lactose 58.5%, microcrystalline Cellulose 25.1%, citric acid 2%, sorbitol 8% and magnesium stearate 1%.
Wherein: the amount of simvastatin is 5mg, 10mg, 20mg or 40mg.
The present embodiment preparation method may further comprise the steps:
(1) takes by weighing BHA and put into glass mortar, add the lactose employing gradually and doubly grind the method mix homogeneously, and 1. 60 mesh sieves obtain compound excessively;
(2) simvastatin that takes by weighing recipe quantity is then put into glass mortar, adds above-mentioned compound then and 1. adopts the method for doubly grinding to mix, and obtains compound 2.;
(3) take by weighing and the 2. lactose of equivalent of above-mentioned compound,, and cross 20 mesh sieves and obtain compound 3. with 2. mix homogeneously of compound;
(4) with compound 3. with remaining lactose, microcrystalline Cellulose, citric acid and sorbitol mix homogeneously in mixer, add the magnesium stearate mix homogeneously again, compacting in flakes.
Embodiment 5
Present embodiment component and mass percent thereof are: simvastatin 5.1%, BHA0.3%, lactose 60.3%, microcrystalline Cellulose 25%, cross-linking sodium carboxymethyl cellulose 5.1%, sorbitol 3.3% and magnesium stearate 0.9%.
Wherein: the amount of simvastatin is 5mg, 10mg, 20mg or 40mg.
The present embodiment preparation method may further comprise the steps:
(1) takes by weighing BHA and put into glass mortar, add the lactose employing gradually and doubly grind the method mix homogeneously, and 1. 60 mesh sieves obtain compound excessively;
(2) simvastatin that takes by weighing recipe quantity is then put into glass mortar, adds above-mentioned compound then and 1. adopts the method for doubly grinding to mix, and obtains compound 2.;
(3) take by weighing and the 2. lactose of equivalent of above-mentioned compound,, and cross 20 mesh sieves and obtain compound 3. with 2. mix homogeneously of compound;
(4) with compound 3. with remaining lactose, microcrystalline Cellulose, cross-linking sodium carboxymethyl cellulose and sorbitol mix homogeneously in mixer, add the magnesium stearate mix homogeneously again, compacting in flakes.
Comparative example
Present embodiment component and mass percent thereof are: simvastatin 5%, BHA0.5%, lactose 65.5%, microcrystalline Cellulose 28% and magnesium stearate 1%.
Wherein: the amount of simvastatin is 5mg, 10mg, 20mg or 40mg.
The present embodiment preparation method may further comprise the steps:
(1) takes by weighing BHA and put into glass mortar, add the lactose employing gradually and doubly grind the method mix homogeneously, and 1. 60 mesh sieves obtain compound excessively;
(2) simvastatin that takes by weighing recipe quantity is then put into glass mortar, adds above-mentioned compound then and 1. adopts the method for doubly grinding to mix, and obtains compound 2.;
(3) take by weighing and the 2. lactose of equivalent of above-mentioned compound,, and cross 20 mesh sieves and obtain compound 3. with 2. mix homogeneously of compound;
(4) with compound 3. with remaining lactose, microcrystalline Cellulose mix homogeneously in mixer, add the magnesium stearate mix homogeneously again, compacting in flakes.
The test example
Get in embodiment 1,2,4 and the comparative example 1 the simvastatin sheet, in weighing botle, weighing botle is placed in the exsiccator, under 25 ℃ of relative humidity 90 ± 1% conditions, placed ten days the content that adopted high performance liquid chromatography to detect simvastatin hydrolyzate simvastatin acid in the simvastatin tablet respectively at the 1st day, 5 days, 10 days.
(1) experiment the 1st day and the 5th day, the simvastatin tablet of embodiment 1,2,4 was compared simvastatin hydrolyzate simvastatin acid content difference very little (＜0.05%) with comparative example 1;
(2) compare with comparative example 1 at the simvastatin tablet of the 10th day embodiment 1,2,4, the simvastatin acid content obviously reduces, particularly the content of simvastatin acid is compared with the content of simvastatin acid in the comparative example 1 and has been reduced by 25% and 29% in embodiment 4 and 2 the simvastatin tablet, and the simvastatin acid content is compared with simvastatin acid content in the comparative example 1 and reduced by 10% in the simvastatin tablet of embodiment 1.
By experimental example 1 explanation: under the inventive method dosage condition, add in the easy hygroscopicity adjuvant one or more to solid preparation in easily the hygroscopicity medicine can produce significant protective effect, making in the solid preparation easily, the hydrolysis of hygroscopicity medicine obviously reduces.
Claims (10)
1. solid preparation based on easy hygroscopicity adjuvant, it is characterized in that its component and content are: active component 1～10%, easy hygroscopicity adjuvant 0.1～60%, antioxidant 0.1～2.0%, excipient 40～75%, disintegrating agent 2～10%, binding agent 1～10% and lubricant 0.5～3%.
2. the solid preparation based on easy hygroscopicity adjuvant according to claim 1, it is characterized in that described active component comprises: procaine hydrochloride, aspirin, tetracaine hydrochloride, simvastatin, probanthine, atropine sulfate, chloromycetin, penicillin, barbital, acetaminophen, vitamin B or stable.
3. the solid preparation based on easy hygroscopicity adjuvant according to claim 1, it is characterized in that described easy hygroscopicity adjuvant is one or more in mannitol, sorbitol, crosslinked carboxymethyl fecula sodium, cross-linking sodium carboxymethyl cellulose, crospolyvinylpyrrolidone, low-substituted hydroxypropyl cellulose, Polyethylene Glycol, polyvidone, sodium alginate or the citric acid.
4. according to claim 1 or 3 described solid preparations, it is characterized in that described easy hygroscopicity adjuvant is one or more in sorbitol, cross-linking sodium carboxymethyl cellulose or the citric acid based on easy hygroscopicity adjuvant.
5. the solid preparation based on easy hygroscopicity adjuvant according to claim 1, it is characterized in that described excipient is a kind of or its combination in lactose, white sugar, maltose, mannitol, maltose alcohol, erithritol, corn starch, rice starch, wheaten starch, microcrystalline Cellulose, cellulose powder, cross-linking sodium carboxymethyl cellulose, low degree of substitution hydroxypropyl cellulose, carboxymethyl cellulose, carboxymethylcellulose calcium, Talcum, light silicon anhydride or the calcium phosphate.
6. according to claim 1 or 5 based on the solid preparation of easy hygroscopicity adjuvant, it is characterized in that described excipient is a kind of or its combination in sugar, starch, cellulose, lactose, white sugar, corn starch, crystalline cellulose, cross-linking sodium carboxymethyl cellulose, carboxymethyl cellulose or the low degree of substitution hydroxypropyl cellulose.
7. the solid preparation based on easy hygroscopicity adjuvant according to claim 1, it is characterized in that described disintegrating agent is a kind of or its combination in crystalline cellulose, cellulose powder, cross-linking sodium carboxymethyl cellulose, low degree of substitution hydroxypropyl cellulose, hydroxypropyl cellulose calcium, corn starch, alphalysed starch, part alphalysed starch, hydroxypropyl starch, Sodium Hydroxymethyl Stalcs or the crospolyvinylpyrrolidone.
8. the solid preparation based on easy hygroscopicity adjuvant according to claim 1, it is characterized in that described binding agent is a kind of or its combination in methylcellulose, carboxymethyl cellulose, carboxy-propyl cellulose, hydroxypropyl cellulose, hydroxypropyl emthylcellulose, crystalline fibers, alphalysed starch, polyvinyl alcohol, polyvinylpyrrolidone, amylopectin, dextrin, arabic gum or the gelatin.
9. the solid preparation based on easy hygroscopicity adjuvant according to claim 1 is characterized in that, described lubricant is a kind of or its combination in magnesium stearate, calcium stearate, fixed oil, sucrose fatty acid ester or the Polyethylene Glycol.
10. the solid preparation based on easy hygroscopicity adjuvant according to claim 1 is characterized in that, described solid preparation is tablet, powder, granule or capsule.
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| CN103127019A (en) * | 2013-03-22 | 2013-06-05 | 成都乾坤动物药业有限公司 | Florfenicol dispersible tablet as well as preparation method and application thereof |
| CN103518902A (en) * | 2012-07-03 | 2014-01-22 | 余仁生国际有限公司 | Auxiliary material-free seven-star tea and preparation method thereof |
| CN104138364A (en) * | 2013-11-12 | 2014-11-12 | 河南润弘制药股份有限公司 | Simvastatin capsule and preparation method thereof |
| CN104382895A (en) * | 2014-10-22 | 2015-03-04 | 湖南明瑞制药有限公司 | Simvastatin composition |
| CN105031211B (en) * | 2015-07-08 | 2018-11-02 | 浙江新光药业股份有限公司 | A kind of HUANGQI SHENGMAI YIN extract powder and preparation method thereof |
| CN109248664A (en) * | 2017-07-12 | 2019-01-22 | 武汉力诚生物科技有限公司 | A kind of powder desiccant |
| CN109331097A (en) * | 2018-11-23 | 2019-02-15 | 鲁南制药集团股份有限公司 | The stagnant Rougan Granule of a kind ofization and its preparation process |
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| CN115554255A (en) * | 2022-09-08 | 2023-01-03 | 北京斯利安药业有限公司 | High-stability folic acid tablet and preparation method thereof |
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| CN103518902B (en) * | 2012-07-03 | 2018-01-02 | 余仁生国际有限公司 | A kind of auxiliary material-free seven-star tea and preparation method thereof |
| CN103518902A (en) * | 2012-07-03 | 2014-01-22 | 余仁生国际有限公司 | Auxiliary material-free seven-star tea and preparation method thereof |
| CN103127019A (en) * | 2013-03-22 | 2013-06-05 | 成都乾坤动物药业有限公司 | Florfenicol dispersible tablet as well as preparation method and application thereof |
| CN103127019B (en) * | 2013-03-22 | 2015-04-22 | 成都乾坤动物药业有限公司 | Florfenicol dispersible tablet as well as preparation method and application thereof |
| CN104138364A (en) * | 2013-11-12 | 2014-11-12 | 河南润弘制药股份有限公司 | Simvastatin capsule and preparation method thereof |
| CN104138364B (en) * | 2013-11-12 | 2016-09-07 | 河南润弘制药股份有限公司 | A kind of simvastatin capsules agent and preparation method thereof |
| CN104382895A (en) * | 2014-10-22 | 2015-03-04 | 湖南明瑞制药有限公司 | Simvastatin composition |
| CN105031211B (en) * | 2015-07-08 | 2018-11-02 | 浙江新光药业股份有限公司 | A kind of HUANGQI SHENGMAI YIN extract powder and preparation method thereof |
| CN109248664A (en) * | 2017-07-12 | 2019-01-22 | 武汉力诚生物科技有限公司 | A kind of powder desiccant |
| CN109331097A (en) * | 2018-11-23 | 2019-02-15 | 鲁南制药集团股份有限公司 | The stagnant Rougan Granule of a kind ofization and its preparation process |
| CN112089693A (en) * | 2020-09-28 | 2020-12-18 | 成都倍特药业股份有限公司 | Penicillin composition for injection and preparation method thereof |
| CN115554255A (en) * | 2022-09-08 | 2023-01-03 | 北京斯利安药业有限公司 | High-stability folic acid tablet and preparation method thereof |
| CN115554255B (en) * | 2022-09-08 | 2024-01-16 | 北京斯利安药业有限公司 | High-stability folic acid tablet and preparation method thereof |
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