CN111297818B - High-drug-loading-capacity piracetam tablet composition and preparation method thereof - Google Patents
High-drug-loading-capacity piracetam tablet composition and preparation method thereof Download PDFInfo
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/4015—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil having oxo groups directly attached to the heterocyclic ring, e.g. piracetam, ethosuximide
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- A61K9/20—Pills, tablets, discs, rods
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- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
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- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
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Abstract
The invention provides a piracetam tablet composition with high drug loading capacity and a preparation method thereof, wherein the piracetam tablet composition comprises 80-90% of piracetam and high-moldability microcrystalline Cellulose (CEOLUS)TM) 10-20%, 2-5% of disintegrating agent, 0.5-2% of lubricating agent and 0-4% of gastric-soluble film coating premix, and the composition can effectively improve the drug loading rate of piracetam tablets and simultaneously solve the problem of poor product friability caused by the increase of the drug loading rate. In addition, the invention also provides a preparation method of the piracetam tablet with high drug loading capacity, and the method is simple and convenient in process operation, high in production efficiency and suitable for industrial production.
Description
The technical field is as follows: the invention relates to a pharmaceutical composition and a preparation method thereof, and in particular relates to a piracetam tablet composition and a preparation method thereof.
Background art:
piracetam is a brain metabolism improving drug, belongs to an annular derivative of r-aminobutyric acid, can promote ATP in the brain, can promote acetylcholine synthesis and enhance nerve excitation conduction, and has the effect of promoting metabolism in the brain. Can be used for resisting brain function injury caused by physical factor and chemical factor, improving retrograde amnesia caused by anoxia, improving memory, and improving learning ability. Is clinically used for treating the senile dementia and is a first-line medicament for treating the senile dementia.
Piracetam formulations are marketed globally, and currently, in China, two dosage forms, i.e., injections and oral tablets, are marketed. The injection needs medical care personnel to inject, is inconvenient for patients to use at home, and further limits the clinical popularization of the injection. Compared with the prior art, the piracetam tablets have great advantages in clinical application, and the dosage of the piracetam tablets on the market in China is 0.4 g/tablet, 2-3 tablets at a time and 3 times a day, so that the piracetam tablets are too many to be taken and are easy to forget. The dosage of the piracetam tablet sold in foreign countries is 0.8 g/tablet or 1.2 g/tablet, the drug loading capacity is increased, and the size of the tablet is also increased, so that the patient has difficulty in swallowing.
Meanwhile, in the process of increasing the drug loading capacity of the piracetam in the tablet from 0.4 g/tablet to 0.8 g/tablet, the facts that the compressibility of piracetam raw material drug is poor, and phenomena such as powder falling, fragmentation, and cracking often occur in the tabletting process, the friability approaches the upper limit of the standard and is far higher than the standard of the national pharmacopoeia (the standard specification is that the friability of the tablet is not more than 1.0%) are discovered. The friability of the tablets is too large, which is not beneficial to tablet coating, and in the storage and transportation process of the medicine, the defects of the tablets, the edge abrasion and even the fragments are easy to occur, so that the dosage is difficult to control, and the effectiveness and the safety of the product are indirectly influenced. In addition, the compressibility of the tablet is poor, the product is unqualified seriously, the production efficiency is low, and the tablet is not beneficial to industrial mass production.
In view of the defects of the existing tablets at present, the piracetam tablet with high drug loading capacity is developed, the size of the tablet can be controlled, the problem of friability can be solved, and the piracetam tablet has important significance on clinical drug safety.
Disclosure of Invention
The invention aims to provide a high drug-loading rate piracetam tablet suitable for industrial production, which can be controlled to be in a proper size and has low friability.
The object of the invention can be achieved by the following measures: the high drug-loading rate piracetam tablet comprises the following components in percentage by weight,
80% -90% of piracetam;
10-20% of high-moldability microcrystalline cellulose produced by Asahi chemical company under the trade name of CEOLUSTMPreferably, the component is one or a mixture of KG802, KG1000, UF702 and UF-711;
2% -5% of a disintegrant, which may be a disintegrant conventional in the art, preferably including but not limited to: one or more of low-substituted hydroxypropyl cellulose, crospovidone, croscarmellose sodium, sodium starch glycolate and croscarmellose sodium, more preferably one or more of low-substituted hydroxypropyl cellulose, crospovidone and croscarmellose sodium, and more preferably croscarmellose sodium.
0.5% to 2% of a lubricant which may be conventional in the art, preferably including but not limited to: one or more of magnesium stearate, stearic acid, calcium stearate, zinc stearate, liquid paraffin, polyethylene glycol, silicon dioxide, colloidal silicon dioxide, aerosil, talcum powder, starch and hydrogenated vegetable oil, more preferably one or more of magnesium stearate, stearic acid, calcium stearate, aerosil and talcum powder, silicon dioxide and colloidal silicon dioxide, and more preferably one or more of magnesium stearate, stearic acid, calcium stearate and aerosil.
0% -4% of coating component, the tablet can be coated by uncoated or by known coating components, preferably one or more of hydroxypropyl cellulose, hydroxypropyl methylcellulose, ethyl cellulose, polyvinylpyrrolidone and vinylpyrrolidone-vinyl acetate copolymer. The coating is preferably a film coating (e.g., a gastric-soluble film coating or an enteric-soluble film coating) or a sugar coating, more preferably a film coating, and further preferably a gastric-soluble film coating.
In certain preferred embodiments of the invention, the high drug-loading piracetam tablet comprises the following components, wherein the components are formulated in weight percent,
80% -90% of piracetam;
10-20% of high-formability microcrystalline cellulose, wherein the high-formability microcrystalline cellulose is produced by Asahi chemical company, and preferably one or more of types KG802, KG1000, UF702 and UF-711.
2% -5% of a disintegrating agent, wherein the disintegrating agent is selected from one or more of low-substituted hydroxypropyl cellulose, crospovidone and croscarmellose sodium.
0.5-2% of lubricant, wherein the lubricant is selected from one or more of magnesium stearate, stearic acid, calcium stearate, superfine silica powder, talcum powder, silicon dioxide and colloidal silicon dioxide.
0% -4% of coating component, wherein the coating component is preferably film coating or sugar coating, and preferably the film coating is gastric-soluble film coating or enteric-soluble film coating.
In certain specific embodiments of the invention, the high drug-loading piracetam tablet comprises the following components, wherein the components are configured in percentage by weight;
84.21% of piracetam, 10.53% of microcrystalline cellulose KG1000, 4.26% of croscarmellose sodium, 1.00% of magnesium stearate and 3% of gastric-soluble film-coated premix.
Or 80% piracetam, 5% microcrystalline cellulose KG802, 10% microcrystalline cellulose UF711, 3% croscarmellose sodium, 1% colloidal silicon dioxide, 1% magnesium stearate.
The invention also aims to provide a preparation method of the high drug-loading piracetam tablet composition, which comprises the following steps:
1. sieving the piracetam raw material drug and the lubricant respectively to complete granules;
2. adding the sized piracetam raw material medicine, the high-formability microcrystalline cellulose and the disintegrating agent into a hopper mixer according to the prescription proportion, then adding the lubricant according to the prescription amount, and uniformly mixing;
3. and adding the mixed materials into a tabletting machine for tabletting.
In certain preferred embodiments of the present invention, the sieving is preferably through a 40 mesh sieve.
In some preferred embodiments of the invention, the mixing speed of the hopper mixer can be set to be 5-20 r/min, the mixing time is 5-30 min, and the mixing speed and the mixing time can be adjusted correspondingly according to the mixing degree of the materials.
In certain preferred embodiments of the present invention, the tablet press may set the parameters to a tablet speed of 5 to 20 ten thousand tablets per hour and a tablet hardness of 60 to 160N.
In some preferred embodiments of the invention, the pressed plain tablets can be further coated, and gastric-soluble film coating premix can be selected for coating, wherein the temperature of a tablet bed is controlled to be 35-45 ℃, and the weight gain of the coating is controlled to be 2-4%.
Advantageous effects
1. In the preparation process of the tablet, 10 to 20 percent of high-formability microcrystalline Cellulose (CEOLUS) is addedTM) The piracetam tablets with high drug loading capacity (the content of the raw material medicine is 80% -90%) prepared from the related auxiliary materials can effectively change the compressibility of the materials, so that the tablets have proper size, and meanwhile, the tablets have low friability and good hardness, and the effectiveness and safety of the medicines are ensured.
2. The preparation method of the piracetam tablet composition with high drug loading capacity provided by the invention has the advantages of simple and smooth operation process, controllable cost and high production efficiency, and is very suitable for industrial production.
Detailed Description
The following examples are presented to further explain or understand the present invention, but are not intended to limit the scope of the invention.
Example 1-high drug-loading piracetam tablet formulation (specification: 0.8g) and method of preparation (1000 tablets basis).
The preparation method comprises the following steps:
1. sieving the piracetam raw material drug and the magnesium stearate with a 40-mesh sieve for granulating;
2. adding 800g of sized piracetam raw material medicine, 100g of high-formability microcrystalline cellulose KG1000 and 40.5g of croscarmellose sodium into a hopper mixer according to the formula proportion, setting the mixing rotating speed to 10 revolutions per minute, starting the mixer for mixing for 20 minutes, then adding 9.5g of magnesium stearate, setting the mixing rotating speed to 10 revolutions per minute, and mixing for 5 minutes;
3. adding the mixed intermediate material into a tablet press for tabletting, wherein the tabletting speed is controlled to be 8 ten thousand tablets per hour, and the tablet hardness is controlled to be 90-130N;
4. and (3) putting the plain tablets into a high-efficiency coating machine, controlling the temperature of a tablet bed to be 35-45 ℃, and increasing the weight of the coating by 3%.
Example 2-high drug-loading piracetam tablet formulation (specification: 1.2g) and its preparation method (1000 tablets basis).
The preparation method comprises the following steps:
1. sieving the piracetam raw material drug, the colloidal silicon dioxide and the magnesium stearate with a 40-mesh sieve for granulating;
2. adding 1200g of sized piracetam bulk drug, 75g of high-formability microcrystalline cellulose KG802, 150g of high-formability microcrystalline cellulose UF711 and 45g of croscarmellose sodium into a hopper mixer according to a formula ratio, setting the mixing speed to 15 r/min, starting the mixer for 25 minutes, then adding 15g of colloidal silicon dioxide and 15g of magnesium stearate, setting the mixing speed to 10 r/min, and mixing for 5 minutes;
3. and adding the mixed intermediate material into a tablet press for tabletting, wherein the tabletting speed is controlled to be 10 ten thousand tablets/hour, and the tablet hardness is controlled to be 100-160N.
Comparative example 1-formulation (specification: 0.8g) of high drug-loading piracetam tablets and preparation method thereof (1000 tablets basis).
The preparation method comprises the following steps:
1. sieving the piracetam raw material drug and the magnesium stearate with a 40-mesh sieve for granulating;
2. adding 800g of granulated piracetam bulk drug, 100g of microcrystalline cellulose PH102 and 40.5g of croscarmellose sodium into a hopper mixer according to the formula ratio, setting the mixing rotation speed to 10 revolutions per minute, starting the machine for mixing for 20 minutes, then adding 9.5g of magnesium stearate, setting the mixing rotation speed to 10 revolutions per minute, and mixing for 5 minutes;
3. and adding the mixed intermediate material into a tablet press for tabletting, wherein the tabletting speed is controlled to be 5 ten thousand tablets per hour, and the tablet hardness is controlled to be 60-80N.
Comparative example 2-formulation (specification: 0.8g) of high drug-loading piracetam tablets and preparation method thereof (1000 tablets basis).
The preparation method comprises the following steps:
1. sieving the piracetam raw material drug and the magnesium stearate with a 40-mesh sieve for granulating;
2. adding 800g of sized piracetam raw material medicine, 798g of microcrystalline cellulose PH102 and 76.5g of croscarmellose sodium into a hopper mixer according to the formula ratio, setting the mixing rotation speed to be 20 revolutions per minute, starting the machine for mixing for 25 minutes, then adding 8.5g of colloidal silicon dioxide and 17g of magnesium stearate, setting the mixing rotation speed to be 10 revolutions per minute, and mixing for 5 minutes;
3. and adding the mixed intermediate material into a tablet press for tabletting, wherein the tabletting speed is controlled to be 8 ten thousand tablets per hour, and the tablet hardness is controlled to be 100-160N.
Examples 1-4 high drug load piracetam tablet friability test
The instrument equipment comprises: FT-2000 friability tester
And (3) testing the sample: the uncoated tablets prepared in example 1, example 2, comparative examples 1-2, test methods: the weight of each sample is more than 0.65g, and 10 samples are taken. The powder that has fallen off is blown off with a blower, precisely weighed, placed in a cylinder and rotated 100 times. Taking out, removing powder by the same method, precisely weighing, and calculating weight loss. (0923 in the four ministry of the pharmacopoeia of China 2015).
Results and discussion: the summary of the information of each test article and the results of the friability test are shown in the following table.
The test results show that the piracetam tablet composition with high drug loading capacity and the preparation method thereof have the advantages that the friability of the piracetam tablets prepared by the piracetam tablet composition with high drug loading capacity is smaller than 0.1-0.3 (far lower than the friability requirement of Chinese pharmacopoeia, namely the weight loss reduction is not more than 1%), and 10-20% of high-moldability microcrystalline Cellulose (CEOLUS) is added into the tabletsTM) The piracetam tablet with large drug loading capacity (the content of the raw material drug is 80% -90%) can be prepared, the compressibility of the material is improved, the prepared tablet has low friability, good hardness and proper size, the effectiveness and safety of the medicine are ensured, and the administration compliance of a patient is improved. The preparation method provided by the invention is simple to operate, high in production efficiency and suitable for industrial production.
Claims (6)
1. A high drug-loading rate piracetam tablet composition, the unit dose of which is 800mg, is characterized by comprising 84.21% piracetam, 10.53% microcrystalline cellulose KG1000, 4.26% croscarmellose sodium, 1.00% magnesium stearate and 3% gastric-soluble film-coated premix.
2. A high drug-loading piracetam tablet composition, the unit dose of which is 1200mg, and the high drug-loading piracetam tablet composition is characterized by comprising 80% piracetam, 5% microcrystalline cellulose KG802, 10% microcrystalline cellulose UF711, 3% croscarmellose sodium, 1% colloidal silicon dioxide and 1% magnesium stearate.
3. A process for preparing a high drug load piracetam tablet composition of any of claims 1-2 comprising the steps of:
1) sieving the piracetam raw material drug and the lubricant respectively to complete granules;
2) adding the sized piracetam original drug, the high-formability microcrystalline cellulose and the disintegrating agent into a hopper mixer according to the prescription proportion, then adding the lubricant according to the prescription amount, and uniformly mixing;
3) and adding the mixed materials into a tabletting machine for tabletting.
4. A process for preparing a high drug load piracetam tablet composition in accordance with claim 3 wherein: the sieving in the step 1) is 40-mesh sieving, the mixing rotating speed in the step 2) is 5-20 r/min, the mixing time is 5-30 min, the tabletting speed in the step 3) is controlled to be 5-20 ten thousand tablets/h, and the tablet hardness is 60-160N.
5. The process for preparing a high drug loading piracetam tablet composition of claim 4, further comprising the step of adding a gastric soluble film coating premix after the compression is complete.
6. The preparation method of the high drug-loading piracetam tablet composition as claimed in claim 5, wherein the temperature of a tablet bed is controlled to be 35-45 ℃ and the weight of the coating is controlled to be 2-4% in the coating process.
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| CN112022816B (en) * | 2020-07-31 | 2022-08-12 | 河北君临药业有限公司 | Piracetam tablet and preparation method thereof |
| CN112933060B (en) * | 2021-04-02 | 2022-07-12 | 江西亿友药业有限公司 | Piracetam tablet and preparation method thereof |
| CN114917195B (en) * | 2022-06-13 | 2024-06-11 | 河北戴桥医药科技有限公司 | Piracetam tablet and preparation method thereof |
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| CN101981059A (en) * | 2008-03-31 | 2011-02-23 | 旭化成化学株式会社 | Processed starch powder with excellent disintegration properties and manufacturing method thereof |
| CN102125524A (en) * | 2010-01-16 | 2011-07-20 | 青岛科技大学 | Piracetam orally disintegrating tablets |
| CN102188420A (en) * | 2011-03-25 | 2011-09-21 | 北京赛科药业有限责任公司 | Levetiracetam medicinal composition and preparation method thereof |
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| RU2262931C2 (en) * | 2003-11-03 | 2005-10-27 | Закрытое Акционерное Общество "Канонфарма Продакшн" | Pharmaceutical composition possessing cerebrovasodilating and nootropic activity |
| JP4145784B2 (en) * | 2003-12-24 | 2008-09-03 | カルソニックカンセイ株式会社 | Instrument panel structure for vehicles |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101981059A (en) * | 2008-03-31 | 2011-02-23 | 旭化成化学株式会社 | Processed starch powder with excellent disintegration properties and manufacturing method thereof |
| CN102125524A (en) * | 2010-01-16 | 2011-07-20 | 青岛科技大学 | Piracetam orally disintegrating tablets |
| CN102188420A (en) * | 2011-03-25 | 2011-09-21 | 北京赛科药业有限责任公司 | Levetiracetam medicinal composition and preparation method thereof |
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