CN111249248A - Blood lipid reducing medicine and preparation method thereof - Google Patents
Blood lipid reducing medicine and preparation method thereof Download PDFInfo
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- CN111249248A CN111249248A CN202010078814.2A CN202010078814A CN111249248A CN 111249248 A CN111249248 A CN 111249248A CN 202010078814 A CN202010078814 A CN 202010078814A CN 111249248 A CN111249248 A CN 111249248A
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
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- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A61P3/06—Antihyperlipidemics
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Abstract
The invention provides a blood lipid reducing medicine and a preparation method thereof. The lipid-lowering medicine comprises the following raw materials in parts by mass: 2 parts of pitavastatin calcium, 2-2.4 parts of magnesium aluminum silicate, 0-0.5 part of montmorillonite, 90-100 parts of lactose, 16-20 parts of low-substituted hydroxypropyl cellulose, 1-3 parts of hydroxypropyl methylcellulose, 0.4-0.8 part of magnesium stearate, 4-5 parts of copovidone S6300-1 and film coating premix (gastric soluble). According to the invention, montmorillonite and copovidone S630 are added into the auxiliary materials of the pitavastatin calcium tablet, so that the stability of the pitavastatin calcium tablet in the storage process is effectively improved, the medication safety is ensured, the defects of complicated working procedures and long consumed time caused by a traditional mixing mode of an equivalent addition method are avoided by adopting a simple mixing-tabletting-coating process, and the process is beneficial to improving the production efficiency and is convenient for commercial production.
Description
Technical Field
The invention belongs to the field of medicines, and particularly relates to a lipid-lowering medicine and a preparation method thereof.
Background
Pitavastatin was developed by Nippon Kabushiki Kaisha and Nissan chemical industries Co., Ltd, and its calcium salt was used clinically. Registered and marketed in japan at 7 months 2003, and approved indications are treatment applicable to patients with hypercholesterolemia and familial hypercholesterolemia. In 2009, 8 months and 3 days, the FDA also approved pitavastatin calcium tablet on the market and the trade name
The indications are primary hyperlipemia and mixed dyslipidemia. The import and the marketing of the original research products are approved in 9, 28 months in 2008 in China, and at present, a plurality of enterprises in China approve the products to be marketed. The commercially available pitavastatin calcium tablets were of three sizes, 1mg, 2mg and 4 mg.
Pitavastatin calcium has high activity, poor stability and low content in the prescription, so the problems of preparation stability and content uniformity exist, and the selection of the types and the dosage of auxiliary materials and the process selection are harsh. At present, in order to improve the stability of pitavastatin calcium, a method of (1) improving the stability of pitavastatin calcium by adding a basic auxiliary material is mainly adopted, for example, CN101890013A discloses a pitavastatin calcium composition stabilized with an alkaline reagent and a preparation method thereof, characterized in that the alkaline reagent is magnesium oxide, and the pH of an aqueous solution or suspension thereof is more than 9 but less than 12, which can significantly improve the stability of the pitavastatin calcium-containing composition; (2) the stability of pitavastatin calcium is improved by adjusting the formula of auxiliary materials, for example, CN1969849A mainly solves the technical problem that the stability of main drugs is influenced by adhesive and drying temperature in a medicinal composition obtained by wet granulation, and the technical scheme is as follows: the preparation process does not contain any adhesive, and the pharmaceutical composition reaches a stable state by adding the alkaline auxiliary material while adopting a dry granulation and tabletting process. The alkaline auxiliary materials are selected from one or more of calcium phosphate, potassium phosphate, calcium hydrogen phosphate, sodium silicate, potassium silicate, magnesium silicate, calcium chloride, sodium salt, iron salt and calcium salt of ethylene diamine tetraacetic acid, calcium citrate, calcium succinate and sodium salt and calcium salt of various amino acids; (3) for example, in CN104367560A, after pitavastatin calcium is mixed with part of the filler, the mixture is pretreated with a coating material, a light-shielding material and a pH adjuster, so that the light-shielding material and the pH adjuster are attached to the surface of pitavastatin calcium through the coating material. The raw material processing mode ensures the pH stability and the light shading performance of pitavastatin calcium, and achieves the same effect of film coating. Adding the treated main drug mixture and the rest filler in equal amount, gradually mixing, adding disintegrating agent, granulating with adhesive, grading, adding disintegrating agent and lubricant, mixing, tabletting, detecting, and packaging.
However, the above methods still have high content of related substances in pitavastatin calcium preparations, such as the tablet prepared in example 1 of CN104367560A, which has a total impurity of 0.6% after being placed at 40 ℃ and a relative humidity of 75% for 3 months, the stability still needs to be improved, and the mixing method using the equivalent gradual addition method makes the process complicated and takes a long time, reduces the production efficiency, and is not suitable for commercial production.
Disclosure of Invention
The invention aims to provide a lipid-lowering medicine and a preparation method thereof.
The blood lipid lowering medicine provided by the invention comprises the following raw materials in parts by mass: 2 parts of pitavastatin calcium, 2-2.4 parts of magnesium aluminum silicate, 0-0.5 part of montmorillonite, 90-100 parts of lactose, 16-20 parts of low-substituted hydroxypropyl cellulose, 1-3 parts of hydroxypropyl methylcellulose, 0.4-0.8 part of magnesium stearate, 4-5 parts of copovidone S6300-1 and a film coating premix (gastric soluble type);
specifically, the blood lipid lowering medicine comprises the following raw materials in parts by mass: 2 parts of pitavastatin calcium, 2.3 parts of magnesium aluminum silicate, 0.1 part of montmorillonite, 95 parts of lactose, 18 parts of low-substituted hydroxypropyl cellulose, 2 parts of hydroxypropyl methylcellulose, 0.6 part of magnesium stearate, 4 parts of copovidone S6300.8 and 4 parts of film coating premix (gastric soluble type);
or the like, or, alternatively,
the lipid-lowering medicine comprises the following raw materials in parts by mass: 2 parts of pitavastatin calcium, 2.0 parts of magnesium aluminum silicate, 0.4 part of montmorillonite, 95 parts of lactose, 18 parts of low-substituted hydroxypropyl cellulose, 2 parts of hydroxypropyl methylcellulose, 0.6 part of magnesium stearate, 4 parts of copovidone S6300.8 and 4 parts of film coating premix (gastric soluble type); or
The lipid-lowering medicine comprises the following raw materials in parts by mass: 2 parts of pitavastatin calcium, 2.1 parts of magnesium aluminum silicate, 0.3 part of montmorillonite, 98 parts of lactose, 16 parts of low-substituted hydroxypropyl cellulose, 3 parts of hydroxypropyl methylcellulose, 0.6 part of magnesium stearate, 4.3 parts of copovidone S6300.5 and a film coating premix (gastric soluble).
The lipid-lowering medicine is prepared by the method comprising the following steps:
1) respectively sieving pitavastatin calcium, lactose, hydroxypropyl methylcellulose, magnesium aluminum silicate, low-substituted hydroxypropyl cellulose and montmorillonite with a 60-mesh sieve, and sieving magnesium stearate and copovidone S630 with a 80-mesh sieve for later use;
2) mixing lactose, magnesium aluminum silicate, low-substituted hydroxypropyl cellulose, montmorillonite, and hydroxypropyl methylcellulose for 1-3 min; adding pitavastatin calcium, mixing for 6-10min, adding magnesium stearate and half of copovidone S630 after uniformly mixing, mixing for 5-7min, and tabletting the uniformly mixed materials;
3) preparing the film coating premix (gastric soluble type) into coating solution with mass concentration of 13% with purified water, adding the rest copovidone S630 into the obtained coating solution, and coating the obtained tablet.
The weight increment of the coating is controlled between 2% and 4%.
According to the invention, montmorillonite and copovidone S630 are added into the auxiliary materials of the pitavastatin calcium tablet, so that the stability of the pitavastatin calcium tablet in the storage process is effectively improved, the medication safety is ensured, the defects of complicated working procedures and long consumed time caused by a traditional mixing mode of an equivalent addition method are avoided by adopting a simple mixing-tabletting-coating process, and the process is beneficial to improving the production efficiency and is convenient for commercial production.
Detailed Description
The present invention will be described below with reference to specific examples, but the present invention is not limited thereto.
The experimental methods used in the following examples are all conventional methods unless otherwise specified; reagents, materials and the like used in the following examples are commercially available unless otherwise specified.
Example 1 preparation of 1000 tablets of 2mg of pitavastatin calcium tablet
2g of pitavastatin calcium, 2.3g of magnesium aluminum silicate, 0.1g of montmorillonite, 95g of lactose, 18g of low-substituted hydroxypropyl cellulose, 2g of hydroxypropyl methylcellulose, 0.6g of magnesium stearate, S6300.8 g of copovidone and 4g of film coating premix (gastric soluble);
the preparation process comprises the following steps:
1) respectively sieving pitavastatin calcium, lactose, hydroxypropyl methylcellulose, magnesium aluminum silicate, low-substituted hydroxypropyl cellulose and montmorillonite with a 60-mesh sieve, and sieving magnesium stearate and copovidone S630 with a 80-mesh sieve for later use;
2) mixing lactose, magnesium aluminum silicate, low-substituted hydroxypropyl cellulose, montmorillonite, and hydroxypropyl methylcellulose for 2 min; adding pitavastatin calcium, mixing for 8min, adding magnesium stearate and 0.4g of copovidone S630 after uniformly mixing, mixing for 5min, and tabletting the uniformly mixed materials;
3) preparing the film coating premix (gastric soluble type) into coating solution with mass concentration of 13% with purified water, adding the rest copovidone S630 into the obtained coating solution, and coating the obtained tablet.
The weight gain of the coating was controlled at 3%.
Example 2 preparation of 1000 tablets of 2mg of pitavastatin calcium tablet
2g of pitavastatin calcium, 2.0g of magnesium aluminum silicate, 0.4g of montmorillonite, 95g of lactose, 18g of low-substituted hydroxypropyl cellulose, 2g of hydroxypropyl methylcellulose, 0.6g of magnesium stearate, S6300.8 g of copovidone and 4g of film coating premix (gastric soluble);
the preparation process is the same as in example 1.
Example 3 preparation of 1000 tablets of 2mg of pitavastatin calcium tablet
2g of pitavastatin calcium, 2.1g of magnesium aluminum silicate, 0.3g of montmorillonite, 98g of lactose, 16g of low-substituted hydroxypropyl cellulose, 3g of hydroxypropyl methylcellulose, 0.6g of magnesium stearate, S6300.5 g of copovidone and 4.3g of film coating premix (gastric soluble);
the preparation process is the same as in example 1.
The content uniformity of the samples in examples 1-3 was determined by the content uniformity detection method in the appendix of the second pharmacopoeia version 2015, and the content uniformity results a +2.2S for the various pieces were less than or equal to 10.0, indicating that the sample content uniformity was good.
Comparative example 1
2g of pitavastatin calcium, 2.4g of magnesium aluminum silicate, 95g of lactose, 18g of low-substituted hydroxypropyl cellulose, 2g of hydroxypropyl methylcellulose, 0.6g of magnesium stearate and 4.8g of film coating premix (gastric soluble);
the preparation process comprises the following steps:
1) respectively sieving pitavastatin calcium, lactose, hydroxypropyl methylcellulose, magnesium aluminum silicate and low-substituted hydroxypropyl cellulose with a 60-mesh sieve, and sieving magnesium stearate with a 80-mesh sieve for later use;
2) mixing lactose, magnesium aluminum silicate, low-substituted hydroxypropyl cellulose, and hydroxypropyl methylcellulose for 2 min; adding pitavastatin calcium, mixing for 8min, adding magnesium stearate after mixing uniformly, mixing for 5min, and tabletting the uniformly mixed materials;
3) preparing the film coating premix (gastric soluble type) into coating solution with mass concentration of 13% with purified water, and coating the obtained tablet.
The weight gain of the coating was controlled at 3%.
Comparative example 2
2g of pitavastatin calcium, 2.3g of magnesium aluminum silicate, 0.1g of montmorillonite, 95g of lactose, 18g of low-substituted hydroxypropyl cellulose, 2g of hydroxypropyl methylcellulose, 0.6g of magnesium stearate and 4.8g of film coating premix (gastric soluble type);
the preparation process comprises the following steps:
1) respectively sieving pitavastatin calcium, lactose, hydroxypropyl methylcellulose, magnesium aluminum silicate, low-substituted hydroxypropyl cellulose and montmorillonite with a 60-mesh sieve, and sieving magnesium stearate with a 80-mesh sieve for later use;
2) mixing lactose, magnesium aluminum silicate, low-substituted hydroxypropyl cellulose, montmorillonite, and hydroxypropyl methylcellulose for 2 min; adding pitavastatin calcium, mixing for 8min, adding magnesium stearate after mixing uniformly, mixing for 5min, and tabletting the uniformly mixed materials;
3) preparing the film coating premix (gastric soluble type) into coating solution with mass concentration of 13% with purified water, and coating the obtained tablet.
The weight gain of the coating was controlled at 3%.
Comparative example 3
2g of pitavastatin calcium, 2.4g of magnesium aluminum silicate, 95g of lactose, 18g of low-substituted hydroxypropyl cellulose, 2g of hydroxypropyl methylcellulose, 0.6g of magnesium stearate, S6300.8 g of copovidone and 4g of film coating premix (gastric soluble);
the preparation process comprises the following steps:
1) respectively sieving pitavastatin calcium, lactose, hydroxypropyl methylcellulose, magnesium aluminum silicate and low-substituted hydroxypropyl cellulose with a 60-mesh sieve, and sieving magnesium stearate and copovidone S630 with a 80-mesh sieve for later use;
2) mixing lactose, magnesium aluminum silicate, low-substituted hydroxypropyl cellulose and hydroxypropyl methylcellulose for 2 min; adding pitavastatin calcium, mixing for 8min, adding magnesium stearate and 0.4g of copovidone S630 after uniformly mixing, mixing for 5min, and tabletting the uniformly mixed materials;
3) preparing the film coating premix (gastric soluble type) into coating solution with mass concentration of 13% with purified water, adding the rest copovidone S630 into the obtained coating solution, and coating the obtained tablet.
The weight gain of the coating was controlled at 3%.
Comparative example 4
2g of pitavastatin calcium, 2.3g of magnesium aluminum silicate, 0.1g of montmorillonite, 95g of lactose, 18g of low-substituted hydroxypropyl cellulose, 2g of hydroxypropyl methylcellulose, 0.6g of magnesium stearate, S6300.8 g of copovidone and 4g of film coating premix (gastric soluble);
the preparation process comprises the following steps:
1) respectively sieving pitavastatin calcium, lactose, hydroxypropyl methylcellulose, magnesium aluminum silicate, low-substituted hydroxypropyl cellulose and montmorillonite with a 60-mesh sieve, and sieving magnesium stearate and copovidone S630 with a 80-mesh sieve for later use;
2) mixing lactose, magnesium aluminum silicate, low-substituted hydroxypropyl cellulose, montmorillonite, and hydroxypropyl methylcellulose for 2 min; adding pitavastatin calcium, mixing for 8min, adding magnesium stearate and copovidone S630 after uniformly mixing, mixing for 5min, and tabletting the uniformly mixed materials;
3) preparing the film coating premix (gastric soluble type) into coating solution with mass concentration of 13% with purified water, and coating the obtained tablet.
The weight gain of the coating was controlled at 3%.
Comparative example 5
2g of pitavastatin calcium, 2.3g of magnesium aluminum silicate, 0.1g of montmorillonite, 95g of lactose, 18g of low-substituted hydroxypropyl cellulose, 2g of hydroxypropyl methylcellulose, 0.6g of magnesium stearate, S6300.8 g of copovidone and 4g of film coating premix (gastric soluble);
the preparation process comprises the following steps:
1) respectively sieving pitavastatin calcium, lactose, hydroxypropyl methylcellulose, magnesium aluminum silicate, low-substituted hydroxypropyl cellulose and montmorillonite with a 60-mesh sieve, and sieving magnesium stearate and copovidone S630 with a 80-mesh sieve for later use;
2) mixing lactose, magnesium aluminum silicate, low-substituted hydroxypropyl cellulose, montmorillonite, and hydroxypropyl methylcellulose for 2 min; adding pitavastatin calcium, mixing for 8min, adding magnesium stearate after mixing uniformly, mixing for 5min, and tabletting the uniformly mixed materials;
3) preparing the film coating premix (gastric soluble type) into coating solution with mass concentration of 13% with purified water, adding copovidone S630 into the obtained coating solution, and coating the obtained tablet.
The weight gain of the coating was controlled at 3%.
Comparative examples 6,
Copovidone S630 in example 1 was replaced with povidone K30, the other components and the preparation method were the same.
The results of comparing the related substances of pitavastatin calcium tablets prepared in the above examples and comparative examples for 6 months in an accelerated test (40 ℃, RH 75%) are shown in table 1.
TABLE 1 impurity content of pitavastatin calcium tablet
Claims (5)
1. The blood lipid reducing medicine comprises the following raw materials in parts by mass: 2 parts of pitavastatin calcium, 2-2.4 parts of magnesium aluminum silicate, 0-0.5 part of montmorillonite, 90-100 parts of lactose, 16-20 parts of low-substituted hydroxypropyl cellulose, 1-3 parts of hydroxypropyl methylcellulose, 0.4-0.8 part of magnesium stearate, 4-5 parts of copovidone S6300-1 and a gastric-soluble film coating premix.
2. The lipid-lowering drug according to claim 1, wherein: the lipid-lowering medicine comprises the following raw materials in parts by mass: 2 parts of pitavastatin calcium, 2.3 parts of magnesium aluminum silicate, 0.1 part of montmorillonite, 95 parts of lactose, 18 parts of low-substituted hydroxypropyl cellulose, 2 parts of hydroxypropyl methylcellulose, 0.6 part of magnesium stearate, 4 parts of copovidone S6300.8 and 4 parts of gastric-soluble film coating premix.
3. The lipid-lowering drug according to claim 1, wherein: the lipid-lowering medicine comprises the following raw materials in parts by mass: 2 parts of pitavastatin calcium, 2.0 parts of magnesium aluminum silicate, 0.4 part of montmorillonite, 95 parts of lactose, 18 parts of low-substituted hydroxypropyl cellulose, 2 parts of hydroxypropyl methylcellulose, 0.6 part of magnesium stearate, 4 parts of copovidone S6300.8 and 4 parts of gastric-soluble film coating premix.
4. The lipid-lowering drug according to claim 1, wherein: the lipid-lowering medicine comprises the following raw materials in parts by mass: 2 parts of pitavastatin calcium, 2.1 parts of magnesium aluminum silicate, 0.3 part of montmorillonite, 98 parts of lactose, 16 parts of low-substituted hydroxypropyl cellulose, 3 parts of hydroxypropyl methylcellulose, 0.6 part of magnesium stearate, 4.3 parts of copovidone S6300.5 and 4.3 parts of gastric-soluble film coating premix.
5. A process for the preparation of the lipid-lowering drug according to any one of claims 1 to 4, comprising the steps of:
1) respectively sieving pitavastatin calcium, lactose, hydroxypropyl methylcellulose, magnesium aluminum silicate, low-substituted hydroxypropyl cellulose and montmorillonite with a 60-mesh sieve, and sieving magnesium stearate and copovidone S630 with a 80-mesh sieve for later use;
2) mixing lactose, magnesium aluminum silicate, low-substituted hydroxypropyl cellulose, montmorillonite, and hydroxypropyl methylcellulose for 1-3 min; adding pitavastatin calcium, mixing for 6-10min, adding magnesium stearate and half of copovidone S630 after uniformly mixing, mixing for 5-7min, and tabletting the uniformly mixed materials;
3) preparing coating solution with mass concentration of 13% from gastric-soluble film coating premix with purified water, adding the rest copovidone S630 into the obtained coating solution, and coating the obtained tablet.
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| CN113768895A (en) * | 2021-10-13 | 2021-12-10 | 北京阳光诺和药物研究股份有限公司 | Blood lipid reducing medicine and its preparation method |
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| WO2006037348A1 (en) * | 2004-10-01 | 2006-04-13 | Lifecycle Pharma A/S | Pharmaceutical compositions comprising fenofibrate and a statin |
| CN102688206A (en) * | 2012-05-29 | 2012-09-26 | 石药集团中奇制药技术（石家庄）有限公司 | Pitavastatin calcium tablet and preparation method thereof |
| CN103356494A (en) * | 2013-04-23 | 2013-10-23 | 上海信谊万象药业股份有限公司 | High-stability simvastatin tablets and preparation method thereof |
| CN104147588A (en) * | 2013-05-13 | 2014-11-19 | 上海信谊万象药业股份有限公司 | Stable lisinopril tablet and preparation method thereof |
| CN103893185A (en) * | 2014-04-23 | 2014-07-02 | 山东司邦得制药有限公司 | Valsartan hydrochlorothiazide dispersible tablet and preparation method thereof |
| CN105078913A (en) * | 2014-05-22 | 2015-11-25 | 山东司邦得制药有限公司 | Irbesartan tablet and preparation method thereof |
| CN107115306A (en) * | 2017-04-17 | 2017-09-01 | 浙江京新药业股份有限公司 | A kind of pharmaceutical composition containing Pitavastatin Calcium and preparation method thereof |
| CN108567759A (en) * | 2018-07-26 | 2018-09-25 | 北京百奥药业有限责任公司 | A kind of valsartan and Hydrochlorothiade piece and preparation method thereof |
| CN108785267A (en) * | 2018-08-14 | 2018-11-13 | 北京百奥药业有限责任公司 | A kind of valsartan amlodipine piece and preparation method thereof |
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| CN113768895A (en) * | 2021-10-13 | 2021-12-10 | 北京阳光诺和药物研究股份有限公司 | Blood lipid reducing medicine and its preparation method |
Also Published As
| Publication number | Publication date |
|---|---|
| CN111249248B (en) | 2021-03-05 |
| CN112891315A (en) | 2021-06-04 |
| CN112891315B (en) | 2022-04-08 |
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