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Hypolipidemic medicament and preparation method thereof

A technology for lowering blood lipids and drugs, applied in the field of medicine, can solve problems such as stability to be improved, unfavorable commercial production, and reduced production efficiency, and achieve the effects of facilitating commercial production, benefiting production efficiency, and improving stability

Active Publication Date: 2020-06-09
北京阳光诺和药物研究股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] But, after adopting above-mentioned these methods, the related substance in the pitavastatin calcium preparation is still higher, as the tablet that embodiment 1 makes among the CN104367560A it puts 3 months total impurity to reach 0.6% at 40 degrees centigrade relative humidity 75%, The stability still needs to be improved, and the mixing method using the equal-volume incremental method makes the process complicated and time-consuming, reduces production efficiency, and is not conducive to commercial production

Method used

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  • Hypolipidemic medicament and preparation method thereof

Examples

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Effect test

Embodiment 1

[0019] Embodiment 1, prepare 1000 pieces of pitavastatin calcium tablets of 2mg

[0020] Pitavastatin calcium 2g, aluminum magnesium silicate 2.3g, montmorillonite 0.1g, lactose 95g, low-substituted hypromellose 18g, hypromellose 2g, magnesium stearate 0.6g, copovidone S630 0.8g and film coating premix (stomach-soluble type) 4g;

[0021] Preparation Process:

[0022] 1) Pass pitavastatin calcium, lactose, hypromellose, magnesium aluminum silicate, low-substituted hypromellose, and montmorillonite through a 60-mesh sieve, magnesium stearate and copovidone S630 through a 80-mesh sieve ,spare;

[0023] 2) Mix lactose, magnesium aluminum silicate, low-substituted hypromellose, montmorillonite, and hypromellose for 2 minutes; add pitavastatin calcium, mix for 8 minutes, and add magnesium stearate and 0.4 g of Copovidone S630, mixed for 5 minutes, and the uniformly mixed material was pressed into tablets;

[0024] 3) The film coating premix (stomach-soluble type) is formulated w...

Embodiment 2

[0026] Embodiment 2, prepare 1000 pieces of pitavastatin calcium tablets of 2mg

[0027] Pitavastatin calcium 2g, aluminum magnesium silicate 2.0g, montmorillonite 0.4g, lactose 95g, low-substituted hypromellose 18g, hypromellose 2g, magnesium stearate 0.6g, copovidone S630 0.8g and film coating premix (stomach-soluble type) 4g;

[0028] The preparation process is the same as in Example 1.

Embodiment 3

[0029] Embodiment 3, prepare 1000 pieces of pitavastatin calcium tablets of 2mg

[0030] Pitavastatin calcium 2g, aluminum magnesium silicate 2.1g, montmorillonite 0.3g, lactose 98g, low-substituted hypromellose 16g, hypromellose 3g, magnesium stearate 0.6g, copovidone S630 0.5g and film coating premix (stomach-soluble type) 4.3g;

[0031] The preparation process is the same as in Example 1.

[0032] The content uniformity of the samples in Examples 1-3 was measured using the content uniformity detection method in the second appendix of the Pharmacopoeia of the 2015 edition. The content uniformity of each sample was A+2.2S less than or equal to 10.0, indicating that the sample had good content uniformity.

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Abstract

The invention provides a hypolipidemic medicament and a preparation method thereof. The hypolipidemic medicament comprises the following components 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, 0-1 part of copovidone S630 and 4-5 parts of a film coating premix (stomach-soluble type). According to the invention, montmorillonite and covidone S630 are added into auxiliary materials of pitavastatin calcium tablets, so that stability of the pitavastatin calcium tablets in a storage process is effectively improved, and medication safety is ensured. A simple mixing-tabletting-coating process is adopted, so that the defects of complex procedures and long time consumption caused by a conventional mixing mode of equal-amount progressive addition are avoided.The process is beneficial to improving production efficiency, and is convenient for commercial production.

Description

technical field [0001] The invention belongs to the field of medicine, and in particular relates to a blood lipid-lowering drug and a preparation method thereof. Background technique [0002] Pitavastatin is jointly developed by Japan Kowa Co., Ltd. and Nissan Chemical Industry Co., Ltd., and its calcium salt is used clinically. It was registered and launched in Japan in July 2003, and the approved indications are for the treatment of patients with hypercholesterolemia and familial hypercholesterolemia. On August 3, 2009, the FDA also approved the listing of pitavastatin calcium tablets. The indications are primary hyperlipidemia and mixed dyslipidemia. my country approved the import and marketing of the original research product on September 28, 2008. At present, there are many companies in my country that have been approved to market this product. There are three specifications of pitavastatin calcium tablets available in the market, 1mg, 2mg and 4mg. [0003] Pitavas...

Claims

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Application Information

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IPC IPC(8): A61K9/30A61K47/02A61K47/32A61K31/47A61K31/4709A61P3/06
CPCA61K9/284A61K9/2009A61K9/2027A61K31/47A61K31/4709A61P3/06A61K9/2054
Inventor 刘宇晶利虔郑柏松韩琳琳万忠民谌宗永
Owner 北京阳光诺和药物研究股份有限公司
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