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Simvastatin tablet

A technology for simvastatin and tablets, which is applied in the field of simvastatin tablets and its preparation, can solve problems such as poor uniformity, and achieve the effects of good uniformity, reasonable structure setting, and improved efficiency

Inactive Publication Date: 2018-05-04
苏州兰灵医药科技有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The uniformity of currently marketed simvastatin tablets is sometimes not good

Method used

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  • Simvastatin tablet

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0016] Example 1: Take 20 parts of simvastatin, 5 parts of starch, 10 parts of tartaric acid, and 1 part of magnesium stearate, first pretreat simvastatin, starch, and tartaric acid; granulate with ethanol, and use a particle multilayer sorting device The granules are sized, magnesium stearate is added for tabletting, dried and dehumidified, and then packaged to obtain simvastatin tablets.

[0017] The particle multi-layer sorting device includes a support 1, a filter housing 2 arranged on the support 1, a feed hopper 3 is arranged on the top of the filter housing 2, and a Discharge port 4, at least three layers of sorting nets 5 parallel to each other are arranged in the filter housing 2 and the apertures from the top stratum sorting net to the bottom sorting net decrease successively. Material dividing plate 6, the quantity of described material guiding dividing plate 6 is identical with the quantity of sorting net 5 and is respectively at the bottom end of sorting net, is p...

Embodiment 2

[0021] Example 2: Take 20 parts of simvastatin, 3 parts of starch, 12 parts of tartaric acid, and 0.8 part of talcum powder, first pretreat simvastatin, starch, and tartaric acid; granulate with ethanol, and use a granule multilayer sorting device for granulation , adding talcum powder to carry out tabletting treatment, drying and dehumidification treatment, and then packaging to obtain simvastatin tablets. (Particle multi-layer sorting device is the same as above)

Embodiment 3

[0022] Example 3: Take 20 parts of simvastatin, 7 parts of starch, 8 parts of tartaric acid, and 1.2 parts of micropowdered silica gel, first pretreat simvastatin, starch, and tartaric acid; granulate with ethanol, and use a particle multilayer sorting device for granulation , adding micropowder silica gel to carry out tabletting treatment, drying and dehumidification treatment, and then packaging to obtain simvastatin tablets. (Particle multi-layer sorting device is the same as above)

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PUM

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Abstract

The invention discloses a simvastatin tablet. The simvastatin tablet is prepared from simvastatin, starch, tartaric acid and a lubricant, wherein the weight ratio of simvastatin to starch to tartaricacid to the lubricant is 1:(0.15-0.35):(0.4-0.6):(0.04-0.06); meanwhile, a particle multilayer sorting device is adopted, drug content uniformity is good, and preparation technology is relatively simple, thereby being applicable to industrial production.

Description

technical field [0001] The invention belongs to the technical field of pharmaceutical solid oral preparations, and in particular relates to a simvastatin tablet and a preparation method thereof. Background technique [0002] Simvastatin is an inactive lactone, which is hydrolyzed into the corresponding β-hydroxy acid after oral absorption, specifically inhibits HMG-CoA reductase, and increases the number of low-density lipoprotein (LDL) receptors on the surface of liver cells , so that the receptor participates in the clearance of low-density lipoprotein cholesterol (LDL-ch) from the circulation, and the precursor of LDL-ch, very low-density lipoprotein cholesterol (VLDL-ch), is also cleared from the circulation through the LDL receptor. Simvastatin can reduce total cholesterol (TC), LDL-ch and VLDL-ch plasma drug concentration, and moderately increase high-density lipoprotein cholesterol (HDL-ch), and reduce triglyceride (TG) blood concentration. As an inactive prodrug, th...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/20A61K31/366A61K47/36A61K47/12A61P3/06B07B1/28B07B1/42B07B1/46
CPCA61K31/366A61K9/2022A61K9/2059B07B1/28B07B1/42B07B1/4609B07B2201/04
Inventor 孙丽华
Owner 苏州兰灵医药科技有限公司