Medicinal composition containing simvastatin and preparation method thereof

Abstract

The invention provides a medicinal composition containing simvastatin and a preparation method thereof. According to the method, the production process is improved by reasonable proportion of high-quality raw and auxiliary materials, strict control over temperature and time and moistureproof dark package, and can be used for overcoming deficiencies of a conventional process through repeated test and demonstration; the prepared simvastatin has the advantages of high content of main drugs, good glossiness, convenience in storage and portability, no antioxidant or acidifier and high medicine safety performance, and is in accordance with current enterprise scale production requirement.

Description

technical field [0001] The present invention relates to a pharmaceutical composition. Specifically, it relates to a pharmaceutical composition containing simvastatin, which is characterized in that it is made of the following raw and auxiliary materials through raw and auxiliary materials processing, soft material preparation, granulation, drying, granulation, blending, tableting, and packaging. The prescription consists of the following raw and auxiliary materials: simvastatin, filler, disintegrant, binder, lubricant. The invention also relates to a process for the preparation of the composition. Background technique [0002] Simvastatin (Simvastatin) is a patented product of Merck & Co. in the United States. It was introduced into my country by Hangzhou Merck Pharmaceuticals in 1997. The trade name is Zocor. This product is a semi-synthetic HMG-CoA reductase inhibitor based on lovastatin. It was first launched in Sweden in 1988 and was approved by the US FDA in December ...

AI Technical Summary

Problems solved by technology

At present, there are nearly 180 approval numbers for simvastatin in China, and the competition is quite fierce. However, due to the thermal instability, light sensitivity and easy oxidation of simvastatin, the requirements for the preparation process are relatively high

[0004] At present, the stability of simvastatin is mainly solved by adding antioxidants and acid-causing agents to obtain satisfactory results. For example, in the instructions of the original research manufacturer, it is clearly proposed to add butylated hydroxyanisole as an antioxidant, and at the same time add citric acid and vitamin c synergistic effect, improve the effect of anti-oxidation, but the detailed dosage is not mentioned in the manual; the patent 200510111264.5 applied by Shanghai Xinyi Vientiane Pharmaceutical Co., Ltd. proposes the use of direct compression technology. At present, as far as the domestic pharmaceutical industry is concerned, The direct tableting process also has technical problems such as unstable tablet weight, poor friability, and sticky punching during the tableting process; the patent 201110033578.3 applied by Chongqing Kerui Pharmaceutical Co., Ltd. reduces the amount of antioxidants and acid-causing agents. To a certain extent, the safety of the product is ensured, but a certain amount of antioxidants and acid-causing agents are still used, and there are still hidden dangers in product safety

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