Simvastatin composition

Abstract

The invention discloses a simvastatin composition. The composition is formed by uniformly mixing simvastatin, as well as a diluent and a flow agent, which are pharmaceutically acceptable. Simvastatin is mixed with the pharmaceutical diluent in an equivalent incremental manner, and then, the mixture is mixed with the pharmaceutically-acceptable flow agent to obtain simvastatin capsule. According to the invention, on the condition of not adding an antioxygen or an acidifier, the qualified simvastatin capsule is prepared through simple mixing and filling, so that the simvastatin capsule is more stable, controllable and applicable to large-scale production.

Description

technical field [0001] The invention relates to a simvastatin composition, in particular to a simvastatin capsule. Background technique [0002] Simvastatin (simvastatin) is a semi-synthetic HMG-CoA reductase inhibitor based on lovastatin. It was first launched in Switzerland in 1988 and was approved by the US FDA in December 1991. It is a treatment for post-onset hypercholesterolemia. disease drugs. [0003] Simvastatin tablets and capsules currently on the market are mainly used clinically to prevent and treat hyperlipidemia and coronary heart disease, especially the latter, which can reduce the risk of death, reduce coronary heart disease death and non-fatal The risk of myocardial infarction, reduce the risk of stroke and transient cerebral ischemia, reduce the risk of myocardial revascularization surgery (coronary artery bypass grafting and percutaneous balloon coronary angioplasty). [0004] Simvastatin itself is unstable in nature, easy to be oxidized and hydrolyzed,...

AI Technical Summary

Problems solved by technology

CN10330693A proposes to adopt the technique of direct tableting, and CN102106835A uses micronization, powder direct compression technology to prepare simvastatin tablets, but the above two kinds have added antioxidant

Although inclusion technology is beneficial to improve the stability of simvastatin, incomplete inclusion often occurs in actual production. At the same time, the actual production process of inclusion technology is relatively cumbersome and prone to errors

CN102657628A discloses a medicine containing simvastatin and a preparation method thereof, mainly by controlling the drying temperature and time, and adopting a brown composite blister film with excellent barrier properties to pack moisture-proof and light-proof packaging without adding antioxidants and stimulants. Acid agent, but wet granulation is used, it is difficult to control the degradation of simvastatin in the production process, especially the controllability of production is poor

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