洛伐他汀澄清度检查的有效性评价

Evaluation the Efficacy of Clarity Test of Lovastatin Solution

目的:建立洛伐他汀澄清度检查的方法,同时考察了国内数批洛伐他汀原料的澄清度结果,并根据结果进行了有效性评价。方法:溶剂采用乙腈,溶解后与浊度标准液进行比较。同时测定原料的比旋度及含量,并将三者结果进行分析。结果:8个厂家16批洛伐他汀原料中,有3个厂家的6批样品的浊度浓于2号浊度标准液,其余样品均清于1号。产品的澄清与否及含量高低和比旋度测定存在相关关系。结论:对澄清度的检查控制方法适用且必要,可有效监测药品生产工艺控制药品质量。

Objective ： To establish a method of test on clarity of Lovastatin solution. Method ： The solvent was acetonitrile, and the solution was compared with reference suspension. At the same time, specific optical rotation and content were determined , theresutts of three items were analyzed. Result： The clarity of six batches of three factouries were pronounced than that of reference suspension 2 in 16 batches of 8 factouries in the country, and the rest of them were clear than that of reference suspension 1. The correlativity were existed between the results of clarity and content and specific optical rotation. Conclusion： Through the control of clarity of solution , it can be monitored the production effectively . The method was suitable and necessary . It can controle the quality of this production.