辛伐他汀片的实时溶出度对比分析研究

Studies and comparison on the process monitoring of dissolution of simvastatin tablets

目的:采用光纤药物溶出度实时测定仪考察不同药厂生产的辛伐他汀片的体外溶出度曲线,比较产品的内在质量差异,分析现行溶出度方法的质量可控性,为进一步加强药品质量控制提供思路与有效手段,为合理制订溶出度方法与检查标准提供依据。方法:分别按照国家标准 WS_1-(X-240)-2004Z 和 WS_1-(X-066)-2003Z 中规定的溶出度方法进行单点溶出度及实时溶出曲线测定。结果:在2种溶出度条件下,单点溶出度符合现行法定标准要求的进口及国产辛伐他汀片,从实时溶出曲线比较来看,其内存的质量仍存在较大差异。进口辛伐他汀片和部分国产辛伐他汀片的实时溶出曲线显示其片间差异小,部分国产企业产品间的实时溶出曲线存在较大差异,个别企业同一批号产品间实时溶出度的差异都较大,反映出产品内在质量的稳定性和均一性较差。结论:用单点溶出度控制药物学溶出行为,对很多产品而言不能全面准确地反映产品的溶出性能与内存质量,特别是不能反映出产品之间的质量差异。单点溶出度测定方法的质量可控性较差,建议加强对药品溶出度的实时监测,确保不同企业生产的同一药品质量的稳定性与均一性,确保用药质量及临床疗效的一致性。

Objective：To compare the qualities of Simvastatin tablets from different manufactures through the method of fiber - optic real time dissolution test. To establish a valuable testing way of dissolution to evaluate the difference between Simvastatin tablets from different manufactures. Methods： Taking the dissolution tests according to the specifications in WS1- （ X-240） - 2004Z and WS1- （ X - 066 ） - 2003Z. Results： There are much more clearly diversities between domestic Simvastatin tablets than imported Simvastatin tablets in two different dissolution conditions. Furthermore, much obvious difference can be found in the same batch of some domestic manufactures. These results show that domestic Simvastatin tablets don＇t have the similar nature. Conclusion：It is impossible to com- pletely control and test the dissolution of some solid oral preparation by one single time. It suggests that we should take the fiber-optic real time dissolution test to strengthen the treatment and improve the quality.