摘要
目的建立考察阿昔洛韦片溶出过程的方法,初步评价其制剂质量。方法用光纤药物溶出度实时测定仪在线监测阿昔洛韦片的溶出过程。结果考察9个厂家阿昔洛韦片的溶出曲线,结果显示部分厂家产品溶出过程不相似,1个厂家产品片间差异很大。结论光纤溶出度实时测定仪能够有效测定固体药物的体外溶出过程,为改进制剂工艺、监控制剂工艺稳定性提供有益的参考。
Objective To establish an analytical method for the dissolution of acyclovir tablets and evaluate their intrinsic quality. Methods The dissolution process of acyclovir tablets was determined with FODT-601 fiber-optic medicine dissolution process real time test system. Results The real-time dissolution profiles of acyclovir tablets from 9 manu facturers were determined. There was significant difference in the dissolution profiles. One of the dissolution profiles showed comparatively large intra-batch variance. Conclusion This process analysis can reflect the real dissolution process and can provide useful information for improving the preparation technology and monitoring its stability.
出处
《中南药学》
CAS
2012年第4期274-276,共3页
Central South Pharmacy
关键词
阿昔洛韦片
实时溶出曲线
光纤溶出度实时测定
acyclovir tablet
real time dissolution profile
fiber-optic medicine dissolution process real time test