摘要
目的:采用光纤药物溶出度实时测定仪考察不同厂家生产的硝苯地平缓释片(Ⅱ)的体外溶出度曲线,比较产品的内在质量差异。方法:按照国家药品标准WS1-(X-058)-2004Z中规定的溶出度方法测定了2个厂家硝苯地平缓释片(Ⅱ)的实时溶出曲线。结果:所测2个厂家硝苯地平缓释片(Ⅱ)的溶出度均达到国家药品标准要求,但它们的溶出曲线存在明显的差异。结论:单点溶出度测定方法不能真正反映出缓释制剂的溶出速率,难以控制其溶出性能与内在质量。有必要进行制剂溶出度的实时监测,确保药品的内在质量,保证用药的安全性及有效性。
Objective:To study the quality of nifedipine sustained-release tablets(Ⅱ)from different pharmaceutical factories with the new method for fiber-optic real time dissolution test system.Methods:According to the specifications in national drug standards WS1-(X-058)-2004Z the dissolution curve of nifedipine sustained-release tablets(Ⅱ)from two pharmaceutical factories were determined.Results:The dissolutions of nifedipine sustained-release tablets(Ⅱ)from two pharmaceutical factories met the requirements of national drug standards.But a significant differenct was observed in their dissolution curves.Conclusion:It is very difficult to characterize the dissolution rate and control the dissolution performance and inherent quality of sustained-release preparation by a single-point dissolution test.It suggests that we should take the real-time dissolution test to ensure the intrinsic quality of medicines and drug safety and efficacy.
出处
《药物分析杂志》
CAS
CSCD
北大核心
2010年第3期513-517,共5页
Chinese Journal of Pharmaceutical Analysis
关键词
硝苯地平缓释片(Ⅱ)
溶出度实时监测
光纤药物溶出度实时测定仪
nifedipine sustained-release tablets(Ⅱ)
real-time dissolution test
fiber-optic real-time dissolution test system
