不同厂家硝苯地平缓释片(Ⅱ)光纤原位实时溶出曲线的考察___

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　所测两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。

AbstractObjective: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.

1SU Jia-yan(苏佳妍)，LIU Xiao-hong(刘晓红)，SUN Ying-hua(孙英华)，et al.lnvestigation on dissolution of nifedipine tablets(硝苯地平片剂溶出度的考察)．J Shenyang Pharm Univ(沈阳药科大学学报)，2007，24(4)：193 2Drug of Specification of State Food and Drug Administration.（国家食品药品监督管理局国家药品标准新药转正标准）.Vol.52（第52册）：124 3XIA Jin-hui(夏锦辉)，LIU Chang-xiao(刘昌孝).Statistical evaluation and analysis on the in vitro dissolution of solid pharmaceutical preparations(固体药物制剂的体外溶出度的统计学评价分析)．Chin Pharm J (中国药学杂志)，2000，35(2)：130