摘要
目的:以实时溶出曲线评价不同厂家缬沙坦胶囊的溶出行为。方法:分别以pH1.2、4.0、6.8溶液和水为溶出介质,设定检测波长250nm、参比波长550nm、转速100r·min-1、光程2.0mm、篮法,用光纤药物溶出度实时测定仪测定原研厂A及仿制厂B、C、D、E、F的缬沙坦胶囊的溶出曲线,并采用相似因子(f2)值比较。结果:各厂家产品在《中国药典》规定的溶出介质即pH6.8溶液中在15min时的累积溶出率均已达到限度(80%)以上,但相似因子统计分析显示仅C(f2值为65.6)、F(f2值为58.3)厂产品与A厂相似;而在其余3种介质中各厂家产品30min时的累积溶出率均未达限度要求。结论:各厂家产品溶出行为有差异;不同pH溶出介质中的实时溶出曲线可全面反映药物在不同体内环境下的溶出行为,能更有效地评价制剂的内在质量。
OBJECTIVE：To evaluate the dissolution of Valsartan capsules from different manufacturer by real-time dissolution profiles.METHODS：The rotary basket method was used at the rate of 100 r·min-1 and signals were detected at 250 nm against the reference wavelength of 550 nm.The dissolution profiles of Valsartan capsules from original manufacturer A and generic B,C,D,E and F were determined with 2.0 mm fiber-optic probe by fiber-optic real-time dissolution monitor in solution（pH 1.2,pH 4.0,pH 6.8）and water.Similarity factor（f2）value was used for comparison of these products.RESULTS：At 15 minutes the dissolution rates of Valsartan capsules from 6 manufacturers were more than the limits（80%）in phosphate buffer（pH 6.8）that defined by Chinese Pharmacopeia.The values of f2 showed only the dissolution profiles of C（f2 =65.6）and F（f2 =58.3）samples were similar with that of original sample in phosphate buffer（pH 6.8）.At 30 minutes the dissolution rates of Valsartan capsules from 6 manufacturers were less than the limits in the other 3 mediums.CONCLUSIONS：The dissolution of products from different manufacturers are different from each other.The dissolution profiles in different mediums can roundly reflect dissolution process in vivo.It can provide a better way to evaluate the intrinsic quality of medicines.
出处
《中国药房》
CAS
CSCD
2012年第45期4278-4280,共3页
China Pharmacy
关键词
缬沙坦胶囊
实时溶出曲线
光纤溶出度实时测定仪
溶出行为
Valsartan capsules
Real-time dissolution profile
Fiber-optic real-time dissolution monitor
Dissolution
