不确定度在速释型固体口服制剂溶出度复验中的应用  

Application of uncertainty evaluation in arbitration test of determination of dissolution rate of immediate release solid oral dosage forms

作　　者：许明哲[1,2] 胡昌勤[2] 金少鸿[2] 李卓荣[1] 

机构地区：[1]中国医学科学院北京协和医学院医药生物技术研究所,北京100050 [2]中国药品生物制品检定所,北京100050

出　　处：《药物分析杂志》2010年第6期1080-1083,共4页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:以统计学为工具建立1种评定溶出度测定结果的不确定度的数学模型,科学地对溶出度测定结果误差有1个定量、准确的描述,使复验结果更加可靠和有说服力。方法:按照中国药典2005年版[1]收载的方法,对2个厂家的速释型固体口服制剂(Immediate Release Solid Oral Dosage Forms,IR)(3批利福平胶囊和3批头孢拉定胶囊)溶出度进行了复验,并根据测量结果不确定度评价原理,结合具体实验操作步骤,对溶出度复验测定结果进行不确定度评价。结果:3批利福平胶囊的溶出度复验测定结果分别为:52.1%,21.9%,32.7%,相对扩展不确定度为3.0%(k=2);3批头孢拉定胶囊的溶出度仲裁结果分别为:52.0%,57.6%,62.2%,相对扩展不确定度为6.2%(k=2)。结论:对复验的溶出度测定结果进行不确定评价,计算出相对扩展不确定度,保证了复验结果的科学、合理、公正,能够严格控制药品质量。Objective：To establish a mathematical model and evaluate the uncertainty of the measurement of dissolution rate with a scientific,statistically based approach and achieve a convincing and science based result in the process of arbitration test.Methods：Dissolution rate of two kinds of immediate release solid oral dosage forms,cefradine capsule（3 batches）and rifampicin capsules（3 batches）,were re-tested（arbitration test）,and consequently,the uncertainty of dissolution rate measurement were evaluated base on the guideline of uncertainty evaluation and the testing procedure.Results：The dissolution rate for three batches of rifampicin were 52.1%,21.9%,and 32.7% respectively,with an expanded uncertainty of 3.0%（k=2）;the dissolution rate for three batches of cefradine were 52.0%,57.6%,and 62.2% respectively,with an expanded uncertainty of 52.0%（k=2）.Conclusion：Evaluation of the uncertainty of dissolution rate measurement makes a scientific explanation and interpretation of the testing data;ensure the results of arbitration test are more accurate,impartial,and convincing.

关 键 词：测量不确定度 复验 溶出度 利福平胶囊 头孢拉定胶囊 

分 类 号：R917[医药卫生—药物分析学]