不确定度在速释型固体口服制剂溶出度复验中的应用

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.