摘要
用化学统计学方法,研究了药物制剂含量均匀度检查和含量测定,所用不同分析方法之间的系统误差及其校正方法。对中国药典(1985,1990),USP(ⅩⅫ)和JP(Ⅺ)收载的7个片剂品种的研究表明,地高辛片和硝酸甘油片各该不同分析方法之间存在的系统误差包括恒差和比例误差。本文扼要地讨论了确定恒差和比例误差的理论,并提出了相应的实验方法,从而提高了含量均匀度检查的判定准确性。给出的校正公式比USP(ⅩⅪ,ⅩⅫ)的对应公式更合理,更有说服力。
In this paper, the constant and proportional systematic errors of analytical methodsfor the content uniformity test were studied with reference to the accurate analytical method for theassay. Seven monographs of tablets admitted to USP(XXII), Ch P (1985, 1990) and JP(Ⅺ) weretaken as cases in point and the systematic errors of two of them, i.e. digoxin and nitroglycerinetablets, were ascertained by the test of significance. To improve the accuracy of analytical methods forthe content uniformity test, a correction formula more reasonable and convicing than that of USP(XXI,XXII) was proposed, and its theoretical basis described briefly.
出处
《药学学报》
CAS
CSCD
北大核心
1992年第9期695-700,共6页
Acta Pharmaceutica Sinica
基金
国家自然科学基金
关键词
药物含量
含量均匀度
分析
Content uniformity test
Systematic error
Constant error
Proportional error
