Guo X J, He C F, Luo X, Wang X
Shenyang College of Pharmacy.
Yao Xue Xue Bao. 1992;27(9):695-700.
In this paper, the constant and proportional systematic errors of analytical methods for the content uniformity test were studied with reference to the accurate analytical method for the assay. Seven monographs of tablets admitted to USP(XXII), Ch P (1985, 1990) and JP(XI) were taken as cases in point and the systematic errors of two of them, i.e. digoxin and nitroglycerin tablets, were ascertained by the test of significance. To improve the accuracy of analytical methods for the content uniformity test, a correction formula more reasonable and convincing than that of USP (XXI, XXII) was proposed, and its theoretical basis described briefly.
本文参照含量测定的准确分析方法，对含量均匀度检查分析方法的恒定系统误差和比例系统误差进行了研究。以美国药典（第XXII版）、中国药典（1985年版、1990年版）和日本药局方（第XI版）收载的7种片剂品种为例，对其中地高辛片和硝酸甘油片两种片剂的系统误差进行了显著性检验。为提高含量均匀度检查分析方法的准确性，提出了一个比美国药典（第XXI版、XXII版）更为合理、有说服力的校正公式，并简要阐述了其理论依据。
