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目的探讨2015年版《中国药典》通则0902澄清度第二法(浊度仪法)测定中出现问题的成因并提出解决方案。方法 2015年版《中国药典》和现行版《欧洲药典》澄清度检查第二法。结果由于浊度仪法的分辨力远高于目测法,当浊度标准原液吸光度符合要求时(A=0.12~0.15),由其稀释配制的各级号标准液的浊度示值均成区间分布。因此,在实际工作中可出现采用第二法测定难以判断供试品是否符合规定的情况。结论本实验对上述两国药典澄清度检查法中的诸操作环结进行了系统比较,发现浊度标准液配制方法的差异,导致《中国药典》各浊度标准液的浊度值约为欧洲药典对应浊度值的75%。
Objective To explore the causes of the problems in the determination of the second method (turbidity meter method) of clarification of 0902 in the “Chinese Pharmacopoeia” in the 2015 edition and propose solutions. Methods 2015 version of “Chinese Pharmacopoeia” and the current version of the “European Pharmacopoeia” Clarity check second method. Results As the turbidity analyzer method resolution is much higher than the visual method, when the turbidity standard stock solution absorbance meet the requirements (A = 0.12 ~ 0.15), prepared by the dilution standards for all grades of turbidity indicators are interval distributed. Therefore, in practice, there may be cases in which it is difficult to determine whether the test product is in compliance with the second method. Conclusions This experiment systematically compares the operation loops of the two Chinese Pharmacopoeia Clarification Tests and finds that the difference of the preparation methods of the turbidity standard solution leads to the turbidity value of each turbidity standard solution of the Chinese Pharmacopoeia is about Europe Pharmacopoeia corresponds to 75% of the turbidity value.