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%。
Abstract
OBJECTIVE To discuss the problem of instrumental test method of clarity and degree of opalescence of liquids in the general notice 0902 of China Pharmacopeia(Ch.P)2015, find out the causes and offer solutions. METHODS The test methods of clarity in Ch.P 2015 and European Pharmacopeia (EP) 8.0 were compared, including instrumental types, applicability, sample requirements, and result evaluation. RESULTS The primary opalescent suspension for the instrumental method is the same as the visual method, using the absorbance (A=0.12-0.15) at 550 nm to control the opalescence. Because the resolving power of the instrumental method is far higher than the visual method, the limit becomes interval distribution instead of simple point. The opalescent value (NTU) of the upper limit (A=0.15) is about 1.35 times of the lower limit (A=0.12).When the NTU value of the test liquid is in this interval, the result evaluation will be hard.CONCLUSION The preparation of the primary opalescent suspension in Ch.P 2015 is different from EP8.0. For this reason, the limit set by Ch.P 2015 is actually stricter than that of EP8.0. The opalescent value of the standard solution used by Ch.P 2015 is about 75% of that used by EP8.0.
关键词
澄清度 /
仪器分析法 /
限度 /
合格判断 /
2015年版《中国药典》
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Key words
turbidity /
instrumental method /
limit /
result evaluation /
Ch.P 2015
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中图分类号：
R917
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参考文献
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