1·OBJECTIVE: This paper reported the asynchronous six points method on the base of the classical method and the pharmacopeia method.
目的:在经典法与药典法基础上,提出了异步六点法。
2·Methods The methods of bacterial endotoxins test and pyrogen test in Chinese pharmacopeia 2000 were used.
方法参照中国药典2000年版细菌内毒素检查法及热原检查法。
3·Method: referring to the 2000 edition pharmacopeia, the sample was disposed and tested according to every items' demand of stability trial of new medicine preparation.
方法:参照中国药典2000年版,按照新药研制稳定性试验各项要求,对样品进行处理和检测。
4·According to Section 501 of the Federal Food Drug and Cosmetic Act assays and specifications in monographs of the United States Pharmacopeia and the National Formulary constitute legal standards.
要依据美国食榀、药榀、化让路法案501款以及美国药典和国家处方集的各论中的含量测定和质量标准来构建法定标准。
5·RESULTS:Processing tortoise shell with vingar is better than that of heating with sand and boiling with vinegar, which was recorded in pharmacopeia of china, 1995.
龟甲炮制品研极细粉入药比1995年版《中国药典》的用时捣碎为优。