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利用鲎试验检测药品中细菌内毒素(热原),是一种快速、灵敏的方法,已被世界许多国家所公认.为改进我国药品热原检查方法,提高药品质量,中华人民共和国卫生部,根据“卫生部鲎试验协作研究组”提供的研究成果,于1988年10月颁布了“细菌内毒素检查法”和“鲎试剂标准”,并在全国试行.最近我们对该法试行情况进行了调查,现将调查情况小结如下(调查结果见表1～4).
It is a rapid and sensitive method to detect bacterial endotoxin (pyrogen) in medicine by using the test of 鲎, which has been recognized by many countries in the world.In order to improve the pyrogen test method and improve the quality of medicine in our country, the Ministry of Health of the People’s Republic of China, According to the research results provided by the Ministry of Health 鲎 Experimental Collaborative Research Group, the “Bacterial Endotoxin Test Method” and “鲎 Reagent Standards” were promulgated in October 1988 and were piloted throughout the country. Recently, we conducted a trial of the law Survey, the investigation is summarized as follows (survey results in Table 1 ~ 4).