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鲎试验法(以下简称鲎法)是利用鲎试剂与细菌内毒素产生凝集反应形成凝胶,以判断供试品中细菌内毒素的限量是否符合规定的一种方法。本法具有快速、灵敏、简易、经济、实用性强等优点,因此受到世界各国科学家们的普遍重视。目前已被世界科学较发达国家如美,英、欧洲药典所收载。我国于1988年10月由中华人民共和国卫生部中国药典委员会颁布了《细菌内毒素检查法和鲎试剂标准(试行)》,并仅做为注射用水、氯化钠注射液、5％和10％葡萄糖注射液细菌内毒素的检查方法。我们参考国内外资料,从1981年开始将此法应用在大输液内毒素的检验,证明该法有实用价值,并把实践中应用的体会写成了《鲎试验检测输液热原的体会》一文载于《辽宁药检通讯》杂志(1987年第一期44页)。我们所阐述的理论及供试品的稀释公式被后来国内外文献报道所证实,是基本一致的。然而,有大量的需要做热原检查的品种,还仍用传统的兔法(费时、费力、不经济),这些品种是否可应用快速、灵敏、经济的鲎法来检查,是科学工作者急待解决的问题。鉴于上述情况,我们从1989年末开始把鲎法应用到抗生素,Vc等注射液的原料药,
鲎 test method (hereinafter referred to as 鲎 law) is the use of 鲎 agents and bacterial endotoxin agglutination reaction to form a gel to determine whether the limits of bacterial endotoxin in the test article is in compliance with the provisions of a method. This law is fast, sensitive, simple, economical, practical and so on, so it has been widely valued by scientists all over the world. At present, it has been accepted by the more developed countries in the world such as the United States, Britain and the European Pharmacopoeia. China in October 1988 by the People’s Republic of China Ministry of Health of the Chinese Pharmacopoeia Commission promulgated the “bacterial endotoxin test method and 鲎 reagent standards (Trial)” and only as water for injection, sodium chloride injection, 5% and 10% Bacterial endotoxin test in glucose injection. We refer to domestic and foreign information, since 1981, this method is applied to the test of the large transfusion endotoxin, proving that the law has practical value, and put the experience of practice written as a “test to test the experience of transfusion pyrogen” article In the “Liaoning Pharmaceutical News” magazine (1987 first phase 44). The theory we have expounded and the dilution formula for the test products have been confirmed by later reports in the literature both at home and abroad, which are basically the same. However, there are a large number of varieties that need to be examined for pyrogen, and the traditional method of rabbit (time-consuming, labor-intensive and uneconomic) is still used. Whether these varieties can be checked quickly, sensitively and economically is a problem for scientists Problem to be solved. In view of the above, we started from the end of 1989 to apply the law to antibiotics, Vc and other injection of API,