对中国药典(二○○五年版一部)收载细菌内毒素检查法的建议

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对中国药典 (二 0 0五年版一部 )收载细菌内毒素检查法提出建议 ,认为药典收载细菌内毒素检查法很有必要和可行 ,理由是 :该法是监控热原反应较成熟和国际上公认较理想的检测方法 ,收载细菌内毒素检查法能体现出药典的中国特色。收载该法更能促进生产厂家的重视 ,有利于该法的推广与使用。并认为中药注射剂的细菌内毒素检查法研究在我国已有一定基础和做了大量工作 ,有条件、有能力做好该项工作 ,并对如何做好该项工作提出几点措施和建议。 The Chinese Pharmacopoeia (2000 edition) to collect bacteria endotoxin inspection method proposed that the Pharmacopoeia bacteria bacterial endotoxin inspection method is necessary and feasible, the reason is that: the law is to monitor the pyrogen reaction is more mature and Internationally recognized as the ideal detection method, bacteria contained endotoxin test method can reflect the Chinese characteristics of Pharmacopoeia. It is more conducive to the promotion and use of the law by collecting the law to promote manufacturers’ attention. It is considered that the study of bacterial endotoxin test in Chinese medicine injection has a certain foundation and a great deal of work in our country. We have the necessary conditions and ability to do this work and put forward some measures and suggestions on how to do this work.
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