注射剂安全性检查法应用指导原则（Guideline for the application of injection safety test）.docVIP

下载本文档

33
0
约1.43万字
约 11页
2017-09-23 发布于河南
举报
版权申诉

注射剂安全性检查法应用指导原则（Guideline for the application of injection safety test）.doc

1、原创力文档（book118）网站文档一经付费（服务费），不意味着购买了该文档的版权，仅供个人/单位学习、研究之用，不得用于商业用途，未经授权，严禁复制、发行、汇编、翻译或者网络传播等，侵权必究。。
2、本站所有内容均由合作方或网友上传，本站不对文档的完整性、权威性及其观点立场正确性做任何保证或承诺！文档内容仅供研究参考，付费前请自行鉴别。如您付费，意味着您自己接受本站规则且自行承担风险，本站不退款、不进行额外附加服务；查看《如何避免下载的几个坑》。如果您已付费下载过本站文档，您可以点击这里二次下载。
3、如文档侵犯商业秘密、侵犯著作权、侵犯人身权等，请点击“版权申诉”（推荐），也可以打举报电话：400-050-0827(电话支持时间：9:00-18:30)。
4、该文档为VIP文档，如果想要下载，成为VIP会员后，下载免费。
5、成为VIP后，下载本文档将扣除1次下载权益。下载后，不支持退款、换文档。如有疑问请联系我们。
6、成为VIP后，您将拥有八大权益，权益包括：VIP文档下载权益、阅读免打扰、文档格式转换、高级专利检索、专属身份标志、高级客服、多端互通、版权登记。
7、VIP文档为合作方或网友上传，每下载1次，网站将根据用户上传文档的质量评分、类型等，对文档贡献者给予高额补贴、流量扶持。如果你也想贡献VIP文档。上传文档

注射剂安全性检查法应用指导原则（Guideline for the application of injection safety test）

注射剂安全性检查法应用指导原则（Guideline for the application of injection safety test） Guideline for the application of injection safety test (Revised Version) This guideline defines the safety and quality control of injectable drugs for clinical use. The safety test of injection includes bacterial endotoxin test, pyrogen test, abnormal toxicity test, anaphylaxis test, depressor substance examination, hemolysis and coacervation test, etc.. According to the prescription of the injection, the raw material, the process, the usage and the dosage, etc., the corresponding examination items shall be set up, and the applicability of the project shall be examined with reference to the guiding principle. Check the formulation of the project I. traditional Chinese medicine injection (1) all the safety inspection items should be set up for intravenous injection. Because of the composition and interference of traditional Chinese medicine injection, the factors of bacterial endotoxin test are complex and changeable, and the pyrogen test is usually preferred. If the pharmacological action of the drug itself affects the body temperature or the acute toxicity of the rabbit, the method of bacterial endotoxins test may be used to check the pyrogen test. (two) intramuscular injection should be given abnormal toxicity, allergic substances and other items. Raw materials and processes are easy to pollute the pyrogen, and when the dosage is large, the pyrogen test should be considered. Two, chemical drugs (including antibiotics, biochemical drugs) injection (I) intravenous injection; 1, all intravenous injection should be set bacterial endotoxin (or pyrogen) inspection items. 2, when the raw materials used are animal sources or microbial fermentation extracts, such as the unclear structure of components, or the possibility of pollution toxicity, and the lack of effective physical and chemical analysis methods, we should consider the establishment of abnormal toxicity inspection items. 3, the raw material