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参麦注射液热原检查的适用性研究
引用本文:张文婷,匡荣,朱社敏. 参麦注射液热原检查的适用性研究[J]. 药物评价研究, 2013, 0(3): 184-186
作者姓名:张文婷  匡荣  朱社敏
作者单位:浙江省食品药品检验研究院,浙江杭州310004
摘    要:目的对热原检查标准制订时开展适用性研究的必要性进行探讨。方法选用参麦注射液按《中国药典》2010年版一部附录ⅩⅧB"中药注射剂安全性检查法应用指导原则"进行热原检查适用性研究。结果参麦注射液热原检查不干扰给药剂量为3mL/kg;参麦注射液给药剂量为5mL/kg时,对细菌内毒素致家兔体温升高有干扰。结论中药注射剂的热原检查有必要进行适用性研究。

关 键 词:热原检查  适用性研究  参麦注射液

Applicability research for pyrogen test of Shenmai Injection
ZHANG Wen-ting,KUANG Rong,ZHU She-min. Applicability research for pyrogen test of Shenmai Injection[J]. Drug Evaluation Research, 2013, 0(3): 184-186
Authors:ZHANG Wen-ting  KUANG Rong  ZHU She-min
Affiliation:Zhejiang Institute for Food and Drug Control, Hangzhou 310004, China
Abstract:Objective To explore the necessity of applicability research when the standards of pyrogen test were formulated. Methods Shenmai Injection (SI) was chosen to formulate the applicability research of pyrogen test according to appendix Ⅹ Ⅷ B of Chinese Pharmacopoeia 2010 "Guidelines for Application of Safety Tests for Injection of Traditional Chinese Medicines". Results The no-interfering dose of pyrogen test of SI was 3 mL/kg, and the SI (5 mL/kg) interfered the increasing of rabbit body temperature induced by bacterial endotoxin. Conclusion The applicability research is necessary for the pyrogen test for the injection of traditional Chinese medicines.
Keywords:pyrogen test  applicability research  Shenmai Injection
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