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[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ⅩⅧ B“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3 mL/kg;参麦注射液给药剂量为5 mL/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。
[Key word]
[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.
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