茴香注射液热原检查方法学研究

Validation on the Pyrogen Test of Red Fennel Injection

目的:验证红茴香注射液热原检查的适用性。方法:参考《中国药典》2010年版一部附录中药注射剂安全性检查法应用指导原则,对红茴香注射液进行热原检查的方法学验证。结果:红茴香注射液原液在剂量为1 mL.kg-1有一定的毒性反应,不适宜进行热原试验;10倍稀释液对热原检查无干扰。结论:可用热原检查法检查红茴香注射液中可能存在的热原,浓度为其10倍稀释液,剂量为1 mL.kg-1。

Objective： To explore the applicability of pyrogen test on Red Fennel Injection. Methods： Refer to the Chinese pharmaco- poeia 2010 edition appendix TCM injections safety test application guidelines, methodology validation of pyrogen test of Red Fennel In- jection was carried on. Results： The Red Fennel Injection is unsuitable for pyrogen test because of its toxicity reaction at dose of 1 mL · kg-1 ,but the solution diluted up to 10 times did not interfere with pyrogen test. Conclusion： Pyrogen test can be used for checking pyrogen existing in Red Fennel Injection at the dose of 1 mL · kg-1 of its 10 times diluted concentration.