目的 對(duì)熱原檢查標(biāo)準(zhǔn)制訂時(shí)開(kāi)展適用性研究的必要性進(jìn)行探討。方法 選用參麥注射液按《中國(guó)藥典》2010年版一部附錄ⅩⅧ B“中藥注射劑安全性檢查法應(yīng)用指導(dǎo)原則”進(jìn)行熱原檢查適用性研究。結(jié)果 參麥注射液熱原檢查不干擾給藥劑量為3 mL/kg；參麥注射液給藥劑量為5 mL/kg時(shí)，對(duì)細(xì)菌內(nèi)毒素致家兔體溫升高有干擾。結(jié)論 中藥注射劑的熱原檢查有必要進(jìn)行適用性研究。

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.