注射用普鲁卡因细菌内毒素检查法可行性研究

目的：建立普鲁卡因注射液的细菌内毒素检查方法(动态浊度法，凝胶法)，以控制药品质量，减少临床热原反应的发生。方法：按《中国药典》2000版附录中细菌内毒素检测法及细菌内毒素检测法指导原则的规定^1]，系统考察注射用普鲁卡因对鲎试剂与细菌内毒素凝集反应的干扰，确定用于细菌内毒素动态浊度法和凝胶法的不干扰浓度。结果：将注射用普鲁卡因配制成1％浓度经20倍稀释后可应用动态浊度法定量检测；凝胶法最佳检测条件为：供试品1：20稀释，鲎试剂灵敏度(γ)=0．25EU／ml。结论：应用动态浊度法定量检测普鲁卡因注射液细菌内毒素含量，结果准确；凝胶法可用于日常检测。细菌内毒素检查法可替代家兔法用于普鲁卡因注射液的热原检查。

Study on feasibility a method for detection of bacterial endotoxin in Procaine Hydrochloride injection

Objective: In order to control drug quality and avoid clinical pyrogen reaction, establish a method for detection bacterial endotoxin in Procaine Hydrochloride injection. Methods: According to the guideline of bacterial endotoxin detection in appendix of China Pharmacopoeia 2 000, conduct systemic research on interferential factor of Procaine Hydrochloride injection to TAL test, find the appropriate concentration of the injection in detection by Kinetic turbidimetric assay or gel clot test. Results: Diluting 1% Procaine Hydrochloride injection 20 times can completely eliminate the interference to the TAL test. The optimal detecting situation: specimen diluting 20 times, TAL sensitivity 0.25 EU/ml. Conclusion: Quantitative detection of bacterial endotoxin in Procaine Hydrochloride injection by kinetic turbidimetric assay can obtain accurate result, and gal clot test can apply to general detection. The bacterial endotoxin detection can replace rabbit pyrogen test.