硫酸庆大霉素盐酸林可霉素注射液细菌内毒素检查法的建立

Establishment of a bacterial endotoxin test for gentamicin sulfate and lincomycin hydrochloride injection

目的建立硫酸庆大霉素盐酸林可霉素注射液细菌内毒素检查方法。方法按照2015版《中国兽药典》附录1143“细菌内毒素检查法”项下凝胶法的要求,根据干扰试验确定样品成分最小不干扰稀释倍数,并进行方法学验证及3批中试产品细菌内毒素检查。结果供试品最小不干扰倍数为100倍,3批中试产品细菌内毒素检查均符合要求。结论建立的方法能够用于硫酸庆大霉素盐酸林可霉素注射液细菌内毒素检查,其细菌内毒素限制为37.5EU/mL。

Objective To establish a bacterial endotoxin test method for gentamicin sulfate and lincomycin hydrochloride injection.Methods According to the requirements of the gel method under the“bacterial endotoxin test”in appendix 1143 of Chinese veterinary pharmacopoeia(2015 edition),the minimum non-interference dilution multiples of the sample components were determined based on the interference test,and the methodological verification and the bacterial endotoxin test of three batches of pilot products were carried out.Results The minimum non-interference multiple of the test product was 100 times,and the bacterial endotoxin test of the three batches of pilot products met the requirements.Conclusion The established method can be used in the bacterial endotoxin test of gentamicin sulfate and lincomycin hydrochloride injection,and the bacterial endotoxin limit is 37.5EU/mL.