注射用醋酸奥曲肽微球细菌内毒素检查法研究

Study on bacterial endotoxin test of octreotide acetate microspheres for injection

目的:对注射用醋酸奥曲肽微球细菌内毒素检查法进行方法学验证。方法:参照《中华人民共和国药典》2020年版四部通则1143方法Ⅰ(凝胶法),用二甲基亚砜(DMSO)溶解注射用醋酸奥曲肽微球并用水稀释制成溶液,对此溶液用2个厂家凝胶法鲎试剂进行了干扰实验和内毒素回收实验。结果:注射用醋酸奥曲肽微球浓度稀释至0.007 mg·mL^(-1)对细菌内毒素与鲎试剂的反应无干扰,DMSO溶解液细菌内毒素回收率在50%~200%之间,可以用DMSO溶解注射用醋酸奥曲肽微球进行细菌内毒素检查。结论:细菌内毒素检查法适用于注射用醋酸奥曲肽微球的检查。

Objective:To verify the method of bacterial endotoxin test for octreotide acetate microspheres for injection. Methods:According to the bacterial endotoxin test method of Chinese Pharmacopoeia(2020 edition), octreotide acetate microspheres for injection was dissolved by DMSO and diluted with water. Interference test and endotoxin recovery test were carried out with two manufacturers’ gel limulus amebocyte lysate. Results:There was no interference between bacterial endotoxin and limulus reagent when the concentration of octreotide acetate microspheres for injection was diluted to 0.007 mg·mL^(-1). The recovery of bacterial endotoxin in DMSO solution was between 50% and 200%. DMSO can be used for dissolving octreotide acetate microsphere to perform bacterial endotoxin test. Conclusion:Bacterial endotoxin test is suitable for the detection of octreotide acetate microspheres for injection.