维生素A棕榈酸酯原料细菌内毒素检查方法研究

Investigation on bacterial endotoxin detection method of vitamin A palmitate raw material

目的:建立维生素A棕榈酸酯细菌内毒素检查法质量标准。方法:维生素A棕榈酸酯以98%乙醇为溶剂溶解,再用细菌内毒素检查用水稀释制成乳浊液,依照《中国药典》2020年版(四部)1143细菌内毒素检查法,对维生素A棕榈酸酯细菌内毒素检查法进行干扰试验预试验和干扰试验,同时增加细菌内毒素回收干扰试验预试验和干扰试验。结果:维生素A棕榈酸酯在实验过程中出现的复析、乳浊现象对细菌内毒素检查无影响,维生素A棕榈酸酯在0.015625 mg·mL^(-1)浓度下对细菌内毒素检查无干扰作用。两个不同厂家各3批维生素A棕榈酸酯的细菌内毒素检查结果符合规定。结论:本法可用于维生素A棕榈酸酯细菌内毒素的质量控制。

Objective:To establish quality standards for vitamin A palmitate bacterial endotoxin testing.Methods:Vitamin A palmitate was dissolved with 98%ethanol as solvent,and then diluted with water for bacterial endotoxin test to make emulsion,in accordance with the Chinese Pharmacopoeia 2020 PartⅣ1143 bacterial endotoxin inspection method,vitamin A palmitate bacterial endotoxin test method interference test pre-test and interference test,while increasing bacterial endotoxin recovery interference test pre-test and interference test.Results:The reanalysis and turbidity of vitamin A palmitate in the experimental process had no effect on the bacterial endotoxin examination,and vitamin A palmitate had no interference effect on the bacterial endotoxin examination at a concentration of 0.015625 mg·mL^(-1).The results of bacterial endotoxin test results of 3 batches of vitamin A palmitate from two different manufacturers were in accordance with the regulations.Conclusion:This method can be used for the quality control of vitamin A palmitate bacterial endotoxin.