难溶性肾上腺素原料药细菌内毒素检查方法学研究
Bacterial Endotoxins Test Method Study of Active Pharmaceutical Ingredient of Insoluble Adrenaline
张菊 1吕晓君 1杨雅婷 1何开勇 1沈佳特1
作者信息
- 1. 湖北省药品监督检验研究院,湖北省药品质量检测与控制工程技术研究中心,国家药品监督管理局血液制品质量控制重点实验室,武汉 430064
- 折叠
摘要
目的 建立难溶性肾上腺素原料药细菌内毒素检查方法.方法 依照2020年版《中国药典》四部通则1143细菌内毒素检查法,用盐酸溶解肾上腺素,再用细菌内毒素检查用水(BET水)稀释,用凝胶法和动态浊度法进行干扰试验和内毒素回收干扰试验.结果 肾上腺素原料药用0.1 mol·L-1盐酸溶解制成质量浓度10mg·mL-1的溶液,再用BET水稀释200倍及以上作为供试品对细菌内毒素检查法无干扰作用.结论 建立的细菌内毒素检查方法可用于肾上腺素原料药的细菌内毒素检查,控制其产品质量.
Abstract
OBJECTIVE To establish a method for bacterial endotoxin test of active pharmaceutical ingredient(API)of insolu-ble adrenaline.METHODS According to the bacterial endotoxin test(BET)method in the general rule 1143 in the Chinese Pharmacopoeia(2020 Edition,Volume Ⅳ),adrenaline API was dissolved with hydrochloric acid and diluted with BET water.The gel method and kinetic turbidimetric assay were used to carry out interference test and endotoxin recovery interference verification test.RESULTS Adrenaline API was dissolved with 0.1 mol·L-1 hydrochloric acid to 10 mg·mL-1,and then diluted 200 times or more by BET water,which had no interference effects to bacterial endotoxin test.CONCLUSION The BET method established in this study can be used for the bacterial endotoxin test of adrenaline API of adrenaline to control the product quality.
关键词
细菌内毒素/难溶性/原料药/肾上腺素Key words
bacterial endotoxin/insolubility/API/adrenaline引用本文复制引用
出版年
2024
NETL
NSTL
万方数据