中国药物评价2024，Vol.41Issue(2)：110-114,5.
动态显色法定量检测泊沙康唑原料药中细菌内毒素的含量
Quantitative Determination of Bacterial Endotoxin in Posaconazole Active Pharmaceutical Ingredients by Kinetic Chromogenic Assay
周年 1王振 2刘宁1
作者信息
- 1. 江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌 330029
- 2. 江西青峰药业有限公司,江西赣州 341000
- 折叠
摘要
Abstract
Objective:To establish a kinetic chromogenic method for the quantification of bacterial endotoxin in water-insoluble active pharmaceutical ingredients(API)of posaconazole.Methods:Based on the clinical dosage of posaconazole injection,a strict limit of 0.25 EU·mg-1 for the posaconazole API was formulated.The posaconazole API was dissolved with a diluent(dimethyl sulfoxide:RIPA strong lysis solution=1∶1)as a solvent,and kinetic chromogenic limulus amebocyte lysate reagents from two manufacturers were used.According to method 2(photometry)in the general rule 1143 in the Chinese Pharmacopoeia(2020 Edition,Volume Ⅳ),the mass concen-tration range of the sample was determined using the kinetic chromogenic assay.Finally,the bacterial endotoxin of three batches of sam-ples was quantitatively detected.Results:The absolute correlation coefficients of the standard curves of limulus amebocyte lysate from two manufacturers were greater than 0.980.When the sample mass concentration was ≤0.02 mg·mL-1,the recoveries of bacterial endotox-in were in the range;The quantitative detection results of bacterial endotoxin in three batches of samples all met the requirements.Conclusion:With a limit of 0.25 EU·mg-1,the kinetic chromogenic assay is feasible and controllable for the quantitative determination of bacterial endotoxin in water insoluble posaconazole API.关键词
泊沙康唑/细菌内毒素/动态显色法/不溶于水/原料药/鲎试剂Key words
Posaconazole/Bacterial Endotoxin/Kinetic Chromogenic Assay/Insoluble/Active Pharmaceutical Ingredients/Limulus Amebocyte Lysate分类
医药卫生引用本文复制引用
周年,王振,刘宁..动态显色法定量检测泊沙康唑原料药中细菌内毒素的含量[J].中国药物评价,2024,41(2):110-114,5.
