Establishment of Bacterial Endotoxin Test for an Insoluble Drug Substance
- VernacularTitle:一种难溶性原料药细菌内毒素检查方法的建立
- Author:
Chengqian YAN
1
;
Meimei HUANG
;
Hongping WANG
;
Lu ZHAO
;
Zuyuan RONG
;
Nan ZENG
Author Information
1. 成都中医药大学 成都611137
- Keywords:
Bacterial endotoxin test;
Interference test;
Insoluble drug substance;
HSSYO-001-3S
- From:
China Pharmacist
2018;21(2):365-368
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish the bacterial endotoxin test for HSSYO-001-3S. Methods: HSSYO-001-3S was dissolved in dimethylsulfoxide,diluted by BET water and centrifuged,and then the supernatant was used for the bacterial endotoxin test. The ex-periment was carried out according to the gel-clot technique for bacterial endotoxin inspection and the related regulations in Chinese Pharmacopoeia (2015 edition,volumeⅣ,general rule 1443). Results:HSSYO-001-3S was added with cosolvent and diluted by BET water to 1 mg·ml-1,and there was no interference effects to bacterial endotoxin test from the supernatant diluted four times or more. Conclusion:Bacterial endotoxin test can be used to control the quality of HSSYO-001-3S.
