Research progress in impurity control of ursodeoxycholic acid
- VernacularTitle:熊去氧胆酸的杂质控制研究进展
- Author:
Xuelin SUN
1
;
Wenfeng XU
1
;
Xin HU
2
Author Information
1. Dept. of Pharmacy，Beijing Hospital，Beijing 100730，China;National Center of Gerontology/Institute of Geriatric Medicine，Chinese Academy of Medical Sciences，Beijing 100730，China;Beijing Key Laboratory of Assessment of Clinical Drugs Risk and Individual Application（Beijing Hospital ），Beijing 100730，China
2. Dept. of Pharmacy，Beijing Hospital，Beijing 100730，China;National Center of Gerontology/Institute of Geriatric Medicine，Chinese Academy of Medical Sciences，Beijing 100730，China
- Publication Type:Journal Article
- Keywords:
ursodeoxycholic acid;
chemical synthesis;
impurities;
quality control
- From:
China Pharmacy
2022;33(21):2681-2684
- CountryChina
- Language:Chinese
-
Abstract:
Ursodeoxycholic acid （UDCA）is a natural hydrophilic bile acid derived from cholesterol ，which has a low content in human body ，and can be used for the treatment of gallstones ，cholestatic liver disease ，fatty liver and so on . Due to the differences in the synthesis process ，source of active pharmaceutical ingredients （API）and impurity control standards of UDCA at home and abroad ，the author summarized the synthesis process of UDCA at home and abroad by searching relevant literature ，and analyzed the impurity sources and impurity control standards of API . The results showed that the pharmacopoeia of the United States，the United Kingdom and Europe put forward clear requirements on the synthesis route and impurity control of UDCA ，and formulated corresponding impurity control standards . However，synthesis process and impurity detection standards of UDCA were relatively simple in China . It is suggested that domestic research institutions constantly improve impurity spectrum ，promote the synthesis process ，and improve the quality detection standards of UDCA ，so as to provide a reference for pharmaceutical study and reasonable clinical application of UDCA .
