Quality analysis of Guizhi Fuling capsule before and after application of in-process quality control in pharmaceutical production.
- Author:
Jia-chun LI
;
Jin-ling WANG
;
Jing-ling WU
;
Wen-zhe HUANG
;
Zhen-zhong WANG
;
Wei XIAO
- Publication Type:Journal Article
- MeSH:
Capsules;
chemistry;
Chemistry, Pharmaceutical;
Chromatography, High Pressure Liquid;
Drugs, Chinese Herbal;
chemistry;
Quality Control
- From:
China Journal of Chinese Materia Medica
2015;40(6):1017-1022
- CountryChina
- Language:Chinese
-
Abstract:
The effects of application of in-process quality control in Guizhi Fuling capsule production were evaluated by 192 batches data analysis. Using a statistical analysis method, each batch of data were to be counted to research for the difference between 96 samples adopting the technologies of in-process control or not. According to quality standards of Guizhi Fuling capsule, all measurements of the 192 batches of the drugs before and after the application of process control technology were analyzed, and they were within the rules. There was a significant difference between adopting the technologies of process control or not. Application of in-process control technology can improve the uniformity of lot-to-lot for Guizhi Fuling capsule.
