Monitoring method of extraction process for Schisandrae Chinensis Fructus based on near infrared spectroscopy and multivariate statistical process control.
10.19540/j.cnki.cjcmm.20170901.015
- Author:
Min XU
1
;
Lei ZHANG
2
;
Hong-Shui YUE
2
;
Hong-Wei PANG
2
;
Zheng-Liang YE
2
;
Li DING
1
Author Information
1. Department of Pharmaceutical Analysis, China Pharmaceutical University, Nanjing 210009, China.
2. Tianjin Tasly Pride Pharmaceutical Co．, Ltd．, Tianjin 300402, China.
- Publication Type:Journal Article
- Keywords:
Yiqi Fumai lyophilized injection;
extraction process of Schisandrae Chinensis Fructus;
multivariate statistical process control;
near infrared spectroscopy (NIR)
- From:
China Journal of Chinese Materia Medica
2017;42(20):3906-3911
- CountryChina
- Language:Chinese
-
Abstract:
To establish an on-line monitoring method for extraction process of Schisandrae Chinensis Fructus, the formula medicinal material of Yiqi Fumai lyophilized injection by combining near infrared spectroscopy with multi-variable data analysis technology. The multivariate statistical process control (MSPC) model was established based on 5 normal batches in production and 2 test batches were monitored by PC scores, DModX and Hotelling T2 control charts. The results showed that MSPC model had a good monitoring ability for the extraction process. The application of the MSPC model to actual production process could effectively achieve on-line monitoring for extraction process of Schisandrae Chinensis Fructus, and can reflect the change of material properties in the production process in real time. This established process monitoring method could provide reference for the application of process analysis technology in the process quality control of traditional Chinese medicine injections.
