Evaluation of key production processes of Schizonepetae Herba formula granules based on characteristic chromatogram and quantitative transfer relationship.
10.19540/j.cnki.cjcmm.20200207.301
- Author:
Wen-Jun YIN
1
;
Jie-Yu HE
1
;
Xin XU
1
;
Cai-Zhen LIAO
2
;
Lan TANG
1
;
Ji-Zhong YAN
1
;
Hui ZHANG
1
Author Information
1. Traditional Chinese Medicine Research Institute, College of Pharmaceutical Sciences, Zhejiang University of Technology Hangzhou 310014, China.
2. Zhejiang Benefit Pharmaceutical Co., Ltd. Lishui 323000, China Zhejiang Yuanda Pharmaceutical Technology Co., Ltd. Lishui 323000, China.
- Publication Type:Journal Article
- Keywords:
Schizonepetae Herba;
characteristic chromatogram;
formula granules;
production process;
pulegone;
quantitative transfer relationship
- MeSH:
Chromatography, High Pressure Liquid;
Drugs, Chinese Herbal/chemistry*;
Lamiaceae/chemistry*;
Medicine, Chinese Traditional;
Quality Control
- From:
China Journal of Chinese Materia Medica
2020;45(6):1357-1362
- CountryChina
- Language:Chinese
-
Abstract:
The aim of this paper was to evaluate the key production processes of Schizonepetae Herba formula granules based on the new model of combining characteristic chromatogram with quantitative transfer relationship. The rationality of production process design was evaluated by studying the intermediates in different processes of formula granules, analyzing the loss of index component pulegone in each step, and establishing the characteristic chromatogram. The content of pulegone in 10 batches of standard decoction ranged between 0.067% and 0.124%(70%-130% of the average value), and the transfer rate of pulegone was 44.58%-93.97%. After the improvement of the production process, the content of pulegone in Schizonepetae Herba formula granules was 0.093%, and the transfer rate of pulegone was 68.38%, which was consistent with the parameters range of standard decoction. This study emphasized the integrality of the research process of traditional Chinese medicine(TCM) formula granules, and provided a new idea for the quality control of TCM with content determination as the main evaluation index for a long time.
