Critical quality attribute assessment of big brand traditional Chinese medicine: study on NIR field detection method of chemical properties of moisture in Tongren Niuhuang Qingxin Pills.
10.19540/j.cnki.cjcmm.20210205.305
- Author:
Yu-Nan WEI
1
;
Xing-Guo HUANG
1
;
Jing-Qi ZENG
1
;
Qian-Qian LI
1
;
Li-Juan MA
1
;
Le-Ting LEI
1
;
Han ZHANG
1
;
Lu YAO
2
;
Shu-Ying WANG
2
;
Zhi-Sheng WU
1
Author Information
1. School of Chinese Materia Medica, Beijing University of Chinese Medicine Beijing 102488, China Engineering Research Center of Chinese Medicine Production and New Drug Development, Ministry of Education Beijing 102488, China.
2. National Engineering Research Center for R&D of TCM Multi-ingredient Drugs, Institute of Science, Beijing Tongrentang Co., Ltd. Beijing 100079, China.
- Publication Type:Journal Article
- Keywords:
NIR;
Tongren Niuhuang Qingxin Pills;
big brand traditional Chinese medicine;
critical quality attribute;
field detection;
moisture content
- MeSH:
Drugs, Chinese Herbal;
Least-Squares Analysis;
Medicine, Chinese Traditional;
Spectroscopy, Near-Infrared
- From:
China Journal of Chinese Materia Medica
2021;46(7):1592-1597
- CountryChina
- Language:Chinese
-
Abstract:
For the field detection problems of critical quality attribute(CQA) of moisture content in traditional Chinese medicine(TCM) manufacturing process, big brand TCM Tongren Niuhuang Qingxin Pills were used as the carrier, to establish a moisture content NIR field detection model with or without cellophane in real world production with use of near infrared(NIR) spectroscopy combined with stoichiometry. With the moisture content determined by drying method as reference value, the partial least square method(PLS) was used to analyze the correlation between the spectrum and the moisture reference value. Then the spectral pretreatment methods were screened and optimized to further improve the accuracy and stability of the model. The results showed that the best quantitative model was developed by the spectral data pretreatment of standard normal variate(SNV) with the latent variable factor number of 2 and 7 of Tongren Niuhuang Qingxin Pills with or without cellophane samples. The prediction coefficient of determination(R_(pre)~2) and standard deviation of prediction(RMSEP) of the model with cellophane samples were 0.765 7 and 0.157 2%; R_(pre)~2 and RMSEP of the model without cellophane samples were 0.772 2 and 0.207 8%. The NIR quantitative models of moisture content of Tongren Niuhuang Qingxin Pills with and without cellophane both showed good predictive performance to realize the rapid, accurate and non-destructive quantitative analysis of moisture content in such pills, and provide a method for the field quality control of the critical chemical attributes of moisture in the manufacturing of big brand TCM.
