Critical quality attribute assessment of big brand traditional Chinese medicine: visualization of blending process for rare medicines in Tongren Niuhuang Qingxin Pills based on spatial distribution uniformity.
10.19540/j.cnki.cjcmm.20210218.303
- Author:
Fang-Yu ZHANG
1
;
Ling LIN
1
;
Jing-Qi ZENG
1
;
Ming-Li ZHU
1
;
Ying LU
1
;
Han ZHANG
1
;
Qian-Qian LI
1
;
Li-Juan MA
1
;
Lu YAO
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 Multiingredient Drugs, Institute of Science, Beijing Tongrentang Co., Ltd. Beijing 100079, China.
- Publication Type:Journal Article
- Keywords:
Tongren Niuhuang Qingxin Pills;
big brand traditional Chinese medicine;
critical quality attribute;
hyperspectral imaging;
mixing uniformity of rare medicines;
production in real world
- MeSH:
Drugs, Chinese Herbal;
Medicine, Chinese Traditional;
Powders;
Quality Control
- From:
China Journal of Chinese Materia Medica
2021;46(7):1585-1591
- CountryChina
- Language:Chinese
-
Abstract:
The spatial distribution uniformity of valuable medicines is the critical quality attribute in the process control of Tongren Niuhuang Qingxin Pills. With the real world sample of the mixed end-point powder of Tongren Niuhuang Qingxin Pills as the research object, hyperspectral imaging technology was used to collect a total of 32 400 data points with a size of 180 pix×180 pix. Spectral angle matching(SAM), classical least squares and mixed tuned matched filtering(MTMF) were used to identify the spatial distribution of rare medicines. MTMF model showed higher identification accuracy, therefore the spatial distribution of the blended intermediates was identified based on the MTMF model. The histogram method was also used to evaluate the spatial distribution uniformity of rare medicines. The results showed that the standard deviation was 4.78, 6.5, 3.48, 1.96, and 3.00 respectively for artificial bezoar, artificial musk, Borneol, Antelope horn and Buffalo horn; the variance was 22.8, 42.3, 12.1, 3.82, and 9.00, and the skewness was 1.26, 1.71, 0.06,-0.86, and 1.04, respectively. The final results showed that the most even blending was achieved in concentrated powder of Borneol, Antelope horn and Buffalo horn, followed by artificial bezoar, and last artificial musk. A visualization method was established for quality attributes of distribution uniformity in blending process of Tongren Niuhuang Qingxin Pills. It could provide evidences of quality control methods in the mixing process of big brand traditional Chinese medicine.
