Real time release testing of disintegration time of uncoated Tianshu Tablets.
10.19540/j.cnki.cjcmm.20191219.303
- Author:
Chun-Yan XIA
1
;
Bing XU
2
;
Fang-Fang XU
3
;
Xin ZHANG
3
;
Qing WANG
1
;
Hui DU
1
;
Le-Wei BAO
3
;
Zhen-Zhong WANG
3
;
Yan-Jiang QIAO
2
;
Wei XIAO
1
Author Information
1. Nanjing University of Chinese Medicine Nanjing 210023, China Jiangsu Kanion Pharmaceutical Co., Ltd.,State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, National & Local Joint Engineering Research Center on Intelligent Manufacturing of Traditional Chinese Medicine, Key Laboratory of New Technology for Extraction and Refining of Traditional Chinese Medicine Lianyungang 222001, China.
2. Department of Chinese Medicine Information Science, Beijing University of Chinese Medicine Beijing 102400, China.
3. Jiangsu Kanion Pharmaceutical Co., Ltd.,State Key Laboratory of New-tech for Chinese Medicine Pharmaceutical Process, National & Local Joint Engineering Research Center on Intelligent Manufacturing of Traditional Chinese Medicine, Key Laboratory of New Technology for Extraction and Refining of Traditional Chinese Medicine Lianyungang 222001, China.
- Publication Type:Journal Article
- Keywords:
Tianshu Tablets;
critical material attributes(CMAs);
design space;
disintegration time;
real time release test(RTRT);
uncoated tablets
- MeSH:
Drug Compounding;
Drug Liberation;
Drugs, Chinese Herbal/chemistry*;
Least-Squares Analysis;
Solubility;
Tablets
- From:
China Journal of Chinese Materia Medica
2020;45(2):250-258
- CountryChina
- Language:Chinese
-
Abstract:
In this paper, a real time release testing(RTRT) model for predicting the disintegration time of Tianshu tablets was established on the basis of the concept of quality by design(QbD), in order to improve the quality controllability of the production process. First, 49 batches of raw materials and intermediates were collected. Afterwards, the physical quality attributes of all materials were comprehensively characterized. The partial least square(PLS) regression model was established with the 72 physical quality attributes of raw materials and intermediates as input and the disintegration time(DT) of uncoated tablets as output. Then, the variable screening was carried out based on the variable importance in the projection(VIP) indexes. Moisture content of raw materials(%HR), tapped density of wet masses(D_c), hygroscopicity of dry granules(%H), moisture content of milling granules(%HR) and Carr's index of mixed granules(IC) were determined as the potential critical material attributes(pCMAs). According to the effects of interactions of pCMAs on the performance of the prediction model, it was finally determined that the wet masses' D_c and the dry granules'%H were critical material attributes(CMAs). A RTRT model of the disintegration time prediction was established as DT=34.09+2×D_c+3.59×%H-5.29×%H×D_c,with R~2 equaling to 0.901 7 and the adjusted R~2 equaling to 0.893 3. The average relative prediction error of validation set for the RTRT model was 3.69%. The control limits of the CMAs were determined as 0.55 g·cm~(-3)
