Manufacturing classification system for oral solid dosage forms of traditional Chinese medicines(Ⅳ): classification of hygroscopicity behaviors of capsules.
10.19540/j.cnki.cjcmm.20230711.302
- Author:
Yu LIN
1
;
Huan-Zheng LI
1
;
Zi-Chen LIANG
2
;
Fang-Fang XU
3
;
Xin ZHANG
3
;
Zhen-Zhong WANG
4
;
Bing XU
2
;
Wei XIAO
4
Author Information
1. Nanjing University of Traditional Chinese Medicine Nanjing 210023, China.
2. Department of Chinese Medicine Informatics,Beijing University of Traditional Chinese Medicine Beijing 102488, China Beijing Key Laboratory of Chinese Medicine Production Process Control and Quality Evaluation, Bejing Municipal Science and Technology Commission Beijing 102488,China.
3. Jiangsu Kang Yuan Pharmaceutical Company Limited Lianyungang 222001, China National Key Laboratory on Technologies for Chinese Medicine Pharmaceutical Process Control and Intelligent Manufacture Lianyungang 222001, China.
4. Jiangsu Kang Yuan Pharmaceutical Company Limited Lianyungang 222001, China National Key Laboratory on Technologies for Chinese Medicine Pharmaceutical Process Control and Intelligent Manufacture Lianyungang 222001, China National & Local Joint Engineering Research Center of TCM Intelligent Manufacturing Technology Lianyungang 222001, China.
- Publication Type:Journal Article
- Keywords:
classification of hygroscopicity behaviors;
factors influencing hygroscopicity;
hygroscopicity curve;
partial least squares;
traditional Chinese medicine capsules
- MeSH:
Medicine, Chinese Traditional;
Wettability;
Capsules;
Powders;
Technology;
Drugs, Chinese Herbal
- From:
China Journal of Chinese Materia Medica
2023;48(15):3997-4006
- CountryChina
- Language:Chinese
-
Abstract:
Hard capsules of traditional Chinese medicine(TCM) have different degrees of hygroscopicity, which affects the stability and efficacy of drugs. In this paper, 30 kinds of commercially available TCM capsules were used as the research object. The hygroscopicity curves of capsule contents, capsule shells, and capsules were tested respectively, and the first-order kinetic equation was used for fitting. The results show that during the 24 h hygroscopicity process, the capsule shell can reduce the weight gain caused by the hygroscopicity of the contents by 0.80%-53.0% and the hygroscopicity rate of the capsule contents by 1.74%-91.3%, indicating that the capsule shell has a strong delay effect on the hygroscopicity of the contents of the TCM capsules. Seven physical parameters of the contents of 30 kinds of TCM capsules were determined, and 14 prescription process-related parameters were sorted out. A partial least squares model for predicting the hygroscopicity rate of the contents of TCM capsules(with shell) for 24 h was established. It is found that the hygroscopicity rate of the capsule shell is positively correlated with the hygroscopicity of the contents of TCM capsules(with shell), suggesting that the capsule shell with a low hygroscopicity rate is helpful for moisture prevention. In addition, the pre-treatment process route of the preparation and the type of molding raw materials affect the hygroscopicity. A larger proportion of the extract in the capsule content and a smaller proportion of the fine powder of the decoction pieces indicate stronger hygroscopicity of the capsule content. The 24 h hygroscopicity rate of 15% was used as the classification node of hygroscopicity strength, and the hygroscopicity rate constant of 0.58 was used as the classification node of hygroscopicity speed. The classification system of hygroscopicity behaviors of TCM capsules was established: the varieties with strong and fast hygroscopicity accounted for about 6.67%, while those with strong and slow hygroscopicity accounted for about 33.3%; the varieties with weak and fast hygroscopicity accounted for about 26.7%, while those with weak and slow hygroscopicity accounted for about 33.3%. The classification system is helpful to quantify and compare the hygroscopicity behavior of different TCM capsules and provides a reference for the quality improvement, moisture prevention technologies, and material research of TCM capsules.
