Material Attribute Research in Quality Control of Traditional Chinese Medicine Pills： A Review
10.13422/j.cnki.syfjx.20211554
- VernacularTitle:物料属性研究在中药丸剂质量控制中的应用进展
- Author:
Shu-ting ZHAO
1
;
Bai-xue YANG
2
;
Jia-rong XIE
2
;
Hao-shu XIONG
2
;
Yu-xia SUN
2
;
Yan-mei LI
2
;
Shun-nan ZHANG
2
;
Wen-yuan LIU
1
Author Information
1. China Pharmaceutical University，Nanjing 211198，China
2. National & Local United Engineering Laboratory for Traditional Chinese Medicine Advanced Manufacturing Technology，Tasly Pharmaceutical Group Co. Ltd.，Tianjin 300410，China
- Publication Type:Journal Article
- Keywords:
traditional Chinese medicine;
pills;
material attributes;
quality by design （QbD）;
quality control;
intelligent
- From:
Chinese Journal of Experimental Traditional Medical Formulae
2022;28(3):259-265
- CountryChina
- Language:Chinese
-
Abstract:
As intelligent production of traditional Chinese medicine （TCM） has been inevitable， informatization and automation of the production process have become the precondition for realizing intelligent manufacturing of TCM， of which the accumulation of critical material attribute and the critical quality attribute are the basis. The study of material properties is of great significance to achieve the quality control of the final product in the process， but there is a lack of systematic induction and summary of the research on the attribute of TCM pills. Therefore， the authors analyzed and summarized the attributes of raw materials， excipients and intermediates in the pill unit process according to the classification of powder properties， rheological properties and texture properties. What’s more， the impact of material attributes on the quality of the final product was summarized. Besides， this review summarized the attribute characterization techniques involved in the pill process and provided some suggestions for the characterization of product quality attributes. Finally， based on the concept of quality by design （QbD）， the authors proposed that the study of material attribute should be combined with process analytical technology （PAT）， and the focus of drug quality control should be moved forward to guide equipment upgrading， so as to realize intelligent continuous manufacturing of TCM pills.
