Manufacturing classification system for oral solid dosage forms of traditional Chinese medicines (Ⅱ): classification of tablets disintegration behavior

• Published in: Zhongguo zhongyao zazhi Vol. 48; no. 12; p. 3180
• Main Authors: Zhao, Xiao-Qing, Liao, Dong-Ling, Qi, Fei-Yu, Liang, Zi-Chen, Tang, Xue-Fang, Dai, Sheng-Yun, Qiao, Yan-Jiang, Xu, Bing
• Format: Journal Article
• Language: Chinese
• Published: China 01.06.2023
• Subjects: Commerce; Drug Compounding; Medicine, Chinese Traditional; Tablets; Water; dissolution curve; disintegration behavior classification system(DBCS); disintegration mechanism; disintegration time; traditional Chinese medicine tablets
• ISSN: 1001-5302
• DOI: 10.19540/j.cnki.cjcmm.20230313.301

In this paper, 50 batches of representative traditional Chinese medicine tablets were selected and the disintegration time was examined with the method in Chinese Pharmacopoeia. The disintegration time and disintegration phenomenon were recorded, and the dissolution behaviors of water-soluble and ultraviolet-absorbent components during the disintegration process of tablets were characterized by self-control method. The results revealed that coating type and raw material type influenced the disintegration time of tablets. It was found that only 4% of traditional Chinese medicine tablets had obvious fragmentation during the disintegration process, while 96% of traditional Chinese medicine tablets showed gradual dissolution or dispersion. Furthermore, according to the disintegration speed, disintegration phenomenon, and whether the cumulative dissolution of measured components was > 90% at complete disintegration, a disintegration behavior classification system(DBCS) was created for the regular-release tradition