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Journal of Chinese Pharmaceutical Sciences ›› 2020, Vol. 29 ›› Issue (2): 102-112.DOI: 10.5246/jcps.2020.02.008

• Original articles • Previous Articles     Next Articles

Comparison of dissolution profile characteristics of 11 berberine hydrochloride tablet brands in different dissolution media

Fei Yu1,2,3,4, Wenli Zhou1,2,3,4, Jiayi Kan4*, Can Peng1,2,3*   

  1. 1. School of Pharmacy, Anhui University of Chinese Medicine, Hefei, Anhui 230012, China
    2. Anhui Province Key Laboratory of Chinese Medicinal Formula, Hefei, Anhui 230012, China
    3. Institute of Pharmaceutics, Anhui Academy of Chinese Medicine, Hefei, Anhui 230012, China
    4. Anhui Institutes for Food and Drug Control, Hefei, Anhui 230051, China
  • Received:2019-10-25 Revised:2019-11-24 Online:2020-02-29 Published:2019-12-24
  • Contact: Tel.: +86-13956024560; +86-13965046611, E-mail: Pengcan@ahtcm.edu.cn; 1487835386@qq.com
  • Supported by:
    National Institutes for Food and Drug Control (Grant No. 017ZX09101001).

Abstract:

Berberine hydrochloride is commonly used to treat bacterial dysentery, gastroenteritis and other diseases. Many manufacturers are available on the market today, while the production process and formulation are quite different, which may directly affect the therapeutic effect of the drug. To this end, 11 different production producers of berberine hydrochloride tablets were collected according to the pharmacopeia berberine hydrochloride dissolution method (basket method). In addition, the dissolution process was carried out in four elution media with different pH, and the difference was similar (f2). Factors were calculated to evaluate in vitro dissolution requirements, and in vitro dissolution of different manufacturers of berberine hydrochloride tablets was determined by high performance liquid chromatography (HPLC). The method was verified by linearity, precision, stability and robustness. Based on the f2 value, there was a significant difference in the dissolution behavior of the formulations of most berberine hydrochloride tablet brands. This research provided the basis for further in-depth research in the later period. Although the drug specifications (0.1 g) were the same, the dissolution curve was different. This phenomenon may be attributed to the fact that the excipients and crystal form of the tablets affected the release and dissolution of the tablets in vitro.

Key words: Berberine hydrochloride, Tablet, Dissolution, HPLC analysis, Method validation, In vitro test

CLC Number: 

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