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Biopharmaceutics Classification of Berberine Hydrochloride Based on Solubility and Permeability Evaluation
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Wenhui LUO1a, Yanyan WEN1a, Shujuan BENG1a, Hailun HAN1a, 1e, Jiayi KAN2, *, Can PENG1a, 1b, 1c, 1d, *
Chinese Pharmaceutical Journal | 2024, 59(13) : 1226 - 1232
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Chinese Pharmaceutical Journal | 2024, 59(13): 1226-1232
Biopharmaceutics Classification of Berberine Hydrochloride Based on Solubility and Permeability Evaluation
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Wenhui LUO1a, Yanyan WEN1a, Shujuan BENG1a, Hailun HAN1a, 1e, Jiayi KAN2, *, Can PENG1a, 1b, 1c, 1d, *
Affiliations
  • 1 a. School of Pharmacy; 1b. MOE-Anhui Joint Collaborative Innovation Center for Quality Improvement of Anhui Genuine Chinese Medicinal Materials; 1c. Rural Revitalization Collaborative Technical Service Center of Anhui Province; 1d. Generic Technology Research center for Anhui TCM Industry; 1e. Anhui Province Key Laboratory of Pharmaceutical Preparation Technology and Application, Anhui University of Chinese Medicine, Hefei 230012, China
  • 2 Anhui Institutes for Food and Drug Control, Hefei 230051, China
Published: 2024-07-08 doi: 10.11669/cpj.2024.13.007
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OBJECTIVE To investigate the attribution of berberine hydrochloride in the biological pharmaceutics classification system (BCS) and to determine its taxonomic properties. METHODS The solubility of berberine hydrochloride was investigated in pH 1.0-8.0 medium; its absorption parameters related to the rat duodenum, jejunum, ileum and colon were derived from in-situ intestinal perfusion model in vivo to determine its permeability. RESULTS The solubility in different pH dissolution media with the value of drug metering number (D0) and combined with the pharmacopoeia regulations found that berberine hydrochloride belonged to the low solubility drugs. From the results of permeability experiments, it was found that the permeability coefficient Peff(rat) of berberine hydrochloride in each intestinal segments was exceeded than 5.0×10-5 cm·s-1 in rats, and the conversion into human absorption Fa(human) was exceeded than 85%, therefore, it was determined to be the high permeability drug. CONCLUSION The combination of solubility and permeability test results proves that berberine hydrochloride is a low solubility and high permeability drug, which belongs to BCS class Ⅱ.

berberine hydrochloride  /  solubility  /  permeability  /  BCS classification  /  in-situ single pass intestinal perfusion
Wenhui LUO, Yanyan WEN, Shujuan BENG, Hailun HAN, Jiayi KAN, Can PENG. Biopharmaceutics Classification of Berberine Hydrochloride Based on Solubility and Permeability Evaluation[J]. Chinese Pharmaceutical Journal, 2024 , 59 (13) : 1226 -1232 . DOI: 10.11669/cpj.2024.13.007
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doi: 10.11669/cpj.2024.13.007
  • Receive Date：2023-07-19
  • Online Date：2026-01-14
  • Published：2024-07-08
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  • Received：2023-07-19
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Affiliations
    1 a. School of Pharmacy; 1b. MOE-Anhui Joint Collaborative Innovation Center for Quality Improvement of Anhui Genuine Chinese Medicinal Materials; 1c. Rural Revitalization Collaborative Technical Service Center of Anhui Province; 1d. Generic Technology Research center for Anhui TCM Industry; 1e. Anhui Province Key Laboratory of Pharmaceutical Preparation Technology and Application, Anhui University of Chinese Medicine, Hefei 230012, China
    2 Anhui Institutes for Food and Drug Control, Hefei 230051, China
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表12种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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