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Preparation and Quality Evaluation of Berberine Hydrochloride Resin Complex Lyophilized Oral Disintegration Tablets
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Xiaoyan ZHU, Jundong DAI*, Pengchuan GUO, Shiyue WU, Qiren ZHOU
Chinese Pharmaceutical Journal | 2024, 59(8) : 724 - 731
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Chinese Pharmaceutical Journal | 2024, 59(8): 724-731
Preparation and Quality Evaluation of Berberine Hydrochloride Resin Complex Lyophilized Oral Disintegration Tablets
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Xiaoyan ZHU, Jundong DAI*, Pengchuan GUO, Shiyue WU, Qiren ZHOU
Affiliations
  • School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 102488, China
Published: 2024-04-22
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OBJECTIVE To prepare berberinehydrochloride resincomplex for good taste-masking effectof lyophilized oraldisintegration tablets using berberine hydrochloride as a model drug and using Kyron-T114 as the drug-loaded resin. METHODS The drug-resin composites were prepared by using the static method. Then drawn the adsorption isotherm and adsorption kinetic curves to study the adsorption mechanism of the resin. Afterwards, the characteristic of the berberine hydrochloride resin complex was studied by using the SEM, DSC, XRD and FTIR. Finally, prepared the oral disintegration tablets of berberine hydrochloride and its resin complex by using the lyophilized extrusion technology. Next, studied the in vitro release experiments and evaluated the effect of masking taste. RESULTS According to the research, a berberine hydrochloride-resin complex with the drug loaded of 43.04% was prepared. And the analysis showed that the adsorption of the drug on the resin was the multilayered chemical adsorption. The dissolution of berberine hydrochloride's powder is mainly affected by the solubility of berberine hydrochloride. Moreover, the dissolution mechanism is mainly based on Fick diffusion. The dissolution of berberine hydrochloride's powder is mainly affected by the pH of the solution, along with the concentration and the type of the ion in the solution. In artificial gastric juice, the drug dissociates rapidly from the resin. So the film diffusion was the rate-limiting step for dissolution. On the contrary, the drug dissociated slowly in the water, artificial saliva, artificial intestinal fluids including pH 4.5 and pH 6.8. So the particle diffusion was the rate-limiting step for dissolution. Besides, the dissolution of lyophilized oral disintegration tablets of drug-resin complexes in artificial saliva was significantly lower than that of berberine hydrochloride oral disintegration tablets. Lastly, the results from sensory evaluation and electronic tongue detection proved that the lyophilized oral disintegration tablets of berberine hydrochloride-resin compound has good taste masking effect. CONCLUSION Berberine hydrochloride resin complex lyophilized mouth collapse has good taste masking effect. Moreover, the drug-resin complex prepared by Kyron-T114, a weak cation exchange resin, is beneficial to improve the dissolution of poorly soluble drugs in artificial gastric juice, thereby improving their oral bioavailability. Thus, it can provide a new idea for the taste masking of traditional Chinese medicine.

berberine hydrochloride  /  ion exchange resin  /  Kyron-T114  /  effect of masking taste  /  drug-resin complex
Xiaoyan ZHU, Jundong DAI, Pengchuan GUO, Shiyue WU, Qiren ZHOU. Preparation and Quality Evaluation of Berberine Hydrochloride Resin Complex Lyophilized Oral Disintegration Tablets[J]. Chinese Pharmaceutical Journal, 2024 , 59 (8) : 724 -731 .
Year 2024 volume 59 Issue 8
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  • Receive Date:2023-04-03
  • Online Date:2026-04-08
  • Published:2024-04-22
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  • Received:2023-04-03
Affiliations
    School of Chinese Materia Medica, Beijing University of Chinese Medicine, Beijing 102488, China
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

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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