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喘平缓释片体外释放与人体内吸收的相关性研究
引用本文:蔡延渠,张志鹏,吴燕红,刘静,谢吉福,柴金珍,罗裕,朱盛山.喘平缓释片体外释放与人体内吸收的相关性研究[J].中国中药杂志,2013,38(20):3473-3478.
作者姓名:蔡延渠  张志鹏  吴燕红  刘静  谢吉福  柴金珍  罗裕  朱盛山
作者单位:广东药学院 中药开发研究所, 广东 广州 510006;湖北科技学院 药学院, 湖北 咸宁 437100;广东药学院 中药开发研究所, 广东 广州 510006;广东药学院 中药开发研究所, 广东 广州 510006;广东药学院 中药开发研究所, 广东 广州 510006;广东药学院 中药开发研究所, 广东 广州 510006;广东药学院 中药开发研究所, 广东 广州 510006;广东药学院 中药开发研究所, 广东 广州 510006
基金项目:国家自然科学基金项目(30973954)
摘    要:目的: 研究喘平缓释片体外释放与人体内吸收的相关性。 方法: 以麻黄碱、伪麻黄碱为指标成分,体外采用转篮法结合HPLC测定喘平缓释片在不同pH介质中的累积溶出率;体内采用尿药法结合HPLC测定尿液中的药物浓度;应用Wagner-Nelson法评价喘平缓释片体内外相关性。 结果: 喘平缓释片人体内不同时间点的吸收百分数F与体外累积溶出率f的线性回归方程分别为F麻黄碱=1.572 5f-20.729(R2=0.974 5),F伪麻黄碱=1.237f-0.147 6(R2=0.959 5)。 结论: 喘平缓释片体内-体外相关性良好,体外释放度测定方法可用于控制喘平缓释片内在质量和预测其生物利用度。

关 键 词:喘平方  缓释片  体外释放度  尿药法  体内外相关性
收稿时间:2013/3/15 0:00:00

Correlation between dissolution in vitro and absorption in vivo of Chuanping sustained release tablets
CAI Yan-qu,ZHANG Zhi-peng,WU Yan-hong,LIU Jing,XIE Ji-fu,CHAI Jin-zhen,LUO Yu and ZHU Sheng-shan.Correlation between dissolution in vitro and absorption in vivo of Chuanping sustained release tablets[J].China Journal of Chinese Materia Medica,2013,38(20):3473-3478.
Authors:CAI Yan-qu  ZHANG Zhi-peng  WU Yan-hong  LIU Jing  XIE Ji-fu  CHAI Jin-zhen  LUO Yu and ZHU Sheng-shan
Institution:Institute of Traditional Chinese Medicine Development, Guangdong Pharmacological University, Guangzhou 510006;Hubei University of Science and Technology, Xianning 437100, China;Institute of Traditional Chinese Medicine Development, Guangdong Pharmacological University, Guangzhou 510006;Institute of Traditional Chinese Medicine Development, Guangdong Pharmacological University, Guangzhou 510006;Institute of Traditional Chinese Medicine Development, Guangdong Pharmacological University, Guangzhou 510006;Institute of Traditional Chinese Medicine Development, Guangdong Pharmacological University, Guangzhou 510006;Institute of Traditional Chinese Medicine Development, Guangdong Pharmacological University, Guangzhou 510006;Institute of Traditional Chinese Medicine Development, Guangdong Pharmacological University, Guangzhou 510006
Abstract:Objective: To investigate the correlation between dissolution in vitro and absorption in vivo of Chuanping sustained release tablets. Method: The ephedrine, pseudoephedrine were chosen as marker components, dissolution in vitro of Chuanping sustained release tablets in the different pH were tested by the rotating basket method and HPLC;urine drug levels were determined by HPLC and absorption fractions were calculated according to Wagner-Nelson's formula and deconvolution technique. Result: The linear regressive equation between the absorption percentage in vivo F and accumulative release percentage in vitro of Chuanping sustained release tablets was established as Fephedrine = 1.572 5f-20.729(R2=0.974 5);Fpseudoephedrine=1.237f-0.147 6(R2=0.959 5). Conclusion: The results suggested that there was fine correlation between the absorption percentage in vivo and the accumulative release percentage in vitro of Chuanping sustained release tablets.
Keywords:Chuanping  sustained release tablet  accumulate release percentage  urinary concentration method  in vitro/in vivo correlation
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