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作 者:蔡延渠[1] 陈健 谢吉福[1] 柴金珍[1] 刘静[1] 彭庆庭[1] 朱盛山[1]
机构地区:[1]广东药学院中药开发研究所,广东广州510006 [2]石药集团欧意药业有限公司,河北石家庄050000
出 处:《中国中药杂志》2013年第9期1360-1365,共6页China Journal of Chinese Materia Medica
基 金:国家自然科学基金项目(30472198;30672670)
摘 要:该文将指纹图谱与体外释放度相结合用于中药复方制剂喘平缓释片复杂成分体外释放的研究。指纹图谱定性确定复方制剂的特征峰,不同释放条件下体外溶出度测定结果显示缓释片中3个药效指标成分(麻黄碱、伪麻黄碱、东莨菪碱)的释放受胃肠道因素影响小,且与指纹图谱中3大特征峰未知物释放曲线的相似因子均大于80,定量证实中药复方复杂多成分在体外按照相似速率溶出,实现中药复方制剂复杂成分的均衡释放,为中药复方缓释制剂的质量评价奠定了理论与实验基础。To combine fingerprint and drug release rate in vitro, in order to study in vitro release of complex components of Chuanping sustained tablets, compound traditional Chinese medicine preparation. A qualitative determination of the characteristic peaks of the compound preparations were conducted by the fingerprint. The results of the dissolution rate determination under different release conditions showed that the release of three index components ( methamphetamine, pseudoephedrine and scopolamine) of Chuan- ping sustained tablets was less affected by gastrointestinal factors, with similarity factors being more than 80 with unknown component release curves of three major characteristic peaks in the fingerprint. The qualitative determination proved that multiple components of the compound traditional Chinese medicine preparation was dissolved in vitro at similar rates, realizing the balanced release of complex components of the compound traditional Chinese medicine preparation. This study layed a theoretical and experimental basis for quality evaluation for the compound traditional Chinese medicine preparation.
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