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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。
In this paper, the combination of fingerprint and in vitro release was used to study the in vitro release of the complex components of traditional Chinese medicine compound asthma sustained release tablets. Fingerprints qualitatively determine the characteristic peaks of compound preparations. The results of in vitro dissolution under different release conditions show that the release of three pharmacodynamic parameters (ephedrine, pseudoephedrine and scopolamine) in sustained-release tablets is less affected by gastrointestinal tract factors, The similarities of the release curves of the three major peaks in the fingerprint were all greater than 80. Quantitatively confirmed that the complex multi-component of Chinese herbal compound was dissolved at a similar rate in vitro to achieve a balanced release of the complex components of the traditional Chinese medicine compound preparation, Evaluation has laid the theoretical and experimental foundation.