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目的:建立止咳平喘缓释片体外均衡释放的评价方法。方法:以麻黄碱、伪麻黄碱、东莨菪碱为指标成分,以色谱基线分离和理论塔板数考察选择止咳平喘缓释片体外释放度评价测定色谱条件;以3个指标成分的释放度曲线条件评价缓释片是否均衡释放。结果:与止咳平喘普通片相比,止咳平喘缓释片3个指标成分在10 h内成均衡释放。结论:止咳平喘缓释片释放度测定选择的3个指标成分和2个色谱条件可作为建立该缓释片均衡释放度评价方法的基础。
Objective: To establish a method for evaluating the balanced release of cough and asthma-relieved sustained release tablets in vitro. Methods: Ephedrine, pseudoephedrine and scopolamine were used as index components. The chromatographic conditions were determined by in vitro release evaluation of Zhike Pingchuan Sustained-release Tablets by chromatographic baseline separation and the number of theoretical plates. The release curves of three indicators were used to evaluate the chromatographic conditions. Whether the release film is released in a balanced manner. RESULTS: Compared with Zhike Pingchuan Tablet, the three index components of Zhike Pingchuan Sustained-release Tablets were released within 10 h. Conclusion: The three index components and two chromatographic conditions selected for the determination of the release of Cough and Asthma Sustained-release Tablets can be used as the basis for the establishment of the evaluation method for the balanced release of the sustained-release tablets.