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目的:考察中药化合物组释放动力学新理论在银翘解毒片释放特征评价中的适用性。方法:以Kalman滤波法为基础,进行紫外分光光度法测定银翘解毒片化合物组标准谱、线性、精密度、稳定性等方法学研究,测定银翘解毒片及其粉末的化合物组释放特征。结果:方法学结果表明,在0.112～1.120mg生药/mL范围内银翘解毒片化合物组呈线性相关(r=0.9997);高、中、低化合物组浓度测定的RSD分别为0.05%、0.07%和0.31%,浓度分别为0.278,0.556,和1.120mg生药/mL的供试液化合物组在24h内稳定。结论:化合物组释放度能简洁、可视、直观地反映银翘解毒片多组分释放动力学特征,中药化合物组释放动力学新理论可以定量地揭示传统中药制剂的新内涵或其给药系统的活性组分释放特征。
OBJECTIVE: To investigate the applicability of the new theory of release kinetics of Chinese medicine compound group in evaluating the release characteristics of Yinqiaojiedu tablets. METHODS: Based on the Kalman filtering method, UV spectrophotometry was used to determine the standard spectrum, linearity, precision, stability and other methodological studies of the compound group of Yinqiao Jiedu Tablet. The release characteristics of Yinqiao Jiedu Tablet and its powder compound group were determined. RESULTS: The methodological results showed that the Yinqiaojiedu compound group was linearly correlated (r=0.9997) in the range of 0.112 to 1.120mg crude drug/mL; the RSDs of high, medium, and low compound group concentrations were 0.05% and 0.07%, respectively. Compound groups with 0.31%, 0.278, 0.556, and 1.120 mg crude drug/mL, respectively, were stable within 24 h. Conclusion: The compound group release can reflect the multi-component release kinetics characteristics of Yinqiao Jiedu Tablets succinctly, visually and intuitively. The new theory of release kinetics of Chinese medicine compound group can quantitatively reveal the new connotation of traditional Chinese medicine preparations or its delivery system. The active ingredient release profile.