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目的引入f_2相似因子法对银杏酮酯(GBE)缓释微丸的大类成分总黄酮和各类成分(包括黄酮类和萜内酯类)的释放曲线进行分析,以能较全面地评价其体外释放。方法运用紫外分光光度法、高效液相-质谱联用(HPLC-MS)测定GBE缓释微丸中大类成分(总黄酮)和各类成分(槲皮苷、异鼠李素、芦丁、槲皮素、银杏内酯A、银杏内酯B、银杏内酯C、白果内酯)的体外释放率,并进行f_2相似因子计算;采用扫描电镜法观察微丸释药前后的微观结构,结合方程拟合分别对微丸中总黄酮和各类成分的释药机制解析,以验证f_2相似因子法的可靠性。结果优化工艺的GBE微丸黄酮类和内酯类的各成分与大类成分总黄酮的f_2均大于50,说明大类成分总黄酮与各类成分体外释放曲线具有较好的相关性。释药机制解析进一步验证了该结果的可靠性。结论 f_2相似因子法可运用于多组分中药缓释制剂大类成分和各类成分的体外释放评价。
OBJECTIVE: To introduce the f_2 similarity factor method to analyze the release profiles of flavonoids and various components (including flavonoids and terpene lactones) of GBE sustained-release pellets in order to evaluate them more comprehensively In vitro release. Methods The main components (total flavonoids) and various components of GBE sustained-release pellets (quercitrin, isorhamnetin, rutin, Quercetin, ginkgolide A, ginkgolide B, ginkgolide C, bilobalide) in vitro were calculated and the f_2 similar factor was calculated. The microscopic structure of the pellets before and after release was observed by scanning electron microscopy The equation fitting was used to analyze the release mechanism of total flavonoids and various components in pellets to verify the reliability of f_2 similarity factor method. Results The results showed that the f_2 values of flavonoids and lactones of GBE microballoons in the optimized process were greater than 50, indicating that the total flavonoids of the major components had good correlation with the in vitro release profiles of various components. Analysis of drug release mechanism further verified the reliability of the results. Conclusion The f_2 similarity factor method can be used to evaluate the in vitro release of various components and components of multi - component traditional Chinese medicine sustained release preparations.