枸橼酸钾缓释微丸的制备及其质量考察

Preliminary Study on Preparation and Quality of Potassium Citrate Sustained-release Pellets

目的:制备枸橼酸钾缓释微丸并对其进行质量初步考察。方法:采用离心造粒粉末层积法制备载药丸芯,以乙基纤维素水分散体为缓释膜材对载药丸芯进行流化包衣;以国外枸橼酸钾缓释片为参比制剂,对自制缓释微丸的释放度、稳定性等主要质量指标作了初步考察。结果与结论:制得的微丸圆整度好,有一定强度,适合包衣;当包衣增重达10%并采用60℃老化4 h工艺时,所制备的缓释微丸在纯化水中的溶出曲线与参比制剂重合度较高,且稳定性良好。

Objective: To prepare potassium citrate(PC) sustained-release pellets and study its quality.Methods: PC pellets were prepared by a centrifugal granulation method. Ethyl cellulose aqueous dispersion was used as the sustained-release coating material in the fluid bed. Using foreign sustained-release tablets of potassium citrate as the reference, a preliminary study was conducted on the self-made sustained-release pellets for dissolution, stability and other major quality indicators. Results and Conclusion: PC pellets prepared by the centrifugal granulation method had good roundness, and were suitable for coating. PC sustained-release pellets showed similar in vitro release behaviors to the commercial product. PC sustained-release pellets had excellent stability.