新型降糖中空俄色总黄酮生物黏附缓释肛门栓的制备研究

目的探讨新型降糖中空俄色总黄酮(ESF)原位凝胶栓剂的制备工艺并建立其质量控制方法。方法采用单因素考察栓剂基质、注模温度以及ESF原位凝胶最佳注入量;对优选后制备工艺所制栓剂的pH、硬度、重量差异、融变时限及ESF的含量及体外释放度进行考察以建立其质量控制方法。结果所制栓剂的pH为6.95,粒度、重量差异、融变时限均符合药典规定;在建立了可行的质量评价方法后,测得ESF的平均含量为80.86 mg/ml,释药时间在12 h以上。结论优选出的制备工艺合理、可行,所制制剂符合栓剂的质量要求。

Research in Pharmaceutics of A Novel Hypoglycemic Hollow ESF Bioadhesive Slow-release Anal Suppository

Objective To explore the preparation process of a new type of Total Flavonoids from E’SE(ESF)in situ gel suppositories,and to establish the quality control method.Methods Single factor was used to investigate the suppository matrix,injection molding temperature and the optimal injection volume of ESF in-situ gel;to investigate the pH,hardness,weight difference,melting time limit,ESF content and in vitro release of suppositories prepared by the optimized preparation process and to establish its quality control methods.Results The pH value of the suppository was 6.95,the particle size,weight difference and melting time were all in accordance with the pharmacopoeia.After the establishment of a feasible quality evaluation method,the average content of ESF was 80.86 mg/mL and the release time was over 12 h.Conclusion The optimized preparation technology is reasonable and feasible,and the preparation meets the quality requirements of suppository.