骨伤跌打康复凝胶贴膏剂处方优选

Optimization of Preparation of Gushang Dieda Kangfu Gel Plaster

目的优选骨伤跌打康复凝胶贴膏剂处方。方法以制剂的初黏力、持黏力、综合感官评分的归一化值为评价指标,以聚丙烯酸钠、甘羟铝、聚维酮K90、酒石酸、甘油、中药粉用量为影响因素,采用Plackett-Burman试验和星点设计-响应面法优选制剂处方,并验证。结果该凝胶贴膏剂制备工艺的关键因素为聚丙烯酸钠、甘羟铝、聚维酮K90的用量,最优处方配比为聚丙烯酸钠5.5 g、聚维酮K902.9 g、甘羟铝0.2 g。制得3批制剂的平均归一化值为0.8044,与理论值(0.817)接近(RSD为1.90%)。结论优化处方后的制剂外观均匀,黏性良好,符合凝胶贴膏剂的质量要求。

Objective To optimize the prescription of Gushang Dieda Kangfu Gel Plaster.Methods The prescription of the gel plaster was optimized by the Plackett-Burman test and the central composite design-response surface methodology(CCD-RSM),with the overall desirability(OD)value of initial viscosity,viscosity retention and comprehensive sensory score of the gel plaster as the evaluation indicator,and with the dosages of sodium polyacrylate,aluminium glycinate,povidone K90,tartaric acid,glycerol and traditional Chinese medicine powder as the influencing factors.Then the verification test was conducted.Results The key factor in the preparation process of the gel plaster was the dosages of sodium polyacrylate,aluminum glycinate and povidone K90.The optimal formula was as follows:sodium polyacrylate was 5.5 g,povidone K90 was 2.9 g,and aluminum glycinate was 0.2 g.The average OD value of the three batches of gel plaster was 0.8044,which was close to the theoretical value(0.817),with an RSD of 1.90%.Conclusion The Gushang Dieda Kangfu Gel Plaster prepared by the optimal prescription has uniform appearance and good viscosity,which meet the quality requirements of gel plaster.