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骨伤跌打康复凝胶贴膏剂处方优选

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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。5g、聚维酮K90 2。9 g、甘羟铝 0。2g。制得 3 批制剂的平均归一化值为 0。804 4,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。
Optimization of Preparation of Gushang Dieda Kangfu Gel Plaster
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 0.804 4,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.

Gushang Dieda Kangfu Gel Plasterprescription optimizationPlackett-Burman testcentral composite design-response surface methodology

陈继英、莫楚铭、吴谋、蓬展鹏、刘淑芳

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广东省东莞市中医院·东莞市中药制剂重点实验室,广东 东莞 523000

骨伤跌打康复凝胶贴膏剂 处方优选 Plackett-Burman试验 星点设计-响应面法

广东省东莞市社会发展科技项目

20211800904392

2024

中国药业
重庆市食品药品监督管理局

中国药业

CSTPCD
影响因子:1.369
ISSN:1006-4931
年,卷(期):2024.33(10)
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