优选中药临方热熔压敏胶贴膏剂的基质处方,得到中药临方热熔压敏胶贴膏剂通用成型基质处方,并验证贴膏成型基质处方的适用性.采用JMP Pro 16.1.0中心复合设计试验法,以苯乙烯-异戊二烯-苯乙烯嵌段共聚物(styrene-isoprene-sty-rene triblock copolymer,SIS)、氢化石油树脂、轻质液体石蜡不同用量进行试验,以中药益脾方细粉为模型药物(载药量10％),以感官评分和客观评价为综合评价指标,建立中药临方热熔压敏胶贴膏剂质量评价体系,优化中药临方热熔压敏胶贴膏剂的成型基质处方.选取16种中药贴膏剂处方对优化后的热熔压敏胶贴膏成型基质处方的适用性进行验证,并通过对不同载药量的考察对热熔胶贴膏成型基质处方的适用性进行进一步研究.热熔压敏胶型中药贴膏剂的通用成型基质处方中基质用量比例为SIS-氢化石油树脂-轻质液体石蜡3∶3∶5.以优化后的成型基质处方所制成的16种模型中药热熔压敏胶贴膏剂成型性好、质量评分较高,并适用于10％～30％载药量的饮片细粉贴膏,提示优化的成型基质处方有较好的适用性,为中药临方热熔压敏胶贴膏剂的应用和推广奠定基础.
Abstract
This study aims to optimize the matrix formulation for the hot-melt pressure-sensitive adhesive plaster of personalized traditional Chinese medicine(TCM)preparations and verify the applicability of the formulation.The central composite design in JMP Pro 16.1.0 was employed to optimize the dosages of styrene-isoprene-styrene triblock copolymer(SIS),hydrogenated petroleum resin,and lightweight liquid paraffin,with the fine powder of Yipifang as the model drug(drug loading of 10％)and the sensory score and objective evaluation as the comprehensive evaluation indicators.The quality evaluation system of hot-melt pressure-sensitive adhesive plaster of personalized TCM preparations was established.The applicability of the optimized matrix formulation of hot-melt pressure-sensitive adhesive plaster was verified with 16 TCM preparations for external application.Furthermore,the applicability of the matrix formulation was investigated with different drug loadings.The general molding matrix formulation was SIS∶hydrogenated petroleum resin:lightweight liquid paraffin 3∶3∶5.The optimized matrix formulation showed good molding properties and high quality scores for 16 TCM preparations and were suitable for the plastering of finely powdered decoction pieces with a loading capacity of 10％to 30％.The results suggest that the optimized matrix formulation has good applicability and is suitable for TCM preparations.The findings lay a foundation for the application and promotion of the hot-melt pressure-sensitive adhesive plasters of personalized TCM preparations.
关键词
中药临方制剂/热熔压敏胶/中药贴膏剂/成型基质处方
Key words
personalized traditional Chinese medicine preparations/hot-melt pressure-sensitive adhesive/traditional Chinese medi-cine plaster/molding matrix formulation
维普
万方数据