挤出搓圆法制备中药临方浓缩水丸的复合辅料研究  

Composite excipients for preparing concentrated water pills of personalized traditional Chinese medicine prescriptions by extruding-rounding method

作　　者：田文秀 薛爱乐 李文杰 郑敏悦 鲜洁晨[2,3] 洪燕龙 TIAN Wen-xiu;XUE Ai-le;LI Wen-jie;ZHENG Min-yue;XIAN Jie-chen;HONG Yan-long(Shanghai Innovation Center of TCM Health Service,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Innovation Research Institute of Traditional Chinese Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 201203,China;Engineering Research Center of Modern Preparation Technology of Traditional Chinese Medicine,Ministry of Education,Shanghai 201203,China)

机构地区：[1]上海中医药大学上海中医健康服务协同创新中心,上海201203 [2]上海中医药大学创新中药研究院,上海201203 [3]中药现代制剂技术教育部工程研究中心,上海201203

出　　处：《中国中药杂志》2024年第3期607-617,共11页China Journal of Chinese Materia Medica

基　　金：国家自然科学基金项目(81973490);上海市“科技创新行动计划”技术标准项目(20DZ2200900);上海中医药慢性病防治与健康服务省部共建协同创新中心项目(2021科技02-37);上海市自然科学基金面上项目(23ZR1463500)。

摘　　要：为优选适于挤出搓圆法制备临方浓缩水丸的复合辅料种类和配比,并探究各辅料在临方浓缩水丸制备过程中的影响作用,该研究首先以“零辅料”临方浓缩水丸制备技术中适宜充当“辅料”的纤维料和粉性料中药为对标物料,以粉体物理性质中对软材物理性质影响较大的吸水性能和转矩流变性为依据,确定复合辅料的种类;进一步采用D-最优混料试验设计方法选出最优复合辅料的配比。为了证明最优复合辅料的通用性,选取3个出膏率分别为低、中、高的中药复方对最优配比进行验证;并以丸剂成型质量的4个参数为指标,探究各辅料对临方浓缩水丸成型的影响。优化得到的复合辅料种类及最佳配比为糊精-微晶纤维素-低取代羟丙纤维素1∶2∶4,采用该复合辅料制备临方浓缩水丸工艺稳定,丸剂成型质量好,适用范围广。其中糊精充当稀释剂,同时会加快丸剂的出条速度;MCC主要起黏合剂的作用,增加丸条的内聚性和黏性;L-HPC作为吸水剂和崩解剂,可以吸收、容纳浓缩液的水分,同时具有强崩解作用。This study aims to optimize the composite excipients suitable for the preparation of concentrated water pills of personalized traditional Chinese medicine prescriptions by the extruding-rounding method and investigate the roles of each excipient in the preparation process.The fiber materials and powder materials were taken as the standard materials suitable as excipients in the preparation of personalized concentrated water pills without excipient.Water absorption properties and torque rheology were used as indicators for selecting the materials of composite excipients.The ratio of composite excipients was optimized by D-optimal mixture design.Moreover,to demonstrate the universal applicability of the optimal composite excipients,this study selected three traditional Chinese medicine prescriptions with low,medium,and high extraction rates to verify the optimal ratio.Finally,the effects of each selected excipient on the molding of personalized concentrated water pills were investigated with the four parameters of the pill molding quality as indicators.The optimized composite excipients were dextrin∶microcrystalline cellulose(MCC)∶low-substituted hydroxypropyl cellulose(L-HPC)at a ratio of 1∶2∶4.The composite excipients were used for the preparation of personalized concentrated water pills with stable process,good quality,and a wide range of application.Dextrin acted as a diluent and accelerated the speed of extruding.MCC mainly served as an adhesive,increasing the cohesion and viscosity of the pills.L-HPC as a water absorbent and disintegrating agent can absorb and hold the water of the concentrate and has a strong disintegration effect.

关 键 词：中药临方浓缩水丸 挤出搓圆法 复合辅料 D-最优混料设计 

分 类 号：R283.6[医药卫生—中药学]