芪黄灌肠剂改芪黄栓的制备工艺及质量评价  

Preparation and quality evaluation on the Qihuang suppository instead of Qihuang enema

作　　者：牛煜 李青 肖元宇 陈达鑫 Niu Yu

机构地区：[1]云南中医学院第三附属医院|昆明市中医院

出　　处：《中医临床研究》2019年第31期25-29,共5页Clinical Journal Of Chinese Medicine

基　　金：云南省科技计划项目中医联合专项：《芪黄栓治疗腹泻型肠易激综合征临床药效学研究》[项目编号：2015FB205(-039）]研究成果

摘　　要：芪黄栓前身为灌肠汤药,称芪黄灌肠剂,临床使用十余年,治疗活动期溃疡性结肠炎中效果突出,后用于肠易激综合征属于脾胃亏虚、湿热内结证型腹泻患者的治疗,临床疗效确切。但原有芪黄灌肠剂面临的问题是给药方式不便、灌肠过程痛苦、患者医从性差、药物浪费及药物吸收量不恒定等。因为上述问题,所以提出了将芪黄灌肠剂改为芪黄栓的研究课题。这次研究也是对基质的最大载药量、生产适宜载药量和临床适合给药量的研究,为将来对该栓剂可以应用于生产和临床打下基础。方法为将中药以不同方式制粉,所制得的粉末用热熔法工艺制成成型的栓剂。再对成型的栓剂进行质量评价。发现采用半浸膏粉末的制作方法制成的栓剂可以达到较高的载原药量,而且制作工艺较简单,适用于生产。Qihuang suppository( 芪黄栓) is from Qihuang enema( 芪黄灌肠剂), which is applied in clinic for more than ten years, with good efficacy on active ulcerative colitis and diarrhea patients with irritable bowel syndrome of Piwei Kuixu and Shire Neijie type( 脾胃亏虚、湿热内结证型). Because of inconvenient administration, painful enema, poor patient susceptibility, drug waste and inaccurate drug absorption in Qihuang enema, Qihuang suppository is proposed. This study is also the study of the maximum drug loading of the matrix, the production of suitable drug loading and the clinically appropriate dose, which will be the basis for the future application of the suppository in production and clinic. TCM medicine is powdered in different ways, and the prepared powder is formed into a shaped suppository by a hot melt process. Than the quality of the formed suppository is evaluated. Conclusion: The suppository made by semi-dip powder can achieve higher loading of the original drug, and the manufacturing process is simpler and suitable for production.

关 键 词：中药栓剂制作工艺 芪黄栓 质量评价 

分 类 号：R283.6[医药卫生—中药学]