三黄中空栓剂的制备及质量标准研究  

Study on Quality Control and Preparation of SanHuang Hollow Suppository

作　　者：程晓华[1] 姜华[2] 徐玉娥[1] 蒋振兴[1] 

机构地区：[1]甘肃省中医院,甘肃兰州730050 [2]甘肃省中医药研究院

出　　处：《西部中医药》2013年第5期28-30,共3页Western Journal of Traditional Chinese Medicine

摘　　要：目的:研究三黄中空栓的制备及质量控制,寻找治疗痔疮的新型中药栓剂。方法:采用水、丙二醇及水和丙二醇的混合液分别做药物分散媒进行试验,以分散度、黏度、沉降度为指标进行考察,同时对外壳基质PEG1000、PEG4000、十六醇的配比进行优选,以栓剂硬度、形成时间及熔融时间为考察指标,确定基质处方最佳方案,最后将黄芩、黄连、黄柏3味中药灌装于半合成脂肪酸酯制成的空心栓壳中,制成三黄中空栓,并对其质量标准进行考察。结果:三黄中空栓各项指标符合标准。结论:制备工艺合理可行,可进行临床研究。Objective： To find a new type of TCM suppository for hemorrhoids through studying the prepara- tion and quality control of SanHuang hollow suppository. Method： Water, glycol propylene and the mixture as drug dispersion-medium, the experiments were performed by investigating degree of dispersion, viscosity and sedimenta- tion rate, the proportion of shell matrix PEG 1 000, PEG 4 000 and cetanol were optimized, the best prescriptions for matrix were chosen by taking the hardness, forming time and melting time as the indexes, HuangQin （Radix Scutel- lariae）, HuangLian（Coptis chinensis Franch） and Huangbai（Cortex Phellodendri Chinensis） were put into the hollow shell made by semi-synthetic aliphatic ester and quality standard was inspected. Result： The indexes met all the crite- ria of SanHuang hollow suppository. Conclusion： Technique of preparation, reasonable and feasible, could be used for clinical study.

关 键 词：三黄中空栓 制备 质量评定 

分 类 号：R283.5[医药卫生—中药学]