节点文献
盐酸依匹斯汀胶囊的制备及质量评价
Preparation and Quality Evaluation of Epinastine Hydrochloride Capsules
【Author】 LI Qiong;LIU Haiping;QU Yan;Ethnic Medicine Institute of Southwest University for Nationalities;College of Pharmacy,Chengdu University of Traditional Chinese Medicine;
【机构】 西南民族大学民族医药研究院; 成都中医药大学药学院;
【摘要】 将盐酸依匹斯汀、预胶化淀粉和微晶纤维素混匀后装填胶囊。考察了原料辅料相容性、胶囊内容物的粉体学性质和溶出度等。初步稳定性考察结果表明,所得盐酸依匹斯汀胶囊在(40±2)℃、相对湿度(75±5)%环境条件下放置6个月或常温放置12个月,含量和溶出度无明显改变,有关物质略有增加。
【Abstract】 The epinastine hydrochloride,pregelatinized starch and microcrystalline cellulose were mixed and then filled into capsules.The drug-excipient compatibility,powder properties of the mixture of drug-excipient with different weight ratio and in vitro dissolution of the product were investigated.The results of preliminary stability test showed that after storage at(40±2)℃ and relative humidity of(75±5)%for 6 months or at room temperature for 12 months,the content and dissolution did not have significant changes but the amount of related substances had a slight increase.
【Key words】 epinastine hydrochloride; capsule; drug-excipient compatibility; in vitro dissolution; stability;
- 【会议录名称】 “好医生杯”中药制剂创新与发展论坛论文集(上)
- 【会议名称】“好医生杯”中药制剂创新与发展论坛
- 【会议时间】2013-10-26
- 【会议地点】中国四川成都
- 【分类号】R943
- 【主办单位】中华中医药学会中药制剂分会、世界中医药学会联合会中药药剂专业委员会