摘要
将治疗宫颈癌的儿黄散研制成温敏凝胶剂,优化设计其处方,建立其制备和质量控制方法.以泊洛沙姆407(P407)用量(A)、泊洛沙姆188(P188)用量(B)、丙二醇用量(C)为考察因素,胶凝温度为指标,采用均匀设计表U9(96)进行处方优化设计,制备儿黄散温敏凝胶;以TLC法对儿黄散温敏凝胶中黄连、儿茶进行定性鉴别;以HPLC法对儿黄散温敏凝胶中盐酸小檗碱、盐酸巴马汀、黄连碱和表小糪碱进行含量测定;以无膜溶出法进行体外释放行为研究.P407、P188、丙二醇以17.55∶10.0∶15.5比例组成最佳;胶凝温度为36.5℃;儿黄散温敏凝胶中盐酸小檗碱、盐酸巴马汀、黄连碱和表小糪碱含量分别为5.06、0.980、0.851、0.705 mg;释放行为符合零级释放方程.
In order to prepare Erhuangsan thermosensitive gel, this paper optimally designed formulation and established the method of preparation and quality control. Taken the amount of P407 （A）, P188 （B） and propylene glycol（C） as factors, the gelation temperature as in- dex, the formulation was optimized by uniform experiment U9 （9^6）. Qualitative identification of eoptis chinensis and eateehu were made by TLC. The content of berberine hydrochloride, palmatine hydrochloride, coptisine, epicoptisine were determined by HPLC. The drug re- lease in vitro was carried out by dissolution method without film. The optimum ratio of P407 ： P188： propylene glycol was 7.55： 10.0： 15.5. The gelation temperature was 36.5 ℃. The content of berberine hydroehloride, palmatine hydrochloride, eoptisine, epieoptisine in Er- huangsan temperature sensitive gel was 5.06 mg, 0.980 mg, 0.851 mg, 0.705 mg, respec- tively. The release behaviour was demonstrated to be a zero order equation. The formulation of Erhuangsan thermosensitive gel was reasonable, its preparation technology was simple and quality was stable and controllable.
出处
《哈尔滨商业大学学报（自然科学版）》
CAS
2013年第2期148-152,共5页
Journal of Harbin University of Commerce：Natural Sciences Edition
基金
黑龙江中医药大学大学生创新科研基金项目(030014)
哈尔滨市科技创新人才研究专项资金项目(2012RFQXS021)
关键词
儿黄散温敏凝胶
宫颈癌
制备
质量控制
Erhuangsan thermosensitive gel
cervical cancer
preparation
quality control
