复方苦参碱阴道生物黏附栓的制备及质量控制  

Preparation and quality control of compound matrine vaginal bioadhesive suppository

作　　者：李晓强[1] 何荣霞[1] 秦龙[1] 李平[1] 

机构地区：[1]兰州大学第二医院,甘肃兰州730030

出　　处：《中国医院药学杂志》2014年第13期1068-1071,共4页Chinese Journal of Hospital Pharmacy

基　　金：甘肃省自然科学研究基金计划(编号:1107RJZA209)

摘　　要：目的:制备复方苦参碱阴道生物黏附栓并建立其质量控制方法。方法:以苦参碱和硼酸为主药,壳聚糖和聚乙烯醇为生物黏附材料,以生物黏附力为考察指标,利用L9(34)正交试验对制备工艺进行优选。采用高效液相色谱法测定复方苦参碱硼酸阴道生物黏附栓中的苦参碱含量。结果:最佳制备工艺为:壳聚糖为2.5%(W/V),明胶为18%(W/V),甘油为16%(V/V),PVA为1.25%(W/V)。本品每粒含苦参碱100 mg,硼酸300 mg。结论:本制剂制备工艺简便可行,质量稳定可控。OBJECTIVE To prepare compound matrine vaginal bioadhesive suppository and to establish a method of quality control for the vaginal suppository. METHODS The vaginal bioadhesive suppository was made of the main drug of matrine and boric acid, and the bioadhesive material was chitosan and PVA. The preparation was optimized by L9 （3^4 ）orthogonal experiment. The concentration of matrine in the vaginal suppository was determined by HPLC. RESULTS The optimum preparation was as follows., chitosan 2. 5%, gelatin 18%, glycerol 16% and PVA 1.25%. Each vaginal suppository contained 100 mg matrine and 300mg boric acid. CONCLUSION The preparing procedure was simple, and quality control was stable and reliable.

关 键 词：苦参碱 硼酸 阴道生物黏附栓 正交试验 质量控制 

分 类 号：R944[医药卫生—药剂学]