摘要
目的研究丙戊酸镁栓剂制备处方和工艺并进行质量考察。方法通过正交实验筛选丙戊酸镁栓剂的处方工艺,考察主药的不同含量对溶出度的影响。采用电位滴定法测定丙戊酸镁的的溶出度。结果最佳基质为甘油明胶基质(甘油:明胶:水=6:2:2),每粒含丙戊酸镁200 mg,累积溶出度为91%。质量控制方法平均回收率为99.93%(RSD=1.88%)。结论该制剂制备工艺简单,质量可控。
Objective To study the formulation,technology and quality control of magnesium valproate suppository. Methods Orthogonal test was used to optimize the formulation and technology of magnesium valproate suppository.The dissolution rate was determined with potentiometric titration.Influence of different concentration of princible drug on dissolution was investigated. Results The best matrix was glycerogelatin（glycerine：gelatine：water=6：2：2）,and each granule contained 200 mg of magnesium valproate.The accumulative dissolution rate was 91%.The average recovery was 99.93%,and RSD was 1.88%（n=9）. Conclusion The preparation technique is simple and praticable,and its quality is controllable.
出处
《医药导报》
CAS
2010年第7期915-918,共4页
Herald of Medicine
基金
武汉市药学会默沙东青年药师基金资助
关键词
丙戊酸镁
栓剂
制备
质量控制
Magnesium valproate
Suppository
Preparation
Quality control
