氨基葡萄糖中空栓剂的制备与质量控制  

Preparation and quality control of glucosamine hollow suppository

作　　者：吴德敏[1] 金涌[1] 蒋培培[1] 余芳[1] 余庆[1] 许曼[1] 

机构地区：[1]安徽医科大学药学院,安徽合肥230032

出　　处：《安徽医药》2013年第2期188-190,共3页Anhui Medical and Pharmaceutical Journal

摘　　要：目的制备氨基葡萄糖中空栓,并建立其质量控制方法。方法以半合成脂肪酸甘油酯为基质制备中空栓,采用邻苯二甲醛(OPA)柱前衍生HPLC法测定其中氨基葡萄糖含量及累积溶出度,检测波长为330 nm。结果氨基葡萄糖在1～50 mg.L-1范围内线性关系良好(r=0.999 8),平均回收率为99.73%(RDS=0.85%)。中空栓含量符合要求,体外溶出迅速,中空栓剂在20 min内累积溶出率达98.51%。结论该制剂制备工艺简单易行,质量可控。中空栓剂比普通栓剂释药速度更快。Objective To prepare and establish quality control for the glucosamine hollow type suppository. Methods The hollow type suppository was prepared with semi-synthetic fatty acid esters of glycerol as ground substance. The content of glucosamine was determined by HPLC system with o-phthalaldehyde preeolumn derivatization at the wavelength of 330 nm. Results The linear range of glucosamine was 1 - 50 mg L-1 （ r = 0. 999 8 ）, with an average recovery rate of 99.73 % （ RDS = 0.85 % ）. The hollow type suppository was up to the quality of content standard, and it released quickly. The hollow type suppository released 98.51% in vitro for 20 minutes. Conclusion This preparation is simple and feasible in technology and controllable in quality. Drug release rate of hollow type suppository is higher than the conventional type suppository.

关 键 词：氨基葡萄糖 中空栓 制备 质量控制 溶出度 

分 类 号：R944[医药卫生—药剂学]