羟丙甲纤维素空心胶囊对诺氟沙星胶囊剂溶出行为的影响  

Effect of HPMC hollow capsule on the dissolution behavior of Norfloxacin capsules

作　　者：郑赟 丁慧璞 张捷[1] 刘利萍[1] ZHENG Yun;DING Huipu;ZHANG Jie;LIU Liping(College of Biological & Environmental Sciences,Zhejiang Wanli University,Ningbo,Zhejiang,315100 P. R. China)

机构地区：[1]浙江万里学院生物与环境学院

出　　处：《华西药学杂志》2019年第4期343-346,共4页West China Journal of Pharmaceutical Sciences

基　　金：国家海洋公益性行业科研专项资助项目(20140515);浙江省生物工程重中之重学科资助项目(ZS2016010)

摘　　要：目的考察羟丙甲纤维素(HPMC)空心胶囊装填的诺氟沙星胶囊剂的溶出曲线,并与明胶空心胶囊进行比较。方法采用2015年版《中国药典》中溶出度通则0931第二法检测不同时间点诺氟沙星胶囊在乙酸缓冲液(pH4)中的溶出量,并绘制溶出曲线;考察高温(40℃)、高湿(RH75%±5%)因素对诺氟沙星胶囊剂溶出曲线的影响;采用相似因子(f2)法对溶出曲线进行比较评价。结果诺氟沙星胶囊剂中药物的含量为90%~110%。在30min内,两种HPMC胶囊剂中诺氟沙星的溶出慢于明胶胶囊剂;但30min后,HPMC胶囊剂与明胶胶囊剂中诺氟沙星的溶出逐渐趋于一致;到45min时,两种HPMC胶囊剂中诺氟沙星的累积溶出率均>75%;无论高温还是高湿因素都不改变HPMC胶囊剂中诺氟沙星的溶出曲线趋势。结论HPMC空心胶囊对诺氟沙星的溶出行为与明胶空心胶囊是有区别的。OBJECTIVE To investigate the dissolution curves of Norfloxacin capsules filled with hydroxypropyl methylcellulose (HPMC) hollow capsules and to compare with gelatin hollow capsules. METHODS The dissolution of Norfloxacin capsules in acetic acid buffer solution ( pH4) at different time was determined by the second method of Chinese Pharmacopoeia dissolution rule 0931 ,and the dissolution curve was drawn. The effects of high temperature (40 ℃)and high humidity ( RH75%±5%) on the dissolution curves of Norfloxacin capsules were investigated. The different dissolution curves were compared and evaluated by similarity factor (f2). RESULTS The content of Norfloxacin capsules was 90%- 110%. Within 30 minutes, the dissolution rate of Norfloxacin in HPMC capsules was slower than that in gelatin capsules. However, after 30 minutes, the dissolution rate of Norfloxacin in HPMC capsules and gelatin capsules was gradually consistent. At 45 minutes, the cumulative dissolution percentage of Norfloxacin in both capsules was more than 75%. No matter the high temperature factor or high humidity factor, the trend of dissolution curve of Norfloxacin in HPMC capsules was not changed. CONCLUSION The dissolution behavior of Norfloxacin in HPMC hollow capsules is different from that in gelatin hollow capsules.

关 键 词：羟丙甲纤维素空心胶囊 诺氟沙星 胶囊剂 溶出曲线 相似因子f2 影响因素试验 明胶空心胶囊 比较 

分 类 号：R94[医药卫生—药剂学]