复方奥硝唑乳剂的制备与质量控制  

Preparation and Quality Control of Compound Ornidazole Emulsion

作　　者：吴畏[1] 杨征[1] 陈雅[1] 舒凌玲[1] 张袭刚[2] 

机构地区：[1]第三军医大学野战外科研究所大坪医院药剂科,重庆400042 [2]贵阳中医学院2000级,550008

出　　处：《医药导报》2005年第4期322-324,共3页Herald of Medicine

摘　　要：目的探讨复方奥硝唑乳剂的制备方法并对其进行质量控制.方法羧甲基纤维素钠加适量注射用水,溶胀完全,加入亚硫酸氢钠,研磨混匀,再依次加入鱼肝油、吐温-80、奥硝唑、酮康唑研磨使混匀,最后加入水继续研磨制成复方奥硝唑乳剂,并采用双波长-系数倍率法测定其含量.结果奥硝唑的浓度在7.04～14.08 μg·mL-1范围内与△A线性关系良好,r＝0.999 5(n＝7),平均回收率100.10%,RSD＝0.58%(n＝4).酮康唑的浓度在9.984～19.968 μg·mL-1范围内与△A线性关系良好,r＝0.999 9(n＝7),平均回收率100.10%,RSD＝0.90%(n＝4).结论该制剂稳定、制备简便,质控方法准确.Objective To develop a method for the preparation and quality control of compound ornidazole emulsion. Methods To sodium carboxymethyl cellulose (CMC Na) was added water for injection quantum satis. Sodium bisulfite was added after complete swelling of the CMC Na, followed by trituration for thorough mixing. Cod liver oil,Tween 80,ornidazole and ketoconazole were then successively added, followed by trituration for thorough mixing.By adding water and further trituration finally, the preparation of compound ornidazole emulsion was finished. The content of ornidazole in the suspension was determined with dual wavelength κ ratio spectrophotometry. Results The calibration curves were linear when the concentrations of ornidazole and ketoconazole were within the ranges of 7.04-14.08 μg·mL 1 , r =0.999 5 and 9.984- 19.968 μg·mL 1 , r =0.999 9 ( n =7), respectively. The average rates of recovery of ornidazole and ketoconazole were 100.10% ( RSD =0.58%, n =4) and 100.10%( RSD =0.90%, n =4), respectively. Conclusion Compound ornidazole emulsion was shown to be stable, handy in preparation and the method of its quality control was accurate.

关 键 词：奥硝唑 酮康唑 乳剂 质量控制 

分 类 号：R944.1[医药卫生—药剂学] R984[医药卫生—药学]