复方奥硝唑泡腾栓的制备与质量控制  

Preparation and Quality Control of Compound Ornidazole Effervescent Suppository

作　　者：高新富[1] 赵永德[1] 姜宏[1] 邢树礼[1] 徐彦飞[1] 

机构地区：[1]滨州医学院附属医院药学部,山东滨州256603

出　　处：《医药导报》2013年第1期78-80,共3页Herald of Medicine

摘　　要：目的制备复方奥硝唑泡腾栓并建立其质量控制方法。方法以奥硝唑,硝酸咪康唑为主药制成泡腾栓,采用高效液相色谱法测定栓剂中奥硝唑及硝酸咪康唑的含量,并考查该制剂稳定性。结果制剂稳定性较好。含量测定方法准确,奥硝唑及硝酸咪康唑均在40～200μg.mL-1浓度范围内线性关系良好,平均回收率分别为100.09%(RSD=0.15%),100.02%(RSD=0.35%)。结论复方奥硝唑泡腾栓处方及制备工艺合理,质量稳定可控。Objective To prepare the compound ornidazole effervescent suppository and establish a method for its quality control. Methods Ornidazole was compatible with miconazole nitrate to form the effervescent suppository, the content of which were determined with high performance liquid chromatography （HPLC）, the stability was tested. Results The preparation was stable. The method for content determination was accurate with a good linear range at the concentration of 40 - 200 μg .mL^-1 for both ornidazole and miconazole nitrate. Their average recovery was 100.09% （ RSD= 0. 15% ） , 100.02% （ RSD = 0.35 % ）, respectively. Conclusion The p,~scription and preparation technology of compound ornidazole effervescent suppository is rational and the quality shows stable and controllable.

关 键 词：奥硝唑 咪康唑 硝酸 泡腾栓 质量控制 

分 类 号：R978.5[医药卫生—药品] TQ460.6[医药卫生—药学]