3种硝酸酯类静脉注射液的制剂质量分析  

Quality analysis of three isosorbide nitrate intravenous injections

作　　者：左明[1] 段更利[1] 高敏洁 顾丽华 蔡磊 刘振 

机构地区：[1]复旦大学药学院药物分析教研室,上海200032

出　　处：《中国新药与临床杂志》2002年第10期595-598,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的 :对市售硝酸酯类 (珠海许瓦兹制药厂和山东齐鲁制药厂的硝酸异山梨酯 ,山东鲁南制药厂的单硝酸异山梨酯 ) 3种静脉注射液的质量进行评价。方法 :参照中国药典 2 0 0 0年版 ,分别采用高效液相色谱法 (HPLC)、气相色谱法 (GC)及渗透压摩尔浓度测定法等 ,对 3种硝酸酯类注射液进行质量考察。结果 :3种产品的大多数项目检查结果差别不大 ,但渗透压却有很大差异 :其中珠海许瓦兹的注射液为等渗 (2 89mmol·L- 1) ,而另外 2种注射液的渗透压均高于 2 0 0 0mmol·L- 1。结合HPLC及GC MS对其进行剖析 ,发现导致渗透压升高的主要原因在于其中分别含有 2 3%～ 2 8% ,17%～ 2 3%(kg·L- 1)的 1,2 丙二醇。结论 :3种硝酸酯类静脉注射液的质量均符合各自的质量标准 ,但渗透压存在差异 ,导致渗透压升高的原因是含有 1,2 丙二醇。AIM: To evaluate the quality of three marketed isosorbide nitrate intravenous injections. (Isosorbide dinitrate from Zhuhai Schwarz Pharma.,Shandong Qilu Pharma., and isosorbide mononitrate from Shandong Lunan Pharma.) METHODS: HPLC, GC, and freezing point depression methods were used to examine the qualities of three isosorbide nitrate intravenous injections. RESULTS:While few differences existed in the assays of the three brands, there was great difference in osmolarities of three products:the product from Zhuhai Schwarz Pharma.was isotonic (289 mmol·L -1 ), but the other two products were both hyperosmotic (>2000 mmol·L -1 ). After analysis by HPLC and GC MS, 1,2 propanediol was found to exist in both injections at concentrations ranged from 23 % to 28 % (kg·L -1 ), and 17 % to 23 % (kg·L -1 ), which led to an abnormal high osmolarity. CONCLUSION:It indicate that all three brands are confirmed with their own product standards, but great difference exists in osmotic pressures of three products, due to 1,2 propanediol containing in two of three products.

关 键 词：硝酸酯类静脉注射液 硝酸异山梨酯 硝酸甘油 单硝酸异山梨酯 质量控制 色谱法 

分 类 号：R927.11[医药卫生—药学] R972.3