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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。
OBJECTIVE: To evaluate the quality of three intravenous injections of commercially available nitrate esters (Isosorbide Mononitrate from Zhuzhou Schweizer Pharmaceutical Factory and Shandong Qilu Pharmaceutical Factory, and Isosorbide Mononitrate from Shandong Lunan Pharmaceutical Factory). Methods: According to the Chinese Pharmacopoeia 2000 edition, three kinds of nitrate injection were investigated by high performance liquid chromatography (HPLC), gas chromatography (GC) and osmolarity determination. Results: Most of the three kinds of products showed little difference in the test results, but the osmotic pressure was quite different. Among them, the injection of Schwanz Zhuhai was isotonic (2 89 mmol·L -1), while the other 2 injection The osmotic pressure was higher than 200 mmoL-1. The main reason for the increase of osmotic pressure was analyzed by HPLC and GC MS. The main reason for the increase of osmotic pressure was 1,2-propanediol containing 23% -28%, 17% -23% (kg · L -1) respectively. Conclusion: The quality of three kinds of nitrate intravenous injection are in accordance with the respective quality standards, but there are differences in osmotic pressure, resulting in increased osmotic pressure is due to contain 1,2-propanediol.