| Isosrbide Mononitrate(5-ISMN)is the active metabolite of Isosrbide Dinitrate(ISDN). The pharmacodynamic action of 5-ISMN is similar to ISDN , broadening coronary vessels and lessening the preload and afterload. 5-ISMN can be used to treat coronary heart disease, angina pectoris and myocardial.Isosrbide Mononitrate Injection(5ml: 20mg) has been on the market in China. According to the regulation of the new drug for examination and approval by the State Food and Drug Administration, the R & D of Isosrbide Mononitrate Injection belongs to the 9th class new drug of chemicals. The studies on project put emphasis on preparation,including formula,artwork,quality and stability so on,without any other requirements in pharmacology and toxicology studies except special safety test.The results dedicate that the artwork of Isosrbide Mononitrate Injection is reasonable. Identification tests are carried out by high performance liquid chromatogram(HPLC)and physical and chemical reaction. The specificity of the identification test is noticeable. The quality researches on description,acidity or alkalinity,colouration,moisture,sterile,endotoxin,clarity,content uniformity conform to the limitation regulations of Pharmacopoeia (2005,â…¡) supplement, so that the samples produced thereby are in line with the regulations. In the quality researches of Isosrbide Mononitrate Injection, such items as content uniformity,relevant materials and assaying are all examined by HPLC which proved to be convenient and accurate. The quality standard can be contributive to the quality measurement of drug, ensuring its scientificity and rationality. Patients can thus safely and conveniently put it into use. According to the results of long-term investigation,the expiration date of Isosrbide Mononitrate Injection is tentatively set on 2 years.This project has great economic advantages , as well as societal advantage , at the same time bring about gospel for more heart and cerebrovascular disease patients. |
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