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Research and Development of Isosrbide Mononitrate Injection

Author: DingZhiGang
Tutor: GaoBo；HouWei
School: Jilin University
Course: Biological Engineering
Keywords: Isosorbide mononitrate Injection Preparation Quality standards Stability
CLC: R943
Type: Master's thesis
Year: 2007
Downloads: 192
Quote: 0
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Abstract


Isosorbide mononitrate (5-ISMN) is the active metabolite of isosorbide mononitrate (ISDN) , and its pharmacological activity similar to the ISDN , with the expansion of the coronary arteries , reducing cardiac afterload role for angina pectoris and treatment of myocardial infarction . Isosorbide mononitrate Injection (5ml: 20mg) sales in the domestic market , the Management Regulations in accordance with the State Drug Administration approval of new drugs , the development of the project isosorbide mononitrate injection is a chemical 9 class of drugs . In accordance with the relevant provisions of the State Drug Administration of Drug Registration Regulation \requirements. The research results show that isosorbide mononitrate process is reasonable to identify high-performance liquid chromatography , and the physical and chemical reactions identification test specificity ; traits , pH, solution quality research projects in the clarity and color , moisture , sterile , bacterial endotoxin , clarity , content uniformity item check two appendices according to the 2005 edition of the Chinese Pharmacopoeia requirements limit the process to produce the samples were found to be . The content uniformity single isosorbide dinitrate injection quality research projects related substances , Determination items check by high performance liquid chromatography checking method is simple and accurate . The quality standards can be an effective measure of the quality of medicines . Samples of the production process are required . To determine the quality standards of scientific rationality , in favor of the pharmaceutical quality control , ease of patient safety , the proper use . According to the long-stay kind of the findings of the study , the validity of this product is tentatively scheduled for 2 years . The project will not only have a huge economic benefit , and will have a positive social benefits , to bring the Gospel to more cardiovascular and cerebrovascular diseases .

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CLC: > Medicine, health > Pharmacy > Pharmacy > Pharmaceutics
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