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Studies On The Dutasteride Crystalline And Quality Standard Of Soft Capsule

Posted on:2019-02-11Degree:MasterType:Thesis
Country:ChinaCandidate:Y P ZhaoFull Text:PDF
GTID:2394330548462109Subject:Pharmaceutical
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The common problems of solid drugs include crystal problems.The polymorphic drugs are the products of the dominant pharmaceutical crystalline substance,which refers to the chemical raw materials with various crystalline solid substances.In contrast to imported drugs and generic drugs,there are significant differences in the efficacy of imported drugs and domestic drugs in addition to the significant differences in price.Therefore,we need to find the advantage crystal of the drug.In generics,we should pay more attention to the consistency between the crystal type and the original research plant.Only the dominant crystal can improve the efficacy and stability of the drug.Dutasteride is a drug produced by glaxosmithkline to fight prostate cancer.The aim of this paper is to provide accurate and reliable data for the crystalloid of histamine and to establish an effective quality standard for the drug.Based on the solvent crystallization method,obtained the degree of his male amine crystal type I,crystal type ?,crystal type ?,also obtained the degree he male amine type of single crystal silicon wafer.The crystal type test and other structural confirmatory techniques were used to identify and analyze the various crystal types of his androidine and his purchase.In the final test,the crystal type of his androgenic amine was consistent with that of his androgenic amine,and all of them were crystalline.The European pharmacopoeia and the American pharmacopoeia only included the test method for the drug of his androidine,while the dhistamine capsule was not included in the European pharmacopoeia and American pharmacopoeia.In order to establish the quality standards of more effective and accurate method,we in the form of quality standards in the United States glaxosmithkline branded soft capsule softcapsule and imported degree he male amine do the reference preparations,to calibrate the homemade degree he male amine soft capsule quality standard.Examined from the system about his male amine soft capsule in appearance,material,antioxidant butylated hydroxytoluene,content,stability and consistency of the original drug,for the following declaration made effective experimental basis.
Keywords/Search Tags:Dutasteride, Polymorphism, Structural confirmation, Quality standard establishment
PDF Full Text Request
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