Establishment Of Quality Standard Of Dalafilide And Verification Of Its Analytical Method

Erectile dysfunction(erectile dysfunction ED)is one of the most common disease of male sexual dysfunction in the crowd,since phosphodiesterase type 5 inhibitor research results come out,according to the treatment of ED has a good curative effect.Tadalafil(Tadalafil)belongs to a phosphodiesterase type V inhibitor(PDE 5),with high activity and low side effect and longer half-life and other advantages,curative effect is obviously superior to other ED drugs,is the effective treatment for ED patients with a new generation of drugs.The main content of this paper is composed of the following:Overview of tadalafil API,summarize the results of clinical trials.Tadalafil API patent expires in January 2015,through literature review,the synthetic route is determined,the yield can reach above 70%.Establish the quality standard of tadalafil,by reference to the European Pharmacopoeia "8 edition","chemical residual solvent research technical guidelines","chemical stability technology guidelines for research","chemical drug impurity technology guidelines for research,combined with the characteristics of this process,the formulation of quality standard of tadalafil.Combined with the quality of our products,respectively,to obtain a detailed test data for comparison,through the data statistics and induction,to verify the feasibility and accuracy of the established quality standards.The method of verification is used to verify the systematic adaptability and specificity,accuracy and linearity of two important intermediates in the synthesis of tadalafil and the content of tadalafil products.,Precision,solution stability,through the accumulation of data and scientific analysis,analysis method is feasible and effective,all the data are in line with the provisions.We study the long-term stability of tadalafil,including influencing factors,accelerating and long-term experiments.The data were summarized and analyzed under different conditions.The requirements were in accordance with the requirements of Pharmacopoeia Determine the best storage conditions of raw materials and the validity of the validity period.Summary of the paper...