Evaluation And Research On Quality Standard Of Bicalutamide

Prostate cancer is a serious threat to the health of middle-aged men,and the incidence in China was increasing year by year.Bicalutamide as a treatment of prostate cancer commonly used drugs,the quality of the pros and cons will directly affect the majority of patients with disease treatment.In order to facilitate the quality control of drugs to ensure the safety of the people's medication,its quality standards are particularly important.Relative to foreign original research drugs,domestic generic drugs in the safety and effectiveness of the prevalence of gaps,quality standards is the existence of the problem.At present,the quality standards of domestic production enterprises are different from each other,and there is a clear gap with the international standards.Therefore,the harmonization and improvement of bicalutamide quality standards has become an urgent requirement.Through the comparison of the standards adopted by the foreign advanced countries or regions with the domestic manufacturers' standards,the quality standards of the scientific and feasible bicalutamide raw materials and their preparations were established.The main works were as follows:(1)The quality standard of bicalutamide raw material was revised.Based on the comparison of current chromatographic conditions of related substances and determination content,the chromatographic conditions in USP 39 for the determination of related substances bicalutamide was adopted,and the method was validated.The system suitability requirement was added,and the limits were unified.(2)The quality standards of bicalutamide preparations were revised.Related substances and content determination methods were unified and USP 39 methods were adopted,and the methods were validated.Dissolution method used by most of standards of bicalutamide tablets was adopted,combined with the actual measurement results of the sample,the limits were unified and improved,which are consistent with the innovator drug standard.Dissolution method used in corporate standards for capsules was adopted,combined with the dissolution of the tablet's limit,the limit was increased to 80%.(3)Other projects,such as identification method,fluorine content and loss on drying were revised and unified.