| The clinical indications of Tolvaptan on significantly higher blood volume and blood volume normal hyponatremia,which is serum sodium content <125mEq / L or cannot change the symptoms of hyponatremia in patients with restricted water intake.These patents include heart failure,cirrhosis of the liver or syndrome of inappropriate antidiuretic hormone secretion.Tolvaptan was exploited by Otsuka Pharmaceutical Research and Development,a Japanese company,and does not come into the market in china currently.Fortunately,this pharmaceutical was developed by our Company and carried out a lot of research work for the quality of its production technology.The raw material of Tolvaptan was made of amorphous spray dried powder,on account of its poorly soluble physicochemical properties,making preparations before production.Then test the compatibility of Tolvaptan and its accessories(crospovidone)prescription products which is inconsistent with the listed product,further screening of prescriptions,determine the final prescription,and try to make samples.Quality of the Pharmaceuticals,mainly for related substances,dissolution,and the contents were studied.The material and content detection method based on "chemical drugs quality control methods to verify technical guidelines" conduct methodological research,using high performance liquid chromatography,the results prove this method is specific,reproducible,and can make good control on product quality.Dissolution rate consults to the dissolution test method from Chinese Pharmacopoeia(2010 edition,Section Two,appendix ?C,the second method).And improved this method: to choose the best dissolution medium,mixing method,rotation speed selection;and the selected method was validation and determination of the dissolution curve,the curve with good uniformity. |
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