The Investigation Of Azelnidipine Tablets' Preparation Technics And Quality

Azelnidipine(Azelnidipine)is Japan'S Sankyo and Ube Corporation jointly developed anew-type of long-acting dihydropyridine calcium antagonists,selectively block L-typecalcium channels As early as 1990 years ago and then began research alad developmentClinical studies show-azelnidipine significantly reduced in essential hypertensive patientsblood pressure during exercise,and no effect on heart function,better for mild essentialhypertension Azelnidipine film in May 2003 approved for marketing in Japma,not in thedomestic marketIn this paper,wet granulation tablet w-as prepared azelnidipine film,after a small test,pilot test,the appearance of the tablet,disintegration time,hardness of the necessaryconditions for the index optimization study and investigate the in vitro release behavior,forfurther study bioequivalence of drugs to provide the basis to determine the azelnidipine tablettechnology．To control azelnidipine Tablets,the establishment of sensitive,accurate and controllableidentification,related substalaces and the content of methods and the Chinese Pharmacopoeia2005 edition Appendix X IX A'S requirements．there are ways to do a special attribute．thematerial,linear ralage and reproducibility of method validation Factors,acceleration aladlong-term test results showed that the agent appearance,dissolution,content,relatedsubstalaces did not change significantl~the results are in line with the relevant requirements,SO as to drug registration phase of quality evaluation and production phases of thequalitycontrol test basis...