吲达帕胺滴丸的制备与质量控制

Preparation and Studies on Indapamide Dropping PillsABSTRACTObjectives:Hypertension,a worldwide common disease ofcardiovascular system is also a public health problem in global.Indapamide has been shown to be effective antihypertensive agents inpatients with chronic renal failure.It was used most frequently for thetreatment of hypertension.In the present experiments,we preparedIndapamide dropping pills to increase its bioavailability and absorption.Methods:The matrix was PEG6000,the coolant was liquid paraffin andthe instrument to make up dropping pills was artificial.Then through theorthogonal experiment of three influencing factors and three levels,takingspherical degree as index,we analyzed the effects of dropping distance,dropping rate and the freeze-pillar height to select the optimal technology.In this experiment we determine the content of Indapamide by UV-VISSpectrophotometry.Results:The optimal formulation determined by rangeanalysis and analysis of variance was just as following:the droppingdistance is 8 cm;the dropping rate is 65 droppings per minute and thefreeze-pillar height is 80cm.The weight variation,disintegration time,dissolution and content uniformity of Indapamide dropping pills accordwith regulation.Conclusions:The preparation technology was feasibleand the method for quality control was liable.Key words:indapamide;drop pill;preparation technology;qualitystandard2