The Preparation And Quality Research Of Valsartan And Hydrochlorothiazide Tablet

Objective According to the survey of nutrition and health status of residents in our country show that China ranks first in the world in hypertensive patients and has gradually increasing. It has become one of the serious impact on human health and economic development, and increased pressure and burden of family and society, It should to be solved quickly that how to provide effective and inexpensive drug to patients. Valsartan and hydrochlorothiazide tablets have been widely used in clinical as first-line antihypertensive drugs, but its main source was imports, that increased pressure and burden of family and society. The purpose of this paper was to preparate Valsartan and Hydrochlorothiazide tablets, then established related methods for quality control. Ensure the quality of it can be used for clinical widely, so that reduce the heavy financial burden of hypertensive patients.Methods This research adopted Dry granulation method to prepare Valsartan and Hydrochlorothiazide tablets. Acoording to the similar factoers f2 of it in different dissolution medium, we can comparing evaluate its dissolution condition.To measure its content and related substances, HPLC was established. According to the Ch.P appendix XC, this paper used UV spectrophotometry to measure dissolution situation.Then built the quality standards based on the test result and actual situation.Results Prepared three batches pale tablets of orange film-coated, remove coating was white,The vitro dissolution of homemade product was same as the reference set the limite as 80% percent of the label amount. The range of content was 95.0-105.0%.According to the related substances test results set the limit of benzothiadiazine related substances A less than 0.5% of hydrochlorothizad; other related substance less than 0.2% of valsartan. The sum of related substances less than 0.8% except of valsartan enantiomers. Ensure the quality, safety and effiency of homemade products same as refence tablets through the resuls of quality control.Conclusion The tablets prepared by this research are same as reference tablets in physical and chemical properties. It provides a basis for further research on VAlsartan and Hydrocholothiazied tablets.