The Consistency Of Metformin Hydrochloride

Metformin hydrochloride?MH?as first-line drug for the treatment of type 2 diabetes,accounts for a large proportion in the oral hypoglycemic agents,and its pharmacological effects have been thoroughly studied,which demonstrate little side effects,and with safe and reliable efficacy.Metformin hydrochloride tablets of many types as generic drugs are already available in domestic market,including products that are manufactured domesticly and imported from other countries,prices vary in relation with brands,and it is reported that different manufacturers of metformin hydrochloride tablets result in a big difference in dissolution and inherent quality,hence,clinical efficacy of different product quality is also of great difference.So,it is necessary to study the consistency between the generic and original metformin hydrochloride tablets.mainly and specificly in two aspects: pharmaceutical equivalence and bioequivalence,namely,in vitro and in vivo evaluation methods.In vitro evaluation mainly includes the comparative studies of a number of dissolution curves and the characteristics of quality testing,in vivo evaluation comprises bioequivalence study.Because of the complexity of in vivo bioequivalence study,cycle is long and cost is high,and generally speaking,in vitro evaluation test can be successfully passed,the in vivo test probability of success will be greatly increased,on the contrary,a number of dissolution curve in vitro is inconsistent,the success rate of the test in vivo bioequivalence study is also low.So in this paper,the consistency evaluation research of generic drug metformin hydrochloride focus on the comparative study of in vitro dissolution test?content and related substances.In chapter 1,a brief introduction about the background and significance of this study were given,a brief overview of metformin hydrochloride tablets in the treatment of diabetes pathology,the physicochemical parameters and pharmacokinetic parameters of the active pharmaceutical ingredients,and the significance and necessity of consistency evaluation were also covered.Chapter 2,in accordance with the physicochemical properties of drugs and relevant pharmacopoeia requirements,HPLC method for measuring metformin hydrochloride tablets related substances,and UV detection in vitro dissolution methods and content were established.The above methods was accurate,quick and sensitive in detecting the in vitro drug dissolution behavior.So it can be used as a in vitro testing methods in the consistent evaluation studies of metformin hydrochloride tablets.Chapter 3,four kinds of domestic products of different manufacturers have been selected to be compared with the original products,contents of study included four dissolution curve,content and related substances,the use of similarity factor f₂ to compare the difference between the various manufacturers about the dissolution.The results showed that each manufacturer of the preparation compared with the reference preparations,similarity on four dissolution curve was not achieved,and there were certain differences in content and related substances.Therefore,this study concludes that currently marketed generic drug metformin hydrochloride tablets is not consistent with the reference preparations,and the quality between the various manufacturers are also in great differences,which is expected for further development,after being evaluated for in vitro dissolution test,in vivo bioequivalence tests should be taken for subsequent evaluation.