An Investigation On Quality Standard And Screening Of Formulation Of Compound Telmisartan Tablets

Objective: To screen the best formulation composition of compound telmisartan bilayer tablets and to establish an analysis method to control quality. Method: The composition of hydrochlorothiazide layer were selected by orthogonal experiment, regarding the parameter of dissolution degree(Td) as index; the proportion of excipients of telmisartan layer were choosed by means of uniform design; Used HPLC method to determine the content of telmisartan and hydrochlorothiazide in compound telmisartan bilayer tablets simultaneously and established the quality standard. Result : Hydrochlorothiazide layer contained hydrochlorothiazide 12.5mg, lactose 46mg, microcrystalline cellulose 16mg, sodium starch glycolate 4mg, converting the whole to granules in the presence of 2% HPMC; telmisartan layer contained telmisartan 40mg, sodium hydroxide 3.36mg, meglumine 12mg, sorbitol 180mg, povidoneK30 11.2mg. Conclusion: The formulation of the bilayer tablets is reasonable, the preparation technology is feasible; the method of quality control is simple and reliable.