ABSTRACT
OBJECTIVE:To prepare Compound benzocaine film and optimize the formulation. METHODS:Compound benzo-caine film was prepared with the base materials of polyving akohol-1788 (PVA) and sodium carboxymethyl cellulose (CMC-Na). With the factors of amounts of the base materials PVA and CMC-Na and the additives glycerol and polysorbate 80,and the indexes of the average of the cumulative release rates (0.25 h and 2 h) of the main drugs benzocaine (BZ) and dexamethasone acetate (DA),the orthogonal experiment was conducted to optimize the formulation,and then the optimal formulation was verified. HPLC was adopted to determine the contents of BZ and DA in the preparation for the calculation of cumulative release rates. RESULTS:The optimal formulation was as follows as PVA of 1.2 g,CMC-Na of 1.2 g,glycerol of 1.6 g, polysorbate 80 of 1.5 ml. The con-tents of BZ and DA in the single film prepared respectively were 21.607 mg(RSD=0.71%,n=6)and 4.375 mg(RSD=0.55%, n=6);the average cumulative release rates were respectively 32.7%(RSD=2.01%)and 69.25%(RSD=1.43%)at 0.25 h and 2 h. CONCLUSIONS:The method of preparing the above-mentioned film with homogeneous contents is simple.