Optimization of Formability Process of Compound Lipid Lowering Tablets by Response Surface Methodology and Its Lipid Lowering Activity

Objective:To optimize the moldability process of compound lipid lowering tablets and to study its lipid-lowering activity. Methods:Using Box-behnken response surface method,the compound lipid lowering tablet extract as the main drug,with the friability,disintegration time and dissolution rate as the evaluation indicators,the ratio of the main drug to the filler,the amount of disintegrant and the concentration of ethanol as the influencing factor,the moldability process of compound lipid lowering tablets were optimized. At the same time,the hyperlipemia rat model was used to evaluate the lipid-lowering activity of compound lipid lowering tablets. Results:The ratio of main drug and auxiliary materials was 80∶15,the amount of disintegrant was 5%,and the concentration of ethanol was 80%.Verification experiment results:The comprehensive score of each batch was 94.01%,and the relative error with the predicted value was 1.49%,and the friability and disintegration time limit were in compliance with pharmacopoeia. Lipid lowering activity test results:Compared with the experimental data of high-fat model group,except for high-density lipoprotein(HDL-C),other indexes in serum of rats in each dose group of compound lipid lowering tablet showed a downward trend,among which the levels of each index in high-dose group significantly decreased(P<0.01),AST and ALT levels in medium dose group significantly decreased(P<0.01),TC,TG and LDL-C levels significantly decreased(P<0.01).The level of HDL-C in medium dose group increased,and had significant difference with the model group(P<0.05). Conclusion:The preferred molding process of this experiment is stable and feasible,and the lipid lowering activity of compound lipid lowering tablets is good. The results of this study provide a reliable basis for the production and development of compound lipid lowering tablets.