Optimization of prescription and process of compound Yixintong orally disintegrating tablets based on pharmacodynamic and orthogonal experiments
OBJECTIVE The prescription and process of compound Yixintong orally disintegrating tablets were investi-gated,screened,and optimized.METHODS A mouse normobaric hypoxia tolerance model was established.SOD,MDA,GSH-Px,CAT levels in myocardium and brain tissues,and survival time were used as indicators to screen the compound ratio of Hawthorn leaf extract and bomeol.Compound Yixintong orally disintegrating tablets were prepared using direct powder pressing method.The melt ratio,filler,disintegrating agent,flow aid,lubricant and flavoring agent in the prescription were screened by single-factor test with the disintegration time limit and taste as indicators.The dosage of disintegrating agent,lubricant and flavor-ing agent in the prescription was optimized by orthogonal experiment,and the optimal prescription was verified.RESULT The pharmacodynamic results showed that the compound ratio of Hawthorn leaf extract and bomeol exhibited superior anti-hypoxia effect in the range of 19.2∶1～12.8∶1.The optimal prescription consisted of a 1∶2 ratio of Hawthorn leaf extract to stearic acid,3％of aspartame,53.1％of mannitol,9％of CCMC-Na and 1.5％of magnesium stearate.The resulting orally disintegrating tablets completely disintegrated within 60 seconds,and had a pleasing taste.CONCLUSION The optimal prescription and preparation process obtained based on pharmacodynamic experiments and orthogonal design are stable and feasible,which provides a basis for the subsequent research and development of compound Yixintong orally disintegrating tablets.
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