Abstract:
OBJECTIVE To study the preparation and In vitro evaluation of Yiganqing-HPMC K4M/PVP K30 matrix tablet. METHODS Yiganqing- matrix sustained-release tablet, whose release period is 12 hours, was developed with HPMC K4M and PVP K30 as its matrix materials and two Chinese Medicine Catch Huangcao and Hypericum perforatum extract as intermediate drugs. The two matrix materials are both hydrophilic polymer and their hydration behavior are much different. Using single factor of formulation and star point design - response surface methodology to optimize the formulation, and the optimum formulation was obtained. In vitro evaluation was done by the verification tests and the in vitro dissolution data. RESULTS The lowest HPMC K4M and PVP K30 amount in the optimal formulation tablet was not less than 20%, and the matrix material’s ratio is that HPMC + PVP K30 total amount of the tablet mass 27.03% and HPMC of HPMC + PVP K30 total amount 49.04%. This prescription had satisfied reproducibility and stability, and the drug release of this preparation meets first-order model. CONCLUSION The hepatitis B clear extract-release tablets with 40% drug loading are prepared, and the prescription of the best preparations has been obtained by optimization.