Optimization of the Formulation and Technology of Lovastatin Capsule by Orthogonal Test / 中国药房

ABSTRACT

OBJECTIVE: To optimize the preparation technology for the lovastatin capsules.METHODS: Orthogonal test was used to optimize the conditions for the technology of preparation meanwhile a dissolution test was conducted.RESULTS: According to the results of the single factor analysis and orthogonal test,the optimal condition for the lovastatin capsules were as follows agglomerant 10%PVP;disintegrator CMS-Na was used by combining exterior and interior addition(2∶1);stuffing capsule by granules;wetting agent of twice granulating 75% alcohol.The 30 min dissolution rate of the capsules prepared in the optimized technology reached above 92%.CONCLUSION: This preparation is stable in technology,reproducible and with high dissolution rate.