OBJECTIVE: To optimize the molding technology of Compound jiangzhi baogan fast-dissolved granules. METHODS: Using hydroscopicity, formability, solubility and disintegration time as index, with multiple index comprehensive score, single factor test and orthogonal test were used to optimize the type and amount of diluents, disintegrating agent and solubilizer. RESULTS: The optimal molding technology as follows as the ratio of dry extract powder and lactose (diluents) was 2 ∶ 3; the amount of sodium dodecyl sulfate(solubilizer) was 2%; the amount of croscarmellose sodium (disintegrating agent) was 1%. The verification experiments indicated solubility and formability of granules prepared by optimal technology was 97.3% and 89.2%; disintegration time was 36 seconds; hydroscopicity was 10.3%; angle of repose was 33.3 °; the content of active ingredient silybin was 1.03 mg/g (RSD≤3.60%, n=3). CONCLUSIONS: This molding technology is reasonable, feasible and stable, and can provide scientific evidence for the production of the preparation.
关键词
复方降脂保肝速溶颗粒成型工艺正交试验吸湿率成型率溶化率崩解时限
Keywords
Compound jiangzhi baogan fast-dissolved granulesMolding technologyOrthogonal experimentHydroscopicityFormabilitySolubilityDisintegration time