复方降脂保肝速溶颗粒的成型工艺研究

摘要

OBJECTIVE:To optimize the molding technology of Compound jiangzhi baogan fast-dissolved granules. METH-ODS:Using hydroscopicity,formability,solubility and disintegration time as index,with multiple index comprehensive score,sin-gle factor test and orthogonal test were used to optimize the type and amount of diluents,disintegrating agent and solubilizer. RE-SULTS: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 verifica-tion experiments indicated solubility and formability of granules prepared by optimal technology was 97.3% and 89.2%;disintegra-tion 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 scien-tific evidence for the production of the preparation.%目的：优化复方降脂保肝速溶颗粒的成型工艺。方法：分别以吸湿率、成型率、溶化率、崩解时限为考察指标，采用多指标综合评分的方法，通过单因素考察和正交试验分别对稀释剂、崩解剂、增溶剂的种类和用量进行优化。结果：优化的成型工艺为干膏粉与稀释剂乳糖的配比为2∶3，增溶剂十二烷基硫酸钠用量为2％，崩解剂交联羧甲基纤维素钠用量为1％。验证试验结果显示，优化后所制颗粒溶化率为97.3％，成型率为89.2％，崩解时限为36 s，吸湿率为10.3％，颗粒休止角为33.3°，有效成分水飞蓟宾含量为1.03 mg/g（RSD≤3.60％，n＝3）。结论：该成型工艺合理、可行、稳定，可为该制剂的生产提供科学依据。