解郁舒心颗粒制备工艺与质量分析

Preparation Process and Quality Analysis of Jieyu Shuxin Granules

目的:优选解郁舒心颗粒的制备工艺,并考察其质量,为该制剂的质量标准制订提供参考。方法:根据颗粒剂的特性,采用湿法造粒,以颗粒剂的溶化性、澄明度及细粉率为考察指标,优选颗粒剂的辅料种类及用量;以粒度合格率为评价指标,通过正交试验考察木糖醇用量、糊精用量、乙醇体积分数对颗粒剂成型效果的影响。应用HPLC-ELSD检测解郁舒心颗粒中酸枣仁皂苷A和酸枣仁皂苷B的含量,流动相乙腈-水(35∶65),柱温35℃。结果:木糖醇辅料澄明度最好,细粉率最小。最佳处方配比为干膏粉-木糖醇-糊精(0.5∶15∶7),50%乙醇为黏合剂。解郁舒心颗粒中酸枣仁皂苷A和酸枣仁皂苷B平均质量分数分别为0.683,1.369 mg·g^(-1)。结论:制备的解郁舒心颗粒剂符合《中国药典》2010年版的质量要求,质控方法简便、准确、可行。

Objective： To optimize preparation process of Jieyu Shuxin granules and set up its quality standard. Method： According to characteristics of granules,wet granulation was employed,kinds and amounts of excipients in granules were optimized with indexes of solubility,clarity and powder ratio. With qualified rate of particle size as index,orthogonal test was adopted to optimize formulation process by taking ethanol concentration,amounts of dextrin and xylitol as factors. HPLC-ELSD was employed to determine contents of jujuboside A and B in this granules with acetonitrile-water（35 ∶ 65） as mobile phase and column temperature at 35 ℃. Result：Xylitol had the best clarity with minimum powder ratio. Optimum recipe ratio was dry extract-xylitol-dextrin（0. 5∶ 15∶ 7）,50% ethanol as a adhesive. Contents of jujuboside A and B in Jieyu Shuxin granules were 0. 683,1. 369 mg·g^-1,respectively. Conclusion： These methods are proved to be reliable,sensitive and specific,which can be used in quality control of Jieyu Shuxin granules.