目的 采用溶化率对水醇双提中药颗粒剂溶化性进行量化表征与评价。方法 在《中国药典》2020年版四部颗粒剂溶化性检测方法的基础上，选择溶化率为检测指标，并对热水温度、搅拌速度、搅拌转子形状、搅拌转子尺寸、除杂方式、离心转速等参数进行优化，用优化后的方法和目视法对20种水醇双提颗粒的溶化性进行测试。结果 热水温度为75 ℃，搅拌转速为300 r/min，搅拌转子尺寸为4.0 cm，除杂方式为1 000 r/min离心5 min，此条件下测量结果准确稳定。根据20种水醇双提颗粒的溶化率和目视法检测结果，制定了水醇双提颗粒剂溶化性的检测标准。结论 用溶化率作为检测指标能对水醇双提颗粒的溶解程度进行量化表征，用溶化率曲线下面积（area under the dissolution rata curve，ADRC）作为评价指标，能为水醇双提颗粒溶化性评价和改善研究提供客观方法，为评价中药颗粒剂溶化性品质提供参考。

Objective The solubility of water-alcohol double-extraction Chinese medicine granules was quantitatively characterized and evaluated by dissolution rate. Methods Based on the dissolution test method of granules in the 2020 edition of Chinese Pharmacopoeia, the dissolution rate was selected as the detection index, and the parameters such as hot water temperature, stirring speed, stirting rotor shape, stirring rotor size, impurity removal method and centrifugal speed were optimized. The optimized method and visual method were used to test the solubility of 20 kinds of water-alcohol double-extraction granules. Results The hot water temperature was 75 ℃, the stirring speed was 300 r/min, the stirring rotor size was 4.0 cm, and the impurity removal method was centrifuged at 1 000 r/min for 5 min. Under this condition, the measurement results were accurate and stable. According to the dissolution rate of 20 kinds of water-alcohol double-extraction granules and the results of visual inspection, the dissolution test standard of water-alcohol double-extraction granules was established. Conclusion Using dissolution rate as a detection index can quantify the degree of dissolution of water-alcohol double-extraction granules. Using the area under the dissolution rata curve (ADRC) as an evaluation index can provide an objective method for the evaluation and improvement of the solubility of water-alcohol double-extraction granules, and provide a reference for evaluating the solubility quality of traditional Chinese medicine granules.

R283.6

国家长三角科技创新共同体联合攻关项目（2023CSJGG1700）