目的 采用溶化率對水醇雙提中藥顆粒劑溶化性進行量化表征與評價。方法 在《中國藥典》2020年版四部顆粒劑溶化性檢測方法的基礎(chǔ)上，選擇溶化率為檢測指標，并對熱水溫度、攪拌速度、攪拌轉(zhuǎn)子形狀、攪拌轉(zhuǎn)子尺寸、除雜方式、離心轉(zhuǎn)速等參數(shù)進行優(yōu)化，用優(yōu)化后的方法和目視法對20種水醇雙提顆粒的溶化性進行測試。結(jié)果 熱水溫度為75 ℃，攪拌轉(zhuǎn)速為300 r/min，攪拌轉(zhuǎn)子尺寸為4.0 cm，除雜方式為1 000 r/min離心5 min，此條件下測量結(jié)果準確穩(wěn)定。根據(jù)20種水醇雙提顆粒的溶化率和目視法檢測結(jié)果，制定了水醇雙提顆粒劑溶化性的檢測標準。結(jié)論 用溶化率作為檢測指標能對水醇雙提顆粒的溶解程度進行量化表征，用溶化率曲線下面積（area under the dissolution rata curve，ADRC）作為評價指標，能為水醇雙提顆粒溶化性評價和改善研究提供客觀方法，為評價中藥顆粒劑溶化性品質(zhì)提供參考。

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

國家長三角科技創(chuàng)新共同體聯(lián)合攻關(guān)項目（2023CSJGG1700）