目的 研究小儿化积颗粒对幼龄大小鼠胃肠功能的影响，并对其主要药效物质进行质量控制。方法 采用幼龄小鼠肠推进、胃排空实验以及大鼠胃液分泌实验进行药效学研究；采用高效液相色谱法和电位滴定法依次对小儿化积颗粒中药效物质槟榔碱和有机酸进行含量测定。结果 小儿化积颗粒能够显著延长幼龄小鼠肠推进百分率（P<0.05），显著减少幼龄小鼠胃中酚红残留率（P<0.001），显著增加大鼠胃液体积和胃蛋白酶活性（P<0.05、0.01、0.001），显著提高胃酸分泌速度（P<0.05、0.01）。建立了槟榔碱以及有机酸含量测定的方法，方法学研究结果均符合规定，3批小儿化积颗粒中试样品含量稳定。结论 小儿化积颗粒能够显著促进幼龄大小鼠胃排空，增强肠推进，改善胃液分泌功能以及胃蛋白酶活性，其作用与同剂量的化积片相当；建立的药效物质质量控制方法简单、专属性强，重复性好，可为小儿化积颗粒的临床应用提供保障。

Objective To study the effect of Xiaoer Huaji Granules (小儿化积颗粒) on gastrointestinal function of young rats and mice, and control the quality of its effective components. Methods Intestinal propulsion test, gastric emptying test in young mice and gastric secretion test in rats were used to study the pharmacodynamics; The content of arecoline in Xiaoer Huaji Granules was determined by HPLC; The organic acid content was determined by potentiometric titration. Results Xiaoer Huaji Granules could significantly prolong the percentage of intestinal propulsion in young mice (P < 0.05), significantly reduce the residual rate of phenol red in the stomach of young mice (P < 0.001), significantly increase the volume of gastric juice and pepsin activity in rats (P < 0.05, 0.01, 0.001), significantly increase the rate of gastric acid secretion (P < 0.05, 0.01). The methods of arecoline and organic acid content determination were established. The results of methodology research were in line with the requirements, and the contents of three batches of Xiaoer Huaji Granule samples were stable. Conclusion Xiaoer Huaji Granules could significantly promote gastric emptying, enhance intestinal propulsion, and improve gastric juice secretion in young mice as well as the activity of pepsin. Its effect was equivalent to Huaji Tablets (化积片) at the same dose. The quality control method was simple, specific and reproducible. This study provide a reliable guarantee for the clinical application of Xiaoer Huaji Granules.

R285.5

国家重点研发计划“中医药现代化”重点专项2022年度项目：儿童型中成药改良创新关键技术研究（2022YFC3501900）