目的 基于三勒浆口服液（Sanajon Oral Liquid，SOL）多元沉淀形成原理，通过优化稳定剂的选择，改善中药口服液SOL的稳定性，并评估复配稳定剂的优化效果。方法 以离心沉淀量为关键评价指标，以乙二胺四乙酸二钠（EDTA-Na₂）、黄原胶、亚硫酸氢钠添加量为调控配方，通过单因素实验和正交试验进行调控配方的优化；测定调控前、后SOL在长期贮藏条件下的离心沉淀量、黏度、色度、光学参数以及化学成分（诃子次酸、没食子酸、儿茶素、柯里拉京、诃黎勒酸、鞣花酸）含量，以评估复配稳定剂优化的效果。结果 添加0.020 g/kg EDTA-Na₂、0.10%黄原胶、0.050 g/kg亚硫酸氢钠的复配稳定剂后，SOL稳定性得到显著改善；调控后的SOL在90 d内沉淀生成量减少41.38%（P＜0.01），黏度、色度及溶液稳定性均有所提高，有效成分较未调控组稳定，沉淀生成得到有效抑制。结论 调控后的SOL在长达90 d的贮藏期间内具有良好的稳定性；研究结果为其制剂开发的工艺研究及质量控制提供了实验基础。

Objective Based on the principle of multivariate precipitation formation in Sanajon Oral Liquid (SOL, 三勒浆口服液), the stability of SOL was improved by optimizing the selection of stabilizers and evaluating the optimization effect of compound stabilizers. Methods The centrifugal precipitation amount was used as the key evaluation index, and the addition of disodium ethylenediaminetetraacetic acid (EDTA-Na₂), xanthan gum, and sodium bisulfite were used as the modulating formulations, and the optimization of the modulating formulations was carried out by one-way experiments and orthogonal experiments; the centrifugal precipitation amounts, viscosities, chromaticities, and optical parameters as well as the chemical compositions of the SOL under the conditions of long-term storage before and after the modulation were determined (chebulinic acid, gallic acid, catechin, corilagin, chebulagic acid, ellagic acid) content to assess the effectiveness of the optimization of the compounding stabilizer. Results The stability of SOL was significantly improved with the addition of 0.020 g/kg EDTA-Na₂, 0.10% xanthan gum and 0.050 g/kg sodium bisulphite. The precipitation generation of the regulated SOL was reduced by 41.38% (P < 0.01) within 90 d, and the viscosity, chromaticity and stability of the solution were all improved, and the active ingredients were more stable than those in the unregulated group. The active ingredients were more stable than those in the unregulated group, and precipitation generation was effectively inhibited. Conclusion The regulated SOL has good stability during the storage period of up to 90 d. The results of this study provide an experimental basis for process research and quality control of its formulation development.

R283.6

国家自然科学基金项目（81973493）;国家自然科学基金项目（82304871）;中国博士后科学基金项目（2023MD734100）;成都中医药大学与三勒浆药业基团联合实验室项目（2019-YF04-00086-JH）