目的 在“药辅合一”理念下导入Pickering乳技术，提升儿科用药羚珠散中石菖蒲挥发油的稳定性。方法 对羚珠散各饮片粉末进行初步表征，确定稳定剂。通过成乳量、包油量和乳剂形态筛选出最佳稳定剂质量浓度、油水比和制备方法。并使用近红外光谱(near infrared spectroscopy，NIRS)分析石菖蒲油在Pickering乳中的包裹状态。比较不同时间下各组别挥发油的保有量、丙二醛和过氧化物的含量。再通过GC-MS分析其中成分的变化趋势。结果 筛选出珍珠粉作为Pickering乳的稳定剂，珍珠粉质量浓度为65 mg/mL，油水比9∶11为最优成乳条件，高压均质法为最优的制备方法，NIRS分析可知石菖蒲挥发油被珍珠粉包裹，Pickering乳液中没有形成新的化学键。对比各组在不同时间段下石菖蒲油的保有率和其中丙二醛和过氧化物含量，可知40 ℃放置1、3、8 h的Pickering乳剂相比于石菖蒲挥发油组有更高的保有率和更低的氧化程度。GC-MS分析结果表明，相比于石菖蒲挥发油组，Pickering乳组挥发性成分的稳定性显著提高。结论 在“药辅合一”理念下Pickering乳可用于含油固体制剂挥发性成分的稳定性提升。

Objective The stability of the calamus oil in the pediatric drug Lingzhu Pulvis (羚珠散) was improved by introducing Pickering emulsion technology under the concept of “combination of medicine and adjuvant”. Methods The preliminary characterization of each drinking tablet of Lingzhu Pulvis was performed to determine the stabilizer. The optimal stabilizer concentration, oil-water ratio and preparation method were screened by the amount of emulsion formation, oil inclusion and emulsion morphology. And the encapsulation state of calamus oil in Pickering emulsion was analyzed using NIR. The retention of volatile oils, malondialdehyde and peroxide contents were compared among the groups at different times. The trends of the components were then analyzed by GC-MS. Results Pearl powder was screened as the stabilizer of Pickering emulsion, the concentration of pearl powder was 65 mg/mL, the oil-water ratio was 9:11 as the optimal emulsion formation conditions, and the high-pressure homogenization method was the optimal preparation method. The NIR analysis showed that the calamus oil was encapsulated by pearl powder and no new chemical bonds were formed in Pickering emulsion. Comparing the retention rate and the malondialdehyde and peroxide content of calamus oil in each group at different time periods, it was found that Pickering emulsion placed at 40 ℃ for 1, 3 and 8 h had higher retention rate and lower oxidation compared to the calamus oil group. The results of GC-MS analysis showed that the stability of volatile components in the Pickering emulsion group was significantly higher compared to the calamus oil group. Conclusion Pickering emulsions can be used to enhance the stability of volatile components in oil-containing solid formulations under the concept of “combination of medicine and adjuvant”.

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陕西省中医药管理局中药制药工程重点学科(2017001)；陕西省中药制药重点学科资助项目(303061107)；陕西中医药大学省级重点实验室开放课题(KF2203)；陕西中医药大学学科创新团队项目(2019-YL11)；国家自然科学基金资助项目(82274105)