目的 为了改善藿香正气软胶囊内容物与囊壳间物质迁移所导致的崩解迟缓现象，对囊壳处方进行优化及性能评估。方法 用电感耦合等离子体质谱（ICP-MS）法研究了藿香正气软胶囊囊壳中铁元素的迁移率；在单因素实验基础之上，以囊壳崩解时间和囊壳拉伸强度作为评价指标，采用响应曲面法对枸橼酸与氨基乙酸质量比、抗氧剂添加量、甘油与明胶质量比和PEG400添加量进行优化；用电子万能试验机分析了囊壳的力学性能；利用红外光谱分析了囊壳的老化现象。结果 藿香正气软胶囊的内容物与囊壳中存在铁迁移现象；当枸橼酸和氨基乙酸质量比为0.70，抗氧剂添加量为0.027（以明胶质量计，下同），甘油与明胶质量比为0.875，PEG400添加量为0.068时，崩解时间较短为24.04 min；根据优化处方制备的囊壳相较于未优化的囊壳具有较好的抗拉强度和柔韧度；红外结果显示优化的囊壳不容易发生老化。结论 通过优化得到的软胶囊囊壳处方较好地改善了由于物质迁移而引起的崩解迟缓现象。

Objective In order to improve the disintegration delay caused by the material migration between the contents and the capsule shell of Huoxiang Zhengqi Soft Capsule (HZSC), the formulation of capsule shell was optimized and its performance was evaluated. Methods The mobility of iron in the capsule shell of HZSC was studied by inductively coupled plasma mass spectrometry (ICP-MS). On the basis of single factor experiment, taking the disintegration time and the tensile strength of the capsule shell as evaluation indexes, and the mass ratio of citric acid to aminoacetic acid, the addition amount of antioxidant, the mass ratio of glycerin to gelatin and the addition amount of PEG400 were optimized by response surface methodology. The mechanical properties of the capsule shell were analyzed by electronic universal testing machine, and the aging phenomenon of the capsule skin was analyzed by infrared spectrum.Results Iron migration existed in the content and shell of HZSC. When the mass ratio of citric acid to aminoacetic acid was 0.70, the amount of antioxidant was 0.027 (based on the quality of gelatin, the same below), the mass ratio of glycerin to gelatin was 0.875, the amount of PEG400 was 0.068, the disintegration time was 24.04 min. The capsule shell prepared according to the optimized formulation had better tensile strength and flexibility compared to the unoptimized capsule shell. The results of infrared absorption spectroscopy showed that the optimized capsule skin was not easy to be aged.Conclusion The optimized formulation of soft capsule shell can improve the disintegration delay caused by material migration.

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国家重点研发计划（2018YFC1706903）；国家重点研发计划（2018YFC1706904）；陕西省重点研发计划（2020SF-315）；陕西省中药基础与新药研究重点实验室基金（19JS019）；陕西中医药大学学科创新团队（2019-YL11）；陕西省自然科学基金资助项目 （2019JM-502）