目的 基于含雄黄儿科制剂及方剂探讨矿物药雄黄在儿科制剂中的应用规律及开发价值。方法 通过Excel 2019统计分析《中国药典》2020年版等国家标准中含雄黄的儿科制剂的应用特点。利用Spss modeler及R语言对《中医方剂大辞典》(1～11册)中含雄黄儿科方剂的药物配伍关联规则进行数据挖掘。利用LC-ICP-MS测定7种含雄黄儿科制剂的总砷及可溶性无机砷含量。结果 与市场常见的儿科中药制剂相比，含雄黄儿科制剂的功能主治在神经系统上具有优势，但存在剂型不合适、服用剂量不合理及质量控制欠缺等问题，含雄黄儿科方剂的药物配伍规律可为治疗儿童惊痫、疳症、痘、疮、痧痢等中药的开发提供参考。常见市售含雄黄儿科制剂中总砷的含量远高于可溶性无机砷含量，且二者之间并无关联。结论 雄黄在儿科制剂的开发中具有疗效广的优势，但现有含雄黄儿童制剂需进一步提升剂型、剂量、质量标准的研究。

Objective To explore the application laws and development value of realgar in pediatric preparations based on the formula and prescriptions containing realgar. Methods Excel 2019 was used to analyze the application characteristics of pediatric preparations containing realgar in national standards such as Chinese Pharmacopoeia. Spss Modeler and R language were used to mine the data of association rules of drug compatibility of the prescriptions containing realgar in the Traditional Chinese Medicine Prescription Dictionary (volumes 1-11). In addition, the contents of total arsenic and soluble inorganic arsenic in seven pediatric preparations containing realgar were measured by HPLC-ICP-MS. Results Compared with the common pediatric traditional Chinese medicine preparations, pediatric preparations containing realgar had advantages in the nervous system, but there were problems such as inappropriate dosage form, unreasonable dosage and lack of quality control, etc. The compatibility rules of pediatric prescriptions containing realgar could provide a reference for the development of modern traditional Chinese medicine for the treatment of eclampsia, malnutrition, pox, sore and Sha. The content of total arsenic in marketed pediatric preparations containing realgar was much higher than that of soluble inorganic arsenic, and there was no correlation between them. Conclusion Realgar has the advantage of wide therapeutic effect in the development of pediatric preparations, but the form, dosage and quality standards need to be further improved.

国家重点研发计划中药现代化专项(2018YFC1706900)；中国药科大学双一流创新团队(CPU2018GY11)；天然药物活性组分与药效国家重点实验室资助项目(SKLNMZZ202025)；江苏省科技成果转化专项资金(BA2020077)