[关键词]
[摘要]
中药口服固体制剂(oral solid dosage,OSD)原辅料理化性质不仅影响制剂的可制造性,而且影响终产品的安全性、有效性和质量可控性。系统表征中药OSD原辅料物性并整理归纳,有利于中药制剂处方和工艺研发规律的总结和应用。介绍了智能中医药(intelligent traditional Chinese medicine,iTCM)中药口服固体制剂原辅料物性数据库的共享平台、数据特征和应用。iTCM物性数据库公开的205批数据显示数据库具备数据代表性和完备性特征。分别采用单变量、双变量和多变量统计方法挖掘物性数据特征,物性周期表和降维分析结果表明,与药用辅料相比,中药物料多具有流动性差、引湿性强、综合成型性差等共性特点。物性数据库可应用于制剂原辅料物性相似性评价;基于物性数据库的物性分类规律与知识发现,可提高中药制剂处方设计效率和可靠性。中药物料物性缺陷校正、制剂处方和工艺智能设计是未来研究方向。
[Key word]
[Abstract]
Pharmaceutical excipient properties of Chinese medicine oral solid dosage (OSD) affect not only the prescription manufacturability, but also the safety, effectiveness and quality controllability of the final products. Systematic characterization and organization of material properties of Chinese medicine OSD can facilitate the generation and application of formulation and process development rules. In this study, a comprehensive review of the iTCM (intelligent traditional Chinese medicine) material database was given. The platform technologies, the features of data and the application of database were introduced. It was shown that 205 open records of material data in the iTCM database were characterized by integrity and representativeness. The univariate, bivariate and multivariate statistical methods were used to perform data mining and data features exploration. By comparing the Chinese medicine materials and pharmaceutical excipients through the periodic table of material properties and the dimension reduction algorithm, it was found that most of Chinese medicine materials shared common characteristics like poor flowability high hygroscopicity and inadequate manufacturability. The iTCM material database could be applied to physical properties similarity evaluation. The material classification rules and knowledge were proved to improve both the efficiency and the reliability of formulation design of Chinese medicine OSD forms. The correction of defect properties of Chinese medicine materials and the intelligent design of pharmaceutical formulation and processes are future research directions.
[中图分类号]
R283
[基金项目]
国家自然科学基金资助项目(82074033);中华中医药学会青年人才托举工程项目(2019-QNRC2-C11);创新药物与高效节能降耗制药设备国家重点实验室开放基金项目(GZSYS202007)