药物与辅料相容性研究进展

Progress in the Study of Drug-Excipient Compatibility in Dosage Forms

目的对药物与辅料的相容性及相互作用机制和研究方法进展作概述和分析。方法结合近年来国内外相关文献进行评述和展望。结果药物与辅料的相互作用可改变药物活性分子的理化性质,影响药物的稳定性和有效性。结论药物与辅料的相容性研究对制剂处方设计、提高制剂质量和安全性至关重要,药物与辅料相容性及作用机制研究的方法有热分析法、光谱法、色谱法等,可根据试验目的和要求选择适宜的分析方法。

OBJECTIVE To summarize and analyze the interaction between drug and excipient, as well as various techniques used in the research of drug-excipient compatibility. METHODS Related literatures in recent years were reviewed. RESULTS The characterization of the drug would be changed by the interactions between pharmaceutical ingredients and excipients, which would influence the stability and efficacy of the drug product. CONCLUSION Drug-excipient compatibility research would be very crucial in the design of dosage forms, improving the quality and safety of the drug in the formulation. Thermal analysis, spectroscopy and chromotography have been frequently applied in evaluating the compatibility of drug and excipient. It is recommended that selecting the most suitable approach according to the purpose and requirement of experiment.