非均相液体制剂沉降稳定性的预测方法研究进展

Research Progress on the Prediction Methods for Settling Stability of Heterogeneous Liquid Preparations

非均相液体制剂在临床应用非常广泛,在药物制剂中占有重要地位,但在溶液的存储过程中易发生沉降、聚结、分层、转相等物理不稳定现象。因此,非均相液体制剂稳定性观察和预测的研究对于其处方设计、生产工艺筛选、质量评价建立和贮存运输等均具有重要的指导意义。然而目前国内外仅在食品饮料、化妆品等领域有相关研究,在液体制剂方面鲜有相关报道。因此,笔者试图参照国内外目前对食品、饮料、化妆品、生物学等领域稳定性预测的研究方法,为今后非均相液体制剂稳定性预测方法的建立提供参考,以期能为液体制剂的稳定性预测建立一种快速、准确、经济、科学和客观的预测手段。

Heterogeneous liquid preparations are widely used in clinic,and played an important role in pharmaceutical preparations. But at the same time,since the instability of the physical and chemical properties of the heterogeneous liquid preparation,the dispersed particles have a large specific surface energy and form a thermodynamic unstable system. Especially when in the traditional Chinese medicine liquid preparation,which has a large number of unknown non quantitative components,can easily appear the phenomenon of subsidence,coalescence,stratification and phase inversion during the storage process. Therefore,it is of great significance to study the stability observation and prediction of heterogeneous liquid preparation for its prescription design,production process screening,quality evaluation,storage and transportation. However,only in the fields of food,beverage,cosmetics and other related fields have some research at home and abroad for the moment,and we fond there are few reports on heterogeneous liquid formulations. This paper attempts to study the methods of stability prediction in the fields mentioned above,and then we expect to provide a reference for the establishment of rapid,accurate,economic,scientific and objective prediction methods of the heterogeneous liquid preparation.