药用辅料二氧化硅生产工艺稳定性评价策略与分析

目的：基于同等重要的质量标准指标和功能性相关指标，提出生产工艺稳定性评价策略作为药用辅料质量控制的一种新方法。方法：首先测定了A、B厂家共14批次二氧化硅的质量标准指标（干燥失重、炽灼失重、酸碱度和含量）和功能性相关指标（引湿性、比表面积、粒度和粒度分布）。然后，通过生产工艺稳定性评价策略获得质量标准指标稳定性差值（PQ）和功能性相关指标稳定性差值 （PF）。结果：A厂家和B厂家二氧化硅的PQ值分别为31.1%和58.1%，PF值分别为15.6%和50.0%。结论：通过比较2个厂家的PQ值和PF值的大小，可以反映特定生产厂家对产品杂质控制效果的好坏和对功能性指标控制与否以及控制要求的差异，从而全面反映特定企业对其产品生产工艺稳定性的控制。PQ 值和PF值为监测二氧化硅生产工艺稳定性提供了一种全面有效的方法，可为其他药用辅料生产工艺稳定性监测提供参考。

Process Stability Evaluation Strategy and Analysis of Pharmaceutical Excipients Silicon Dioxide

Objective: Based on the equally important quality standard itemsand functionality-related characteristics, to put forward a process stability evaluation strategy as a new method for the process stability control of pharmaceutical excipients. Methods: Firstly, the quality standard items (loss on drying, ignition loss, pH and content) and functionality-related items (moisture absorption, specific surface area, particle size, and particle size distribution) of a total of 14 batches of silica from manufacturers A and B were determined. Subsequently, the quality standard items stability difference (PQ) and functionality-related characteristics stability difference (PF) were obtained by the process stability evaluation strategy. Results: The PQ values of silica of manufacturers A and B were 31.1% and 58.1%, and the PF values were 15.6% and 50.0%, respectively. Conclusion: By comparing PQ values and PF values of two manufacturers, it could refl ect the quality of product impurity control effect of specific manufacturers, the control of functionality-relatedcharacteristics and the difference in control requirements, so as to fully reflect the process stability control of specific manufacturers on their products. The PQ value and PF value provide a comprehensive and eff ective method for monitoring the process stability evaluation of silica, which can provide a reference for the process stability evaluation monitoring of other pharmaceutical excipients.