利巴韦林注射液处方工艺优化研究

Study on the Optimization of Prescription Process of Libavirin Injection

通过对不同p H值条件下样品的有关物质、含量等质量情况的考察,确定了最佳p H值为5.2-5.4;通过对不同灭菌条件下样品有关物质、含量等质量情况的考察,确定了灭菌工艺为115℃×30min的湿热灭菌;通过对活性炭添加量的优化,确定了原料药100%理论标示量投料,活性炭加入质量与药液体积的比例为0.1%。优化后的处方工艺提高了利巴韦林注射液生产过程中的无菌保证能力,且随之使其生产方式由除菌过滤加无菌灌装转变为最终灭菌,降低了人员过程操作和生产环境控制的难度。

The optimal p H was determined to be 5. 2 - 5. 4 by the examination of the quality of the samples under different p H conditions. Through the investigation of the quality of the samples under different sterilization conditions,it was determined that the sterilization process was 115 ℃ × 30 minutes of wet and hot sterilization. By optimizing the amount of activated carbon added,it was determined that the ratio of the added quality of activated carbon to the volume of the liquid was 0. 1 %. The optimized prescription technology improves the aseptic assurance ability in the production process of ribavirin injection,and the resulting transformation of its production method from bacterial filtration plus sterile filling to final sterilization reduces the difficulty of personnel process operation and production environment control.