医药辅料PVPP的后处理工艺研究

Aftertreatment of Pharmaceutical Excipient Crospovidone

目的采用有机溶剂对共聚合成的交联聚维酮(PVPP)进行后处理,以保证所得产品符合《中国药典》2015版要求。方法以产品中N-乙烯基-2-吡咯烷酮(NVP)含量与水中可溶物为主要指标,考察洗涤溶剂、乙醇/水比例和洗涤温度的影响。结果洗涤溶剂采用乙醇/水混合溶剂,其体积比为1∶1,洗涤温度为40℃最佳工艺条件。结论采用50%的乙醇溶液处理PVPP,所得产品均符合《中国药典》2015版规定。

OBJECTIVE Reprocessing Pharmaceutical excipient Crospovidone by organic solvent to ensure that the products conform to the requirements of the Chinese Pharmacopoeia. METHODS Using two factors：the content of NVP and the quality of the soluble content in water to evaluate the effect of cleaning solvent, ethanol/water ratio and temperature. RESULTS Use ethanol/water mixture solvent as cleaning solvent,its volume ratio of 1 ： 1, washing temperature for optimum process conditions of 40℃. CONCLUSION Using 50% ethanol solution to deal with PVPP,and the products all consistent with The Chinese Pharmacopoeia 2015 edition.