摘要
目的对2020-2021年全国生产及流通领域的50型硬脂酸进行考察,对本品的功能性指标进行分析评价。方法考察39批次样品的凝点、碘值、酸值、硬脂酸与棕榈酸的比率、粒径分布及比表面积,并对检验数据按不同生产企业、不同级别、不同生产工艺进行统计分析。结果不同厂家硬脂酸部分功能性指标存在显著性差异,同一厂家不同批次产品部分功能性指标存在批间差异。结论本品功能性指标的均一性相对较差,本研究对制剂处方中辅料拟定、选择以及一致性评价中与辅料相关的问题剖析均有一定的参考价值。
Objective To evaluate the functionality related characteristics of stearic acid type 50 in the production and circulation in China from 2020 to 2021.Methods The freezing point,iodine value,acid value,ratio of stearic acid to palmitic acid,particle size distribution and specific surface area of 39 batches of samples were determined.The test data were analyzed according to different manufacturers,grades and production processes.Results Some functionality related characteristics of stearic acid greatly varied with manufacturers,and there were differences among different batches of products from the same manufacturer.Conclusion The functionality related characteristics of stearic acid type 50 are relatively poor.This study has certain reference value for excipient formulation and selection,and analysis of excipient related problems in consistency evaluation.
作者
谢莹莹
刘雁鸣
郑金凤
张悦
蒋贇
赵勇
周颖
刘杨
石蓉
李颖
粟贵
XIE Ying-ying;LIU Yan-ming;ZHENG Jin-feng;ZHANG Yue;JIANG Yun;ZHAO Yong;ZHOU Ying;LIU Yang;SHI Rong;LI Ying;SU Gui(Hunan Institute for Drug Control,NMPA Key Laboratory of Pharmaceutical Excipients Engineering Technology Research,Changsha 410001)
出处
《中南药学》
CAS
2022年第8期1839-1843,共5页
Central South Pharmacy
基金
湖南省自然科学基金-科药联合基金项目(No.2021JJ80042)。
关键词
药用辅料
硬脂酸
功能性指标
pharmaceutical excipient
stearic acid
functionality related characteristic
