红花注射液沉淀颗粒的表征及沉淀原因分析  

Characterization of Sedimentary Particles in Safflower Injection and the Analysis of the Sedimentation Cause

作　　者：魏娜 何亚婕 张水淼 孙宁[1] 刘洋 董川 宋胜梅 WEI Na;HE Yajie;ZHANG Shuimiao;SUN Ning;LIU Yang;DONG Chuan;SONG Shengmei(School of Chemistry and Chemical Engineering,Shanxi University,Taiyuan 030006,China;School of Environment and Resources,Shanxi University,Taiyuan 030006,China;Institute of Environmental Science,Shanxi University,Taiyuan 030006,China)

机构地区：[1]山西大学化学化工学院,山西太原030006 [2]山西大学环境与资源学院,山西太原030006 [3]山西大学环境科学研究所,山西太原030006

出　　处：《山西大学学报（自然科学版）》2023年第4期903-909,共7页Journal of Shanxi University(Natural Science Edition)

基　　金：国家自然科学基金(91843301);山西省自然科学基金(201901D111038);山西大学省级大学生创新创业项目(2021022)。

摘　　要：目前市场上的部分红花注射液因副反应而被召回。本文针对红花注射液产品放置一段时间后,有白色固形物析出的问题展开研究。为了分析出样品中白色固形物的成分及结构,将红花注射液样品中的固形物过滤、干燥,得到白色固形物的粉末。将所得粉末以电感耦合等离子体质谱(ICP-Mass)、红外光谱(FTIR)、X射线衍射(XRD)、热重差热(TG-DSC)分析和扫描电镜(SEM)表征,结果表明该颗粒主要为二水草酸钙(COD)。同时常规检验表明,红花注射液样品中钾离子和树脂含量过量。导致沉淀生成的原因可能是生产过程中沉淀、离子去除工艺不够精细,使得红花注射液中存在大分子树脂及过量的K+离子,静置后形成沉淀,不仅影响澄明度,还会在临床使用过程中发生不良反应。后续拟在红花注射液制备工艺中加入阳离子交换工艺,可进一步除去过量的K+;并改进醇沉工艺,降低树脂的含量。该工作可为优化红花注射液的生产工艺提供参考。Currently, some safflower injections in the market have been recalled due to the side effects. The problem of white solid precipitation produced after being placed for a period was studied in this paper. The white solid precipitations in the safflower injection sample were obtained by filtering and dring, and it's composition and structure were analyzed. The precipitation powder was characterized by inductively coupled plasma mass spectrometry(ICP-Mass), fourier transform infrared spectrometry(FTIR), X-ray diffraction(XRD), thermogravimetric differential thermal analysis(TG-DSC) and scanning electron microscope(SEM). The results showed that the white solid precipitation was mainly calcium oxalate dihydrate(COD). Simultaneously, routine test indicated that the contents of K+ and resin in the safflower injection sample were excessive. The reason for the formation of the precipitation may be due to the precipitation and ion removal process in the production are not fine enough, leading to the existence of excess macromolecular resins and K+ ions in the safflower injection, and thus the precipitate formed after standing. This not only affects the clarity, but also produces adverse reactions during the application in dinic. To solve this cation exchange process will be added to the preparation process of safflower injection to further remove excess K+. Furthermore, the alcohol precipitation process will be improved to reduce the content of resin. This work provides a reference for optimizing the production process of safflower injection.

关 键 词：红花注射液 沉淀颗粒 性质表征 草酸钙 

分 类 号：O436[机械工程—光学工程]