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引用本文:贺周扬,王琴,郭秀彩,李闫飞,吴艳华,蔡文坚,岳峰.快速稳定性分析方法研究增稠剂对丙泊酚乳状注射液稳定性的影响[J].中国现代应用药学,2021,38(11):1358-1362.
HE Zhouyang,WANG Qin,GUO Xiucai,LI Yanfei,WU Yanhua,CAI Wenjian,YUE Feng.Study on Effect of Thickening Agents on the Stability of Propofol Emulsion Injection by Rapid Stability Analysis Instrument[J].Chin J Mod Appl Pharm(中国现代应用药学),2021,38(11):1358-1362.
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快速稳定性分析方法研究增稠剂对丙泊酚乳状注射液稳定性的影响
贺周扬1, 王琴1, 郭秀彩2, 李闫飞1, 吴艳华1, 蔡文坚1, 岳峰1
1.广东嘉博制药有限公司, 广东 清远 511500;2.广州市第十二人民医院, 广州 510620
摘要:
目的 考察增稠剂对丙泊酚乳状注射液稳定性的影响。方法 选用快速稳定性分析仪LUMiSizer,结合静置观察、离心沉淀率测定、平均粒径和Zeta电位测定的方法考察3种增稠剂——羧甲基纤维素钠、透明质酸、羧甲基壳聚糖的不同添加量对丙泊酚乳状注射液稳定性的影响。结果 羧甲基纤维素钠和羧甲基壳聚糖容易造成乳液的絮集沉淀,透明质酸在0.02%~0.1%用量下具有良好的悬浮稳定效果。结论 透明质酸通过形成的网状结构可以减少乳液中组分的沉降速度,对丙泊酚乳状注射液的稳定性有明显的提高作用。
关键词:  增稠剂  稳定性分析  LUMiSizer  丙泊酚
DOI:10.13748/j.cnki.issn1007-7693.2021.11.014
分类号:R927.1
基金项目:
Study on Effect of Thickening Agents on the Stability of Propofol Emulsion Injection by Rapid Stability Analysis Instrument
HE Zhouyang1, WANG Qin1, GUO Xiucai2, LI Yanfei1, WU Yanhua1, CAI Wenjian1, YUE Feng1
1.Guangdong Jiabo Pharmaceutical Co., Ltd., Qingyuan 511500, China;2.Guangzhou Twelfth Peoples's Hospital, Guangzhou 510620, China
Abstract:
OBJECTIVE To investigate the effect of thickening agents on the stability of propofol emulsion injection.METHODS The influence of three kinds of thickening agents including sodium carboxymethyl cellulose, hyaluronic acid, carboxymethyl chitosan amount on the stability of propofol emulsion injection were investigated by rapid stability analysis instrument LUMiSizer, combined with standing observation, centrifugal precipitation, average particle size, and Zeta potential. RESULTS Sodium carboxymethyl cellulose and carboxymethyl chitosan were easy to cause flocculation and sediment of emulsion, but good inhibition effect of sedimentation with 0.02%–0.1% of hyaluronic acid. CONCLUSION Hyaluronic acid can reduce the sedimentation rate of components in the emulsion by forming a reticular structure, and significantly improves the stability of propofol emulsion injection.
Key words:  thickening agent  stability analysis  LUMiSizer  propofol
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