复方延胡索乙素止痛凝胶制备及含量测定方法研究
Study on preparation and determination of compound tetrahydropalmatine pain relief gel
王建芬 1姜玉梅 1赵一纯 1沈苗 1王维1
作者信息
- 1. 湖南化工职业技术学院,株洲 412000
- 折叠
摘要
目的 确定复方延胡索乙素止痛凝胶的制备工艺及含量测定方法.方法 正交试验确定凝胶剂的处方配比,采用反相高效液相色谱法.色谱柱为Eclipce XDB-C18(200 mm×4.6 mm,5 µm),流动相为甲醇-0.6%冰醋酸溶液(三乙胺调pH至6.0)30∶70,检测波长280 nm,流速1 mL/min.结果 1 g卡波姆940、20 g丙二醇、8 g甘油、0.5 g三乙醇胺配比作为凝胶基质,含量测定结果表明延胡索乙素和欧前胡素的线性范围分别为 16.1～96.6 µg/mL(r=0.9999)、10.4～62.4 µg/mL(r=0.9999);平均加样回收率分别为99.13%(RSD为0.79%)、99.26%(RSD 为0.82%).结论 该制剂制备方法简单,含量测定方法准确、快速,简便,为该制剂的生产与质量控制提供了科学的参考依据.
Abstract
Objective To study the preparation technology and determination of compound tetrahydropalmatine pain relief gel.Methods Orthogonal test was performed to determine the prescription ratio of the gel.RP-HPLC method was adopted.The determination was performed on Eclipce XDB-C18(200 mm×4.6 mm,5µm)column with mobile phase consisted of methanol-0.6%glacial acetic acid(pH 6.0)30∶70.The detection wavelength was 280 nm,the flow rate was 1 mL/min.Results With 1 g carbomer 940,20 g propylene glycol,8 g glycerol,0.5 g triethanolamine as the gel matrix,the linear ranges of tetrahydropalmatine and imperatorin were 16.1～96.6µg/mL(r=0.9999)and 10.4～62.4 µg/mL(r=0.9999),respectively.The average recoveries were 99.13%(RSD was 0.79%)and 99.26%(RSD was 0.82%),respectively.Conclusion The preparation method is simple,thedetermination method is accurate,rapid and simple,and provides a scientific reference for the production and quality control of calcium preparation.
关键词
延胡索乙素/欧前胡素/凝胶剂/高效液相色谱法Key words
tetrahydropalmatine/imperatorin/gels/high performance liquid chromatography引用本文复制引用
出版年
2024
NETL
NSTL
万方数据