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,5μm),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16.1~96.6μg/mL(r=0.9999)、10.4~62.4μg/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。
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 10.4~62.4μg/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.
作者
王建芬
姜玉梅
赵一纯
沈苗
王维
WANG Jian-Fen;JIANG Yu-Mei;ZHAO Yi-Chun;SHEN Miao;WANG Wei(Hunan Chemical Vocational Technology College,Zhuzhou 412000,China)
出处
《实验室检测》
2024年第10期131-134,共4页
Laboratory Testing
基金
2022年湖南省教育厅科学研究项目:欧前胡素–延胡索乙素固体脂质纳米粒凝胶剂制备及镇痛研究(湘教通[2022]323号–22C0896)
关键词
延胡索乙素
欧前胡素
凝胶剂
高效液相色谱法
tetrahydropalmatine
imperatorin
gels
high performance liquid chromatography
