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作 者:蔡靖波 任琦 袁铭铭 许妍 Cai Jin-bo;Ren Qi;Yuan Ming-ming;Xu Yan(Jiangxi Institute for Drug Control,NMPA Key Laboratory of Quality Evaluation of Traditional Chinese Patent Medicine,Jiangxi Province Engineering Research Center of Drug and Medical Device Quality,Nanchang Jiangxi 330029,China)
机构地区:[1]江西省药品检验检测研究院,国家药品监督管理局中成药质量评价重点实验室,江西省药品与医疗器械质量工程技术研究中心,江西南昌330029
出 处:《江西化工》2023年第5期38-40,共3页Jiangxi Chemical Industry
基 金:江西省重点研发计划项目(20202BBGL73007)。
摘 要:目的:建立高效液相色谱法用于消炎镇痛膏中颠茄流浸膏的质量控制,为科学评价及有效控制消炎镇痛膏中颠茄流浸膏真实投料提供可靠方法。方法:以十八烷基硅烷键合硅胶为填充剂(Intersil ODS-SP C18色谱柱,柱长为25cm,内径为4.6mm,粒径为5μm);以乙腈为流动相A,以0.4%磷酸溶液为流动相B,进行梯度洗脱;检测波长为344nm;柱温为25℃;流速为每分钟1.0ml。结果:采用高效液相色谱法,能够容易、快速地鉴别消炎镇痛膏中颠茄流浸膏特征性成分。结论:该方法简便、准确、阴性无干扰,可有效地提高消炎镇痛膏质控水平,控制方中颠茄流浸膏真实投料。Objective:To establish an HPLC method for the quality control of Belladonna Liquid Extract in Xiaoyan Zhentong Ointment.To provide a reliable method for scientific evaluation and effective control of the true feeding of Belladonna Liquid Extract in Xiaoyan Zhentong Ointment.Methods:Octadecylsilane bonded silica gel(Intersil ODS-SP C18 column,25 cm in length,4.6 mm in diameter,5μm in particle size)was used as the packing agent;acetonitrile was used as the mobile phase A,and 0.4%phosphoric acid solution was used as the mobile phase B for gradient elution;the detection wavelength was 344nm;the column temperature was 25℃;the flow rate was 1.0 ml/min.Results:the characteristic components of Belladonna Liquid Extract in Xiaoyan Zhentong Ointment could be identified easily and quickly by HPLC.Conclusion:the method is simple,accurate,negative and non-interference,which can effectively improve the quality control level of Xiaoyan Zhentong Ointment and control the real dosage of semen Ziziphi Spinosae.
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