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作 者:戚兴会 龙瑞 唐伟铭 聂宗恒 王鹏飞 郝大伟 QI Xing-hui;LONG Rui;TANG Wei-ming;NIE Zong-heng;WANG Peng-fei;HAO Da-wei(Lunan Hope Pharmaceutical Co.,Ltd.,Shandong Linyi 276006,China;State Key Laboratory for Generic Manufacture Technology of Traditional Chinese Medicine of Lunan Pharmaceutical Group Co.,Ltd.,Shandong Linyi 276006,China)
机构地区:[1]鲁南厚普制药有限公司,山东临沂276006 [2]鲁南制药集团股份有限公司中药制药共性技术国家重点实验室,山东临沂276006
出 处:《中国医院药学杂志》2022年第19期1990-1994,共5页Chinese Journal of Hospital Pharmacy
基 金:山东省重点研发计划(重大科技创新工程)项目(编号:2021CXGC010508);山东省新旧动能转换重大产业攻关项目(编号:鲁动能办[2021]23号)。
摘 要:目的:建立HPLC一测多评法同时测定胡黄连提取物中的10个成分,验证该方法在胡黄连质量分析中应用的科学性及可行性。方法:采用Sepax HP-C_(18)(250 mm×4.6 mm,5μm),流动相为乙腈-0.5%乙酸水溶液,梯度洗脱,流速1.0 mL·min^(-1),检测波长294 nm,柱温30℃。以胡黄连苷Ⅱ为内参物,建立该成分与云杉苷、草夹竹桃苷、胡黄连苷Ⅰ、胡黄连苷Ⅲ、胡黄连苷Ⅳ、黄金树苷、米内苷、6-阿魏酸梓醇、藏黄连苷B的相对校正因子,采用相对校正因子计算各成分的质量分数,同时用外标法进行测定。比较2种测定结果,评价一测多评法在胡黄连中应用的准确性及科学性。结果:10个成分在测定范围内线性良好,平均回收率在98.0%~102.0%,相对校正因子耐用性良好;采用外标法和一测多评法测定3批胡黄连提取物中10个成分含量,2种测定方法结果无明显差别。结论:以胡黄连苷Ⅱ为内标同时测定其多种成分的一测多评法可用于定量分析。OBJECTIVE To establish a quantitative analysis of multi-components by single marker(QAMS)for the determination of 10 components in Rhizoma Picrorhizae extract,and prove the scientificity and feasibility of the method in the quality analysis.METHODS The HPLC separation was performed on a Sepax HP-C_(18)(250 mm×4.6 mm,5μm)column with acetonitrile-0.5%acetic acid as the mobile phase.The flow rate was 1.0 mL·min^(-1),the column temperature was 30℃and the detection wavelength was 294 nm.With picroside-Ⅱas the internal standard(IS),the relative correction factors(RCFs)of picein,androsin,picroside-Ⅰ,picroside-Ⅲ,picroside-Ⅳ,specioside,minecoside,6-feruloylcatalpol and scroside B were established,which were used to calculate the mass fraction of each component.The mass fractions of the 10 effective constituents in Rhizoma Picrorhizae extract weres calculated by the external standard method(ESM)at the same time.By comparing the content results of ESM and QAMS,the accuracy and feasibility of QAMS method were evaluated.RESULTS The 10 components all showed good linear relationships within their investigated ranges.The average recoveries ranged from 98.0%to 102.0%.The robustness of relative correction factor of each component was perfect.No significant difference was found in the quantitative results of the 10 components in 3 batches of Rhizoma Picrorhizae extract determined by the ESM and QAMS.CONCLUSION The method with a single marker using picroside-Ⅱas IS is accurate and feasible in the quantitative analysis of several components in Rhizoma Picrorhizae extract.
关 键 词:胡黄连 相对校正因子 一测多评法 云杉苷 草夹竹桃苷 黄金树苷 米内苷
分 类 号:R917[医药卫生—药物分析学]
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