HPLC法同时测定枣仁安神胶囊中6种成分

Simultaneous determination of six index components analysis in Zaoren Anshen Capsules

目的建立同时测定枣仁安神胶囊中五味子醇甲、五味子醇乙、隐丹参酮、丹参酮Ⅰ、丹参酮ⅡA、五味子乙素的方法,为枣仁安神胶囊的质量控制提供科学的方法。方法采用HPLC法,选用Thermo 120?-C18色谱柱(250 mm×4.6 mm,5μm);以乙腈-0.1%冰醋酸水溶液为流动相梯度洗脱,对枣仁安神胶囊中6种主要指标性成分的含量进行同时分析测定;检测波长:五味子醇甲、五味子醇乙、五味子乙素为250 nm,隐丹参酮、丹参酮Ⅰ、丹参酮ⅡA为270 nm;体积流量1.0 mL/min,柱温为30℃。结果五味子醇甲在4.7~3153.6 ng(r=0.9999)、五味子醇乙在7.864~314.500 ng(r=0.9999),隐丹参酮在14.4~1256.9 ng(r=0.9999)、丹参酮I在15.1~1103.8 ng(r=0.9999)、丹参酮ⅡA在15.3~1532.0 ng(r=0.9999)、五味子乙素在6.134~204.500 ng(r=0.9999)内呈良好的线性关系。平均加样回收率分别为五味子醇甲为100.4%、五味子醇乙为98.7%、隐丹参酮为99.4%、丹参酮I为100.0%、丹参酮ⅡA为99.3%、五味子乙素100.2%,RSD分别为1.4%、2.7%、2.2%、2.2%、2.5%、2.1%;8批样品中各指标成分的质量分数分别为五味子醇甲1.5457~1.9099 mg/g、五味子醇乙0.1298~0.2351 mg/g、隐丹参酮0.5084~0.5234 mg/g、丹参酮Ⅰ0.1117~0.1223 mg/g、丹参酮ⅡA 0.7558~0.8744 mg/g、五味子乙素0.1202~0.1901 mg/g。结论建立的含量测定分析方法灵敏度高、专属性强,可很好地控制枣仁安神胶囊质量。

Objective To establish a method for determining the contents of schisandrin,schisandrol B,cryptotanshinone,tanshinoneⅠand tanshinoneⅡA,γ-schisandrin in Zaoren Anshen Capsules(ZAC),and provide scientific method for quality control of ZAC.Methods HPLC was used by using Thermo 120?-C18 column,with the mobile phase consisted of acetonitrile and 0.1%acetic acid solution with gradient elution for simultaneous determination of six main index components.The detection wavelengths were set at 250 nm for schisandrin,schisandrol B,γ-schisandrin and 270 nm for cryptotanshinone,tanshinoneⅠ,and tanshinone IIA,flow rate was 1.0 m L/min,and column temperature was 30℃.Results Schisandrin,schisandrol B,γ-schisandrin,cryptotanshinone,tanshinoneⅠ,and tanshinoneⅡA showed good the linear ranges relationships in the range of 4.7-3153.6 ng(r=0.9999),7.864-314.500 ng(r=0.9999),14.4-1256.9 ng(r=0.9999),15.1-1103.8 ng(r=0.9999),15.3-1532.0 ng(r=0.9999)and 6.134-204.500 ng(r=0.9999),respectively.The average recoveries were 100.4%,98.7%,99.4%,100.0%,99.3%and 100.2%,RSD were 1.4%,2.7%,2.2%,2.2%,2.5%and 2.1%,respectively.The contents of each index component in 8 batches of sample were schisandrin 1.5457-1.9099 mg/g,schisandrol B 0.1298-0.2351 mg/g,cryptotanshinone 0.5084-0.5234 mg/g,tanshinoneⅠ0.1117-0.1223 mg/g,tanshinoneⅡA 0.7558-0.8744 mg/g,γ-schisandrin 0.1202-0.1901 mg/g.Conclusion The established analytical method is highly sensitive with strong specificity and it can be used efficiently in the quality control of ZAC.