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目的建立HH胶囊的高效液相色谱(HPLC)指纹图谱,并观察HH胶囊的抗乙肝病毒(Hepatitis B virus,HBV)疗效。方法采用大连依利特ODS-BP C18色谱柱对HH胶囊的HPLC指纹图谱研究。HBV转基因小鼠随机分4组,苦参素组小鼠给予同体积含150mg/(kg·d)苦参素混悬液,高、低剂量HH胶囊组小鼠分别给予同体积含7,2g/(kg·d)HH混悬液,5周后,Elisa法检测血清及肝组织HBs Ag,荧光定量PCR法检测血清及肝组织HBVDNA。结果标定14个特征峰构成HH胶囊的指纹图谱,确定其中1号峰为没食子酸、8号峰为柯里拉京、9号峰为虎杖苷、10号峰为鞣花酸、13号峰为甘草酸、14号峰为齐墩果酸。高剂量HH胶囊[7g/(kg·d)]可以显著降低HBV转基因小鼠肝脏和血清中的HBs Ag、HBVDNA水平,差异具有统计学意义(P<0.01、P<0.05),与苦参素组比较差异无统计学意义(P>0.05)。结论 HH胶囊具有确切的抗HBV作用,HPLC法对HH胶囊质量控制可靠。
Objective To establish HPLC fingerprint of HH capsule and observe the curative effect of HH capsule on Hepatitis B virus (HBV). Methods HPLC fingerprint of HH capsules was determined by OEL-ODS-BP C18 column. HBV transgenic mice were randomly divided into 4 groups, the same volume of mice were given oxymatrine 150mg / (kg · d) oxymatrine suspension, high and low doses of HH capsules were given the same volume of 7,2g / kg / d HH suspension. After 5 weeks, serum and liver tissue HBs Ag were detected by Elisa method and HBVDNA in serum and liver tissue by fluorescence quantitative PCR. Results The fingerprint of 14 HH capsules was calibrated. The peak of No. 1 was gallic acid, the peak No. 8 was Corilagin, the peak No. 9 was polydatin, the peak No. 10 was ellagic acid, the peak No. 13 was licorice Acid, No. 14 peak for oleanolic acid. High-dose HH capsules [7g / (kg · d)] significantly reduced the levels of HBsAg and HBVDNA in the liver and serum of HBV transgenic mice, with statistical significance (P <0.01, P <0.05) There was no significant difference between the two groups (P> 0.05). Conclusion HH capsule has definite anti-HBV effect, and the HPLC method is reliable for quality control of HH capsule.