地龙配方颗粒多指标成分测定及质量评价  

Determination of multi-index components and quality evaluation of Dilong formula granules

作　　者：李雷 张成中 张汉明 卜其涛 张磊 LI Lei;ZHANG Chengzhong;ZHANG Hanming;BU Qitao;ZHANG Lei(School of Pharmacy,Naval Medical University,Shanghai 200433,China)

机构地区：[1]海军军医大学药学院,上海200433

出　　处：《药学实践与服务》2023年第9期547-551,共5页Journal of Pharmaceutical Practice and Service

基　　金：国家自然科学基金(31970316,32170274)。

摘　　要：目的建立同时测定地龙配方颗粒中次黄嘌呤、肌苷、鸟苷和腺苷含量的HPLC方法,结合测定结果和HPLC指纹图谱对地龙配方颗粒进行质量评价。方法采用Thermo AcclaimTM120 C18色谱柱(4.6 mm×250 mm,5μm),以乙腈-水为流动相,梯度洗脱,流速0.6 ml/min,柱温25℃,检测波长254 nm,对10批次样品进行4种成分含量测定和HPLC图谱采集;对所得图谱应用《中药色谱指纹图谱相似度评价系统(2012.130723版)》进行分析评价。结果次黄嘌呤、肌苷、鸟苷和腺苷成分在各自范围内线性关系良好(r≥0.9999),平均加样回收率99.20%~102.98%,RSD 0.26%~0.71%;10批样品中4种成分含量范围分别为:0.7400~4.4574 mg/g、2.1323~7.8050 mg/g、0.3254~1.5961 mg/g、0.5372~2.2229 mg/g;不同厂家地龙配方颗粒HPLC图谱与对照指纹图谱的相似度均大于0.91。结论该方法可用于地龙配方颗粒中次黄嘌呤、肌苷、鸟苷和腺苷等核苷类成分的含量测定;HPLC指纹图谱可用于地龙配方颗粒的质量评价;不同厂家生产的地龙配方颗粒的HPLC指纹图谱相似度较高,但次黄嘌呤、肌苷、鸟苷和腺苷成分的含量差异较大。Objective To establish the method for the simultaneous determination of hypoxanthine,inosine,guanosine and adenosine in Dilong formula granules by HPLC and compare the fingerprints of Dilong formula granules from different manufacturers by HPLC chromatogram.Methods The contents of hypoxanthine,inosine,guanosine and adenosine were determined by Thermo AcclaimTM120C18 column(4.6 mm×250 mm 5μm).The mobile phase was acetonitrile-water.Gradient elution with flow rate of 0.6 ml/min was used.Column temperature was 25℃.Detection wavelength was 254 nm.10 batches of samples were tested.The HPLC chromatogram were compared and analyzed by using the similarity Evaluation system of chromatographic fingerprint of traditional Chinese Medicine(version 2012.130723).Results The linear ranges for the detection of hypoxanthine,inosine,guanosine and adenosine showed good linear relationships within their own ranges(r≥0.9999).The average recoveries were 99.20%~102.98%with RSD of 0.26%~0.71%.The contents of 4 components in 10 batches of samples were 0.7400~4.4574 mg/g,2.1323~7.8050 mg/g,0.3254~1.5961 mg/g,0.5372~2.2229 mg/g respectively.The similarity between HPLC chromatogram and control fingerprints of Dilong formula granules from different manufacturers was greater than 0.91.Conclusion The method could be used to determine the contents of hypoxanthine,inosine,guanosine and adenosine in Dilong formula granule.HPLC fingerprints could be used to evaluation the quality in Dilong formula granule.The similarity of HPLC fingerprints from different manufacturer production of Dilong formula granule is high,but 4 contents in composition are difference.

关 键 词：地龙配方颗粒 指纹图谱 次黄嘌呤 肌苷 鸟苷 腺苷 质量评价 

分 类 号：R286.0[医药卫生—中药学]