基于HPLC指纹图谱及多成分含量测定的健儿消食口服液质量评价及稳定性研究  

Evaluation of Quality and Stability of Jian′er Xiaoshi Oral Liquid by HPLC Fingerprint and Multi-component Content Determination

作　　者：田莹莹 张金莲[2] 戴迪 李晶[1] 廖卫波 TIAN Ying-ying;ZHANG Jin-lian;DAI Di;LI Jing;LIAO Wei-bo(Jiangxi Provincial Institute of Traditional Chinese Medicine,Nanchang 330046,China;Jiangxi University of Chinese Medicine Nanchang 330004,China;State Key Laboratory of Dao-di Herbs,Beijing 100700,China)

机构地区：[1]江西省中医药研究院,江西南昌330046 [2]江西中医药大学,江西南昌330004 [3]道地药材国家重点实验室,北京100700

出　　处：《中国现代中药》2023年第3期597-603,共7页Modern Chinese Medicine

基　　金：中央本级重大增减支项目(2060302);江西省中医药标准化研究项目(2021A06);江西省中医药中青年骨干人才(第一批)培养计划项目(赣中医药科教字〔2020〕20号);江西省卫健委中医药科技计划项目(2021B644)。

摘　　要：目的:建立健儿消食口服液高效液相色谱法(HPLC)指纹图谱,并结合多指标成分定量分析,对健儿消食口服液进行质量评价及稳定性研究。方法:采用Agilent ZORBAX SB-C18色谱柱(150 mm×4.6 mm,3.5μm),以乙腈-1%乙酸溶液为流动相,梯度洗脱,流速为1.0 mL·min^(–1),检测波长为242 nm,柱温为30℃。建立健儿消食口服液HPLC指纹图谱,并对20批健儿消食口服液进行相似度评价。选择3批样品进行6个月加速试验,考察毛蕊异黄酮苷、橙皮苷、黄芩苷的含量变化及HPLC指纹图谱的变化。结果:建立的健儿消食口服液HPLC指纹图谱确定了29个共有峰,指认了毛蕊异黄酮苷、橙皮苷、黄芩苷、黄芩素、汉黄芩素、芥子碱硫氰酸盐、山梨酸钾7个成分。20批健儿消食口服液生成的对照图谱的相似度为0.971~1.000;6个月加速试验后,3批样品的毛蕊异黄酮苷、橙皮苷含量呈降低趋势,指纹图谱相似度也发生明显变化,但仍在0.9以上。结论:HPLC指纹图谱及多指标成分定量分析可为健儿消食口服液的质量控制及进一步研究提供参考。Objective:To establish the high performance liquid chromatography(HPLC)fingerprint of Jian′er Xiaoshi Oral Liquid and combine with the multi-index component determination to evaluate its quality and stability.Methods:The HPLC conditions are as below:Agilent ZORBAX SB-C18(150 mm×4.6 mm,3.5μm)column,gradient elution with the mobile phase of acetonitrile-1%acetic acid solution,flow rate of 1.0 mL·min^(–1),detection wavelength of 242 nm,and column temperature of 30℃.The HPLC fingerprint of Jian′er Xiaoshi Oral Liquid was established and the similarity of 20 batches of the prescription was evaluated.Three batches of samples were selected for 6 months of accelerated test to investigate the content changes of calycosin-7-glucoside,hesperidin,and baicalin and the changes of HPLC fingerprint.Results:Twenty-nine common peaks were identified in HPLC fingerprint of Jian′er Xiaoshi Oral Liquid and seven compounds were clarified:calycosin-7-glucoside,hesperidin,baicalin,baicalein,wogonin,sinapine thiocyanate,and potassium sorbate.The similarity of reference fingerprints of 20 batches of Jian′er Xiaoshi Oral Liquid ranged from 0.971 to 1.000.After 6 months of accelerated test,the content of calycosin-7-glycoside and hesperidin in the three batches of the samples showed a decreasing trend,and the fingerprint similarity also changed obviously but was still above 0.9.Conclusion:HPLC fingerprint combined with multi-index component quantitative analysis can be used for quality control of and further research on Jian′er Xiaoshi Oral Liquid.

关 键 词：健儿消食口服液 高效液相色谱法指纹图谱 毛蕊异黄酮苷 橙皮苷 黄芩苷 稳定性研究 

分 类 号：R286[医药卫生—中药学]