银杏蜜环口服溶液中单糖HPLC特征图谱及其质量评价

目的 利用HPLC建立银杏蜜环口服溶液中糖的特征图谱，并对不同来源的银杏蜜环口服溶液质量进行评价。方法 采用1-苯基-3-甲基-5-吡唑啉酮（1-phenyl-3-methyl-5-pyrazolone，PMP）柱前衍生HPLC，结合中药指纹图谱相似度分析软件对4批次市售银杏蜜环口服溶液和6批次自制口服溶液中单糖进行相似度分析，同时通过对组方中成分单糖组成进行测定，对共有峰进行了归属和确认。结果 通过对自制口服溶液与市售口服溶液的HPLC特征图谱进行研究，确定了5个共有峰，经过归属验证，分别为甘露糖、鼠李糖、葡萄糖、半乳糖和阿拉伯糖，相似度介于0.998~1.000之间；同时对口服溶液及其组方中原药材进行了单糖组成测定，发现水解口服液中单糖来源于蜜环菌粉、银杏叶提取物及矫味剂甜菊糖；进一步对不同厂家的银杏叶提取物和蜜环菌粉进行单糖组成测定，结果显示不同厂家的银杏叶提取物和蜜环菌粉单糖组成有明显差异。最后通过对口服液及其原辅料中多糖进行提取、测定，发现口服液中多糖主要来源于蜜环菌粉。结论 本研究建立的方法能较全面地体现银杏蜜环口服溶液组分中单糖的特征，将市售口服溶液、自制口服溶液及其原药材的水解单糖进行归属及溯源，可用于口服液及其原料药材、辅料的质量评价。

HPLC Characteristic Chromatogram of Monosaccharides in Ginkgo Armillaria Oral Solution and Its Quality Evaluation

OBJECTIVE To establish the characteristic chromatogram of monosaccharides in Ginkgo Armillaria oral solution by using HPLC and to evaluate the quality control methods of Ginkgo Armillaria oral solution from different sources, METHODS The monosaccharides in 4 batches of commercial Ginkgo Armillaria oral solution and 6 batches of self-made oral solution were analyzed by 1-phenyl-3-methyl-5-pyrazolone(PMP) precolumn derivatization HPLC combined with traditional Chinese medicine fingerprint similarity analysis software. At the same time, the common peaks were assigned and confirmed by measuring the composition of monosaccharides in the formula. RESULTS By studying the HPLC characteristic chromatography of the self-made oral solution and the commercially available oral solution, five common peaks were identified. After attribution verification, they were mannose, rhamnose, glucose, galactose, and arabinose. The similarity was between 0.998 and 1.000; at the same time, the monosaccharide composition of the oral solution and its ingredients was determined, and it was found that the monosaccharide in the hydrolyzed oral solution was derived from Armillaria mellea powder, Ginkgo biloba extract and the flavoring agent stevioside; The monosaccharide composition of Ginkgo biloba extract and Armillaria mellea powder from different manufacturers was determined, and the results showed that the monosaccharide composition of Ginkgo biloba extract and Armillaria mellea powder from different manufacturers was significantly different. Finally, through the extraction and determination of the polysaccharides in the oral liquid and its raw and auxiliary materials, it was found that the polysaccharides in the oral liquid were mainly derived from Armillaria mellea powder. CONCLUSION The method established in this study can comprehensively reflect the characteristics of monosaccharides in components of Ginkgo Armillaria oral solution. The hydrolyzed monosaccharides of the commercially available oral solution, self-made oral solution and its original medicinal materials can be attributed and traced, which can be used for the quality evaluation of oral solution, raw medicinal materials and recipes.