5种发酵虫草菌丝类制剂的特征图谱及其模式识别研究

 目的 采用高效液相色谱-二极管阵列检测器,建立5种发酵虫草菌丝类制剂的核苷类成分特征图谱的质量控制方法。方法 采用色谱柱:Lichrospher RP-C₁₈(4.6 mm×250 mm,5 μm),甲醇-水二元梯度洗脱模式,流速为1.0 mL·min^-1,检测波长:260 nm,柱温为25 ℃,建立5种发酵虫草菌丝类制剂68批样品的核苷类成分特征图谱,同时指认了5个核苷类成分,并采用相似度分析和系统聚类分析方法对特征图谱数据进行模式识别研究。结果 采用系统聚类分析法对样品分析,百令胶囊、金水宝胶囊和心肝宝胶囊各自聚为一类,说明对于独家生产的品种质量差异小,样品质量较为一致。而多厂家生产的品种如至灵胶囊,样品的差异性较大,进一步分析表明,不同厂家的同一制剂质量存在着较大差异,甚至同一厂家不同批次的样品差异性也较大,应引起足够的重视。结论 所建立的发酵虫草菌丝类制剂的核苷类成分特征图谱的特征性和专属性强,方法简便、快速、可靠,可用于各发酵虫草菌丝制剂的质量控制及综合评价。

HPLC Characteristic Fingerprint and Chemical Pattern Recognition of Fermentation Mycelium Preparations

OBJECTIVE To establish a method of HPLC characteristic fingerprint annlysis for the quality control of five fermentation mycelium preparations. METHODS The HPLC analysis was carried out on a C₁₈ column(4.6 mm×250 mm, 5 μm) by gradient elution with methanol-water as mobile phase at a folw rate of 1.0 mL·min^-1, the column temperature was set at 25 ℃, and the detection wavelength was set at 260 nm. The HPLC characteristic fingerprint of 68 batches of five fermentation mycelium preparations was developed, and the components of adenosine, uridine, guanosine, uracil and adenine were identified. Similarity analysisi and hierarchical cluster analysis (HCA) were applied to study the HPLC characteristic fingerprint and chemical pattern recognition. RESULTS The chemical pattern recognition analysis showed that 15 batches of Bailing capsules, 18 batches of Jinshuibao capsules and 10 batches of Xinganbao capsules were clustered together respectively, indicating that the preparation quality of single enterprise was consistent. The HPLC chromatograms of 15 batches of Zhiling capsules were different and the difference in samples of different enterprises was obvious. CONCLUSION This method is accurate and reliable, and it can be used to control the quality of fermentation mycelium preparations.