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基于评价抽检的市售钩藤质量评价

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目的 全面评价市售钩藤的质量。方法 对29批钩藤进行法定标准(性状、鉴别、检查、浸出物)检验;使用薄层色谱(TLC)法对钩藤对照药材、毛钩藤碱、去氢毛钩藤碱、钩藤碱、异钩藤碱进行鉴别;使用高效液相色谱(HPLC)法建立钩藤特征图谱,采用聚类分析、主成分分析(PCA)-X及正交偏最小二乘法判别分析(OPLS-DA)法对共有峰峰面积进行统计分析,筛选出钩藤的关键质量控制成分,同时测定钩藤中喜果苷、异去氢钩藤碱、去氢钩藤碱、异钩藤碱、钩藤碱、去氢毛钩藤碱、毛钩藤碱的含量,整体评价钩藤质量。结果 29批样品中,合格样品23批,合格率79。31%;TLC法鉴别发现:不同基源钩藤化学成分差异较大,大叶钩藤未检出毛钩藤碱,华钩藤未检出去氢毛钩藤碱,毛钩藤未检出4种成分,仅基源为钩藤的样品在与对照药材和对照品色谱相应的位置上显相应的斑点;HPLC法测定结果表明:不同基源钩藤的化学成分及含量差异较大,大叶钩藤未检出去氢钩藤碱和毛钩藤碱,华钩藤未检出异去氢钩藤碱、去氢钩藤碱和去氢毛钩藤碱,毛钩藤仅检出喜果苷,且喜果苷含量较低。基于统计分析,不同批次钩藤间存在差异,并发现可能导致钩藤质量差异的3个已知关键质控成分:异去氢钩藤碱、去氢钩藤碱、异钩藤碱。结论 钩藤整体质量不理想,现行炮制规范和检验标准无法确保产品质量,影响临床用药的安全性和有效性,不同基源钩藤的化学成分类别及含量差异较大,增加了制定统一质量标准的难度。
Quality Evaluation of Uncaria Hook in the Market Based on Evaluation Sampling
Objective To evaluate the quality of Uncaria Hook(UH)in the market.Methods Twenty-nine batches of UH were tested by legal standards(character,identification,inspection,and extract detection).The TLC method was used to explore the identification of the control herbs,pilocarcinine,dehydropilocarcinine,pilocarcinine and isocarcinine.The HPLC method was used to establish the characteristic spectrum of UH.Then cluster analysis,PCA-X,and OPLS-DA analysis methods were used to perform statistical analysis on the common peak area of unguttine,and determine the contents of heicoside,iso-dehydrounguttine,iso-unguttine,iso-unguttine,and unguttine,to screen out the key quality control components of UH and evaluate their quality.Results Among the 29 batches of samples,23 batches were qualified,and the qualified rate was 79.31%.The results of the TLC analysis showed that the chemical constituents of different base sources were very different.No pilocarcinine was detected in Uncaria macrophylla no hydropilocarcinine was detected in Uncaria sinensis,and four components were not detected in Uncaria hirsuta.Only the samples with the base source of the plant showed corresponding spots in the chromatographic position with the control drug and the control substance.The results of HPLC showed that the chemical composition and content of different base sources of UH were very different.No hydrouncinine and pilocarcinine were detected in Uncaria macrophylla.No iso-dehydrouncinine,dehydrouncinine,and dehydropilocarcinine were detected in Uncaria sinensis.And only heicoside was detected in Uncaria sinensis,and the content of heicoside was low.Based on statistical analysis,there were differences among different batches of UH,and three key quality control ingredients,iso-dehydrounguocarcinoma,dehydrounguocarcinoma,and iso-unguocarcinoma that may lead to quality differences of unguocarcinoma were found.Conclusions Overall,the UH is of poor quality,the current processing standards and testing standards can not ensure the quality of the product,affecting the safety and effectiveness of clinic use.The chemical composition categories and contents of different base sources of UH are very different,which increases the difficulty of formulating a unified quality standard.

Uncaria HookThin layer chromatographyCharacteristic mapContent determinationPattern recognitionQuality evaluation

范秀春、彭晓丹、胡建勇、李文锐、董坤

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大理白族自治州药品检验所药品检验室,大理 671000

钩藤 薄层色谱法 特征图谱 含量测定 模式识别 质量评价

2025

医药导报
中国药理学会 华中科技大学同济医学院附属同济医院 中国医药商业协会

医药导报

北大核心
影响因子:1.042
ISSN:1004-0781
年,卷(期):2025.44(1)