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市售圣约翰草制剂中金丝桃素和假金丝桃素含量的分析。

Analysis of the hypericin and pseudohypericin content of commercially available St John's Wort preparations.

作者信息

Draves Andrew H, Walker Scott E

机构信息

Department of Pharmacy, Sunnybrook and Women's College Health Science Centre, 2075 Bayview Avenue, Toronto, Ontario M4N 3M5, Canada.

出版信息

Can J Clin Pharmacol. 2003 Fall;10(3):114-8.

Abstract

CONTEXT

The use of herbal medications and supplements has been growing worldwide with over four billion dollars a year spent on alternative medicines in the United States. St John's wort herbal preparations are generally standardized to "total hypericins" as a means of illustrating a degree of quality control to the consumer. This standardization has been based on a nonspecific method that overestimates and sums the two major naphthodianthrone compounds (hypericin and pseudohypericin) that are found in these products.

OBJECTIVE

To use a more specific and sensitive method to accurately determine the total hypericin content (sum of hypericin and pseudohypericin) in commercially available St John's wort herbal preparations.

DESIGN

The current standard method for determining the naphthodianthrone content is a spectrophotometric method specified in the United States Pharmacopeia. Compounds other than hypericin and pseudohypericin can contribute falsely to the naphthodianthrone concentration, reducing this methods specificity.

SETTING

Fifty-four commercially available St John's wort products were purchased in Canada and the United States.

MAIN OUTCOME MEASURES

A specific and sensitive liquid chromatographic method with fluorescent detection was used to specifically quantify the hypericin and pseudohypericin content in commercially purchased St John's wort products.

RESULTS

Analysis revealed large variations in total naphthodianthrone content, with the percentage of label claim varying from 0% to 108.62% for capsules, and from 31.34% to 80.18% for tablets. The content of tinctures varied from zero to 118.58 microg/ml. Only two products were observed to have a total naphthodianthrone concentrations within 10% of their label claim.

CONCLUSIONS

When the active or marker compounds in an herbal or alternative medicine have been identified, standardization is an important step to ensure consistency from batch to batch. However, consistency is not apparent between brands and most products have inaccurate label claims. On average, most labels overestimate the hypericin and pseudohypericin content by a factor of almost two.

摘要

背景

草药和补充剂的使用在全球范围内不断增加,在美国,每年在替代药物上的花费超过40亿美元。圣约翰草属植物草药制剂通常以“总金丝桃素”进行标准化,以此向消费者说明质量控制的程度。这种标准化基于一种非特异性方法,该方法高估并累加了这些产品中发现的两种主要萘骈二蒽酮化合物(金丝桃素和假金丝桃素)。

目的

使用更特异、灵敏的方法准确测定市售圣约翰草属植物草药制剂中总金丝桃素含量(金丝桃素和假金丝桃素之和)。

设计

目前测定萘骈二蒽酮含量的标准方法是美国药典规定的分光光度法。除金丝桃素和假金丝桃素外的其他化合物可能会错误地影响萘骈二蒽酮浓度,从而降低该方法的特异性。

地点

在加拿大和美国购买了54种市售圣约翰草产品。

主要观察指标

采用特异、灵敏的带荧光检测的液相色谱法,专门定量市购圣约翰草产品中金丝桃素和假金丝桃素的含量。

结果

分析显示,萘骈二蒽酮总含量差异很大,胶囊的标示量百分比从0%到108.62%不等,片剂从31.34%到80.18%不等。酊剂含量从零到118.58微克/毫升不等。仅观察到两种产品的萘骈二蒽酮总浓度在其标示量的10%以内。

结论

当确定了草药或替代药物中的活性或标志性化合物后,标准化是确保批次间一致性的重要步骤。然而,各品牌之间的一致性并不明显,大多数产品的标签标示不准确。平均而言,大多数标签将金丝桃素和假金丝桃素含量高估了近两倍。

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