翻译： JULIA 来源：Julia法规翻译
Ph. Eur. endorses semi-quantitative HPTLC testingfor traditional Chinese medicines
EP采纳半定量HPTCL方法用于中药检测
European Pharmacopoeia
Ph. Eur. Commission
News
03 April 2019
Strasbourg，France
The European Pharmacopoeia (Ph. Eur.) Commissionhas decided to accept semi-quantitative High-Performance Thin-Layer Chromatography (HPTLC) tests as an alternative quality control which could beused instead of liquid chromatography (LC) assays in monographs on Traditional Chinese Medicines (TCM). The use of the HPTLC test, which aims at maintainingthe level of quality control provided by the monograph without requiring additional assays, will be limited for the time being to monographs on herbal drugs used in TCM that are not subject to marketing authorisations.
EP委员会已决定接受半定量高效薄层色谱（HPTLC）作为可替代的质量控制方法用于代替中药各论中的液相色谱（LC）分析。HPTLC检测的应用目的是维持各论所提供的质量控制水平但不需要进行额外的检测，这些检测目前对不需要进行上市许可的TCM中所用草药各论形成了限制。
The decision, which was taken during the 163rd session of the Ph. Eur. Commission, is the result of a pilot study on the use of the HPTLC method for a semi-quantitative evaluation of the levels of amarker. The study was initiated following Ph. Eur. users’ feedback and was carried out by the TCM working party of the Ph. Eur. to assess the possible replacement of HPLC assays in monographs on TCM. The semi-quantitative approach involved evaluating the intensity of the spot due to the marker in the test solution and comparing it with the intensity of the same spot in a reference solution containing the marker at a concentration equal to the limit.
该决定是在EP委员会第163次会议中做出的，是对HPTCL方法进行示踪物半定量评估的试验研究中得出的结论。该研究是在收到EP用户的反馈后，由EP的TCM工作组启动并执行的，其目的是评估替代TCM各论中HPLC检测的可能性。半定量方法涉及到评估供试液中示踪物的斑点深度，并与含有限度浓度示踪物的对照液中同一斑点比较。
The method was tested in collaborative trials to evaluate whether it was robust and reproducible. The trial involved several laboratories and samples that were representative of current batches with marker contents above and below the provisional limit.
该方法的耐用性和重现性采用了合作试验进行评估。试验使用了几个实验室和代表当前标记物含量高于和低于临时限度的现行批次样本。
After one year of work, the pilot study was successfully completed for Thunberg fritillary bulb (Fritillaria thunbergii Miq.: Beimu) and Corydalis rhizome (Corydalis yanhusuoW. T. Wang:Yanhusuo). The participating laboratories obtained reproducible results for marker levels, identity and system suitability using HPTLC, which was alsofound to give the same pass/fail results as the HPLC assay. Marker levels were evaluated by visual inspection or using appropriate software which converted the HPTLC chromatogram into peak profiles.
在一年工作之后，成功完成了浙贝母（Fritillaria thunbergiiMiq.: Beimu）和夏天无（CorydalisyanhusuoW. T. Wang: Yanhusuo）小试研究。参与实验室获得了HPTCL在标记物水平的可重复结果、鉴别和系统适用性，这些试验在HPLC检测中得到的合格/不合格结果亦相同。标记物水平采用目视检测或适当的将HPTLC谱图转为峰概况的软件进行评估。
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