Hoban Claire L, Musgrave Ian F, Byard Roger W, Nash Christine, Farrington Rachael, Maker Garth, Crighton Elly, Bunce Michael, Coghlan Megan
Adelaide Medical School, The University of Adelaide, Adelaide, SA, 5005, Australia.
Forensic Science SA, Adelaide, SA, 5000, Australia.
Pharmaceut Med. 2020 Feb;34(1):49-61. doi: 10.1007/s40290-019-00314-y.
Methods for assessing the quality of herbal medicine preparations have advanced significantly in recent years in conjunction with increases in herbal medicine use and reports of adulteration and contamination.
This study examined the quality of analgesic and anti-inflammatory herbal medicine preparations available on the Australian market by detecting the presence of listed ingredients, adulterants and contaminants.
Forty-nine analgesic and anti-inflammatory herbal medicine preparations were randomly sourced from Australian capital cities. They were audited using a dual approach of liquid chromatography-mass spectrometry (LC-MS) combined with next-generation DNA sequencing. Once screened, a comparison of listed ingredients with verified ingredients was conducted to determine the accuracy of labelling, and the extent of adulteration and contamination.
Twenty-six of 49 (53%) herbal medicines were adulterated or contaminated with undeclared ingredients. LC-MS revealed the presence of pharmaceutical adulterants including atropine and ephedrine. DNA sequencing uncovered concerning levels of herbal substitution, adulteration and contamination, including the use of fillers (alfalfa, wheat and soy), as well as pharmacologically relevant species (Centella asiatica, Panax ginseng, Bupleurum and Passiflora). Pig/boar and bird DNA was found in some preparations, inferring substandard manufacturing practices. Of the 26 contaminated samples, 19 (73%) were manufactured in Australia, and 7 (27%) were imported from other countries (6 from China, 1 from New Zealand). In 23 of 49 (47%) herbal medicine samples, no biological ingredients were detected at all. These were predominantly pain and anti-inflammatory preparations such as glucosamine and eicosapentaenoic and docosahexaenoic acids found in krill and fish oils, so DNA would not be expected to survive the manufacturing process.
The high level of contamination and substitution of herbal medicine preparations sourced from Australian dispensaries supports the need for more stringent pharmacovigilance measures in Australia and abroad.
近年来，随着草药使用量的增加以及掺假和污染报告的增多，评估草药制剂质量的方法有了显著进展。
本研究通过检测所列成分、掺假物和污染物的存在情况，对澳大利亚市场上的止痛和抗炎草药制剂质量进行了检查。
从澳大利亚首都城市随机抽取了49种止痛和抗炎草药制剂。采用液相色谱 - 质谱联用（LC-MS）结合下一代DNA测序的双重方法对其进行检测。筛选后，将所列成分与经核实的成分进行比较，以确定标签的准确性以及掺假和污染的程度。
49种草药中有26种（53%）掺有未申报成分或被污染。LC-MS检测出含有阿托品和麻黄碱等药物掺假物。DNA测序发现了令人担忧的草药替代、掺假和污染水平，包括使用填充剂（苜蓿、小麦和大豆）以及具有药理相关性的物种（积雪草、人参、柴胡和西番莲）。在一些制剂中发现了猪/野猪和鸟类的DNA，这表明生产工艺不合格。在26个受污染的样本中，19个（73%）是在澳大利亚生产的，7个（27%）是从其他国家进口的（6个来自中国，1个来自新西兰）。在49个草药样本中有23个（47%）根本未检测到生物成分。这些主要是止痛和抗炎制剂，如在磷虾油和鱼油中发现的葡萄糖胺以及二十碳五烯酸和二十二碳六烯酸，因此预计DNA在生产过程中无法留存。
从澳大利亚药房采购的草药制剂的高污染和替代水平表明，澳大利亚国内外都需要更严格的药物警戒措施。
