Koh H L, Woo S O
Department of Pharmacy, National University of Singapore.
Drug Saf. 2000 Nov;23(5):351-62. doi: 10.2165/00002018-200023050-00001.
Traditional Chinese medicine (TCM) is gaining popularity as a form of complementary and alternative medicine. Reports of efficacy of TCM are increasing in numbers. TCM includes both crude Chinese medicinal materials (plants, animal parts and minerals) and Chinese proprietary medicine (CPM) [final dosage forms]. Despite the belief that CPM and herbal remedies are of natural origin, unlike Western medicine, and are hence safe and without many adverse effects, there have been numerous reports of adverse effects associated with herbal remedies. Factors affecting the safety of herbal medicines include intrinsic toxicity, adulteration, substitution, contamination, misidentification, lack of standardisation, incorrect preparation and/or dosage and inappropriate labelling and/or advertising. Hence, new regulations on the control of CPM were enforced in Singapore with effect from 1 September 1999. These include licensing and labelling requirements, as well as control of microbial contamination. This article also reviews reports of excessive toxic heavy metals and undeclared drugs in CPM in Singapore between 1990 and 1997. The names, uses, toxic heavy metal or drug detected and the year of detection are tabulated. Information on the brand or manufacturer's name are provided whenever available. The public and healthcare professionals should be better informed of the basic concept of TCM and its usefulness, as well as the potential adverse effects associated with its use. Greater control over the safety and quality of CPM could be achieved through good manufacturing practice, regulatory control, research, education, reporting usage of Chinese medicine (as in drug history) as well as reporting of adverse events.
传统中医作为一种补充和替代医学形式正日益受到欢迎。关于中医疗效的报道数量不断增加。中医包括中药材（植物、动物部位和矿物）和中成药（最终剂型）。尽管人们认为中成药和草药是天然来源的，与西医不同，因此是安全的且没有许多不良反应，但已有大量关于草药不良反应的报道。影响草药安全性的因素包括内在毒性、掺假、替代、污染、错误识别、缺乏标准化、制备和/或剂量不正确以及标签和/或广告不当。因此，新加坡于1999年9月1日起实施了关于中成药管制的新规定。这些规定包括许可和标签要求，以及对微生物污染的控制。本文还回顾了1990年至1997年间新加坡中成药中有毒重金属超标和未申报药物的报道。将检测到的有毒重金属或药物的名称、用途以及检测年份制成表格。如有可用信息，还提供品牌或制造商名称。公众和医疗保健专业人员应更好地了解中医的基本概念及其效用，以及使用中医可能产生的潜在不良反应。通过良好生产规范、监管控制、研究、教育、报告中药使用情况（如药物史）以及报告不良事件，可以更好地控制中成药的安全性和质量。
