Jeong Hye-In, Kim Kyeong-Han, Won Jae-Hee, Sung Gi-Un, Kim Ji-Won, Han Ji-Eun, Sung Angela Dong-Min, Park Eun-Jung, Sung Soo-Hyun
Department of Preventive Medicine, College of Korean Medicine, Woosuk University, Jeonju, South Korea.
Department of Public Infrastructure Operation, National Development Institute of Korean Medicine, Seoul, South Korea.
J Pharmacopuncture. 2020 Jun 30;23(2):71-78. doi: 10.3831/KPI.2020.23.011.
This study was conducted to development of hazardous materials management standards for the decoction type of personalized herbal medicines (PHMs).
This study was conducted in two stages. We searched documents about criteria to use words such as 'Herb', 'Herbal medicine', and 'Botanical Drug' and summarized the results. We organized the committee consisted of seven experts, and held two meetings to reach an agreement on hazardous management standards of the decoction type of PHMs.
The seven documents were presented in the literature review and six items related to hazardous management standards of decoction were identified. The second expert meeting brought that a total of six items, including heavy metal, pesticide residues, sulfur dioxide, benzopyrene, mycotoxin, and micro-organism limits, were selected for safety management of decoction type of PHMs. Also, the criteria and test methods for each standard were suggested for monitoring the decoction type of PHMs.
The study suggested hazardous material management standards and criteria for the decoction types of PHMs. In the future, it would be necessary to conduct a pilot test to ensure the validity and credibility of the safety management standard and criteria. Furthermore, the government level safety management system should be introduced to verify the safety of decoction medicines.
本研究旨在制定个性化草药汤剂类型的有害物质管理标准。
本研究分两个阶段进行。我们搜索了关于使用“草药”“草药 medicine”和“植物药”等词汇的标准文件，并总结了结果。我们组建了由七位专家组成的委员会，并召开了两次会议，以就个性化草药汤剂类型的有害物质管理标准达成一致。
在文献综述中列出了七份文件，并确定了与汤剂有害物质管理标准相关的六个项目。第二次专家会议提出，总共六项，包括重金属、农药残留、二氧化硫、苯并芘、霉菌毒素和微生物限量，被选为个性化草药汤剂类型的安全管理项目。此外，还建议了每种标准的标准和测试方法，以监测个性化草药汤剂类型。
该研究提出了个性化草药汤剂类型的有害物质管理标准和规范。未来，有必要进行试点测试，以确保安全管理标准和规范的有效性和可信度。此外，应引入政府层面的安全管理系统，以验证汤剂药物的安全性。
