Hakamatsuka Takashi
National Institute of Health Sciences, Division of Pharmacognosy, Phytochemistry and Narcotics.
Yakugaku Zasshi. 2020;140(6):783-788. doi: 10.1248/yakushi.19-00253-6.
The latest edition of the Japanese Pharmacopoeia (JP) is the second supplement to the 17th edition containing 324 herbal medicines, of which 176 are crude drugs and 35 are Kampo extracts. Although 148 prescription Kampo extracts are covered by national health insurance, only 35 are listed in the latest JP. However, the sales volume of these 35 Kampo extracts accounts for more than 70% of the total sales volume of Kampo products, as Kampo formulas with higher sales volumes are preferentially listed in the JP. The JP officially defines the origin and description of the listed crude drugs and Kampo extracts and elaborates on their limited values and testing methods. As crude drugs and Kampo extracts are derived from natural products and have the characteristics of traditional medicines, some degree of variation has been experienced during their long-term use, which is one of the crucial differences from chemical drugs. The Japanese Pharmacopoeia Committee on Crude Drugs promotes standardization of the JP by reflecting the actual Japanese market situation. This review explains the characteristics of natural and traditional medicines in crude drug-related items, the JP drafting process and points to be noted, and the significance of listing in the JP.
日本药局方（JP）的最新版本是第17版的第二增补版，其中包含324种草药，其中176种为生药，35种为汉方药提取物。尽管有148种处方药汉方药提取物纳入了国民健康保险范围，但最新的JP中仅列出了35种。然而，这35种汉方药提取物的销售额占汉方产品总销售额的70%以上，因为销售额较高的汉方配方优先列入JP。JP正式定义了所列生药和汉方药提取物的来源及描述，并详细阐述了它们的限量值和检测方法。由于生药和汉方药提取物源自天然产物，具有传统药物的特性，在长期使用过程中出现了一定程度的变异，这是与化学药物的关键区别之一。日本药局方生药委员会通过反映日本实际市场情况来推动JP的标准化。本综述解释了生药相关项目中天然和传统药物的特点、JP起草过程及注意要点，以及列入JP的意义。
