Herbal Medicine EBM Research Center, Korea Institute of Oriental Medicine, 483 Expo-ro, Yusung-gu, Daejeon 305-811, Republic of Korea.
J Ethnopharmacol. 2011 Jan 27;133(2):696-703. doi: 10.1016/j.jep.2010.10.050. Epub 2010 Oct 30.
Pyungwi-san (PWS, Heii-san in Japanese) is a mixture of six herbs and is traditionally used in Northeast Asia (especially Korea and Japan) for the treatment of gastrointestinal disorder, such as dyspepsia and inappetance induced by gastric dilatation and gastrointestinal catarrh.
Although PWS is a widely used herbal prescription in Korea and Japan, little information is available in the literature on the safety and toxicity of PWS. As part of a safety evaluation of PWS, the present study evaluated the potential genotoxicity of PWS using a standard battery of test.
We prepared PWS using a water extraction method and simultaneously extracted three compounds from PWS using high performance liquid chromatography. The PWS extract that was obtained was assayed for genotoxicity using the standard three tests recommended by the Korea Food and Drug Administration. These tests included the bacterial reverse mutation test (Ames test), the chromosomal aberration test using China hamster lung cells, and the micronucleus test using ICR mice.
The Ames test showed that the PWS extract did not induce an increase in the number of revertant colonies compared with vehicle control at any dose in all of tester strains. In the micronucleus test, no significant increase was observed in micronucleated polychromatic erythrocytes (MNPCEs) at any dose of PWS extract compared with vehicle control. Conversely, chromosomal aberration test showed that the PWS extract at a dosage of 4500 μg/mL induced an increase in the number of chromosomal aberrations in the 6 h group with metabolic activation compared with the vehicle control.
PWS extract exhibits genotoxicity, based on the results of the chromosomal aberration test. Thus, further detailed experiments will be needed to identify the ingredient responsible for inducing this genotoxicity and to determine its mechanism.
Pyungwi-san（日语中为 Heii-san）是由六种草药混合而成，传统上用于治疗东北亚（特别是韩国和日本）的胃肠道疾病，如消化不良和由胃扩张和胃肠道卡他引起的食欲不振。
虽然 Pyungwi-san 是韩国和日本广泛使用的草药方剂，但关于 Pyungwi-san 的安全性和毒性的文献信息很少。作为 Pyungwi-san 安全性评估的一部分，本研究使用标准测试组合评估了 Pyungwi-san 的潜在遗传毒性。
我们使用水提取法制备 Pyungwi-san，并同时使用高效液相色谱法从 Pyungwi-san 中提取三种化合物。获得的 Pyungwi-san 提取物通过韩国食品和药物管理局推荐的标准三项测试进行遗传毒性测试。这些测试包括细菌回复突变测试（Ames 测试）、中国仓鼠肺细胞染色体畸变测试和 ICR 小鼠微核测试。
Ames 测试表明，与任何剂量的对照溶剂相比，在所有测试菌株中，Pyungwi-san 提取物均未导致回复突变菌落数量增加。在微核测试中，与对照溶剂相比，任何剂量的 Pyungwi-san 提取物均未观察到多色红细胞微核（MNPCE）的数量显著增加。相反，染色体畸变测试表明，在有代谢激活的 6 小时组中，4500μg/mL 剂量的 Pyungwi-san 提取物与对照溶剂相比，染色体畸变数量增加。
根据染色体畸变测试的结果，Pyungwi-san 提取物表现出遗传毒性。因此，需要进一步进行详细实验，以确定引起这种遗传毒性的成分及其机制。
