Choi Min-Ji, Kim Sung-Chul, Cho Seung-Hun
Department of Neuropsychiatry, College of Korean Medicine, Kyung Hee University, Seoul, Korea.
Department of Acupuncture & Moxibustion Medicine, Wonkwang Gwangju Oriental Medical Hospital, Gwangju, Korea.
J Pharmacopuncture. 2014 Jun;17(2):67-72. doi: 10.3831/KPI.2014.17.018.
This study evaluated the single-dose toxicity of Saeng Maek San (SMS) in rats.
All experiments were conducted at Biotoxtech (Chungwon, Korea), an institute authorized to perform non-clinical studies under the regulations of Good Laboratory Practice (GLP). A single-dose intravenous toxicity study was carried out on 40 6-week-old Sprague-Daley rats. The animals were randomly divided into the following four groups of ten animals each: Group 1 (G1) was the control group, with each animal receiving an intravenous injection of 1.0 mL of saline, and Groups 2, 3 and 4 (G2, G3 and G4) were the experimental groups, with the animals in the groups receiving an injection of 0.1, 0.5 and 1.0 mL of SMS, respectively. Mortality, clinical signs, body-weight changes and gross pathological findings were observed for 14 days following a single administration of SMS or saline. Organ weights, clinical chemistry and hematology were analyzed at 14 days. This study was conducted with the approval of the Institutional Animal Ethics Committee.
No deaths occurred in any of the four groups,indicating that the lethal dose of SMS in rats is greater than 1.0 mL/animal. Some changes in weights of male rats between the control group and the experimental groups were observed, but no significant changes in the weights of female rats were noted. To identify abnormalities in organs and tissues, we stained representative sections of each specified organ with hematoxylin and eosin for examination with a light microscope. No significant abnormalities were observed in any of the organs or tissues.
The results suggest that intravenous injection of SMS is a safe method of treatment.
本研究评估了生脉散（SMS）对大鼠的单剂量毒性。
所有实验均在Biotoxtech（韩国忠原）进行，该机构是一家根据良好实验室规范（GLP）法规被授权进行非临床研究的机构。对40只6周龄的Sprague-Daley大鼠进行了单剂量静脉毒性研究。动物被随机分为以下四组，每组10只动物：第1组（G1）为对照组，每只动物静脉注射1.0 mL生理盐水，第2、3和4组（G2、G3和G4）为实验组，各组动物分别注射0.1、0.5和1.0 mL的SMS。在单次给予SMS或生理盐水后观察14天的死亡率、临床症状、体重变化和大体病理结果。在第14天分析器官重量、临床化学和血液学指标。本研究经机构动物伦理委员会批准进行。
四组中均未发生死亡，表明大鼠中SMS的致死剂量大于1.0 mL/动物。观察到对照组和实验组之间雄性大鼠体重有一些变化，但未注意到雌性大鼠体重有显著变化。为了识别器官和组织中的异常，我们用苏木精和伊红对每个指定器官的代表性切片进行染色，以便在光学显微镜下检查。在任何器官或组织中均未观察到显著异常。
结果表明，静脉注射SMS是一种安全的治疗方法。
