参茸五子丸的急性毒性试验研究
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【摘 要】目的：对参茸五子丸进行急性毒性试验，评价参茸五子丸的安全性，为临床应用提供依据。方法：40只小鼠，每组20只，随机分为2组，标记为参茸五子丸组和空白组，试验前禁食不禁水12h，参茸五子丸组按40.0mL·kg-1灌服参茸五子丸溶液（1.15g·mL-1），每日2次，空白组小鼠等体积同方法纯水灌服。给药后，观察两周，对比小鼠是否有中毒反应并记录小鼠死亡数目。结果：观察期间动物生长正常，未见任何中毒现象，未见死亡;14d后处死小鼠，各器官均正常。结论：小鼠的最大给药量为92.0g生药/kg。小鼠给予参茸五子丸灌胃的最大耐受剂量大于92.0g生药/kg。
【关键词】 参茸五子丸;急性毒性试验;小鼠;半数致死量;最大给药量
【中图分类号】R285.5 【文献标志码】 A 【文章编号】1007-8517（2020）5-0009-04
Study on Acute Toxicity Test of Shenrong Wuzi Pill
JIAO Yu1 HUANG Dehong1 YANG Yanfang2 HU Sirong1 ZHANG Li1
1.Xiangyang Hospital of Traditional Chinese Medicine，Xiangyang 441000，China;
2. Pharmaceutical College，Hubei University of Traditional Chinese Medicine，Wuhan 430065，China
Abstract：
Objective Acute toxicity test was performed on Shenrong Wuzi Pills to evaluate the safety of Shenrong Wuzi Pills and to provide a basis for clinical application. Methods 40 mice，20 in each group，were randomly divided into two groups，marked as Shenrong Wuzi pill group and blank group. Before the test，the mice in Shenrong Wuzi pill group were fasted but not water for 12 hours. The mice in Shenrong Wuzi pill group were given 40.0mL kg-1 solution （1.15g mL-1） twice a day，and the mice in blank group were given the same volume of pure water. After administration，the mice were observed for two weeks to compare whether there was toxic reaction and record the number of mouse deaths. during the observation period，the animals grew normally without any poisoning or death. After 14 days，all organs were normal. Results During the observation period，the animals grew normally without any poisoning or death;after 14 days，all organs were normal. Conclusion The maximum dose for mice was 92.0 g crude drug / kg. The maximum tolerated dose of mice given Shenrong Wuzi Wan gavage is greater than 92.0g crude drug / kg.
Key words：Shenrong Wuzi Pill; Acute toxicity test; Mice; Median lethal dose; Most tolerance dose
甲状腺功能低下是老年患者的常见疾病之一，是甲狀腺激素合成及分泌减少或组织利用不佳导致的全身代谢性疾病，96%的甲状腺低下患者于老年阶段发病[1]。西医治疗该病以甲状腺功能达标为主，但整体治疗效果有待提高，所以研究领域迫切希望能发现新的中药来完善治疗[2]。参茸五子丸为湖北中医名师胡思荣主任医师多年临床验方，以古方 “五子衍宗丸” 加减而成。全方以红参、鹿茸为君药，能温肾壮阳，用于肾阳和精血亏虚而致女子宫寒不孕及甲状腺功能不足。为了初步评价参茸五子丸的安全性，根据《中药、天然药物急性毒性研究技术指导原则》[3]的技术要求，对参茸五子丸进行急性毒性试验。
1 材料与方法
1.1 材料
1.1.1 试验药物 参茸五子丸，176g/瓶，由襄阳市中医医院提供（批号：20150216）。
1.1.2 试验动物 种属与品系：SPF级昆明小鼠。性别和数量：24只小鼠，雌雄各半，用于预实验;40只小鼠，雌雄各半，用于正式试验。动物体重：18～22g。
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