| 薛蕊,杨国卉,李万芳,杨春燕,鲁碧楠,周文斌,许嘉鹏.SD大鼠灌胃妙茯止痛颗粒单次给药毒性试验[J].,2023,32(1):20-23 |
| SD大鼠灌胃妙茯止痛颗粒单次给药毒性试验 |
| Single Dose Toxicity Test of Miaofu Zhitong Granules by Gavage in SD Rats |
| 投稿时间：2022-05-11 |
| DOI： |
| 中文关键词: 妙茯止痛颗粒 单次给药毒性 大鼠 |
| 英文关键词: Miaofu Zhitong Granules Single Dose Toxicity Rats |
| 基金项目:国家重点研发计划（2017YFC1704005） |
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| 中文摘要: |
| 目的：通过对大鼠灌胃妙茯止痛颗粒后进行观测，阐明该药的急性毒性作用，为临床毒副反应监测提供依据。方法：本试验采用最大给药量法，灌胃给药。试验共给药2次，间隔4h，每次给药剂量为20g/kg，给药体积为40mL/kg；另设溶媒对照组，每组20只，雌雄各半。观察给药后动物出现的中毒症状及中毒症状出现的时间、表现程度、发展过程。给药后连续观察2周，观察期结束剖检动物，观察主要脏器改变。结果：动物一般状况观察：给药当天，第一次给药后给药组所有动物均未见明显异常；第二次给药后给药组部分动物可见活动减少、竖毛，且4h内未恢复。给药后第1天雌鼠No.23出现肛周污秽，雄鼠No.31~35出现肛周污秽。给药后第2天雌鼠No.23出现肛周污秽，雄鼠No.34出现肛周污秽。给药后第3～14天，所有动物外观、行为活动情况、呼吸状态、分泌物、排泄物等均未见异常。动物体重：试验期间，给药组雌雄鼠各阶段体重与溶媒对照组相比均无显著性差异。动物大体解剖：14d观察期结束后对全部动物实施安乐死并进行解剖观察，所有动物心、肝、肾、脾、肺、胃肠等脏器均未见明显异常。结论：在本次试验条件下，SD大鼠24h内2次灌胃给予妙茯止痛颗粒的最大耐受剂量(MID）大于40g/kg。 |
| 英文摘要: |
| Objective The acute toxic effects of Miaofu Zhitong granules were elucidated through observation of the granules afterintragastric administration in rats, so as to provide basis for clinical monitoring of toxic and side effects. Methods The maximum dosemethod was used in this study. Intragastric administration was conducted for 2 times with an interval of 4 hours, with a dose of 20 g/kgand a volume of 40 mL /kg. Another solvent control group was set. There were 20 males and females in each group. To observe thepoisoning symptoms and the time, manifestation and development of poisoning symptoms in animals after administration. After adminis-tration, the animals were observed for 2 weeks. After the observation period, the animals were dissected and the changes of main or-gans were observed. Results Observation of general conditions of animals: on the day of administration, no obvious abnormality wasobserved in all animals of the administration group after the first administration; After the second administration, some animals in theadministration group showed decreased activity and hair standing, and did not recover within 4 hours. On the first day after administra-tion, female rat numbered 23 developed perianal filth, Male rats numbered 31 to 35 presented with perianal filth; On the second dayafter administration, female rat numbered 23 developed perianal filth, Male rat numbered 34 presented with perianal filth; From thethird day to the fourteenth day after administration, there was no abnormality in the appearance,behavior, activity, respiratory state,secretion and excreta of all animals. Animal weight: during the test, there was no significant difference in the body weight of male andfemale rats in the administration group compared with the vehicle control group. Gross observation of spleen, liver and other organs was not found in all animals 14 days after euthanasia. Conclusion: under the conditions of this test, the maximum tolerated dose (MTD) ofMiaofu Zhitong granules given to SD rats by gavage twice within 24 hours is greater than 40 g/kg. |
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