中国药物警戒 ›› 2026, Vol. 23 ›› Issue (4): 432-437.
DOI: 10.19803/j.1672-8629.20250450

• 基础与临床研究 • 上一篇    下一篇

补肾痹通丸安全性评价研究

王云飞1, 刘欢2Δ, 舒合拉·朱马别克1, 帕依曼·亥米提1, 于宁1,*   

  1. 1新疆维吾尔自治区药物研究院,新疆维吾尔药重点实验室,新疆 乌鲁木齐 834000;
    2中国辐射防护研究院药物安全性评价中心,药物毒理与放射损伤药物山西省重点实验室,中核放射毒理与放射性药物临床前评价重点实验室,山西 太原 030006
  • 收稿日期:2025-07-08 出版日期:2026-04-15 发布日期:2026-04-15
  • 通讯作者: *于宁,女,硕士,研究员,中药新药研究与开发。E-mail: ynjy798@163.com
  • 作者简介:王云飞,女,硕士,高级实验师,中药新药研究与开发。∆为并列第一作者。
  • 基金资助:
    新疆维吾尔自治区重点研发计划（2021B03006-3）

Safety Evaluation of Bushen Bitong Wan

WANG Yunfei1, LIU Huan2Δ, SHUHELA·Zhumabieke1, PAYIMAN·Haimiti1, YU Ning1,*   

  1. 1Xinjiang Institute of Materia Medica, Xinjiang Uyghur Pharmaceutical Laboratory, Urumqi Xinjiang 834000, China;
    2Drug Safety Evaluation Center in China Institute for Radiation Protection, Shanxi Key Laboratory of Drug Toxicology and Drug for Radiation Injury, Key Laboratory of Radiological Toxicology and Radiological Drugs Preclinical Evaluation in China National Nuclear Corporation, Taiyuan Shanxi 030006, China
  • Received:2025-07-08 Online:2026-04-15 Published:2026-04-15

PDF (PC)

26

摘要： 目的 通过SD大鼠急性毒性和长期毒性试验,评价补肾痹通丸的安全性,为临床安全用药的剂量设计提供参考。方法 急性毒性试验采用最大耐受剂量法,SD大鼠以最大给药量12.0 g·kg-1灌胃给药,给药后严密观察大鼠的毒性反应情况。长期毒性试验采用SD大鼠160只,分为给药高（6.0 g·kg-1）、中（3.0 g·kg-1）、低（1.5 g·kg-1）剂量组和对照组,每组40只大鼠,连续给药26周,恢复4周,检测指标包括动物体重、饲料消耗量、血液学指标、血清生化、凝血、尿液指标和组织病理学检查等。结果 急性毒性试验中,SD大鼠灌胃补肾痹通丸最大给药量>12.0 g（生药）·kg-1,相当于临床拟用剂量的94.38倍,在此剂量下未出现死亡和明显毒性反应。长期毒性试验中,SD大鼠灌胃给予补肾痹通丸浸膏粉,重复给药26周,无毒反应剂量为6.0 g（生药）·kg-1,相当于临床拟用剂量的47.19倍。高剂量组指标出现一过性改变,未见与药物相关的毒性病理改变。结论 在本研究实验条件下,补肾痹通丸对受试动物未见明显毒性反应,在拟临床使用剂量范围及疗程内,长期口服用药是安全的。

关键词: 补肾痹通丸, 急性毒性试验, 长期毒性试验, 非临床安全性评价, 大鼠

Abstract: Objective To evaluate the safety of Bushen Bitong Wan and provide a reference for the dosage design of safe clinical medications via acute and long-term toxicity tests in SD rats. Methods In the acute toxicity test, SD rats were administered with tolerated doses up to 12.0 g·kg-1 by gavage twice daily. The rats were closely observed for toxic reactions. In the long-term toxicity test, 160 SD rats were divided into high-dose (6.0 g·kg-1), medium-dose (3.0 g·kg-1), low-dose (1.5 g·kg-1) groups and a control group, with 40 rats in each. The rats were given the drug for 26 weeks, followed by 4 weeks of recovery. The test indicators involved body weight, feed consumption, hematological parameters, serum biochemistry, blood coagulation, urine parameters, and histopathological examination. Results In the acute toxicity test, the maximum tolerated dose of Bushen Bitong Wan in SD rats exceeded 12.0 g·kg-1, equivalent to 94.38 times the intended clinical dose, but no obvious toxic or side effects were observed. In the long-term toxicity test, SD rats were given the extract powder of Bushen Bitong Wan by gavage for 26 weeks. The non-toxic response dose was 6.0 g (crude drug)·kg-1, which was 47.19 times the intended clinical dose. Conclusion Under the conditions used in this test, Bushen Bitong Wan produces no obvious toxicity in the tested animals. Long-term oral administration is safe within the intended clinical dosage range and courses of treatment.

Key words: Bushen Bitong Wan, Acute Toxicity Test, Long-Term Toxicity Test, Non-Clinical Safety Evaluation, Rats

中图分类号: