清金止咳饮的急性和亚急性毒性评价*

作者：江雷敏1,2，青 冰1，魏江存1,2，吴超权3，舒莉莉1，钟 文1

单位：1.广西中医药大学附属国际壮医医院，广西 南宁 530201； 2.广西中医药大学，广西 南宁 530200； 3.广西壮族自治区药品检验研究院，广西 南宁 530021

引用：引用：江雷敏，青冰，魏江存，吴超权，舒莉莉，钟文.清金止咳饮的急性和亚急性毒性评价[J].中医药导报,2026,32(3):61-69.

DOI：10.13862/j.cn43-1446/r.2026.03.011

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摘要：目的：研究清金止咳饮经口给药的急性和亚急性毒性。方法：取KM小鼠雌雄各半，共20只，以清金止咳饮最大剂量灌胃给药，2次/d（等同于原药材259.2 g/kg，临床每日剂量106倍），观察给药期间及给药后14 d小鼠的状态及死亡情况。在亚急性毒性试验中，取120只SD大白鼠，随机分为对照组、清金止咳饮高剂量组（54.4 g/kg）、清金止咳饮中剂量组（27.2 g/kg）和清金止咳饮低剂量组（13.6 g/kg），每组30只，连续给药30 d，于给药期间及停药后检测并记录大鼠体质量及摄食量变化、血液学及血液生化学指标、尿液、各脏器指数。结果：在急性毒性实验中，清金止咳饮对小鼠无明显毒性及致死。在亚急性毒性试验中，清金止咳饮高、中剂量组雌性大鼠体质量均高于对照组（P＜0.05或P＜0.01），雄性大鼠体质量低于对照组（P＜0.05或P＜0.01），于停药30 d后高剂量组雌性及雄性大鼠均与对照组存在差异；此外，清金止咳饮高、中剂量组血清丙氨酸氨基转移酶（ALT）、γ-谷氨酰转移酶（GGT）值较对照组显著增高（P＜0.01或P＜0.05），肝脏及肾脏系数较对照组显著增大（P＜0.01），于停药30 d后均具有恢复趋势；对于上述情况在组织病理学检查中未见明显异常。结论：清金止咳饮经口毒性试验无可见有害作用水平值＞259.2 g/kg，具有高安全性，但长期高剂量清金止咳饮对肝脏和肾脏可能有潜在影响。

关键词：清金止咳饮；急性毒性试验；亚急性毒性试验；小鼠

Abstract：

Objective: To study the acute and sub-acute toxicity of Qingjin Zhike Decoction administered orally. Methods: A total of 20 KM mice (half male and half female) were given the maximum dose of Qingjin Zhike Decoction by gavage, twice daily (equivalent to 259.2 g/kg of the crude drug, 106 times the clinical daily dose). The condition and mortality of the mice were observed during the administration period and for 14 days thereafter. In the sub-acute toxicity test, 120 SD rats were randomly divided into a control group, a high-dose Qingjin Zhike Decoction group (54.4 g/kg), a medium-dose Qingjin Zhike Decoction group (27.2 g/kg), and a low-dose Qingjin Zhike Decoction group (13.6 g/kg), with 30 rats in each group. Each group was administered the respective treatment continuously for 30 days. Changes in body weight and food intake, hematological and blood biochemical indices, urine parameters, and organ coefficients were measured and recorded during the administration period and after drug withdrawal. Results: In the acute toxicity experiment, Qingjin Zhike Decoction showed no obvious toxicity or lethality in mice. In the sub-acute toxicity test, the high-dose Qingjin Zhike Decoction group and medium-dose Qingjin Zhike Decoction group showed higher body weight of female rats than control group (P<0.05 or P<0.01), while the body weight of male rats was lower than that of the control group (P<0.05 or P<0.01). After a 30-day washout period, differences in body weight between the high-dose Qingjin Zhike Decoction group and the control group persisted in both female and male rats. Furthermore, serum ALT and GGT levels in the high-dose Qingjin Zhike Decoction group and medium-dose Qingjin Zhike Decoction group were significantly higher than those in the control group (P<0.05 or P<0.01), and the liver and kidney coefficients were significantly higher than those in the control group (P<0.01). These parameters showed a trend of recovery after the 30-day washout period. Histopathological examination revealed no significant abnormalities corresponding to these changes. Conclusion: The oral toxicity test of Qingjin Zhike Decoction showed a no-observed-adverse-effect level greater than 259.2 g/kg, indicating a high safety profile. However, long-term administration of high-dose Qingjin Zhike Decoction may have potential effects on the liver and kidney.

Key words：Qingjin Zhike Decoction; acute toxicity test; sub-acute toxicity test; mice

发布时间：2026-03-28

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