芩黄清肺散的急性毒性和长期毒性研究

为探索芩黄清肺散（Qinhuang qingfei powder,QQP）的安全性,对其进行急性毒性试验和长期毒性试验。急性毒性试验中,小鼠灌服QQP水煎液（6.00 mg/g体重）1周,测定其半数致死量（LD₅₀）;长期毒性试验中,将96只SD大鼠随机分为高、中、低剂量组（QQP 32.00、16.00、8.00 mg/g体重,相当于临床拟用剂量的96、48和24倍）和对照组。每组24只,雌雄各半。QQP制成药化饲料,喂养30 d。每周记录大鼠的饮水量、耗料量、体重及精神活动等,在喂养第30天和恢复期（第45天）分别对大鼠进行血液学、血液生化、病理学方面的检查。结果表明,急性毒性试验小鼠LD₅₀>6.00 mg/g体重,实际无毒;长期毒性试验中,各剂量组大鼠饮水量、耗料量、体重、血液学指标、血液生化指标和脏器系数与对照组相比均无显著差异（P>0.05）。大鼠主要器官大体解剖和心脏、肝脏、脾脏、肺脏、肾脏、睾丸/卵巢等脏器组织病理学检查未见任何病变。综合以上结果,芩黄清肺散临床用药具有安全性。

Study on Acute Toxicity and Long-term Toxicity of Qinhuang Qingfei Powder

The acute toxicity and long-term toxicity tests were carried out in order to explore the safety of Qinhuang qingfei powder (QQP).In the acute toxicity test, mice were given QQP decoction (6.00 mg/(g·BW))for one week, and the LD₅₀ was measured. In long-term toxicity test, 96 SD rats were randomly divided into high, middle and low dose groups (giving QQP decoction 32.00, 16.00 and 8.00 mg/(g·BW), respectively, which was equivalent to 96, 48 and 24 times clinical dose) and control group, each group of 24, half male and half female. QQP was processed and added to rats' feed for 30 d. The rats were weighed every week and the rats' water intake, feed intake, body weight and mental activity were recorded. On the 30th day and the 45th day of feeding, blood samples were taken for measuring the indexes of hematology, blood biochemistry and pathology. The results showed that LD₅₀ of mice was more than 6.00 mg/(g·BW) in acute toxicity test. It was non-toxic actually. In the long-term toxicity test, the differences were not significant in body weight, water intake, feed intake, hematological index or blood biochemical index between dose groups and control group (P>0.05). Most of the major organs of rats were dissected without any lesions and no lesion was observed within histopathological samples (including heart, liver, spleen, lung, kidney and testis/ovary). The test showed that QQP was a safe drug in clinical practice.