药典方剂止咳散的毒理学研究

为了从现代药理学角度评价兽药典方剂"止咳散"临床用药的安全性,受国家药典办委托,对其进行了毒理学研究。通过小鼠灌胃给药对止咳散的急性毒性进行了测定;以生理盐水对照组、止咳散低剂量组(7 g/kg)、止咳散高剂量组(14 g/kg)对大鼠连续灌胃给药4周,记录每日饮水量、饲料采食量及每周体重,测定给药后24 h及停药2周后血液生化指标及血常规,做病理切片,评定其长期毒性。结果表明,止咳散的LD50120 g/kg,且对大鼠连续灌胃给药4周,期间各剂量组体重、饲料采食量、饮水量与对照组相比均无显著性差异(P0.05);末次给药后24 h及停药2周后尿素氮、肌酐、血糖等血液生化指标及白细胞、红细胞、血红蛋白等血常规指标,与对照组相比均无显著差异(P0.05);观察心、肺、脾、肝、肾等主要脏器组织切片亦未见异常。以上结果表明,止咳散毒性较小,临床用药较为安全。

Study on Toxicology of Anti-cough Powder in Chinese Veterinary Pharmacopoeia

To evaluate the clinical safety of the anti-cough powder, one of the traditional Chinese patent medicines collected in Chinese Veterinary Pharmacopoeia, from the perspective of modern pharmacology, we were commissioned by the Office of China Pharmacopoeia to make studies on the toxicology of the anti-cough powder. In the present study, we examined the acute toxicity of anti-cough powder in mice by intragastric administration and assessed its long-term toxicity in rats by recording the amount of hydroposia and feeds-foraging per day and body weight per week, measuring hematologic and blood biochemical indexes after administration for 24 hours and withdrawal for 2 weeks, and making pathological section after intragastric administration for 4 weeks in rats with low (7 g/kg) and high (14 g/kg) dosage groups. Our results showed that the medial lethal dose (LD50) of anti-cough powder is above 120 g/kg; during 4 weeks intragastric administration, the rats’ body weight, amount of hydroposia and feeds-foraging of each dosage group showed no significant difference compared to the control group（P＞0.05）; blood biochemical indicators such as urea nitrogen, creatinine, blood glucose and hematologic indexes such as white cell, red cell and hemoglobin had no significant difference compared to the control group as well（P＞0.05）; tissue sections of main organs such as heart, lung, spleen, liver and kidney were observed no abnormality. Taken together, these above results indicated that the anti-cough powder has a lower toxicity and its clinical medication is safe.