2023 年第 5 期 第 18 卷

珍珠通络丸对大鼠机体安全性及毒性研究

Study on the safety and toxicity of Zhenzhu Tongluo pills in rats

作者：董鹏飞1周霖2王旺3薛连平2杜洋4王肖辉5

英文作者：Dong Pengfei1 Zhou Lin2 Wang Wang3 Xue Lianping2 Du Yang4 Wang Xiaohui5

单位：1郑州大学第二附属医院中医科，郑州450014；2郑州大学第一附属医院药学部，郑州450052；3郑州大学基础医学院，郑州450001；4郑州卷烟厂康复医院内科二病区，郑州450099；5郑州大学第一附属医院超声科，郑州450052

英文单位：1Department of Chinese Medicine the Second Affiliated Hospital of Zhengzhou University Zhengzhou 450014 China; 2Department of Pharmacy the First Affiliated Hospital of Zhengzhou University Zhengzhou 450052 China; 3School of Basic Medical Sciences Zhengzhou University Zhengzhou 450001 China; 4Second Ward of Internal Medicine Rehabilitation Hospital of Zhengzhou Cigarette Factory Zhengzhou 450099 China; 5Department of Ultrasound the First Affiliated Hospital of Zhengzhou University Zhengzhou 450052 China

关键词：珍珠通络丸；安全性；毒性；评价

英文关键词：ZhenzhuTongluopills;Safety;Toxicity;Evaluation

• 摘要：

• 目的 评价珍珠通络丸对大鼠机体安全性及毒性。方法 选取无特定病原体级雄性成年SD大鼠32只，采用随机数字表法分为对照组、低剂量组、中剂量组、高剂量组。对照组大鼠予0.9%氯化钠溶液灌胃，低、中、高剂量组分别予5、10、20 g/L珍珠通络丸悬浊液灌胃，连续给药4周。给药期间记录大鼠体质量、进食量、饮水量。末次给药后，检测各组大鼠血常规、肝肾功能指标，观察心脏、肝脏、脾脏、肺、肾脏、小肠、背根神经节组织细胞形态。结果  给药第21、28天中、高剂量组大鼠体质量及给药第28天低剂量组大鼠体质量均高于对照组（均P<0.05）；给药第28天，中、高剂量组饮食量均高于对照组（均P＜0.05）。末次给药后，4组红细胞计数等血常规指标比较，差异均无统计学意义（均P＞0.05）；4组天冬氨酸转氨酶等肝功能指标比较差异均无统计学意义（均P＞0.05）；低剂量组血肌酐水平低于对照组，高剂量组血尿素氮水平高于低剂量组［（9.1±0.8）mmol/L比（7.8±0.8）mmol/L］（均P＜0.05），4组血尿酸、血清胱抑素C水平比较差异均无统计学意义（均P＞0.05）。末次给药后，4组大鼠肝脏、肾脏、心脏等脏器组织细胞均未见明显病理形态改变。结论   珍珠通络丸对大鼠无显著的毒性作用，具有较高安全性。

• Objective  To investigate the safety and toxicity of Zhenzhu Tongluo pills in rats. Methods Totally 32 specific pathogen free male adult SD rats were selected and divided into control group, low-dose group, medium-dose group, and high-dose group according to random number table method. The control group was given 0.9% sodium chloride solution by oral administration. The low-dose group, medium-dose group, and high-dose group were respectively given Zhenzhu Tongluo pills turbid liquid 5, 10 and 20 g/L by oral administration, with continuous administration for 4 weeks. Body mass, food consumption and water consumption of rats were recorded during administration. Blood routine, liver and kidney function indexes of rats were detected after the last administration, and cell morphology in tissues of heart, liver, spleen, lung, kidney, small intestine, dorsal root ganglion were observed. ResultsThe body mass in the medium-dose group and the high-dose group on the 21st and 28th days of administration and in the low-dose group on the 28th day of administration were higher than those in the control group (all P<0.05). The food consumptions in the medium-dose group and the high-dose group on the 28th day of administration were higher than those in the control group (both P<0.05). After the last administration, there were no statistically significant differences among the four groups in red blood cell count and other blood routine indexes(all P>0.05); there were no statistically significant differences among the four groups in the aspartate aminotransferase and other liver function indexes(all P>0.05); the level of serum creatinine in the low-dose group was lower than that in the control group and the level of blood urea nitrogen in the high-dose group was higher than that in the low-dose group ［（9.1±0.8）mmol/L vs （7.8±0.8）mmol/L］(both P<0.05), while there were no statistically significant differences in levels of blood uric acid and serum cystatin C among the four groups (both P>0.05). After the last administration, no obvious pathomorphological changes were found in liver, kidney, heart and other organs of rats among the four groups. Conclusion Zhenzhu Tongluo pills has no significant toxic effects on rats, with a high safety.