贺一新+樊静恒+董金鹏+邢泽田

摘要：目的 觀察双黄连口服液（仅适用于儿童）对SD离乳大鼠一般状况、体质量、摄食量、生长发育、血常规和病理学的影响，为临床安全用药提供实验依据。方法 SD离乳大鼠按体质量随机分为对照组和双黄连口服液低、中、高剂量组，每组30只。各给药组给予相应剂量双黄连口服液（仅适用于儿童）浓缩膏灌胃，每日1次，连续33 d。分别观察给药期、恢复期（停药25 d）各组大鼠毒性反应。结果 各组大鼠给药期和恢复期一般状况、个体发育、脏器质量和系数，以及剖检肉眼观察和病理结果均无明显差异。双黄连口服液高剂量组雌鼠和雄鼠体质量与摄食量不同程度低于对照组；给药期血常规检测显示，双黄连口服液高剂量组雌鼠和雄鼠淋巴细胞比率显著降低、中性粒细胞比率显著升高，恢复期恢复正常。结论 双黄连口服液（仅适用于儿童）浓缩膏对幼年大鼠全身脏器和组织无相关毒性作用，安全性好。

关键词：双黄连口服液（仅适用于儿童）；毒理学实验；安全剂量；大鼠

DOI：10.3969/j.issn.1005-5304.2017.04.016

中图分类号：R285.5 文献标识码：A 文章编号：1005-5304（2017）04-0061-06

Rat Toxicological Study of Shuanghuanglian Oral Solution （Only for Children） HE Yi-xin， FAN Jing-heng， DONG Jin-peng， XING Ze-tian （Pharmaceutical Engineering Center， Henan Taloph Pharmaceutical Stock Co.， Ltd， Zhengzhou 450001， China）

Abstract： Objective To study the effects of Shuanghuanglian Oral Solution （only for children） on general condition， body weight， food intake， growth and development， blood routine and pathologic changes of SD weanling rats； To provide experimental references for clinical safe medication. Methods SD weanling rats were randomly divided into control group， Shuanghuanglian （only for children） Oral Solution low-， medium- and high-dose group according to body mass， with 30 rats in each group. Each administration group was given corresponding amount of Shuanghuanglian Oral Solution （only for children） concentrated ointment for gavage， once a day， for 33 d. The toxicity of the rats during dosing period and recovery period （medicine withdrawal 25 d） was observed. Results There were no significant differences in general condition， individual development， organ mass and coefficient， and internal fixation and pathological findings of rats in administration groups during dosing period and recovery period. The body mass and food intake of female and male rats in the Shuanghuanglian Oral Solution high-dose group were lower than those in the control group. The blood routine test during dosing period showed that the lymphocyte ratio of female rats and male rats in Shuanghuanglian Oral Solution high-dose group decreased significantly， neutrophil ratio increased significantly， and then returned to normal level in recovery period. Conclusion Shuanghuanglian Oral Solution （only for children） concentrated ointment has no toxic effect on the whole body organs and tissues of juvenile rats， and the safety is good.

Key words： Shuanghuanglian Oral Solution （only for children）； toxicological test； safe dosage； ratsendprint

双黄连口服液全方由金银花、黄芩、连翘3味中药组成，具有抗菌、抗病毒和解热消炎的功效[1]。双黄连口服液（仅适用于儿童）是在双黄连口服液原有基础上应用先进工艺将其制成儿童适宜的药分含量。由于儿童生理解剖特点与成人不同，对药物的吸收代谢、疗效和毒性反应等均有其特殊性[2]，为保证儿童

用药的安全性，本实验对双黄连口服液（仅适用于儿童）毒理学进行研究，为临床安全用药提供实验依据。……