|
|
Safety evaluation of a compound Chinese medicine preparation of gardenia |
XIA Yong, FU Jian-yun, CAI De-lei, ZHANG Shi-xin, XU Cai-ju, CHEN Qing, YAN Jun
|
Zhejiang Provincial Center for Disease Control and Prevention,Hangzhou,Zhejiang 310051,China |
|
|
Abstract Objective To evaluate the toxicological safety of a compound Chinese medicine preparation of gardenia. Methods Eighty healthy SD rats with half males and half females were randomly divided into four groups. The low-,moderate- and high-dose group were given 1.00 g/kgbw,2.00 g/kgbw and 4.00 g/kgbw of the preparation,while the control group was given distilled water,by gavage for 30 days. The changes of diet,weight,hematological parameters and major organs of rats were observed,and the histopathological examination of the main organs was performed. Results The rats in the high-dose group reduced activities and their urine turned dark yellow or green,while the other rats showed no abnormality. No rats died during the experimental period. Compared with the control group,the weight,the total weight gain,the food utilization rate,the fasted weight of the rats in the high-dose group and the hemoglobin content of the female rats in the high-dose group were significantly decreased(P<0.05);the ratio of liver to body weight,the ratio of kidney to body weight,the serum creatinine levels of the rats in the high-dose group and the serum urea nitrogen levels of the male rats in the high-dose group were significantly higher(P<0.05). The livers and kidneys of the rats in high-dose group turned different degrees of dark green;the hepatic pigmentation,hepatocyte vacuolar degeneration,bile duct hyperplasia accompanied with inflammatory cell infiltration,renal pigmentation,renal tubular epithelial cellular swelling,and renal interstitial inflammatory cell infiltration were observed. Conclusion This preparation at a dose of 4.0 g/kgbw has hepatotoxicity and nephrotoxicity to rats. A dose of 2.0 g/kgbw has no harmful effect but less than 100 times of the possible human intake,the safety is not guaranteed.
|
Received: 20 March 2019
Revised: 17 May 2019
Published: 02 August 2019
|
|
|
|
|
[1] 杨楠,刘雁勇,郝文宇,等. 栀子粗提物对拟痴呆模型鼠学习记忆功能障碍的影响[J]. 中国康复理论与实践,2010,16(4):308-310. [2] 秦川,吴善球,陈保生,等. 灵芝制剂治疗APP/PS-1阿尔茨海默病转基因小鼠模型的病理学改变[J]. 中国医学科学院学报,2017,39(4):552-56l. [3] 罗浩铭,陈英红,周婷婷,等. 人参糖蛋白对小鼠学习和记忆能力的影响[J].吉林大学学报(医学版),2016,43(3):439-440. [4] 周珂,谭勇,刘忠第,等. 中药寒热药性及其毒副作用研究现状[J]. 中国中医药信息杂志,2015,22(4):129-131. [5] 林华杰. 中药的副作用研究报告[J]. 中医临床研究,2015,7(23):14-15. [6] 王亭. 中药栀子有效成分及药理作用的研究进展[J]. 中国药师,2015,18(10):1782-1783 [7] 王清然,邓中平. 栀子肝脏毒性研究进展[J]. 中成药,2016, 28(6):1351-1353. [8] 赖荣陶,王晖,桂红莲,等. 138 例药物性肝损伤患者的临床特征及肝脏组织学改变[J]. 中华肝脏病杂志,2012,20(3):185-189. [9] OU P,CHEN Y,LI B,et al.Causes,clinical features andoutcomes of drug-induced liver injury in hospitalized patients in a Chinese tertiary care hospital[J]. Springfield,2015,4:802. [10] 中华人民共和国国家卫生和计划生育委员会.食品安全国家标准食品安全毒理学评价程序:GB 15193.1—2014[S].2014:1-4. [11] 傅剑云,陈苘,张世鑫,等. 含咖啡因保健食品30天喂养实验受试物处理与评价[J]. 预防医学,2016,28(7):649-657. [12] 王清然,周斌,张泽安,等. 栀子水提物致大鼠肝脏毒性的时效与量效关系[J]. 中成药,2017,39(4):689-693. [13] 王波,杨洪军,高双荣,等. 栀子对大鼠肝肾毒性的病理学观察[J]. 中国实验方剂学杂志,2007,13(5):45-48. [14] 周飞,王浩安,陈涛,等. 栀子苷类药物引起SD大鼠胆红素沉着的案例分析[J]. 实验动物与比较医学,2018,38(4):284-286. [15] 方文娟,苗琦,罗光明. 栀子毒性研究进展[J].江西中医药,2015(6):70-72. [16] FRAZIER K S,SEELY J C,HARD G C,et a1.Proliferative and nonproliferative lesions of the rat and mouse urinary system[J].Toxicol Pathol,2012,40(4 Suppl):14-86. [17] 葛均波,徐永健. 内科学[J]. 8版. 北京:人民卫生出版社,2013:413-417. [18] 张红雷,徐游贵,王泰龄. 特殊染色法在肝脏病理诊断中的应用[J].诊断病理学杂志,2017,24(3):238-239. |
|
|
|