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Study on safety dose and long-term toxicity of Gushuning Oral Liquid |
WU Yong-mei1 LIANG Zhi-min1 WEI Yu-yan1 QIN Liang2▲ |
1. Department of Pharmacy, Hospital of Integrated Traditional Chinese and Western Medicine of Yulin City
2. Department of Pharmacology, Guangxi Zhuang Autonomous Region Institute of Traditional Chinese Medicine |
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Abstract Objective To observe the toxicity and safe dose of Gushuning Oral Liquid in rats after long-term repeated administration. Methods A total of 80 SD rats were selected and randomly divided into the low, middle, high dose group and the control group, 20 rats in each group. The low, middle and high dose groups were given Gushuning Oral Liquid 5.38, 10.76, 21.50 g medicine/(kg·d), respectively, and the control group were given equal volume distilled water, which were were gavaged for 12 weeks. During the period of administration, the general performance and toxic reaction of animals were observed daily, and recovered for 2 weeks after discontinuation. Routine toxicological observation and hematological and biochemical indexes were detected and compared. Results The weight gain of the low,medium and high dose groups were normal, and there was no significant difference compared with the control group (P>0.05). There was no significant difference in hematological examination and blood biochemical examination between the low, medium and high dose groups and the control group (P>0.05). In the histopathological examination of main organs,there was no obvious pathological change caused by drug toxicity. Conclusion The safe dose of Gushuning Oral Liquid to rats by gavage is 21.50 g medicine/(kg·d), which is 120 times of the daily dose of clinical adults. There is no toxic reaction after long-term repeated administration
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[1] |
韦玉燕,吴勇梅,何科.骨疏宁口服液提取工艺的研究[J].中国民族民间医药,2018,27(11):33-36.
|
[2] |
吕琳,庞声航,曾翠琼,等.骨疏宁颗粒对维甲酸致大鼠骨质疏松的影响[J].广西中医学院学报,2008,11(1):3-5.
|
[3] |
庞声航,曾翠琼,吕琳,等.骨疏宁颗粒治疗去卵巢后骨质疏松大鼠的实验研究[J].广西中医药,2008,31(2):54-56.
|
[4] |
李永斌,李开静,赖祥林.骨疏宁治疗原发性骨质疏松症骨痛63 例[J].辽宁中医药大学学报,2007,9(6):115.
|
[5] |
陈涛,黎观保,贾世青,等.经皮椎体成形术联合骨疏宁片治疗胸腰椎椎体骨折的临床疗效分析[J].中国临床新医学,2016,9(3):201-204.
|
[6] |
国家药典委员会.中华人民共和国药典(一部)[M].北京:中国医药科技出版社,2015:102,357.
|
[7] |
中华人民共和国卫生部药政管理局.中药新药研究指南(药学、药理学、毒理学)[M].北京:中华人民共和国卫生部药政管理局,1994:205
|
[8] |
国家食品药品监督管理局.中药、天然药物长期毒性研究技术指导原则[EB/OL].(2005-03).http://www.360doc.com/document/17/0818/19/363181_680228586.shtml.
|
[9] |
王霖,张雪,孔令雷,等.仙茅等有小毒记载的祛风除湿中药毒性的历史认识与评价[J].中药药理与临床,2018,34(5):157-160.
|
[10] |
陈洪雷.仙茅提取物的毒性实验研究[D].曲阜:曲阜师范大学,2011.
|
[11] |
朱芳芳,杨明华,陈婉姬,等.不同配伍比例仙茅-淫羊藿药对的毒性与含量相关性[J].中国实验方剂学杂志,2015,21(5):175-177.
|
[12] |
钟捷,陈艳,周德生.仙茅等中药致药物中毒性周围神经病1 例[J].现代中西医结合杂志,2010,19(24):3107-3108.
|
[13] |
于金高,刘培,段金廒.药用蜈蚣生物活性物质与毒性物质研究进展[J].中国现代中药,2016,18(11):1521-1527.
|
[14] |
车景超.中药娱蚣药用历史沿革及其安全性探讨[J].中医临床研究,2013,5(12):118-119.
|
[15] |
田莎,田雪飞,黄晓蒂,等.蜈蚣药理作用、临床用量及毒性研究概况[J].湖南中医杂志,2018,34(5):212-214.
|
|
|
|