同仁安神丸的安全性评价

刘靖; 李春英; 赵雍; 易艳; 王连嵋; 田婧卓; 邓诺; 李小龙; 李桂琴; 潘辰; 韩佳寅; 张宇实; 刘素彦; 解素花; 李晋生; 梁爱华

doi:10.13422/j.cnki.syfjx.2018010142

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同仁安神丸的安全性评价

安全性评价 | 更新时间：2024-01-04

- 同仁安神丸的安全性评价
- Safety of Tongren Anshen Pill
- 中国实验方剂学杂志 2018年24卷第1期页码：142-149
- 作者机构：
- 作者简介：
- 基金信息：
  
  国家“重大新药创制”科技重大专项（2015ZX09501004）;公益性行业科研专项（201507004）;中国中医科学院重点领域研究专项（ZZ10-025）;北京市科技计划项目（Z151100000115012，Z161100004916025）
- DOI：10.13422/j.cnki.syfjx.2018010142
  中图分类号： R285.5
- 纸质出版日期：2018
- 稿件说明：
移动端阅览
刘靖, 李春英, 赵雍, 等. 同仁安神丸的安全性评价[J]. 中国实验方剂学杂志, 2018,24(1):142-149.

LIU Jing, LI Chun-ying, ZHAO Yong, et al. Safety of Tongren Anshen Pill[J]. Chinese journal of experimental traditional medical formulae, 2018, 24(1): 142-149.
刘靖, 李春英, 赵雍, 等. 同仁安神丸的安全性评价[J]. 中国实验方剂学杂志, 2018,24(1):142-149. DOI： 10.13422/j.cnki.syfjx.2018010142.

LIU Jing, LI Chun-ying, ZHAO Yong, et al. Safety of Tongren Anshen Pill[J]. Chinese journal of experimental traditional medical formulae, 2018, 24(1): 142-149. DOI： 10.13422/j.cnki.syfjx.2018010142.

摘要

目的：通过对同仁安神丸长期用药的安全性评价，明确其潜在的毒性作用及可逆性、毒性靶器官、无不良作用剂量及用药时间，为临床安全用药提供依据。方法：SD大鼠随机分为4组，正常组（每日灌胃给予饮用水）和同仁安神丸高、中、低剂量组（含生药6.4，3.2，1.6 g·kg-1）。每日灌胃1次，连续给药3个月。分别于给药1，3个月和停药2个月后解剖并分析血液生化、血液细胞、尿常规、脏器系数和组织形态学等指标。结果：给药1个月，除高剂量组体重降低、饲料消耗量减少外，血液细胞、生化、尿常规、脏器系数等指标及脏器组织病理学检查等均未见明显与毒性相关的变化。给药3个月，高剂量组雌性动物的天门冬氨酸氨基转换酶（AST），肌酸激酶（CK）较正常组显著增高；病理检查可见肝细胞、肾小管轻度变性和肾间质炎性浸润等病理变化，其他血液生化学指标及血液学、尿常规、脏器系数等指标均在该品系动物的正常值范围内，故不认为有毒性学意义。停药2个月后，高剂量组上述肝功能指标和肝、肾组织形态学基本恢复正常。结论：高剂量组大鼠长期给药时，可见轻度肝肾毒性损伤。给予同仁安神丸3个月的无明显不良作用剂量（NOAEL）为3.2 g·kg-1·d-1，相当于临床剂量的29倍。临床上服用该药时，应严格控制剂量，服药时间不宜过长。

Abstract

Objective:To define potential toxicity and reversibility

target organs of toxicity

no adverse effect dosage and medication time of Tongren Anshen pill through the safety evaluation for long-term medication of Tongren Anshen pill

in order to provide basis for clinical safety medication. Method:SD rats were randomly divided into four groups:the control group and high-dose

medium-dose and low-dose Tongren Anshen pill groups (containing 6.4

3.2

1.6 g·kg-1 of medicinal herbs). The rats were administered with the drugs by gavage once daily for 3 months. The blood biochemistry

hematology

urinalysis

relative organ weights (ROWs) and histomorphological indexes were examined in the 1st and 3rd months after administration

and the 2nd month after drug discontinuance. Result:In the study

the results of hematology

biochemistry

urinalysis

ROWs and histopathological examination showed no significant change related to drug toxicity after 1 month of administration; however

the body weights and food consumption of rats in high-dose Tongren Anshen pill group were significantly decreased. After 3 months of administration

aspartate aminotransferase (AST) and creatine kinase (CK) of female rats in the high-dose group significantly increased compared with those in the control group. The histopathological changes in livers and kidneys were observed

including hepatocytes

mild renal tubular degeneration and renal interstitial inflammatory infiltration. There were no significant difference in other indexes

including serum biochemistry

hematology

urinalysis and ROWs. Two months later after drug discontinuance

no significant change in liver function parameters and morphology of liver and kidney was observed in the high-dose group. Conclusion:Long-term administration with high-dose Tongren Anshen pill could induce slight hepatic and renal damages. No observed adverse effect level (NOAEL) is 3.2 g·kg-1·d-1

which was equivalent to 29 times of clinical dosage. Its dosage and medication time shall be strictly controlled in clinic.

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