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疏肝和胃方水提醇沉法的急性毒性试验及部分药效学研究
徐亭亭,朱生樑,周秉舵
0
(上海中医药大学附属岳阳中西医结合医院,上海,200437)
摘要:
目的:探索疏肝和胃方水提醇沉法的安全性并验证其疗效,为疏肝和胃方新药的推广提供实验依据。方法:1)急性毒性试验。将昆明小鼠分为药物高、中高、中、低剂量组及对照组,每组各10只,雌雄各半。灌胃剂量根据昆明小鼠10倍生药量计算,并按85%等比递减,按照4 ml/10 g体质量,1 d内灌胃2次,连续14 d。观察14 d内实验小鼠的一般情况、体质量变化、内脏湿重与内脏病理改变。2)药效学研究。将SD大鼠分为假手术组(0.9%氯化钠注射液1.5 ml)、模型组、中药组(中药混悬液1.5 ml)、西药组(奥美拉唑水溶液1.5 ml),每组各10只。对除假手术组外的其余组大鼠制备酸反流模型后给药,每天2次,连续14 d。观察各给药组大鼠食管病理改变及食管下段组织白细胞介素-1β(IL-1β) mRNA、白细胞介素-6(IL-6) mRNA表达情况。结果:急性毒性试验结果显示,各组小鼠精神状态良好,组间体质量差异无统计学意义(P>0.05),组间内脏湿重无明显改变、内脏无明显病理改变。药效学研究结果显示,中药组大鼠食管下段组织黏膜上皮基底层更为平坦,棘细胞减少,无黏膜糜烂与溃疡。各给药组大鼠食管IL-1β mRNA、IL-6 mRNA表达较模型组、西药组下降,差异有统计学意义(P<0.05)。结论:疏肝和胃方水提醇沉法安全性高,且可修复食管黏膜,抑制食管炎症。
关键词:  疏肝和胃方  提取方法  急性毒性试验  药效学实验
DOI:
Acute toxicity test of the water-extraction and alcohol-precipitation method for Shugan Hewei prescription and a partial pharmacodynamics study
XU Tingting,ZHU Shengliang,ZHOU Bingduo
(Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine,Shanghai 200437,China)
Abstract:
Objective:To investigate the safety of the water-extraction and alcohol-precipitation method for Shugan Hewei prescription and its clinical effect,and to provide an experimental basis for promoting the new drug of Shugan Hewei prescription.Methods:In the acute toxicity test,Kunming mice were divided into high-,medium-high-,middle-,and low-dose drug groups and control group,with 10 mice (5 male mice and 5 female mice) in each group.The dose for gavage was calculated as 10 times of crude drug in Kunming mice and was reduced proportionally at a percentage of 85%,and the drug was given by gavage twice a day at a dose of 4 ml/10 g body weight for 14 consecutive days.The mice were observed in terms of general status,change in body weight,visceral wet weight,and pathological changes of viscera.In the pharmacodynamic study,Sprague-Dawley rats were divided into sham-operation group (0.9% sodium chloride injection 1.5 ml),model group,traditional Chinese medicine (TCM) group (TCM suspension 1.5 ml),and Western medicine group (omeprazole solution 1.5 ml),with 10 rats in each group.All rats except those in the sham-operation group were used to establish a model of acid reflux,and then the drug was given twice a day for 14 consecutive days.The rats were observed in terms of the pathological changes of the esophagus and the mRNA expression levels of interleukin-1β (IL-1β) and interleukin-6 (IL-6) in the lower segment of the esophagus.Results:The acute toxicity test showed that the mice in each group had a good general status,and there was no significant difference in body weight between groups (P>0.05),while there were no obvious changes in visceral wet weight or no pathological changes of viscera.The pharmacodynamic study showed that the TCM group had a smooth basal layer of the mucosal epithelium in the lower segment of the esophagus and a reduction in prickle cells,with no mucosal erosion or ulceration.The medication groups had significantly lower mRNA expression levels of IL-1β and IL-6 than the model group and the Western medicine group (P<0.05).Conclusion:The water-extraction and alcohol-precipitation method shows high safety for Shugan Hewei prescription,and Shugan Hewei prescription can repair esophageal mucosa and inhibit esophageal inflammation.
Key words:  Shugan Hewei prescription  extraction method  acute toxicity test  pharmacodynamic study

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