对双藤颗粒进行急性毒性试验及质量控制试验的结果分析

The results of acute toxicity test and quality control test of shuangteng granule were analyzed

目的 :分析对双藤颗粒进行急性毒性试验及质量控制试验的结果。方法 :在24h内,以双藤颗粒的最大允许浓度和实验动物的最大给药容积在小鼠的胃内灌注给药2次。给药7d后,脱颈处死小鼠,对其进行解剖。用肉眼观察小鼠体内的各个脏器是否出现病理改变。采用薄层色谱法对双藤颗粒中的忍冬藤和大血藤进行质量控制试验。结果 :给药7d后,两组小鼠均健康生存,未发生中毒反应。对两组小鼠的尸体进行解剖的结果显示,其体内各个脏器均未发生病理改变。小鼠对双腾颗粒的最大耐受量为203.2 g/Kg。对双藤颗粒中的忍冬藤进行薄层鉴别试验的结果显示,在供试品样品溶液的色谱中,在与对照品样品溶液色谱的相应位置上出现相同颜色的荧光斑点。对双藤颗粒中的大血藤进行薄层鉴别试验的结果显示,在供试品样本溶液的色谱中,在与对照药材溶液色谱相同的位置上出现相同的颜色荧光斑点。结论 :双藤颗粒的安全性较高。可将薄层色谱法作为对双藤颗粒的质量进行控制的首选方法。

objective:to analyze the results of acute toxicity test and quality control test of shuangteng granule.Methods:in 24 h,the maximum allowable concentration of shuangteng granule and the maximum dose volume of experimental animals were injected into the stomach of mice for 2 times.After 7 days of administration,the mice were sacrificed by removing their necks and dissected.The pathological changes of various organs in mice were observed by naked eye.TLC was used to control the quality of lonicera japonicum and hemathyma japonicum in shuangteng granules.Results:after 7 days of administration,the mice in both groups were healthy and had no toxic reaction.The results of autopsy on the cadavers of the two groups of mice showed that no pathological changes occurred in all the internal organs.The maximum tolerance of mice to shuangteng granules was 203.2 g/Kg.The results of TLC identification of honeysuckle in shuangteng granule showed that fluorescence spots of the same color appeared in the chromatogram of sample solution and the corresponding position of the control sample solution.The results of TLC identification test on radix sanguineae in shuangteng granule showed that the fluorescence spots of the same color appeared in the chromatogram of the sample solution and the same chromatogram of the control medicine solution.Conclusion:shuangteng granule is safe.TLC can be used as the preferred method to control the quality of shuangteng granules.