摘要
①目的 对三术克异汤进行质量标准及急性毒性研究 ,为临床用药质量和安全提供依据。②方法采用薄层色谱法对制剂中的丹参、元胡进行定性鉴别。元胡的薄层色谱鉴别采用延胡索乙素为对照品 ,以正己烷 氯仿 甲醇 (7.5∶4 .0∶1.0 )为展开剂 ;丹参的薄层色谱鉴别采用丹参酮ⅡA 为对照品 ,以苯 醋酸乙酯 (19∶1)为展开剂。用高效液相色谱法对丹参中主要有效成分丹参酮ⅡA 进行定量测定。以三术克异汤的最大允许浓度和动物最大给药容积 ,2 4h内 2次灌胃给药 ,观察小鼠死亡率和脏器的大体病理改变。③结果 薄层色谱鉴别实验中 ,供试品分别在与延胡索乙素、丹参酮ⅡA 对照品色谱相应的位置上 ,显示相同颜色的斑点 ,阴性对照品无干扰。绘制丹参酮ⅡA 标准曲线 ,回归方程为 y =2 72 3.0 12 9x - 84 6 9.2 0 84 ,线性范围 4 0～ 6 4 0ng ,r =0 .9999;平均加样回收率为 99.6 1% (n =6 ,RSD =1.36 % )。急性毒性试验中 2 0只小鼠观察 7d无 1例死亡 ,亦无任何异常及中毒反应 ,第 8天全部脱颈处死 ,肉眼观察各主要脏器均无异常改变。④结论 上述方法简便、准确、专属性强、不受共存组分干扰 ,可作为三术克异汤的质量控制方法。小鼠的急性毒性试验表明三术克异汤临床用药安全。
Objective To study the quality standard and the acute toxicity of Sanzhukeyitang(SZ),a herbal decoction of traditional Chinese medicine, to provide the basis for its clinical administration. Methods Radix Salviae Miltiorrhiae and Rhizoma coyclalis in SZ were quantitatively identified by TLC. Hexane-chloroform-methanol(7.5∶4.0∶1.0)was used as developing solvent for Rhizoma Coryclalis with dl-tetrahydropal-matine as reference; Benzene-acetic acid was used for Radix Salviae Miltiorrhizae with Tanshinone Ⅱ A as reference. The content of Tanshinone Ⅱ A in Radix Salviae Miltiorrhizae was determined by HPLC. Experimental mice were administrated orally twice in 24 hours with the most permitted concentration and administration quantity of SZ. The mortality rate and pathologic changes of visceras of the mice were observed. Results The chromatogram of measurement sample was respectively identical with that of dl-tetrahydropalmatine and that of Tanshinone Ⅱ A , while the negative control was not disturbed. Standard curve was drawn, and the regression equation was y=2 723.012 9x-8 469.208 4,linear range was 40- 640 ng ,r=0.999 9. The average reclaim rate of the sample was 99.61%(n=6, RSD=1.36%). Seven days later, no death of animals, toxicity, or side effects occurred in the acute toxicity test. The mice were killed on the eighth day, and abnormal changes of the major visceras not found in gross anatomy. Conclusion The quality control of SZ is simple, accurate, and specific. SZ is safe and can be applied clinically.
出处
《齐鲁医学杂志》
2004年第4期300-302,共3页
Medical Journal of Qilu
