| By establishing microscopic identification, TLC(thin-layer chromatography) and HPLC(high performance liquid content) determination methods as well as an acute toxicity experiment to examine the safety of Wucao Shi′erwei and to form its quality criterion.Methods:To identify the content of Kuanjinteng, Tumuxiang, Qiancao, Jiegumu, Hezirou in Caowu Shierwei tablets by counting crystal fiber, inulin, calcium oxalate crystal needle, large ducts, thick-walled cells under microscope. Tumuxiang was identified by TCL with cyclohexane-acetic ether-chloroform(10:1:1) as an agent to observe the content of alantolactone and isoalantolactone. Qiancao was identified by TCL with diethyl (60～90 ℃)-acetone(4:1) as an agent with the content of Rubimaillin being its measure standard. The procedure of HPLC was performed on the chromatographic column of ODS, and the mobile phase in the gradient elution was methanol-water-tetrahydrofuran (310: 90:3). The detection wavelength was 250 nm. Giving rats Wucao Shi′erwei for 14 days, once a day (22.5 g /kg, 334.87 times of the clinical standard) to observe its safety.Results:The method is effective in identifying Kuanjinteng, Tumuxiang, Qiancao, Jiegumu, and Hezi. Rubimaillin showed a good linear relationship at a range from 0.16 to 1.6 μg (r2=0.9997). The average recovery was 103.1%, RSD=1.11%, and the determination limit is smaller than 0.035%. No death of rats were observed during 14 days of experiment.Conclusion:This method can be used for the quantitative deternmination of Mongolian Medicine Caowu Shi′erwei tablets. Besides, the toxicity of Caowu Shierwei tablets is small and could be used in clinical treatment. |
