A Study On Quality Standard And Acute Toxicity Of San Zhu Ke Yi Tang

Objective: To study the quality standard and the acute toxicity of San Zhu Ke Yi Tang(SZ)and provide the basis of quality and safty of therapy for endometriosis.Method:The herbal medicines,Radix Salviae Miltiorrhiae,Rhizoma coyclalis were identified by TLC.Hexane-chloroform-methanol(7.5:4:l)was used as developing solvent for Rhizoma Coryclalis with dl-tetrahydropal-matine as reference standard; Benzene-acetic acid was used for Radix Salviae Miltiorrhizae with Tanshinone II_a as reference standard. The content of Tanshinone II_A in Radix Salviae Miltiorrhizae was determined by HPLC. The chromatographic conditions were as follow:Thermo Hypersil-keystone colum(150mm × 4.6mm,5u) methanol-water solution(80:20)as mobile phase,colum temperature 25 ℃, velocity of flow 1ml ·min^-1,detection wavelength at 268nm.Mice were administrationed by oral twice in 24 hours with the most permited concentration and adrainistrational cubage of SZ, mortality rate of the mice and pathologic change 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 , negative control was not disturbed. Standard curve was drew , regression equation was as follow : y=2723.0129x-8469.2084, linear range was 40—640ng, r=0.9999, linear relation was well, average reclaim rate of sample that was plused was 99.61% (n=6, RSD=1.36%). After seven days, no death of animals or toxicity and side-effect occurred in the acute toxicity test. The mice were put to death on the eighth day, abnormal changes of the major visceras of the mice were not found in gross anatomy.Conclusion: (1)The quality control method of San Zhu Ke Yi Tang is simple, accurate, specificity. The quality of San Zhu Ke Yi Tang is stable . (2)It has low toxicity and can be used in clinical application.