Development And Study On New Drug Of Huang Jiang Su

Huang Jiang Su is the total steroid saponin from Huang Jiang(Dioscorea Zingiberensis), a medicinal plant. We have studied the chemical constituents of HJ and developped it into HJS and its capsule,a kind of 2nd category new drug for coronary heart disease and hyperlipidemia.We investigated the transplant and culture of HJ and analysed the factors leading to its good quality and high output .Three main steroid saponins were isolated from rhizoma of HJ and identified as:HJS-A,zingiberensis newsaponin,Dioscin.The contents of zingiberensis newsaponin and diosin in HJ were determined by TLCS.Paper applying for pre-clinical research of new drug as 2nd categary CTM were finished.Preparation technology: Technologys of extraction,puration and capsule manufaction were optimized.The best technology is as following:Material plant is reflux extracted three times,by six times alcohal of its weight and two hours each time.Mix up the extraction fluid,recover alcohol,Add three times weight water to extraction fluid,mix well,keep the mixture in stationary and centrifugate,Let the up clear fluid through treated macroporous resin column.Elute the resim column by water till the elution becomes no color. Water eaqual to ten times of clear fluid added to the resin column will be used.Discard:the water elution.Then elute the resin column by five times of 50% alcohol.Collect the elution and recover alcohal.The drug fluid was condensed,till its relative dencity is 1.30-1.35 under reduce pressure.Dry by raccume,gimel,then the material drug is ready.Add suitable amount of starch to material huang jiang su.which contains 100g total steroid saponin,mix up.Add 85% alcohal to the mixture, to moist the mixture ,12% mixtur's weight alcohal is used, soft stuff is made.make particle.Dry and fillthe particles into 1000 capsules as Huang jiang su capsule.Qality standard reseach:set up the qulity standard of mertial huang jiang su and capsule.We also set up a special identification method by TLC method.using Huang jiang su A as standard substance and crud huang jiang as comparation drug.Test items include weight lost by dry,heavy metal,arsenical,survival and break down substance of resm(benzoy,methylbenzene,dimethylbenzene,n-hexane,vinyl benzene).The contents of steriod saponin in huang jiang su and its capsule were determmed,use huang jiang su A as standard substance by colorimetery.The method was investigated on many aspects of methology(raction condition,standard curve,preceision recovery,stability,etc.).Pharmacodynamics:Huang jiang su taken by oral can increase coronary blood flow,cardiac output stroke volume output,cardiac index,stroke index and improve left rentricular work, at sametime ,decrease peripheral vessel resistance ,coronary vascular resistance, lower blood pressure moderately, have no effect on cardiac rate, huang jiang su taken by cral can decrease total cholesterol ,triglycerides LDL and very LDL,increase HDL and HDL/LDL ratio in blood serum.huang jiang su also can reduce the cardiac ischemic degree and cardiac infarct area caused by ligation the coronary brand inanesthethia dog.Toxicity: (1)Acute toxixity.The maximum lethal dose of HJS is 24g/kg in mouse taken byoral,this dose is 1440 times as the dose tried in human.(2) Chronic toxicity:when given rats HJS with 120,60,1200mg/kg(12,60,120 times as the dose tried in human) and dog with 50,250,500mg/kg(5,25,50times as the dose tried in human) once every day by three months,then stop two weeks,There are no abnormities with the weight,hair,movement,psychosis, blood biochemistry,hematology,urine and hislology of the animal.