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US 2005/0142231A1 Jun.30,2005 PHARMACEUTICAL ACTIVITY AND MANUFACTURING METHOD OF THE FIVE-PLANT COMPOUND HYPOLIPEMIC PRODUCTS BACKGROUND OF THE INVENTION [0001] Thepharmacologicalactivityandmanufacturing process of the ?ve-plant compound hypolipermic products, belong to the combined patent on the pharmacological activity of natural products and methods of isolating and purifying the same products in the US. patents. The ?ve plantcompoundproductshavethepharmacologicalactivity to inhibit the rise in serum cholesterol in rabbit remarkably, reduce the content of serum cholesterol and triglyceride and enhance the activity of the esteri?cartion of cholesterol noticeably. [0002] IntheUSA,patentprotectionisprovidedfornot onlythedrugsusedinthetreatmentofdiseases,butalsothe curative methods. If an invention is claimed to have the practicability of curing diseases in people or animals, then the applicable standard to judge Whether the claimed prac ticability meets the requirement of the practicability speci ?ed in the Patent LaW should be the same as that in other technical ?elds. It is specially stressed that the requirement ofpracticabilityoftreatmentinthePatentLaW shouldnotbe confusedWiththatofsafetyandef?cacyfordrugssoldinthe US. market speci?ed by FDA of the US. The basis on Which the practicability of the invention is assessed in the action of the treatment, prevention of disease or pharmaco logicalactivityoftheinvention.The actualrequirementof practicability is satis?ed by identifying the invention of the compound With pharmacological activity. The pharmaco logicalactivityandmanufacturingprocessofthe?ve-plant compoundhypolipemicproductshavemettherequirements ofpatentabilityandpatentpracticabilitybyUS. Trademark & PatentAdministration. [0003] AtheroslerosisisanaffectionoccurringintheWall of the artery With lipid deposition, cell in?ltration, cell proliferation in vascular smooth muscle, increased extracel lular stromata including collagen and elastin as Well as formationoffoamy cellinsome partsofthebody.As aresult the endarterial membrane is thickened, deep atheroma is softned and vascular cavity blocked, even disrupted. This is the main pathological foundation of many cardiovascular diseases. [0004] Lipometabolism disorder is a major factor for formation of AS. The lipids in the plasma cover total cholesterol(TC),triglyceride(TG),phospholipidandfree fattyacid;TC includescholesterol(CH)andcholesterolester (CE): They are combined With different apolipoproteins and lipoproterins in different proportion in the plasma. The lipoproterins can be classi?ed into chylomicron (CM), very loW density lipoproterin (VLDL), loW density lipoprotein (LDL), high density lipoprotein (HDL) and apolipoprotein (a).CM ismainlyforcarryingexogenousTG;VLDLis ?nally decomposed to LDL; LDL contains rich CH; Which isthechiefcomponentfortheformationofAS.HDL carries CH intheWallofthearterytothekidneyformetabolism through antiport and is therefore resistant to AS. [0005] Atpresent,CHcontentisstiltheindicatorinthe clinicaldeterminationofvariouslipoproteins,such asLDL Cholesterol (LDL-C), VLDL-Cholesterol (VLDL-C) and HDL-Cholesterol (HDL-C). Unusual riseinTC, TG, LDL or VLDL iscalledhyperlipemia,Whichisclassi?edintothe types shoWn in the folloWing table by WHO. Classi?cation of Hyperlipemia Type I 11a 11b III IV V Rise CM LDL VLDL B-VLDL VLDL CM Lipoprotein LDL VLDL Serum lipid Note : +rise TC+++ TC++ TC++ TC+ TC+ TG++ TG++ TG++ TG+++ TG+++ [0006] Besides,unusualfallinHDLandriseinLP(a)are also major contributory factors to AS. The classical hypo lipemic is atromid-S, Which can reduce TG and VLDL markedly, reduce TC and LDL-C mildly, reduce HDL-C mildly, increase the activity of LDL, control synthesis and release of TQ strengthen the elimination of LDL and pro mote synthesis of apo A. The compound products have a more pronounced effect to enhance the esteri?cation of cholesterol than atromid-S. BRIEF SUMMARY OF THE INVENTION [0007] RabbitsWerefedWithhighcholesterolandlipid feed. In several Weeks, remarkable hyperlipemia occurred. The compound products can reduce the source of serum cholesterol by inhibiting part of exogenous cholesterol absorptionandsuppressingsynthesisofendogenouscholes terol, and promote the removal and re-distribution of cho lesterol tissue by increasing the conversion and excretion of cholesterol so as to speed up the consumption of cholesterol, thereby inhibiting the rise in serum cholesterol. The results of pharmacological activity experiment shoW that the com poundproductscanremarkablyinhibittheriseincholesterol in rabbits fed With feed containing cholesterol and high lipids. [0008] AfterfeedingWithhighlipidfeedforsometime, the serum cholesterol and triglyceride levels in rates Were raised and an experimental model of rate suffering of from hyperlipernia Was obtained. Using this model, hypolipermic drugsWerescreened.Theresultsofpharmacologicalactivity experimentsshoWthatfeedingmiceWithhighlipidfeedWill increase content of serum cholesterol and triglyceride more remarkably than With conventional feed. The compound productscanreducethecontentofserumcholesterolmore remarkably than the high lipid group and can also reduce the content of serum triglyceride. [0009] Theoriginallecithinandcholesterolintheserum Were used as substrates, Which Were kept Warm for some time. Because of the effect of lecithin cholesterol acyltrans ferase (LCAT), cholesterolester (CE) in serum Was increased, but free cholesterol (FC) decreased. Then cho lesterol Was oxidiZed by cholesterol oxidase and hydrogen peroxide Was produced. The latter reacted With 4-amidopy rine and phenol under the action of horseradish peroxidase to produce red quinone imide, Which can be used for colorimetricanalysistodeterminethecontentofFC.The decrease in EC, ie, the esteri?cation of cholesterol can indicate the activity of LCAT in magnitude. The results ofPDF Image | PHARMACEUTICAL ACTIVITY AND MANUFACTURING METHOD
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