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PHARMACEUTICAL ACTIVITY AND MANUFACTURING METHOD

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PHARMACEUTICAL ACTIVITY AND MANUFACTURING METHOD ( pharmaceutical-activity-and-manufacturing-method )

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US 2005/0142231A1 Jun.30,2005 [0012] Table3PharmacologicalActivityoftheFive-Plant Compound Hypolipemic Products [0013] 1.EffectoftheFive-PlantCompoundHypolipemic Products (Brie?y Referred to as Compound Products) to Reduce Total Cholesterol in Rabbit Serum [0014] (1)Modellingofhyperlipemiarabbits:Whiterab bits of 1.8-2.5 kg Were chosen regardness of sex and fed With basal feed. After three Weeks of adaptation, they Were randomly divided into three groups according to Weight, each group composed of ten. In addition to basal feed, each group Was perfused With 0.2 g/kg cholesterol (With lard as solvent), once a day. The drugs should be administered tWice a day. For small dose group, 0.1 mg/kg compound products Were perfused; large dose group, 0.3 ml/kg compound products and control group, equal volume of normal saline for 8 consecutive Weeks. [0015] (2)AtWeek2,4,6and8aftermodeling,bloodWas taken through the ear vein, centrifuged at 3000 rpm and serum Was isolated for analysis. [0016] (3)LightdensityWasdeterminedandcontentof cholesterol calculated. [0017] Result:Compoundproductscaninhibittherisein serum cholesterol in rabbits fed With cholesterol and high fat feedgreatly(Table1). [0020] Result:ComparedWithmicefedWiththenormal feed, mice fed With high lipid feed had greater content of serum cholesterol and triglyceride. In comparison With the highlipidgroup,thecompoundproductsgroupcouldreduce the content of serum cholesterol greatly and that of serum triglyceridetoo(Table2). TABLE 2 Effect of compound products upon the content of serum cholesterol and triglyceride in rats sufferingfromexperimentalhyperlipemiaI1SD n=12 Group TABLE 1 Effect of compound products upon total cholesterol in serum Dose Number of Total cholesterol (mg %) (x 1 SD) (ml/kg) animal(pcs)Normalvalue 2Weeks 4Weeks 6Weeks 8Weeks 692.71 1 55.88 303.06 1 24.25*** 175.64 1 24.40*** Control Normal 10 saline Compound 0.1 10 products Compound 0.3 10 products 78.23 1 12.87 83.64 1 17.57 73.20 1 10.24 374.80 1 29.86 558.62 1 77.90 591.64 1 60.54 331.66 1 66.94 325.82 1 70.75** 316.09 1 54.19 302.14 1 38.50 265.19 1 29.64** 237.31 1 20.52*** [0018] Products Upon the Serum Lipid in Rats Suffering from ExperimentalHyperlipemia [0019] Method:Ratsof130130g,halfmaleandhalf female, Were randomly divided into three groups. The ?rst group Was normal control and fed With conventional feed for ?fteendays.Beginningfromday16,10ml/kgnormalsaline Was perfused once a day for 4 consecutive Weeks. The second group Was high lipid control and fed With high lipid feed for ?fteen days. Beginning from day 16, 10 ml/kg Was perfused once a day for 4 consecutive Weeks, the third group Was compound products and fed With high lipid feed for ?fteen days. Beginning from day 16, 4.2 g crude drug/kg compound products Were perfused once a day for 4 con secutiveWeeks.Afterthecompletionofthetest,theanimals fasted for 8-12 hours, but Water Was supplied stil. Then mixed blood Was taken from the artery and vein, collected inthetesttubenumbered,andcentrifuged.A ?xedamount of serum Was taken and operated as shoWn in Table 21-3 9.1Aand21-3-9.3Atodeterminethecontentofcholesterol andtriglyceriderespectively. 2.EffectoftheFive-PlantCompound Hypolipemic Was given normal saline, the other tWo Were perfused With 3.0 or 6.0 g/kg compound products respectively and another group performed With 0.13 g/kg atromid-s for seven days, after Which each group fasted for 12 hours. Blood Was taken from the orbit and serum Was prepared. [0023] (2)TWoportionsof0.1mlfreshserumWeretaken from each animal of each group and Were preheated in Water bath at 37° C. for ?ve minutes, to one portion of Which 3 ml cholesterol enzyme-linked reagent application solution Was added (30 ml enZyme reaction solution for 1 ml cholesterol enzyme-linked reagent), mixed thoroughly and heated in Water bath at 37° C. for 15 minutes While blank control tube and standard tube (0.05 ml standard cholesterol absolute alcohol solution) Were made. Zero calibration against bland tube Was made by Model 721 spectrophotomer at a Wave length of 500 nm. OD Was read and FC content Was calculated in terms of Beer’s laW, Which Was the serum FC content before reaction. The other portion of serum Was kept Warm forfortyminutes.ThenFC contentWasdeterminedas above, expressed as OD, Which Was the serum FC content Group Normal control Highlipidcontrol Compoundproducts Cholesterol(mg%) Triglyceride(mg%) 99.6 r 37.3 657.4 : 207.8AAA 456.1 1 140.5** 58.4 r 23.8 207.8 : 142.7AAA 159.3 1 63.3** [0021] 3.EffectoftheFive-PlantCompoundHypolipemic Products Upon the Activity of Lecithin Cholesterol Acyl transferase in Rats Suffering from Hyperlipemia [0022] (1)50Wistarratsof150~200g,halfmaleandhalf female, Were randomly divided into ?ve groups, each Was composedoften.Onegroupservedasnormalcontroland the remaining four Were perused With 17.5 ml/kg cholesterol emulsion once every morning. In the afternoon, one group

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