Studies On Quality Of FUTU Capsules

The prescription of FUTU capsules come fromPrescription of Peaceful Benevolent Dispensary. It contains fivekinds of herbal medicine such as Cuscuta chinensisLam,Schisancra chinensis, Nelumbo nucifera, Poria cocos (Schw.)Wolf and Dioscorea opposita Thunb. It was recorded in bookthat it had effects on diabetes and emission, etc. According tothe recordation, the prescription was effective in diabetestherapy. There were many documents to report the same action.The FUTU pill is also published in Ministry-issued Creterion inwhich the actions of FUTU pill can tonify the kidney and stopemission without reducing diabetes. So FUTU capsules to treatdiabetes are developed and studied.Pill was recorded originally in Prescription of PeacefulBenevolent Dispensary, which had many disadvantages such asbig dosage, slow absorption and low absorption rate, etc.According to the technological requirements about studying onnew Chinese Traditional Medicine, on the base of analyzingbioactive components and pharmacological effect of eachtraditional medicine, combining with the clinical requirements,category, active ingredients or effective parts and its physicaland chemical proprieties, the traditional medicine was extractedso that chemical constituents were isolated selectively in orderto prepare appropriate formulation by the characteristics ofsemi-manufactured sample.Objective: To study the extracting process of herbalmedicine in order to optimize the best conditions; To explorethe process of preparation for manufacturing FUTU capsules.Methods: Conditions of extraction were chosen by meansof orthogonal test. With the content of total flavone as indexes,concentration of ethanol, ethanol volume, extracting time andtimes as factors, the optimal extracting condition for totalflavone from Cuscuta chinensisLam and Schisancra chinensiswas investigated. With the content of total polysaccharides asindexes, the volume of water, extracting time and times asfactors, the optimal extracting process for total polysaccharidesfrom Nelumbo nucifera, Poria cocos (Schw.) Wolf, Dioscoreaopposita Thunb with residue after total flavone extracted wasexplored. Then every kind of traditional medicine was extractedby the optimal extracting conditions, and concentrated to grease,evaporated by vacuum. The parameters of preparation mouldingwere studied to make capsules such as quantities of dextrine,characteristics of moisture absorption and fluid.Results: The optimal conditions for extracting with ethonalwere selected: 8 volumes of 70% ethanol was added intoCuscuta chinensisLam and Schisancra chinensis and refluxedfor two times and 4 hours once. The optimal extractionconditions by water were chose: 10 volumes of water was addedand decocted for 1 hour for three times. The extraction wasevaporated to dry and the residue was then powdered finely. 20% dextrine was added into the powder and mixed. 80%ethanol was added to make into soft material and granules weremade. At last the granules were filled into capsules.Conclusions: The optimal extraction and preparationtechnique of FUTU capsules were ascertained by means oforthogonal test.According to the technology of pharmacology tests,hypoglycemic action of FUTU capsules was studied primarily.Objective: To study the effects of FUTU capsules on bloodglucose in normal mice and alloxan-induced diabetic mice, andon weight in alloxan-induced diabetic mice.Methods: Normal mice and alloxan-induced diabetic micewere randomly divided into different groups, respectively. Everygroup had ten mice. Perform tests at the same time, take blooduntill the administration was completed, and determine theblood-glucose value by glucose oxidase technique (GOD).Statistical analysis was done with t test.Results: FUTU capsules couldn't affect the blood glucoseof normal mice, but could decrease blood glucose remarkablyand increase the weight of alloxan-induced diabetic mice.Conclusions: FUTU capsules had great hypoglycemiceffects.Quality control of drug is one of its basic attributes and thebasement of security and validity. Quality control standard isvital to drug quality, and it is also embodiment for qualitycontrol. In order to control quality of FUTU capsules, thephysical and chemical properties were studiedObjective: To establish a series of thin-layerchromatography (TLC) methods to identify traditional Chinesemedicine in prescription such as Cuscuta chinensisLam,Schisancra chinensis and Dioscorea opposita Thunb. Toestabliah a reversed-phase HPLC method for determination ofquercetin in FUTU capsules in order to provide one guidelinefor their quality controls.Methods: (1)Studies on identification methods:Ingradientsin FUTU capsules were identified with TLC. (2) Studies ondetermination methods: â‘ Quercetin was extracted from FUTUcapsules with methanol through sonication, and the extractedsolution was filtered.â‘¡Chromatogram conditions: Chooseappropriate column, different formulation and proportion ofmobile phase and adjust flow rate and wavelength in order toseparate the peak of quercetin from others well. â‘¢Preparationof standard curve: Prepare a series of the reference solution,examine peak area, then the regress equation was obtained withthe content of quercetin as abscissa, the relevant peak area asordinate. â‘£Lowest detection limitation: Dilute the referencesolution to the value of S/N was not less than 3. The relevantconcentration was the lowest detection limitation. ⑤Precision:Inject the same test solution into the chromatograph for fivetimes, measure the responses of quercetin, and then calculate theprecision. â‘¥Stability: Prepare the test solution to measure therelevant responses at 0, 1, 2, 4, 6, 8, 10, 12 and 24 hour,respectively.⑦Reproducibility: Prepare the test solution fiveshares in the same way respectively to determine the content ofquercetin. ⑧Recovery: Transfer a portion of contents ofcapsules, add a certain volume of reference solution of quercetinto it, and mix. Prepare five shares parallelly. Inject anddetermine the content of quercetin respectively, and caculate theaverage recovery in the end. ⑨The content of quercetin inFUTU capsules was analyzed under above-mentionedconditions.Results: (1) Identification: TLC methods were establishedfor the identification of Cuscuta chinensisLam, Schisancrachinensis and Dioscorea opposita Thunb. The principal spot inthe chromatogram obtained from the test solution was similar inposition, colour and intensity to the principal spot in thechromatogram obtained from the reference solution. (2) Assay:â‘ Extract the sample by sonication for 30 minutes, withmethanol as solvent. â‘¡A ODS column (250 mm×4. 6 mm, 5μm) was used for HPLC. The mobile phase was a mixtureconsisted of acetonitrile and 1% Acetic acid(27:73)at a flowrate of 1.0 ml·min-1 and the detective wavelength was set at360nm. Under the system, the peaks of samples were separatedwell with the resolution of not less than 1.5. The retention timeis about 10min. The theoretical plates were more than 4000 andthe tailing factor of the quercetin peak was from 1.02 to 1.12.â‘¢Regress equation was Y=106033X-17883,r=0.9998(n=6).The liner range for quercetin was 1.20μg·ml-1³.59μg·ml-1.â‘£The lowest detection limitation was 0.236ng·ml-1. ⑤The RSDvalue in the precision test was 0.74%. â‘¥The sample was stablein 24 hours. ⑦The RSD value of repeatability was 1.40%.⑧Average recovery is 99.44% and the value of RSD was 0.53%.⑨The average content of quercetin was 34.50 μg per granule;The value of RSD was 0.49%.Conclusions: In identification, the relevant spots wereclear and characteristic and could be used to differ them fromothers in FUTU capsules. The RP-HPLC method wasestablished to determine concentration of quercetin in FUTUcapsules. The method was found to be accurate, sensitive, quickand stable. It can be used to control the quality of FUTUcapsules.The Chinese compound medicine is the mainlyapplications of traditional medicine. On account of complexingredients in them, the pharmacokinetics between Chinesecompound medicine and chemical component are differentobviously. It is one of important methods of Chinese compoundmedicine modernization that Chinese compound medicine isstudied and reciprocity and changement among erery kind ofchemical component is showed quantificationally by appropriatepharmacokinetics ways. It is very much significant to illuminateprinciple of compound medicine and action and to promotereasonable application of Chinese medicine in clinic.Objective: To establish a method of RP-HPLC fordetermines the content of quercetin in plasma; to study thepharmacokinetic characteristics of Cuscuta chinensisLam andFUTU capsules in rats.Methods: Rats were divided into different groupsrandomly, six rats each group, and each one was given orallywith the water solution of FUTU capsules (or CuscutachinensisLam) at the dose of 10ml·kg-1. Blood samples werecollected from eyeball of rats after given drugs at prearrangedtime (2, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240min). Bloodsamples were drawn into tubes containing heparin sodium,respectively. Plasma was obtained by centrifugation atapproximately 4000 rpm for 10min. Take 0.2ml of blood plasma,add acetic ether 600μL to it, centrifugate, transfer the uppersolution, dry this solution and resolve the residue withmethanol,inject 20μl of each sample into the instrument. TheHPLC systems was carried out on DiamonsilTM C18( 250mm×4.6mm , 5μm ) column with acid sodiumphosphate-acetonitrile-methanol (58: 37: 5) as mobile phase,the detection wavelength was 360 nm. Flow rate is 1.0ml·min-1.The peak area was used to calculating unknown concentrationsof sample solvent according to the regress equation. Analyse theoriginal data with 3P97 pharmacokinetics software. Make thebest compartment model according to the biggest correlationcoefficient and the smallest AIC obtained from realconcentration.Results: The linear range of standard curve was1.706ng·ml^-12.184μg·ml^-1. The regress equation wasY=0.0005X+0.008,r=0.9994(n=7). The lowest quantitationlimitation was 0.856ng·ml^-1, and the recoveries in three differentconcentrations (low, middle and high) were 88.89%, 94.96%,and 91.03%. RSD values were 2.5%, 1.7%, and 4.7%. The RSDvalues of within-day were 4.1%, 2.9%, 3.0%, respectively, andthose of between-day for the method were 4.7%, 3.1%, 5.4%,respectively. The concentration-time curves of quercetin after...