Pharmaceutical Study Of Huaji Granules

The endometriosis into serious threat women in general health one kind of olddisease, strengthens to this sickness preventing and controlling research has thevital significance.Huaji granulesis composed clinically by Paeoniae radix,Rhizomasparganii,Rhizoma Curcumae, Radix Astragali,Semen Coicis,Flos Carthami,RadixScutellariae,Rhizoma Cyperi,Thallus Laminariae,Eupolyphaga Seu Steleophagaand Herba Taraxaci effectively after the proven prescription. We according to theactive constituent which the prescription medicine contains, obeys the hospitalpreparation original side, the choice production, takes, the carryhome, stores theproduct, the transportation convenient granules makes.Present paper including following 8 parts:1.Huaji granules to the endometriosis, as well as its craft basis, quality researchwork literature summary.2.Appraisal raw material for medicine origin.Granules raw material for medicine Paeoniae radix,Rhizomasparganii,Rhizoma Curcumae,Radix Astragali,Semen Coicis,Flos Carthami,RadixScutellariae,Rhizoma Cyperi,Thallus Laminariae,Eupolyphaga Seu Steleophagaand Herba Taraxaci originates separately from northeast, Henan, Jiangsu, Sichuan,Jiangsu, Shanxi, Hebei, Jiangsu, Shanxi, Inner Mongolia and Shandong. Conformsto Pharmacopoeia of People’s Republic of China English Edition 2005, partⅠ, arelated stipulation, orthogonal experiment3.Craft research summary3.1 Rhizoma Curcumae, Rhizoma Cyperi. extraction craft and volatile oilcyclodextrin of knot craft research. Withdraws take the volatile oil rate as the target,uses the orthogonal array to carry on the orthogonal experiment, the inspectionwatering quantity, the infiltration time, the extraction time to the volatile oilextraction influence, the result after the variance analysis, obtains the volatile oilbest extraction technological conditions is: Raw material for medicine adds 6 timeof quantity water, soaks for 1 hour, the wet distillation withdraws for 8 hours. Takethe volatile oil package knot rate, Bao Hewu receives rate as a target, Uses theorthogonal array L₉ （3⁴） to carry on the orthogonal experiment, the inspectionvolatile oil cyclodextrin the package gathers the time, the package gathers factordifferent levels and so on the temperature as well as mixing speed to the volatile oilpackage knot rate, Bao Hewu receives rate the influence, the result obtains the best package after the variance analysis to gather the technological conditions is: 6 timeof quantity beta-link dextrin, when 40℃,by 120r/min mixing speed agitationpackage of knot 1.5 hours3.2 Herbaceous peonies and so on four tastes propose the craft research to use L₉（3⁴） orthogonal experiment table mellowly, after the HPLC measuring methoddetermination orthogonal sample in the paeoniflorin, AstragalosideⅣcontent,take the paeoniflorin, AstragalosideⅣas the target, the inspection ethyl alcoholdensity, the ethyl alcohol amount used, the extraction number of times, theextraction time factor different level to the extraction efficiency influence. Theresult after the variance analysis, obtains best puts forward the technologicalconditions is mellowly: Namely adds the raw material for medicine total quantity12 time of quantities 60% ethyl alcohol to divide three extractions, each time 2.0hours.3.3 After the technique, attaches the deliver oil of Rhizoma Curcumae, RhizomaCyperi oil refining fragrant the dregs of medical decoction, raises the dregs ofRhizoma sparganii, Semen Coicis, Rhizoma Cyperi,Eupolyphaga Seu Steleophaga,Radix Scutellariae, Herba Yaraxaci water decoction craft research mellowly.Uses L₉ （3⁴） orthogonal experiment table, after HPLC measuring methoddetermination orthogonal sample in astragalosideⅣcontent, after obviously-ultraviolet spectrophotometric method determination orthogonal sample inpolysaccharide content, inspection watering quantity, decoction time, extractionnumber of times factor different level to extraction efficiency influence. The resultafter the variance analysis, obtains the best water to put forward the technologicalconditions is: Namely adds the raw material for medicine total quantity 18 time ofquantities the moisture content three decoctions, each time 1.5 hours3.4 Ethyl alcohol precipitation craft comparison research.In order to reduce the granular formulation to take the dosage, improves itsdeliquescence, the clear brilliance, the experiment continues to use the ethyl alcoholprecipitation to carry on the separation purification. After determines astragalosideⅣand the polysaccharide content, and considered the pellet the deliquescence, theclear brilliance and take factors and so on quantity, finally determined sinks thedensity is mellowly 50%.3.5 Concentrations, dry craft research.Take the paeoniflorin and astragalosideⅣthe content as the target, around the reduced pressure concentration compares （the T-test）, has not seen the significancedifference, explained uses the thin film concentration method to be feasible.According to produces the pre-experiment to choose this preparation spraydrying related parameter, the determination spray drying condition is: Raw materialfor medicine extracts after has filtered, the concentration to the relative density1.10～1.15（50℃）, in entering the rumor warm 165～175℃, in the tower negativepressure 300～350Pa, leaves under the rumor warm 85～90℃condition the spraydrying, obtained spurts does the powder to assume the yellow brown loose solidpowder, the water content in 5%.3.6 Granules formation craft research.According to the granular formulation formation technological requirement tothe supplementary material, the coniferous wood preparation and the clearbrilliance carries on the inspection. Of the determination extracts ratio of thepowder, the supplementary material amount used isextracts the powder: Powderedsugar: The dextrin （1:1.2:0.8）, take 85% ethyl alcohol wet legal system pellet,the pellet which the system results in 60℃dryly to the pellet water content as 3%.According to the findings, determines this product the production craft.4.The quality specification research summarizesIn order to establish this product the quality specification, according to thisprescription medicine composition, unifies contains the medicine ingredientcharacteristic, uses in the TLC distinction preparation theHerba Taraxaci,RadixAstragal,Paeoniae radix, Eupolyphaga Seu Steleophaga, Flos Carthami,RhizomaCurcumae, uses in the HPLC determination preparation the AstragalosideⅣcontent, simultaneously defers to Pharmacopoeia of People’s Republic of ChinaEnglish Edition 2005, partⅠan appendix general rule mixture under related requestinspection, has established this product quality specification.5.Preparation general rule inspectionpreparation general rule inspection mainly includes the granularity, the moisturecontent, the deliquescence, the load difference and the microorganism limit, afterthe inspection and the determination, three batch of samples conforms to thestipulation requirement.6.AstragalosideⅣcontent determinationAstragalosideⅣcontent determination methodology research mainly includesthe system operational test, the linear relations inspection, the stability test, the accuracy experiment, the duplicated experiment as well as adds the typereturns-ratio experiment, the findings indicated that, conforms to the relatedspecification.7.Investigations into stabilityKeep the type inspection and the acceleration stability trial method through theroom temperature to this preparation quality specification under character, thedistinction, the microorganism limit, the AstragalosideⅣcontent and so on carryon the experiment, the inspection preparation stability.8.Pair of above research, give the summary.