| Objective:Total alkaloids,total flavonoids and total polysaccharides of compound pueraria hypoglycemic prescription,were extracted and prepared granules with hypoglycemic effect.Preformulation study,extraction process,preparation technology,quality evaluation and pharmacodynamics study were accomplished.Methods:Methodology establishment:Berberine hydrochloride,quercitrin and puerarin content determination method was established with the basis of HPLC.Total alkaloids,total flavonoids and total polysaccharides content determination method was established on the basis of UV spectrophotometer.The comprehensive evaluation of pharmacodynamics and the content of HPLC were determined by regression analysis.The linear regression equation was used to evaluate the extraction process.Extraction technology:The optimal alcohol extraction process and water extraction process were confirmed by single factor study and orthogonal test.Preparation technology:The optimal preparation technology was ensured with the indicator of soft material condition,difficult and easy level of granulating,granules condition,ratio of briquetting,dissolubility etc by investigating medicine supplementary ratio,wheel pressure,wheel speed and feed speed.Quality evaluation:Compound pueraria hypoglycemic granules were evaluated by characters,thin layer chromatography,examination and content determination..Results:Establishment of standard curve of HPLC berberine hydrochloride:y=61.912x+23.554(R2=0.9996),it had good linear relationship within the scope of 2.88～72 μg/ml.Establishment puerarin standard curve of HPLC puerarin:y=1.966x-2.6664(R2=0.9996),it had good linear relationship within the scope of 2.6～65 μg/ml.Establishment of standard curve of HPLC quercitrin:y=15858x-2042.8(R2=0.9998),it had good linear relationship within the scope of 2.3～23μg/ml.Establish the standard curve of total flavonoids:Y=0.0121x-0.0089(R2=0.9991),it had good linear relationship with absorbance within the scope of 12.24～73.44 μg/ml.Establishment of standard curve of total alkaloids:y=0.0684x-0.0057(R2=0.9993),it had good linear relationship with absorbance within the scope of 1.9～11.4 μg/ml.Establishment of standard curve of total polysaccharides:y=0.0307x-0.0092(R2=0.9992),it had good linear relationship with absorbance within the scope of 6.84～27.35 μg/ml.These six ways had good precision,repeatability,stability,standard recovery met the demand,methods were feasible.According to the statistical analysis of SPSS,the regression equation was established:Y=1.046X1+0.616X2+1.490X3-0.180(P<0.05),which has statistical significance.Extraction technology:The optimal alcohol extraction process was 80%alcohol,3 0-fold,extracted 3 times,1.5 h every time.Three groups of validation test indicated that technological conditions were stable,reasonable and feasible.Preparation technology:The water content of extract was 4%,the drug loading was 100%and the rolling wheel speed was 3 r/min,feeding speed 28 r/min,rolling wheel pressure was 50 kg/cm2.Quality Evaluation:External properties fitted the demand,Thin layer chromatography of four kinds of crude drugs had vigoroso specificity,the total of granules and powder that couldn’t pass first sieve and could pass five sieve were less than 15%,moisture was less than 8%,content uniformity was less than ± 5%,which fitted pharmacopoeia.Dissolubility fitted the demand.The content determination of berberine hydrochloride was no less than 44.03 mg/g,transport rate was 79.09%.Puerarin was no less than12.61 mg/g,transport rate was 77.99%.Conclusions:The extraction process parameters with traditional extraction technology with comprehensive score,cell pharmacodynamics have significant differences,and in compound pueraria hypoglycemic granules,berberine,quercitrin played a major role in the treatment of diabetes.The optimal process of alcohol extraction and water extraction in extraction technology study,the optimal preparation technology of compound pueraria hypoglycemic granules confirmed in preparation technology study,the evaluation indicators of compound pueraria hypoglycemic granules were confirmed in quality evaluation.The paper based on cell pharmacodynamics aimed to develop compound pueraria hypoglycemic granules that were stable and reliable in quality,took conveniently,tasted good and had perfect effect in this paper,which laid a solid theoretical foundation for further research on drug action mechanism in future. |
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