Studies On The Preparation Technics, Quality Control, Primary Evaluation On The Main Pharmacodynamics And The Acute Toxicity Testing Of Anti-h Yperplasia Pills

Obejective: ANTI-HYPERPLASIA PILLS is based on clinical experience of AnhuiTraditional Medicine College Professor Liang Wenzhen.It composed of SemenVaccariae,Cortex Moutan Radias,Radix Paeoniae Rubra and other drugs,the clinicfunction mainly for the treatment of cystic hyporplasia and mastitis preliminary.In thisstudy we studied the preparation technics and quality standard of the compoundpreparation and made a primary evaluation on its main pharmacodynamics,so as toestablish the foundation for the further study on treating breast hyperplasia with ChineseMedicine.Methods: In the studies on its preparation technics,orthogonal trial wasadopted to select extraction and purification conditions.Comparison test was used toselect the concentration technics, drying technics,types of auxiliary materials andformulation and performs a comparison to determine particle preparation process. Inthe studies on its quality standard,the thin layer chromatography (TLC) method wasestablished to identify Semen Vaccariae,Cortex Moutan Radias,Radix Paeoniae Rubraand Radix Rhapontici. The high performance liquid chromatography (HPLC) methodwas established to determine the content of paeonol in Cortex Moutan Radicis,thecontent of paeoniflorin in Cortex Moutan Radicis and Radix PaeoniaeRubra.Pharmacodynamics study examined the effect of the diameter of rat breast andnipple height, the content of serum E2、P，the prothrombin time and hemorheologicaland acute toxicity testing.Results: The mass of water added for extracting paeonol wasdetermined to be12.50times than that of medical material, and the solution collectionwas determined to be11times than that of medical material,standing for the night, andthen filter.Precipitation was dried at40℃blast.The Semen Impatientis and Tribulusterrestris crusehed (over10mesh sieve),and then with paeonol dregs and the remainingherbs should be extracted3times with10time amount of water,and1hour per time;and the water extracted solution should be concentrated into extractum with relativedensity as1.04（40℃)， then the extractum should be precipitated with alcohol so thatthe sediments contains70%of alcohol for24hours.In the comparison trial, it is determined that the precipitated alcohol solution should be vacuum concentrated intothick paste with relative density as1.06(20-30℃). Then the thick paste should be in70℃in spray drying and crushed into fine powder.Weigh the pregelatinized starch20grams (over80mesh sieve) and7grams of sodium carboxymethyl cellulose (over80mesh sieve) mixed evenly, use the granulator, particles are formed by dry granulation(over30mesh sieve). Then add3grams of magnesium stearate, uniform mixing,tabletting and coating.The studies on its quality standard indicated that the TLC foridentifying Semen Vaccariae,Cortex Moutan Radias,Radix Paeoniae Rubra and RadixRhapontici is simple and practicable, and negative control sample has no interference inTLC. When the concentration of paeonol was within the range of7.002μg/ml--70.02μg/ml, it had good linear relationship with its peak area (r=0.9999).The recovery of paeonol was96.56%,RSD=1.33%(n=9).When the concentration ofpaeoniflorin was within the range of5.920μg/ml—59.200μg/ml, it had good linearrelationship with its peak area (r=0.9995). The recovery of paeonol was98.35%,RSD=1.17%(n=9).The study on pharmacodynamics test indicated thatANTI-HYPERPLASIA PILLS had some therapeutic effect and can significantlyimprove hemorheological on mammary hyperplasia rat model.It also can reduce thewhole blood and plasma viscosity and extend the prothrombin time of rat. It was safeand innocuous. Conclusion：The preparation technics of the ANTI-HYPERPLASIAPILLS are reasonable and feasible. The quality standard can be used to control thequality of the product. The study on pharmacodynamic reveals that theANTI-HYPERPLASIA PILLS has anti-inflammatory and analgesic effects.The acutetoxicity testing proved that this product is innocuous and safe.