The Pharmaceutical Study On Anti Infection NZ Granula

Objective:Completion the pharmaceutical research on Anti Infection NZ, to provide pharmaceutical information of new traditional Chinese medicine.Methods:Use constituents P,MIC as index to choose the best accessories for NZ preparation,and use the Stability, constituents P,MIC as index to optimize the best formulation;Use constituents P,molding rate,MIC as evaluation parameter to optimize the best ratio of extract and accessories.Use granulation,molding rate as index and use single factor method to optimize the relationship between the ratio of mixed materials,extract water,ethanol concentration;Use drying condition,molding rate to optimize drying temperature.? Use Thin-Lay Chromatography(TLC) method to identified Anti Infection NZ granule and use High Performance Liquid Chromatography(HPLC) method to determined the concentration of NZ granule;?Use humidity,high-temperature, light and acceleration to investigate the modified Anti Infection NZ granule stability.Results:①The best materials of NZ preparation is: E which had the least impact on the formulation.The best formulations is granule which is better than cataplasm on constituents P,MIC and Stability and overcome the shortcomings of the long precipitation, easy to paste the moldy metamorphism.②The best preparation process is Extract: materials =1:2,Mixed accessories a:b=2:1,extract moisture: 40%,wetting agent: 70% ethanol,drying temperature: 60 ℃. NZ granules critical relative moisture(CRH) is near 68%.Process validation show the process is stable, reliable and reproducibility is good.③The best separation conditions of TLC is:developer: chloroform-ethyl acetate-dicarboxylic acid(5: 5: 1),reference solution spotting amount 1ul and the test solution spotting amount 2μL,reagent: 1% ferric chloride ethanol solution.In this condition the spots were clear, the Rf value is moderate, show that the method is uncomplicated, sensitive. The chromatographic conditions to determine the Pingredients of NZ granules: Column is JADE-PAK ODS-AQ(4.6×200mm,5um),mobile phase:methanol-0.2% phosphoric acid solution(5:95), the column temperature was 25℃,detection wavelength of 273 m,detector: DAD,analysis time: 25 min,the flow rate was 1.0m L/min.④NZ granules resistance high temperature and light,but it easy to absorb moisture in solution under high humidity conditions.The influencial factor tests show that the granules should be stored in a cool dry place.During the accelerated Stability test period, various quality checks indicators of the sample are in accordance with the provisions,which indicate that sample stability is good and identifies the amount dropped to 90% of the drug is valid so preliminary speculate that this product is valid for two years.Conclusion: The preparation process of NZ granule was Stable, reasonable and feasible.The established quality standard Was stable and controllable.Basic research to achieve the desired purpose and provided the experimental basis for future new drug application.