The Prepare And Develop Of Guwei Soft Capsule

Objective:To formulate and optimize the preparation technology of guwei soft capsule;To study on the effective components of Guwei soft capsule;To establish the quality standard of guwei soft capsule;To investigate the preliminary stability of Guwei soft capsule;To provides theoretical basis and experimental basis for further study on the preparation of guwei soft capsule and its effective components and some physical and chemical properties.Methods:1.Orthogonal experiment was performed to optimize the extraction technology of the Chinese medicinal materials in Guwei soft capsule.The conditions of softcapsule were optimized by analyzing the extraction times,extraction time,extraction solvent,and extraction temperature.Adopt the content of total flavonoids as investigate index to define the best extraction technology by ultraviolet spectrophotometry.The preparation and extraction technology of Guwei soft capsule was performed by an orthogonal experiment.The factors influencing of Guwei soft capsule,such as the ratio of gelatin to glycerin water,sol temperature and the disintegration time,were investigated to select the optimum conditions.Therefore,the best proportion of gelatin,glycerin and water was selected,defined the preparation technology of Guwei soft capsule.2.LC-MS was performed on the column filled with octadecyl silica gel(4.6 mm×150 mm,5 ?m)with mobile phase of 0.1%formic acid water-acetonitrile,gradient elute at a flow rate of 0.8 mL·min-1,column temperature was maintained at 35?,in this way inject the sample,and injection volume was 10 ?L;Mass spectrum condition:select HESI ion source,adopt positive ion detection mode,Full mass,the scanned area:m/zl30.00-1000.00,determination the effective components of Guwei soft capsule.3.HPLC was performed on the column filled with octadecyl silica gel(4.6 mm×250 mm,5 ?m)with mobile phase of 0.3%phosphoric acid:water-acetonitrile,gradient elute,at a flow rate of 1.0 mL·min-1column temperature was 35?.Detection wavelength was 254 nm.To detection the contents of four components of icariin,verbascoside,cinnamate and chlorogenic acid in Guwei soft capsule at the same time,establish a method for the determination of Guwei soft capsule.Select the illumination experiment,high temperature,high humidness,accelerated test,long-term stability experiment to measure the character of the capsule,content of effective constituent and the disintegration time,formulate the stability of Guwei soft capsule.4.Gauged the difference of weight between the disposed soft capsule and the original soft capsule to detection content uniformity;The dissolution experiment selected the 900 mL PH4.5 acetate buffer solution,40 rpm,detection dissolution;Microbiological limit experiment Escherichia coil,Staphylococcus aureus,Bacillus subtilis,Candida albicans and Aspergillus Niger and Guwei soft capsule the treatment group,colony group and control group,sign it colony number.Results:1.The Optimum extraction condition was mix the solid-liquid rate 1:6 water with the Chinese medicinal materials,and the extraction rate was highest when the temperature was 100? for 1 h and the number of times was 2 times.The diluent of soft capsule content was soybean oil,the best weight ratio of dry paste:soybean oil is 1:2,choose 1.5%beeswax as suspension aid,to make the contents of soft capsule;The best weight of gelatin,glycerin and water was 140 kg,60 kg,140 kg,add 0.2%ethyl hydroxybenzoate as a preservative,the sol temperature is 72 ?.2.Determine the content in the Chinese medicinal,the characteristic of this method is high sensitivity and high selectivity with good separation degree.3.The equation of regression of icariin,verbascoside,cinnamate and chlorogenic acid is y=1×107x-35691(R=0.9991),y=7×106x-710.28(R=0.9998),y=7×107x+288.01(R=0.9997),y=8×106x-2209.9(R=0.9994).The results showed that the four components had good linear relationship with peak area in the concentration 0.0502?0.1506 mg·mL-1,0.011?0.033 mg·mL-1,0.013?0.039 mg·mL-1,0.0004?0.0012 mg·mL-1,respectively,the average of recovery rate is 100.13%,99.77%,99.92%,100.33%.The stability experiment conforms to the requirement of soft capsule stability,the results showed that Guwei soft capsule have good stability.4.The experiment proved that the content uniformity of Guwei soft capsule is less than ±10%;The dissolution is good;Microbiological limit experiment shows that the average recoveries of experimental group is more than 70%,the dilution group is more than 70%,its all meet the requirements of pharmacopoeia.