Pharmaceutical Study Of Compound Jinjie Granules

In recent years,serious environmental pollution,coupled with changes in people's diet,drug abuse,smoking,drinking,staying up late and other bad habits,leads to the increasing incidence of pharyngitis.Although drug resistance,floradisorders and other disadvantages exit,antibiotics is widely recognized as the most effective treatment at present.Therefore,it is very important to develop some new TCM.The prescription consists of honeysuckle,platycodon,scutellaria and licorice.The extract was mixed with other excipients to prepare granules which could clear the throat.Objectives: To evaluate a new TCM named Compound Jinjie Granules,extraction process,preparation molding process,quality standard and preliminary stability will be conducted.It will provide theoretical guidance and experimental evidence for research,development and production.Methods: The extraction process of chlorogenic acid in compound preparation was used as the evaluation index,and the optimal extraction process was determined by single factor test and orthogonal test.The hygroscopic rate and molding rate were measured to determine the optimal molding process.TLC was employed on the qualitative identification of honeysuckle,platycodon grandiflorum,scutellaria baicalensis and licorice.The content of chlorogenic acid was determined by HPLC.Long-term test and accelerated test were made to evaluate its preliminary stability.Results:(1)The dosage ratio of honeysuckle,platycodon grandiflorum,Scutellaria baicalensis and licorice was 3:2:1:1.(2)The optimal extraction process was the concentration of 65% ethanol,medicine than the solution of 12:1,once with 4times the amount,plus 1.5 h of the extraction time.The optimal preparation molding process was honeysuckle 450 g,platycodon grandiflorum 300 g,scutellaria baicalensis150 g,licorice 150 g.The aboved powder was mixed with accessories to make of particles 1000 g.(3)Spots of honeysuckle,platycodon grandiflorum,scutellaria baicalensis and licorice were obtained from the test solutions without anyinterferences,which was included in the standard.Platycodon grandiflorum was used for assistant identification.(4)The linear regression equation of chlorogenic acid was Y=3.0×106X-150935,r=0.9997.It was a good linearity of chlorogenic acid in the range of 0.24 ?g to 3.85 ?g.The content cletermination for specificity,precision,repeatability,durability,stability and recovery were well-done.(5)The purity of chlorogenic acid was no less than 14 mg/g.(6)The results of long-term test and accelerated test showed that the indicators were in line with the requirements.Conclusion: The extraction and preparation process of Compound Jinjie Granules are reasonable.The established quality standard is simple and feasible.In addition,the nature of the preparation has good stability.