Study On Preparation And Quality Standard Of Biqiuning Spray

Objective: Biqiuning spray is a traditional Chinese medicine compound preparation composed of Fructus Xanthii,Fructus Viticis,Angelica dahurica,Mulberry Leaf,Chrysanthemum,Biond Magnolia Flower,Ligusticum wallichii and Mint.This prescription is a fumigation experienced prescription for clinical treatment of allergic rhinitis,with remarkable curative effect.This subject is based on clinical experience prescription,abandoning traditional fumigation method,using modern preparation technology to develop and prepare a traditional Chinese medicine spray for allergic rhinitis,and systematically studying the preparation process and quality standard of the preparation,preliminary stability and preliminary pharmacodynamics of the preparation,and preliminarily discussing the stability and pharmacodynamics of the preparation.Method: 1.Extraction process: the extraction rate of compound volatile oil was taken as the index and the best extraction process was determined by single factor and orthogonal test;with the content of total phenolic acid and total flavonoids in the compound extract as the index,the weight coefficients of each index were calculated by three different weighting methods,and the optimumalcohol precipitation process was determined by orthogonal test.2.Preparation molding process: through multiple groups of preliminary experiments,the selection and dosage of solubilizer,antioxidant,preservative and p H regulator were investigated to determine the final preparation process.3.Quality standard study:TLC was used for qualitative identification of Angelica dahurica,Biond Magnolia Flower and Mint in the preparation;the volatile components in the preparation were identified by GC-MS;the conent of chlorogenic acid and ferulic acid were determined by HPLC.4.Preliminary stability study: according to the guidelines for stability testing of raw materials,drugs and preparations in the2015 edition of Chinese pharmacopoeia(general rule 9001),based on the quality standard draft of Biqiuning spray,the preliminary stability of 3 batches of samples was investigated.5.Preliminary pharmacodynamic study: the anti-inflammatory effect of the preparation was studied by ear swelling induced by xylene and foot swelling induced by carrageenan in mice.Result: 1.Extraction process: Fructus Xanthii,Fructus Viticis,Angelica dahurica,Mulberry Leaf,Chrysanthemum,Biond Magnolia Flower,Ligusticum wallichii and Mint were crushed into coarse powder,add 14.5 times water,soak for 0.5 hours,steam distillation for 4 hours,collect volatile oil,set aside;after distillation,the aqueous solution was filtered,and the filtrate concentrated to the relative density of 1.08~1.12(50?),ethanol was added to make the alcohol content reach 60%,stirred evenly and let stand for 12 hours,after filtration,ethanol was recovered from the filtrate and concentrated until the relative density was 1.20~1.25(50?).2.Preparation molding process: add benzyl alcohol andpolysorbate 80 to compound volatile oil,mix well,then add compound extract extract,stir well,add water to nearly the total amount,add sodium bisulfite,stir well,adjust p H value to 5.5~6.0,filter,filling,ready.3.Quality standard study: TLC identification methods of Angelica dahurica,Biond Magnolia Flower and Mint were established;the method of GC-MS analysis and identification of volatile components in preparation was established;HPLC method for determination of chlorogenic acid and ferulic acid in the preparation was established,and it was stipulated that the contents of the two in the preparation should be no less than 133.90 and 73.94 ?g/m L.4.Preliminary stability study: Biqiuning spray is stable.In order to ensure the efficacy of the product,it is recommended that the light,sealed storage.5.Preliminary pharmacodynamic study: Biqiuning spray can reduce ear swelling caused by xylene and foot swelling caused by carrageenan in mice,showing certain anti-inflammatory effect,and it is comparable to that of fluticasone propionate nasal spray.Conclusion: the preparation technology of this product is reasonable,stable,feasible,the quality standard specificity and repeatability are strong,simple and reliable,the preparation is stable,the efficacy is significant,has laid the foundation for the later product development.