Study On The Preparation Process And Quality Standard Of Pediatric Xin Zhi Tong Qiao Syrup

Allergic rhinitis is a common disease that endangers the respiratory health of children and is a chronic inflammation of the nasal mucosa and submucosa.Pediatric Xin Zhi Tong Qiao Syrup is a preparation prepared by decocting 5 Chinese herbs,namely,fried Cang Er Zi,Fang Feng,Bai Zhi,Xin Yi and fried Atractylodes,which is mainly used for the treatment of pediatric allergic rhinitis.Objective: To prepare an adjustable dose,safe and convenient to take,and suitable for children’s Tongkatong syrup preparation.And to determine its quality standard and provide a basis for the clinical pediatric formulation study of this prescription.Methods: The extraction process of Cimicifugae oil was studied by orthogonal test,and the preparation process of Cimicifugae oil microemulsion was optimized by pseudo-ternary phase diagram method and CCD response surface method;the extraction process of Dahurica dahuricae Central Europe prebiotics and the extraction process of the remaining three herbs mixed by Box-Behnken Design response surface method were optimized;the removal of impurities,the improvement of clarity and the syrup forming process were studied;the quality standard of syrup was studied by thin layer chromatography and high performance liquid chromatography.Results: the volatile oil of Sinapis alba was extracted by soaking time of 30 min,liquid to liquid ratio of 7 times,and heating time of 2 h;the microemulsion of Sinapis alba oil was prepared by 34.39 % of oil phase,30.71 % of emulsifier,and 34.90 % of co-emulsifier;dahurica dahurica was extracted by extraction temperature of 72±1 ℃,liquid to liquid ratio of 8 times,and extraction time of 1.5 h;the remaining three herbs were extracted by extraction times of 2times,liquid to liquid ratio of 10 times,and extraction time of 2 h.The remaining three herbs were extracted twice with a liquid to material ratio of 10 and an extraction time of 2 h;250 m L of the solution was added with 20 m L of 2 % chitosan quaternary ammonium salt solution,and the monosaccharide syrup was prepared by adding 45 g of sucrose to 30 m L of purified water,boiled and dissolved,and cooled to room temperature;the preservative was selected as ethyl hydroxybenzoate with a dosage of 0.02 %,and the final syrup was prepared.Thin layer chromatography was used to identify the oil of Simmondsia chinensis,Angelica dahurica,fried Caulis dahurica and fried Atractylodes macrocephala in the syrup,and high performance liquid chromatography was used to determine the content of Euphorbiae,and the identification and content determination methods were specific and feasible;the syrup was examined in accordance with the relevant provisions under Syrups(0116)of the four general rules of the Pharmacopoeia of the People’s Republic of China,2020 edition,mainly including loading differences,characterization The results of the examination were all in accordance with the regulations.Conclusion: The preparation process of the traditional Chinese medicine compound preparation of pediatric Xin Zhi Tong Qiao Syrup is feasible and the quality can be controlled.