Study On The Process And Quality Of Pediatric Suhuang Cough Syrup

Pediatric Suhuang Cough Syrup is made from Herba Ephedrae,Radix Scutellariae,Pericarpium Citri Reticulatae,Fritillaria thunbergii,Perilla frutescens and other medicinal materials.According to the improvement of’Maxingshigan Decoction’in the classic masterpiece Treatise on Febrile Diseases,the single-branch syrup is prepared by studying the extraction,concentration,refining and molding process,which is in line with people’s pursuit of convenient modern life concept.The research content of this topic is mainly divided into four parts.The first part mainly summarizes the literature,and provides sufficient theoretical basis for this study through the basic analysis of the prescription of Pediatric Suhuang Cough Syrup.In the second part,the volatile oil from the single herb Pericarpium Citri Reticulatae in the prescription was extracted to prepare tangerine peel oil microemulsion,which expanded the application of insoluble tangerine peel oil and laid the foundation for the combination of tangerine peel oil microemulsion and Pediatric Suhuang Cough Syrup.In the third part,the extraction,concentration,purification and molding of pediatric Suhuang cough syrup were studied.The fourth part studies the quality control of Pediatric Suhuang Cough Syrup,mainly including qualitative identification and content determination.The specific research contents are as follows1.Extraction of volatile oil from single herb Pericarpium Citri Reticulatae in pediatric Suhuang Zhike Syrup prescription and preparation of tangerine peel oil microemulsionTo study the extraction process of volatile oil from Pericarpium Citri Reticulatae in Pediatric Suhuang Cough Syrup.The three factors determined by single factor experiment in this chapter are solid-liquid ratio,soaking time and extraction time.The method of steam distillation is used to extract tangerine peel oil,and the extraction efficiency is used as the evaluation index.The orthogonal experiment design L₉（3⁴）is used to carry out the experiment.According to the evaluation indexes,the optimal extraction process of tangerine peel oil was determined as 1:10g/m L,soaking time was 1 h,and extraction time was 6 h.The preparation of tangerine peel oil microemulsion was further studied.The self-emulsifying method was used to prepare the microemulsion of tangerine peel oil.The above extracted tangerine peel oil was used as the oil phase,and the purified water was used as the water phase.The area size of the microemulsion was used as the evaluation index.According to the pseudo-ternary phase diagram,the appropriate emulsifier,co-emulsifier and Km values were obtained.Firstly,the particle size and PDI were used as the comprehensive evaluation indexes,and then the prescription of tangerine peel oil microemulsion was optimized by the central composite design-response surface method to obtain the optimal prescription.According to the comprehensive evaluation index,the best prescription composition is emulsifier 26.10%,co-emulsifier 26.10%,oil phase 47.80%,water phase 47.80%.Limonene,as one of the main chemical components of tangerine peel oil,has the effect of stimulating phlegm.In this chapter,tangerine peel oil was prepared into microemulsion,which expanded the application of insoluble tangerine peel oil to expectorant and enhanced the effect of pediatric Suhuang Zhike Syrup on cough and expectorant.2.Study on the preparation technology of Pediatric Suhuang Cough SyrupIn order to establish the preparation process of pediatric Suhuang cough syrup.Taking the transfer rate of ephedrine and baicalin and the extraction rate as the comprehensive evaluation indexes,the three factors determined by single factor experiment in this chapter were solid-liquid ratio,extraction times and extraction time.The orthogonal experiment L₉（3⁴）was used to design the experiment.According to the comprehensive score,the optimal extraction process was obtained as follows:solid-liquid ratio 1:10 g/m L,2 h each time,and extracted twice.Taking the transfer rate and extraction rate of ephedrine and baicalin as comprehensive evaluation indexes,the volume of the extract was concentrated by gradient concentration by decompression concentration.According to the comprehensive score,the optimal concentration volume was 600m L（relative density was 1.10～1.20）.Taking the transfer rate of ephedrine and baicalin and the extract rate as comprehensive evaluation indexes,several common clarification methods in clarification process were preliminarily screened,and the purification effect of flocculant ZTC1+1 was determined to be the best.Then,with the concentration ratio,temperature and ZTC 1+1clarifying agent dosage as the main influencing factors,the orthogonal experiment design L₉（3⁴）was used to carry out the experiment.According to the comprehensive score,the optimal clarification process was optimized as follows:when the temperature was 80°C,in the concentrated solution with the concentration ratio of 1:3,the B component of 1%ZTC 1+1clarifying agent was added,and the dosage was 4 m L/100 m L.After 2 h,0.1%A component was added,and the dosage was 20 m L/100 m L.The molding process was based on the appearance of the solution,microbial limit test and taste,and the types and dosages of preservatives,sweeteners and flavors were investigated.The optimal molding process was determined as follows:under the conditions of 37±2°C and 500 r/min of magnetic stirring in water bath,45%sucrose,0.3%sodium benzoate and 0.05%strawberry flavor were added to the concentrated solution in turn.Finally,the microemulsion of tangerine peel oil was slowly added,stirred well,added with purified water to 1000 m L,and subpackaged into 10 m L/branch.3.Study on the quality of Pediatric Suhuang Cough SyrupIn order to further determine the quality of this product,the safety and effectiveness of syrup were investigated.Pediatric Suhuang Cough Syrup is a multi-component compound preparation of traditional Chinese medicine with complex active ingredients,so its quality control was studied.According to the requirements of syrup in the fourth part of’Chinese Pharmacopoeia’2020 edition,the p H value,relative density and microbial limit of syrup were examined.The qualitative identification of Fritillaria thunbergii and Perilla frutescens leaves in Pediatric Suhuang Cough Syrup was established by thin layer chromatography.The multi-component qualitative identification of ephedra,Scutellaria baicalensis,pericarpium citri reticulatae,fried apricot kernel and forehead was carried out by HPLC.HPLC method was used to determine the contents of ephedrine and baicalin in Pediatric Suhuang Cough Syrup and the content limits were determined.The average content of ephedrine in Syrup should not be less than 0.2779 mg/m L and the average content of baicalin should not be less than 4.5873 mg/m L.The methodological verification showed that within a certain range,ephedrine and baicalin had a good linear relationship（r²>0.9991）.The RSD of precision,repeatability and stability tests was less than 2.8%,and the average recovery test of the test samples was between 95%and 98%,which was in line with the provisions of the Chinese Pharmacopoeia 2020 edition.The method was reasonable,reliable,high accuracy and good repeatability,which could effectively control the quality of Pediatric Suhuang Cough Syrup.This paper has 26 figures,40 tables and 135 references.