The Study Of Xiaoer Wenre Oral Liquid

Xiaoer Wenre Oral Liquid is based on the ancient side of the mulberry drink,combined with modern clinical medication and composed of mulberry leaf,chrysanthemum,forsythia,Herba houttuyniae,bitter almond,platycodon root,mint,radix scutellariae,radix isatidis,reed rhizome,licorice gypsum,12 traditional Chinese medicine.With the Qingwen detoxification,ease of wind and heat,xuanfei cough effect,for the treatment of influenza,fengreganmao,heat poisoning lungs,zheng Jian fever or high fever,cough,headache,dry throat,sore throat and other symptoms.The long-term clinical practice,the clinical effect is significant,but the traditional decoction taste is poor,is not conducive to preservation and carrying,and taking large amounts,is not easy to taking for children.To ensure the essence of traditional Chinese medicine prescription,follow the characteristics of clinical medication,the subject from the child’s position,to oral liquid for the development of formulations,from the preparation process and quality standards research.In the extraction process research,through analgesic,anti-inflammatory,antipyretic pharmacological experiments,the optimal process route was selected.The extraction process of volatile oil was optimized by single factor experiment.The results showed that the content of forsythoside A and baicalin were the same as the comprehensive evaluation index,and the binomial fitting was used to establish the index and factor.The optimum extraction process was as follows: Houttuynia cordata,mint,chrysanthemum,Forsythia were added 10 times water,steam distillation for 6hours,collecting volatile oil,After the distillation of the aqueous solution of another collection;dregs and mulberry leaves and other 8 herbs(bitter almonds,scutellaria adding after water boiling)plus 10 times water,boiling 2 times,each 80 min.In the perparation of the molding process,through analgesic,anti-inflammatory,antipyretic pharmacological experiments,the optimum purification methods were selected.with the content of forsythoside A and baicalin as the evaluatingindicator,the purification process parameters were optimized by single factor test,the proportion of polysorbate 80 and the amount of potassium sorbate were studied,the corrigent and dosage are selected through the number of childrend acceptance about oral liqiud mouth feel.The final preparation process was as follows: the extract is concentrated to the relative density of 1.05-1.08(80℃),adding ethanol to make the alcohol content reached 50%,refrigerated standing for 8h,filtering,supernatating,vacuum recovery ethanol to no alcohol,adding 0.3% aspartame,0.08% citric acid,0.1% potassium sorbate,heating to dissolve,adding volatile oil and1%polysorbate 80,static,filtration,adding water to 1000 ml,stir well,filling,120℃sterilized for 15 minutes.Through the three batches of pilot scale experiment and clarify the traits of three batches of samples,the experimental results show that the preparation process is stable and reproducible,and it is suitable for mass production.On the quality standard study,we founded TLC identified methods of mulberry leaves,forsythia,bitter almond,campanulaceae,radix,licorice,six herbs,the spots were clear and good separation;according to "China Pharmacopoeia " 2015 four edition 0181 general rule,the oral liquid pH value,relative density,microbial limits were checked;In addition,we systematically studied the effective components of baicalin and forsythoside A,and determined the content.The experiment is based on the pharmacodynamics experiments,combined with multiple indicators of ingredients to determine the preparation of Xiaoer Wenre oral liquid,and establish the stable and controllable quality standards to ensure the safety and efficacy of clinical medication.