Study On The Improvement Of The Quality Standard Of XiaoerGuangpu Zhixie Oral Liquid And The Forming Technology Of Volatile Oil Plasmid

Objective:1.Research of improving the standard of Xiaoer Guangpu Zhixie oral liquid to promote the quality and to get further confirmation of the safety and effectiveness of Chinese patent medicine.2.The volatile oil in Xiaoer Guangpu Zhixie oral liquid made into volatile oil body,which provided a feasible method for expanding the application of volatile oil.Method:1.Identify Atractylodes Macrocephala,Magnolia Officinalis and Pogostemon cablin in Xiaoer Guangpu Zhixie oral liquid by TLC combined with one test and multiple evaluations.2.Atractylodin,magnolol,honokiol and hesperidin as index,employ HPLC to establish assay method and formulate the limit of four components.3.Scan full wavelength to choose the best absorption wavelength,and test 22 samples by HPLC to establish the fingerprint of Xiaoer Guangpu Zhixie oral liquid.By comparing with reference substance,identify the attribution and composition of the characteristic peak as well as determine the position of the characteristic peak with the relative retention time as the parameter.Utilize the similarity evaluation system of the traditional Chinese medicine fingerprint for analysis.4.The method of ethanol injection was used to prepare volatile liposomes.The liposomes and free drugs were separated by ultra-high-speed centrifugation.The method of determination of entrapment efficiency was established with Atractylodin as the index component.Use single factor investigation to optimize the preparation conditions of volatile liposomes and evaluate the stability of liposomes.Result:1.Establish a thin layer chromatography multi-evaluation identification method for Atractylodes,patchouli,and magnolia,petroleum ether((60-90°C)-ethyl acetate-formic acid(85:15:2)as a developing agent.Unfold the same piece of silica gel G,and the spotting amount is 5 μL with the 5% vanillin sulfuric acid test solution as the developer.Heated at105 ° C until the spots were clear.2.Establish a method for the determination of atractylol,magnolol,honokiol and hesperidin.The content of atractylodesin,honokiol,honokiol and hesperidin in Xiaoer Guangpu Zhixie oral liquid of children is stipulated to be not less than 0.48 mg,1.67 mg,0.64 mg,2.74 mg per branch.3.Established 22 batches of Xiaoer Guangpu Zhixie oral liquid fingerprints.There are 16 common peaks,and the chemical components of 7 peaks are confirmed,which are caffeic acid,hesperidin,chuanchenpi,tangerine,honokiol,honokiol,atractylodin.The similarity software calculation results show that the similarity of 22 batches of samples is greater than0.9,which shows that the process is stable and the quality is consistent4.The best technology for the preparation of volatile oil plastid by ethanol injection is soybean phospholipid: cholesterol = 1:6:1.5,and hydration temperature is 55℃.According to the best technology,preparing three samples,the average encapsulation rate is 45.3%,and the average particle size is 704.6nm,in line with the specification.Conclusion:From the quantitative and qualitative perspectives,the subject has established an evaluation method higher than the original standard from three aspects of thin-layer chromatography identification,content determination,and fingerprint spectroscopy,which provides a sufficient scientific basis for rationally controlling the quality of preparations.The new formulation of volatile oil liposomes shows excellent stability,but the encapsulation rate still needs to be further improved.This method proposes new ideas and methods for solving the problems of volatile oil stability and irritating odour in traditional Chinese medicine preparations with research value.