Study On Preparation Technology And Quality Standard Of Hydrogel Patch Of Compound Evodia Officinalis

Hydrogel patch of compound evodia officinalis is a hydrogel patch of compound Chinese medicine taking compound evodia officinalis,a clinical experience prescription,as the basic prescription and combining the modern pharmaceutical preparation method to extract the main active ingredients in the compound evodia officinalis and store it in the hydrogel matrix.The prescription is derived from the compound treatment of diarrhea in a city hospital of traditional Chinese medicine—the compound evodia officinalis,which combines five kinds of traditional Chinese medicine including evodia officinalis,syzygium aromaticum,folium artemisiae argyi,zanthoxylum bungeanum maxim and rhizoma zingiberis.The current clinical method only makes the drug pulverized and then applied the umbilical treatment.Hydrogel patch of compound evodia officinalis is a new type of preparation having done the dosage form design based on the clinical original formulation.It has abandoned the primitive and simple pharmaceutical method and having combined with the characteristics and requirements of clinical application to prepare a modern hydrogel patch with convenient use,stable dosage form and controllable quality.This study takes the extraction rate of volatile oil from compound evodia officinalis as the index of evaluation.The orthogonal experiment was carried out on the basis of single factor investigation on the addition ratio of water,soaking time and extraction time of the compound drugs to determine the best compound volatile oil extraction process.The total flavonoid content in compound extracts was used as an index to investigate the effects of different ethanol concentrations on the extraction of total flavonoid in order to optimize the best alcohol-precipitation concentration.The orthogonal experiment was carried out on the basis of single factor investigation on solid-liquid ratio,extraction time and ethanol concentration;the index of evaluation is the content of evodiamine and rutaecarpine.Taking adhesion properties,moisturizing properties and matrix cohesive properties of hydrogel patches as index of evaluation,the response surface test was carried out on the basis of single factor investigation on three factors of water content,moisturizer content and the extract content of compound Chinese medicine of compound evodia officinalis hydrogel patch matrix to screen out the best preparation molding process.In order to ensure the safety and effectiveness of the preparation,detailed quality standards were formulated for hydrogel patch of compound evodia officinalis during the experiment.In the test,evodia officinalis,syzygium aromaticum,folium artemisiae argyi,zanthoxylum bungeanum maxim and rhizoma zingiberis in the compound hydrogel patch were respectively performed a thin layer chromatography(TLC)for qualitative identification;the volatile oil of the compound drug is added to the hydrogel patch,thus the volatile components are identified and analyzed by gas chromatography-mass spectrometry(GC-MS);the contents of the main components of rutaecarpine and eugenol in the preparation were determined by reverse-phase high-performance liquid chromatography(RP-HPLC).In order to control the stability of hydrogel patch of compound evodia officinalis,the preliminary stability of the hydrogel patch was investigated,including high temperature test,high humidity test,strong light exposure test,accelerated test and long-term test.The test results show that in the process of stability test,the various indexes and the content of main active ingredients of hydrogel patch of compound evodia officinalis are in compliance with the regulations.Based on the above tests,this study preliminarily prepared a quality standard book for hydrogel patch of compound evodia officinalis,which laid the foundation for its product development and industrial production.