| Objective: Taishengsubai prescription from is a clinical experience prescription,it can relieve cough,eliminating phlegm and smooth wheezing,so it is used for treat chronic cough,bronchitis,asthma,COPD,pulmonary fibrosis and other respiratory system diseases widely.In this research,we try to develop it into granules that can be taking portable.According to the technical requirements for six classes new Chinese herbal,in view of the effective constituents in the prescription of physical,chemical properties and pharmacological effects,we studied on preparation process,quality standard,acute toxicity and pharmacodynamics of " Taishengsubai particles ".Methods: Optimize the extraction process by orthogonal test,paste rate and chlorogenic acid content as an index for optimizing.About molding process,inspect the dosage of the adjuvant materials,the concentration of the wetting agent,determine the optimal process route and process conditions.Useing TLC method to identifiy the qualitatiy of the main medicine of the prescription.Using high performance liquid chromatography(HPLC)method to content determination of chlorogenic acid in flos lonicerae,set up product quality standard.Observe preliminary stability of the particles at room temperature.Observe the safety of the drug by acute toxicity test,and preliminary pharmacodynamics by reduce cough frequency which lead by the ammonia and increase excretion amount of phenol red in sputum.Results: The preparation technology research,finally determine the process parameters for the extraction of circumfluence 3 times,each time 1 hour,the amount of solvent for 8 times,enrichment process main consideration concentrated temperature influence on liquid composition,concentrated temperature is 100 ℃.Dosage of auxiliary materials are 1 times for dry paste powder,wetting agent of 80% ethanol.Quality criteria established TLC identification method of honeysuckle,Fritillaria thun-bergli,Scutellaria baicalensis,ephedra,liquorice.Systematically established HPLC determination method of chlorogenic acid inTaishengsubai particles.According to the results of the experiment of three groups of samples,set up the quality standards for “Taishengsubai particles” are as follows: contain chlorogenic acid is not less than 15 mg,baicalin is not less than 30 mg.Preliminary stability test results showed that the preparation quality is stable under the condition of room temperature.Pharmacodynamics test showed that this preparation has good cough expectorant effect. |
