Study On The Preparation Technology And Quality Standard Of Fuyinshu Spray

Fuyinshu is a spray of feminine care for gynecological bacterial vaginitis with abnormal vaginal discharge,genital itching symptoms such as pain.It consists of six herbs for honeysuckle,licorice,angelica,Herba Violae,Fructus Kochiae and perilla leaf.The prescription is derived from the clinical experience and has definite curative effect.The original dosage form is a traditional external lotion,this subject is based on Chinese medicine theory and on the basis of the principle of compatibility of prescription of the monarch.Extract the active ingredients of traditional Chinese medicine prescription and use modern preparation technology.The prescription extract is prepared to be suitable for clinical use.This subject adopts the orthogonal design experiment.The active constituents of the prescription were extracted by water extraction and ethanol precipitation.Respectively,chlorogenic acid and Aesculetin as index component of comprehensive score,experimental factors and levels influence the extraction rate.Therefore,the optimum extraction process was optimized,namely:taking prescription medicine,add 8 times the amount of water under the temperature of 70?,heating reflux extraction 2 times,each time 2h,filtering,merging filtrate,the filtrate vacuumconcentrated to the relative density of 1.020,adding alcohol,the alcohol content reached 80%,the static 12 h.The supernatant was filtered,ethanol recovery to a certain concentration,transferred to bath evaporation to no alcohol taste,low temperature drying 5h prepared extract.In the optimum extraction process of the prescription,verified the test.The test results show that the extraction process of prescription has the advantages of simple operation,stable and suitable for industrial production.In the study of the formulation and preparation process,the formulation was determined to be a solution spray.The solvent,latent solvent,antiseptic and dosage were investigated in further.The prescription consists of extracts 1%,80% ethanol,solvents 15%,1% Tween-80,1,2-propylene glycol 5%,benzoic acid 0.2%,and the rest are distilled water.The preparation process of the spray is in 40? water,the amount of extract added to 80% ethanol,stirring,adding benzoic acid,mixed evenly,then add Tween-80 and 1,2-propylene glycol,stirring,filtration,the filtrate is added with distilled water to the full amount,shake,i.e.In order to ensure the quality of Fuyinshu spray,the TLC were identified of honeysuckle,Herba Violae,Angelica.The experimental results showed that the method was simple,rapid and reproducible.The research on the content of effective components in Fuyinshu spray determination method by high performance liquid chromatography method for the determination of the content of chlorogenic acid in Fuyinshu spray,Aesculetin,ferulic acid and various indicators of luteolin composition.The experimental results show that the method has high accuracy and good reproducibility.The stability test is one of the important contents of the quality control of the solution,so the preliminary stability test was carried out.The appearance,properties and content of the Fu Yin Shu aerosol were investigated regularly under the irradiation of high temperature,strong light and accelerated stability test.The stability test results showed that the indexes were basically stable and accord with the quality standard.The subject of the Fuyinshu spray extraction,preparation technology and quality standard were studied.The draft quality standard of Fu Yin Shu spray was preliminarily developed,which laid the foundation for the product development and industrial production.