Study On Prepration Process And Quality Studards Of Wind Hot Cold Granules

The wind hot cold granules is a kind of traditional Chinese medicine compound preparations,the preparations that come from radix isatidis,fructus forsythiae,mint,herba schizonepetae,mulberry leaf,phragmites communis,fructus arctii,chrysanthemum,bitter almond,ramulus mori and medicated leaven of 11 herbs have the effect of evacuation nourish,spasmolysis and rash,are often used to headache and sore throat discomfort,blocked nose runny nose,etc.Guided by the theory of traditional Chinese medicine,This study improved the extraction process of granules and purification.And the forming process of granules standard were analyzed in this study,and the study investigated the quality standard and the stability of wind hot cold granules.Extraction technique research of the wind hot cold granules:in the fact of extraction process,fructus forsythiae glycosides and burdock glycosides content and extract rate is a comprehensive index,and through the orthogonal experiment method to investigate extraction effect with the water addition,decoction time,number of times of decoction in this study.The forming technique research of granules:through the extract concentration method,drying method for further investigation,the wind hot cold granules forming conditions were determined,and the moisture absorption characteristics was investigated in this study.The quality standards research of granules:according to the pharmacopoeia standards,the study used thin layer chromatography(TLC)to identify the products of fructus forsythiae,fructus arctii,chrysanthemum,radix isatidis.In addation,the HPLC method is adopted to the wind hot cold content determination indexes of grain composition of forsythia nucleoside.Preliminary stability research:in accordance with the requirements for new drug research and development,we have searched the wind hot cold granules in preliminary stability test,accelerated stability test,respectively,on a regular basis at 0,1,2,3 months of preparation for appearance,TLC identification,examination and content determination of detection.The result shows that the water extract of optimum process is for 12 times water,extracting 2 times,each time 0.5 h;Enrichment condition is for temperature 75℃,the relative negative pressure-0.06～0.09 Mpa.Dry method is for vacuum drying(75℃temperature,vacuum degree to 0.09 MPa),and these are the best accessories for sodium carboxymethyl starch granules.In the study of preparation quality standards,we set up and check out the forsythia,fructus arctii,chrysanthemum,radix isatidis thin layer identification,the identification result shows that the spots were clear,and have good repeatability,negative control without interference.Forsythia glycosides content determination result shows that:fructus forsythiae glycosides in sample quantity 0.216～1.080(including g range inside sex is good,the standard curves of linear regression equation for y=27532+584.565 x,r=0.9995,the sample solution is stable within 24 h,RSD=0.67%,repeatability RSD=0.63%,recovery rate 98.47%,RSD=0.75%;Arctiin content determination result shows that:Arctiin in sample quantity0.002-0.01mg/ml including range inside sex is good,the standard curves of linear regression equation for Y=10966325.0000X+30901.9500,r=0.9997,the sample solution is stable within 24 h,RSD=1.75%,repeatability RSD=1.53%,recovery rate 98.67%,RSD=1.89%,conform to the requirements.According to the Chinese pharmacopoeia granules under the relevant inspection requirements,both within the rules.Preliminary stability test and accelerated stability test results show that the particles are in a simulated city medicine packing condition,and the preliminary stability is good.