Study On The Preparation Technology And Quality Standard Of Yeju Qingyan Buccal Tablets

Yejuhua Qinyan Buccal Tablets come from the hospital preparations,composed of Chrysanthemi Indici Flos,Scutellariae Radix and Belamcandae Rhizoma,etc.with the effect of clearing heat,resolve toxin and relieving sore throat.The tablets are mainly used for acute pharyngitis and acute tonsillitis induced by heat pathogen,whose symptoms includeburning sensation of pharynx,throat pain,nuclear swelling,difficulty in swallowing or intensified pain while swallowing fever,slightaversion to cold,thirsty,tip and edges of the tongue red,tongue for thin and yellow,pulse floating and rapid.This assignment is to research and develop the preparation used inyears hospital according toTraditional Chinese Medicine,using technology of research and development of modern Chinese Medicine and compliance with the requirements of the national traditional Chinese medicine of 6 kinds of new technology.The research content mainly includes Study on extraction process,Study on preparation process,Study on quality standard and Study on stability of Yejuhua Qinyan Buccal Tablets.The purpose is to establish the production process and quality standards,to provide the process which can be operated and repeated for the production of the product,and to make the quality standards of raw materials,semi-finished products and finished product,in order to control the quality of products comprehensively.1 Literature reviewThe pathogenesis,syndrome differentiation typing,and clinical treatment of acute pharyngitis and acute tonsillitis were reviewed from the point of traditional Chinese medicine and Western medicine;the main chemical components,the main pharmacodynamics research and clinical application of each ingredient in the prescription were reviewed.2 ExperimentsStudy on Preparation TechnologyAccording to medicinal herbs in the prescription contained effective components and pharmacodynamics,and combine the characteristic of Buccal Tablets can directly contact the lesion,quickly release pharyngeal pain and laryngeal nuclear swelling and other symptoms,buccal tablet was selected and used for this product formulations.The ethanol extraction of Chrysanthemi Indici Flos and other medicinal herbs,water extraction and acid precipitation process of scutellaria baicalensis,preparation process,etc.were researched respectively.Design production process based on the above research results.Besides,the designed production process,was processed technology validation and trial production,then the method suitable for the product of industrial production is determined.The specific method is as follows:Crushing radix Scutellariae into coarse powder,decocting with water three times,first adding boiling water for 30 minutes,second and third times for 30 minutes and also,filtrating,putting the filtrate together,using hydrochloric acid to adjust the pH to 2.0,heating preservation in 80℃ for 30 minutes,standing,filtering,precipitating with water to neutral,low temperature drying,crushing into fine powder,spare.Extracting the herbs such as Chrysanthemi Indici Flos for two times with 70%ethanol,1.5 hours each time,filtrating,recycling ethanol from the filtrate,concentrating to thick cream that relative density of 1.25-1.30(60℃).Crushing appropriate amount of sucrose into fine powder,mixing with baikal skullcap root dry extract powder,adding paste extracted from Chrysanthemi Indici Flos and other medicinal herbs,granulating,drying.Spray with menthol ethanol liquid,add appropriate amount of stevioside,magnesium stearate and citric acid,mix,tablet and coat.2)Study on quality standardAccording to the prescription,preparation method and functions of Yejuhua Qinyan Buccal Tablets,the quality standard was studied and the TLC identification of Chrysanthemi Indici Flos,Scutellariae Radix,Belamcandae Rhizoma and scrophulariae Radix was formulated.TLC identification of Physalis Calyx Seu Fructus was studied,but not included in the standard text because of the specific problems,In the study on Determination of content,HPLC method were taken to determinate the content of baicalin and Buddleoside in the product,and the method for content determination was established.The method of microbial limit test for this product was established:the membrane filtration method and medium dilution method.3)Study on stabilityYejuhua Qinyan Buccal Tablets were packed with the blister(batch 0804011,0804021,0804031)and high density polyethylene bottles(batch 0804012,0804022,0804032),placed at 40±2℃,RH75%±5%conditions,studied for 6 months,and examinated according to the drug quality standard draft and microorganisms limit standard.The six batches of samples showed no significant differences in the character,identification,weight variation,content determination,microbial limit etc.The six batches of samples were placed at 25 ±2℃,RH60%±5%conditions,studied for 24 months,and examinated according to the drug quality standard draft and microorganisms limit standard.The six batches of samples showed no significant differences in the character,identification,weight variation,content determination,microbial limit etc.The results showed that the preparation process is stable and the quality can be controlled.Validity can be determined as 24 months,storage conditions is sealed.