Study On Preparation Technology And Quality Standard Of Keke Oral Liquid

"KEKE oral liquid" is for Guizhou Yi Bai pharmaceutical company has listed products"KEKE capsules" for secondary development of varieties.With cough,shortness of breath,expectorant effect,in the treatment of cough,acute and chronic bronchitis,bronchial asthma,elderly patients with cough and have a significant effect.Suitable for upper respiratory tract infections caused by cough,bronchial asthma,acute and chronic bronchitis,pharyngitis,cough caused by smoking too much,old symptoms such as cough,frequent acute illness,intractable coughing is particularly applicable.Despite its small dose capsule dosage forms,easy to carry,can hide bad smells,and other advantages,but for esophagus narrow,gastrointestinal function is weak,children and the elderly,are inconvenient to take,effect to play slower and other shortcomings.So in effect does not change based on the original prescription is a secondary development,according to the prescription of the medicine in physical and chemical properties and production conditions,study of KEKE oral liquid preparation,based on pilot studies the products with the quality standards.In preparation process aspects,to ephedra in the of hydrochloride ephedra alkali,and poppy shell in the of morphine,licorice in the of licorice acid,index sex components and out cream rate phase combined,used orthogonal experiment method,on prescription in the poppy shell,and ephedra,licorice,and semen raphani child,and Kikyo,and gypsum,and bitter almond of extraction process respectively for has study eventually get optimal extraction process for:poppy shell crushed into rough particles,ephedra cut paragraph,joined 10 times volume of acid water solution(with 10%hydrochloric acid solution of pH value to 3 per cent)immersion 1.5 hours later,decocted twice,boiling at a time 1.5 hours.Hydrolysis of amygdalin in bitter almonds produce prussic acid,relieving cough and asthma effects,amygdalin is easy to be broken down by emulsin in itself,before the boiling steam 30 minutes,the most convenient and practical,and enzyme inactivation effect is better.Traditional of gypsum fried Cook method for first fried,according to information research gypsum first fried does not science,because fried Cook time of length and cannot effect gypsum of dissolved degrees product,fried Cook time had long,gypsum will paste Yu other herbs surface,effect other components dissolved out,so used gypsum with 300 purpose filter cloth package and other herbs collection fried of method.To licorice acid content,and dry cream rate for index study licorice,herbs of best extraction method for:licorice,and Kikyo slice and semen raphani child,and gypsum with added 8 times volume water soaking 1.5 hours,bitter almond steam 30 minutes Hou,and above soaking good of herbs again added water to 10 times volume,fried Cook two times,each 1.5 hours.Alcohol precipitation conditions is investigated,the best conditions for:liquid mix,at 60～70℃ concentrator to relative density of 1.10(60° c measured),cool,add alcohol to alcohol content as 60%,standing 18 hours filter.Filtrate recycling ethanol Hou,joined distilled water,produced large of precipitation,by times filter,proceeds oral liquid still not Cheng Ming,so used water sank method,and study has water sank conditions,results best conditions for:filtrate recycling ethanol,continues to concentrated to relative density for 1.25(60 ℃ measuring)of heavy cream,added water to total of 60%,(4 ℃～8℃)refrigerated 72h,filter.Oral liquid obtained more clarity,long equipped with rock scattered precipitation.For joining materials and content were studied to determine the sugar content for 20%,the amount of preservatives for 0.3%.Oral liquid of pH is an important factor affecting the stability of when pH 4.50~5.50 between,oral liquid is relatively stable.Confirming the " KEKE oral" parameter,the method is convenient,stable and viable.On the basis of these studies,conducted three pilot study,results show,reliable and practical.On the research of quality standard,established in oral liquid of ephedra,poppy,liquorice,TLC and morphine and ephedrine hydrochloride by HPLC method,refer to the Chinese Pharmacopoeia2010 Edition preparation mixture under the General principles provided for the establishment of the "KEKE oral liquid" draft quality standards.To sum up,subject to prepare" KEKE oral liquid",preliminary studies and quality standards.Development becomes liquid,bringing a new drug to the patients choice,provide a scientific basis for promoting long-term clinical,laid the Foundation for further product declarations.