Study On Preparation Process And Quality Standards Of The L-Malic Acid Multiple Electrolytes Injection

L-Malic Acid Multiple Electrolytes Injection was developed base on the products of German Fresenius company-Malic Acid Electrolyte Injection which is used to adjust metabolic disturbance of water and electrolyte in body fluid and is also useful for isotonic dehydration,Especially applicable caused by vomiting,intestinal digestive fluid losing caused by acute,abdomino infection,intestinal obstruction,burns and other fluid loss.Because L-malic acid as the main product of Three Carboxylic Acid?TCA?Cycle and Glyoxylate Cycle,so it has special physiological functions to change the traditional infusion products with low added value and status of malignant price competition.This study focuses on the amount of active carbon?W/V?,the action time of activated carbon,liquid pH,sterilization temperature and time of sterilization.Through single factor experiment and orthogonal experiment design,the affection of factors and the optimum process parameters?the amount of active carbon is 0.06%,the action time is 15min,the optimum pH is 6.5,121?sterilization for 15mins?were determined.With this process,the sample was prepared and the quanlity standards was studied,the result showed that,the process is reasonably praticable.According to the"Chinese Pharmacopoeia"?2010?,the character,identification of L-malic acid multiple electrolytes injection,pH,bacterial endotoxin,sterile,visible foreign matter,insoluble particles,volume,osmolality and related substances,concent of metal ions?Na,K,Ca,Mg?,chloride ion,sodium acetate,and L-malic acid were determined,initially determined the quality standard of L-Malic Acid Multiple Electrolytes Injection.In the process of quality standard researching about L-Malic Acid Multiple Electrolytes Injection,determination of the content of L-malic acid and sodium acetate is studied.Aprecise and accurate method for determination of L-malic acid and sodium acetate at the same time by HPLC was establishedt?the chromatographic column is Hypersic SCX,4.6×150mm,5?m;mobile phase is KH₂PO₄?0.025mol\/L?-acetonitrile?95:5,pH2.5?;flow rate is 0.8mL\/min,column temperature is 30?;sample size is 25?L.?According to requirement of injection in second part of"Chinese Pharmacopoeia"?2010?,the results meet the the relevant requirements of injection in 2010 version of"Chinese Pharmacopoeia"and L-Malic Acid Multiple Electrolytes Injection quality standard.