Glucose Production Process At High PH Anhydrous

In the "Chinese Pharmacopoeia"2010edition of the second part, the glucose injectionstandards specified in the pH value of3.2to5.5, the range is wide, Its lower limit greater impact onthe stability of commonly used antibiotics and other drugs and the body’s acid-base balance. Withanhydrous glucose production technology is mature, stable quality, a lot of glucose injectionmanufacturers not be concentrated with filtration, shorten the production process, while significantlyreducing their production costs. Glucose injection is now used primarily to original drug anhydrousglucose dissolved in sterile water for injection that was filtered. In particular, the production ofhypertonic injection manufacturers, anhydrous glucose in pH raised new demands to the APIanhydrous glucose pH above5.2. Through the relevant literature on the impact of the drug in theclinical treatment of glucose injection to analyze the pH, pH, glucose affects the stability of theinjection. From the study of the production process is now starting anhydrous glucose, anhydrousglucose raise the pH to meet current market demand. Therefore, this article by theoretical argumentsand experimental results, the pH of the success of the API anhydrous glucose increased to5.5, toensure the quality of clinical drug compatibility. Experimental results:First,Preparing a high purity liquid saccharificationLiquefaction is the key process of starch into glucose, good or bad quality of the process,directly affects the separation and purification processes. In order to obtain higher puritysaccharification liquid, choose low starch concentration, the second jet liquefaction technology. Byamylase, glucoamylase nature study showed lower glycosylated substrate concentration, the morecomplete saccharification. The experiments indicate that, when the concentration of the starch milk15-16degrees Baume, amylase beneficial effect, while controlling the amount of amylase enzyme toobtain a liquefied solution of a low DE value, while ensuring starch the extent of liquefaction,liquefied DE value of the minimum test proceeds to go to10%.For best results liquefaction, the procedure provides for the optimum production conditions.American companies using hydrothermal injector using the second jet liquefaction technology,making the starch milk in an instant broken link, chain scission and uniform cutting opportunitiesa-1-4glycosidic bond in amylase. Under this condition, the resultant liquefied solution after thecompletion of saccharification, producing disaccharides, trisaccharides, and at least three or morepolymers of sugar, glucose content of up to98.7%, higher than the average1.5percent liquefaction.Second, low temperature, high vacuum boiling sugarTo effectively control the5-(hydroxymethyl) furfural generated in boiling sugar crystallizationprocess, we used to run under50mbar vacuum conditions so that the boiling sugar at around60degrees Celsius, effectively reducing the glucose solution boiling temperature, lower glucoseaggregation and degradation rate. Slowly to control the degree of supersaturation and the sugar, thecrystal nuclei grow slowly under mild conditions to ensure the purity of the crystal.Third, determine the critical high pH environmentIn the refining process of glucose solution, particularly in the ion exchange step, based on theremoval of the impurity ions, the pH of the resulting solution was controlled at about4.5, the sugar isno longer adjusted by adding sodium carbonate, sodium hydroxide and other alkaline substances the pH value of the solution, the pH of the sugar solution to avoid the decomposition and polymerizationof the moment caused by high glucose, furfural generated avoid environmental conditions.Fourth, choose the best time to cook sugar plus seed crystalThe process of boiling sugar, add the seed crystal of the factors affecting the final product wasanalyzed, in order to set the orthogonal test program, and ultimately determine the glucose DX morethan99.5%, pH4.6, to control the temperature of boiling sugar at64℃when boiling sugar and stirultimate power control at the time of9.0kw, the pH of the resulting anhydrous glucose highest to meetcustomer needs, and improve the stability of the product.Fifth. Optimization of seed crystal selectionDirectly affect the quality of the product nuclei of crystal properties and purity of the obtainednuclei and the size will affect the formation of crystals in the process of boiling sugar. For this to addthe amount of seed, the number of milliliters of alcohol solution, grinding time factor, design testprogram to determine the parameters of nuclei, nuclei further optimize the production process.