Research On The Preparation And Quality Method Of Medicinal Xanthan Gum

Xanthan gum was approved by FDA in 1985,indacting it's no harmful for human and no irritation to skin and mucous membrane.Xanthan gum has advantages in anticular injection and oral drug releasing.However,the relatively late work of research and application limits its application,and problem of the quality control may increasing the difficulity.1.Extracting conditions were optimized on the basis of the predecessors? study of the Xanthan gum in food grade.Three main methods: ethanol,Sodium hydroxide ethanol,ethanol calcium chloride.Considering quality,cost and dispose of fishing.We make the ethanol calcium chooride as the final extracting conditions,by testing the effect of dosage on the yield of product in different proportions of ethanol and calcium chloride,we determine the pilot production process: the dissolved concentration of Xanthan gum was selected as 3%,the amount of calcium chloride was 5.3 times the weight of Xanthan gum,the volume of ethanol was 2.5 times the purified water.We expanded the scale of production on the basis of the pilot production process,in three batches,by analysis and detection,which all meet the standard requirements of pharmacopoeia 2015.2.We carry out quality research to the Xanthan gum,the accuracy and precision of key indicationgs,the study on the applicability of microbial method,verifying that the test is accurate and effective.3.In order to make sure the production meet the market,we carried out stability study to the three batches,including stress testing,accelerated testing and long-term testing.Stress testing method: the product is placed 10 days under the following conditions separately,high temperature(40? and 60?),high humidity(25?,RH92%;25?,RH75%)and strong light irradiation conditions(4500Lx).We tested in 5days and 10 days,by analysis the critical items,the productions have no significant change in mass,which showed that the quality is stable.Accelerated testing method: the product is placed under the following conditions,high temperature(40?),humidity(75%),We tested in 1 month,2 months 3 months and 6 months,by analysis the critical items,the productions have no significant change in mass besides the viscosity,which showed that the quality is stable.Long-term testing method: the product is placed under the following conditions,temperature(25?),humidity(60%),We tested in 3 months,6 months,9 months,12 months,18 months and 24 months,by analysis the critical items,the productions have no significant change in mass besides the viscosity,which showed that the quality is stable.