Research On The Quality And Process Of Amoxicillin Capsule Based On Consistency Evaluation

The article describes the history and produce of penicillin and amoxicillin.The character of amoxicillin and the situation that manufacturer of amoxicillin capsule with the market share.Sales in recent years,the market share of penicillin(6-APA intermediates),The article Provides an overview of Consistency evaluation of generic drugs.There are some drugs that are placebo as China is Generic drugs giants,and the level of generic is low.So it is necessary to carry out the generics quality consistency evaluation work.We choose amoxicillin as the first variety of quality consistency evaluation work for the prepare of future varieties.To prepare for re?registration of amoxicillin capsule in the future.we will investigate the content and the dissolution curve of amoxicillin capsule,and first of all,we should investigation on dissolution performance tester.We use prednisone tablets to verify the dissolution tester.Determination of 6 manufacturers of content and related substances.Draw the dissolution curve of amoxicillin capsules in four different media.Value the similarity comparison of dissolution curve with f2.The results show that the quality of six manufacturers amoxicillin capsule are accorded with the standard of Pharmacopoeia,and the dissolution cruves are similar.But the amoxicillin of our manufacturers have difference compared with the reference.Show that there is difference between individual manufactoers.Our manufacturers of amoxicillin capsules of poor quality and may have eliminated after the review.To optimize the process and prescription of amoxicillin capsule and investigate the disintegrating agent,solvent and drying temperature of one by one.The result shows that disintegrating agent in the dissolution rate of maximum 2—4%.Select the drying temperature below 60oC,and the twain 80 below 0.18ml.Orthogonal test shows that the best process is the disintegrant amount is 2%(1.18 g),the drying temperature is 40?,twain 80 is 0.18ml.The dissolution of amoxicillin capsule have been greatly improved,a marked increase in dissolution,thereby improving the bioavailability.In this paper,the new formulation of amoxicillin capsule on the 3 batch of production process of confirmatory test and stability test.The results show that the quality of preparation and stability in full compliance with the requirements of Pharmacopoeia.The dissolution curve is similar with reference preparation.It shows that the quality of amoxicillin capsules is better after the prescription.The dissolution is higher and more close to the reference preparation.Laid the foundation for re-registration of production.