| Amoxicillin Clavulanate Potassium Film Coating Tablet(AUGMENTIN)is a combination of broad-spectrum antibiotics(Amoxicillin)and enzyme inhibitors(Clavulanate Potassium),and is widely used in the treatment of various sensitive bacteria,such as respiratory tract infections,urinary tract infections and soft tissue infections.The patent expired on December 31,2002,and there are many generic drugs on the market.However,with the requirement of national consistency evaluation,it is of great market space and policy significance to evaluate the consistency of the drug.Based on the physical and chemical properties of the original reference preparation and the related methods of the Chinese Pharmacopoeia,the quality attributes of the amoxicillin clavulanate film coating tablets were studied,including the average slice weight,hardness,disintegration time and four dissolution curves in vitro,and the prescription composition was dissected using the reverse engineering,i.e.the content of amoxicillin trihydrate,potassium clavulanate-microcrystalline cellulose(1:1),silica gel,sodium carboxymethyl starch and magnesium stearate were 70.2%,20.8%,1.1%,3.4% and 1.3%,respectively.Based on the preliminary analysis of the original prescription composition,pre-experiment and optimization of prescription screening,the prescription composition was optimized,i.e.,the amount of magnesium stearate was 22 mg,the amount of silicon dioxide was 10 mg,the amount of sodium carboxymethyl starch was 56 mg,and the ratio of internal and external was 1:1.The products produced under stable process parameters had good quality uniformity and reproducibility.Finally,the dissolution consistency of the self-made tablets and reference preparations in vitro was investigated.The formulation of the self-made tablets is reasonable with good stability,the dissolution in vitro is consistent with the reference,which lays the foundation for further bioequivalence test and generic drug declaration. |
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