Preparation Of Compound Amoxicillin For Dry Suspension And Its Determination Of Stability

Amoxicillin-clavulanate compound preparation can inhibit the activity ofbeta-lactamase in order to bring amoxicillin’s broad-spectrum antibacterial action intofull play and have synergistic effects to each other. Clavulanate can help amoxicillinto broaden antibacterial spectrum and enhance its antibacterial activity. As acommonly used antibiotics in clinic, amoxicillin-clavulanate compound preparationhas been applied to inhibit drug-resistance bacteria and sensitive bacteriain withadvantages of less adverse reactions, low toxicity and dosage. It has a variety offormulations, such as capsules, tablets, syrups, injections, chewable tablets,suspension, etc. Due to its small dosage, easy to swallow and flavor, good patientscompliance, amoxicillin-clavulanate dry suspension is especially suitable for childrento take. It has a high dispersity, quick absorption, and good bioavailability, whendrugs are taken into gastrointestinal tract. In a word, amoxicillin-clavulanate drysuspension has a great deal of clinical and market value.The prescription is originated referring to Nanjing Simcere’AN QI Granules (brandname). The prescription contains125mg amoxicillin and31.25mg clavulanate persack. Suspending agents are selected based on single factor experiment. Usingorthogonal design test the prescription is optimized based on the characteristic of drysuspension. According to the related rules of Pharmacopoeia and Chemical drugquality control guidelines, three batches of samples were produced and evaluated.The results show that the samples can meet the relevant requirements.Making use of three batches of samples,6-months accelerated tests and6-monthslong-term stability tests were finished. The results indicate that the quality of thismedicine is stable under the packaging standard, with all indexes up to the qualityspecifications for suspension, and the packaging standard can reach the requirements of the storage and transport. Considering with the influential factor tests, the samplesshould be sealed and storaged in a cool dry place.