I Gede Edy Sagitha (2019) Uji Stabilitas Mikrobiologi Sediaan Ampisillin Sulbaktam Setelah Rekonstitusi. Thesis thesis, UNIVERSITAS AIRLANGGA.

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Abstract

Background: Repeated use of antibiotic ampicillin sulbactam after reconstitution, therefore in storage various variables can affect it stability. Objectives: To analyze the microbiological stability of three parenteral products of sulbactam ampicillin in repeated use with the parameters of the solvent and storage temperature Methods: Three kinds of ampicillin sulbactam antibiotic products were weighed and reconstituted using WFI and NS solvents, diluted ad 20 ppm and put into sterile vials. Then stored at room temperature (25-30 ° C) and refrigerator temperature (4-8 ° C). Storage is carried out for 24 hours which is divided into 5-time series, namely 0, 1, 4 and 24 hours. Each time series is microbiological tested and after 18 hours the inhibition zone is observed and its diameter measured using calipers. The results are analyzed by making tables and graphs of inhibition zones and the percentage of decreased inhibition zone and also statistically tested by Two Way Anova Results: Based on the graph of the percentage of decreased inhibition zone which is associated with a reduction in potency, at the 4th hour the majority of the samples of sulbactam ampicillin products no longer met the requirements of FI edition V so it was not feasible to administer to patients. Product M in NS solvent and product K in WFI solvent showed better stability compared to other samples. After statistical testing the results at the 0th hour of the sample and the solvent had a significant effect, the activity of the K sample was greater than the other brands on the NS solvent. In the first hour, all samples give the same results as the 0th hour. At the 4th hour of the sample and the storage temperature which had a significant effect, the activity of the S brand was greater than that of other brands at the refrigerator storage temperature. At the 24th hour of the sample, the storage temperature and solvent had a significant effect, the activity of the S brand was greater than that of other brands with NS solvent at the refrigerator storage temperature. Conclusion: K product activity before storage is greater than S and M products, the maximum decrease in activity obtained after storage 24 hours at the refrigerator temperature in the NS solvent compared before storage, storing at the refrigerator in the WFI solvent for 24 hours does not cause a decrease in activity and at 4 the majority of samples of sulbactam ampicillin products are no longer stable and meet the requirements of FI edition V so it is not feasible to administer to patients.

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