Preparation And Antibacterial Activities In Vitro Of Metronidazole Sustained-release Film

Objective:To improve the process from prescribing, and its establishment of quality control methods, to study the bacteriostasis in vitro of Metronidazole Sustained-release Film.Methods:1、Main drug ingredients was Metronidazole and borneol, Bletilla was good film-forming performance and convergence hemostatic effect,to choose the appropriate proportion, together with polyvinyl alcohol, sodium carboxymethyl cellulose as film forming material. the new film has a better performance.2、 According to China Pharmacopoeia (2010edition) by high performance liquid chromatography (HPLC) method to determine the content of Metronidazole, using membrane filtration method to inspect the microbial limits.3、 According to agar dilution method by CLSI, determination of Metronidazole sustained-release film of25clinical isolates of anaerobic bacteria strains minimum inhibitory concentration (MIC), and with Metronidazole film (no borneol) and Metronidazole to contrast, to evaluate the bacteriostasis in vitro of Metronidazole sustained-release filmResults:1、A prescription of Metronidazole sustained-release film was improved, Bletilla was added to film-forming material. Bletilla and polyvinylalcohol mass ratio of20:80, to improve the appearance and performance of the film.2、Determine the prescription preparation and quality control methods. Metronidazole concentration detection in0.0389-0.972mg·mL-1, the concentration had good linear relationship with the peak area (r=0.9999). the average recovery was96.19%, RSD=1.15%(n=9), In a300ml diluent washing, the perfect microbial limit reference to Chinese pharmacopoeia standards compliance.3、The minimal inhibitory concentrations (MIC) of Metronidazole sustained-release film.Metronidazole film (no borneol) and Metronidazole for25clinical isolates of anaerobic, Compared with the control group, t=2.823, P<0.05, it shows significant differences in statistics.Conclusion:Select the excellent prescription process, develop the effective quality control standards, and further confirmed the reasonableness of prescription. In vitro antibacterial activity against common vaginal bacteria was stronger, to provide a solid theoretical basis. The study has a better theoretical and clinical value, to lay the foundation for further product development.