Ornidazole Vaginal Effervescent Tablet Formulation Screening And Quality Research

Ornidazole,it isathird generation following the new nitroimidazole derivatives metronidazole,tinidazole after,It has a good anti-anaerobic and anti trichomonas infection.Mainly used to treat protozoal infections,especially in the treatment of bacterial vaginosis and trichomonas vaginitis better effect.Ornidazole main form of tablets and suppositories,but there are many shortcomings,So,we ornidazole further studies to expect better treatment.This paper focuses on the prescription,preparation,related substances,determination and stability of ornidazole vaginal effervescent tablets for a more comprehensive study.It laid the foundation for the study of ornidazole vaginal effervescent tablets.In the preparation process,the wet granulation method,And effervescent tablets prepared by the conventional acid were granulated,Using 50℃～55℃ ventilated dry particles,Finally,mix compressed into tablets.In tablet exterior,foam volume,pH indicators selected for the optimal prescription.Finally obtained ornidazole vaginal effervescent tablet is slightly hidden spots of white tablets,foam volume and pH are in line with regulations.Bychoosing orthogonal design,dry particles of water,pore size and the amount of granulation adhesive mesh sieve(ie,accounting for dry material percentage)for the three factors,Preferably carried out to determine the final preparation process:2%dry particles of water,granulated aperture 20 mesh sieve and a binder in an amount(ie percentage of dry material)18%.Simple equipment needed for the operation,the use of inexpensive and readily available materials,prepared ornidazole vaginal effervescent tablets comply with the relevant provisions of pharmacopoeia.In this paper,high-performance liquid chromatography sample ornidazole content and related substances:Chromatographic conditions were determined octadecylsilane bonded silica as a filler;Methanol-water(20:80)as the mobile phase,detection wavelength of 318nm,the flow rate was 1.0ml/min.By tabletting excipients,damage(acids,alkalis,heat,oxygen,light damage)Check the decomposition products,demonstrate the use of this method to detect the specificity of this product related substances,methodological study with good results.By repeatability,precision test,stability test,recovery test prove that the method is accurate and reliable measurement.This method can be used to determine the content.By ornidazole vaginal effervescent stress testing,accelerated testing,long-term trials,the results show that ornidazole vaginal effervescent character,content and related substances as well as the disintegrationtime did not change significantly,indicating that at high temperatures,humidity,light conditions,ornidazole vaginal effervescent good stability.