Studies On Ornidazole Injection

Anti microbial effect,is reduced into amino nitro molecules in the anaerobic environment,or by free radicals,resulting in the formation of the interaction between the microbial cell death.This product can be widely used for anaerobic bacteria causing,amoeba,Jia Di bug,the treatment of various diseases infection Trichomonas.Bacterial.Bacterial vaginosis treatment effect is obvious,ornidazole,drugs in the treatment of bacterial vaginal disease the most effective.In addition,the product also can treat endometritis,uterine myositis,tubal or ovarian abscess,pelvic soft tissue infection.Ornidazole in anti anaerobic bacteria,compared the efficacy of Tinidazole and metronidazole were better,anti anaerobic bacteria were higher than that of Tinidazole and metronidazole,plasma elimination half-life is long,lasting effect,less frequent dosing,mutation and teratogenicity induced no,and animal experiment of Tinidazole and metronidazole are mutagenic and teratogenic effect.Tolerance of ornidazole,adverse reactions,the total incidence of drugwas significantly lower than that of metronidazole,tinidazole,ornidazole as the third generation of nitroimidazoles antibiotics,nitroimidazoleis the hospitaldrug commonly prescribedclass of drugs,applied to clinical widely,the market capacity,the firstand second generation products metronidazole and Tinidazole since its clinical application has a good market performance,ornidazole product itself than in the first two generation drugs with anti anaerobic bacteria and Trichomonas activity is strong,broad antibacterial spectrum,high curative effect,short treatment period,less side effects,good effect of single dose.The current market sale situation,the demand for Omidazole Injection increased year by year,therefore,for the convenience of patients,reduce drug costs,patients to meet the needs of the market,so I decided to copy Ornidazole Injection unit.The test for the study of quality standard and stability of the process,Ornidazole Injection.The process of research,the prescription prescription screening,propylene glycol dosage,pH value of screening screening,activated carbon dosage selection,sterilization conditions,screening laboratory sample preparation,small sample evaluation and analysis.The quality standard of character,identification,examination(determination of acidity,colour,insoluble particles,volume,visible foreign matter,bacterial endotoxin,sterile,related substances,content(determination of durability test,specificity test,linear range test,precision test,accuracy test,the sample content)and the associated method validation testing,test results show,the Ornidazole Injection sample quality was stable,comply with relevant quality requirements.The compatible stability test for stability,this product with 0.9%Sodium Chloride Injection and 5%glucose injection of compatibility,the index had no change.The test of high temperature,light,influencing factors,the samples in the light impurity increases slightly under high temperature,no obvious change.The acceleration of long-term stability,in June,the final various indexes and 0 months without significant change,product quality and stability.The production process and process parameters can be feasible,stable product quality,inter consistent product,good product stability.