Preparation And Quality Investigation Of Enrofloxacin Uterus Perfusion

Endometritis is one of the most common diseases that lead to reproductive disorders in sows and is mainly caused by the infection of bacterial pathogens(including Escherichia coil,Staphylococus aureus,Proteusbacillus vulgaris,Pseudomonas aeruginosa)on the uterine mucosa.Enrofloxacin belongs to the group of fluorinated quinolones with broad antimicrobial spectrum,high bactericidal activity and widely distribution in the body,that is used in veterinary practice for treatment of respiratory and gastrointestinal infections.However,there were not reported about the preparation of enrofloxacin uterus perfusate suspension and applied to the sow endometritis.In this study,we regarded enrofloxacin as based medicine and chose the appropriate suspending agent,wetting agent,p H adjuster,antioxidant,flocculant and deflocculant to develop a high-quality enrofloxacin uterus perfusate suspension and to establish the quality control method and stability research,while assessing the special safety of enrofloxacin uterus perfusate suspension to ensure the safety and clinical efficacy of clinical medication.In this study,we used univariate test and orthogonal experiment design to screen the optimum prescription and investigated pharmacy properties of enrofloxacin uterus perfusate suspension include physical charateristics experiment,further dispersion test,volumetric ratio of sedimentation experiment.The quality control analysis method of enrofloxacin uterus perfusion was tested by high performa nce liquid chromatography(UV)method with content and related substances determination.The stability of enrofloxacin uterus perfusion was studied by influencing factor test,accelerated test and long-term test.The specific safety was verified by enroflo xacin uterus perfusion on hemolytic,allergic and irritating tests.The optimum prescription as follows,50 m L suspensions contained enrofloxacin,sodium carboxymethyl cellulose,Tween-80,sodium citrate,citric acid,sodium carbonate,sodium sulfite:1.0 g,0.5 g,0.4 g,1.0 g,0.5 g,0.3 g,0.02 g respectively.Volumetric ratio of sedimentation was 0.98 after 3h;sample further dispersion was 5 times after 24 h;the granularity of suspension less than 15 ?m particles was about 94%.The pharmacological examination results met the "People's Republic of China Veterinary Pharmacopoeia" 2015 edition of a suspension requirements.The results showed that the average recoveries were 98.44%,the inter-assay RSD was 0.12%;the precision was 97.90% and 98.23%,the inter-assay RSD was 0.29%;the content was 98.10%,the inter-assay RSD was 0.20%.The results showed that the average recoveries were 99.54% and the inter-assay RSD was 0.08%,The linear range of determination and impurity determination was good,and the other tests were in accordance with the "Technical Guidelines for Veterinary Drug Research" verification requirements.The results of the stability test showed that the content of enrofloxacin was not degraded and the impurity content was not significantly increased under the experimental conditions.The test items were in accordance with the research requirements of veterinary chemical stability in the Guidelines for Veterinary Drug Research.The results of the special safety test showed that it had no irritating reaction to the female rabbit through the uterus administration,no allergic reaction to guinea pigs and no obvious hemolytic or agglutination reaction was observed in erythrocytes.In this study,the optimal prescription of enrofloxacin uterine perfusion was determined and the preparation was successfully prepared,and the quality control of enrofloxacin uterine perfusion was performed.The results showed that the preparation process was simple;the pharmacological characteristics were stable;the qua lity analysis method was controllable;the stability was good;the special safety results were negative.The preparation can be used for uterine perfusion and provide a broader prospect for clinical treatment of sow endometritis.