Development And Clinical Efficacy Of Diclofenac Sodium Injection

Veterinary effective components of Diclofenac Sodium Injection for diclofenac sodium,suitable for the target animal pig,can alleviate the surgery,trauma,arthritis and other causes of pain reduction caused by bacterial infection and other causes of fever fever;can alleviate the swine fever,joint and muscle pain,claudication and other diseases.In this paper,the prescription and technology,quality,stability,clinical efficacy and so on were summarized and evaluated.With diclofenac sodium as raw material,on the basis of pharmacy data,combined with the preparation process of the test in a series of solubility and stability of drugs,prescription screening,preparation process validation,prescription to determine the amount of active ingredient content,solvent,Diclofenac Sodium Injection was successfully prepared,and the industrial production of amplification.At high temperature(60 DEG C),light(4500 + 500LX)under the condition of main drugs and solvent were investigated the influence factors of the 10 day,on the fifth day and tenth days for the identification,examination and content determination were compared with zeroth days,the results show that our selection of the appropriate solvent,stable chemical properties and the main drug does not react on the content of main drugs did not interfere with the determination of the nature of the stability of preparation,Diclofenac Sodium Injection.To establish a method for determination the content of diclofenac sodium in Diclofenac Sodium Injection,diclofenac sodium linear equation was y=21.052 x 30.792(R~2=0.9999,n=5),diclofenac sodium has good linearity in the concentration range of 23.4~376.0 g/mL;diclofenac impurity A linear equation: y= 36.324 x 0.057(R~2=0.9998,n=5),diclofenac impurity A good linearity in the concentration range of 0.4~4.8 in g/m L.The lowest detection concentration of diclofenac sodium diclofenac and impurity A were105.8ng/mL and 81.4ng/m L,the lowest detection concentration were 52.9ng/mL and40.7ng/mL;in different C18 chromatographic column,column temperature,mobile phase ratio and velocity conditions,the durability is good,the main peak and impurity peak can reach the baseline separation of RSD was 1.3%,determination of content accurate.To verify the effect of anti-inflammatory and antipyretic analgesic Diclofenac Sodium Injection on the target animal pig and reasonable dosage on the target animal pigs underwent clinical analgesic antipyretic clinical test,Diclofenac Sodium Injection Diclofenac Sodium Injection on endotoxin induced fever of pig castrated piglets pain test.Determine Diclofenac Sodium Injection dosage: at a dose of 1 kg body weight per pig,injection of 0.05 mL,has anti-inflammatory and antipyretic effects,suitable for surgery,trauma,arthritis and other inflammatory pain caused by high fever fever infection secondary to bacterial infection and other diseases;can relieve fever,joint and muscle pain,lameness and other diseases.The preparation process of Diclofenac Sodium Injection is reasonable,the quality is controllable,and the effect of antipyretic and analgesic effect on the target pig is good.