Development And Safety Evaluation Of Ivermectin Suspension Injection

The parasites that endanger livestock include protozoa,nematodes,and various worms in vitro,which cause serious economic losses to the livestock industry each year.Ivermectin is a broad-spectrum antiparasitic drug,the development of sustained-release and efficient ivermectin injection of clinical anti-parasitic infection is of great significance.The aim of this study was to investigate the preparation and stability of ivermectin suspension injection,and to evaluate the specific safety of ivermectin suspension injection.On the basis of a large number of pre-test,ivermectin as the main drug,in accordance with the principle of suspension formulations,50%of the prescription containing the initial screening.The concentration of soybean oil,emulsifier,antioxidant and suspending agent was screened according to the orthogonal test of L9(3~4).The optimal prescription was selected as the index of redispersibility,The According to the optimized formulation of soybean oil 50%,emulsifier(poloxamer:soybean phospholipid=6.8:3.2)8%,antioxidant(propyl gallate)0.05%,suspending agent(methylcellulose)0.20%Preparation of ivermectin suspension injection.In this study,the contents,appearance,re-dispersibility,particle size,decomposition products and pH value of ivermectin suspension injection were investigated.At the same time,the stability of self-made ivermectin suspension was studied by high-temperature test,high humidity test,accelerated test and long-term test.The results showed that Ivermectin suspension injection was stable to light and had good dispersibility,and the drug particles were fine,and no degradation products were found.The pH value was stable.Ivermectin suspension injection in the temperature of 40±2?,relative humidity of 60±5%under the conditions of 6 months of accelerated test,the appearance of the preparation of the color is always maintained as milky white,no emulsion demulsification,drugs The sedimentation is slow,the dispersibility is good,the drug particles are fine,the content of the active ingredient ivermectin is stable,only about 0.3%in 6 months,no degradation product is found.The pH value continued to decrease,decreasing by 0.5,but still within the range required by the injection(pH4 to 9),indicating that the formulation was stable under accelerated conditions.This test through the irritation test,in vitro hemolytic test,allergy test to examine the special safety of ivermectin suspension injection,the test results show that the drug does not produce significant irritation of rabbits,pathological sections and No abnormalities;no allergic reactions to guinea pigs;no hemolysis of red blood cells.Suggesting that the application of this product is safe,clinical use of safety,in line with the requirements of injection,it is worth further clinical application.