For M Test Star Gel Pellets Technology And Quality Standards

Tilmicosin has been used specially for livestock and poultry as antibiotics because it has excellent antibacterial activity and pharmacokinetics characteristics.The curative effect of tilmicosin is certain, significant and safe.But due to its bitter taste it is very difficult to drive animals taking the medicine,in addition tilmicosin is forbidden to be used by intravenous injection.All of these limit the use oftilmicosin.To explore the optimum preparation technology of tilmicosin calcium alginate gel micro pills,the effect factors,such as the concentrations of sodium alginate and calcium chloride,the time of calcification,drip system parameters and the ratio of sodium alginate and tilmicosin were investigated by single-factor test, using drug loading and encapsulation efficiency as indicators.In addition,the best preparation technology was obtained by the four factor-three level orthogonal experiment with the ratio of sodium alginate and tilmicosin,the concentration of sodium alginate and calcium chloride and the time of calcification.The optimum preparation technology is afforded as follows:2%concentration of sodium alginate,2% concentration of calcium chloride,1 hour time of calcification,8cm distance between the solution surface and needle,30 drops/min speed of dripping,No 12 needle type and 1:5 ratio of sodium alginate and Tilmicosin. Under the optimum conditions,the gel micro pills enclosing Tilmicosin can be obtained,which have better appearance,higher drug loading and encapsulation and lower bitterness.RP-HPLC method was used to assay quantificationly the content of Tilmicosin containd in gel micro pills. Mobile phase was composed with water-acetonitrile-tetrahydrofuran-Phosphate Dibutylamine(805:115:55:25) buffer solution,the column temperature was about 30℃,the wavelength of detection was 280 nm,the sample injection volumn is 10μL.A good linear relationship were found between the peak area sum(Y) of cis and trans tilmicosins and their concentration(X).In 0.25-0.85mg/ml concentration range of tilmicosins,the regression equation is Y=565252X+53876,R~2=0.9993.The content of tilmicosins contained in calcium alginate gel micro pills was 76.13%.To explore the stability of micro pills under different conditions,influencing factors were tested, including high-temperature test,humidity test,the pilot light,accelerated test and long-term test.The experimental results showed that micro pills are sensitive to light and the color,cluster and content of tilmicosin were changed seriously after micro pills were heated on 60℃for 24 hours.But,the micro pills keep a good stability at room temperature.All of these evidence indicated that the micro pills can not be stored under higher temperature.In the thesis,the preparation technology of tilmicosin calcium alginate gel micro pills explored is perfect and stable with better appearance,higher drug -loading rate and lower bitterness.RP-HPLC method to assay quantificationly the content of tilmicosin containd in gel micro pills is accuate and rapid with good repeatability.At the same time,favorable storage conditions of tilmicosin calcium alginate gel micro pills is obtained.Micro pills should be preserved at lower temperature and away from the light.This thesis supply a beneficial base for tilmicosin researching and exploring futher.