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Study On The Preparation And Pharmacodynamics Of Toltrazuril Oral Solution

Posted on:2011-06-13Degree:MasterType:Thesis
Country:ChinaCandidate:X L ZhangFull Text:PDF
GTID:2213360308985387Subject:Veterinarians
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Toltrazuril, a tirazinetrione anticoccidial srugs, have been widely used in preventing and treatmenting coccidial in chicken. It has a special effect, antiresistance, security and broad-spectrum characteristic, Toltrazuril solution was a new dosage form. Stability, security and pharmacodynamics were studied in order to provide proof for clinic practice. It provides an important data for further studying the epidemiologic study characteristics of Coccidiosis, and laid the foundations of Coccidiosis diagnose, precaution and control. It provides a new treatment method to reduce the economy loss.1,According to the standard of solution, the description, clarity test, pH and the sterility test, was inspected. The results suggested that the relative density was 1.120~1.140, pH of solution was from9.0 to 10.0,water content was less than 0.5%. There were no evident foreign substance, no bacterium. It showed that physical chemistry property of toltrazuril solution was stable, consistent with the test request of new drug which reported to a higher authority clinical test.2,Dtermination of toltrazuril in solution by HPLC. In this section, the content of toltrazuril in its solution with a HPLC method was studied. C18 column was used as the stationary phase and the mobile phase was acetonitrile and phosphate buffered saline (53:46), the flow rate of mobile phase was 1.0mL/min, the detection wavelength was 240nm. The RSD of intra-day and inter-day were smaller than 10%. This method could be used for quality control. The result accorded with theregulation of veterinary drug criterion.3,Acute toxic test in mice was determined , in order to evaluate the safety of toltrazuril solution. The oral LD50 of toltrazuri was 500 mg·kg-1·bw, and the confidence areas of 95% were 3785~6863 mg·kg-1·bw. The results was conformde to what was reported by EMEA. The results showed that the LD50 of toltrazuril in mice was more than 5000 mg·kg-1·bw w, and it belonged to the actually non-tocicity. The toxicity of toltrazuril in mice was small, and it and treatment of coccidiosis in chicken were studied in this paper.4,The efficacy of toltrazuril against E.tenella were researched in chickens via drinking warter at dosage of 12.5 mg·L-1,25 mg·L-1,50 mg·L-1 respectively. The results showed that the ACI of the 25 mg·L-1,50 mg·L-1 groups were 192.4 and 199.3, kept in high effect against Coccidiosis, the growth gate were 93.5% and 99.3%, and the survival rate were100%. The ACI of 12.5 mg·L-1 group was 178.0, kept in middling effect. To consider the efficacy and the cost, it suggested that toltrazuril could be used cia drinking water at doses of 25 mg·L-1 for 2 consecutive days.5,Efficacy were researched against E.tenella in chickens with toltrazuril oral solution at doses of 25 mg·L-1 in drinking water, Baycox at doses of 25 mg·L-1 in drinking water, Diclazuril at doses of 1 mg·L-1 in drinking water, Sulfachloropyrazine at doses of 300 mg·L-1 in drinking water, Amprolium Hydrochloride at doses of 125 mg·L-1in drinking water. The results showed that the anticoccidial index of toltrazuril, Baycox, diclazuril, Sulfachloropyrazine and Amprolium Hydrochloride were 192.0,191.5,175.0,155.0 and 147.0 reapectively.
Keywords/Search Tags:Toltrazuril oral solution, Preparation, Pharmacodynamics, Tocitity, ACI, HPLC
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