| The best formula was determined by L9(3~4)orthogonal experiment, selecting starch, CMC, Tween-80, glycerol as the main base with 3 levels, and humectant properties, appearance, thermostability and adhesion were used as evaluation parameters. Test results showed that the primary and secondary order of the factors was starch > glycerol > CMC >Tween-80. And the optimum composition ratio of gels is 1% CMC, 10% starch, 15% glycerol and 1% ween-80. The purpose of this study was to establish a method for determination Enrofloxacin in oral gels by ultraviolet spectrophotometry(UV). The results showed that Enrofloxacin solution in the concentration range of 2.0~14.0 μg/m L had good linear relation and the standard regression equation curve was Y=0.0389X+0.0019(R=0.9998). The average recovery was 101.06% with 0.32% RSD and the inter-day and intra-day precision( RSD) were less than 5%. The average content of Enrofloxacin in oral gels was 30.43 mg/g. It indicated that the method is practical, economical and effective one for determination Enrofloxacin in oral gels manufacture. Three batches enrofloxacin oral gels were chosen for humid stability test, heat stability test, cold test and long-term observation test to evaluate enrofloxacin oral gels stability. The tests showed that the enrofloxacin oral gels concentration had no significant change(P > 0.05) after staying at room temperature 6 months and 75% humidity and 37℃ one month. But the viscosity of gels decreased under high temperature, high humidity with precipitation of water. These indicated that the enrofloxacin oral gels should be stored in 4℃ dry place, and away from light and could be saved at room temperature for long term.Test randomly selected 40 semi-natural yak calves which were 2~3 months of age. 30 diarrhoea yak calves were grouped into 3 groups, n=10 and there were enrofloxacin oral gel group, enrofloxacin injection group and diarrhoea group. The health control group included 10 healthy yak calves. The yak calves in treatment groups were administrated for 3 days continuously. The blood samples of health control group and enrofloxacin oral gel group between pre and post treatment were collected. Then blood samples were centrifuged for investigating biochemical indices. Test results showed that the cure rates of the yak calves in the enrofloxacin gel group and the enroflixacin injection group were 90% and 70%, respectively. The effective rates were 100% and 80%, respectively and the difference of effective rates between the experimental groups and the diarrhoea control group was singnificant(P < 0.01). The volume of serum TP、UA、ALP、ALT、AST before the yak calves were treated with enrofloxacin oralgel were significantly lower than that of health control group(P < 0.05). The volume of serum TP、UA、ALP、ALT、AST after the yak calves were treated were not different from that of health control group(P > 0.05). The volume of serum TP、ALP、AST in post treatment were significantly higher than those in pre treatment(P < 0.05). These results indicated that the effects of enrofloxacin oral gel on curing the diarrhoea of yak calves were remarkable and it can improve many serum biochemical indices of diarrhea yak calves.Test randomly selected 6 healthy yak calves and divided into 2 groups on average, oraling enrofloxacin power and gels at a dosage of 10 mg/ kg, respectively. enrofloxacin concentration of plasma in different point of time was detected by HPLC for studying pharmacokinetics of enrofloxacin in yak calf. Test results showed that the pharmacokinetic parameters of two groups were t1/2Ke=4.375±0.913 h, T(peak)=0.952±0.256 h, C(max)=1.380 ± 0.060 μg/m L, AUC=10.117 ± 0.199(μg/m L)·h and t1/2Ke=2.201±2.860 h, T(peak)=1.961±0.086 h, C(max)=1.115±0.017 μg/m L 、AUC=10.970±0.334(μg/m L)·h, resprctively. The t1/2Ke, T(peak) and C(max) were extremely significant different(P < 0.01). The research reveals that compared with Enrofloxacin powder, in yak calf Enrofloxacin oral gel has longer T(peak) and elimination half life, and it has a certain sustained-release effect.To evaluate the safety of enrofloxacin, a total 80 ICR mice were divided randomly into four groups including low-dose group(10 mg/kg), middle-dose group(30 mg/kg), high-dose group(50 mg/kg) and control group.Different dose of enrofloxacin gels were employed to mice by gavage. Blood samples were collected on the 1st, 6th, 11 th and 16 th from each grop, resprctively. After collection, each of the samples was centrifuged at 1000 × g for 10 min, and serum was separated and tested of biochemical indices. Weight of mice in each group were recorded before trail and on the 6th, 9th, 13 th before gavage, respectively. The hearts, livers, spleens and kidneys of each group were collected for weighing. Pathological section were preformed of livers, spleens and kidneys in each group, respectively. The results indicated that there was a significant difference in the TP of high-dose group on the 16 th than that before trail(P < 0.05). The weight of mice in middle-dose group on the 6th and 9th were significant lower than that in other groups(P < 0.05). The weight of mice in high-dose group were significant lower than that in control group from 6th day(P < 0.05). There were no obvious pathological changes in other tissues in each group. In conclusion, the present research reveals that the recommended dosage and course of treatment(10 mg/kg; 3~6 d) is safe and without side-effect. |
PDF Full Text Request