Résumé
OBJECTIVE:To establish a method for the plasma concentration determination of carboplatin,and study the phar-macokinetics of carboplatin in female rats after intravenous injection and intraperitoneal injection. METHODS:HPLC was per-formed on the column of Agilent TC-C18 with mobile phase of methanol-water(5:95,V/V)at a flow rate of 1.0 mL/min,detection wavelength was 229 nm,and column temperature was 25 ℃. The inner standard was 5-bromouracil,and injection volume was 20 μL. 24 SD rats were randomly divided into 4 groups,6 in each group. The rats were intravenously injected and intraperitoneally in-jected carboplatin 20,40 mg/kg respectively. 0.5 mL blood sample was taken from eyes before administration and after administra-tion of 0.25,0.5,1,1.5,2,4,6,8,10,12 h. The plasma concentration of carboplatin was determined,and DAS 2.0 was used to calculate the pharmacokinetic parameters. RESULTS:The linear range of carboplatin in plasma was 0.30-60.00 μg/mL (r=0.9991);RSDs of intra-day,inter-day precision were lower than 10%(n=5);RSD of peak area in stability test was lower than 10%(n=5);method recovery was 98.7%-102.4%(RSD≤6.08%,n=5),and extraction recovery was 83.38%-85.45%(RSD≤5.97%,n=5). AUC0-12 h of carboplatin 20,40 mg/kg by intravenous injection and intraperitoneal injection in female rats were (15.503 ± 4.172),(23.402 ± 4.266),(6.716 ± 2.306),(9.384 ± 2.205)μg·h/mL;AUC0-∞ were (16.424 ± 4.846),(23.404 ± 4.266),(6.790±2.378),(9.765±2.095)μg·h/mL;t1/2z were(1.246±0.765),(0.394±0.058),(0.513±0.156),(0.884±0.460) h;and tmax were(0.700±0.274),(0.400±0.335),(0.542±0.368),(0.833±0.289)h,respectively. CONCLUSIONS:The meth-od is simple,economic and accurate,with suitable internal standard,and can be used for the plasma concentration determination of carboplatin in female rats and the pharmacokinetic studies.
Résumé
BACKGROUND: Chitosan wound dressing has been extensively used in the treatment of wounds and burns, not only because of its bacteriastasis, hemostasis and promoting the wound healing, but also its good biocompatibility,biodegradability and biological functions.OBJECTIVE: To evaluate the efficacy and safety of chitosan wound dressing for deep second-degree burn, thereby providing clinical basis for its registration.METHODS: Sixty patients with deep second-degree burn were randomly allotted to two groups, and then subjected to the external application of chitosan wound dressing (experimental group) or chitosan biomedical dressing (control group),respectively. Then, the therapeutic efficacy was evaluated through healing time, recovering rate and pain scores, and the safety was evaluated through the incidence of adverse reactions and laboratory indexes before and after treatment.RESULTS AND CONCLUSION: There were no significant differences in the wound healing time [(21.23±6.84) days vs.(23.77±4.26) days], recovery rate and pain scores between the experimental and control groups at 14, 21 and 28 days after treatment (P > 0.05). The blood routine, liver function and kidney function indexes before and after treatment did not differ significantly between groups. Additionally, neither adverse nor severe adverse events occurred in the two groups.These results indicate that the therapeutic efficacy and safety of the chitosan wound dressing are equivalent to the control product in the treatment of deep second-degree burn.