医用生物蛋白胶携载加替沙星的体外释药率测定

目的:建立测定医用生物蛋白胶携载加替沙星(MBG-Gat)的体外释药率的方法。方法:采用高效液相色谱法测定含量,色谱柱为ZORBAX300SB-C18,流动相为磷酸二氢钾缓冲溶液(pH3.5)-乙腈=76:24,检测波长为293nm,柱温为30℃,流速为1mL.min-1,进样量为20μL。将MBG-Gat置于生理盐水中释放,每12小时1次取释放液测定,连续9d。结果:Gat检测浓度线性范围为5～80μg.mL-1(r=0.9997);平均回收率为99.77%～103.53%,RSD≤2.77%(n=5)。MBG-Gat在生理盐水中释放9d时累积释药率在70%以上。结论:所建立的体外释药率的测定方法灵敏度高,重复性好,适用于在体外条件下Gat的分析检测。Gat以MBG携载后具有缓释性。

Determination of the in Vitro Release Rate of Gatifloxacin Carried by Medical Biofibrin Glue

OBJECTIVE： To establish a method for determination of the in vitro release rate of gatifloxacin carried by medical biofibrin glue （MBG- Gat） . METHODS： The content of Gat was determined by HPLC on ZORBAX300SB- C18 column with column temperate kept at 30 ℃ and detection wavelength was 293 nm; the mobile phase consisted of potassium dihydrogen phosphate buffered solution （pH 3.5） -acetonitrile （76 ： 24） at a flow rate of 1 mL · min^- 1. The volume of injection was 20μL. MBG - Gat was placed in normal saline for drug release, with the release solution determined in every 12 h for consecutive 9 days. RESULTS： The linear range of Gat was 5-80 μg · mL ^-1 （r = 0.999 7） with an average recovery rate of 99.77%- 103.53%, RSD≤2.77% （n = 5）. The accumulative release rate of MBG Gat in normal saline within 9 days reached above 70%. CONCLUSION： The established method for determination of the in vitro drug release of Gat is proved to be sensitive and reproducible, and it is applicable for the determination and analysis of Gat in vitro. The Gat carried by MBG is characterized by sustained release.