论文部分内容阅读
目的:制备氟康唑莫西沙星眼用即型凝胶并建立其质量控制方法。方法:试验不同浓度的泊洛沙姆为基质制备凝胶,采用高效液相色谱法测定氟康唑、莫西沙星和羟苯乙酯的含量。色谱柱为依利特Hypersil ODS,流动相为三乙胺缓冲液(pH3.3)-甲醇(61∶39),流速为1.0 mL.min-1,柱温为30℃,检测波长为260 nm。结果:以15.5%泊洛沙姆407为基质制备凝胶,其胶凝温度为32℃。氟康唑、莫西沙星、羟苯乙酯的检测浓度线性范围分别为100～600(r=0.999 9)、100～600(r=0.999 9)、10～60μg.mL-(1r=0.999 8),平均回收率分别为99.75%、99.89%、100.10%,RSD分别为1.26%、1.08%、1.72%。结论:该制剂处方设计合理,制备方法简单,质量可控。
Objective: To prepare fluconazole moxifloxacin ophthalmic gel and to establish its quality control method. Methods: Different concentrations of poloxamers were used as matrix to prepare gels. Fluconazole, moxifloxacin and hydroxyphenylethyl ester were determined by high performance liquid chromatography. The column was Hypersil ODS. The mobile phase consisted of triethylamine buffer (pH 3.3) -methanol (61:39) at a flow rate of 1.0 mL · min-1. The column temperature was 30 ℃ and the detection wavelength was 260 nm. Results: The gels were prepared with 15.5% Poloxamer 407 as the base and the gelation temperature was 32 ° C. The linear ranges of fluconazole, moxifloxacin and phenethyl were 100 ~ 600 (r = 0.999 9), 100 ~ 600 (r = 0.999 9), 10 ~ 60μg.mL- (1r = 0.999 8 ), The average recoveries were 99.75%, 99.89% and 100.10% respectively, with RSDs of 1.26%, 1.08% and 1.72%, respectively. Conclusion: The formulation prescription is reasonable, preparation method is simple, quality controllable.