滞留型复方氧氟沙星滴眼液的制备及质量控制
Preparation and quality control of resident compound ofloxacin eye drops
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摘要: 目的 研究滞留型复方氧氟沙星滴眼液的制备及质量控制方法。方法 以氧氟沙星为主药配伍地塞米松磷酸钠,选择磷酸盐作为缓冲剂,卡波姆940作为增稠滞留剂,采用高效液相法测定氧氟沙星、地塞米松的含量。结果 制剂稳定;氧氟沙星平均回收率为(99.8±0.5)%(n=5),地塞米松磷酸钠为(100.6±0.8)%(n=5)。结论 制备工艺简单,质控方法可靠。Abstract: Objective To study the preparation of resident compound ofloxacin eye drops and its quality control. Methods Ofloxacin was used as main drug mixed with dexamethasone sodium phosphate and phosphate was adopted as buffer, while carbomer 940 as residence. The content of ofloxacin was determined by HPLC method. Results The preparations was stable, the average recovery rate of ofloxacin was (99.8±0.5)% (n=5) and that of dexamethasone sodium phosphate was (100.6±0.8)%(n=5). Conclusion; The preparing technique is simple and the quality control is reliable.
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Key words:
- ofloxacin /
- eye drops /
- quality control /
- residence /
- dexamethasone sodium phosphate
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