氧氟沙星木糖醇注射液的研制与质量控制

Preparation and quality control of ofloxacin and xylitol injection

目的 开发一种具有抗菌和供能作用且适应糖尿病、高血压和肥胖病患者的氧氟沙星木糖醇注射液,建立该制剂的含量测定方法并对其稳定性进行初步考察。方法 优化处方组成与制备工艺,建立质量研究方法,采用紫外分光光度法测定氧氟沙星含量,容量法测定木糖醇含量;影响因素试验考察其稳定性。结果 氧氟沙星的含量可于293 nm波长处直接测定,平均回收率为100.47％,RSD=0.76％(n=9);在光照、低温及高温条件下5 d及10 d的样品与0 d比较,其主要质量指标均无明显变化。结论 该制剂处方合理,制备工艺可行,含量测定方法准确,稳定性良好。

OBJECTIVE To develop and prepare ofloxacin and xylitol injection in the treatment of anaerobic or/and other bacterial infection, and provide energy for diabetes, hypertebsion and corpulency, and to study the quality control and stability. METHODS Single-factor design was employed for the formulation and the methods for quality control, including identification methods, related materials determination and concentration determination. The content of xylitol and ofloxacin was determined by the vessel analysis method and UV-spectrum method, respectively. RESULTS Concentration of ofloxacin in the solution was assayed at wavelength 293 nm, the mean recovery was 100. 47%, and within-day RSD was 0. 76% (n=9). The new solution was stable in the condition of illumination, low temperature (6℃), and high temperature (60 ℃) within 10 days. CONCLUSIONS The formulation and the methods for quality control are rational, accurate and reproducible. The preparation is stable.