替硝唑木糖醇注射液的制备与质量控制

Preparation and quality control of tinidazol 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替硝唑木糖醇注射液,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 拟定处方组成与制备工艺;并进行性状、鉴别、杂质和有关物质检查等质量研究,采用紫外分光光度法测定替硝唑含量,容量法测定木糖醇含量;影响因素试验考察其稳定性。结果 替硝唑的含量可于317 nm波长处直接测定,平均回收率为99.07％,RSD=0.63％(n=9);本品在光照、低温及高温条件下5 d及10 d的样品与0 d比较,其外观性状、pH值、澄明度、有关物质及含量等均无明显变化。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 prepare a tinidazol and xylitol injection to provide energy for diabetes, hypertebsion and corpulency, and to assay the content and its stability. METHODS The composition of recipe and manufacturing technique was designed. The property, identification, related materials of the preparation were studied. The content of xylitol was determined by the vessel analysis method. The content of tinidazol was determined by UV-spectrum method and its stability tested. RESULTS The content of tinidazol was assayed at wavelength 317 nm, the average of recovery was 99. 07%, and inter-day RSD was 0. 63% (n=9). Under illumination, low temperature, and high temperature, comparison between the samples of the 5th day and the 10th day with the primary sample found its property, identification, pH value, related materials, and the content were not significantly different. CONCLUSIONS The design of the preparation and manufacturing technique are rational. The results are accurate and reproducible. The preparation is stable.