替硝唑灌肠液的制备与质量控制

Preparation and Quality Control of Tinidazole Enema

目的:制备替硝唑灌肠液,并建立其质量控制方法。方法:以替硝唑为主药制备灌肠液。采用紫外分光光度法于317nm波长处测定替硝唑的含量,同时考察制剂在室温放置6个月内的稳定性。结果:所制制剂为无色或几乎无色的黏稠液体,鉴别、检查项均符合相关规定。替硝唑检测浓度的线性范围为5～25μg·mL-(1r=0.9999),平均回收率为99.94%,日内平均RSD为0.36%(n=6),日间平均RSD为0.30%(n=6)。该制剂在6月内性质稳定。结论:该制剂制备工艺简单,质量控制方法可靠,制剂质量稳定。

OBJECTIVE： To prepare Tinidazole enema and to establish quality control method of it. METHODS： Tinidazole was used as main component to prepare Tinidazole enema. The content of tinidazole was determined by UV spectrophotometry at detection wavelength of 317 nm. The stability of Tinidazole enema was investigated at room temperature for 6 months. RESULTS： Preparation was colorless or nearly colorless viscous liquid. The identification and examination items were in line with the standards. The linear range of tinidazole was 5～25 ？g·mL-1（r=0.999 9） with an average recovery of 99.94%. The RSD of intra-day and inter-day were 0.36% and 0.30% （n=6）. Preparation was stable within 6 months. CONCLUSION： The method is simple and the quality control method is stable. Preparation is stable in quality.