目的:制备复方肌苷口服液并对其进行质量考察.方法:以肌苷为主药加入硒酸脂多糖制备口服液,采用高效液相色谱法测定含量,通过6个月加速试验和12个月长期留样试验考察其稳定性.结果:所制溶液为微黄色澄明溶液;肌苷检测浓度线性范围为10.24～35.84 μg·mL-1(r=0.999 9),平均回收率为100.2％,RSD=1.11％;稳定性试验中样品在考察期内各项指标均未见明显改变,pH值略有下降.结论:该制剂处方工艺合理可行,质量可控,稳定性良好.%OBJECTIVE: To prepare Compound inosine oral solution (CIOS) and to establish the method for quality control of it. METHODS: Inosine was taken as the main component and added into selenium polysaccharide for the preparation of CIOS, and HPLC method was used to determine the content of it. 6-month accelerated test and 12-month long-term test were done to study its stability. RESULTS: Prepared solution was yellowish, clear and bright. The linear range of inosine was 10.24～35.84 μg·mL-1 (r= 0.999 9) with mean recovery of 100.2% (RSD=1.11%) ; no obvious changes were observed in stability test, and pH value was decreased slightly. CONCLUSION: The preparation is reasonable and feasible in technology, controllable and stable in quality.
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