香菇多糖冻干粉针剂的制备及质量评价

Preparation and Quality Evaluation of Lentinan for Freeze-dried Powder Injection

研究香菇多糖冻干粉针剂的处方及制备工艺,并对其进行质量评价.经预实验选定复合赋形剂及配比,实验考察其用量对制剂成型性的影响,用正交法筛选最优处方,以冷冻干燥法制备粉针剂,并测定其有关质量指标.通过筛选的优化处方为:香菇多糖50 mg,赋形剂L-精氨酸300mg和甘露醇250 mg,加水量为75 mL,溶液PH值为7.0-7.5;制备的冻干粉针剂质量优良、综合评定其分值为5.处方合理,制备工艺可行,检验结果准确可靠.

The formula and preparation technology of Lentinan for treeze-dried powder rejection was investigated, and its quality was evaluated. With the investigation of differem kinds of exeipients and influenee of different dosage on preparation formability, the best formula was selected by orthogonal test. And powder injection was prepared by the technology of freeze-drying and relevant quality indicators were determined. The prepared freeze-dried powder injection was in good quality with comprehensive evaluation score of 5 by the optimized formula：Lentinan （50 mg）, excipients L- arginine （300 mg） and mannitol （250 mg） with adding water to 75 ml and solution PH value of 7.0-7.5. The formula is reasonable with feasible preparation technique, and the test results are accurate and reliable.