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目的通过处方筛选及工艺研究,制备出合格样品,产品质量不低于原研参比制剂。方法处方参照FDA药品说明书确定,制备过程中考察配液温度、是否避光、p H值筛选、配液过程中是否充氮气、灭菌温度进行筛选,确定工艺参数。结果按照所确定处方及制备工艺制备样品,各项考察指标均符合质量标准规定,杂质谱与参比制剂一致,所制备样品产品质量不低于参比制剂。结论所建立工艺参数可行,可以制备出合格样品。
Objective Through prescription screening and process research, prepare qualified samples, the quality of products not less than the original reference preparation. Method prescription reference FDA drug specification to determine the preparation process to examine the dosing temperature, is dark, p H value screening, dosing with nitrogen, sterilization temperature screening, to determine the process parameters. Results The samples were prepared according to the prescription and the preparation process. All the indexes were in accordance with the quality standards. The impurity spectra were consistent with the reference preparations. The quality of the prepared samples was not lower than that of the reference preparations. Conclusion The established process parameters are feasible and qualified samples can be prepared.