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目的通过处方筛选及工艺研究,所制备样品的产品质量不低于参比制剂。方法参照参比制剂药品说明书确定拟研制产品处方,制备过程中对配液温度、配液及灌装是否避光与充氮气、p H值筛选、灭菌温度进行考察,确定处方及工艺参数。结果按拟定处方及制备工艺所制备样品,各考察指标均符合质量标准规定,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 the prescription screening and process research, the quality of the prepared samples is not less than the reference preparation. Methods Reference prescription drug specification to determine the product to be developed prescription, the preparation process of the dosing temperature, dosing and filling is protected from light and nitrogen, p H value screening, sterilization temperature to determine the prescription and process parameters. Results According to the prescription prepared and the preparation process, the test indexes all met the quality standards and the quality of the prepared samples was not less than that of the reference preparations. Conclusion The established process parameters are feasible and qualified samples can be prepared.