CAJ | 학술논문

目的：探讨替硝唑葡萄糖注射液制备过程中相关因素对其质量的影响，以确定其最佳生产工艺。方法对pH值、药用炭加入量、配制时间、灭菌温度等因素进行考察，检查有关物质变化情况。结果根据实验考察数据，得出生产替硝唑葡萄糖注射液的最佳生产工艺条件为：控制配制pH值在4.0~4.5，药用炭使用量定为0.01%，放置时间不超过10 h。结论优化后的替硝唑葡萄糖注射液生产工艺可行，质量可控，适用于工业化大生产。
목적：탐토체초서포도당주사액제비과정중상관인소대기질량적영향，이학정기최가생산공예。방법대pH치、약용탄가입량、배제시간、멸균온도등인소진행고찰，검사유관물질변화정황。결과근거실험고찰수거，득출생산체초서포도당주사액적최가생산공예조건위：공제배제pH치재4.0~4.5，약용탄사용량정위0.01%，방치시간불초과10 h。결론우화후적체초서포도당주사액생산공예가행，질량가공，괄용우공업화대생산。
Objective To explore the influence of pH value, preparation time,added amount of activated carbon, the sterilization temperature and other factors in the production of tinidazole glucose injection on its quality ,so as to determine the op-timum production technology. Methods The pH value,added amount of activated carbon,preparation time,sterilization temper-ature and other factors were investigated to inspect the changes of quality. Results Based on the experimental data,the optimum production technology of tinidazole glucose injection:the pH value was 4.0-4.5,the usage amount of activated carbon was 0.01%and the storage time should not exceed 10 h. Conclusion The optimized production technology of tinidazole glucose injection is feasible with controllable quality,it is suitable for industrial production.