CAJ | 학술논문

目的：对塞克硝唑阴道泡腾片的制剂工艺和质量进行研究。方法采用非水溶剂法，以pH值、崩解时限、发泡量为指标对处方进行筛选，并且利用高效液相色谱法测定主药塞克硝唑的含量。结果制备的塞克硝唑阴道泡腾片经过加速和长期实验，质量符合要求，塞克硝唑的质量浓度在5.051～45.459μg·mL-1范围内线性关系良好，r为0.99998。结论该制剂设计合理，稳定性好，建立的含量测定方法准确可靠。
목적：대새극초서음도포등편적제제공예화질량진행연구。방법채용비수용제법，이pH치、붕해시한、발포량위지표대처방진행사선，병차이용고효액상색보법측정주약새극초서적함량。결과제비적새극초서음도포등편경과가속화장기실험，질량부합요구，새극초서적질량농도재5.051～45.459μg·mL-1범위내선성관계량호，r위0.99998。결론해제제설계합리，은정성호，건립적함량측정방법준학가고。
Objective To prepare Secnidazole Vaginal Effervescent Tablets and to study its quality standard .Methods By using non-aqueous solvent ,the formulations were evaluated by pH ,disintegration time and effervescent effect .The content of secnidazole in the tablets was determined by HPLC .Results The quality of Secnidazole Vaginal Effervescent Tablets met the requirement after accelerated and long-term testing .The standard curves were obtained with a linear range of 5 .051-45 .459 μg · mL -1 ,the r was 0 .9999 8 .Conclusion The Secnidazole Vaginal Effervescent Tablets were rational and stable ,and the established HPLC was ac-curate and precise .