摘要
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。
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 .
出处
《西北药学杂志》
CAS
2014年第5期505-507,共3页
Northwest Pharmaceutical Journal
