硝酸芬替康唑阴道泡腾片的制备与质量控制

Preparation and Quality Control of Fenticonazole Nitrate Vaginal Effervescent Tablets

目的:制备硝酸芬替康唑阴道泡腾片,并制定其质量标准。方法:采用等量递加法混合原辅材料制作软材,直接压片包装;采用高效液相色谱法测定主药含量;通过影响因素试验、加速稳定性试验和长期稳定性试验考察制剂稳定性。结果:制备的泡腾片为白色或类白色片;硝酸芬替康唑进样量线性范围为0.4～3.6μg(r=0.9999,n=5),平均回收率为99.52%(RSD=0.44%,n=9)。多数稳定性考察指标结果无明显变化。结论:采用的制备方法简单,建立的含量测定方法简便、准确,制剂稳定性较好。

OBJECTIVE： To prepare Fenticonazole nitrate vaginal effervescent tablets and to develop its quality standard. METHODS： Raw material mixed with excipients using equal additive method. Mixture was directly compressed into tablets then packed. The content of main component was determined by HPLC. The stability of the tablets was investigated by influence factors test, accelerated stability test and long-term stability test. RESULTS： Prepared effervescent tablet is white and off-white in color. The linear range of fenticonazole nitrate was 0.4～3.6 μg （r=0.999 9, n=5）with a recovery rate of 99.52% （RSD=0.44%, n=9）. Results of stability index had no obvious change. CONCLUSION： The preparation method is simple. Established determination method is simple, accurate and stable.