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目的:对制备的甲硝唑阴道原位凝胶的质量控制方法进行研究。方法:参照《中国药典》有关规定对原位凝胶的性状、鉴别、检查进行研究;采用高效液相色谱法测定甲硝唑的含量;对其稳定性及模拟生理条件下的流变学特性进行了初步考察。结果:所制备原位凝胶为无色或淡黄色透明液体,具有明显的温敏相变特性。鉴别、检查均符合2005年版《中国药典》中的相关规定;HPLC法检测甲硝唑浓度的线性范围为5.0～30.0μg·ml~(-1)(r=0.999 9),平均回收率分别为99.4%(RSD=0.7%)。稳定性试验中性状、pH及含量在考察期内无明显变化,胶凝温度及胶凝时间变异系数分别小于5%和8%。模拟生理条件下胶凝温度有所提高,黏附力有所降低。结论:筛选出的原位凝胶处方可行,制备工艺简单,质量稳定可控。进行原位凝胶质量控制时应对生理条件下的流变学特性进行评价和控制。
Objective: To study the quality control method of metronidazole vaginal in situ gel. Methods: According to the relevant regulations of Chinese Pharmacopoeia, the properties, identification and examination of in situ gel were studied. The content of metronidazole was determined by high performance liquid chromatography. The stability and the rheological properties under simulated physiological conditions Conducted a preliminary inspection. Results: The prepared in situ gel was a colorless or light yellow transparent liquid with obvious temperature-sensitive phase transition characteristics. The linear range of metronidazole was 5.0 ~ 30.0μg · ml ~ (-1) (r = 0.999 9). The average recoveries of metronidazole were 99.4% (RSD = 0.7%). In the stability test, the traits, pH and contents did not change significantly during the study period, and the coefficients of variation of the gelation temperature and the gelation time were less than 5% and 8% respectively. Under the simulated physiological conditions, the gelling temperature increased and the adhesion decreased. Conclusion: The in-situ gel prescription is feasible, the preparation process is simple and the quality is stable and controllable. In situ gel quality control should be under physiological conditions, the rheological properties of evaluation and control.