甲硝唑阴道原位凝胶质量控制研究

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=0．9999），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。

Quality Control of Metronidazole in-situ Vaginal Gel

Objective ： To study on quality control method of metronidazole in-situ vaginal gel. Method ： The appearance, identification and test of metronidazole in-situ vaginal gel was studied and described. The determination of metronidazole was performed with HPLC. The stability of in-situ gel and rheological properties under simulated physiological condition were investigated preliminarily. Result ： The prepared in-situ gel was colorless or yellowish limpid liquid with character of reverse phase transformation. Its test and identification results were in conformity with the related stipulation of China Pharmacopeia （ 2005 edition）. The linear range of metronidazole was 5.0 -30.0μg · ml^-1（ r = 0. 999 9）, and the average recovery was 99.4% （RSD = 0.7% ）. There was no significant change for indexes in the accelerated test and sample test. RSD of gelation temperature and gelation time during stability test were less than 5% and 8% , respectively. The gelation temperature became high and bioadhesive force was reduced under simulated physiological condition. Conclusion： The quality of metronidazole in-situ vaginal gel is stable and controllable, and variation of theological properties under simulated physiological condition should be taken into account.