| 环丙沙星温度敏感原位凝胶的制备及质量控制 |
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| 引用本文： | 孙海燕,;曲淑君,;周晓单.环丙沙星温度敏感原位凝胶的制备及质量控制[J].中国药房,2009(16):1239-1241. |
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| 作者姓名： | 孙海燕 ;曲淑君 ;周晓单 |
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| 作者单位： | [1]烟台毓璜顶医院,烟台市264000; [2]烟台市烟台山医院,烟台市264001; [3]大连医科大学附属第一医院,大连市116000 |
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| 摘 要： | 目的:制备环丙沙星温度敏感原位凝胶,并建立其质量控制方法。方法:以环丙沙星为主药,通过考察相变温度得出以16%泊洛沙姆407为适宜基质处方制备凝胶;采用紫外分光光度法测定其中环丙沙星的含量,并进行初步稳定性考察。结果:所制制剂为透明度高、流动性良好的凝胶剂;环丙沙星检测浓度的线性范围为1.92～9.60μg.mL-1,平均回收率为99.73%(RSD=1.80%);稳定性考察制剂外观无变化。结论:本制剂制备工艺简单可行,质量稳定可控。
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| 关 键 词： | 原位凝胶 环丙沙星 紫外分光光度法 制备 质量控制 |
Preparation and Quality Control of Ciprofloxacin Thermosensitive in Situ Gels |
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| Institution: | SUN Hai-yan,QU Shu-jun,ZHOU Xiao-dan(1.Yantai Yuhuangding Hospital, Yantai 264000, China;2.Yantai Municipal Yantaishan Hospital, Yantai 264001, China;3.Dalian Medical University First Affiliated Hospital, Dalian 116000, China) |
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| Abstract: | OBJECTIVE： To prepare Ciprofloxacin in situ thermosensitive gels and to establish its quality control method. METHODS： The ciprofloxaci in situ thermosensitive gels were prepared with ciprofloxacin as chief ingredient with 16% poloxamer407 selected as the base material through investigating the phase transition temperature. The concentration of ciprofloxacin was determined by ultraviolet spectrophotometry. The preliminary stability of the gels were investigated. RESULTS： The gels were found to be of high transparency and good fluidity. The linear range of ciprofloxacin was 1.92--9.60 ug·mL^-1, and the average recovery was 99.73% （RSD = 1.80%） . The preparation was stable in apperance in the stability test. CONCLUSION： The preparation is simple and feasible in technology, and its quality is stable and controllable. |
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| Keywords: | In situ gel Ciprofloxacin Ultraviolet spectrophotometry Preparation Quality control |
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