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, 0(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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Affiliation: | 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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