| 丝裂霉素C眼用凝胶的制备及质量控制 |
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| 引用本文： | 毕宏生,苏卫华,郭俊国,刘大美,吴建峰.丝裂霉素C眼用凝胶的制备及质量控制[J].山东生物医学工程,2011(3):181-183. |
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| 作者姓名： | 毕宏生 苏卫华 郭俊国 刘大美 吴建峰 |
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| 作者单位： | [1]山东中医药大学,济南250355 [2]山东中医药大学眼科研究所,济南250002 |
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| 基金项目： | 山东省中医药科学技术研究项目（2009HZ091） |
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| 摘 要： | 制备丝裂霉素C眼用凝胶剂并建立其质量控制方法。以丝裂霉素为主药,以卡波姆和羧甲基纤维素（HPMC K4M）为基质制备眼用凝胶,采用HPLC法测定制剂中丝裂霉素C的含量。所制得的眼用凝胶为淡紫色透明状,丝裂霉素C在21-210μg/ml范围内呈良好的线性关系,A=0.482C＋0.009,精密度RSD为0.049%,稳定性RSD为1.28%。该法制备工艺简单,质量可控,有关项目符合眼用凝胶的质量要求。
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| 关 键 词： | 丝裂霉素 眼用凝胶 制备 高效液相色谱 质量控制 |
Preparation and Quality Control of Mitomycin C Ophthalmic Gel |
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| BI Hongsheng,SU Weihua,GUO Junguo,LIU Damei,WU Jianfeng.Preparation and Quality Control of Mitomycin C Ophthalmic Gel[J].Shandong Journal of Biomedical Engineering,2011(3):181-183. |
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| Authors: | BI Hongsheng SU Weihua GUO Junguo LIU Damei WU Jianfeng |
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| Affiliation: | 1.Shandong University of Traditional Chinese Medicine,Jinan 250355,China;2.Eye Institute of Shandong University of Traditional Chinese Medicine,Jinan 250002) |
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| Abstract: | To prepare mitomycin C ophthalmic gel and the establishment of its quality control methods.Eyegel was prepared based on mitiomycin medicine and taking Carbomer and carboxymethyl cellulose（HPMC K4M） as a substrate.Mitonycin c content was determinated wing HPLC.The obtained eye gel is transparent lavender,within the scope of mitomycin C in 21~210μg/ml good linear relationship,A=0.482C＋0.009,precision RSD of 0.049%,stable of the RSD is 1.28%.The preparation process is simple,quality control,the project meets the quality requirements of the eye gel. |
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| Keywords: | Mitomycin C Ophthalmic gel Preparation High performance liquid Chromatography Quality control |
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