| 复方芩E涂膜剂的制备与质量控制 |
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| 作者姓名： | 宋冷梅 姜宏 宋征 李保院 |
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| 作者单位： | 滨州医学院附属医院,山东 滨州,256603 |
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| 摘 要： | 目的 制备复方芩E涂膜剂,并对其质量进行控制.方法 以聚乙烯醇-124为成膜材料,按药剂学原理制备复方芩E涂膜剂,建立质量控制方法 并对主成分含量测定方法 进行了方法 学验证.结果 制备工艺合理、简单,质量控制方法 可行,制剂质量稳定,对家兔皮肤无刺激.结论 符合涂膜剂质量标准和要求,可供临床应用.
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| 关 键 词： | 黄芩苷 涂膜剂 放射性皮炎 高效液相色谱 质量控制 |
Preparation and quality control of Compound Qin E Plastics |
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| Authors: | SONG Lengmei JIANG Hong SONG Zheng and LI Baoyuan |
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| Institution: | Affiliated Hospital of Binzhou Medical University,Binzhou 256603,China,Affiliated Hospital of Binzhou Medical University,Binzhou 256603,China,Affiliated Hospital of Binzhou Medical University,Binzhou 256603,China and Affiliated Hospital of Binzhou Medical University,Binzhou 256603,China |
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| Abstract: | Objective To study the preparation and quality control method for Compound Qin E Plastics.Methods Compound Qin E Plastics was prepared with polyvinyl alcohol-124 as the membrane material,a quality control method was established,and determination methods of the main components was developed and validated.Results The preparation process was reasonable,the method of quality control was feasible,the product had stable quality,and the drugs did not cause skin irritation in rabbits.Conclusion Compound Qin E Plastics was in line with the standards and requirements of plastics,and available for clinical application. |
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| Keywords: | Baicalin Plastic Radiation dermatitis HPLC Quality control |
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