| 复方盐酸丁卡因凝胶剂的制备及质量考察 |
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| 引用本文： | 王燕萍,曹小强.复方盐酸丁卡因凝胶剂的制备及质量考察[J].中国新药杂志,2006,15(12):985-987. |
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| 作者姓名： | 王燕萍 曹小强 |
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| 作者单位： | 1. 兰州大学第一医院,兰州,730000
2. 兰州大学,兰州,730000 |
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| 摘 要： | 目的：制备复方盐酸丁卡因凝胶,并建立质量控制方法.方法：用卡波姆-940作为凝胶剂基质,制备复方盐酸丁卡因凝胶,建立酸碱度、鉴别、含量测定等质控方法,进行加速实验和室温留样观察.结果：复方盐酸丁卡因凝胶剂的pH值为6.0-7.0,其他各项检查均符合2005年版中国药典凝胶剂的各项规定,含量测定丁卡因平均回收率98.22%,RSD=1.47%（n=5）.结论：制备该凝胶剂工艺简单,性质稳定,质量可控,适于作为医院制剂开发.
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| 关 键 词： | 盐酸丁卡因 凝胶剂 质量控制 |
| 文章编号： | 1003-3734（2006）12-0985-03 |
| 收稿时间： | 2006-01-11 |
| 修稿时间： | 2006年1月11日 |
Preparation and quality control of compound tetracaine hydrochloride gel |
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| WANG Yan-ping,CAO Xiao-qiang.Preparation and quality control of compound tetracaine hydrochloride gel[J].Chinese Journal of New Drugs,2006,15(12):985-987. |
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| Authors: | WANG Yan-ping CAO Xiao-qiang |
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| Institution: | 1. The First Hospital Affiliated to Lanzhou University, Lanzhou 730000 China;2 Lanzhou University,Lanzhou 730000, China |
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| Abstract: | Objective :To establish a quality control of compound tetracaine hydrochloride gel newly prepared.Methods:Carbopol-940 was used as an herbal stroma in the preparation of compound tetracaine hydrochloride gel.The quality control of the gel was featured with acid-base value and assay of main compo- nents.The stability of gel was assessed by an accelerated test at room temperature.Results:The quality of compound tetracaine hydrochloride gel with pH 6.0-7.0 met the specifications of gel preparation described under China Pharmacopeias(2005 version).The average recovery was 98.22% with RSD of 1.47%(n=5). Conclusion:Compound tetracaine hydrochloride gel is stable and the quality control is feasible. |
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| Keywords: | tetracaine hydrochloride gel quality control |
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