| 盐酸丁卡因壳聚糖滴眼液的制备与质量控制 |
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| 引用本文： | 蔡永豪,刘小飞.盐酸丁卡因壳聚糖滴眼液的制备与质量控制[J].海峡药学,2009,21(8):56-58. |
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| 作者姓名： | 蔡永豪 刘小飞 |
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| 作者单位： | 1. 温州医学院附属眼视光医院,温州,325000
2. 浙江海康生物制品有限责任公司,温州,325000 |
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| 摘 要： | 目的制备盐酸丁卡因壳聚糖滴眼液并建立其质量控制方法。方法以壳聚糖为增稠、增效剂，盐酸丁卡因为主药制备滴眼液；采用紫外分光光度法测定制剂中盐酸丁卡因的含量。并对其稳定性及兔眼刺激性进行考察。结果盐酸丁卡因在2．5—12．5μg·mL^-1。范围内线性关系良好（r=0．9999）。含量测定平均回收率为101．54％，RSD=0．69％（n=6）；制剂稳定性良好。结论本制备工艺简单。质量控制方法可靠．可满足眼科临床用药。
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| 关 键 词： | 盐酸丁卡因 壳聚糖 滴眼液 |
Preparation and quality control of tetracaine hydrochloride chitosan eye drops |
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| CAI Yong-hao,LIU Xiao-fei.Preparation and quality control of tetracaine hydrochloride chitosan eye drops[J].Strait Pharmaceutical Journal,2009,21(8):56-58. |
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| Authors: | CAI Yong-hao LIU Xiao-fei |
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| Affiliation: | CAI Yong-hao, LIU Xiao-fei(1. Eye Hospital of Wenzhou Medical College, Wenzhou 325000 China; 2. Haikang Zhejiang Biological Products Co. Ltd., Wenzhou 32.5000, China) |
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| Abstract: | OBJECTIVE To prepare tetracaine hydrochloride chitosan eye drops and establish its quality control methods. METHODS Chitosan as a means of thickening, synergist, tetraeaine hydrochloride is as the principle mcim in eye drops preparation; using UV agents in the determination of tetraeaine hydroehloride content, and its stability and eye irritation in rabbits inspection. RESULTS Tetraeaine hydroehloride in the range of 2.5 12.5μg· mL^-1has a good linear relationship （r = 0. 9999）, determination of the average recovery was 101.54 %, RSD= 0.69 % （n = 6） ; the preparation has good stability. CONCLUSION The preparation of Tetraeaine hydrochloride chitosan eye drops is easy in process, reliable in quality control, so it is suitable for ophthalmology clinical use. |
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| Keywords: | Tetraeaine hydrochloride Chitosan Eye drops |
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