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盐酸利多卡因凝胶剂的制备工艺研究
引用本文:张珩,施春阳,王兰,丁倩.盐酸利多卡因凝胶剂的制备工艺研究[J].西北药学杂志,2012,27(1):68-70.
作者姓名:张珩  施春阳  王兰  丁倩
作者单位:1. 陕西省妇幼保健院药械科,西安,710003
2. 陕西科技大学生命科学与工程学院,西安,710021
3. 西安利君制药有限责任公司,西安,710077
摘    要:目的制备并优化盐酸利多卡因凝胶剂。方法以盐酸利多卡因为主药,卡波姆-941、PEG-400和azone等为基质,制备凝胶剂;以离体皮肤渗透速率为指标,采用正交实验优化处方。结果最优处方为:盐酸利多卡因8.8g,卡波姆-941 3.5g,1,2-丙二醇62.5g;azone 6.5g,PEG-400 13.0g,蒸馏水加至200g。该凝胶剂的盐酸利多卡因离体皮肤渗透速率为744.45μg.h-1.cm-2,稳定性好。结论制备的盐酸利多卡因凝胶剂符合药典要求,质量稳定。

关 键 词:盐酸利多卡因  凝胶剂  处方优化

Study on preparation of Lidocaine Hydrochloride Gelatin
ZHANG Heng,SHI Chunyang,WANG Lan,DING Qian.Study on preparation of Lidocaine Hydrochloride Gelatin[J].Northwest Pharmaceutical Journal,2012,27(1):68-70.
Authors:ZHANG Heng  SHI Chunyang  WANG Lan  DING Qian
Institution:1.Shaanxi Women and Children Hospital and Health Institute,Xi’an 710003,China;2.School of Life Science and Engineering,Shaanxi University of Science &Technology,Xi’an 710021,China;3.Xi’an Lijun Pharmaceutical Co.Ltd.,Xi’an 710077,China)
Abstract:Objective To optimize the preparation procedure of Lidocaine Hydrochloride Gelatin.Method Gelatin was prepared by using lidocaine hydrochloride as the main component and carbomer-941,PEG-400 and azone as the matrix.The permeation rate of skin in vitro was used as an indicator in orthogonal design tests.Results The optimized conditions were as follows:lidocaine hydrochloride 8.8 g,carbomer-941 3.5 g,1,2-propanediol 62.5 g,azone 6.5 g,PEG-400 13.0 g,distilled water to 200 g.The gel permeation rate of lidocaine was 744.45 μg·h-1·cm-2.Conclusion The proposed procedure could obtain Lidocaine Hydrochloride Gelatin which can attain the requirement of Chinese Pharmacopoeia.
Keywords:lidocaine hydrochloride  Gelatin  formulation optimization
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