菊冰鼻腔喷雾剂质量标准研究  

Quality Standard of Jubing Nasal Spray

作　　者：姚曦[1] 何伟[1] 朱怡洁[1] 魏金津[1] 

机构地区：[1]广东药学院药物研究所,广东省药物新剂型重点实验室,广州510006

出　　处：《中药新药与临床药理》2011年第6期656-658,共3页Traditional Chinese Drug Research and Clinical Pharmacology

基　　金：广东省社会发展领域科技计划项目“中药新药-复方菊冰鼻腔喷雾剂的研制”(73061)

摘　　要：目的建立菊冰鼻腔喷雾剂的质量标准。方法采用薄层色谱(TLC)法对制剂中川芎、冰片、菊花3味中药进行定性鉴别,采用高效液相色谱(HPLC)法对制剂中阿魏酸含量进行测定。结果 TLC法能检出川芎、冰片、菊花,斑点清晰,且阴性对照无干扰;HPLC法测定阿魏酸在0.02458～0.36870μg之间呈现良好的线性关系,r=0.9999;平均加样回收率为100.75%,RSD=0.91%。结论所建立的定性、定量检测方法操作简便、结果准确可靠、重现性好,能有效地控制菊冰鼻腔喷雾剂的质量。Objective To establish the quality standard for Jubing Nasal Spray.Methods Rhizoma Chuanxiong,Borneol and Flos Chrysanthemi were identified with the method of TLC,and the content of ferulic acid was determined by HPLC.Results The relevant spots on TLC plates were clear without any interference of the blank reference.The content of ferulic acid showed a good linearity in the range of 0.02458~ 0.36870 μg.The average recovery was 100.75 % and RSD was 0.91 %.Conclusion Established qualitative and quantitative method are simple,accurate,reliable and reproducible,and can be effectively used for the quality standards of Jubing Nasal Spray.

关 键 词：菊冰鼻腔喷雾剂 质量标准 薄层色谱法 高效液相色谱法 

分 类 号：R284.1[医药卫生—中药学]