川芎挥发油鼻腔喷雾剂的制备及质量控制  

Preparation and quality control of Chuanxiong rhizome volatile oil nasal spray

作　　者：闫沁远[1] 高保英[1] 汪忠波[1] 李凌云[1] 程曙文[1] 

机构地区：[1]湖北职业技术学院医学院,湖北孝感432000

出　　处：《中国医院药学杂志》2013年第4期287-290,共4页Chinese Journal of Hospital Pharmacy

摘　　要：目的:研制川芎挥发油鼻腔喷雾剂并建立其质量控制方法。方法:采用水蒸气蒸馏法提取川芎挥发油,并以其为主药制备鼻腔喷雾剂;建立川芎挥发油鼻腔喷雾剂质量控制标准,采用高效液相色谱(HPLC)法测定川芎挥发油中藁本内酯含量。结果:所制备的川芎挥发油鼻腔喷雾剂为无色、微粘、澄明液体,其鉴别和检查符合中国药典2010年版中的相关规定;川芎挥发油中藁本内酯在5.0～15.0μg·mL-1范围内线性关系良好(r=0.999 9);平均回收率为99.36%～100.3%,RSD为0.15%～1.17%;所制备样品24 h内稳定性良好。结论:鼻腔喷雾剂可作为川芎挥发油新制剂品种开发的研究对象。OBJECTIVE To prepare Chuanxiong rhizome volatile oil nasal spray and establish its quality control method. METHODS The Chuanxiong rhizome volatile oil was extracted by steam distillation and used as principal agent to prepare the nasal spray. The quality standards of the Chuanxiong rhizome volatile oil nasal spray were established and the content of ligust- ilide in the Chuanxiong rhizome volatile oil was determined by HPLC. RESULTS The prepared nasal spray was colorless transparent glutinous limpid liquid with its identification and inspection items all up to the relate standards stipulated in Chinese Pharmacopoeia （2010 edition）. The linear range of ligustilide was 5.0 - 15.0 fig-mL-~ （r = 0. 999 9）. The average recovery was 99. 36% - 100. 3%, RSD was 0. 15 % - 1.17%. The samples prepared were stable within 24 h. CONCLUSION Nasal spray is valuable to be further studied as a new preparation of the Chuanxiong rhizome volatile oil.

关 键 词：川芎挥发油 鼻腔喷雾剂 制备 质量控制 

分 类 号：R943[医药卫生—药剂学]