咪达唑仑滴鼻液的制备及质量控制  

Preparation and Quality Control of Midazolam Nasal Drops

作　　者：孙丽蓉[1] 林芳[2] 葛建[2] 熊建华[1] 陈慧菲[1] 

机构地区：[1]浙江温州市第三人民医院,温州市325000 [2]中国计量学院生命科学学院药学系,杭州市310018

出　　处：《中国药房》2011年第13期1191-1193,共3页China Pharmacy

基　　金：温州市医药卫生科学研究项目资助(2008007)

摘　　要：目的:制备咪达唑仑滴鼻液并建立其质量控制方法。方法:将咪达唑仑用生理盐水稀释至全量制备滴鼻液;采用反相高效液相色谱法测定咪达唑仑的含量,色谱柱为Shimadzu ODS C18,流动相为甲醇-乙腈-0.05mo·lL-1乙酸铵-三乙胺=50∶6∶44∶0.2(V/V/V/V),流速为1.0mL·min-1,柱温为30℃,紫外检测波长为254nm。结果:所制滴鼻液外观澄明;咪达唑仑检测浓度线性范围为1～100μg·mL-1(r=0.9998),平均回收率为100.68%,日内和日间RSD分别为1.54%、2.89%(n=5)。结论:制剂处方及制备方法简单,质量控制方法准确、可靠。OBJECTIVE： To prepare Midazolam nasal drops and to establish quality control method of it. METHODS： Midazolam was diluted by normal saline to prepare nasal drops. RP-HPLC method was used to determine the content of midazolam. The determination was performed on Shimadzu ODS C18 column with mobile phase consisted of methanol-acetonitrile-0.05 mol. L-1 ammonium acetate-triethylamine （50：6：44：0.2, V/V/V/V） at a flow rate of 1.0 mL.min^-1. The column temperature was 30 ℃ and UV detection wavelength was set at 254 nm. RESULTS： Prepared nasal drops were clear and bright in appearance. The linear range of midazolam was 1-100 μg.mL^-1（r=0.999 8） with average recovery rate of 100.68%. The RSDs of intra-day and inter-days were 1.54% and 2.89% （n=5）. CONCLUSION： The formula and preparation technology of Midazolam nasal drops are simple and quality control method is accurate and reliable.

关 键 词：咪达唑仑 滴鼻液 制备 质量控制 

分 类 号：R943[医药卫生—药剂学] R971.3[医药卫生—药学]