呼吸通口服液的质量标准提高研究  

Study on the Quality Standard of Huxitong Oral Solution

作　　者：景霞[1] 许静[1] 湛雯[1] 孙芳[1] 

机构地区：[1]南京医科大学附属南京儿童医院,南京210008

出　　处：《中国药房》2016年第36期5137-5139,共3页China Pharmacy

基　　金：南京医科大学科技发展基金项目(No.2012NJMU068)

摘　　要：目的：提高呼吸通口服液的质量标准。方法：采用薄层色谱法（TLC）对制剂中百部、黄芩、牛蒡子进行定性鉴别;采用高效液相色谱法（HPLC）测定制剂中黄芩苷的含量：色谱柱为Agilent Eclipse Plus-C18,流动相为甲醇-0.1%磷酸溶液（48∶52,V/V）,流速为0.8 ml/min,检测波长为280 nm,柱温为25℃,进样量为20μl。结果：百部、黄芩、牛蒡子的TLC图斑点清晰,分离度好,阴性对照无干扰。黄芩苷检测进样量线性范围为0.378 03.779 5μg（r=0.999 9）;精密度、稳定性、重复性试验的RSD〈2.0%;加样回收率为96.52%104.95%（RSD=1.28%,n=9）。结论：提高的标准能更加有效地控制呼吸通口服液的质量。OBJECTIVE： To establish the quality standard for Huxitong oral solution. METHODS： TLC was conducted for the qualitative identification of Sternonajaponica, Scutellaria baicalensis and Fructus arctii; HPLC was adopted for the content determination of baicalin： the column was Agilent Eclipse Plus-C18 with mobile phase of methanol-0.1% phosphoric acid solution （48 ： 52, V/V） at a flow rate of 0.8 ml/min, the detection wavelength was 280 nm, column temperature was 25 ℃, injection volume was 20μl. RE- SULTS： TLC spots of S. japonica, S. baicalensis and E arctii were clear and well separated, with no interference in negative control. The linear range of baicalin was 0.378 0-3.779 5μg （r=.999 9） ; RSDs of precision, stability and reproducibility tests were lower than 2.0 % ; recovery was 96.52 %- 104.95 % （RSD= 1.28 %, n = 9）. CONCLUSIONS ： The improved standard can more effectively control the quality of Huxitong oral solution.

关 键 词：呼吸通口服液 质量标准 百部 黄芩 牛蒡子 薄层色谱法 黄芩苷 高效液相色谱法 

分 类 号：R927[医药卫生—药学]