二母安嗽丸的质量标准研究  

Study on quality standard for Ermu Ansou Pill

作　　者：赵晨[1] 于鹏[2] 郑歆[3] 腾怀凤[4] 

机构地区：[1]天津市药品检验所,天津300070 [2]天津药物研究院信息中心,天津300193 [3]天津中新药业集团股份有限公司达仁堂制药厂研究所,天津300457 [4]辽宁省食品药品检验所,辽宁沈阳110023

出　　处：《现代药物与临床》2010年第1期52-57,共6页Drugs & Clinic

摘　　要：目的 提高二母安嗽丸的质量控制标准。方法 采用薄层色谱法对儿母安嗽丸中的知母、玄参、罂粟壳、款冬花、紫苑、苦杏仁进行定性鉴别，采用高效液相色谱法测定二母安嗽丸中吗啡的量。色谱柱为Dikma Diamonsil C18柱（250 mm×4.6 mm,5μm）；流动相为乙腈-0.1%磷酸溶液（15：85）（每100 mL加0.1 g庚烷磺酸钠）；柱温为40 ℃；体积流量为1.0 mL/min；检测波长为220 nm。结果 知母、玄参、罂粟壳、款冬花、紫苑、苦杏仁薄层色谱半点清晰，重现性好，无干扰；吗啡在2.078～83.12 μg线性关系良好，平均回收率为96.18%，RSD为1.03%（n＝6）。结论 所建立的定性和定量方法结果准确、可靠，重现性好，可用于二母安嗽丸的质量控制。Objective To improve the quality standard for Ermu Ansou Pill. Methods TLC was applied to identify Rhizoma Anemarrhenae, Radix Scrophulariae, Pericarpium Papaveris, Flos Farfarae, Radix Et Rhizoma Asteris and Semen Armeniacae Amarum, HPLC was applied to determine the content of morphine ine the medicine. Results The TLC spots were distinct and reproducible. The linear range of morphine was 2.078～83.12% μg/mL. The average recovery rate was 96.18%, ang RSD was 1.03% （n=6）. Conclusion The qualitative and quantitative methods established in this study are feasible, accurat and reproducible. The can be well used as the quality standard control for Ermu Ansou Pill.

关 键 词：二母安嗽丸 定性分析 定量分析 薄层色谱 高效液相色谱 质量控制 

分 类 号：R927.11[医药卫生—药学]