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机构地区:[1]沈阳军区总医院药物临床试验研究管理办公室,沈阳110016 [2]沈阳军区政治部门诊部,沈阳110013 [3]沈阳军区总医院附属北方医院药械科,沈阳110031
出 处:《药学服务与研究》2016年第5期386-389,共4页Pharmaceutical Care and Research
基 金:军队医疗机构制剂标准提高科研专项课题重点项目(14ZJZ09)
摘 要:目的:建立镇癎康脑A胶囊的成分研究方法。方法:采用显微鉴别法对镇癎康脑A胶囊中的全蝎、蜈蚣进行鉴别;采用薄层色谱(TLC)法对柴胡、天麻进行鉴别;采用HPLC法测定制剂中细叶远志皂苷的含量,色谱条件:Phenomenex Luna 5u18(2)100AC_(18)柱(250mm×4.6mm,5μm);流动相:甲醇-0.05%磷酸水溶液(69∶31);检测波长:210nm;流速:1.0ml/min;进样量为20μl。结果:显微镜下,镇康脑A胶囊中的全蝎可见棕褐色刚毛,蜈蚣有明显的气管碎片;柴胡、天麻TLC鉴别斑点清晰,分离效果好;细叶远志皂苷在80.2~802.5μg/ml范围内线性关系良好(r=0.999 3),精密度、稳定性、重复性实验的RSD均〈2%,平均加样回收率为(101.0±1.02)%(n=6)。结论:该方法操作简单,灵敏度高,专属性强,重复性好,可用于镇康脑A胶囊的成分研究。Objective: To establish the identification methods of Zhenjiankangnao A capsules constituents. Methods: Scor- pion and centipede were identified under the microscope. Gastrodia Elata and Radix Bupleuri were identified by thin layer chro- matography(TLC) method. The content of tenuifolin was also determined by HPLC method. Phenomenex Luna 5u 18(2)100A C18 column(250 min×4.6mm,5μm) was used for separation. The mobile phase consisted of methanol-0.05 % phosphate solu- tion(69 : 31) at a flow rate of 1.0 ml/min. The detection wave-length was 210 nm. The injection volume was 20 μl. Results: Brown setae of scorpion and trachea fragments of centipede were observed under the microscope. The TLC spots were clear and the test substances were well separated. The level of tenuifolin was in good linear within the range of 80.2-802.5 μg/ml(r= 0. 999 3). The RSD of precision, stability and reproducibility tests were 〈2% and the average recovery rate was (101.0± 1.02)% (n=6). Conclusion:This method has the following advantages: easy operation, high sensitivity, good specificity and reproducibility, which could be used for constituents study of Zhenjiankangnao A capesules.
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