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小儿咽扁颗粒剂的制备工艺优化与质量标准深化

Optimizing and Deepening the Preparative Technique and Quality Standard of Xiao'er Yanbian Granules
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摘要 目的:对小儿咽扁颗粒剂的制备工艺和质量标准分别进行优化与深化。方法:采用正交试验对水提工艺条件进行优化;采用薄层色谱法对金银花、射干、冰片、人工牛黄分别进行定性鉴别;采用高效液相色谱法对金银花中绿原酸进行定量分析,色谱柱为C18Diamonsi(l200 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸溶液(13∶87),流速为1.0 mL.min-1,检测波长为327 nm。结果:制备工艺简便可行;薄层色谱斑点清晰,专属性强;绿原酸进样量在0.0411-0.3699μg范围内线性关系良好(r=0.99996),平均回收率为98.31%,RSD%为0.71%。结论:所建立的定性定量方法简便、准确、重复性好,可作为小儿咽扁颗粒剂的质量控制方法。 Objective: To optimize and deepen the preparative technique and quality standard of Xiao'er Yanbian granules. Methods: The orthogonal test was adopted to optimize the extraction process in water. Flos Lonicerae, Rhizoma Belamcandae, Borneolum Syntheticum and Bovis Calculus Artifactus were identified by TLC; and the contents of chlorogenic acid in Flos Lonicerae were determined simultaneously by HPLC.The chromatographic column was Diamonsil C18 column(200 mm×4.6 mm, 5 μm), the mobile phase was acetonitrile-0.1% phosphoric solution(13:87) at the flow rate of 1.0 mL'min-l,and the detecting wave- length was 327 nm. Results: The preparative technique is simple and feasible. The TLC identification was highly specific and spots were clear. Chlorogenic acid showed a good linear relationship at a range of 0.0411-0.3699 μg(r=0.99996), and the aver- age recovery was 98.31% with RSD of 0.71%. Conclusion: The qualitive and quantitative methods established is simple, accu- rate and reproducible, and can be used for the quality control of Xiao' er Yanbian granules.
出处 《中医药导报》 2013年第3期82-84,共3页 Guiding Journal of Traditional Chinese Medicine and Pharmacy
关键词 小儿咽扁颗粒剂 绿原酸 工艺优化 定性定量 Xiao'er Yanbian granules Chlorogenic acid Technology optimization Quality and quantity
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