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生肌软膏质量标准的建立 被引量:3

Study on Quality Standard for Shengji Ointment
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摘要 目的:提高完善生肌软膏的质量标准。方法:采用TLC法对处方中的龙血竭、乳香进行鉴别;采用HPLC法测定磺胺嘧啶银的含量。色谱柱为Wondasil C18(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸溶液(8∶92),检测波长为254nm,流速:1.0 ml·min^(-1),柱温:30℃,进样量为5μl。结果:薄层色谱斑点清晰,专属性强,重复性好。磺胺嘧啶在40.97~1 024.18μg·ml^(-1)范围内质量浓度与峰面积线性关系良好(r=0.999 9),平均回收率为100.17%,RSD=0.64%(n=6)。结论:本方法操作方便、专属性强、回收率高、结果准确,可用于该制剂的质量控制。 ABSTRACT Objective: To improve the quality standard for Shengji ointment. Methods: A TLC method was used to identify Resirta draconis and Olibanum. An HPLC method was used to determine the content of silver sulfadiazine. The detection wavelength was set at 254 nm. The determination was performed on a Wondasil C18 column(250 mm ×4.6mm,5μm) with the mobile phase consisting of acetonitrile-0.1% phosphoric acid(8: 92). The injection volume was 5 μl. Results: The TLC spots were clear, specific and repro- ducible. A good linear relationship was obtained between the peak areas and the concentrations of sulfadiazine within the range of 40.97-1 024.18 μg ml -1 ( r = 0. 999 9 ). The average recovery was 100.17 % ( RSD = 0.64%, n = 6 ). Conclusion: The methods are easy-operated, specific, reproducible and accurate, which can be used for the quality control of the preparation.
作者 童达 邱婧 李瑞莲 Tong Da Qiu Jing Li Ruilian(Hunan Institute for Food and Drug Control, Changsha 410001, China)
出处 《中国药师》 CAS 2017年第3期565-567,共3页 China Pharmacist
关键词 生肌软膏 质量标准 薄层色谱 高效液相色谱法 磺胺嘧啶银 Shengji ointment Quality standard TLC HPLC Silver sulfadiazine
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