麝香祛痛搽剂的质量标准提高研究 点击下载
论文标题: 麝香祛痛搽剂的质量标准提高研究
英文标题:
中文摘要: 目的:优化和提高麝香祛痛搽剂的质量标准。方法:采用薄层色谱(TLC)法对制剂中龙血竭、地黄进行定性鉴别。测定制剂总固体和醚溶性提取物的质量分数。采用气相色谱法测定制剂中麝香酮的含量:色谱柱为Thermo-TG-WAXMS毛细管柱,采用程序升温,检测器为氢火焰离子化检测器,检测器温度为250 ℃,进样口温度为200 ℃,载气为高纯氮气,流速为1.0 ml/min,分流比为5 ∶ 1,进样量为1 μl。结果:龙血竭、地黄的TLC图斑点清晰,分离度好。各批样品总固体≥0.6%,醚溶性提取物≥3.0%。麝香酮检测质量浓度线性范围为15.21~243.36 μg/ml(r=0.999 8);精密度、稳定性、重复性试验的RSD<2%;加样回收率为97.70%~99.63%(RSD=0.78%,n=6)。结论:经优化和提高的标准可用于麝香祛痛搽剂的质量控制。
英文摘要: OBJECTIVE:To improve the quality standard of Shexiang qutong liniment. METHODS: TLC was used for qualitative identification of Resina draconis and Rehmannia. The determination of total solids and ether-soluble extracts in the preparation was detected. GC was used for the content determination of muscone: the column was Thermo-TG-WAXMS capillary column by programmed temperature, the detector was FID detector, the detector temperature was 250 ℃, inlet temperature was 200 ℃, carrier gas was high purity nitrogen at a flow rate of 1.0 ml/min, split ratio was 5 ∶ 1, and the injection volume was 1 μl. RESULTS:The TLC pots of R.draconis and Rehmannia were clear with good separation. The total solids in preparations were not less than 0.6%, and extracts were not less than 3.0%. The linear range of muscone concentration was 15.21-243.36 μg/ml(r=0.999 8); RSDs of precision, stability and reproducibility tests were lower than 2%; recovery was 97.70%-99.63%(RSD=0.78%,n=6). CONCLUSIONS: The established method can be used for the quality control of Shexiang qutong liniment.
期刊: 2016年第27卷第12期
作者: 张楠,雷成康
英文作者: ZHANG Nan,LEI Chengkang
关键字: 麝香祛痛搽剂;质量标准;提高;薄层色谱法;气相色谱法
KEYWORDS: Shexiang qutong liniment; Quality standard; Improvement; TLC; GC
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