麝香祛痛搽剂的质量标准提高研究

Study on the Quality Standard of Shexiang Qutong Liniment

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1μl。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15.21~243.36μg/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。

OBJECTIVE： To improve the quality standard of Shexiang qutong liniment. METHODS： TLC was used for qualita- tive 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 ~C, inlet temperature was 200 ~C, carri- er 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 ixl. 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） ; RS- Ds of precision, stability and reproducibility tests were lower than 2%; recovery was 97.70%-99.63%（RSD=0.78% ,n=6）. CON- CLUSIONS： The established method can be used for the quality control of Shexiang qutong liniment.