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目的:确立风痛灵膏的最佳成型工艺并及建立其有效成分水杨酸甲酯的气相色谱测定法,为该制剂的工业化生产与质量控制提供参考。方法:以熔点、光泽、软硬度、细腻度为综合评价指标,采用正交试验确定基质间(石蜡、蜂蜡、白凡士林、羊毛脂)的最佳配比。采用气相色谱法测定水杨酸甲酯含量,PEG-20M毛细管柱(0.25 mm×30 m,0.25μm),程序升温(初始温度100℃,以15℃·min-1升温至190℃,保持9 min),分流比50∶1,检测器温度300℃,进样口温度250℃。结果:石蜡、蜂蜡、白凡士林、羊毛脂最佳配比分别为4%,6%,5%,3%,药液温度65~75℃。制备的3批样品均符合《中国药典》2010年版软膏剂项下的规定。水杨酸甲酯的线性范围0.66~13.25 g·L-1,平均加样回收率98.94%,RSD 0.7%。结论:优选的制备工艺稳定可行,建立的含量测方法简便、快速、准确,可用于风痛灵膏的质量控制。
OBJECTIVE: To establish the best forming process of Gutongling cream and to establish its gas chromatographic method for the determination of methyl salicylate, and to provide a reference for its industrial production and quality control. Methods: The optimal ratio of matrix (paraffin, beeswax, white petrolatum and lanolin) was determined by orthogonal experiment with melting point, glossiness, hardness and exquisiteness as the comprehensive evaluation indexes. The content of methyl salicylate was determined by gas chromatography. The temperature was programmed on a PEG-20M capillary column (0.25 mm × 30 μm, 0.25 μm). The initial temperature was raised to 100 ℃. The temperature was raised to 190 ℃ at 15 ℃ · min-1, min), split ratio 50: 1, detector temperature 300 ° C, inlet temperature 250 ° C. Results: The optimal ratio of paraffin, beeswax, white petrolatum and lanolin was 4%, 6%, 5% and 3%, respectively. The temperature of liquid was 65 ~ 75 ℃. All the 3 batches of samples were prepared under the Chinese Pharmacopoeia 2010 edition ointment. The linear range of methyl salicylate ranged from 0.66 to 13.25 g · L-1, with an average recoveries of 98.94% and RSD of 0.7%. Conclusion: The optimal preparation process is stable and feasible. The established method for determination of content is simple, rapid and accurate and can be used for the quality control of Fengtong Lingzhi.