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目的建立伊痛舒注射液中α-蒎烯、莰烯、柠檬烯和甲基丁香酚4种成分含量测定的方法。方法采用挥发油提取器,利用GC法进行测定。采用DB-1石英毛细管柱(30 m×0.25 mm,0.25μm),氢火焰离子化检测器,程序升温,流速为1.0 mL.min-1,进样量为1μL,分流比为10∶1,内标物为丁香酚。结果α-蒎烯、莰烯、柠檬烯和甲基丁香酚质量浓度分别在22.77～728.6 mg·L-1、5.069～162.2 mg·L-1、4.844～155.0 mg·L-1和65.58～2 099 mg·L-1内线性关系良好,平均回收率分别为(94.0±1.2)%、(93.3±1.6)%、(93.1±2.2)%和(92.4±1.6)%。结论该方法准确,重复性好,可为伊痛舒注射液的质量控制提供依据。
Objective To establish a method for the determination of 4 constituents of α-pinene, camphene, limonene and methyl eugenol in Yi Tong Shu injection. Methods Volatile oil extractor was used to determine by GC method. A DB-1 quartz capillary column (30 m × 0.25 mm, 0.25 μm) was used with a flame ionization detector. The temperature was programmed and the flow rate was 1.0 mL · min-1. The injection volume was 1 μL and the split ratio was 10: The internal standard for eugenol. Results The concentrations of α-pinene, camphene, limonene and methyl eugenol were 22.77 ~ 728.6 mg · L -1, 1.5696 ~ 162.2 mg · L -1, 4.5844 ~ 155.0 mg · L -1 and 65.58 ~ 2099 mg · L-1. The average recoveries were (94.0 ± 1.2)%, (93.3 ± 1.6)%, (93.1 ± 2.2)% and (92.4 ± 1.6)%, respectively. Conclusion The method is accurate and reproducible, which can provide the basis for the quality control of Yitong Shu Injection.