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目的:建立小儿牛黄退热巴布贴的质量标准。方法:采用TLC法对小儿牛黄退热巴布贴中体外培育牛黄、金银花、薄荷脑进行定性鉴别。采用HPLC法测定制剂中栀子苷的含量,色谱柱为KromasiL C18(250 mm×4.6 mm,5μm);流动相为水-乙腈-磷酸(86∶14∶0.01);流速1.0 mL.min-1;检测波长238 nm;采用GC法,用挥发油提取器蒸馏制备供试品溶液,以奈作为内标物,测定制剂中薄荷脑含量,以Kromat KB-1301(30 m×0.53 nm,1.0μm)毛细管柱为气相色谱柱,载气:氮气压力40 kPa,流速为2.0mL.min-1,柱温120℃,分流比50∶1,进样口/检测器温度250℃,氢火焰离子检测器。结果:所采用的TLC方法能有效鉴别出体外培育牛黄、金银花、薄荷脑;栀子苷在0.168～2.688μg内呈良好的线性关系(r=0.999 9),平均回收率为99.56%,RSD为1.28%。薄荷脑在0.0775～1.549μg范围内线性关系良好(r=0.999 5),平均回收率为98.48%,RSD为1.89%。结论:该法操作简单,结果准确,专属性强,可用于小儿牛黄退热巴布贴的质量控制。
Objective: To establish the quality standard of pedicure in children. Methods: TLC method was used to qualitatively identify bezoar, honeysuckle and menthol in vitro. The content of geniposide was determined by HPLC. The chromatographic column was KromasiL C18 (250 mm × 4.6 mm, 5 μm). The mobile phase was water-acetonitrile-phosphoric acid (86:14:0.01). The flow rate was 1.0 mL.min-1 ; The detection wavelength was set at 238 nm; the GC method was used to prepare the test solution by evaporation with a volatile oil extractor. The content of menthol in the preparation was determined by Kromat KB-1301 (30 m × 0.53 nm, 1.0 μm) The capillary column is a gas chromatographic column. Carrier gas: nitrogen pressure 40 kPa, flow rate 2.0 mL.min-1, column temperature 120 ℃, split ratio 50:1, inlet / detector temperature 250 ℃, hydrogen flame ionization detector . Results: TLC method was used to identify the in vitro culture of Begonia, honeysuckle and Menthol. Geniposide showed a good linearity (r = 0.999 9) in 0.168 ~ 2.688μg with the average recovery of 99.56%. The RSD was 1.28%. Menthol had a good linear relationship (r = 0.999 5) in the range of 0.0775-1.549 μg with an average recovery of 98.48% and a RSD of 1.89%. Conclusion: The method is simple, accurate and specific. It can be used for the quality control of Pycnogenol in children.