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目的:对颠茄流浸膏进行定性定量研究,鉴别真伪,提高颠茄流浸膏的质量标准。方法:运用薄层色谱法对颠茄流浸膏进行定性分析;采用高效液相色谱法测定硫酸天仙子胺的含量,色谱柱为Shim-pack VP-ODS(4.6 mm×250 mm,5μm)柱,流动相为0.004%磷酸溶液(含0.25%十二烷基硫酸钠)-乙腈(60∶40),流速1.0 mL.min-1,检测波长210 nm,柱温30℃。结果:薄层色谱方法能有效识别非法添加硫酸阿托品,鉴别特征明显,专属性强;硫酸天仙子胺进样量在0.2888～16.50μg范围内线性良好(r=1.000),平均回收率为103.8%(RSD=1.6%,n=6)。结论:本方法专属性强、灵敏度高、操作简便,对30余批不同生产企业颠茄流浸膏进行鉴别和含量测定,结果有6批次样品检出非法添加硫酸阿托品,该方法可为颠茄流浸膏的质量控制提供依据。
OBJECTIVE: To qualitatively and quantitatively study the belladonna flow extract, to identify authenticity and improve the quality standard of belladonna flow extract. Methods: TLC was used to characterize the fluid extract of belladonna. HPLC was used to determine the concentration of celastrine sulfate. The chromatographic column was Shim-pack VP-ODS (4.6 mm × 250 mm, 5 μm) The mobile phase consisted of 0.004% phosphoric acid solution (containing 0.25% sodium lauryl sulfate) -acetonitrile (60:40) at a flow rate of 1.0 mL · min-1. The detection wavelength was 210 nm and the column temperature was 30 ℃. Results: The thin layer chromatographic method can effectively identify illegally added atropine sulfate, and its distinguishing characteristic is obvious and its specificity is strong. The injection rate of the fairy amine sulfate is good (r = 1.000) in the range of 0.2888 ~ 16.50μg with the average recovery of 103.8% (RSD = 1.6%, n = 6). Conclusion: The method is highly specific, sensitive and easy to operate. The identification and determination of belladonna extract in more than 30 batches of different production enterprises resulted in six batches of samples illegally added with atropine sulfate, Eggplant flow extract provide the basis for quality control.