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目的:建立复方续断胶囊质量控制方法。方法:采用薄层色谱法,以硅胶G为固定相,氯仿-甲醇-正丁醇-水(9∶7∶3∶3)为展开剂,对4种主要活性成分木通皂苷D、三七皂苷R1、人参皂苷Rg1、人参皂苷Rb1进行鉴别;采用硫酸-香草醛比色法测定总皂苷含量;采用反相高效液相色谱法,以KromasilC18为色谱柱,乙腈-水作为流动相梯度洗脱,测定木通皂苷D、三七皂苷R1、人参皂苷Rg1、人参皂苷Rb1含量。结果:薄层图斑点清晰,空白无干扰。总皂苷含量测定的平均回收率为(102.2±3.02)%(RSD=2.95%),线性范围为24.68～98.72μg(r=0.9992)。高效液相色谱定量方法达到基线分离,木通皂苷D、三七皂苷R1、人参皂苷Rg1、人参皂苷Rb1均有良好的线性范围,平均回收率分别为100.2%(RSD=2.84%),101.4%(RSD=1.38%),100.9%(RSD=1.45%),97.13%(RSD=1.42%)。结论:首次建立了复方续断胶囊中主要活性成分的定性定量方法。该法准确、专属性及重现性好且快速简便,可作为该制剂质量控制方法。
Objective: To establish a method for quality control of compound sessocating capsules. METHODS: TLC was used with silica gel G as the stationary phase and chloroform-methanol-n-butanol-water (9:7:3:3) as the developing solvent. Identification of ginsenoside R1, ginsenoside Rg1, and ginsenoside Rb1; determination of total saponin using sulfuric acid-vanillin colorimetry; RP-HPLC with Kromasil C18 as the mobile phase and acetonitrile-water gradient elution , Determination of wood saponin D, notoginsenoside R1, ginsenoside Rg1, ginsenoside Rb1 content. Results: The thin layer maps are clear and the blanks are free from interference. The average recovery of the total saponin content was (102.2±3.02)% (RSD=2.95%), and the linear range was 24.68 to 98.72 μg (r=0.9992). High-performance liquid chromatography quantitative method to achieve baseline separation, wood saponin D, notoginsenoside R1, ginsenoside Rg1, ginsenoside Rb1 all have a good linear range, the average recovery rate was 100.2% (RSD = 2.84%), 101.4% (RSD = 1.38%), 100.9% (RSD = 1.45%), 97.13% (RSD = 1.42%). Conclusion: The qualitative and quantitative method for the main active components in compound skein capsules was established for the first time. The method is accurate, specific and reproducible, and quick and simple, and can be used as a quality control method for the preparation.