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目的:建立苗山消渴康复颗粒的质量标准。方法:采用薄层色谱法鉴别苗山消渴康复颗粒中的葛根、山茱萸、黄柏、黄芪、苍术、翻白草、水蛭、枸杞、丹参;采用高效液相色谱法对制剂中的葛根素进行含量测定,流动相为甲醇-1%醋酸水(21∶79),流速1.0 mL/min,检测波长250 nm,柱温30℃。结果:葛根、山茱萸、黄柏、黄芪、苍术、翻白草、水蛭、枸杞、丹参的薄层鉴别斑点清晰,专属性强;葛根素在0.2031～2.0310μg之间呈良好的线性关系(r=0.9998,n=6),平均回收率为98.20%,RSD为0.70%(n=5)。结论:所建立的方法操作简单,专属性强,重现性好,结果准确可靠,可作为苗山消渴康复颗粒的质量控制方法。
Objective: To establish the quality standard of Miaoshan Diabetes Rehabilitation Granule. Methods: The Puerariae, Fructus Corni, Phellodendri, Astragalus, Atractylodes, Rhizoma Bletilla striata, Leech, Lycium, Radix Salviae Miltiorrhizae in the Miao-San Diabetes-Recuperation Granule were identified by TLC. The content of puerarin in the preparation was determined by HPLC The mobile phase consisted of methanol-1% acetic acid water (21:79), the flow rate was 1.0 mL / min, the detection wavelength was 250 nm and the column temperature was 30 ℃. Results: The spots of Pueraria, Dogwood, Phellodendron, Astragalus, Atractylodes, Tuber, Leech, Chinese wolfberry and Salvia miltiorrhiza were clear and specific; puerarin showed a good linearity between 0.2031 ~ 2.0310μg (r = 0.9998 , n = 6) with an average recovery of 98.20% and RSD of 0.70% (n = 5). Conclusion: The established method has the advantages of simple operation, strong specificity, good reproducibility and accurate and reliable results, which can be used as a quality control method for Miao-shan Diabetes Rehabilitation Granules.