| 居敏俐,李霞,顾建萍,杨明华.双石通淋胶囊质量标准提升研究[J].,2025,34(1):29-33 |
| 双石通淋胶囊质量标准提升研究 |
| The Improvement of the Quality Standard of Shuangshi Tonglin Caspules |
| 投稿时间：2024-04-01 |
| DOI： |
| 中文关键词: 双石通淋胶囊 质量标准提升 薄层色谱(TLC)法 高效液相色谱(HPLC）双波长法 |
| 英文关键词: Shuangshi Tonglin Caspules Improvement of the Existing Quality Standard Thin – layer Chromatography (TLC)Method High – Performance Liquid Chromatography (HPLC) – Dual Wavelength Method |
| 基金项目: |
|
| 摘要点击次数: 362 |
| 全文下载次数: 0 |
| 中文摘要: |
| 目的：提升双石通淋胶囊质量标准。方法：采用薄层色谱（TLC）法对制剂中粉草薢进行定性鉴别；采用高效液相色谱（HPLC)双波长法测定制剂中的盐酸小檗碱、丹参酮ⅡA、京尼平苷酸、苍术素的含量，色谱柱为WelchXtimate C1g4.6mm ×150mm,3um,以乙腈为流动相A,以0.1%磷酸溶液（含0.02 mol/L磷酸二氢钠）为流动相B,进行梯度洗脱，流速为0.8mL/min，检测波长为254nm和345nm，柱温为30℃，进样量为10μL。结果：粉草薢的TLC图斑点清晰，分离度高，阴性样品无干扰。盐酸小檗碱、丹参酮IⅡIA、京尼平苷酸、苍术素的浓度分别在6.196～198.257 μg/mL、1.598~51.131 μg/mL、6.364~203.656 μg/mL、0.156~4.985 μg/mL范围内与峰面积线性关系良好；精密度、稳定性、重复性试验RSD均小于2.0%；平均加样回收率分别为99.25%、99.95%、98.13%、98.20%，RSD分别为2.50%、2.80%、1.38%、2.71%（n=6）。结论：该方法操作简便、结果准确、重复性好，可用于提升双石通淋胶囊的质量标准。 |
| 英文摘要: |
| Objective To improve the existing quality standard of Shuangshi Tonglin Caspules. Methods The thin – layer chroma-tography (TLC) method was used to identify Dioscoreae Hypoglaucae Rhizoma in preparation qualitatively. The high – performanceliquid chromatography (HPLC) – dual wavelength method was used to determine the contents of Berberine Hydrochloride, Tanshi-none II_, Geniposidic Acid and Atractylodin in the preparation; the chromatographic column was Welch Xtimate C1g 4.6 mm × 150mm, 3 um, the mobile phase was acetonitrile –0. 1% phosphoric acid aqueous solution ( with 0. 02mol/L sodium dihydrogen phos-phate), the flow rate was 0. 8 mL/min, the detection wavelength was 254 nm and 345 nm, the column temperature was 30 ℃, andthe injection volume was 10 uL. Results The TLC chromatography of Dioscoreae Hypoglaucae Rhizoma showed clear spots, high reso-lution, and no interference from the negative reference. The linear ranges of Berberine Hydrochloride, Tanshinone IA, GeniposidicAcid, Atractylodin were 6. 196 – 198. 257 μg/mL, 1. 598 – 51. 131 μg/mL, 6. 364 – 203. 656 μg/mL, 0. 156 – 4. 985 μg/mL re-spectively. The RSDs of precision, stability and repeatability were all lower than 2.0%. The average recovery rates of BerberineHydrochloride, Tanshinone ⅡA, Geniposidic Acid, Atractylodin were 99. 25% , 99. 95% , 98. 13% , 98. 20%, with RSD of2. 50% , 2. 80% , 1.38% , 2.71% respectively (n =6). Conclusion This method is simple, accurate and repeatable, which canbe used to improve the quality standard of Shuangshi Tonglin Caspules. |
|
查看全文
查看/发表评论 下载PDF阅读器 |
|
|
|
