| 血通胶囊提取工艺优化及质量控制研究 |
| 投稿时间：2024-09-02 修订日期：2024-12-25 点此下载全文 |
| 引用本文：陈方剑,赵娟娟,叶侃倜,孙煜昕,刘继勇,杨骏.血通胶囊提取工艺优化及质量控制研究[J].药学实践杂志,2025,43(2):82~86,91 |
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| 基金项目:上海市2022年度“科技创新行动计划”生物医药科技支撑专项项目（22S21903600） |
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| 中文摘要:目的 优化血通胶囊提取工艺，建立质量控制方法。方法 采用乙醇回流法，通过正交试验考察不同因素对二苯乙烯苷、芦荟大黄素、浸膏得率的影响；采用HPLC法同时测定血通胶囊5种蒽醌类成分含量。结果 最佳提取工艺为加10倍乙醇，乙醇浓度70%， 提取3次，每次1 h；5种成分在一定浓度范围内与峰面积具有良好的线性关系， 相关系数r均>0.999 7；平均加样回收率在93.66%～96.85%之间，RSD范围在1.48%～1.66%。3 批血通胶囊中5种成分的含量测定结果分别为（0.632～0.641）、（0.660～0.681）、（1.968～1.991）、（2.547～2.580）、（1.076～1.101） mg/g。结论 该方法准确、重复性好、可行性高，对血通胶囊生产和质量控制标准提高具有参考意义。 |
| 中文关键词:血通胶囊 正交试验 提取工艺优化 高效液相色谱法 含量测定 |
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| Extraction process optimization and quality control of Xuetong capsules |
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| Abstract:Objective To optimize the extraction process of Xuetong capsules and establish its quality control method. Methods The extraction process was optimized by orthogonal experiment using ethanol reflux method to investigate the effects of different factors on diphenylstilbene, aloin and extraction yield. The content of 5 anthraquinone compounds in Xuetong capsule was determined by HPLC. Results The optimal extraction process was to add 10 times ethanol, with an ethanol concentration of 70%, and extract 3 times, each time for 1 h; 5 components had a good linear relationship with peak area within a certain concentration range, r>0.999 7; The range of sample recovery rate was 93.66%-96.85%, RSD range of 1.48%-1.66%. The content determination results of the 5 components in three batches of Xuetong capsules were （0.632-0.641）, （0.660-0.681）, （1.968-1.991）, （2.547-2.580）, and （1.076-1.101） mg/g. Conclusion The method was accurate, reproducible, and highly feasible, which could be references for producing and improving the quality control standards of Xuetong capsules. |
| keywords:Xuetong Capsule Orthogonal experiment Extraction process optimization High performance liquid chromatography method Content determination |
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