| 李思光,王纪伟,尹安坤,等.脉痹颗粒提取工艺优化及质量标准研究[J].安徽医药,2026,30(10):1953-1959. |
| 脉痹颗粒提取工艺优化及质量标准研究 |
| Study on the extraction technology optimization and quality standard of Maibi granules |
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| DOI：10.3969/j.issn.1009-6469.2026.10.009 |
| 中文关键词: 中草药 脉痹颗粒 提取工艺 薄层色谱法(TLC) 高效液相色谱法(HPLC) 柚皮苷 质量标准 |
| 英文关键词: Drugs, Chinese Herbal Maibi granules Extraction process Thin-layer chromatography (TLC) High-performance liquid chromatography (HPLC) Naringin Quality standard |
| 基金项目: |
| 作者 | 单位 | E-mail | | 李思光 | 亳州市中医院,药学部,安徽亳州 236706 | | | 王纪伟 | 亳州市中医院,药学部,安徽亳州 236706 | | | 尹安坤 | 亳州市中医院,药学部,安徽亳州 236706 | | | 刘旭东 | 蒙城县中医院制剂室,安徽亳州 233501 | | | 牛海军 | 安徽九方药物研究院有限公司,安徽合肥 230088 | | | 马奎军 | 亳州市中医院,脑病科,安徽亳州 236706 | | | 袁如柏 | 亳州市中医院,药学部,安徽亳州 236706 | 18712233588@163.com |
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| 中文摘要: |
| 目的优化脉痹颗粒的提取工艺，建立脉痹颗粒的质量标准。方法 2022年 5月至 2024年 5月以加水量、提取时间、提取次数为影响因素，黄芪甲苷含量及干膏得率的综合评分为评价指标，使用正交试验进行提取工艺优化。采用薄层色谱法(TLC)定性鉴别黄芪、三七、化橘红和丹参，高效液相色谱法( HPLC)测定柚皮苷含量。结果脉痹颗粒的最佳提取工艺为加水量 6倍，提取 2次，每次 1h。黄芪、三七、化橘红和丹参的 TLC斑点清晰，具有明显的专属性且没有阴性干扰；柚皮苷在浓度范围为 11.97~299.25 mg/L时呈现良好的线性关系( r=1.00，n=5)；在该实验中，精密度、稳定性和重复性实验的相对标准偏差(RSD)均低于 2.0%；平均加样回收率为 97.3%，RSD值为 1.78%(n=6)。结论优化了脉痹颗粒的提取工艺，建立的色谱方法简便可行，可用于脉痹颗粒的质量控制，为相关制剂开发利用提供参考。 |
| 英文摘要: |
| Objective To optimize the extraction process of Maibi granules and establish the quality standard of Maibi granules. Methods From May 2022 to May 2024, an orthogonal test was adopted to optimize the extraction process, with water addition amount,extraction duration and extraction times as influencing factors, and the comprehensive score of astragaloside content and dry extractyield as evaluation indexes. Thin-layer chromatography (TLC) was used for the qualitative identification of Astragali Radix, Notogin-seng Radix et Rhizoma, Citri Exocarpium Rubrum and Salviae Miltiorrhizae Radix et Rhizoma, and high-performance liquid chromatog-raphy (HPLC) was applied to determine the naringin content.Results The best extraction technology of Maibi granules was adding 6times of water, extracting 2 times, 1 hour each time. The TLC chromatograms of Radix Astragali, Notoginseng Radix et Rhizoma, Exo-carpium Citri Grandis and Salviae Miltiorrhizae Radix et Rhizoma showed clear spots with obvious specificity and no negative interfer-ence. Naringin showed a good linear relationship within the concentration range of 11.97-299.25 mg/L (r = 1.00, n = 5). In this experi-ment, the relative standard deviations (RSD) of precision, stability, and repeatability tests were all lower than 2.0%. The average recov-ery rate was 97.3%, RSD value was 1.78% (n = 6).Conclusion The extraction process of Maibi granules is optimized, and the estab-lished chromatographic method is simple and feasible, and suitable for the quality control of Maibi granules, providing a reference for the development and utilization of related preparations. |
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