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彭志荣, 王旭易, 欧阳威, 雷雨菁, 李爽, 夏新华, 颜红.经典名方沙参麦冬汤颗粒制备工艺及质量标准研究[J].湖南中医药大学学报,2024,44(7):1181-1192[点击复制] |
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| 经典名方沙参麦冬汤颗粒制备工艺及质量标准研究 |
| 彭志荣,王旭易,欧阳威,雷雨菁,李爽,夏新华,颜红 |
| (湖南中医药大学药学院, 湖南 长沙 410208;湖南中医药高等专科学校附属第一医院(湖南省直中医医院), 湖南 株洲 412000) |
| 摘要: |
| 目的 制备经典名方沙参麦冬汤颗粒，并建立沙参麦冬汤颗粒的质量标准。方法 以熵权法及正交实验优选沙参麦冬汤回流提取工艺，与古法煎煮工艺进行对比，并进一步筛选颗粒的成型工艺。采用高效液相色谱法（high performance liquid chromatography, HPLC）建立沙参麦冬汤颗粒的指纹图谱和甘草苷、甘草酸的含量测定方法，并考察基准样品（煎液、冻干粉）、颗粒剂生产各环节（提取液、中间体、成品）指纹图谱的相似度和甘草苷的转移率。采用薄层色谱法（thin layer chromatography, TLC）对方中麦冬、桑叶、天花粉、白扁豆、甘草5味药材进行鉴别。结果 优化的回流提取工艺为浸泡0 h，提取两次，加水量分别为10、8倍，提取时间分别为2.0、1.5 h；成型工艺为以90%乙醇为润湿剂，加入20%的糊精制软材，经16目筛挤压制粒，60 ℃下干燥，过80筛整粒制备沙参麦冬汤颗粒。10批沙参麦冬汤颗粒、基准样品与颗粒生产各环节的指纹谱图相似度均大于0.90；基准煎液、冻干粉、提取液、中间体、成品的甘草苷转移率分别为75.60%、75.24%、91.67%、90.22%、73.57%。5味中药的TLC特征斑点清晰，且阴性无干扰。结论 指纹图谱相似度结果表明，各批次、各生产环节沙参麦冬汤颗粒的质量相对稳定，且与基准样品保持一致。经回流提取、浓缩、干燥、制粒后，甘草苷的转移率有所下降，颗粒的甘草苷转移率与原方汤剂的较为接近。本研究所建立的沙参麦冬汤颗粒制备工艺稳定可靠，质量标准检测方法简便可行，重复性好，以期为沙参麦冬汤颗粒的规模生产及其质量控制提供参考。 |
| 关键词: 经典名方 沙参麦冬汤 颗粒剂 指纹图谱 制备工艺 质量标准 |
| DOI：10.3969/j.issn.1674-070X.2024.07.006 |
| 投稿时间：2023-11-10 |
| 基金项目:湖南中医药大学重点学科中药学科（校行发规字〔2023〕2号）；湖南省重点研发计划项目（2018SK2114）；湖南省自然科药联合基金项目（2023JJ60133）。 |
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| Preparation technology and quality standards of the classic formula, Shashen Maidong Granule |
| PENG Zhirong, WANG Xuyi, OUYANG Wei, LEI Yujing, LI Shuang, XIA Xinhua, YAN Hong |
| (Schoool of Pharmacy, Hunan University of Chinese Medicine, Changsha, Hunan 410208, China;The First Hospital of Hunan Chinese Medical College (Hunan Province Directly Affiliated TCM Hospital), Zhuzhou, Hunan 412000, China) |
| Abstract: |
| Objective To prepare the classic formula Shashen Maidong Granule (SSMDG) and establish its quality standards. Methods The reflux extraction process of Shashen Maidong Decoction was optimized by entropy weight method and orthogonal experiment, compared with the traditional decoction process, and the molding process of granules was further screened. High performance liquid chromatography (HPLC) was used to establish the fingerprint of SSMDG and the content determination method of liquiritin and acid glycyrrhizinate. The similarity of fingerprint and transfer rate of liquiritin in the reference sample (decoction, freeze-dried powder) and each link of granule production (extract, intermediate, finished product) were investigated. Thin layer chromatography (TLC) was used to identify Maidong (Ophiopogonis Radix), Sangye (Mori Folium), Tianhuafen (Trichosanthis Radix), Baibiandou (Lablab Semen Album), and Gancao (Glycyrrhizae Radix Et Rhizoma). Results The optimized reflux extraction process involved soaking for 0 h, extracting twice, adding 10 and 8 times of water, and extracting for 2.0 h and 1.5 h, respectively. The molding process was as follows: 90% ethanol was used as wetting agent, 20% dextrin for soft material, extruded and granulated by 16 mesh sieve, dried at 60 ℃, and granulated by 80 mesh sieve to prepare SSMDG. The similarity of fingerprints of 10 batches of SSMDG, reference samples, and each link of granule production was greater than 0.90. The transfer rates of liquiritin in the standard decoction, freeze-dried powder, extract, intermediate, and finished product were 75.60%, 75.24%, 91.67%, 90.22%, and 73.57%, respectively. The TLC characteristic spots of 5 Chinese medicines were clear and negative without interference. Conclusion The results of fingerprint similarity showed that the quality of SSMDG in each batch and each production link was relatively stable and consistent with the reference sample. After reflux extraction, concentration, drying, and granulation, the transfer rate of liquiritin decreased, and the transfer rate of liquiritin in granules was close to that of the original decoction. The preparation process of SSMDG established in this study is stable and reliable, and the quality standard detection method is simple, feasible, and reproducible, hoping to provide reference for the scale production and quality control of SSMDG. |
| Key words: classic formula Shashen Maidong Granule granules fingerprint preparation technology quality standard |
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