| 健脾消积颗粒提取工艺及质量标准研究 |
| 投稿时间：2024-03-15 点此下载全文
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| 引用本文：文志云,沈泓佑,张颖,李星宇,邱宏聪,韦韡.健脾消积颗粒提取工艺及质量标准研究[J].中国现代中药,2024,26(10):1765-1772 |
| DOI：10.13313/j.issn.1673-4890.20240315001 |
| 摘要点击次数: 45 |
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| 作者中文名 | 作者英文名 | 单位中文名 | 单位英文名 | E-Mail |
| 文志云 |
WEN Zhi-yun |
广西中医药研究院 制剂研发中心，广西 南宁 530022 |
Preparation Research and Development Center, Guangxi Institute of Chinese Medicine and Pharmaceutical Science, Nanning 530022, China |
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| 沈泓佑 |
SHEN Hong-you |
广西中医药研究院 制剂研发中心，广西 南宁 530022 |
Preparation Research and Development Center, Guangxi Institute of Chinese Medicine and Pharmaceutical Science, Nanning 530022, China |
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| 张颖 |
ZHANG Ying |
广西中药质量标准研究重点实验室，广西 南宁 530022 |
Guangxi Key Laboratory of Traditional Chinese Medicine Quality Standards, Nanning 530022, China |
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| 李星宇 |
LI Xing-yu |
广西中药质量标准研究重点实验室，广西 南宁 530022 |
Guangxi Key Laboratory of Traditional Chinese Medicine Quality Standards, Nanning 530022, China |
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| 邱宏聪 |
QIU Hong-cong |
广西中药质量标准研究重点实验室，广西 南宁 530022 |
Guangxi Key Laboratory of Traditional Chinese Medicine Quality Standards, Nanning 530022, China |
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| 韦韡* |
WEI Wei |
广西中医药研究院 药品食品检验检测中心，广西 南宁 530022 |
Drug and Food Inspection Center, Guangxi Institute of Chinese Medicine and Pharmaceutical Science, Nanning 530022, China |
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| 基金项目:广西重点研发计划项目（20193116）；广西中医药多学科交叉创新团队项目（GZKJ2306） |
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| 中文摘要:目的 优化健脾消积颗粒的提取工艺，建立其质量标准。方法 以柚皮苷和新橙皮苷的含量为主要评价指标，利用单因素考察和正交试验确定健脾消积颗粒的最佳提取工艺。将枳壳和莪术作为指标成分建立样品的薄层色谱法（TLC）；测定样品的水分、粒度和溶化性；使用高效液相色谱法（HPLC）同时测定该样品中柚皮苷和新橙皮苷的含量。结果 健脾消积颗粒的最佳提取工艺为10倍量水煎煮2次，第1次2 h、第2次1 h，稠膏相对密度为1.20~1.25（70 ℃）；枳壳和莪术的TLC图斑点清晰且阴性样品无干扰；6批样品的水分为2.80%~3.78%，粒度为1.29%~4.97%，溶化性为全部溶化，无异物、无焦屑；HPLC测定柚皮苷、新橙皮苷质量浓度分别为9.78~97.80、10.34~103.40 μg·mL–1时与峰面积线性良好，加样回收率分别为99.31%~100.69%（RSD=0.49%）、99.69%~100.98%（RSD=0.47%），精密度、稳定性、重复性的RSD均小于2%，每袋健脾消积颗粒样品中柚皮苷不得少于20 mg、新橙皮苷不得少于12 mg。结论 该方法重复性好、专属性强，可用于控制健脾消积颗粒的质量。 |
| 中文关键词:健脾消积颗粒 柚皮苷 新橙皮苷 质量标准 薄层色谱法 |
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| Extraction Technology and Quality Standards of Jianpi Xiaoji Granules |
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| Abstract:Objective To optimize the extraction process of Jianpi Xiaoji Granules and establish quality standards for Jianpi Xiaoji Granules.Methods With the content of naringin and neohesperidin as the main evaluation indicators, the optimal extraction process was determined by single-factor investigation method and orthogonal experiment. Aurantii Fructus and Curcumae Rhizoma were used as index components to establish a thin-layer chromatography (TLC) identification method for samples. The moisture, particle size, and solubility of the sample were determined. High-performance liquid chromatography (HPLC) was used to determine the content of naringin and neohesperidin in the sample simultaneously.Results The optimal extraction process of Jianpi Xiaoji Granules involved decocting with 10 times the amount of water twice, for 2 hours the first time and 1 hour the second time, with a relative density of the dense paste of 1.20-1.25 at 70 ℃. The TLC spots of Aurantii Fructus and Curcumae Rhizoma were clear and had no interference in the negative controls, which can be used as a thin-layer identification of Jianpi Xiaoji Granules. The moisture content of six batches of samples was 2.80%-3.78%, the particle size was 1.29%-4.97%, and the solubility showed complete dissolution, with no foreign matter or scorched residue. HPLC results indicated that naringin showed good linearity in the range of 9.78-97.80 μg·mL–1 and neohesperidin in the range of 10.34-103.40 μg·mL–1, and the sample recovery rates were 99.31%-100.69% (RSD=0.49%) and 99.69%-100.98% (RSD=0.47%), respectively. The RSDs of precision, stability, and repeatability were less than 2%. The naringin in each bag of samples shall not be less than 20 mg, and the neohesperidin shall not be less than 12 mg.Conclusion This method has good repeatability and exclusivity and can be used to control the production quality of Jianpi Xiaoji Granules. |
| keywords:Jianpi Xiaoji Granules naringin neohesperidin quality standard TLC |
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