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| 胡氏养胃颗粒的制备工艺与质量控制研究 |
| Study on the Preparation Process and Quality Control of Hu"s Stomach Nourishing GranulesPAN Xiang jun Xu Jian Bing WANG Guo jun* |
| 投稿时间：2025-02-24 修订日期：2025-02-24 |
| 中文关键词: 胡氏养胃颗粒 提取工艺 TLC鉴别 盐酸小檗碱 含量测定 |
| 英文关键词: Hu"s stomach nourishing granules Extraction process Identification by thin layer chromatography Berberine hydrochloride Content determination |
| 基金项目:金华市科技计划重点项目资助(2022-3-113) |
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| 中文摘要: |
| 目的：确定胡氏养胃颗粒的制备工艺,建立质量控制方法。方法：以盐酸小檗碱转移率为指标,正交试验优化胡氏养胃颗粒的制备工艺,采用薄层色谱法(TLC)对处方中的炒黄连进行了定性鉴别,并利用高效液相色谱法(HPLC)测定了胡氏养胃颗粒中盐酸小檗碱的含量。结果：最佳提取工艺条件为提取3次,分别以10倍量水、8倍量水、8倍量水,提取1.0h、0.5h、0.5h；所建立的TLC方法具有良好的专属性与重现性,适用于炒黄连的鉴别。此外,盐酸小檗碱在0.14µg～0.74µg范围内呈现良好的线性关系,平均加样回收率为101.58%,相对标准偏差(RSD)为1.38%。实验结果显示,该方法在精密度、稳定性等方面均符合分析要求。结论：胡氏养胃颗粒制备工艺简便易行,建立的TLC定性和HPLC定量方法可用于胡氏养胃颗粒的质量控制。 |
| 英文摘要: |
| Objective: To determine the preparation process of Hu"s Yangwei granules and establish a quality control method. Method:Using the transfer rate of berberine hydrochloride as an indicator, an orthogonal experiment was conducted to optimize the preparation process of Hu Shi Yang Wei granules. Qualitative identification of the medicinal flavors such as fried Huanglian in the prescription was carried out using TLC method, and the content of berberine hydrochloride in Hushi Yangwei granules was determined by HPLC method. Result: The determined extraction process conditions were 3 times of extraction, with 10 times, 8 times, and 8 times the amount of water extracted for 1.0h, 0.5h, and 0.5h, respectively; The established TLC identification method has good specificity and reproducibility. Berberine hydrochloride has a good linear relationship in the range of injection amount of 0.14 µ g to 0.74 µ g, with an average recovery rate of 101.58% and RSD of 1.38%. The precision and stability meet the requirements. Conclusion: The preparation process of Hu"s Yangwei granules is simple and feasible, and the established TLC qualitative and HPLC quantitative methods can be used for quality control of Hu"s Yangwei granules. |
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