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| 牛黄咽痛散的制备工艺和质量标准研究 |
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瞿晶田1,2, 陈涛1,2, 王洋1,2, 吕明远1,2, 李连萍1,2, 柴士伟1,2
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1.天津中医药大学第一附属医院, 天津 300193;2.中医国家临床医学研究中心, 天津 300193
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| 摘要: |
| [目的] 制备牛黄咽痛散，建立其质量标准。[方法] 利用单因素实验考察原料的干燥温度、干燥时间、混合时间和辐照剂量，确定牛黄咽痛散的最佳制备工艺。应用薄层色谱法（TLC）鉴别样品中的靛蓝、靛玉红和盐酸小檗碱；应用理化鉴别法鉴别样品中的冰片；应用显微鉴别法鉴别样品中的青黛和蒲黄；应用HPLC测定样品中胆红素的含量。[结果] 青黛、黄柏、蒲黄和甘草片80℃常压干燥5 h，粉碎成最细粉，过120目筛，兑入冰片、人工牛黄最细粉，混合30 min，过120目筛，分装，即得牛黄咽痛散。靛蓝、靛玉红和盐酸小檗碱的TLC图斑点清晰且阴性样品无干扰；冰片理化鉴别显紫色至紫红色；青黛显微鉴别可见不规则块片或蓝色颗粒；蒲黄显微鉴别可见花粉粒相关特征；HPLC测定胆红素质量浓度为3.04~48.51 μg/mL时与峰面积线性良好，加样回收率，精密度、稳定性、重复性的RSD均合格，牛黄咽痛散中胆红素的含量47.30~53.52 μg/g，平均含量为50.62 μg/g。[结论] 牛黄咽痛散的制备和质量控制方法重复性好、专属性强。 |
| 关键词: 牛黄咽痛散 制备工艺 质量标准 |
| DOI：10.11656/j.issn.1672-1519.2026.09.11 |
| 分类号:R283.6 |
| 基金项目:天津市南开区中医药传承创新发展示范试点项目（20240204005）。 |
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| Preparation technology and quality standards of Bezoar Pharyngalgia Powder |
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QU Jingtian1,2, CHEN Tao1,2, WANG Yang1,2, LYU Mingyuan1,2, LI Lianping1,2, CHAI Shiwei1,2
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1.First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin 300193, China;2.National Clinical Research Center for Chinese Medicine, Tianjin 300193, China
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| Abstract: |
| [Objective] To establish the preparation process and quality standards for Bezoar Pharyngalgia Powder. [Methods] The optimal preparation process was determined by single-factor investigation method. Indigo，Indigo red and berberine hydrochloride were used as index components to establish a thin-layer chromatography（TLC） identification method for samples. Borneol in samples was identified by physical and chemical identification methods. Indigo and cattail pollen in samples were identified by microscopic identification. The content of bilirubin in this sample was determined by high-performance liquid chromatography（HPLC）. [Results] Indigo，yellow bark，cattail pollen and licorice slices were dried at 80 ℃ under atmospheric pressure for 5 hours. Afterwards， the decoction pieces are ground into the finest powder，sieved through a 120-mesh screen，and mixed with the powder of borneol and artificial bezoar. After mixing for 30 minutes，sieve through 120 meshes and pack separately，the product of Bezoar Pharyngalgia Powder is obtained. The TLC spots of Indigo，Indigo red and berberine hydrochloride were clear and had no interference in the negative controls，which can be used as a thin-layer identification of Bezoar Pharyngalgia Powder. HPLC results indicated that bilirubin showed good linearity in the range of 3.04 to 48.51 μg/mL. The RSDs of sample recovery rates，precision，stability and repeatability were all qualified. The content of bilirubin in Bezoar Pharyngalgia Powder was 47.30 to 53.52 μg/ g，with an average content of 50.62 μg/ g. [Conclusion] This method can be used to control the preparation process and production quality of Bezoar Pharyngalgia Powder. |
| Key words: Bezoar Pharyngalgia Powder preparation process quality standardsa |
