| 邵旭红,李玉华,李佳,利安娜,田旭,叶晶.小儿湿疹洗液质量标准研究[J].,2025,34(24):14-20 |
| 小儿湿疹洗液质量标准研究 |
| Study on Quality Standards of Pediatric Eczema Lotion |
| 投稿时间：2025-03-01 |
| DOI： |
| 中文关键词: 小儿湿疹洗液 质量标准研究 薄层色谱法 含量测定 高效液相色谱法 |
| 英文关键词: Pediatric Eczema Lotion Quality Standard Research Thin - layer Chromatography (TLC) Content Determination High - performance Liquid Chromatography (HPLC) |
| 基金项目:宁夏回族自治区2023年度青年科技托举人才培养项目（宁科协发组字〔2024〕6号）。 |
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| 中文摘要: |
| 目的：建立小儿湿疹洗液的薄层色谱鉴别和含量测定方法 ，并制定小儿湿疹洗液的质量标准。方法： 采用薄层色谱法 (TLC) 和高效液相色谱法 (HPLC) 进行质量评价并进行微生物检测 ；采用《中华人民共和国药典》 (2020年版） 四部通则进行装量 、相对密度和 pH 值测定。结果：TLC 法显示小儿湿疹洗液中金银花 、蒲公英 、麸炒枳壳 、 白鲜皮 、首乌藤 、连翘在色谱图相应位置上显相同颜色的斑点 ；有效性 、安全性 、微生物限度检查均符合标准 ；定量检测中绿原酸在 13 . 99 ~ 111 . 90 μg/mL 的范围内有良好的的线性关系（线性回归方程为 y = 41654x - 21958 , R = 1) , 加样回收率为96. 5% (RSD 为 1 . 04% ) 。结论： 以上检验方法的建立为小儿湿疹洗液的规范化生产提供了有力的质量控制依据 ，为患者临床用药安全 、有效 、稳定提供了科学保障。 |
| 英文摘要: |
| Objective To establish thin - layer chromatography (TLC) identification and content determination methods for pediat- ric eczema lotion and to develop its quality standards. Methods Quality evaluation was performed using thin - layer chromatography (TLC) and high - performance liquid chromatography (HPLC) , along with microbial testing. The volume , relative density , and pH value were determined according to the general guidelines of the pharmacopoeia of the People’sRepublic of China (2020 Edition , Part IV) . Results TLC results showed that the pediatric eczema lotion exhibited spots of the same color at the corresponding positions on the chromatogram for lonicera japonica (honeysuckle) , taraxacum mongolicum (dandelion) , citrus aurantium (stir - fried bran) , dic- tamnus dasycarpus , polygonum multiflorum , and forsythia suspensa. The effectiveness , safety , and microbial limit tests all met the standards. In the quantitative analysis , chlorogenic acid showed a good linear relationship within the range of 13 . 99 - 111 . 90 μg/mL (linear regression equation : y = 41654x - 21958 , R = 1) , with a recovery rate of 96. 5% (RSD = 1 . 04% ) . Conclusion The estab- lishment of these testing methods provides a strong basis for the standardized production of pediatric eczema lotion and ensures the safe- ty , efficacy , and stability of clinical medication for patients . |
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