| 郑棵林,周思茹,陆华,何成章,秦银燕,雷宇,黄春喜.清热化痰通腑外用制剂的质量标准研究[J].,2025,34(8):51-55 |
| 清热化痰通腑外用制剂的质量标准研究 |
| Study on the Quality Standard for Qingre Huatan Tongfu External Preparation |
| 投稿时间：2024-07-18 |
| DOI： |
| 中文关键词: 清热化痰通腑外用制剂 大黄素 薄层色谱 高效液相色谱 质量标准 |
| 英文关键词: Qingre Huatan Tongfu external preparation Emodin TLC HPLC Quality Standard |
| 基金项目:广西中医药适宜技术开发与推广项目[GZSY22-63]。 |
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| 中文摘要: |
| 目的：建立清热化痰通腑外用制剂的质量标准。方法：采用薄层色谱方法对清热化痰通腑外用制剂中的大黄、枳实、黄芩、石菖蒲进行定性鉴别；采用高效液相色谱法对制剂中大黄素、大黄酸、大黄酚进行含量测定，流动相采用甲醇-0.1%磷酸水溶液(70∶30);流速为1.0mL·min-1;检测波长为227nm;柱温为30℃;进样量为10μL。结果：薄层色谱法能定性检出大黄、枳实、黄芩、石菖蒲，斑点清晰，分离度好且阴性对照无干扰；大黄酸、大黄素、大黄酚分别在1.13~22.08μg·mL-1(r=0.9999)、1.00~9.99μg·mL-1(r=0.9999)、1.08~10.81μg·mL-1(r=0.9999)范围内与峰面积均呈现良好的线性关系，平均回收率分别为102.61%(RSD=1.37%)、100.26%(RSD=2.16%)、102.32%(RSD=1.06%)。结论：所建立的定性、定量检测方法简便快速，结果准确，专属性强，可用于清热化痰通腑外用制剂的质量控制。 |
| 英文摘要: |
| Objective To establish the quality standard for Qingre Huatan Tongfu external preparation. Methods TLC was used to identify Radix et Rhizoma Rhei , Fructus aurantii immaturus , Radix Scutellariae and Rhizoma Acori Tatarinowii in the preparation; the contents of rhein , emodin and chrysophanic in Qingre Huatan Tongfu external preparation were determined by HPLC . Mobile phase was methanol - 0. 1% phosphoric acid solution (70 ∶30) ,the flow rate was 1.0 mL·min - 1 , the detection wavelengths were 227 nm ,the column temperature was 30 ℃ , and the volume injection was 10 μL. Result TLC spots were clear and well - separated without negative interference; the calibration curves of rhein , emodin and chrysophanic were linear over the range of 1 .13 -recoveries were 102. 61% , 100. 26% and 102. 32% with the RSDs of 1.37% , 2.16% and 1.06% ,respectively (n = 6) . Conclusion The method is fast and accurate with good specificity , and can be used for the quality control of Qingre Huatan Tongfu external preparation. |
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