| 摘要: |
| 目的：建立水蛭超微饮片的质量标准。方法：以水蛭对照药材为对照，建立薄层色谱方法；以次黄嘌呤和水蛭胺C为指标，建立高效液相色谱法（high performance liquid chromatography，HPLC）的含量测定方法。结果：水蛭超微饮片在薄层色谱中，与对照药材相应位置上显相同颜色的主斑点，且分离度较好；建立的次黄嘌呤和水蛭胺C的HPLC含量测定方法通过方法学验证；次黄嘌呤在1.00～100.04 μg/mL范围内，水蛭胺C在1.28～79.89 μg/mL范围内，线性关系良好，平均回收率分别为104.04%、102.12%，相对标准偏差（relative standard deviation，RSD）分别为0.84%、2.66%。不同柱温、不同流速、不同色谱柱条件下，检测的含量RSD均小于3%，方法耐用性良好；15批次水蛭超微饮片中，次黄嘌呤的含量为0.33～2.01 mg/g，水蛭胺C的含量为0.048～0.200 mg/g。结论：通过薄层色谱和HPLC法建立的方法操作简单，专属性强、准确度高，可作为水蛭超微饮片的质量控制。 |
| 关键词: 水蛭 超微饮片 次黄嘌呤 水蛭胺C 质量标准 |
| DOI： |
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| Quality standard for ultrafine decoction pieces of the animal medicine leech |
| XIE Yi,SHEN Bingbing,LI Xiang,ZHANG Shuihan,GE Jinwen |
| (Hunan Academy of Chinese Medicine, Changsha 410013, Hunan, China) |
| Abstract: |
| Objective： To establish the quality standard for leech ultrafine decoction pieces. Methods： A thin-layer chromatography （TLC） method was established using the reference medicinal material of leech as a reference, and a high-performance liquid chromatography （HPLC） method was established to determine the content of hypoxanthine and hirudonucleodisulfide C. Results： On TLC, the leech ultrafine decoction pieces showed main spots of the same color at the corresponding positions to the reference medicinal material, with good separation. Methodological validation was performed for the HPLC method established for determining the content of hypoxanthine and hirudonucleodisulfide C; hypoxanthine showed a good linear relationship within the range of 1.00-100.04 μg/mL, and hirudonucleodisulfide C showed a good linear relationship within the range of 1.28-79.89 μg/mL, with an average recovery of 104.04% and 102.12%, respectively, and a relative standard deviation （RSD） of 0.84% and 2.66%, respectively. The RSDs of the contents measured were <3% under different column temperatures, flow rates, and chromatographic columns, suggesting good method ruggedness; in the 15 batches of leech ultrafine decoction pieces, the content of hypoxanthine ranged from 0.33 to 2.01 mg/g, and that of hirudonucleodisulfide C ranged from 0.048 to 0.200 mg/g. Conclusion： The methods established using TLC and HPLC are simple, specific, and accurate and can be used for the quality control of leech ultrafine decoction pieces. |
| Key words: leech ultrafine decoction pieces hypoxanthine hirudonucleodisulfide C quality standard |
