| 引用本文: | 李雅雅,刘伯宇,黄绳武.蟾酥缓释微丸的质量标准[J].中国现代应用药学,2015,32(11):1324-1329. |
| LI Yaya,LIU Boyu,HUANG Shengwu.Quality Standard of Venenum Bufonis Sustained-release Pellets[J].Chin J Mod Appl Pharm(中国现代应用药学),2015,32(11):1324-1329. |
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| 摘要: |
| 目的 研究并制定蟾酥缓释微丸的质量标准。方法 采用TLC鉴别制剂中各成分；采用HPLC分别测定华蟾酥毒基及酯蟾毒配基的含量；采用紫外分光光度计测定制剂中吲哚生物碱类成分。结果 3批制剂均出现与对照品相对应的斑点，阴性制剂无干扰；华蟾酥毒基在0.018 4~0.570 4 μg内呈良好线性关系(r=0.999 8，n=6)，平均加样回收率为100.46%，RSD为3.08%(n=9)；酯蟾毒配基在0.007 8~0.241 8 μg内呈良好线性关系(r=0.999 8，n=6)，平均加样回收率为98.28%，RSD为2.22%(n=9)。初步确定3批样品中华蟾素毒基与酯蟾毒配基的总量不得<0.006 g·g-1，吲哚生物碱类含量不得<0.007 g·g-1。结论 本法专属性强、简便可行，可作为蟾酥缓释微丸的质量标准。 |
| 关键词: 蟾酥缓释微丸 薄层色谱法 高效液相色谱法 紫外分光光度计 质量标准 |
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| Quality Standard of Venenum Bufonis Sustained-release Pellets |
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LI Yaya, LIU Boyu, HUANG Shengwu
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Pharmaceutical College, Zhejiang Chinese Medical University, Hangzhou 310053, China
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| Abstract: |
| OBJECTIVE To study and develop the quality standards of Venenum Bufonis sustained-release pellets. METHODS TLC method was used to identify agents in various medicinal materials. The content of cinobufagin and resibufogenin were determined by HPLC. The ultraviolet spectrophotometer was used to determine indole alkaloids. RESULTS Corresponding spots were observed in 3 batches of samples by comparing with the reference substance. Negative preparations had no interference. The linear range of cinobufagin was 0.018 4-0.570 4 μg(r=0.999 8, n=6), and the average recovery rate was 100.46%, RSD=3.08%(n=9). The linear range of resibufogenin was 0.007 8-0.241 8 μg(r=0.999 8, n=6), and the average recovery rate was 98.28%, RSD=2.22%(n=9). It was preliminarily determined that the total content of cinobufagin and resibufogenin of 3 batches of samples was not <0.006 g.g-1, and the content of indole alkaloids contents was not <0.00 7 g.g-1. CONCLUSION This method is specific, simple and feasible to be the quality standard of Venenum Bufonis sustained-release pellets. |
| Key words: Venenum Bufonis sustained-release pellets TLC HPLC ultraviolet spectrophotometer quality standard |
