蟾酥缓释微丸的质量标准

Quality Standard of Venenum Bufonis Sustained-release Pellets

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 4μg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 8μg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。

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.