蟾皮缓释滴丸质量标准及初步稳定性研究

Quality Standard and Preliminary Stability of Toad Skin Sustained-release Dropping Pills

关键词:  蟾皮缓释滴丸  质量评价  初步稳定性

Key words:  toad skin sustained-release dropping pills  quality standards  preliminary stability

摘要:

目的 确立蟾皮缓释滴丸的质量标准。方法 采用TLC鉴定各成分，HPLC分别测定华蟾素毒基及酯蟾毒配基的含量，X衍射及扫描电镜观察药物存在状态，考察该制剂初步稳定性。结果 TLC鉴别能从样品中检出相应斑点，华蟾酥毒基和酯蟾毒配基线性范围分别是0.002 12~0.012 72 g·L^-1和0.000 44~0.002 64 g·L^-1，重复性好，回收率符合要求；药物可能是以无定形状态均匀分散于基质中；稳定性较好。结论 该质量评价方法专属性良好、准确、可靠，能有效控制蟾皮缓释滴丸的质量。

Abstract:

OBJECTIVE To establish the quality standard of toad skin sustained-release dropping pills(TSSDP). METHODS TLC testing was used to identify agents in various medicinal materials. The content of cinobufagin and resibufogenin were determined by HPLC. X-ray diffraction and SEM techniques wrer used to study drug statu，and preliminary stability testing were taken. RESULTS Corresponding spots were detected from the sample. The linear range of cinobufagin was 0.002 12-0.012 72 g·L^-1 and resibufogenin was 0.000 44-0.002 64 g·L^-1. They had a good linear relationship, reproducibility and recovery. The drug was possibly dispersed in the matrix with an amorphous state by X-ray diffraction and SEM techniques. The pills had good stability. CONCLUSION This method of quality evaluation is specific, accurate and reliable. It can effectively control the quality of the toad skin sustained-release dropping pills.