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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。
Objective To establish the quality standard of toad skin sustained-release dropping pills. Methods The constituents were identified by TLC. The concentrations of cinobufacibinyl and bufalotoxine were determined by HPLC. The drug presence was observed by X-ray diffraction and scanning electron microscopy. The preliminary stability of the preparation was investigated. Results TLC was able to detect the corresponding spots from the sample. The linear ranges of cinobufagin and resibufogenin were 0.002 12 ~ 0.012 72 g · L -1 and 0.000 44 ~ 0.002 64 g · L -1, respectively. Repeatability Good, the recovery rate to meet the requirements; Drugs may be evenly dispersed in the amorphous matrix; Stability is better. Conclusion The quality evaluation method is of good specificity, accuracy and reliability and can effectively control the quality of the toad skin sustained-release dropping pills.