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目的:建立蟾酥透皮贴剂的质量控制方法。方法:以初黏力、持黏力、剥离强度为指标控制黏附力,采用HPLC法对蟾酥透皮贴剂中华蟾酥毒基和脂蟾毒配基进行含量和释放度测定。结果:3批样品结果显示,初黏力、持黏力、剥离强度均符合要求,表明该贴剂具有良好的黏附能力;华蟾酥毒基在0.263 2~1.579 2μg范围内呈线性关系,平均回收率为99.30%,RSD=1.19%(n=6);脂蟾毒配基在0.320 8~1.924 8μg范围内呈线性关系,平均回收率为99.09%,RSD=1.06%(n=6);24 h累积释放率达86.37%。结论:该检测方法科学、合理,可用于蟾酥透皮贴剂质量控制。
OBJECTIVE: To establish a quality control method for toad skin transdermal patch. Methods: The adhesive force was controlled by the indexes of initial viscosity, holding capacity and peel strength. The content and release of toad venom toxin and toadine in toad transdermal patch were determined by HPLC. Results: The results of three batches of samples showed that the initial adhesive strength, holding capacity and peel strength all met the requirements, indicating that the adhesive had good adhesive ability. The concentration of cinobufagin was linear in the range of 0.263 2 ~ 1.579 2 μg The average recovery was 99.09% and the RSD was 1.06% (n = 6). The average recovery was 99.30%, RSD = 1.19% (n = 6) h cumulative release rate of 86.37%. Conclusion: The method is scientific and reasonable and can be used for quality control of toad skin transdermal patches.