蟾酥透皮贴剂质量控制研究

Study on Quality Control of Chansu Transdermal

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 method for quality control of Chansu Transdermal. Methods ： Take initial adhesion, viscosity, peel strength as the index, the adhesion of Chansu Transdermal was controlled and the content of Cinobufagin and Bufogenin and release rate were determined by HPLC in Chansu Transdermal. Results ： The results of 3 hatches of samples showed that the initial adhesion, viscosity and peel strength met the requirement, and the piaster had good adhesion force. The calibration curves was linear between 0.2632-1.5792 μg, and the average recovery was 99.30%, RSD=l.19% （n=6）for Cinobufagin. The calibration curves was linear between 0.3208-1.9248 μ g, and the average recovery was 99.09%, RSD=l.06% （n=6）for Bufogenin. The cumulative release rate of 24 h was 86.37%. Conclusion：The detection method is scientific, reasonable, and can he used for the quality control of Chansu Transdermal.