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目的:探讨冠心贴凝胶膏剂中丹参素等有效组分的体外经皮渗透性能。方法:采用改良Franz扩散池法,选取生理盐水为吸收液,通过HPLC测定丹参素、阿魏酸、盐酸川芎嗪、隐丹参酮、丹参酮ⅡA等组分经大鼠皮的累积释放量和经皮渗透量,考察5种组分的经皮渗透性,色谱条件为Kromasil C18色谱柱(4.6 mm×250 mm,5μm),检测波长280 nm,流速1.0 mL·min-1,流动相甲醇(A)-0.5%乙酸水溶液(B)进行二元线性梯度洗脱,柱温室温,进样量10μL。结果:冠心贴凝胶膏剂中各组分的累积释放量和经皮渗透量顺序为阿魏酸>丹参素>盐酸川芎嗪>隐丹参酮>丹参酮ⅡA,在24 h内各组分的累积相对经皮渗透率依次为73.09%,82.62%,82.89%,37.22%,24.80%。丹参素等5种组分经大鼠皮肤的累积释放率和累积经皮渗透率均符合Higuchi方程,相关系数均为0.999 9。结论:冠心贴凝胶膏剂中丹参素等组分具有较好的释药性能和经皮渗透性能。
Objective: To investigate the in vitro transdermal permeation of effective components such as Danshensu in Guanxin Paste Gel. Methods: The modified Franz diffusion cell method was used to select the physiological saline as absorption liquid. The cumulative release and transdermal penetration of Danshensu, ferulic acid, ligustrazine hydrochloride, cryptotanshinone and tanshinone ⅡA were determined by HPLC The transdermal permeability of the five components was investigated. The chromatographic conditions were Kromasil C18 column (4.6 mm × 250 mm, 5 μm), detection wavelength at 280 nm and flow rate of 1.0 mL · min -1. The mobile phase methanol (A) 0.5% acetic acid aqueous solution (B) binary linear gradient elution, column temperature, injection volume 10μL. Results: The cumulative release amount and transdermal permeation amount of each component in Guanxin plaster gel were Ferulic acid> Danshensu> Ligustrazine Hydrochloride> Cryptotanshinone> Tanshinone Ⅱ A, and the accumulation of each component within 24 h Percutaneous permeability followed by 73.09%, 82.62%, 82.89%, 37.22%, 24.80%. The cumulative release rate and cumulative transdermal permeability of five components such as Danshensu were consistent with Higuchi equation, and the correlation coefficient was 0.999 9. CONCLUSION: Danshensu and other components of Guanxin plaster have good release properties and transdermal permeability.