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制备盐酸川芎嗪(1)凝胶膏剂,并以SD大鼠离体皮肤为屏障考察其体外透皮性能。根据所得渗透曲线得到1凝胶膏剂的体外渗透速率为350.51?g·cm-2·h-1。以SD大鼠为模型进行体内药动学试验。DAS 3.1.6软件拟合结果表明制品在体内的药动学符合二室模型,cmax、AUC0→∞和tmax分别为(92.40±16.40)mg/L、(1 024.32±39.98)mg·L-1·h和(4.20±0.94)h。采用Loo-Riegelman方法计算体内累积吸收百分数,进行体内外相关性考察。结果表明本品体内外相关性良好(R2=0.941)。
Preparation of Ligustrazine Hydrochloride (1) gel ointment, and in vitro SD rat skin as a barrier to investigate its in vitro transdermal performance. According to the obtained infiltration curve, the in vitro penetration rate of 1 gel ointment was 350.51 g · cm-2 · h-1. In vivo pharmacokinetics test was performed in SD rats. The software fitting results of DAS 3.1.6 showed that the pharmacokinetics of the product accord with the two-compartment model. The values of cmax, AUC0 → ∞ and tmax were (92.40 ± 16.40) mg / L and (1024.32 ± 39.98) mg · L-1 · H and (4.20 ± 0.94) h. Loo-Riegelman method was used to calculate the cumulative absorption percentage of the body, in vitro and in vivo correlation study. The results show that this product is good in vivo correlation (R2 = 0.941).