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目的:考察取代度为60%的N-三甲基壳聚糖(TMC60)对哈西奈德软膏体外透皮速率的影响。方法:将2%TMC60用于哈西奈德软膏中作为吸收促进剂,并以含2%月桂氮芯卓酮的哈西奈德软膏作为阳性对照,以不含任何促渗剂的哈西奈德软膏作为阴性对照,采用Franz扩散池法进行小白鼠离体皮肤渗透实验,HPLC法测定接受液中哈西奈德的含量,计算累积透过量Q,得出Q-t回归方程及稳态渗透速率J。结果:哈西奈德线性范围为2.5~75mg.L-1,回归方程为Y=0.133 8+4.491 6X,r=0.999 9;回收率为(100.0±0.9)%;日内精密度为1.26%;日间精密度为2.40%。月桂氮芯卓酮组和TMC60组的J分别为3.71,3.89(μg.m-2.h-1),两者差异无显著性(P>0.05),而与阴性组相比差异均具有显著性(P<0.05)。结论:2%TMC60对哈西奈德软膏的体外透皮吸收有较好的促进作用,其作用与2%月桂氮芯卓酮相似。
OBJECTIVE: To investigate the effect of TMC60 with a substitution degree of 60% on the transdermal rate of halcinonide ointment in vitro. METHODS: 2% TMC60 was used as an absorption enhancer in hashimycin ointment, and as a positive control, hashin ointment containing 2% azacitidine, and without any penetration enhancer as Negative control, Franz diffusion cell method was used to in vitro skin penetration test in mice. HPLC method was used to determine the content of halcinonide in the receiving solution. The cumulative permeation Q was calculated. The Qt regression equation and steady state permeation rate were obtained. Results: The linear range of halcinonide was 2.5-75 mg.L-1, the regression equation was Y = 0.133 8 + 4.491 6X, r = 0.999 9; the recovery was (100.0 ± 0.9)%; intraday precision was 1.26% Between the precision of 2.40%. There was no significant difference between the two groups (P> 0.05), but the differences between the two groups were significant (P <0.05). CONCLUSION: 2% TMC60 can promote the transdermal absorption of halcinonide ointment in vitro, and its effect is similar to that of 2% laurocapram.