伤痛宁巴布剂的制备及透皮吸收的研究

目的:优选伤痛宁巴布剂基质的最佳配比,评价巴布剂的体外生物有效性。方法:通过均匀设计法试验,以黏着力为考察指标,选出最佳处方;通过琼脂凝胶扩散法,测定巴布剂的体外透皮吸收率。结果:伤痛宁膏基质的最佳处方为聚丙烯酸钠:聚乙二醇:明胶:高岭土:甘油:丙二醇=3.5:4.5:9:0.6:2:4,模拟透皮吸收率为3.3%。结论:优化的处方基质可以用于本品巴布剂的制备。

Comparative Studies on Detection of Antibodies against Infectious Bursal Disease Virus with Test Strips and Agar Gel Immunodiffusion Method

[Objective] This study aimed to compare the detection results of antibodies against infectious bursal disease virus with test strips and agar gel immunodiffusion method. [Method] Antibodies against infectious bursal disease virus in chicken serum were detected using test strips developed in our laboratory, and the results were comparad^with that using traditional agar diffusion method. [Result] The comparative study of the two methods showed that the sensitivity of test strips was eight times over agar gel immunodiffusion; test strips showed higher detection rate in the deter- mination test of 216 clinical samples, with high specificity, easy preservation, and simple and rapid operation, thereby being more suitable for the monitoring of clinical antibodies. [Conclusion] Test strips could replace the existing serological methods, having great promotion and application value in antibody monitoring.

过氧苯甲酰凝胶的研制和体外评价

制备了一种过氧苯甲酰凝胶,并与原研制剂进行体外等效性评价。采用琼脂凝胶扩散法测定凝胶中药物的扩散系数(K),并以此为指标用单因素试验筛选出自制凝胶的处方组成。所得优化处方中采用d(0.9)为5.86μm过氧苯甲酰原料药,含泊洛沙姆407 0.3%,卡波姆980 1.5%。根据过氧苯甲酰在不同介质中的饱和溶解度结果筛选接收介质。以市售凝胶剂班赛~?为对照,比较自制凝胶与原研制剂体外释放曲线的相似性,结果显示二者一致性良好(相似因子为72)。以猪皮为屏障进行体外透皮释放试验,HPLC法测定接收液、皮肤表面和皮肤层内过氧苯甲酰浓度,以及皮肤内的苯甲酸浓度。结果显示,自制凝胶与原研制剂中绝大部分药物都滞留在皮肤表面,皮肤中均检出少量过氧苯甲酸和苯甲酸。自制凝胶和市售凝胶的体外释放行为和体外透皮释放特性相似,提示自制凝胶在体外具有相同的有效性。