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目的以聚氰基丙烯酸正丁酯(PBCA)纳米粒为载体,制备包载中药单体蟾毒灵的纳米粒制剂。方法采用醇中聚合法制备了包载蟾毒灵的PBCA纳米粒,通过单因素试验及正交试验设计对制备工艺进行考察,并测定了纳米粒的粒径分布、形态、包封率、载药量及溶血性等理化性质。结果醇中聚合法制备的蟾毒灵PBCA纳米粒形态均匀,平均粒径为(151.2-6.1)nm,多分散系数为0.133±0.024,Zeta电位为(-7.09±0.58)mV,包封率为(70.812±6.139)%,载药量为(1.990±0.291)%;与蟾毒灵原料药相比,该制剂的溶血性更低,安全性有所提高。结论蟾毒灵PBCA纳米粒的制备方法,可有效缩短中药单体与酸性介质的接触时间,制得的纳米粒各项理化性质良好,可为易水解中药单体纳米粒载体的制备提供新思路。
OBJECTIVE To prepare nanoparticle preparations containing bufalin, a traditional Chinese medicine, with polybutylcyanoacrylate (PBCA) nanoparticles as carrier. Methods Bufalin-loaded PBCA nanoparticles were prepared by alcohol polymerization. The preparation process was investigated by single factor test and orthogonal design. The particle size distribution, morphology, entrapment efficiency, Drugs and hemolytic and other physical and chemical properties. Results The prepared bufalin PBCA nanoparticles showed a uniform morphology with an average diameter of (151.2-6.1) nm, a polydispersity of 0.133 ± 0.024 and a Zeta potential of (-7.09 ± 0.58) mV. The encapsulation efficiency was (70.812 ± 6.139)%, and the drug loading was (1.990 ± 0.291)%. Compared with the Chinese medicine Bufalin, the preparation had lower hemolytic activity and improved safety. Conclusion The preparation method of bufalin PBCA nanoparticles can effectively shorten the contact time of traditional Chinese medicine monomer with acidic medium. The physical and chemical properties of the prepared nanoparticles are good, which can provide a new idea for the preparation of simple nanoparticle carrier .