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目的考察经羟丙基-β-环糊精和γ-环糊精包合罗红霉素制备出的注射液Ⅰ和Ⅱ的热稳定性,初步筛选出适合临床应用的罗红霉素注射液。方法研磨法制备包合物,HPLC测定罗红霉素注射液Ⅰ和Ⅱ经不同温度处理后的含量,以初均速法预测其有效期。结果罗红霉素注射液Ⅰt0.925℃=1.8a;罗红霉素注射液Ⅱt0.925℃=0.87a。结论由羟丙基-β-环糊精包合罗红霉素所制备的注射液,有效期可达1.8年,基本可以满足临床应用。
OBJECTIVE To investigate the thermal stability of injection Ⅰ and Ⅱ prepared by hydroxypropyl-β-cyclodextrin and γ-cyclodextrin inclusion roxithromycin, the roxithromycin injection suitable for clinical application was initially screened . Methods The inclusion compound was prepared by grinding method. The contents of roxithromycin injection Ⅰ and Ⅱ after different temperature treatments were determined by HPLC. The effective rate was estimated by the method of initial average velocity. Results roxithromycin injection Ⅰ t0.925 ℃ = 1.8a; roxithromycin injection Ⅱ t0.925 ℃ = 0.87a. Conclusion Hydroxypropyl-β-cyclodextrin inclusion roxithromycin prepared injection, valid for up to 1.8 years, basically meet the clinical application.