目的：探讨机械振荡法制备激肽原酶载药微泡的最佳参数。方法：机械振荡法制备激肽原酶载药微泡，利用不同的振荡时间，激肽原酶与微泡不同的混合比例，检测载药微泡的携带率、激肽原酶的效价、载药微泡的粒径及粒径分布、浓度、pH值、包封率。结果：振荡时间在45 s，载药微泡携带率最高，为（93.46±1.7）%。激肽原酶与微泡混合比在4∶1的条件下，激肽原酶效价最高且达到合格标准。载药微泡的表面电位为（-56.47±8.23）mV，平均粒径为（13.2±7.3）μm，粒径范围为6~20μm，浓度为（6~7）×108/mL，pH 值为（6.20±0.01），包封率为（52.5±0.8）%。结论：采用机械振荡法可成功制备激肽原酶载药微泡，该载药微泡药物携带率高，稳定性较好，且能维持良好的药物效价。%ObjectiveTo investigate the optimal parameters for preparing Kallidinogenase-loaded microbubbles (KLMs) by mechanical shaking method. Methods: Kallidinogenase-loaded microbubbles were prepared using mechanical shaking method. Different shaking time and mixing ratio were used. The carrying rate and stability of Kallidinogenase were analyzed. The A405nm value of the Kininogenase was tested and calculated for the assay of the Kallidinogenase. The characterization and properties (appearance, surface potential, size, distribution, concentra-tion, and pH value) of the microbubbles were observed. The enclosed efficiency of Kininogenase was detected. Results:The best shaking time was 45 s with carrying rate of (93.46±1.7)%. Kininogenase assay was up to stan-dard when the Kininogenase and microbubbles mixture ratio was 4:1. The mean surface potential was (-56.47±8.23)mV, the mean diameter was (13.2±7.3)μm,ranged from 6~20μm. The concentration was (6~7)í108/mL, pH value was (6.20±0.01), the drug enclosed efficiency was(52.5±0.8)%. Conclusion:The Kallidinogenase-load-ed microbubbles, with ideal characters of safety and efficacy, could be successfully prepared via mechanical shaking method.
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