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目的药物本身的物理性质在药物纳米混悬液/药物纳米晶体的制备中起着重要作用,决定了最终的粒径和生产效率。目前已发表的研究大量集中在过程参数(如稳定剂筛选等),而药物本身对粒径减小的影响尚不清楚。方法本实验采用中药活性物橙皮素为研究对象,不同于以往的研究,初始药物物理性质通过喷雾干燥、旋转蒸发、淬火冷却进行改造,改造后的药物和初始药物物理性质(药物结晶度、颗粒微结构等)将进行对比并分别用于高压均质机制备纳米混悬液。结果喷雾干燥后的橙皮素能被高压均质得到最小的粒径。结论药物颗粒微结构的改变应为影响高压均质过程粒径减小效率的重要原因。同时,药物在最终的纳米混悬液中均为晶体,重结晶现象发生。
The physical properties of the target drug itself play an important role in the preparation of drug nanosuspension / drug nanocrystals and determine the final particle size and production efficiency. At present, a large number of published studies have focused on process parameters (such as stabilizer screening), while the effect of the drug itself on particle size reduction is not clear. Methods In this experiment, the active substance of hesperetin was used as the research object. Different from the previous studies, the physical properties of the initial drug were modified by spray drying, rotary evaporation and quenching. The physical properties of the modified drug and initial drug (drug crystallinity, Particle microstructure, etc.) will be compared and were used for high-pressure homogenizer preparation nanosuspension. Results The hesperetin after spray drying can be homogenized by high pressure to obtain the smallest particle size. Conclusion The change of microstructure of drug particles should be the important reason that affects the particle size reduction efficiency in high pressure homogenization process. At the same time, the drug is crystalline in the final nanosuspension and recrystallization occurs.