共研磨法制备吸入用丹酚酸-丹参酮复合微粉及其表征

发布时间：2018-12-16 19:45

【摘要】：建立了一种将丹参中的脂溶性和水溶性有效成分共微粉化的方法,制备得到了适用于肺部吸入给药的丹酚酸-丹参酮复合微粉。以湿法球磨粉碎为制备方法,复合微粉1~5μm体积分数为评价指标,采用中心组合实验设计(central composite design,CCD)-效应面法进行工艺优化。通过扫描电镜、激光粒度分布仪、X-射线衍射分析仪等对复合微粉进行质量评价,并测定其流动性和引湿性。结果显示最优制备工艺条件下得到的丹酚酸-丹参酮复合微粉粒径分布均一,D50为2.33μm,1~5μm体积分数为80.82%,休止角为(50.60±1.13)°,临界相对湿度约为77%。共微粉化使药物微粒的粒径显著减小,药物的无定形物稍有增加,对粉体的流动性、吸湿性无显著影响。该研究表明湿法球磨可用于性质差异大的多种成分的共微粉化,制备得到适于吸入的丹酚酸-丹参酮复合微粉,为进一步吸入粉雾剂的制备提供基础。
[Abstract]:A new method was developed to prepare salvianolic acid-tanshinone compound powder for lung inhalation by co-pulverizing the liposoluble and water-soluble active components in Salvia miltiorrhiza (Salvia miltiorrhiza). With wet ball milling as the preparation method and the volume fraction of 1 渭 m of the composite powder as the evaluation index, the central combination experiment was used to design (central composite design,CCD) -effect surface method to optimize the process. The quality of the composite powder was evaluated by scanning electron microscope, laser particle size distribution instrument and X-ray diffraction analyzer, and its fluidity and wettability were measured. The results show that the particle size distribution of Salvianolic acid-tanshinone composite powder is uniform under the optimum preparation conditions, the D50 is 2.33 渭 m, the volume fraction is 80.82, the angle of repose is (50.60 卤1.13) 掳, and the critical relative humidity is about 77. The particle size of the drug particles was significantly decreased and the amorphous substance of the drug slightly increased, which had no significant effect on the fluidity and hygroscopicity of the powder. This study shows that wet ball milling can be used for the comminution of many components with great difference in properties, and a suitable compound powder of Salvianolic acid and tanshinone can be prepared, which provides the basis for the further preparation of inhaled powder aerosols.
【作者单位】：北京中医药大学中药学院;
【基金】：北京中医药大学自主选题项目(2015-JYB-XS108)
【分类号】：R283

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