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目的以市售奥美拉唑肠溶微丸为模型药物探索微丸制剂相对圆形度测定的新方法。方法首先采用图像分析法对样品进行初步形态学分析,随后结合微丸制剂自身特点,采用圆弧面滚动法对其相对圆形度进行进一步量化测定和结果分析。结果多批次样品A的相对圆形度均>80%且各批次样品间相对圆形度均无显著性差异;各厂家生产的微丸样品在制剂外观形态学方面存在较大差异性,其中样品A的相对圆形度为(82.74±1.48)%,样品B和C的相对圆形度分别为(88.03±3.40)%和(88.20±3.42)%,而样品D的相对圆形度仅为(65.63±5.91)%,表明国内各厂家在本品处方组成、制备工艺或关键工艺参数控制条件方面均有可能存在一定差异。结论该测定方法操作简单、样本采集量大,数据测定准确度好。
OBJECTIVE To explore a new method for determination of relative circularity of pellets by taking omeprazole enteric-coated pellets as a model drug. Methods Firstly, the morphological analysis of the samples was carried out by image analysis. Then the relative circularity of the pellets was further quantified and analyzed by circular arc rolling according to its own characteristics. Results The relative circularity of multi-batch sample A was> 80% and there was no significant difference in the relative circularity between batches of samples. The pellet samples produced by various manufacturers showed great differences in appearance morphology, The relative circularity of sample A was (82.74 ± 1.48)%, the relative circularity of sample B and C were (88.03 ± 3.40)% and (88.20 ± 3.42)% respectively, while the relative circularity of sample D (65.63 ± 5.91)%, indicating that the domestic manufacturers in this product prescription, preparation process or key process parameters control conditions may have some differences. Conclusion The method is simple, the amount of sample collection, data determination accuracy.