| 引用本文: | 谢俊,杨俊,汤卫国,张静,赵志英,戴岳.市售奥美拉唑肠溶微丸相对圆形度测定新方法[J].中国现代应用药学,2017,34(7):997-1001. |
| XIE Jun,YANG Jun,TANG Weiguo,ZHANG Jing,ZHAO Zhiying,DAI Yue.New Method for Determination of Omeprazole Enteric-coated Pellets Relative Sphericity[J].Chin J Mod Appl Pharm(中国现代应用药学),2017,34(7):997-1001. |
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| 市售奥美拉唑肠溶微丸相对圆形度测定新方法 |
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谢俊1, 杨俊1, 汤卫国1, 张静2, 赵志英3, 戴岳3
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1.金陵药业股份有限公司技术中心, 南京 210009;2.中国药科大学药剂教研室, 南京 210009;3.中国药科大学中药学院, 南京 210009
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| 摘要: |
| 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。 |
| 关键词: 奥美拉唑 微丸 相对圆形度 |
| DOI：10.13748/j.cnki.issn1007-7693.2017.07.014 |
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| New Method for Determination of Omeprazole Enteric-coated Pellets Relative Sphericity |
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XIE Jun1, YANG Jun1, TANG Weiguo1, ZHANG Jing2, ZHAO Zhiying3, DAI Yue3
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1.R & D Center of Jinling Pharmaceutical Co., Ltd., Nanjing 210009, China;2.Department of Pharmaceutics, China Pharmaceutical University, Nanjing 210009, China;3.Department of Traditional Chinese Medicine, China Pharmaceutical University, Nanjing 210009, China
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| Abstract: |
| OBJECTIVE To develope a new method for the determination of pellets relative sphericity by using commercially available omeprazole enteric-coated pellets as model drug.METHODS The initial morphological analysis of the samples was carried out by image analysis method.Then the relative sphericity was quantitatively measured and analyzed by the circular surface rolling method combined with the characteristics of pellets.RESULTS The relative sphericity of multi-batch samples A was >80%,and there was no significant difference in the relative sphericity in batches.The pellet samples produced by each manufacturer had great differences in appearance morphology,the relative sphericity were (82.74±1.48)%,(88.03±3.40)%,(88.20±3.42)% and (65.63±5.91)% for sample A,B,C and D,indicating that the domestic manufacturers in the prescription composition,preparation process or key process parameters control conditions were likely to exist some differences.CONCLUSION The established method is simple,good for large samples and accurate. |
| Key words: omeprazole pellets relative sphericity |
