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布地奈德鼻喷雾剂粒度分布的测定及一致性分析
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| 篇名： | 布地奈德鼻喷雾剂粒度分布的测定及一致性分析 |
| TITLE： | |
| 摘要： | 目的：建立布地奈德鼻喷雾剂样品粒度分布的测定方法，并分析其粒度分布的一致性。方法：以水为分散剂，搅拌（1 800 r/min）分散；分别以累积粒度分布为10％、50％、90％所对应的粒径[d（0.1）、d（0.5）、d（0.9）]为特征值。采用光散射法测定样品的粒度分布，并采用SAS 9.3统计软件分析2个厂家（A和B）样品间、同一厂家不同批次间及同一批次内样品粒度分布的一致性。结果：A厂3批样品d（0.1）平均值为3.96 μm，d（0.5）平均值为29.58 μm，d（0.9）平均值为67.10 μm；B厂3批样品d（0.1）平均值为2.00 μm，d（0.5）平均值为7.53 μm、d（0.9）平均值为28.51 μm。通过分析得出，2个厂家样品粒度分布差异较大，A厂样品的粒径大于B厂；B厂样品各批次之间的一致性好于A厂；2个厂家各批次内的一致性均较好。结论：所建立的方法适用于测定布地奈德鼻喷雾剂的粒度分布，并可用于分析其粒度分布的一致性。 |
| ABSTRACT： | OBJECTIVE： To establish the method for the determination of particle size distribution of Budesonide nasal spray， and to analyze the consistency of particle size distribution of spray samples. METHODS： Water was used as dispersant for mixing and dispersing （1 800 r/min）. The particle sizes [d（0.1）， d（0.5）， d（0.9）] corresponded to accumulative particle size of 10％， 50％ and 90％ were used as characteristic value. The distribution of granularity was determined by laser scattering method. The consistency of particle size distribution of samples from 2 manufacturers （A， B） were analyzed among different batches or same batch of same manufacturer by SAS 9.3 statistical software. RESULTS： The mean values of d（0.1）， d（0.5） and d（0.9） were 3.96 μm， 29.58 μm and 67.10 μm in manufacturer A. The mean values of d（0.1）， d（0.5） and d（0.9） were 2.00 μm， 7.53 μm and 28.51 μm in manufacturer B. By analysis， there was great difference in particle size of samples from 2 manufacturers. The particle size of the samples from manufacturer A were larger than that of manufacturer B. The consistency among different batches from manufacturer B was better， and the consistency among same batch were all good from 2 manufacturers. CONCLUSIONS： The established method is suitable for particle size distribution of Budesonide nasal spray and the consistency analysis of particle size distribution. |
| 期刊： | 2017年第28卷第18期 |
| 作者： | 钟潇骁，曹雯，杨必勇 |
| AUTHORS： | ZHONG Xiaoxiao，CAO Wen，YANG Biyong |
| 关键字： | 布地奈德；鼻喷雾剂；粒度分布；光散射法；一致性 |
| KEYWORDS： | Budesonide； Nasal spray； Particle size distribution； Light scattering method； Consistency |
| 阅读数： | 720 次 |
| 本月下载数： | 9 次 |
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