首页|混悬型鼻喷雾剂的喷雾特性评价

混悬型鼻喷雾剂的喷雾特性评价

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采用激光衍射粒径分析技术测定雾滴粒度分布,采用SprayVIEW激光成像系统测定喷雾模式和喷雾形态,比较了 2类4种混悬型鼻喷雾剂原研药与仿制药的喷雾特性,并对不同厂家鼻喷雾剂喷雾特性的批内、批间一致性进行分析.结果显示,4种鼻喷雾剂的喷雾雾滴d(0.5)均在27~51μm,雾滴粒度分布有一定差异,鼻喷雾剂①的原研药A雾滴粒度分布的批内、批间一致性优于仿制药B,鼻喷雾剂②的仿制药D雾滴粒度分布的批内、批间一致性优于原研药C.2类鼻喷雾剂原研药与仿制药的喷雾面积有显著性差异,喷雾形态差异较小,喷雾横截面接近圆形,椭圆比为1.13~1.41.该研究表明,鼻喷雾剂仿制药的喷雾特性与原研药存在一定差异,在产品开发过程中应加强喷雾特性的研究和产品比较.
Evaluation of Spray Characteristics of Suspension Nasal Sprays
The droplet size distribution was measured by the laser particle size measurement system,while the spray pattern and plume geometry were measured by SprayVIEW laser imaging system.The spray performances of two kinds of suspension nasal sprays between the original drugs and the generic drugs were compared.Additionally,the consistency of spray performances between different batches of the samples from 4 companies(A,B,C,D)was analyzed in this study.The results showed that d(0.5)was in the range of 27-51 μm.The droplet size distribution results of the products from companies A and B,C and D were different.The intra-and inter-batch variabilities of the droplet size distribution of nasal sprays from companies A and D were less than those of the products from companies B and C,respectively.The spray area showed a significant difference between the original drugs and the generic drugs.The plume geometry results of the products from companies A and B,C and D were similar.The cross section of the spray was nearly circular with elliptical rate of 1.13 to 1.41.The spray performance results of the products from the original drugs and the generic drugs were different.Therefore,it was necessary to strengthen the investigation on detection methods of the spray performances and comparison study of different products in the development of nasal spray products.

suspension nasal spraydroplet size distributionspray patternplume geometryconsistency

童颖、李文博

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武汉药品医疗器械检验所,国家药监局药物制剂质量研究与控制重点实验室,湖北武汉 430075

混悬型鼻喷雾剂 雾滴粒度分布 喷雾模式 喷雾形态 一致性

国家药监局药物制剂质量研究与控制重点实验室开放课题

YWZJQN-202202

2024

中国医药工业杂志
上海医药工业研究院,中国化学制药工业协会

中国医药工业杂志

CSTPCD
影响因子:0.487
ISSN:1001-8255
年,卷(期):2024.55(8)