鼻喷雾剂雾滴粒径的一致性分析

Consistency Evaluation of Particle Size Distribution of Nasal Spray

以盐酸氮斯汀鼻喷雾剂为模型药,建立了一种采用激光粒度仪测定溶液型鼻喷雾剂含药气溶胶粒度分布的方法,并考察了触发力和喷雾距离对雾滴粒度分布的影响。结果显示,触发力对雾粒粒度分布的影响显著。继而对不同厂家(A厂和B厂)、不同批次产品中气溶胶粒径及分布的批内、批间一致性进行分析。结果显示,A厂产品粒度分布的批内、批间变异性均优于B厂产品,A厂和B厂产品的粒度分布结果具有一定的差异,可能与处方、工艺等因素相关。因此,鼻喷雾剂产品开发过程中应加强喷雾粒径及分布的检测方法探究和产品对比研究。

A method for determination of particle size distribution(PSD) of sprayed aerosols by laser diffractometer was established with azelastine hydrochloride nasal sprays as the models.And the influences of actuation force and spray distance on the PSD of aerosols were investigated.The results showed that actuation force had a significant impact on the PSD of aerosols.Then,the consistency of aerosol PSD between different batches of samples from two companies(A and B) was analyzed by this method.The results showed that the intra-and inter-batch variability of the aerosol PSD of nasal spray from company A was less than that of the product from company B.The aerosol PSD results of the products from companies A and B were different,which might be attributed to the differences in formulation and preparation process.Therefore,it was necessary to strengthen the investigation on detection methods of aerosol PSD and comparison study of different products in the development of nasal spray product.