供雾化器用液体制剂的雾化特性质量控制进展

Progress in Quality Control of Atomization Characteristics of Inhalation Products for Nebulisation

供雾化器用的液体制剂因其独特的优势,广泛应用于呼吸道疾病的治疗,中国药典2015版中已收载了此类制剂的质控项目及检测方法,目前国际上对此类制剂的雾化特性已经开展了大量新型检测方法的研究,为此类制剂的质量控制提供科学数据与参考,通过模拟体内药物吸收与分布的体外测定方法研究,与药物制剂的体内行为建立相关性,可更好地为临床应用提供参考。供雾化器用液体制剂的临床使用效果由雾化器和雾化溶液决定。雾化溶液的雾化特性受雾化器影响较大,因此亟需加强对雾化器的质量控制和管理,本文对此提出意见及建议。

The inhalation products for nebulisation are used widely in treatment of respiratory disease due to their unique advantages. The quality control items and methods of atomization characteristics for nebulization have been adopted in Chinese Pharmacopoeia 2015 edition. More and more new in-vitro methods of atomiza- tion characteristics were investigated worldwide for the purpose of providing the scientific support for quality control standard. The in-vitro method was carried out by simulating the absorption and distribution of drug in- vivo to establish the in-vivo and in-vitro correlation. That would provide the references for the clinical practice. The clinical efficacy of preparations for nebulisation is decided by the nebulizer and the nebulisation liquid. The atomization characteristics of the products for nebulisation are significantly influenced by nebulizers. Therefore, the quality control and administration of the nebulizers should be strengthened. The paper puts forward some comments and recommendations.