供雾化器用液体制剂中药新药研发的思考

Research and development of new traditional Chinese medicines for liquid preparations for nebulizers

供雾化器用的液体制剂通过雾化吸入给药方式可直接将药物递送到呼吸道和肺部,与口服给药相比起效迅速,并可减少用药剂量,其适应证主要涉及呼吸系统疾病。目前,暂无正式批准的供雾化器用液体制剂中药新药。考虑到中药成分的复杂性和吸入给药的特殊性,供雾化器用液体制剂中药新药的研发需重点关注立题依据的合理性以及与给药途径相关的安全性,并考虑制剂处方、质量控制等是否满足吸入制剂的相关要求。

Liquid preparations for nebulizers can directly deliver the drug to the respiratory tract and lungs via aerosol inhalation administration,which can ensure a faster onset of effect than oral administration and reduce the dosage of the drug.The indications mainly involve respiratory diseases.However,there is no officially approved new traditional Chinese medicine that can serve as liquid preparations for nebulizers.Given the complexity of traditional Chinese medicine components and the particularity of inhaled administration,the development of new traditional Chinese medicines for liquid preparations for nebulizers needs to focus on the rationality of the research and safety of the route of administration,and on the ability of the prescription and quality control to meet the related requirements of inhalation preparations.