中药注射剂稳定性研究进展

Progress in Research of Stability of Chinese Medicine Injection

中药注射剂是我国现代中医药的创新剂型,具有药物起效迅速、可定位定向给药、生物利用度高等特点,已成为急症治疗中不可或缺的一部分。随着中药注射剂种类增加以及临床配伍使用的扩展,不良反应也逐渐增多,其临床应用的安全性问题引起了人们的高度重视,而中药注射剂的稳定性直接影响其临床应用的安全性。本文从3个方面综述中药注射剂不稳定因素产生的来源:(1)中药注射剂的原材料质量的差异等形成了其不稳定性的直接因素;(2)中药注射剂的生产工艺包括提取、精制、配制等以及包装材料与输液容器、剂型等,构成了影响中药注射剂稳定性的外在因素;(3)中药注射剂成分复杂、性质多样,在临床使用中与不同溶媒和药物的配伍使其稳定性发生了变化,形成了其不稳定性的内在因素。并提出控制中药原材料质量、优化生产工艺与剂型、严格把握临床使用(严禁混合配伍,谨慎联合用药)等相关措施,以提高中药注射剂的稳定性和安全性。

Chinese medicine injection is an innovative dosage form of modern Chinese medicine in China,which has the characteristics of being rapid in starting an effect,targeted drug delivery and high bioavailability.It has been widely used in the clinical practice of emergency treatment.With the increase of the number of Chinese medicine injection types and with the widening of its clinical combined use with other drugs,the adverse reactions have gradually increased,and the safety in clinical use has attracted people’s attention.For the stability of the Chinese medicine injection has direct impact on its clinical safety,we made a review of the origin of the impact factors for Chinese medicine injection stability from three aspects.It is suggested that the quality variance of herbal medicinal material for Chinese medicine injection contributes to the direct influence factor of the instability of Chinese medicine injection,the process such as extraction,refinement,and preparation,the packing material,infusion container,and dosage forms for the injection contribute to the external influence factors of Chinese medicine injection,and the complicated ingredients with various properties of Chinese medicine injection as well as its compatibility with various solvents and medicines contribute to the internal influence factors of Chinese medicine injection stability.Finally,the measures for controlling the quality of Chinese medicinal material,optimizing the production process and dosage forms,and being cautious about the clinical practice in mixed computability and combined medication have been put forward,so as to increase the stability and safety of Chinese medicine injection.