28种静脉用中药注射剂不溶性微粒的研究

Studies on the Insoluble Particles in Traditional Chinese Drugs for Ⅳ Injection

28种静脉用中药注射剂按治疗剂量加入各自溶媒后不溶性微粒的检测表明：每种药物均含有不同粒径及数量的微粒。其中多数符合《中国药典》标准，但有4种药物≥10μm的微粒数在20个以上或≥25μm的微粒多于2个，超过《中国药典》标准。值得注意的是，中药静脉注射剂中小于10μm的微粒个数明显多于西药静脉注射液。提示中药静脉注射剂质控的难度和改善工艺质量的迫切性。本实验对国产精密药液过滤器的滤过作用亦作了考察。

The size and number of insoluble particles in 28 different traditional Chinese drugs for Ⅳ injection were determined.The results showed that 4 kinds of solution contained insoluble particles (≥10μm) more than 20/ml or particles (≥25μm) more than2/ml,so they outnumbered the standard of Chinese pharmacopeia.In addition,the number of small particles (2-10μm) in sometraditional Chinese drugs for Ⅳ injection was much more than that in western medicines for infusion.It indicates that thepharmaceutical factories should further improve the technique and management of production,so as to ensure the safety of druguse.Meanwhile,the efficiency of domestic precision liquid medicine filter has been investigated.