中药静脉注射液不溶性微粒研究

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

目的 :考察复配中药针剂在静脉注射液中的不溶性微粒的变化及解决方法。方法 :将61种中药注射剂按治疗剂量溶配于0 9 %氯化钠注射液中 ,用库尔特仪计数该液中直径大于2 5、5 0、10 0、25 0μm的微粒数 ;对微粒进行理化性质显微鉴别 ;考察精密药液过滤器流速、流量、吸附性和截留作用。结果 :(1)26种中药注射剂微粒数超过《中国药典》 (2000年版 )标准 ,占实验总数42 6 % ;(2)不溶性微粒有玻璃渣、活性炭、橡胶屑、毛屑索条和药物残渣 ;(3)精密药液过滤器的流速、流量符合临床要求 ,截留率为88 5 % ,未见其有吸附作用。结论 :精密药液过滤器可截留中药输液的微粒 ,保证患者用药安全。

OBJECTIVE:To observe the changes of insoluble particles in traditional Chinese drugs injections(TCDI)mixed with infusion fluid and to study the way to solve METHODS:61 kinds of TCDI in therapeutic dosages were mixed in 0 9% sodium chloride solution,then the insoluble particles formed with diameters of 2 5?5 0?10 0 and 25 0μm were counted with Coulter counter,and determined with physical method and microscope The precise filter for liquid medicine were investigated in respect to its flow rate,quantity of flow,adsorbability and scavenging action RESULTS:(1)The number of insoluble particles in 26 kinds of TCDI exceeded the standard in ChP accounting for 42 6% of total samples observed (2)The insoluble particles included glass fragments,active carbon,rubber particles,soft flocks and residue of drugs (3)The flow rate and quantity of flow met the clinical requirement with a scavenging rate of 88 5%,and no adsorbability was found CONCLUSION:Precise infilter for liquid medicine can scavenge the particles in TCDI so as to ensure the safe use of drugs for patients