PVC软包装4∶1输液的不溶性微粒考察

Investigation on insoluble particles of 4∶1 infusion in PVC package

目的 考察PVC软包装 4∶ 1输液的不溶性微粒。方法 应用ZWF - 4DⅡ型注射液微粒分析仪测定 4∶ 1输液的≥ 2 5μm、≥ 10 μm、≥ 5 μm和≥ 2 μm的 4个通道不溶性微粒数。结果 5批PVC软包装 10 0ml的 4 ∶1输液在≥ 2 5 μm、≥ 10 μm、≥ 5 μm和≥ 2 μm的 4个通道不溶性微粒数 ( x±s,n =5 )分别为 (0 .9± 0 .7)粒 /ml、(10 .0± 5 .0 )粒 /ml、(6 3.5± 16 .2 )粒 /ml和 (2 0 4 7.3± 6 34.6 )粒 /ml。结论 PVC软包装 4∶ 1输液的≥ 10 μm和≥ 2 5 μm不溶性微粒符合《中国药典》的要求 ,≥ 5 μm的不溶性微粒符合《英国药典》的要求 ,但其≥ 2 μm的不溶性微粒不符合《英国药典》的要求 ,提示输液中≥ 2

Objective To observe the insoluble particles of 4∶1 infusion in package of PVC. Methods The number of insoluble particles in size of ≥25 μm,≥10 μm,≥5 μm and≥2 μm was counted by ZWF-4DⅡ particle counter. Results The insoluble particles in size of ≥25μm,≥10μm,≥5μm and≥2μm were (±s,n=5) (0.9±0.7), (10.0±5.0),(63.5±16.2) and (2 047.3±634.6)/ml,respectively. The insoluble particles in size of ≥25μm,≥10μm of 4∶1 infusion in package of PVC agreed with Chinese Pharmacopoeia,these in sizes of ≥5 μm agreed with the standard of British Pharmacopeia, but these in size of ≥2μm didnt conform to the standard of British Pharmacopoeia. Conclusion Great attention should be paid to the insoluble particles of 4∶1 infusion in package of PVC.