注射用双黄连在不同材质输液中不溶性微粒变化的研究

目的考察注射用双黄连粉针在玻璃瓶、聚氯乙烯软袋、聚丙烯可立袋、非PVC复合膜软袋4种不同材质包装常用大输液中的不溶性微粒变化。方法注射用双黄连粉针分别配制于4种材质的氯化钠注射液及5％葡萄糖注射液中，采用《中国药典》附录光阻法测定配伍前，配伍后Oh，4h，及通过输液器后混合液中不溶性微粒数。结果配伍后混合溶液中的不溶性微粒均显著增加，不同材质间差异无统计学意义（P〉0．05）。结论注射用双黄连粉针在4种材质包装的常用输液中不溶性微粒数比空白输液显著增加，不同材质输液间差异无统计学意义，选择合格的输液器具，可大大减少溶液中的不溶性微粒。

THE CHANGES OF INSOLUBLE PARTICLES OF SHUANGHUANGLIAN INJECTION IN DIFFERENT INFUSION SOLUTION

Objective To observe the changes of insoluble particles of Shuanghuanglian Injection in dif-ferent packaging material such as glass bottles, soft PVC bag, PP can stand up pouches, non PVC composite film bags. Methods Shuanghuanglian Injection were prepared from 4 kinds of Sodium Chloride Injection and 5% Glucose Injection. Insoluble particles count was determined by using ＂Chi-nese Pharmacopoeia appendix＂ light blockage method on mixed before, after mixing with Oh, 4h, and the infusion apparatus in the mixed solution. Results After compatibility, insoluble particles count in the mixed solution was increased significantly, and there was no significant difference between differ-ent materials （P〉0.05）. Conclusions Shuanghuanglian injection insoluble particles increases signifi-cantly than the blank infusion in the infusion of 4 kinds of packaging material, there is no significant difference between the different materials of infusion, the infusion apparatus selection of qualified, can greatly reduce the insoluble particles in solution.