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[摘要]
目的 考察前列地尔脂微球载体制剂与生理盐水、5%葡萄糖注射液配伍的稳定性。方法 在室温25 ℃避光条件下,考察配伍液的pH值及外观的变化,采用高效液相色谱法测定前列地尔配伍液在0~4 h含量及有关物质的变化,并采用静态激光散射计测定配伍液的平均粒径、90%累积粒径的变化。结果 前列地尔脂微球载体制剂分别与生理盐水注射液、5%葡萄糖注射液配伍后4 h内pH值、外观、含量、有关物质、平均粒径及90%累积粒径均未发生明显变化。结论 前列地尔脂微球载体制剂在室温避光条件下放置4 h内稳定性较好,各项指标均符合国家标准,临床使用时可以依照病人情况选用静脉滴注的方式给药。
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[Abstract]
Objective To study the compatibility stability of lipo prostagradin E1 in compatibility with normal saline (NS) and 5% glucose injection. Methods Content changes of prostagradin A1 in lipo prostagradin E1 during 0 — 4 h were determined by RP-HPLC, protected protected form light at the room temperature 25 ℃. The changes in appearance and pH value were observed. The particle diameters including mean diameter and 90% accumulative diameter were also measured by Static Laser Light Scattering Meter. Results The pH value, appearance, content, prostagradin A1, and particle diameter were not changed significantly within 4 h in lipo prostagradin E1 combined with NS and 5% glucose injection for injection. Conclusion Lipo prostagradin E1 is stable at room temperature for 4 h, and the indicators are conformed with national standards which may be used in clinical by iv administration according to the specific condition of the patients.
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