Section of Internal Medicine, Endocrinology and Metabolism, Department of Medicine, Perugia University Medical School, Perugia, Italy.
Section of Internal Medicine, Endocrinology and Metabolism, Department of Medicine, Perugia University Medical School, Perugia, Italy.
Diabetes Metab. 2018 Sep;44(4):368-372. doi: 10.1016/j.diabet.2017.05.004. Epub 2017 Jun 7.
This study measured the insulin concentration (Ins) of NPH insulin in vials and cartridges from different companies after either resuspension (R+) or not (R-; in the clear/cloudy phases of unsuspended NPH).
Measurements included Ins in NPH(R+) and in the clear/cloudy phases of NPH(R-), and the time needed to resuspend NPH and time for NPH(R+) to separate again into clear/cloudy parts.
In vials of NPH(R+) (assumed to be 100%), Ins in the clear phase of NPH(R-) was<1%, but 230±41% and 234±54% in the cloudy phases of Novo Nordisk and Eli Lilly NPH, respectively. Likewise, in pen cartridges, Ins in the clear phase of NPH(R-) was<1%, but 182±33%, 204±22% and 229±62% in the cloudy phases of Novo, Lilly and Sanofi NPH. Time needed to resuspend NPH (spent in tipping) in vials was brief with both Novo (5±1s) and Lilly NPH (6±1s), but longer with all pen cartridges (50±8s, 40±6s and 30±4s from Novo, Lilly and Sanofi, respectively; P=0.022). Time required for 50% separation into cloudy and clear parts of NPH was longer with Novo (60±7min) vs. Lilly (18±3min) in vials (P=0.021), and affected by temperature, but not by the different diameter sizes of the vials. With pen cartridges, separation into clear and cloudy parts was significantly faster than in vials (P<0.01).
Ins in NPH preparations varies depending on their resuspension or not. Thus, subcutaneous injection of the same number of units of NPH in patients with diabetes may deliver different amounts of insulin depending on its prior NPH resuspension.
本研究测量了来自不同公司的瓶装和笔芯装 NPH 胰岛素在重新混悬（R+）或未混悬（R-；混悬的 NPH 处于澄清/混浊相）后的胰岛素浓度（Ins）。
测量包括 NPH（R+）中的 Ins 和 NPH（R-）的澄清/混浊相中的 Ins，以及重新混悬 NPH 所需的时间以及 NPH（R+）再次分离为澄清/混浊部分所需的时间。
在 NPH（R+）瓶中（假设为 100%），NPH（R-）澄清相中的 Ins<1%，但 Novo Nordisk 和 Eli Lilly NPH 的混浊相分别为 230±41%和 234±54%。同样，在笔芯装中，NPH（R-）澄清相中的 Ins<1%，但 Novo、Lilly 和 Sanofi NPH 的混浊相分别为 182±33%、204±22%和 229±62%。在 Novo（5±1s）和 Lilly NPH（6±1s）中，重新混悬 NPH（在翻转瓶中花费的时间）很短，但所有笔芯装的时间都更长（分别为 50±8s、40±6s 和 30±4s；P=0.022）。在 Novo（60±7min）与 Lilly（18±3min）瓶中，NPH 分离成混浊和澄清部分的 50%所需的时间更长（P=0.021），且受温度影响，但不受瓶直径大小的影响。在笔芯装中，与瓶中相比，NPH 澄清和混浊部分的分离速度明显更快（P<0.01）。
NPH 制剂的 Ins 取决于其是否重新混悬。因此，糖尿病患者皮下注射相同单位数的 NPH 可能会因先前的 NPH 重新混悬而导致不同量的胰岛素输送。
