胰岛素在多腔袋肠外营养液中的稳定性研究

Experimental study on the stability of insulin in parenteral nutrition in multi-cavity bag

目的探讨胰岛素在多腔袋肠外营养液中的稳定性。方法2018年1月至3月于北京医院国家老年医学中心进行胰岛素体外对照实验研究,分为3组:多腔袋组、院内配置组、葡萄糖组。多腔袋组使用工业化多腔袋肠外营养制剂[脂肪乳氨基酸(17)葡萄糖(10%)注射液,每袋均含葡萄糖97 g,大豆油长链甘油三酯51 g,氨基酸34 g,液体总量1440 mL,乙烯-醋酸乙烯共聚物(EVA)袋];院内配置组为自配型肠外营养液(总量1500 mL,含20%长链脂肪乳剂250 mL,8.6%复方18种氨基酸500 mL,50%葡萄糖溶液250 mL,0.9%氯化钠溶液500 mL等,EVA袋);葡萄糖组为10%葡萄糖注射液1000 mL,使用苯乙烯、乙烯、丁烯共聚物(SEB)袋,加入15%氯化钾1.5 g;每组各10袋。分别加入精蛋白生物合成人胰岛素10、20、30、40、50 IU,混匀后静置30 min,模拟临床应用模式体外匀速输注12 h,分别测定混匀后即刻,输注前,输注2、4、6、8、10、12 h肠外营养液中胰岛素浓度;计算加入胰岛素10、50 IU 3组不同时相点胰岛素浓度变化值与变化幅度。结果标准操作规范下,添加胰岛素剂量10 IU,多腔袋组混匀后即刻,输注前,输注2、4、6、8、10、12 h肠外营混合液中胰岛素浓度分别为1375、1355、1290、1215、1260、1270、1310、1275μU/mL;添加胰岛素量50 IU,多腔袋组混匀后即刻,输注前,输注2、4、6、8、10、12 h肠外营养混合液中胰岛素浓度分别为4710、4675、4915、4525、4805、4575、4805、4570μU/mL。加入胰岛素10 IU,多腔袋组输注前,输注2、4、6、8、10、12 h对应的胰岛素浓度变化值分别为-20、-85、-160、-115、-65、-100μU/mL;加入胰岛素50 IU,多腔袋组输注前,输注2、4、6、8、10、12 h对应的胰岛素浓度变化值分别为-35、205、-185、95、-135、95、-140μU/mL。加入胰岛素10 IU,多腔袋组输注前,输注2、4、6、8、10、12 h对应的的胰岛素浓度变化幅度分别为1.5%、6.2%、11.6%、8.4%、7.6%、4.7%、7.3%;加入胰岛素50 IU,多腔袋组输注前,输注2、4、6、8、10、12 h对应的胰岛素浓度变化幅度分别为0.7%、4.4%、3.9%、2.0%、2.9%、2.0%、3.0%。多腔袋组不同时相点胰岛素浓度较为稳定,不受胰岛素加入剂量和使用时间的影响;院内配置组胰岛素浓度变化趋势与多腔袋组相似;葡萄糖组胰岛素浓度稳定性尚好,但相对浓度低于前2者水平。结论胰岛素在多腔袋肠外营养制剂中稳定性较好,不受浓度和时间影响。

Objective To study the stability of insulin in parenteral nutrition in multi-cavity bag.Methods From January to March 2018,a comparative study of insulin in vitro was conducted and divided into 3 groups(multi-cavity bag group,hospital configuration group,glucose group)in Beijing Hospital,National Geriatrics Center.Multi-cavity bag group was injected with the parenteral nutrition in multi-cavity bag[Fat milk amino acid(17)glucose(10%)injection,each bag contains glucose 97 g,soybean oil long-chain triglyceride 51 g,amino acid 34 g,total liquid 1440 mL,ethylene vinyl acetate(EVA)bag].Hospital configuration group was injected with self-made PN mixture(1500 mL volume in total,containing 250 mL 20%long-chain fat emulsion,500 mL 8.6%compound 18 amino acids,250 mL 50%glucose,500 mL 0.9%sodium chloride solution,EVA bag).Glucose group was injected with 1000 mL 10%glucose injection,styrene,ethylene,butene copolymer[styrene ethylene butene copolymer(SEB)]bags were used,15%potassium chloride 1.5 g was added.Ten bags were in each group which was added with protamine biosynthetic human insulin of 10,20,30,40 and 50 IU,stimulating the clinical infusion of 12 hours in constant speed in vitro.After mixing,insulin concentration of multi-cavity bag was detected in the time of immediately after mixing,before infusion,2,4,6,8,10 and 12 h after infusion.The change value and amplitude of insulin concentration at different time points in 3 groups with insulin 10 and 50 IU were calculated.Results Under the standard operation specifications,added insulin dose of 10 IU,immediately after mixing in the multi-cavity bag group,before infusion,2,4,6,8,10,and 12 h after infusion were 1375,1355,1290,1215,1260,1270,1310 and 1275μU/mL;50 IU of insulin was added,the insulin concentration in the time of immediately after mixing,before infusion,2,4,6,8,10 and 12 h after infusion were 4710,4675,4915,4525,4805,4575,4805,4570μU/mL.Ten IU of insulin was added,the change values of insulin concentration in the time of before infusion,2,4,6,8,10 and 12 h after infusion were-20,-85,-160,-115,-65 and-100μU/mL,respectively.Fifty IU of insulin was added,the change values of insulin concentration in the time of before infusion,2,4,6,8,10 and 12 h after infusion were-35,205,-185,95,-135,95 and-140μU/mL,respectively.Ten IU of insulin was added,the rangeability of insulin concentration in the time of before infusion,2,4,6,8,10 and 12 h after infusion were 1.5%,6.2%,11.6%,8.4%,7.6%,4.7%and 7.3%,respectively.Fifty IU of insulin was added,the rangeability of insulin concentration in the time of before infusion,2,4,6,8,10 and 12 h after infusion were 0.7%,4.4%,3.9%,2.0%,2.9%,2.0%and 3.0%,respectively.The insulin concentration in different time of the multi-cavity bag group was stable,and was not affected by the dosage and using time of insulin.The change trend of insulin concentration in the hospital group was similar to that in the multi-cavity bag group.The insulin in glucose group was stable with time,while the relative concentration was lower than those in the other two groups.Conclusion The stability of insulin in anteriorly pouch parenteral nutrition preparation is good,and is not affected by the concentration or time.