部份中文羟乙基淀粉处方资料(仅供参考) 药品英文名 Hydroxyethyl Starch 药品别名 淀粉代血浆、706代血浆、低分子羟乙基淀粉、贺斯、斯特尔、Haes-Steril、Hespan、Hetastarch、Hydroxyethylamylum、Steril 药物剂型 1.羟乙基淀粉氯化钠注射剂(平均分子量25000~45000):15g(250ml),30g(500ml); 2.6%羟乙基淀粉注射剂(平均分子量45000):500ml。 药理作用 本药为一种较好的血容量扩张剂。本药经静脉滴注后,可较长时间停留于血液中,从而提高血浆胶体渗透压,使组织液回流增多,血容量迅速增加,同时出现红细胞计数、血细胞比容、血红蛋白量和血液黏滞度均下降,并且可延缓血栓的形成和发展。在失血性休克时,输入本药可使血压回升,肾血流量和尿量增多,微循环障碍改善。6%羟乙基淀粉(即高分子羟乙基淀粉,平均分子量450 000)的胶体特性与人血白蛋白相似。 药动学 本药经静脉给药30min后起效,最大效应时间为1.5h(国产制剂)。单次静脉给药的药效持续时间为24~48h。小分子量的羟乙基淀粉(分子量小于50 000)以原形分子经肾脏排泄,高分子量的羟乙基淀粉经网状内皮系统或淀粉酶降解后,随尿液或胆汁排泄,故肾脏是主要的排泄途径。目前尚不清楚本药是否经母乳排泄。中分子量的母体化合物半衰期约为12h。 适应证 1.用于各种原因引起的血容量不足,如失血性休克、烧伤、手术、败血症及其他创伤等。 2.本药还可预防和治疗腰麻或硬膜外麻醉时因血管扩张、有效循环血量减少而致的低血压。 3.用于血栓闭塞性疾病及各种原因导致的微循环障碍的辅助治疗。 4.高分子羟乙基淀粉尚可用于白细胞分离。 禁忌证 (尚不明确) 注意事项 1.慎用: (1)心功能不全或肾清除率受损者(应警惕循环负担过重); (2)曾有出血性疾患; (3)需预防颅内出血的神经外科手术患者。 2.使用前应仔细检查液袋,如发现有滴漏、袋内有沉淀,溶液浑浊或有菌落者,均应停止使用。 3.注射剂应一次用完,如未用完,应将余液弃去,不可储存再用。 4.使用时保持溶液温度在37℃左右。 5.由于制剂中含0.9%氯化钠,大量输入可致钾排泄增多,应注意适当补钾。 6.在两个疗程之间应停药1周,以免大分子羟乙基淀粉在体内蓄积。 7.本药虽无抗原性,但有过敏反应的报道,遇此情况应即刻停药,必要时给予抗组胺药物。 8.药物对妊娠的影响:尚不明确本药对人类孕期的影响,故孕妇(尤其是妊娠早期妇女)不宜使用。 9.本药可改变凝血机制,导致一过性凝血酶原时间、活性部分凝血活酶时间及凝血时间延长,其大量应用时亦可引起一过性出血时间延长。 10.用药前后及用药时应当检查或监测: (1)多次输注本药的患者中,有间接胆红素升高的报道,但可于末次注射后96h恢复正常,故曾有肝病史的患者使用本药时应注意监测肝功能; (2)使用本药进行白细胞分离时,可引起血小板计数及血红蛋白浓度下降,但在24h内可恢复正常,故反复进行分离时应注意监测血液指标。 不良反应 1.偶有过敏反应(如荨麻疹、瘙痒等),亦可出现发热、寒战、呕吐、流感样症状、颌下腺与腮腺肿大及下肢水肿等。 2.大量输入后可影响凝血功能,出现自发性出血。 用法用量 静脉滴注: 1.在低血容量休克时,为尽快增加血容量,可较快滴注,滴速及用量视病情而定,一般为每次500~1000ml,最大量不超过每天1500ml(相当于每天20ml/kg)。出血少于500ml,且血红蛋白及血压正常者,可只输本药,不输全血。为减低血液黏稠度,改善微循环,可每天滴注250~500ml,连续滴注10~14天。 2.在体外循环中作为预充液的主要成分之一时,用量为0.66~1.16g/kg,平均0.9g/kg。 3.用于白细胞分离,一般用量为250~700ml,其与静脉血的比例为1∶8。每周分离2次或总数7~10次为安全范围。 药物相应作用 1.本药与双嘧达莫、维生素B12混用时会发生变化。 2.与卡那霉素、庆大霉素、巴龙霉素等合用,会增加肾毒性。 专家点评 本品在体内不易分解,可较长时间地保留在血液中,能维持较高的血浆胶体渗透压,有较好的扩充血容量和维持血压的作用。其作用机制与右旋糖酐基本相同,本品可增强红细胞膜负电荷,使已聚集的红细胞聚集,可以减低血液的黏度,改善微循环。适用于低血容量性休克、血栓栓塞性疾病(脉管炎)、心脑梗死性疾病。
Hesupanda infusion Therapeutic category name Plasma substitutes, extracorporeal circulation diluent Brand Name Hesupanda infusion composition Component-content (g/100mL) Hydroxyethyl starch 70000 6.0 Day stations sodium chloride 0.5 Day stations potassium chloride 0.03 Japanese Pharmacopoeia calcium chloride hydrate 0.02 Sodium lactate 0.224 Additive (g/100mL) Day stations glucose 1.0 pH adjusting agent suitable amount Electrolyte composition (mEq/L) Na + 105.6 K + 4.0 Ca ++ 2.7 Cl- 92.3 C3H5O3- 20.0 Contraindication Patients with congestive heart failure [The increase in circulating blood flow which may exacerbate congestive heart failure] Patients with renal failure or dehydration state with the oliguria, etc. [There is a risk of renal failure] Efficacy or effect In the case of excessive bleeding in each department area Blood dilution in extracorporeal circulation Adult is injected once 100~1,000mL intravenously. Children usually per kg of body weight, using a within 10mL. Depending on the symptoms, it is increased or decreased as appropriate. The blood dilution in extracorporeal circulation, using a normal body weight per kg 10~20mL. Clinically significant adverse reactions Shock, anaphylactic-like symptoms (dyspnea, wheezing, etc.) Shock, anaphylactic-like symptoms (dyspnea, wheezing, etc.) because they may appear, carefully monitored, and if any abnormalities are observed, administration should be discontinued and appropriate treatment. Pharmacology Clinical pharmacological action Colloid osmotic pressure and crystalloid osmotic pressure and body water balance Colloid osmotic pressure and crystalloid osmotic pressure of this drug, because it is close to the osmotic pressure of each plasma, also uptake in the blood vessels of the cell interstitial fluid, also, early transition to the extravascular even less, the body water balance It did not disturb (intraoperative use). Circulating blood volume effect of maintaining The effect of maintaining blood volume results were examined using the 131I, the effect of maintaining the circulating blood volume compared to Ringer's lactate was superior (intraoperative use). Peripheral circulation improving action Slightly lowered the blood viscosity and improved peripheral circulation (preoperative use). Basic pharmacological action Circulating plasma volume and blood pressure retention effect An equal volume infusion Rabbit at 3mL/min, 20mL/ kg Datsuchishi, and immediately equal amount instillation after blood removal end, blood pressure immediately showed 95% of the recovery, blood pressure retention effect was observed until the subsequent 5 hours 1.5 times the amount transfusion The 15mL/kg in dogs Datsuchigo, when the infusion of 1.5 times the amount of Datsuchiryou, an equal volume infusion or more of blood pressure retention effect was observed. Furthermore, 1.5 volumes heart rate by infusion, ECG, cardiac workload, and the like central venous pressure, it was confirmed that no particular burden on the heart. Lowering effect blood viscosity As a result of administration of this drug, and 10% dextran 40 together in 60~90mL / 30 minutes of speed in the dehydration state house rabbit, despite the decrease in the hematocrit value was less than 10% dextran 40, a decrease in blood viscosity people of this drug was marked. The agent as compared to 10% Dextran 40 and effectively acts to lower blood viscosity. Osmotic pressure and red blood cells form Since osmotic pressure is close to the plasma, it does not adversely affect the red blood cell morphology (in vitro). Electrolyte composition and acid-base balance And electrolyte composition is similar to extracellular fluid, also by formulated lactate, is effective in preventing acidosis (dogs). Physicochemical knowledge of active ingredient Generic name: Hydroxyethyl starch 70000 (Hydroxyethylated Starch) [JAN] Intrinsic viscosity: 0.09 to 0.14 Degree of substitution: 0.50 to 0.55 Weight average molecular weight (Mw): About 70000 (GPC-LALLS method) 15) 完整资料附件:http://www.info.pmda.go.jp/go/pack/3319547A4035_1_06/ ---------------------------------------- 产地国家: 日本 原产地英文商品名: HESPANDER fluid solution(ヘスパンダー輸液)500ml/vial 20vial/box 原产地英文药品名: Hydroxyethylated Starch 中文参考商品译名: HESPANDER溶液(ヘスパンダー輸液)500毫升/瓶 20瓶/盒 中文参考药品译名: 羟乙基淀粉 生产厂家中文参考译名: 费森尤斯卡比 生产厂家英文名: Fresenius Kab
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