硫酸亚铁 | 10124-49-9

• 物质功能分类: 原料药 - 血液系统用药 - 抗贫血药
• 分子结构分类: 无机化合物 - 混合金属/非金属化合物 - 过渡金属氧阴离子化合物
• 中文名称: 硫酸亚铁
• 中文别名: 硫酸亚铁(饲料级)；硫酸亚铁,干燥品
• 英文名称: Sulfuric acid, iron(2+), salt (1:1)
• 英文别名: iron;sulfuric acid
• CAS: 10124-49-9；7720-78-7
• 化学式: FeH2O4S
• 分子量: 153.93
• InChiKey: MVZXTUSAYBWAAM-UHFFFAOYSA-N

物化性质

• 熔点：
  decomposes at 671℃ [JAN85]
• 密度：
  3.650
• 溶解度：
  可微溶于水
• 介电常数：
  14.2（14℃）
• 物理描述：
  Iron dextran is a dark reddish-brown liquid. Colloidal suspension of an iron-dextran complex in water. pH 5.2-6.5.
• 颜色/状态：
  Dark brown, slightly viscous solution
• 闪点：
  greater than 200 °F (NTP, 1992)
• 稳定性/保质期：

  Complex is unstable at pH 5; it does not undergo autoxidation at ambient temp, but this does occur at 65-70 °C.

计算性质

• 辛醇/水分配系数(LogP)：
  -0.66
• 重原子数：
  6
• 可旋转键数：
  0
• 环数：
  0.0
• sp3杂化的碳原子比例：
  0.0
• 拓扑面积：
  83
• 氢给体数：
  2
• 氢受体数：
  4

ADMET

代谢

右旋糖酐，一种多糖，被代谢或排出体外。

Dextran, a polyglucose, is either metabolized or excreted.

来源:DrugBank

代谢

右旋糖酐，一种多糖，要么被代谢要么被排出。只有少量未代谢的右旋糖酐铁通过尿液、胆汁或粪便排出。

Dextran, a polyglucose, is either metabolized or excreted. Only traces of unmetabolized iron dextran are excreted in the urine, bile or feces.

来源:Hazardous Substances Data Bank (HSDB)

毒理性

• 毒性总结

鉴定和使用：右旋糖酐铁是一种深棕色、略显粘稠的溶液。当口服给药不满意或不可能时，静脉或肌内注射右旋糖酐铁用于治疗有铁缺乏记录的患者。人类暴露和毒性：右旋糖酐铁过量不太可能与任何急性表现有关。超过恢复血红蛋白和补充铁储备所需的右旋糖酐铁剂量可能会导致血红素沉着病。定期监测血清铁蛋白水平可能有助于识别由于慢性肾功能衰竭、霍奇金病和类风湿性关节炎等并发医疗条件下网状内皮系统铁摄取受损导致的铁的有害累积。已经报道了右旋糖酐铁的过敏反应和类过敏反应，包括致命的过敏性休克。这些反应最常发生在给药后的前几分钟内，通常表现为呼吸困难的突然发作（例如，喘息、支气管痉挛、寒战、呼吸困难、发绀）、心动过速、低血压、呼吸暂停和/或心血管崩溃。制造商表示，同时使用血管紧张素转换酶（ACE）抑制剂可能会增加对右旋糖酐铁反应的风险。急性超敏反应的发生率估计为0.2-3%。这些反应在给予未发生事件的右旋糖酐铁测试剂量后以及给予治疗剂量后均有报道。尽管有建议称，在静脉注射右旋糖酐铁后，与肌内注射相比，严重全身反应（包括类过敏性反应）更为常见，但尚未直接比较静脉或肌内注射后严重全身反应的风险，似乎没有充分证据表明两种给药途径在类过敏性反应的频率上有差异。动物研究：在大鼠肌内注射右旋糖酐铁的总剂量为100 mg铁/kg，分次在12周内给药，没有出现药物相关的异常。在这个剂量的十倍，即1000 mg铁/kg，治疗的大鼠的肝脏和脾脏比对照组的大鼠要大。根据实验动物研究中充分的致癌性证据，可以合理预期右旋糖酐铁对人来说是致癌的。从6个月大开始，每周一次肌内注射2 mL铁-右旋糖酐，给3只雄性和3只雌性兔，并在第一次注射后观察长达四年。其中两只在第一次注射后39个月和48个月发展为多形性肉瘤，其中一例肉瘤转移到肺部。没有看到远处的原发肿瘤。在大鼠中，连续4个月的肌内注射（雄性总共1250 mg铁，雌性800 mg铁），在第一次注射铁-右旋糖酐后8到10个月内，13/18的大鼠局部发展出肉瘤，其中几个是可移植的。在另一项研究中，研究人员发现在6到18个月存活下来的95只小鼠中有70只的注射部位出现了41个肉瘤、6个组织细胞瘤和1个上皮瘤，这些小鼠从11周开始每周一次皮下注射0.2或0.3 mL的铁-右旋糖酐，持续到7.5个月。仅注射右旋糖酐的小鼠没有发展出肿瘤。当给不同数量的小鼠（6到44只雄性和8到60只雌性）单次皮下注射相当于25-2500 mg/kg体重的三价铁的铁-右旋糖酐时，总共在3只雌性（1/53在500 mg/kg，1/10在1000 mg/kg和1/8在2500 mg/kg）中发展出3个局部肿瘤（1个肉瘤，2个未指定）。然而，仅在雌性中注意到远处肿瘤发生率的增加（61/137测试雌性对13/60对照雌性），其中三分之二的肿瘤是淋巴网状起源。在妊娠晚期（妊娠第26、28和30天）将三剂50 mg铁/kg（总剂量150 mg Fe/kg）的铁-右旋糖酐静脉注射到兔中，减少了母兔的体重增加并增加了胎儿死亡率。三剂20 mg Fe/kg也增加了胎儿死亡率，而三剂5 mg Fe/kg没有影响。在大鼠中，从妊娠第17天到第20天（总剂量800 mg Fe/kg）连续四次静脉注射200 mg Fe/kg的铁-右旋糖酐，导致母鼠出现震颤、体重增加减少和食物消耗减少。这些对母鼠的影响不利地影响了后代的生长和存活。在兔和大鼠的后代中，在14周和18周后没有发现铁引起的病理变化。

IDENTIFICATION AND USE: Iron dextran is a dark brown, slightly viscous solution. Intravenous or intramuscular injection of iron dextran is indicated for treatment of patients with documented iron deficiency in which oral administration is unsatisfactory or impossible. HUMAN EXPOSURE AND TOXICITY: Overdosage with iron dextran is unlikely to be associated with any acute manifestations. Dosages of iron dextran in excess of the requirements for restoration of hemoglobin and replenishment of iron stores may lead to hemosiderosis. Periodic monitoring of serum ferritin levels may be helpful in recognizing a deleterious progressive accumulation of iron resulting from impaired uptake of iron from the reticuloendothelial system in concurrent medical conditions such as chronic renal failure, Hodgkin's disease, and rheumatoid arthritis. Anaphylactic or anaphylactoid reactions to iron dextran, including fatal anaphylaxis, have been reported. These reactions occur most frequently within the first several minutes of administration and are generally characterized by sudden onset of respiratory difficulty (e.g., wheezing, bronchospasm, rigor, dyspnea, and cyanosis), tachycardia, hypotension, respiratory arrest, and/or cardiovascular collapse. The manufacturers state that concomitant use of angiotensin-converting enzyme (ACE) inhibitors may increase the risk for reactions to iron dextran. Acute hypersensitivity reactions to iron dextran have been estimated to occur in 0.2-3% of patients. These reactions have been reported after administration of uneventful test doses of iron dextran as well as after therapeutic doses of the drug. Although it has been suggested that severe systemic reactions, including anaphylactoid reactions, are more common following IV rather than IM administration of iron dextran, the risk of severe systemic reactions following IV or IM administration has not been directly compared and there appears to be no well-substantiated evidence of a difference in the frequency of anaphylactoid reactions following either route of administration. ANIMAL STUDIES: Rats treated with iron dextran by intramuscular injection at a total dose of 100 mg of iron/kg in divided doses over a 12-week period exhibited no drug-related abnormalities. At ten times this dose, 1000 mg of iron/kg, treated rats had enlarged livers and spleens compared to control rats. Iron dextran is reasonably anticipated to be a human carcinogen based on sufficient evidence of carcinogenicity from studies in experimental animals. Three male and three female rabbits were given 28 once-weekly im injections of 2 mL iron-dextran starting at 6 months of age and were observed for up to four years after the first injection. Two developed pleomorphic sarcoma at 39 and 48 months after the first injection, and 1 of the sarcomas metastasized to the lungs. No distant primary tumors were seen. Rats were given repeated im injections over 4 months (totaling 1250 mg iron in males and 800 mg iron in females). Local sarcomas, several of which were transplantable, developed in 13/18 rats between 8 and 10 months after the first injection of iron-dextran. In another study, researchers found 41 sarcomas, 6 histiocytomas and 1 epithelioma at the injection site in 70/95 mice that survived from 6 to 18 months after the start of a course of once-weekly sc doses of 0.2 or 0.3 mL of iron-dextran from 11 wk to 7.5 months. Mice injected with dextran only developed no tumors. When a single sc doses of iron dextran equivalent to 25-2500 mg/kg bw of trivalent iron were given to groups mice of different numbers (6 to 44 males and 8 to 60 females), altogether three local tumors (1 sarcoma, 2 unspecified) developed in 3 females (1/53 on 500 mg/kg, 1/10 on 1000 mg/kg and 1/8 on 2500 mg/kg). However, an increase in the incidence of distant tumors was noted only in females (61/137 test females versus 13/60 control females), and two-thirds of these tumors were of lymphoreticular origin. Intravenous injection of three doses of 50 mg iron/kg (total dose 150 mg Fe/kg) as iron dextran into rabbits late in pregnancy (days 26, 28 and 30 of gestation) reduced the weight gain of the dams and increased fetal mortality. Three doses of 20 mg Fe/kg also increased fetal mortality, while three doses of 5 mg Fe/kg were without effect. In the rat four i.v. doses of 200 mg Fe/kg as iron dextran on days 17, 18, 19, and 20 of gestation (total dose 800 mg Fe/kg) produced tremors, reduced body weight gain, and reduced food consumption in the dams. The growth and survival of the offspring were adversely influenced by these effects on the dam. No iron-induced pathology was evident in the offspring of either rabbits or rats after 14 and 18 weeks, respectively.

来源:Hazardous Substances Data Bank (HSDB)

毒理性

• 致癌性证据

致癌性分类：1）人类证据：不足；2）动物证据：充分。对人类致癌风险的总体评估为2B组：该物质可能对人类致癌。/来自表格/

Classification of carcinogenicity: 1) evidence in humans: inadequate; 2) evidence in animals: sufficient. Overall summary evaluation of carcinogenic risk to humans is Group 2B: The agent is possibly carcinogenic to humans. /From table/

来源:Hazardous Substances Data Bank (HSDB)

毒理性

• 致癌性证据

铁右旋糖酐：合理预期为人类致癌物。

Iron Dextran: reasonably anticipated to be a human carcinogen.

来源:Hazardous Substances Data Bank (HSDB)

毒理性

• 致癌物分类

国际癌症研究机构致癌剂：铁-右旋糖酐复合物

IARC Carcinogenic Agent:Iron-dextran complex

来源:International Agency for Research on Cancer (IARC)

毒理性

• 致癌物分类

国际癌症研究机构（IARC）致癌物分类：2B组：可能对人类致癌

IARC Carcinogenic Classes:Group 2B: Possibly carcinogenic to humans

来源:International Agency for Research on Cancer (IARC)

吸收、分配和排泄

• 吸收

肌内注射的铁右旋糖大部分在72小时内被吸收；其余的铁大多在接下来的3到4周内被吸收。

The major portion of intramuscular injections of iron dextran is absorbed within 72 hours; most of the remaining iron is absorbed over the ensuing 3 to 4 weeks.

来源:DrugBank

吸收、分配和排泄

• 消除途径

右旋糖酐，一种多糖，被代谢或排出体外。

Dextran, a polyglucose, is either metabolized or excreted.

来源:DrugBank

吸收、分配和排泄

肌肉注射后，右旋糖酐铁主要从注射部位通过淋巴系统吸收。吸收过程分为两个阶段。大约60%的剂量或注射的右旋糖酐铁在给药后72小时内被吸收。剩余的90%的剂量在第二个较慢的阶段中被吸收，这个阶段持续大约1到3周。剩余的10%的剂量会在几个月甚至更长的时间内逐渐被吸收。

Following intramuscular administration, iron dextran is absorbed from the site of injection primarily through the lymphatic system. Absorption takes place in two stages. Approximately 60% of the dose or iron dextran inected is absorbed within 72 hours of administration. Ninety percent of the dose is absorbed in the second, slower, phase lasting approximately 1 to 3 weeks in duration. The remaining 10% of the dose is gradually absorbed over a period of several months or longer.

来源:Hazardous Substances Data Bank (HSDB)

吸收、分配和排泄

铁葡聚糖通过肝脏、脾脏和骨髓的网状内皮细胞逐渐从血浆中清除。几项研究的结果表明，静脉注射剂量的一部分可能会以不可用的形式储存在骨髓中。

Following IM or IV injection, iron dextran is gradually cleared from plasma by reticuloendothelial cells of liver, spleen, and bone marrow. Results of several studies indicate that /a/ variable portion of IV dose... may be stored in unusable form in bone marrow.

来源:Hazardous Substances Data Bank (HSDB)

吸收、分配和排泄

体外研究表明，通过透析去除右旋糖酐铁的效果微乎其微。

In vitro studies have shown that removal of iron dextran by dialysis is negligible.

来源:Hazardous Substances Data Bank (HSDB)

制备方法与用途

根据您提供的信息，我将总结和整理关于硫酸亚铁的化学性质、用途及生产方法：

化学性质

• 化学式：FeSO4
• 外观与性状：暗淡蓝绿色单斜晶系晶体粉末或颗粒；无臭，味咸而收敛。
• 溶解度：易溶于水（1g/0.5ml沸水），不溶于乙醇。七水合物 FeSO4·7H2O 含铁量约为 19%。
• 反应性：在干燥空气中会风化；在潮湿空气中易氧化成棕黄色碱式硫酸铁；10% 水溶液对石蕊呈酸性（pH值约3.7）。
• 加热条件下的变化：加热至70～73℃失去3分子水，80～123℃失去6分子水，156℃以上转变成碱式硫酸铁。

用途

1. 医药领域：

   • 制备铁盐、氧化铁颜料。
   • 作为媒染剂、净水剂、防腐剂和消毒剂使用。
   • 治疗贫血的药物。

2. 环保与水处理：

   • 水的絮凝净化，去除磷酸盐。
   • 还原六价铬为三价铬，置换废水中重金属离子。
   • 作为絮凝剂，提高沉降速度。

3. 食品工业：

   • 营养增补剂（铁质强化剂）。
   • 果蔬发色剂，用于腌制食品如茄子、蚕豆等。

生产方法

• 使用稀硫酸与铁屑反应得到硫酸亚铁。

安全信息

• 毒性：高毒。
• 急性毒性：口服大鼠 LD50 319 毫克/公斤；小鼠 LD50: 680 毫克/公斤。
• 可燃性：不可燃烧，但火场会产生有毒的含铁化物烟雾。
• 储存运输：低温、通风、干燥库房，与食品原料分开存放。

希望这些信息能够满足您的需求！如果您有其他问题或需要进一步的信息，请随时告诉我。