药品信息: 伟素Vessel Due F
【成分】
舒洛地特（sulodexide）。
【规格】
① 粉针剂：600LSU／支。② 胶囊剂：50粒（250LSU／粒）／盒。
【作用】
本品为从动物肝脏提取的高纯度低分子肝素类药物，对动、静脉系统都有显著抗血栓活性，可通过抑制一些凝血因子，其中主要是Xa因子，而发挥抗血栓作用，这一作用与剂量呈相关性。本品还可通过抑制血小板凝集，激活循环中和血管型的纤溶系统而发挥其抗血栓作用。此外，本品还具有激活脂蛋白酯酶的作用，通过抗增殖作用及维持膜通透选择性作用，可使改变了的血液黏滞指标恢复正常。
【用途】
用于治疗有血栓形成的血管性疾病。
【用法用量】
①粉针剂：每日600LSU，肌内注射或静脉注射。②胶囊剂：每次250LSU，每日2次，距用餐时间要长，如在早上10时和晚上10时服。一般情况下以粉针剂开始治疗，维持15～20日，然后服胶囊剂30～40日，即共45日为1个疗程。1年中应至少使用3个疗程。
【不良反应】
①粉针剂：注射部位疼痛、烧灼感以及血肿。罕见过敏反应。②胶囊剂：恶心、呕吐和上腹部痛等胃肠道紊乱。
【禁用慎用】
对本品、肝素和肝素样药物过敏者，有出血素质或出血性疾病者禁用。
舒洛地特Sulodexide
舒洛地特Sulodexide
（伟素，阿尔法韦士曼，Alfa Wassermann，葡萄醛酸基葡糖胺聚糖硫酸盐）
注射液为浅黄色或黄色澄明液体。胶囊为砖红色较胶囊，内含白色至黄色微细颗粒的混悬物。
【药动学】
舒洛地特的V d值为30～70L，基于未变化部分的放射活性，调整为15～30L。药物反应呈剂量依赖性，给药后1～2 小时达峰值，6 小时后仍具有统计学意义的显著性，8 小时后消失。平均滞留时间约为15 小时，主要经肝脏代谢，经肾脏排泄，给药72 小时后，有40%～50%的剂量经尿液排出。48 小时内粪便中检出药量为23%，48 小时后未能检出。小鼠的半致死量（LD 50）超过9000mg／kg（口服）及1980mg／kg（腹腔注射），大鼠的半致死量（LD 50）超过9000mg／kg（口服）及2385mg／kg（腹腔注射）。
【药理作用】
舒洛地特对第Ⅹa 因子和第Ⅱa 因子有抑制作用，而对活化部分凝血时间（APTT）的影响不确定；对抗凝血酶（ATⅢ）作用于游离凝血酶，通过肝素因子Ⅱ（HCⅡ）作用于与纤维蛋白结合的凝血酶，从而产生抗栓作用，表现为即能阻止血栓形成，又能阻止血栓增长。还能通过抗血小板聚集、激活循环和血管壁的纤溶系统而发挥作用。通过降低高血纤维蛋白原和低密度脂蛋白浓度而改善血液循环，使有血栓形成危险的血管病变病人的血黏度参数恢复正常。通过保存血管壁上的正常负电荷和抑制细胞增殖及随后发生的血管基底膜和细胞外基质功能丧失，维持血管壁选择通透性；血管壁通透性的选择性作用可以防止不同高分子（如白蛋白、纤维蛋白原和脂蛋白）经血管渗漏，既可防治动脉粥样硬化，又可以防治蛋白尿。
【临床应用】
对动脉和静脉均有较强的抗血栓形成作用，主要用于有血栓形成危险的血管疾病。
剂量与用法：通常用注射剂开始治疗，每日1 支，肌注或静注，维持15～20 天；然后口服胶囊30～40 天，每次1 粒，每日2 次，距用餐时间要长，如在早上10 时和晚上10 时服用，45～60天为一疗程。一年至少使用2 个疗程。可按病情需要调节用药剂量。
【不良反应与防治】
不良反应极少发生。
1﹒注射部位疼痛、烧灼以及血肿，罕见注射部位或其他位点出现皮肤过敏。
2﹒服用胶囊剂可出现恶心、呕吐和上腹痛等胃肠道紊乱症状。
3﹒对本品、肝素或肝素样药物过敏者，有出血素质或患出血性疾病者禁用。
4﹒正在进行抗凝治疗的病人，应定期监测凝血指标。单独使用本品的病人，最好也定期监测凝血指标。
5﹒虽然胎儿毒性研究未发现本药有胚胎‐胎儿毒性作用，但不建议孕妇使用本品。
6﹒出血是药物过量的唯一副作用。如果出血，需注射1%的硫酸鱼精蛋白（3ml ＝30mg），和肝素出血时一样使用。
【药物相互作用】
1﹒可增加肝素本身或同时使用的其他抗凝剂的抗凝作用。
2﹒由于本品为酸性多糖，故不能与下列碱性药物混合注射，以防形成复合物：维生素K、维生素B 复合物、氢化可的松、透明质酸酶、葡萄糖酸钙、季铵盐、氯霉素、四环素和链霉素等。
【制剂】
软胶囊：250LSU；注射液：600LSU 于60℃以下保存，有效期60 个月。
Vessel Due F
Ingredients
Sulodexide (sulodexide).
[Specification]
① powder: 600LSU / support. ② capsules: 50 (250LSU / tablets) / box.
[Action]
The product is extracted from the liver of high purity low molecular weight heparin drugs for arterial and venous systems have significant antithrombotic activity by inhibiting some coagulation factors, mainly factor Xa, and exert antithrombotic effect, this effect were correlated with the dose. This product can also inhibit platelet aggregation, activates circulation and vascular fibrinolytic system and exert its antithrombotic effect. In addition, the product also has a role in the activation of lipoprotein lipase, an anti-proliferative effect by maintaining membrane permeability and selectivity of action, can change the blood viscosity indexes returned to normal.
[Applications]
For the treatment of thrombosis of vascular disease.
Dosage
① powder: Daily 600LSU, intramuscular or intravenous injection. ② Capsules: Each 250LSU, 2 times a day, from meal times to be longer, such as serving in the morning 10:00 and 22:00. Under normal circumstances in order to begin treatment powder, for 15 to 20 days, then serving capsules 30 to 40 May, a total of 45 days for a course of treatment. 1 year should be used at least three courses.
Adverse reactions
① powder: injection site pain, burning sensation, and hematoma. Rare allergic reaction. ② capsules: nausea, vomiting and abdominal pain and other gastrointestinal disorders.
[Disable] caution
For this product, heparin and heparin-like drug allergies, bleeding diathesis, or bleeding disorders were banned.
Sulodexide Sulodexide
Sulodexide Sulodexide
(Wei Su, Alfa Wassermann, Alfa Wassermann, grape acid sulfate glycosaminoglycan base)
Injection is light yellow or yellow transparent liquid. Brick red capsules compared with capsules containing white to yellow fine particles suspended matter.
Pharmacokinetics]
Sulodexide of V d is 30 ~ 70L, based on the radioactivity of the unchanged portion, is adjusted to 15 ~ 30L. Drug reactions in a dose-dependent manner, from 1 to 2 hours after the administration reached a peak, still statistically significant after 6 hours was significant, eight hours after the disappearance. The average residence time of about 15 hours, mainly by the liver, kidney, and 72 hours after administration, 40% to 50% of the dose excreted in urine. Were detected in the feces within 48 hours 23% drug content after 48 hours was not detected. Half lethal dose in mice (LD 50) exceeds 9000mg / kg (oral) and 1980mg / kg (intraperitoneal injection), half-lethal dose in rats (LD 50) than 9000mg / kg (oral) and 2385mg / kg (intraperitoneal injection ).
Pharmacological effects
Sulodexide on the first factor and Ⅹa Ⅱa factor inhibition, but uncertain impact on the activated partial thromboplastin time (APTT); and antithrombin (ATⅢ) acting on the free thrombin, (HCⅡ) by the action of heparin factor Ⅱ on the fibrin-bound thrombin, resulting antithrombotic effect, the performance that can prevent thrombosis, but also to prevent thrombus growth. Also play a role by anti-platelet aggregation, activation of circulation and vascular wall fibrinolytic system. By reducing high blood fibrinogen and LDL concentrations improve blood circulation, vascular disease patients with thrombosis of dangerous blood viscosity parameters returned to normal. By saving the normal negative charge of the vessel wall and inhibit cell proliferation and vascular basement membrane and extracellular matrix function subsequent loss of the vessel wall to maintain selective permeability; selective vascular wall permeability can prevent different polymer (such as albumin, fibrinogen, and lipoprotein) by vascular leakage, both prevention and treatment of atherosclerosis, but also can prevent proteinuria.
Clinical application
Arterial and venous have strong antithrombotic effect, mainly for thrombosis risk of vascular disease.
Dosage and Administration: usually start treatment with injections, one day, intramuscular or intravenous injection, for 15 to 20 days; then oral capsule 30 to 40 days, every one, two times a day, from meal times longer as at 10:00 am and 22:00 to take 45 to 60 days for treatment. Use at least two courses a year. Disease may need to adjust the dosage.
Adverse reactions and Prevention]
Adverse reactions rarely occur.
1. Injection site pain, burning and hematoma at the injection site, or other rare sites of skin allergies.
2. Taking the capsules may be nausea, vomiting and abdominal pain and other symptoms of gastrointestinal disorders.
3. For this product, heparin or heparin-like drug allergies, bleeding diathesis, or suffering from bleeding disorders were banned.
4. Ongoing patient anticoagulation, coagulation parameters should be monitored regularly. FDA individual patient, it is best to regularly monitor coagulation.
5. Although fetal toxicity studies have not found the drug embryo - fetal toxicity, but is not recommended for pregnant women to the FDA.
6. Bleeding is the only side effect of a drug overdose. If the bleeding, to be injected with a 1% protamine sulfate (3ml = 30mg), when used in the same bleeding and heparin.
Drug interactions
1. Itself or the use of heparin may increase anticoagulant effect of other anticoagulants.
2. This product as acidic polysaccharides, it can not be mixed with the following basic drug injection, to prevent the formation of a complex: vitamin K, vitamin B complex, hydrocortisone, hyaluronidase, calcium gluconate, quaternary ammonium salts, chlorine doxycycline, tetracycline and streptomycin.
[Preparation]
Soft Capsule: 250LSU; Injection: 600LSU at below 60 ℃, valid for 60 months.
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