依诺肝素钠是由来源于猪肠粘膜的肝素钠经成盐、酯化后得到的肝素-苯索氯铵盐的苄基酯衍生物在碱性条件下发生beta-消除反应裂解生成的低分子肝素钠，其主要特征为在糖链的非还原末端具有4—烯醇毗喃糖酸，在糖链的还原末端具有1，6一脱水结构，后者占全部糖的15—25%。
本品主要用于预防深静脉血栓形成及肺栓塞；治疗已形成的静脉血栓；预防血液透析时体外循环中血栓的形成；治疗不稳定性心绞痛和非Q波心梗。
浩然生物可以供应以下规格的依诺肝素钠原料。也可以根据客户的需求准备其他规格的产品
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白色或类白色粉末, 具引湿性 |
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溶解性 |
易溶于水 |
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鉴别 |
A. 得到的图谱与依诺肝素钠的CRS相似 B. 抗Xa因子和抗IIa因子活性的比值: 3.3-5.3 重均分子量范围在3800和5000之间 C. 分子量低于2000的链的百分比: 12.0％～20.0％ 分子量在2000和8000之间的链的百分比： 68.0％～82.0％ D. 显钠盐的鉴别A反应 |
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溶液性状 （10% w/v溶液） |
溶液澄清，颜色不得比最相近颜色的6号标准比色液更深 |
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pH (10% w/v 溶液) |
6.2～7.7 |
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吸光系数 （干燥品） |
14.0～20.0 |
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氮 （干燥品） |
1.5%～2.5% |
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钠 （干燥品） |
11.3%～13.5% |
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重金属 |
≤30ppm |
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干燥失重 |
≤10.0% |
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硫酸根离子与羧酸根离子的摩尔比 |
≥1.8 |
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细菌内毒素 |
不多于0.01 EU/1 IU 抗Xa因子活性 |
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效价测定 （干燥品） |
抗Xa因子活性：90 IU-125 IU/mg 抗IIa因子活性：20.0 IU-35.0 IU/mg 抗Xa因子和抗IIa因子活性的比值： 3.3-5.3 |
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苯甲醇 |
≤0.1%(m/m) |
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残留乙醇 |
≤5000 ppm |
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微生物计数试验 |
总需氧微生物计数：≤1000cfu/g 总联合酵母/霉菌计数：100cfu/g |
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指定微生物测试 |
大肠埃希氏菌：没有检测到/g |
Enoxaparin sodium is the sodium salt of a low-molecular-mass heparin that is obtained by alkaline depolymerisation of the benzyl ester derivative of heparin from porcine intestinal mucosa. The majority of the components have a 4-enopyranose uronate structure at the nonreducing end of their chain
It is mainly indicated for the prophylaxis of Deep Venous Thrombosis (DVT) and pulmonary embolism, treatment of venous thrombosis, prevention of clotting during hemodialysis, treatment of unstable angina and non-Q-wave myocardial infarction.
Haoran Biopharma can supply bulk Enoxaparin Sodium with the following specifications. Products of various specifications can also be prepared according to customers' requests.
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Appearance |
White or almost white powder, hygroscopic |
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Solubility |
Freely soluble in ** |
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Identification |
A. The spectrum obtained is similar to enoxaparin sodium CRS B. The ratio of Anti-factor Xa activity to anti-factor IIa activity: 3.3-5.3 The mass-average relative molecular mass ranges between 3800 and 5000 C. The mass percentage of chains lower than 2000：12.0%～20.0% The mass percentage of chains between 2000 and 8000: 68.0%～82.0% D. It gives reaction (a) of sodium |
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Appearance of solution (10% solution w/v) |
The solution is clear and not more intensely coloured than intensity 6 of the range of reference solutions of the most appropriate colour |
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pH (10% W/V solution) |
6.2～7.7 |
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Specific absorbance (dried substance) |
14.0～20.0 |
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Nitrogen (dried substance) |
1.5%～2.5% |
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Sodium (dried substance) |
11.3%～13.5% |
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Heavy metals |
≤30ppm |
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Loss on drying |
≤10.0% |
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Molar ratio of sulfate ions to carboxylate ions |
≥1.8 |
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Bacterial endotoxins |
N.M.T. 0.01 EU/1 IU anti-factor Xa activity |
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Assay (dried substance) |
Anti-factor Xa activity: 90 IU-125 IU/mg Anti-factor IIa activity: 20 IU-35 IU/mg The ratio of anti-factor Xa activity to anti-factor IIa activity: 3.3～5.3 |
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Benzyl alcohol |
≤0.1% (m/m) |
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Residual ethanol |
≤5000 ppm |
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Microbial enumeration tests |
Total aerobic microbial count: ≤1000cfu/g Total combined yeast/moulds count: 100cfu/g |
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Test for specified micro-organisms |
Escherichia coli: not detected/g |
