依諾肝素鈉是由來源于豬腸粘膜的肝素鈉經(jīng)成鹽、酯化后得到的肝素-苯索氯銨鹽的芐基酯衍生物在堿性條件下發(fā)生beta-消除反應(yīng)裂解生成的低分子肝素鈉，其主要特征為在糖鏈的非還原末端具有4—烯醇毗喃糖酸，在糖鏈的還原末端具有1，6一脫水結(jié)構(gòu)，后者占全部糖的15—25%。
本品主要用于預(yù)防深靜脈血栓形成及肺栓塞；治療已形成的靜脈血栓；預(yù)防血液透析時(shí)體外循環(huán)中血栓的形成；治療不穩(wěn)定性心絞痛和非Q波心梗。
浩然生物可以供應(yīng)以下規(guī)格的依諾肝素鈉原料。也可以根據(jù)客戶的需求準(zhǔn)備其他規(guī)格的產(chǎn)品
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白色或類白色粉末, 具引濕性 |
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溶解性 |
易溶于水 |
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鑒別 |
A. 得到的圖譜與依諾肝素鈉的CRS相似 B. 抗Xa因子和抗IIa因子活性的比值: 3.3-5.3 重均分子量范圍在3800和5000之間 C. 分子量低于2000的鏈的百分比: 12.0％～20.0％ 分子量在2000和8000之間的鏈的百分比： 68.0％～82.0％ D. 顯鈉鹽的鑒別A反應(yīng) |
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溶液性狀 （10% w/v溶液） |
溶液澄清，顏色不得比最相近顏色的6號標(biāo)準(zhǔn)比色液更深 |
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pH (10% w/v 溶液) |
6.2～7.7 |
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吸光系數(shù) （干燥品） |
14.0～20.0 |
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氮 （干燥品） |
1.5%～2.5% |
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鈉 （干燥品） |
11.3%～13.5% |
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重金屬 |
≤30ppm |
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干燥失重 |
≤10.0% |
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硫酸根離子與羧酸根離子的摩爾比 |
≥1.8 |
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細(xì)菌內(nèi)毒素 |
不多于0.01 EU/1 IU 抗Xa因子活性 |
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效價(jià)測定 （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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殘留乙醇 |
≤5000 ppm |
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微生物計(jì)數(shù)試驗(yàn) |
總需氧微生物計(jì)數(shù)：≤1000cfu/g 總聯(lián)合酵母/霉菌計(jì)數(shù)：100cfu/g |
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指定微生物測試 |
大腸埃希氏菌：沒有檢測到/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 |
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