Standardisation of Unfractionated and Low-Molecular-Weight Heparin

Gray, Elaine

doi:10.1007/978-3-642-23056-1_4

Cited by 7 publications

(6 citation statements)

References 18 publications

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“…World Health Organization international and pharmacopeial reference standards are available for potency assignment of heparin products. The history and development of heparin and LMWH units, standardization landmarks, and statistical considerations for bioassays are detailed by Gray (2012). Bioassays using citrated plasma or purified reagents are designed based on the ability of heparin to potentiate the inhibitory action of plasma coagulation factor inhibitors such as AT and HCII.…”

Section: E Measurement Of Anticoagulant Activity Of Heparinmentioning

confidence: 99%

Pharmacology of Heparin and Related Drugs

et al. 2015

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Section: E Measurement Of Anticoagulant Activity Of Heparinmentioning

confidence: 99%

Pharmacology of Heparin and Related Drugs

et al. 2015

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“…Heparin has the potential role in the treatment of sepsis because of similar anticoagulant actions 8 . Heparin can be divided into unfractionated and low-molecular-weight heparin(LMWH) 9 . Unfractionated heparin is the most commonly used anticoagulant worldwide.…”

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Efficacy and safety of low-molecular-weight heparin in patients with sepsis: a meta-analysis of randomized controlled trials

Fan

Jiang

Gong

et al. 2016

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Low-molecular-weight heparin (LMWH) is part of standard supportive care. We conducted a meta-analysis to investigate the efficacy and safety of LMWH in septic patients. We searched Pubmed, Embase, CKNI and Wanfang database prior to July 2015 for randomized controlled trials investigating treatment with LMWH in septic patients. We identified 11 trials involving 594 septic patients. Meta-analysis showed that LMWH significantly reduced prothrombin time (mean differences [MD] −0.88; 95% CI −1.47 to −0.29), APACHE II score (MD −2.50; 95% CI −3.55 to −1.46), and 28-day mortality (risk ratio [RR] 0.72; 95% CI 0.57–0.91) as well as increased the platelet counts (MD 18.33; 95% CI 0.73–35.93) than the usual treatment. However, LMWH did not reduce D-dimer (MD −0.34; 95% CI −0.85 to 0.18). LMWH also significantly increased the bleeding events (RR 3.82; 95% CI 1.81–8.08). LMWH appears to reduce 28-day mortality and APACHE II score among septic patients. Bleeding complications should be monitored during the LMWH treatment. As for limited data about LMWH and sepsis in the English literature, only trials published in the Chinese were included in the meta-analysis.

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“…Three of them had spectra similar to that of the 5th International Heparin Standard from NBISC (National Institute for Biological Standards and Control–U.K. ), sourced from porcine-mucosa (HPI), in effect at that time, while the other two presented spectra similar to one another but bearing striking differences in the proportions of some fingerprinting signals (11, 12). The major structural difference seen in the conflicting spectra of those two UFHs certainly was an extensive 6-desulfation of their α-glucosamine units, as shown by the 1D 1 H NMR spectra depicted in the Figure 1A.…”

Section: The Starting-pointmentioning

confidence: 99%

Heparins Sourced From Bovine and Porcine Mucosa Gain Exclusive Monographs in the Brazilian Pharmacopeia

et al. 2019

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Most of the unfractionated heparin (UFH) consumed worldwide is manufactured using porcine mucosa as raw material (HPI); however, some countries also employ products sourced from bovine mucosa (HBI) as interchangeable versions of the gold standard HPI. Although accounted as a single UFH, HBI, and HPI have differing anticoagulant activities (~100 and 200 IU mg−1, respectively) because of their compositional dissimilarities. The concomitant use of HBI and HPI in Brazil had already provoked serious bleeding incidents, which led to the withdrawal of HBI products in 2009. In 2010, the Brazilian Pharmacopeia (BP) formed a special committee to develop two complementary monographs approaching HBI and HPI separately, as distinct active pharmaceutical ingredients (APIs). The committee has rapidly agreed on requirements concerning the composition and presence of contaminants based on nuclear magnetic resonance and anion-exchange chromatography. On the other hand, consensus on the anticoagulant activity of HBI was the subject of long and intense discussions. Nevertheless, the committee has ultimately agreed to recommend minimum anti-FIIa activities of 100 IU mg−1 for HBI and 180 IU mg−1 for HPI. Upon the approval by the Brazilian Health Authority (ANVISA), the BP published the new monographs for HPI and HBI APIs in 2016 and 2017, respectively. These pioneer monographs represent a pivotal step toward the safest use of HBI and HPI as interchangeable anticoagulants and serve as a valuable template for the reformulation of pharmacopeias of other countries willing to introduce HBI.

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Standardisation of Unfractionated and Low-Molecular-Weight Heparin

Cited by 7 publications

References 18 publications

Pharmacology of Heparin and Related Drugs

Pharmacology of Heparin and Related Drugs

Efficacy and safety of low-molecular-weight heparin in patients with sepsis: a meta-analysis of randomized controlled trials

Heparins Sourced From Bovine and Porcine Mucosa Gain Exclusive Monographs in the Brazilian Pharmacopeia

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