Development of an Industrial Processing Method for Removing Contaminating Mucopolysaccharides from Low Molecular Weight Heparin Preparations
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- Murata Hiroshi
- Interdisciplinary Graduate School of Agriculture and Engineering, University of Miyazaki Fuso Pharmaceutical Industries, Ltd
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- Shimamura Hideo
- Fuso Pharmaceutical Industries, Ltd
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- Matsuhisa Akio
- Fuso Pharmaceutical Industries, Ltd
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- Yamamoto Keiichi
- Fuso Pharmaceutical Industries, Ltd
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- Sugiyama Kouji
- Fuso Pharmaceutical Industries, Ltd
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- Kawakami Takao
- Fuso Pharmaceutical Industries, Ltd
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- Yoden Hikaru
- Fuso Pharmaceutical Industries, Ltd
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- Uemura Hidetoshi
- Fuso Pharmaceutical Industries, Ltd
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- Toda Takao
- Fuso Pharmaceutical Industries, Ltd
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- Muguruma Michio
- Faculty of Agriculture, University of Miyazaki
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- Kawahara Satoshi
- Faculty of Agriculture, University of Miyazaki
Bibliographic Information
- Other Title
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- 低分子ヘパリン中の夾雑ムコ多糖類の工業的除去方法
- テイブンシ ヘパリン チュウ ノ キョウザツ ムコ タトウルイ ノ コウギョウテキ ジョキョ ホウホウ
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Abstract
We have developed a simple method for removing mucopolysaccharide (MS) impurities from low molecular weight heparin (LMWH) preparations. Crude dalteparin sodium (DN-C) containing high molecular weight impurities such as sodium salts of over-sulfated chondroitin sulfate (OSH) and dermatan sulfate (DSH) was used as a model of LMWH preparations. In preliminary experiments, the sensitivities of OSH and DSH to ethanol were quite different, even though their molecular weights are similar. A two-step ethanol precipitation was used to remove these contaminants. Upon the first treatment, OSH was removed as a precipitate, and upon the second treatment, DSH was recovered in the supernatant. LMWH was concentrated in the precipitate following the second treatment. The contaminants were detected easily by nitrous acid de-polymerization followed by gel permeation HPLC. In contrast, it was difficult to detect small amounts of impurities by 1H-NMR. We also tried purifying commercial DN products (DNG 1-3) to confirm the efficacy of this methodology and concluded that the two-step ethanol precipitation of LMWH, followed by purity analysis by gel permeation HPLC after nitrous acid de-polymerization of MSs, holds promise for the manufacture of high-quality LMWH preparations.
Journal
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- Nippon Shokuhin Kagaku Kogaku Kaishi
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Nippon Shokuhin Kagaku Kogaku Kaishi 61 (2), 85-94, 2014
Japanese Society for Food Science and Technology
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Keywords
Details 詳細情報について
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- CRID
- 1390001206408457728
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- NII Article ID
- 130003393537
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- NII Book ID
- AN10467499
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- ISSN
- 18816681
- 1341027X
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- NDL BIB ID
- 025250124
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- Text Lang
- ja
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- Data Source
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- JaLC
- IRDB
- NDL
- Crossref
- CiNii Articles
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- Abstract License Flag
- Disallowed