著者

齋藤 秀之 瀬々 潤 小倉 淳

出版者

北海道大学

雑誌

挑戦的萌芽研究

巻号頁・発行日

2014-04-01

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ブナ目を代表してブナのゲノム構築法について検討を行い、ドラフトゲノムを構築した。ゲノム配列をアセンブリするソフトウェアはPlatanusが最良であった。ブナゲノムは対立する遺伝子座のヘテロ配列が大きく頻度が高い特徴をもつことが示唆された。RNA-seqのDe novoアセンブリは遺伝子の配列決定において配列数が収束せず、遺伝子推定にはゲノム配列情報が必須と考えられた。遺伝子ファミリー内での遺伝子の機能予測には、塩基配列情報に加えて遺伝子発現パターンが補助情報として有用であることが示唆された。最終的に523Mbp(カバー率96.9%)が完成した。

著者

本田 義輝 齋藤 秀之

出版者

一般社団法人日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.31, no.5, pp.391-398, 2005-05-10 (Released:2011-03-04)

参考文献数

15

被引用文献数

9 11

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Very little quality information is available for generic pharmaceutical preparations and this is particularly so for injectable preparations for which few quality studies have been conducted. With this in mind, we conducted an inter-lot quality variation investigation on nafamostat mesilate preparations for both the original and generic products and compared the results. The investigation involved measuring amounts of impurities other than those of the active ingredient by high performance liquid chromatography.For the nine generic products investigated, impurity amounts were about 2.4 times that of the original (min. 2.0 times-max. 3.1 times). We determined that these differences were not due to hydrolysates of the active ingredient but to unknown substances since the amounts of these unknown substances in the generic products were about 5.7 times (min. 4.7 times-max. 8.0 times) their amount in the original product.Concerning inter-lot variation (maximum value-minimum value), we found that the variation in total impurity amounts for the generic products was 1.8 times (min. 0.7 times-max. 2.8 times) that of the original product, while the variation in unknown substance amounts for the generics was 3.1 times (min. 1.0 times-max.4.6 times) that for the original.The results of the present study suggest that it is necessary to take inter-lot variation into account in evaluating the quality of generic products. They also suggest that the higher contents of unknown impurities in the generics could be a cause of the in-circuit precipitation which has been reported with generic versions of nafamostat mesilate during blood purification in the clinical setting.

著者

本田 義輝 齋藤 秀之

出版者

日本医療薬学会

雑誌

医療薬学 (ISSN:1346342X)

巻号頁・発行日

vol.31, no.5, pp.391-398, 2005-05-10

参考文献数

15

被引用文献数

8 11

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Very little quality information is available for generic pharmaceutical preparations and this is particularly so for injectable preparations for which few quality studies have been conducted. With this in mind, we conducted an inter-lot quality variation investigation on nafamostat mesilate preparations for both the original and generic products and compared the results. The investigation involved measuring amounts of impurities other than those of the active ingredient by high performance liquid chromatography. For the nine generic products investigated, impurity amounts were about 2.4 times that of the original (min. 2.0 times-max. 3.1 times). We determined that these differences were not due to hydrolysates of the active ingredient but to unknown substances since the amounts of these unknown substances in the generic products were about 5.7 times (min. 4.7 times-max. 8.0 times) their amount in the original product. Concerning inter-lot variation (maximum value-minimum value), we found that the variation in total impurity amounts for the generic products was 1.8 times (min. 0.7 times-max. 2.8 times) that of the original product, while the variation in unknown substance amounts for the generics was 3.1 times (min. 1.0 times-max. 4.6 times) that for the original. The results of the present study suggest that it is necessary to take inter-lot variation into account in evaluating the quality of generic products. They also suggest that the higher contents of unknown impurities in the generics could be a cause of the in-circuit precipitation which has been reported with generic versions of nafamostat mesilate during blood purification in the clinical setting.