• Proceedings of the PSK Conference
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• 2002.10a
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• pp.329.2-330
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• 2002

This study was intended to establish test methods equivalent to those of "Interferon alfa-2 concentrated solution" monograph in European Pharmacophoeia(EP). Two recombinant interferon alfa concentrated solutions manufactured in Korea were tested according to the monograph of EP. Tests of identification(biological activity. isoelectric focusing. SDS-PAGE under reducing condition, peptide mapping). related proteins. impurities of moducular masses differing from that of interferon alfa-2(SDS-PAGE under reducing and non-reducing condition). bacterial endotoxin, protein, potency, host-cell-derrved proteins. and host-cell-derived DNA were performed in the laboratories of manufacrues and division of biotechnology. KFDA. The results of this study showed that specitications of interfenon alfa concentrated solutions manufactured in Korea were within the aceptance criteria of EP. Based on the study. specitications and test methods for interferon alfa concentrated solution can be established according to the monograph of EP suggesting the revision of Minimum requirements for biological products

• The Korea Journal of Herbology
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• v.31 no.5
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• pp.55-62
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• 2016

Objective : TM-MC was constructed to provide information on the chemical compounds of medicinal plant materials which were listed in Korean, Chinese, and Japanese pharmacopoeias. The aim of this study was to compare of the chemical compounds of TM-MC with those of domestic pharmacopoeias.Methods : First of all, TM-MC was updated on medicinal materials and chemical compounds which were extracted from articles up to the PubMed identifier of 26 millions. After searching for medicinal plant materials with information on their major compounds in Korean pharmacopoeias, we identified that the information on medicinal materials and chemical compounds were also existed in TM-MC. Then, we figured out how much the compounds have been studied by counting the number of articles for those compounds in TM-MC.Results : Information on 9 medicinal materials and about 1,700 compounds was newly added to TM-MC after manually curating 645 articles. Korean pharmacopoeias contained a total of 91compounds from 53 medicinal plant materials, while TM-MC provided information on the 89 compounds from the 53 medicinal materials in Korean pharmacopoeias. The compounds stated in Korean pharmacopoeias has been much studied by comparison with other compounds of each medicinal material in TM-MC.Conclusion : Most of chemical compounds stated in Korean pharmacopoeias were also listed in TM-MC, excluding two compounds. Thus, we concluded that information in TM-MC is mostly consistent with that of Korean pharmacopoeias. In the future, we will periodically update TM-MC with articles added to the MEDLINE.