• Journal of Pharmaceutical Investigation
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• 제34권5호
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• pp.427-433
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• 2004

With the Sunshine policy, exchange of materials and cultures inter Koreas has been broadened and expectancy of reunification is getting higher. Especially, medical supplies and medicines are one of the biggest parts in the exchange goods. So, preparing an unified official drug standard preparing new medical administration system is required. We compared the Korean pharmacopoeia with North Korean Pharmacopoeia. Two pharmacopoeias have been developed in different direction and have many differences in the nomenclature and format. In this study, we compared general notices, general rules for preparations and crude drugs, monographs, general tests, processes and apparatus.

• 대한본초학회지
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• 제31권6호
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• pp.11-20
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• 2016

Objectives : This study aims to examine validity of the following guideline for Zanthoxyli Pericarpium in the Korean Pharmacopoeia regarding foreign materials: "the seeds of Zanthoxyli Pericarpium that are mixed should not exceed 20%." Methods : Varied compliance guidelines for and original plants of Zanthoxyli Pericarpium across countries were compared and contrasted. In order to do this, pharmacopoeias from a number of different countries including Korea were used as references. Results : The weights including seed parts were Z. piperitum 3.48g, Z. schinifolium 2.94g, and Z. bungeanum 2.16g; while the weights of peel parts were Z. piperitum 1.45g, Z. schinifolium 1.69g, and Z. bungeanum 0.98g. In terms of weight, Z. piperitum was the heaviest with its entire part including the seed, whereas Z. schinifolium was the heaviest with its peel part. The proportions of each seed in the whole part were Z. piperitum 58.33%, Z. schinifolium 42.52%, and Z. bungeanum 54.63%. Considering these figures, including seed parts in the guideline up to 20% is inappropriate; however, this guideline is inevitable in order to use seed parts for medicinal purpose. Conclusion : In this article, the author argues if any changes were to made on the guideline for Zanthoxyli Pericarpium with respect to foreign materials - "the seeds of Zanthoxyli Pericarpium that are mixed should not exceed 20%" - its seed part should firsthand be separated from its peel part and be designated as one kind of medicine. Then, revisions on the foreign materials compliance guidelines for Zanthoxyli Pericarpium should also be made.

• 분석과학
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• 제29권6호
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• pp.277-282
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• 2016

영국약전(BP 2013), 미국약전(USP 39) 그리고 대한민국약전 (KP XI)에 디오스민 원료의 정량법으로 HPLC법이 수재되어 있다. 그러나 위의 외국약전들에는 디오스민 제제의 정량법이 수재되어 있지 않으며 대한민국약전 (KP XI)에는 디오스민 캡슐의 정량법으로 HPLC법보다 덜 특이적인 자외가시부흡 광도측정법이 수재되어 있다. 이 실험에서는 최근의 추세에 따라 원료의 정량법과 같고 특이성이 좋은 HPLC 분석법으로 디오스민 캡슐의 정량법을 개발하였고 이를 검증하였다. HPLC분석법의 검증을 위해 직선성, 정밀성, 정확성, 시스템 적합성, 실험실내 정밀성과 완건성 실험을 실행하였다. 직선성은 결정계수($r^2$)가 0.999 이상으로 우수하였다. 일내 정밀도는 상대표준편차 0.15~0.29%, 일간 정밀도는 1.05~1.74%로, 회수율은 101.2~103.2%로 나타났다. 시스템적합성에서는 머무름시간 상대표준편차(RSD %) 0.37 %, 피크면적 상대표준편차(RSD%) 0.06%, 이론단수 평균값 3591.293 그리고 비대칭계수 평균값 1.35을 나타내었다. 개발한 시험법을 이용하여 시중 유통 중인 디오스민 캡슐 중 디오스민의 함량측정에 응용하였다. 개발된 시험법은 대한민국약전의 개정에 기여할 것이다.

• 대한본초학회지
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• 제34권5호
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• pp.13-20
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• 2019

Objectives : To ensure the safety, quality and pharmacological efficacy of Batryticatus Bombyx, it is important to discriminate with adulterants. In Korean Herbal Pharmacopoeias (KHP), the authentic species of Batryticatus Bombyx is defined only Bombyx mori. Therefore, the aim of this study is establishment of PCR assay method using the sequence characterized amplified region (SCAR) marker based on COI DNA barcode for discriminating six species related to Batryticatus Bombyx. Methods : Seventeen samples of six species (Bombyx mori, Bombyx mandarina, Rhodinia fugax, Oberthueria caeca, Actias artemis, and Caligula japponica) were collected from different habitate and nucleotide sequences of cytochrome c oxidase subunit I(COI) barcode regions were analyzed by Sanger sequencing methods. To develop SCAR-based PCR assay method, we designed species-specific primers based on COI sequence variabilities and verified those specificities using 17 samples of six species as well as commercial herbal medicines. Results : In comparative multiple analysis of COI sequences, six species were distinguished by species-specific nucleotides at the species level. To develop rapid and reliable PCR assay method for genetic authentication of Batryticatus Bombyx, therefore, we designed species-specific SCAR primers based on these nucleotide sequences and confirmed those specificities. Using these SCAR primers, We also established simple conventional PCR assay method using these SCAR primers at the species level. Conclusions : The comparative analysis of COI sequences and SCAR-based PCR assay methods represented equal results for distinguishing authentic Batryticatus Bombyx and adulterations at the species level. Therefore, our results are expected protecting adulteration of herbal medicine Batryticatus Bombyx.