• Title/Summary/Keyword: Pharmacopoeias

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Comparative Study of the Korean Pharmacopoeia with North Korean Pharmacopoeia (남.북한 약전에 대한 비교조사연구)

  • Choi, Myoeng-Sin;Kang, Chan-Soon;Kim, Hye-Soo;Kim, Eun-Jung;Hong, Chong-Hui;Ko, Yong-Seok;Kim, Sang-Hyun;Jang, Sung-Jae
    • Journal of Pharmaceutical Investigation
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    • v.34 no.5
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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.

Study on Original Plants of and Foreign Materials Compliance Guidelines for Zanthoxyli Pericarpium (산초(山椒)의 기원(基原)식물과 이물 규격에 관한 연구)

  • Lee, Young-Jong
    • The Korea Journal of Herbology
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    • v.31 no.6
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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.

Development of high performance liquid chromatography assay method of diosmin capsules (디오스민 캡슐의 HPLC 분석법의 개발)

  • Shim, Dae Hyun;Shin, Dong Han;Truong, Quoc Ky;Mai, Xuan Lan;Kang, Jong-Seong;Woo, Mi Hee;Na, Dong-Hee;Chun, In-Koo;Kim, Kyeong Ho
    • Analytical Science and Technology
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    • v.29 no.6
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    • pp.277-282
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    • 2016
  • British Pharmacopoeia (BP 2013), the United States Pharmacopoeia (USP 39) and the Korean Pharmacopoeia (KP XI) contain monographs for the quality control of raw diosmin using high performance liquid chromatography (HPLC). However, official monographs detailing pharmaceutical formulations for diosmin are not available in foreign pharmacopoeias. In the KP XI, ultraviolet-visible (UV-Vis) spectroscopy-which is less specific than HPLC-is reported for the testing of diosmin capsules. In this study, we present an alternative HPLC assay for such testing that is more specific than UV-Vis methods. Method validation was performed to determine linearity, precision, accuracy, system suitability, and robustness. The linearity of calibration curves in the desired concentration range was high ($r^2$>0.999), while the RSDs for intra- and inter-day precision were 0.15-0.29 % and 1.05-1.74%, respectively. Accuracies ranged from 101.2-103.2 %, while the retention time and peak area RSDs were 0.37 % and 0.06 %, respectively. Additionally, the plate number and asymmetry factor values for diosmin were 3591.293 and 1.35, respectively. Since the intermediate-precision and robustness of the assay were satisfactory, this method will be a valuable addition to the Korean Pharmacopoeia (KP XI).

Development SCAR marker for the rapid authenticaton of Batryticatus Bombyx based on COI Sequences (COI 염기서열 기반 백강잠 신속 감별용 SCAR marker 개발 - 백강잠 유전자 감별 -)

  • Kim, Wook Jin;Yang, Sungyu;Noh, Pureum;Park, Inkyu;Choi, Goya;Song, Jun-Ho;Moon, Byeong Cheol
    • The Korea Journal of Herbology
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    • v.34 no.5
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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.