• Title/Summary/Keyword: official compendium

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Origin and description study for Rhizoma Dioscoreae Bulbiferae unregistered in official documents

  • Lee, Sang-Chang
    • Journal of Evidence-Based Herbal Medicine
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    • v.2 no.2
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    • pp.9-15
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    • 2009
  • In order to build up the infrastructure of the globalization of herbal material, the system of culture, distribution, treatment and sale should be established on the basis of the official documents. In this context, the state compendium needs to be theoretically established in perfection 0in order that it may be globally authoritative. The ultimate goal of this study is to clarify the origin and description of the herbal material unregistered in the official documents, as well as to establish the criteria of assessment. The technical books on herbage, published in the country and other countries, were compared with each other. Also, on-the-spot surveys were made to learn specialists' know-how. The description of the collected drug-stuffs Were analyzed in connection with external morphology, internal morphology and microscopy. And the laboratory test was performed to differentiate such drug-stuffs.

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Determination of the quantity of tolperisone hydrochloride in tablets by high performance liquid chromatography

  • Truong, Quoc-Ky;Mai, Xuan-Lan;Kim, Dae Hyun;Kim, Jeon Kyung;Kang, Jong-Seong;Woo, Mi Hee;Na, Dong-Hee;Chun, In-Koo;Kim, Kyeong Ho
    • Analytical Science and Technology
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    • v.30 no.1
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    • pp.32-38
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    • 2017
  • In attempt to contribute in official monographs of Korean Pharmacopoeia, an HPLC method was developed and fully validated for the determination of tolperisone hydrochloride in tablets which have never been published in other forgein Pharmacopoeia. Analysis was carried out in an ODS column ($250{\times}4.6mm$ I.D., $5{\mu}m$) with common solvents include acetonitrile and ammonium hydrophosphate buffer as mobile phase. The assay was validated according to International Conference on Harmonization (ICH) guidelines. The method has good linearity in the range of $5-200{\mu}g/mL$ tolperisone. Intra-day precision varied between 0.04 and 0.10 %. Relative standard deviations of inter-day precision ranged between 0.43 and 1.24 % for peak area. The percentage recovery of the tolperisone ranged between 99.8 and 101.2 % in material. Recoveries in tablets were ranged between 98.7 and 100.8 %, thus confirmed the suitability of method for estimation of tolperisone hydrochloride in tablet dosage form.

Optimization of the experimental conditions for determination of roxithromycin in bulk and dosage forms

  • Jeong, Kyung Min;Lee, Cheong Hoon;Kim, Su Hyun;Lee, Jeongmi
    • Analytical Science and Technology
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    • v.30 no.1
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    • pp.39-48
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    • 2017
  • Roxithromycin (RXT), which is an antibiotic used to treat respiratory tract and urinary infections, is official in Korean Pharmacopoeia (KP) and is marketed in various dosage forms including tablet, granule, suspension, and tablet for suspension in Korea. This study presents how a universal and reliable method to quantify RXT in bulk drug and formulations was developed. Effects of factors including column type, buffer concentration, type and concentration of organic solvent, buffer pH, and type and concentration of mobile phase additive, were examined, and some categorical or crucial factors including the types of column, organic solvent, mobile phase additive and the buffer pH were optimized by one-factor-at-a-time approach. Subsequently, concentrations of the buffer and additive and column temperature were optimized by response surface methodology using Box-Behnken design aiming to acquire the RXT peak of good shape. The optimized method employed a Phenomenex Gemini $5{\mu}$ C18 110A ($150{\times}4.60mm$, $5{\mu}m$) maintained at $30^{\circ}C$ with the mobile phase consisting of 25 mM phosphate buffer (pH 6.0) with 0.3 % tetrabutylammonium hydroxide and methanol at a ratio of 37:63 (v/v). Method validation results showed that the developed method was linear, precise, and accurate. Compared to the compendial methods in KP 10 that exhibited a significant tailing of the RXT peak despite using unfavorably high buffer concentrations and were not harmonized among bulk drug and formulations, this method could be universally applied to RXT bulk drug and marketed products in various dosage forms and thus was adopted in KP 11.

Development of HPLC assay method of fusidate sodium tablets

  • Lee, GaJin;Choi, Min;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.30 no.3
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    • pp.154-158
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    • 2017
  • The Korean Pharmacopoeia (KP XI), British Pharmacopoeia (BP 2013) and Japanese Pharmacopoeia contain monographs for the quality control of raw fusidate sodium and its formulations using high performance liquid chromatography (HPLC). However, the assay method for the determination of fusidate sodium in commercial tablets is titration which is less specific than HPLC. In this study, we present an alternative HPLC method for quantitation of fusidate sodium in tablets. 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 ($r^2=0.9999$), while the RSDs for intra- and inter-day precision were 0.25-0.37 % and 0.11-0.60 %, respectively. Accuracies ranged from 99.46-100.85 %. Since the system suitability, intermediate-precision and robustness of the assay were satisfactory, this method will be a valuable addition to the Korean Pharmacopoeia (KP XI).

Ecological Distribution of Medicinal Plants in Miho Stream, Korea (충남 미호천 일대 약용식물의 생태적 분포)

  • Song, Hong-Seon;Seo, Joung-Seok;Nam, Yun-Gyu;Ahn, Young-Sup;Park, Chung-Berm;Kim, Seong-Min
    • Korean Journal of Medicinal Crop Science
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    • v.19 no.6
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    • pp.407-413
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    • 2011
  • This study was analyzed and investigated to evaluate ecological distribution of medicinal plants in Miho Stream of Korea. Totality 463 taxa of vascular plants were appeared in lower part of Miho Stream. Medicinal plants were distributed 253 taxa, which were 54.6% of the total vascular plants appeared. Medicinal plants of official drug compendium(Korean pharmacopoeia) were 85 taxa. Medicinal plants were distributed most of the forest area, and followed field surrounding, stream surrounding and paddy surrounding respectively. The distribution of life form hemicryptophyte was the most frequent. Plant community of appearing area of medicinal plants was classified into Salix koreensis, Phragmites japonica, Echinochloa crusgalli, Artemisia selengensis, Miscanthus sacchariflorus, Setaria faberii, Panicum dichotomiflorum, Bidens frondosa, Humulus japonicus, Monochoria vaginalis var. plantaginea, Eleocharis kuroguwai, Erigeron acris, Pinus densiflora, Pinus rigida, Quercus acutissima, Quercus serrata, Robinia pseudoacacia and Castanea crenata community. Medicinal plants in plant communities that occur frequently were Humulus japonicus, Corylus heterophylla and Liriope spicata.

An HPLC method for the determination of thioctic acid in raw material and tablets

  • Mai, Xuan-Lan;Ahn, GyeChan;Lee, SeokHan;Kang, Jong-Seong;Woo, Mi Hee;Na, Dong-Hee;Chun, In-Koo;Kim, Kyeong Ho
    • Analytical Science and Technology
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    • v.30 no.5
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    • pp.221-225
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    • 2017
  • Thioctic acid is a vitamin-like antioxidant which is prepared as tablets and injection. The Korean Pharmacopoeia (KP XI) contains monograph for the quality control of raw thioctic acid using ultra-violet visible spectrophotometry and its formulations using high performance liquid chromatography (HPLC). In British Pharmacopoeia 2013 (BP2013), another HPLC method is used for the assay test of thioctic acid material. For the international harmonization, we present an HPLC method for quantitation of thioctic acid in both raw material and tablets. 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 ($r^2=0.9995$), while the RSDs for intra- and inter-day precision were 0.93 ~ 1.26 % and 1.40 ~ 1.76 %, respectively. Accuracies ranged from 98.13-100.00 %. Since the system suitability, intermediate-precision and robustness of the assay were satisfactory, this method will be a valuable addition to the Korean Pharmacopoeia (KP XI).

A Study on Cold Damage(傷寒) in the Compendium of Prescription from the Countryside(鄕藥集成方) - Focusing on citation, medical theory, prescription, medicinal herbs - (조선 의서 『향약집성방』 중에 실린 상한(傷寒) 논의 연구 - 인용 문헌, 의론(醫論), 처방, 본초 등을 중심으로 -)

  • Oh, Chae-Kun
    • The Journal of Korean Medical History
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    • v.25 no.2
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    • pp.121-136
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    • 2012
  • The purpose of this paper is to derive the features of cold damage clinical medicine during the early days of the Chosun(朝鮮) period by analyzing discussions on cold damage published in the official medical book of the Chosun period, Compendium of Prescription from the Countryside(鄕藥集成方, CPC). Cold damage was one of the typical diseases in East Asia where there was constant seeking of the utilization of prescriptions, ways of preparations, and awareness regarding cold damage as shown in Zhang, Zhongjing(張仲景)'s Treatise on Cold Damage Disease(傷寒論, TCDD) below. Traditional Korean medicine which possessed the medical universality of East Asia also was no exception and through an analysis of the part on cold damage in CPC, it is expected that medical features of cold damage in Korea passed down from the Koryo(高麗) Dynasty to the early Chosun period will be revealed. For this, first there needs to be an organization of past discussions on cold damage surrounding the existence of infection and after checking the issues, exploring which of the writings related to TCDD and editions are being utilized through an analysis on citing literature of Cold Damage Disease Literature(傷寒門) and Heat Pathogen Disease Literature(熱病門) which have developed discussions on cold damage in CPC. In addition, by comparing Peaceful Holy Benevolent Prescription(太平聖惠方, PHBP) and Complete Record of Sacred Benevolence(聖濟總錄, CRSB), known to have greatly influenced CPC and Cold Damage Literature and Heat Pathogen Disease Literature, features of form and content used by CPC were analyzed. Features of form were examined through pattern of organization and number of citing literature were examined and for features of content, cold damage infection, classification, syndrome differentiation method, and utilization of materia medica among prescriptions were examined. Discussions on cold damage as being uninfectious as stated in Treatise on the Pathogenesis and Manifestations of All Diseases(諸病源候論) unlike pestilence, epidemic pathogen(時氣), warm pathogen disease(溫病), and heat pathogen disease were excluded in PHBP. PHBP opened the possibility of cold damage infection and later writings, CRSB and CPC also follow this. As a result of analyzing citing literature of the part on cold damage in CPC, it is uncertain which edition of TCDD is being utilized; however, the most distinctive feature was that Classified Emergency Materia Medica(證類本草) and not writings specializing in cold damage are in use. In general, although CPC in terms of form is similar to CRSB, content creation predominantly depended on PHBP. More specifically; first, in terms of the existence of cold damage infection, arguments of PHBP and CRSB are maintained. Second, in terms of cold damage classification, although CRSB is followed, heat pathogen disease is classified separately developing PHBP as is. Third, in terms of method, as Book of Keep Healthy(南陽活人書) and CRSB compiled in later times are cited, it is deemed that arguments were raised to a certain extent regarding six-meridian syndrome differentiation(六經辨證). Fourth, although the majority of utilized materia medica among cold damage prescriptions utilize Materia Medica from the Countryside(鄕藥本草) in CPC and materia medica from Korean Peninsula, this is due to the desire for the compilation performance of CPC to be propagated to ordinary citizens and not the ruling class. CPC as the official medical book compiled in the early days of the Chosun period was greatly influenced by the Song(宋) Dynasty's medical books, PHBP and CRSB shows that cold damage medicine in the early Chosun Period indeed possesses the medical universality of East Asia. Furthermore, the features of published medical theory and prescriptions reveal the existence of the cold damage medical tradition of the Chosun period serving as clues for cold damage research tradition among Korea's medical history.

Determination of triflusal in raw material and capsules by HPLC

  • Pham, Thuy-Vy;Mai, Xuan-Lan;Lee, Ji-Hyeon;Lee, Jong-Ha;Jo, Hyeon-Ah;Kang, Jong-Seong;Woo, Mi Hee;Na, Dong-Hee;Chun, In-Koo;Kim, Kyeong Ho
    • Analytical Science and Technology
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    • v.31 no.4
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    • pp.143-148
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    • 2018
  • Currently, the Korean Pharmacopoeia (KP XI) recommends HPLC and potentiometric titration (which is less specific than HPLC) for the determination of triflusal content in capsules and raw materials, respectively. Additionally, the British Pharmacopoeia (BP 2017) and European Pharmacopoeia (EP 8.0), which include a monograph for triflusal in raw materials only, describe a titration method for the assay. The latest version of the United States Pharmacopoeia (USP 39) and Japanese Pharmacopoeia (JP 17) still have not published monographs for triflusal and its preparations. To improve the specificity and efficacy of the assay, we present an HPLC method to determine triflusal content in both raw materials and capsules. The proposed method was validated in accordance with the requirements of the International Conference on Harmonization. A good linear relationship was achieved for triflusal in the range of $200-1250{\mu}g/mL$ with a coefficient of determination of approximately 0.9996. The relative standard deviations (RSDs) of inter- and intraday precision were 0.73-1.12 % and 0.34-0.51 %, respectively. The recovery percentage of triflusal was in the range of 98.80-101.31 %. Because its system suitability, intermediate precision, and robustness were satisfactory, this method could be suitable for determining triflusal content in raw materials and capsules.

Development of high performance liquid chromatography assay method of tramadol hydrochloride injection

  • Kim, DongHyeon;Rhee, Hee Jae;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.31 no.3
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    • pp.107-111
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    • 2018
  • Currently, ultraviolet-visible spectrophotometry and titration methods are used for assay tests of tramadol hydrochloride injection and raw material in the Korean Pharmacopoeia XI (KP XI). Titration has also been used in the British Pharmacopoeia (BP 2013) for the assay test of tramadol hydrochloride, and the HPLC assay for tramadol hydrochloride raw material has been used in the United States Pharmacopeia (USP 39). In this study, we developed an alternative HPLC assay method for tramadol hydrochloride injection that is up to date and specific, and employs the same method as tramadol hydrochloride capsules. Validation of the HPLC method was conducted to determine linearity, precision, accuracy, system suitability, and robustness. The linearity of the calibration curves in the desired concentration range was good ($r^2$ > 0.9999). RSDs of intra-day precision obtained were 0.05-0.08 % and inter-day precision obtained were 0.08-0.19 %. Accuracy was obtained with recoveries in the range of 98.16 % and 100.90 %. As a result of the system's suitability, the RSD of both retention time and the peak area obtained were 0.07 %. The values of the plate number and tailing factor of tramadol hydrochloride obtained were 7076 and 1.16, respectively. Because of the intermediate precision and robustness of the developed assay, it is expected to become a valuable tool for revising the Korean Pharmacopoeia (KP XI).