• 제목/요약/키워드: Korean Pharmacopoeia

검색결과 160건 처리시간 0.026초

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
    • 분석과학
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    • 제30권1호
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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.

Simultaneous determination of ampicillin sodium and sulbactam sodium in powder for injection by HPLC

  • Mai, Xuan-Lan;Pham, Thuy-Vy;Han, Ga-Hyun;Kum, Su-Jin;Woo, Sang-Hoon;Kang, Jong-Seong;Woo, Mi Hee;Na, Dong-Hee;Chun, In-Koo;Kim, Kyeong Ho
    • 분석과학
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    • 제32권4호
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    • pp.147-154
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    • 2019
  • Ampicillin and Sulbactam (2:1, w/w) are combined in formulation to provide broader antibacterial action in treatment of many infections. The development of analytical method for simultaneouly determine these two compounds was difficult because of the differences in their chemical structures and ratio in the formulation. Current published methods still have some limitations. In this study, we developed an alternative high-performance liquid chromatography (HPLC) assay method for simultaneously determination of ampicillin sodium and sulbactam sodium in powder for injection. Method validation of HPLC method was conducted to determine linearity, precision, accuracy, system suitability, robustness. The linearity of the calibration curves in the desired concentration range was good ($r^2$> 0.9994). RSDs of intra-day and inter-day precision obtained were less than 2.00 %. Accuracy was obtained with the recoveries in range of 98.42 % and 101.36 %. As a result of system suitability, RSD of both retention time and the peak area obtained were not more than 1.0 %. The values of plate number were more than 7000 and symmetric factors obtained were 0.8. As intermediate-precision and robustness of the developed assay, it could be expected to become valuable tools for revising the Korean Pharmacopoeia (KP XI).

한약재 품질 관리에 관한 연구 (Studies on the Administration of the Quality of Herbal Medicine)

  • 최선미;정희진;윤유식;이미영;최환수;성현제
    • 대한한의학회지
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    • 제21권3호
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    • pp.99-112
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    • 2000
  • Objective: This study was conducted to suggest a proper administration system of the quality of herbal medicine. Methods: Related literature was carefully inspected and discussions among specialists in the field of herbal medicine's growth, production, circulation and administration were conducted. Results: 1. The administration of herbal medicine's quality should be done in each stage of its circulation; growing stage, harvesting stage, importing stage, production stage, quality examination stage, wrapping stage, circulating stage, and administration stage. 2. A safety standard should be established for items, parts and origins of each medicinal herb. A standard for the identification of forged products and objective standards for quality discrimination should also be established. 3. A national system for the training of herbal medicine quality administration personnel and herbal medicine discrimination personnel should be established. A data base of standardized product specimens should be established and a pharmacopoeia of herbal medicine should be published as a standard of quality administration in herbal medicine. 4. Research into the following preliminary areas should be conducted to investigate quality adminstration of herbal medicine: research related to herbal medicine's raw materials and herbal medicinal drugs; quality estimation of raw materials and drugs; quality administration in oriental medical hospitals; herbal medicine administration law; herbal medicine administration organization; herbal medicinal pharmacology; and policy-related research for the quality improvement of domestically grown medicinal herbs. Conclusion: For the proper administration of herbal medicine's quality, governmental support and intensive research among specialists should be done for the supply of good quality medicinal herbs and the improvement of the efficacy of herbal medicine.

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한약재 품질관리체계 선진화 모형에 관한 연구 (Studies on the advanced model for quality control system of oriental medicine)

  • 최선미;윤유식;최환수;이미영;신순식;이계남;정희진;김희수;성현제
    • 대한예방한의학회지
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    • 제4권2호
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    • pp.193-204
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    • 2000
  • In this study, advanced model for quality control of oriental medicine and methods for practice was suggested through literature inspection, analysis of foreign system such as China and Japan, survey analysis on the current system, quality analysis of randomly selected oriental medicine samples, and intensive discussions among oriental medicine specialists 1. The quality of oriental medicine should be consistently controlled by Ministry of Health and Welfare form its cultivation or import to its circulation process to final consumer 2. All oriental medicines should be circulated as standardized goods which should be marked by lot numbers. The packing material and Packing size should be liberalized. The qualify should be differentialized though free competition among makers. 3. Realistic standards for pesticide, heavy metal and decolorant should be established though long-term monitoring process according to each oriental medicine's origin, therapeutic part, cultivation area, harvesting time, and cultivation method. 4. Ministry of Health and Welfare should educate oriental medicine's quality control personnel regularly or on demand, and establish specialist pool. Ministry of Health and Welfare should also establish oriental medicine information system to provide informations about quality of domestic or foreign oriental medicinal raw materials. 5. The government should provide information about foreign of oriental medicine market to importers. Quality of imported oriental medicine should be inspected before its customs clearance, and all imported oriental medicine should be circulated by standardized oriental medicine makers. 6. Oriental medicine's pharmacopoeia should be Published to provide quality standard of oriental medicine and improve it.

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한(韓) 중(中) 일(日)의 공정서(公定書)(약전(藥典) 및 규격집(規格集))에 수재(收載)된 전통천연약물(傳統天然藥物)의 품질(品質)에 관한 조사(調査) (I) -기원(起源)에 관한 분류학적(分類學的) 검토(檢討)- (Systematic Botanical Survey of Traditional Herbal Medicines Listed in the Official Drug Compendia(Pharmacopoeia and Natural Drug Standards) of Korea, China and Japan)

  • 박상희;염정록;장일무
    • 생약학회지
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    • 제22권2호
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    • pp.112-123
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    • 1991
  • Traditional drugs(herbal and animal drugs) of Korea, China and Japan have developed essentially from the same origin, since the traditional medicine of three countries has been originated from ancient China. Due to different geographical locations and discrepancy of plant resources of the traditional drugs, some divergency in terms of systematic botany in traditional drug materials has appeared in the three countries. Present report aims to survey traditional herbal drugs that have been called same traditional names in three countries, but they are actually different with respect to systematic botanical view-point. The official drug compendia(pharmacopoeia and natural drug standards) of three countries were subject to examination. Survey was conducted by the following categories. Traditional drugs were listed under same name, however, 1) they belong to different genus; 7 traditional herbal drugs were listed. 2) they belong to same genus, but different species; 24 traditional herbal drugs were found. 3) a variety of related species are used; 15 traditional drugs were listed. 4) actually same plant, but taxonomical name is differently called and/or different parts of plant are used; 10 traditional drugs were counted. 5) animal drugs belong to one of the above categories; 7 traditional animal drugs were found. Total 63 traditional drugs(herbal and animal) were found to comprise different taxonomical names when the official drug compendia of Korea, China and Japan were examined.

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ITS 염기서열 기반 방기 신속 감별용 SCAR marker 개발 (Development SCAR marker for the rapid authenticaton of Sinomeni Caulis et Rhizoma based on ITS Sequences)

  • 김욱진;노수민;최고야;문병철
    • 대한본초학회지
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    • 제37권4호
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    • pp.9-16
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    • 2022
  • Objectives : In the Korean Pharmacopoeia 12th edition (KP 12) and the Korean Herbal Pharmacopoeia (KHP), two authentic herbal medicines are described, namely Bang-gi (Cheong-pung-deung) and Mok-bang-gi, respectively. In China, Bun-bang-gi is also used as herbal medicine. This study was conducted to develop a molecular authentication tool for distinguishing the three herbal medicine used as Bang-gi, which are Sinomeni Caulis et Rhizoma (Rhizome of Sinomenium acutum), Stephaniae Tetrandrae Radix (Root of Stephania terandra), and Cocculi Radix (Root of Cocculus trilobus). Methods : Twelve samples of three species (four samples of S. acutum, five samples of S. tetrandra, and three samples of C. trilobus) were collected from different habitats. The sequences of internal transcribed spacer (ITS) regions were obtained and comparatively analyzed to design the species-specific sequence characterized amplified region (SCAR) primers. The specificity of each pair of SCAR primers that amplified species-specific amplicon was evaluated for establishing the singleplex and multiplex PCR assay tools. Results : The singleplex SCAR markers show discriminability in C. acutum, S. tetrandra, and C. trilobus. These SCAR markers were also efficiently authenticated three species in the multiplex SCAR amplification using single PCR reaction. Furthermore, these PCR assay methods were applicable to authenticate dried herbal medicines distributed in the markets. Conclusions : The SCAR markers and PCR assay tools help discriminate the three herbal medicines used as Bang-gi at the species levels and provide a reliable genetic method to prevent the inauthentic distribution of these herbal medicines.

Phytochemical and Anti-Termite Efficiency Study of Guibourtia tessmanii (harms) J. Léonard (Kévazingo) Bark Extracts from Gabon

  • NKOGO, Ley-Fleury ELLA;BOPENGA, Christ Stone Arnaud BOPENGA;NGOHANG, Franck Estime;MENGOME, Line Edwige;ANGONE, Sophie ABOUGHE;ENGONGA, Prosper EDOU
    • Journal of the Korean Wood Science and Technology
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    • 제50권2호
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    • pp.113-125
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    • 2022
  • This study aimed to explore the biodiversity of chemical compounds found in the bark of Guibourtia tessmannii from Gabon, commonly called Kévazingo, and evaluate their anti-termite activity to determine their potential values as a source of development of anti-termite products that can be valued in the fields of fine chemicals and wood preservation. Extraction of G. tessmannii bark powders was carried out using the cold maceration method with trichloroethylene, acetone, ethanol, and water. Phytochemical screening made it possible to highlight groups of chemical families present in the extracts. Anti-termite activity was tested on the wild termites "Cubitermes sp" of the genus Isoptera. The yield of the extracts were 17.11% for the buttress and 13.42% for the height at 6 m. Phytochemical tests revealed that alkaloids, polyphenols, sterols, tannins, reducing compounds, flavonoids, saponins, and anthraquinones were present in the extracts. Results of anti-termite activity indicated that anti-termite activity varied with the different parts of the bark studied, extraction solvent, and concentration (50/50) and (25/75) of the extracts used. The extracts at 50/50 concentration showed a slightly better anti-termite activity compared to the 25/75 concentration. In addition, the buttress Kévazingo or buttress showed the strongest anti-termite activity for the aqueous extract with a survival rate of 0% after 2 days.

수열침전법에 의한 비정질 인산알루미늄 분말의 합성에 관한 연구 (A study on the synthesis of amorphous aluminium phosphate powders by hydrothermal precipitation method)

  • 김판채;최종건;황완인;이충효
    • 한국결정성장학회지
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    • 제11권5호
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    • pp.185-189
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    • 2001
  • 비정질 인산알루미늄 분말은 화학양론조성비의 $Al_2(SO_4)_3$$H_3PO_4$혼합물을 NaOH 또는 KOH 용액을 이용하여 중화 반응시킨 뒤 이를 수열침전법에 의해 단일상으로 얻을 수 있었으며, 합성조건은 다음과 같다. 즉, 출발원료; $Al_2(SO_4)_3$$H_3PO_4$, 중화반응의 pH범위; 5.6~6.0, 수열반응의 온도범위; 170~$180^{\circ}C$, 수열반응의 시간범위; 4~5시간이었다. 이와 같은 조건하에서 얻어진 생성물은 0.1~0.3$\mu\textrm{m}$ 크기의 비정질 인산알루미늄 미립자였으며 그리고 미국약전에 따라 실험한 결과 모두 적합하였다.

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Determination of diphencyprone and its photo-degradation product incompounded preparations using HPLC

  • Cho, Chong Woon;Kim, Kyung Tae;Park, Miyeon;Kim, Jin Seog;Lee, Jinbok;Kang, Jong Seong
    • 분석과학
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    • 제31권5호
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    • pp.179-184
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    • 2018
  • Diphencyprone (DPCP) is frequently used as a compounded preparation in dermatology for the treatment of alopecia and recalcitrant warts based on the immune reaction of skin allergy. However, DPCP is a non-recognized agent in Pharmacopoeia, because there are no criteria or analytical method for quality control of its powder and formulation. DPCP is unstable under light irradiation because as it easily decomposes to diphenylacetylene (DPA). This study aims to develop a simultaneous HPLC analytical method for analyzing DPCP and DPA in the raw materials and compounded preparation. The method required a C18 column ($250{\times}4.6mm$, $5{\mu}m$) at $40^{\circ}C$ with a mobile phase of (A) 0.01 M phosphoric acid in water and (B) acetonitrile at UV 220 nm. DPA conversion to DPCP in the powder and compounded preparations was accelerated after light exposure for 60 min. In addition, this resulted in different patterns depending on the wavelength of light and the formulation. That is, DPCP in compounded preparation was more unstable than that in the powder. However, the DPCP formulation in amber bottles was observed to remain stable, although the measured concentrations of DPCP were somewhat different from the nominal concentration of the compounded preparations. The control of the exact concentration is required for effective disease treatment, depending on the state of the patient. In conclusion, these results will be useful for the recognition of DPCP in Pharmacopoeia and new DPCP formulation development to prevent photodecomposition.

택사의 Alisol B, Alisol B acetate 함량과 안정성 (Content and Stability of Alisol B, Alisol B acetate in Alismatis Rhizoma)

  • 백미은;이영종;원재희
    • 생약학회지
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    • 제48권4호
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    • pp.343-349
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    • 2017
  • The current definition of Arismatis Rhizoma is the tuberous root of Alisma orientale Juzepzuk in the Korean Pharmacopoeia, but there is still no marker compound. So it has difficulties in quality control. Therefore, in this study, we have established a method to analyze alisol B and alisol B acetate using HPLC as a marker compounds of Arismatis Rhizoma. As the result of the analysis, alisol B content was ranged from 0.02% to 0.50% and alisol B acetate content was ranged from 0.12% to 0.25% in 40 samples. The stability of alisol B and alisol B acetate was investigated during 24 months. As a result, alisol B acetate was significantly decreased. The marker compound of Arismatis Rhizoma is alisol B acetate and the content of 0.05% or more is suitable by applying the stability results.