• 제목/요약/키워드: natural drug standards

검색결과 19건 처리시간 0.027초

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)(II) -대한약전(大韓藥典) 및 대한약전외(大韓藥典外) 한약(韓藥)(생약)(生藥) 규격집(規格集)의 확인시험법(確認試驗法)에 대한 검토(檢討)- (Examination of the Chemical Tests for Herbal Medicines Listed in the Official Drug Compendia(Pharmacopoeia and Natural Drug Standards) of Korea)

  • 박상희;염정록;장일무
    • 생약학회지
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    • 제22권2호
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    • pp.124-127
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    • 1991
  • In the preceding paper, it was reported that total 63 traditional Korean herbal medicines listed in the Korean Pharmacopoeia and Korean Natural Drug Standards were found to be different plants in terms of systematic botany when those were compared with other two countries' drug compendia, Chinese Pharmacopoeia, Japanese Pharmacopoeia and Japanese Natural Drug Standards. Among 63 traditional Korean herbal drugs, 28 items were subject to the chemical identification test by using official methods that are described in the Korean Pharmacopoeia and the Korean Natural Drug Standards. In addition, 5 items were also tested by using the official methods described in Chinese and Japanese drug compendia, since there are no official chemical tests available in the Korean drug compendia. It was found that most of chemical tests appeared to be suitable. It was noted that the chemical test for Atractylodis Rhizoma(蒼朮) was incorrect and unapplicable. Those chemical tests for Clematidis Radix(威靈仙), Rubi Fructus(覆盆子) and Viticis Fructus(蔓荊子) are desirable to be revised for more accurate identification.

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The worldwide trend of using botanical drugs and strategies for developing global drugs

  • Ahn, Kyungseop
    • BMB Reports
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    • 제50권3호
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    • pp.111-116
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    • 2017
  • Natural product drugs, or botanical drugs, are drugs composed of natural substances which have constituents with healthenhancing or medicinal activities. In Korea, government-led projects brought attention to botanical drugs invigorating domestic botanical drug industry. Foreign markets, as well, are growing bigger as the significance of botanical drugs stood out. To follow along with the tendency, Korea puts a lot of effort on developing botanical drugs suitable for global market. However, standards for approving drug sales vary by countries. And also, thorough standardization, certification, clinical studies and data of these will be required as well as data confirming safety and effectiveness. Meanwhile, as an international exchange in botanical drug market continues, the importance of plant resources was emphasized. Thus countries' ownership of domestic natural resources became vital. Not only establishing a systematic method to secure domestic plant resources, but also cooperation with other countries on sharing natural resources is essential to procure natural resources effectively. Korea started to show visible results with botanical drugs, and asthma/COPD treatment made out of speedwell is one example. Sufficient investment and government's active support for basic infrastructure for global botanical drugs will bring Korea to much higher level of botanical drug development.

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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COSMOS-standard AISBL과 우리나라 유기농 화장품 기준에 관한 분석 (Comparative Analysis with The COSMOS-standard AISBL and The Regulation of Korean Organic Cosmetic Standard)

  • 최성철;손상목
    • 한국유기농업학회지
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    • 제23권1호
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    • pp.1-18
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    • 2015
  • The purpose of this study is to examine the tendency of certified organic cosmetics market and the certification standards and regulations they are under, compare one of the most commonly used COSMOS-standard AISBL with the Korea Ministry of Food and Drug Safety (MFDS) organic cosmetic standard regulation. And then examining their differences and any potential issues is to present suggestions to be made as data for certification standard for natural & organic cosmetics in Korea regulation. This contents of study will be used as good research and development to promote the sustainable growth of the natural & organic cosmetic ingredients which have been grown by organic farmers certified. Also certified organic ingredients may help to growth the organic industry. I believe these are actual comparative for application to develop of natural and organic cosmetics in Korea as well the strengthening of the competitiveness of organic cosmetics certified in the world.

Standardization and Quality Evaluation of Kampilla

  • Joseph, G.V.R.
    • Natural Product Sciences
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    • 제6권3호
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    • pp.151-153
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    • 2000
  • Kampilla is an important herbal drug of indigenous system of medicine. Fruit dust of Mallotus philippensis Muell-Arg constitutes the genuine drug Kampilla. However, due to limited distribution of this plant and its high medicinal value, the drug is heavily adulterated with the cheaper substances. Hence the present study was undertaken to evaluate both the authentic and market samples. The drug consists of resin glands and trichomes. Resin glands are lined by a delicate yellowish thin membrane and bear a pore at the tip. Quantitative standards of the drug powder showed 82.50% yield in total ash while alcohol soluble extract of market and authentic sample exhibit 0.97% and 3.458% respectively. The main adulterant noticed in the market sample is brick powder. Simple methods are suggested to identify the genuine drug.

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한약・생약제제 품목허가신고심사 규정 변화에 관한 고찰 - 건국이후부터 2012년까지 - (A Study on the Changes in Regulations Regarding Approval, Notification and Review of Herbal Medicinal Preparations and Crude Drug Preparations - From 1948 to 2012 -)

  • 엄석기
    • 한국의사학회지
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    • 제27권2호
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    • pp.11-37
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    • 2014
  • Objectives : The purpose of this study was to analyze and identify the problems of the changes in regulations that are relevant to approval, notification, and review of herbal medicinal preparations and crude drug preparations. Methods : I collected the regulations of approval, notification, and review of medicinal products mostly from official gazettes, analyzed enactment and amendments regarding herbal medicinal preparations and crude drug preparations, and studied it from the view point of Korean medicine field. Results : Regulations in regards to approval, notification, and review of herbal medicinal preparations and crude drug preparations were first established in 1978. Herbal drugs started to be categorized as crude drug preparations in 1981 and the regulatory outlines were completed in 1999. From 2008 to 2012, the regulatory standards that let crude drug preparations be new drugs from natural products were established. Through those procedures, the followings became crude drug preparations: 1) wholly new prescriptions that are not recorded in Korean Medical Classics, 2) prescriptions that are recorded in Korean Medical classics but prepared with new standard, composition and efficacy, 3) prescriptions that are recorded in Korean Medical classics but prepared with new formulation, and 4) herbal drugs. In case of herbal medicinal preparations, however, only regulations that are related to 1) drugs prepared with new compositions that are not recorded in Korean Medical Classics, 2) drugs with same prescription and same formulation, and 3) drugs with new formulation were arranged. Conclusions : Actual circumstances on crude drug-oriented regulations regarding approval, notification and review and future forms of prescription and drug administration in Korean Medical Institutions can be expected due to expansion in range of herbal medicinal preparations and shrink in that of on-site preparations. Reasonable improvement in efficient usage of modernized herbal medicinal preparations in Korean medical institutions and prospective cooperation from related pharmaceutical industry are needed.

Application of Metabolomics to Quality Control of Natural Product Derived Medicines

  • Lee, Kyung-Min;Jeon, Jun-Yeong;Lee, Byeong-Ju;Lee, Hwanhui;Choi, Hyung-Kyoon
    • Biomolecules & Therapeutics
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    • 제25권6호
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    • pp.559-568
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    • 2017
  • Metabolomics has been used as a powerful tool for the analysis and quality assessment of the natural product (NP)-derived medicines. It is increasingly being used in the quality control and standardization of NP-derived medicines because they are composed of hundreds of natural compounds. The most common techniques that are used in metabolomics consist of NMR, GC-MS, and LC-MS in combination with multivariate statistical analyses including principal components analysis (PCA) and partial least squares-discriminant analysis (PLS-DA). Currently, the quality control of the NP-derived medicines is usually conducted using HPLC and is specified by one or two indicators. To create a superior quality control framework and avoid adulterated drugs, it is necessary to be able to determine and establish standards based on multiple ingredients using metabolic profiling and fingerprinting. Therefore, the application of various analytical tools in the quality control of NP-derived medicines forms the major part of this review. $Veregen^{(R)}$ (Medigene AG, Planegg/Martinsried, Germany), which is the first botanical prescription drug approved by US Food and Drug Administration, is reviewed as an example that will hopefully provide future directions and perspectives on metabolomics technologies available for the quality control of NP-derived medicines.

약사법규 중의 기존한약서 활용에 대한 고찰 (Study on the Application of Established Korean Medical Classics in the Korean Pharmaceutical Affairs Act)

  • 엄석기
    • 대한한의학회지
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    • 제35권3호
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    • pp.135-154
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    • 2014
  • Purpose: There is an issue in applying various principles introduced in established Korean medical classics to "Pharmaceuticals Approval, Notification and Review" of "herbal medicinal preparations" and "new drugs from natural products" that are used for western forms of medical treatment. Thus, an analysis of the origin, purpose, and application of established Korean medical classics in the Korean Pharmaceutical Affairs Act is essential. Methods: We collected data regarding the origin, purpose, and application of established Korean medical classics in the Korean Pharmaceutical Affairs Act, and classified them by periodical change and subjects. Results: Established Korean medical classics are applied as follows: 1) as criteria for Korean medicine distributors' sales of mixed herbal drugs (Pharmaceutical Affairs Act; since 1953), 2) as official compendiums for pharmacists' preparation of Korean medicine (Ministry of Health and Welfare's authoritative interpretation; from early 1970s to 1993), 3) as standards for oriental pharmacists' quality measurement of preparations (notification of the Ministry of Health and Welfare; since 1995), 4) as criteria for "Pharmaceuticals Approval, Notification and Review" of herbal medicinal preparations and crude drug preparations (notifications regarding drug approval process by the Ministry of Health and Welfare and the Ministry of Food and Drug Safety; since 1978), and 5) as standards for the quality of materials of health functional food (from 2004 to 2011). Conclusion: The application of Korean medical classics has been closely related with the change of the laws, regulations, and systems that are relevant to Korean medicine, and it seems to be more favorable for pharmacists than oriental pharmacists. Meanwhile, regulations that apply prescriptions that are recorded in Korean medical classics - dosage, indications, and preparation methods - as criteria for the approval of crude drug preparations for western medical treatment should be abolished.

Review of Changing Judging Standards for Bodybuilding and Fitness Competition Category

  • Sang-Hyun Lee
    • International journal of advanced smart convergence
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    • 제12권4호
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    • pp.418-425
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    • 2023
  • This study examined the importance of screening for changing bodybuilding and fitness category. The screening criteria for bodybuilding, the background and reason for the creation of new bodybuilding and fitness items, the screening criteria for new items, and the use of drugs were described. The current bodybuilding gives high marks to excessive muscles and excessive diet conditions, and new bodybuilding category have been newly established in line with the recent global trend of pursuing natural beauty over abnormally excessive muscles, and the screening criteria also prioritize the balance of ideal and overall muscles to fit your height and weight. In addition, fitness events such as physique and bikini are gaining popularity with the establishment because they focus on not excessive muscles and natural elements of the body that ordinary people can challenge. Since athletes as well as ordinary people are using drugs to increase muscles and suffer side effects, IFBB(International Federation of BodyBuilding) and KBBF(Korea Body Building Federation) should consider and improve the current bodybuilding screening standards that avoid excessive muscles, and it is believed that bodybuilding and fitness events will develop only when strict punishment and continuous anti-doping education are carried out.

The Assessment of Carbendazim, Cyazofamid, Diethofencarb and Pyrimethanil Residue Levels in P. ginseng (C. A. Meyer) by HPLC

  • Choi, Jeong-Heui;El-Aty, A.M.Abd;Park, Young-Seok;Cho, Soon-Kil;Shim, Jae-Han
    • Bulletin of the Korean Chemical Society
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    • 제28권3호
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    • pp.369-372
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    • 2007
  • A fast and simple high-performance liquid chromatography (HPLC) method for the simultaneous determination of four pesticides having fungicide properties has been proposed for Panax ginseng, C. A. Meyer grown for 4, 5, or 6 years. Analytical separation was performed on C18 columns using ultraviolet detector under gradient conditions. Spiked blank samples were used as standards to counteract the matrix effect observed in the chromatographic determination. The HPLC response for all pesticides was linear, with determination coefficients > 0.9986. The average rate of recovery for pesticides spiked with 2 fortification levels was > 72% with relative standard deviations < 9%. The limits of quantification (LOQ) ranged from 0.03 to 0.16 ppm. These LOQs were lower than the respective maximum residue limits (MRL) established by the Korean Food and Drug Administration (KFDA), except for cyazofamid. The proposed method was used to determine pesticide residue levels in samples of ginseng obtained from Jeonnam Province (Republic of Korea). None of the pesticides were found in ginseng samples grown for 4, 5, or 6 years.