• Title/Summary/Keyword: Pharmacopoeia

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A Study on the Herbal Name and Four Qi(四性) of Genus Curcuma in the Korea Pharmacopoeia Ninth Edition ($\ll$대한약전$\gg$ 제9개정에서 Curcuma속(屬)의 한약명과 약성에 관한 연구)

  • Kim, In-Rak
    • The Korea Journal of Herbology
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    • v.24 no.3
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    • pp.21-28
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    • 2009
  • Objectives : The purpose of this study is to determine the herbal name and four Qi(四性) of genus curcuma in the Korea Pharmacopoeia ninth Edition. Methods : Compare with the name and four qi of genus curcuma from the Korea Pharmacopoeia ninth Edition and the other nation's Pharmacopoeia and main herbal medicine books. Results : 1. The Rhizoma of Curcuma longa is called Kanghwang in KP 9, but is called Ulgeum in the main herbal medicine book. 2. The Rhizoma of genus curcuma except Curcuma longa is called Achul in KP 9, but is called Kanghwang in the main herbal medicine book. 3. The root of genus curcuma is called Ulgeum in KP 9, but is called Achul in the main herbal medicine book. 4. The four qi of the Rhizoma and Radix of genus curcuma is recorded worm and cold in the Ch. p 2005, but is recorded cold and worm in the main herbal medicine book. Conclusions : Kanghwang, Achul, Ulgeum in the KP 9 is equivalent Ulgeum, Kanghwang, Achul in the main herbal medicine book. The four qi of Rhizoma is cold, Radix is warm.

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.

Reconsideration about Nomenclature of Herbs Listed in the Korean Pharmacopoeia (대한민국약전에 수재된 식물성 한약재의 학명에 대한 재고)

  • Doh, Eui-Jeong;Lee, Guem-San
    • The Korea Journal of Herbology
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    • v.28 no.3
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    • pp.61-68
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    • 2013
  • Objectives : A precise and simple system of nomenclature was required to avoid error, ambiguity or confusion. Although medicinal plants must be produced or distributed based on a pharmacopoeia described origin including scientific name, the Korean Pharmacopoeia tenth edition (KP 10) had many names against the nomenclature. Therefore, this study aimed at searching correct scientific names for 241 plants in KP 10. Methods : Authoritative databases - The Plant List, International Plant Name Index, YList, Tropicos, eFloras, World Checklist of Selected Plant Families, The Global Compositae Checklist, The International Legume Database and Information Service, et al. - and previously performed researches, floras were cross-checked. Results : The arrangement of this list was designed for four cases, errors including illegitimate, nomenclatural synonyms, recommended names and decision reserved names. Consideration about the scientific names produced nine correct names for ten misspellings and illegitimate, and thirty-six correct names for forty-one nomenclatural synonyms. These results should be reflected in the next of KP 10. Separately, ten recommended names were also suggested for taxonomic synonyms which had been used indiscriminately due to diverse taxonomic opinions. In addition to those, decision reserved names were suggested for thirteen species which had been corridor of uncertainty. Then again, there was need to study about authorship, because KP 10 did not keep recommendations for author citations. Conclusions : Correction of scientific names for some medicinal plants which violated the International Code of Nomenclature would be useful to improve the accuracy of a Pharmacopoeia as the criterional materials.

Studies on the alkalinity of pharmaceutical containers (의약품에 사용되는 유리용기의 용출알카리도에 대하여)

  • 김상민;이규송
    • YAKHAK HOEJI
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    • v.12 no.1_2
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    • pp.35-39
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    • 1968
  • Alkalinity of pharmaceutical containers is to be highly influenced for liquid pharmaceuticals. The criteria of the alkalinity of ampoules and vials used as pharmaceutical containers is established in the Korean Pharmacopoeia. However, the criteria of general containers for liquid pharmaceuticals is not eatablished in the Korean Pharmacopoeia. Therefore, we tried to perform comparing test for domestic products and foreign products of following group: 1) vials 2) general containers for liquid pharmaceutical 3) general containers for tablet pharmaceuticals It was found that the domestically produced vials were good enough for criteria, while almost fifty percent of non-established containers was unsaticefactory.

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Dereplication and Quantification of Steroidal Saponins in Polygonatum Species Using LC-MS

  • Kim, Jin-Woong;Ahn, Mi-Jeong
    • Proceedings of the PSK Conference
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    • 2003.10b
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    • pp.66.1-66.1
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    • 2003
  • Rhizomes of Polygonatum species belong to Liliaceae are important herbal drugs in the traditional medical practice of Asian region. Two representative Chinese drugs derived from this genus are Hwangjeong and Okjuk. Though botanical origins of these drugs are officially listed as P. falcatum, P. sibiricum and P. kingianum for Hwangjeong and P. odoratum var. pluriflorum for Okjuk in the Korean Pharmacopoeia and Korean Herbal Pharmacopoeia, respectively, they are often sold as a mixture of several different species in the market. (omitted)

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Quality monitoring of Oriental medicines (유통한약 품질규격 모니터링 연구)

  • Kim, Ho-Kyoung;Chun, Jin-Mi;Lee, A-Young;Lee, Hye-Won;Choi, Ji-Hyun;Jang, Seol;Ko, Byoung-Seob
    • Korean Journal of Oriental Medicine
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    • v.11 no.2
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    • pp.155-165
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    • 2005
  • This study was investigated to determine the quality control of Oriental medicine from stores dealing in Oriental medicine around Seoul and Daegu. We tested total 120 samples that widely used 15 species in herbal medicine (Lycii Fructus, Platycodi Radix, Angelicae Gigantis Radix and 12 others) being collected from Oriental medicine clinic, pharmacy, Oriental pharmacy, Oriental medical hospital and Oriental drug store. We have estimated Oriental medicine by K.P. (Korean Pharmacopoeia), K.H.P(Korean Herbal Pharmacopoeia) and announcement of KFDA. The items of examination were identification, purity, loss on drying, ash, acid insoluble ash, extract content, essential oil content, assay, heavy metal limit, and pesticides residue(BHC, DDT, Aldrin, Endrin, Dieldrin). As a result, 20 samples in total 120 samples were not satisfied with the standard and 7 species in total 15 species were not satisfied with the standard. Identification test, extract content test and pesticides residue(BHC, DDT, Aldrin, Endrin, Dieldrin) were satisfied with the standard. The result will be the basic data for the quality control of Oriental medicine.

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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).

Investigation on Adhesion Control Standards and Skin Adverse Effects of Skin Attached Formulations (파스제의 점착력 관리기준 및 피부 부작용 조사연구)

  • Kim, Ji Yeon;Kim, Kwang Joon;Park, Sang-Wook;Bang, Joon Seok;Lee, Wonjae
    • Korean Journal of Clinical Pharmacy
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    • v.24 no.3
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    • pp.219-228
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    • 2014
  • Objectives: This paper was aimed to investigate the adhesion control standards of pain relieving patch (PRP) drugs and to survey it's adverse effects on the skin of patients for safe use of PRP drugs. Methods: In this study, the related documents of PRP drugs of Korea pharmacopoeia (KP), United States pharmacopoeia (USP), Japanese Pharmacopoeia (JP), European pharmacopoeia (EP), and information web sites of the Ministry of Food and Drug Safety (MFDS) were surveyed. Also, the past and current labeling of PRP drugs marketed in the pharmacy was investigated and compared. Results: In KP and JP, the lower limit standard for PRP's adhesion control is established, but the upper limit standard is not designated. In USP and EP, neither the lower nor upper limit standard is established. The main reasons of skin adverse effects are considered as inherent adverse reactions of the applied drugs for PRP. Another reason is involved in patient's medication mistakes related to PRP's adhesion control, respiratory depression of skin according to physical skin closure, and microbial growth, etc. Conclusion: For safe use of PRP drugs, we proposed ensured guidelines like additional instructions of pharmacist's prescription and detailed labeling systems for usage of PRP drugs applied on skin.

A comparative study about the origins of Apiaceae (Umbelliferae) taxa in the Pharmacopoeias of five Northeast-Asian countries based on the taxonomic concepts (분류학적 개념을 기반으로 한 동북아 5개국 공정서 미나리과(산형과) 기원종 비교 연구)

  • Song, Jun-Ho;Yang, Sungyu;Kim, Hong Bin;Choi, Goya
    • The Korea Journal of Herbology
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    • v.36 no.3
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    • pp.25-37
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    • 2021
  • Objectives : Herbal medicines have been used a lot traditionally in Northeast Asia. In particular, various Apiaceae plants (Umbelliferae) are widely used for medicinal purposes among countries. However, the original species designated in each pharmacopoeia standards, are sometimes different and confuse. In this study, herbal medicines in the pharmacopoeia were analyzed for Apiaceae taxa to compare the taxonomic identity and different taxonomic opinions for each country based on their local flora and recent taxonomic studies. Methods : The scientific names of herbal medicines were analyzed origins from Pharmacopoeias of Republic of Korea, Democratic People's Republic of Korea, People's Republic of China, Taiwan, and Japan. Especially, we compared their local floras, international plant scientific name database, and recently published taxonomic studies to confirm the correct scientific name. Results : The analyzed apiaceous herbal medicines in pharmacopoeias were all 21 items and 39 taxa; the highest percentage, genus Angelica (21%) and roots including rhizomes (62%) the registered genera and medicinal parts, respectively. Eleven items were in all five country's pharmacopoeias. Four items were in more than two countries' pharmacopoeias. Six items were registered in only one pharmacopoeia. Conclusions : Our research provides necessary information, e.g., corrected scientific names of original species based on taxonomic species concepts, taxonomic reviews, and figures of medicines. These results will help in the understanding of the apiaceous taxa among the five countries' pharmacopoeias. Moreover, these extensive nomenclatural reviews of authentic apiaceous taxa will help for the next revision of Korea Pharmacopoeia.

A Philological study on Submersion Property of Aquilariae Lignum (침향(沈香)의 침수성(沈水性)에 관한 문헌적 연구)

  • Park, Su-Jin;Kim, In-Rak
    • The Korea Journal of Herbology
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    • v.27 no.4
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    • pp.25-31
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    • 2012
  • Objectives : The purpose of this study is searching for grounds of new regulations about submerging properties of Aquilariae Lignum described in the Korean Herbal Pharmacopoeia. Methods : Through the investigation of the various Chinese histories and herbal classics, the definitions of Aquilariae Lignum and documents on actual trade and discrimination methods by sinking under water. Results : In Jiaozhouyiwuzhi(交州異物志) written in the early 2nd century, Aquilariae Lignum was defined as heart wood part or knots sinking under water due to hard and dark deposition of resins. Also, which are not sinking were defined as zhan xiang(棧香), and which are floating were named as qian xiang(槧香). The definitions of Aquilariae Lignum had not been changed till Ching Dynasty era, but the classification and the names about not-sinking and floating Lignum materials were a little changed. Conclusions : These results indicate that it is reasonable to make a regulation that "Aquilariae Lignum sinks under water" in the property description of The Korean Herbal Pharmacopoeia.