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KMID : 0895820160260010033
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Journal of Oriental Rehabilitation Medicine
2016 Volume.26 No. 1 p.33 ~ p.40
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Identification of Standard Compound of Ja-ha-guh Pharmacopuncture and Validation of Analytic Methods
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Park Sang-Won
Lee Jae-Woong
Lee Jin-Ho
Ha In-Hyuk
Byun Jang-Hun
Jung Bum-Hwan
Chung Hwa-Jin
Lee In-Hee
Kim Min-Jeong
Kim Eun-Ji
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Abstract
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Objectives : Despite the increasing use of Ja-ha-guh (Hominis-placenta ) pharmacopuncture in rehabilitative medicine field, its standard compound has yet to be investigated. The purpose of this study is to provide standardization for future studies and increase satisfaction of patients by utilizing standard pharmacopuncture.
Methods : Alanine and leucine were selected as potential standard compounds. LC/MS was used to devise an analytic method. This analytic method was subject to validation. According to validation guideline of Korea Food and Drug Administration, the specificity, linearity, precision, range, quantitative limits, detection limits and accuracy were measured. With this analysis, 3 lots of Ja-ha-guh pharmacopuncture were analyzed.
Results : Because the specificity, linearity, precision, range, quantitative limits, detection limits and accuracy meet criteria of the guideline, the analytic method was validated. It was found that Ja-ha-guh pharmacopuncture contained 211.02±7.28 ug/ml of alanine and 372.03±7.58 ug/ml of leucine.
Conclusions : Both alanine and leucine appear to be suitable standard compounds. These results are likely to contribute to further standardization of Ja-ha-guh for medical use.
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KEYWORD
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Hominis-placenta, Pharmacopuncture, Standardization, LC/MS, alanine, leucine
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