Identification of Standard Compound of Ja-ha-guh Pharmacopuncture and Validation of Analytic Methods

자하거 약침의 지표물질 선정 및 분석법 벨리데이션

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 $211.02{\pm}7.28ug/ml$ of alanine and $372.03{\pm}7.58ug/ml$ 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.