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Establishment of content criteria of marker compounds through the monitoring of Achyranthis Radix collected from Korea and China

한국 및 중국 지역에서 수집된 우슬의 모니터링을 통한 지표성분의 함량기준 설정

  • Received : 2012.03.16
  • Accepted : 2012.07.30
  • Published : 2012.08.25

Abstract

Two marker compounds of Achyranthis Radix, ecdysterone and inokosterone, were analyzed by HPLC on an ODS column ($250{\times}4.6$ mm, 5 ${\mu}m$) with a mobile phase of 15% acetonitrile containing 0.08% formic acid at a flow rate of 1.0 mL/min and a detection wavelength of UV 254 nm. The method was validated by ICH guideline and applied to the monitoring of marker compounds in 93 samples of Achyranthis Radix collected at various areas in Korea and China. The new content criteria of ecdysterone and inokosterone, established using linear regression method were 0.033% and 0.020%, respectively. When the new content criteria were applied to the quality control test of commercial Achyranthis Radix, 95.4% of total samples including 100% of Korean and 92.6% of Chinese samples were passed the test. Application of new content criteria could protect the Korean products and decrease the distribution of Chinese products with lower quality.

우슬의 지표성분인 ecdysterone과 inokosterone을 HPLC방법으로 분석하였다. 이 때 ODS 컬럼과 이동상으로 0.08% 포름산을 함유하는 15% 아세토니트릴 용액을 사용하였고, 이동상의 유속은 1.0 mL/min, 검출파장은 254 nm였다. 사용된 방법을 ICH 가이드라인에 따라 우효성을 확인하였고, 한국 및 중국의 각 지역에서 수집된 우슬 시료 93점에 대한 지표성분의 모니터링에 적용하였다. 직선회귀법에 의해 산출된 ecdysterone과 inokosterone에 대한 새로운 함량기준은 각각 0.033%와 0.020%로 나타났다. 새로운 기준을 시판되는 우슬에 적용하였을 경우 국산은 모두가 합격하였고 중국산은 92.6%가 합격하여 전체적 합격률은 95.4%였다. 새로운 기준은 지표성분의 함량이 낮은 중국산의 유통을 감소시켜 양질의 국산 생약을 보호할 수 있을 것으로 판단된다.

Keywords

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