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정영희,강지연,임은희,이은주,여수정,진전성,이경아,김영호,강종성 충남대학교 약학대학 의약품개발연구소 2005 藥學論文集 Vol.20 No.-
Herbal drugs have been playing an important role in the medical therapy system in the oriental culture for thousands of years. Nowadays, the needs for the quality evaluations of these materials are very strong. In this research costunolide in Saussureae Radix was analyzed and the content of regulation was established for the quality evaluation of Saussureae Radix. Costunolide in the acetone extract of Saussureae Radix was successfully separated on Zorbax Eclipse XDB C_(18)(2.1×150 ㎜) with methanol-water(65:35, v/v) as mobile phase. The flow rate was 0.25 ㎖/min and detection was carried out at UV 215 ㎚. The HPLC method was validated by ICH guide lines comparing the linearity, precision, accuracy and detection limit. The average content of costunolide in Saussureae Radix was 1.04%. The highest costunolide content among the samples was 18 times higher than the lowest content. The content of costunolide for regulation in Saussureae Radix, set as the lowest costunolide content of analyzed sample which lied in the range of 95% confidence interval, was 0.68%. The appropriate number of samples to establish the costunolide content for regulation was proposed as 20, with the error level of not higher than 10%. These results provided the statistical back ground for the quality evaluation of Saussureae Radix.