A monitoring study of marker contents in the Hwangnyeonhaedok-tang Ex preparations on the market

시판 황련해독탕 Ex제제의 성분함량 모니터링 연구

Objectives : Hwangnyeonhaedok-tang(HNHDT) is the one of well-known traditional herbal formula and has been widely used for the treatment of various diseases in Korea. For the quality improvement of commercial traditional herbal formula, we investigated the quality of prepared HNHDT. Methods: We measured the contents of baicalin, berberine and geniposide in the HNHDT Ex preparations on the market by HPLC and compared with the official notice of ingredients. Results: In 3 preparations of HNHDT covered with the national health insurance(NHI), the content of baicalin was various from 32.83mg to 185.05mg, the total berberine was $12.0{\sim}50.75mg$ and geniposide was $12.57{\sim}44.84mg$. Contents of marker ingredients in NHI Preparations were below the standard and showed a large variation. In 7 non NHI Preparations of HNHDT and the standard(STD) HNHDT manufactured in laboratory, the content of baicalin was $37.16{\sim}115.69mg$, the total berberine was $5.62{\sim}28.43mg$ and geniposide was $10.98{\sim}113.47mg$. But, because composition of non-NHI preparations is different from NHI preparations, every maker's contents were up to the notice for baicalin and berberine. There was newly enforced standard regulations of geniposide in non-NHI preparations, so contents of geniposide was up to that standard only in JI and STD. Conclusions: There was a large variation of contents in the HNHDT Ex preparations on the market and the quality differences were existed between NHI and non-NHI preparations of HNHDT. Further studies for evaluation of efficacy differences and standardization of manufacturing processes are necessary.