Background : Recently, there has been an increase in the use of herbal drugs for healthcare. The reference standards of herbal medicine is used to quality control for herbal medicines. It have been produced and re-evaluated by Ministry of Food and Drug Safety, starting from 2002. In this study, we re-tested the quality of a variety of Herbal Reference Standards (HRS). We analyze the HRSs with identification test by High Performance Thin Layer Chromatography (HPTLC). All test is based on experimental method of the Korean Pharmacopoeia, the Korea Herbal Pharmacopoeia. Methods and Results : To check the stability of reference standards of herbal medicine, we annually performe real-time monitoring under storage condition (4℃). The aim of this study is to perform a stability testing for 200 national reference standards to ensure the reliability of standards. For example, there are reference standards of Osterici Radix, Polygoni Multiflori Radix, Lithospermi Radix etc. It was achieved by comparing the colors and Rf values of the bands in TLC with those of the marker compounds using High Performance Thin Layer Chromatography (HPTLC). Tests for each item are based on experimental methods of the official compendium or the previous study on establishment of HRSs. Through re-test system, we confirm stability and reliability of HRSs condition. Also, based on the results, these HRSs will be continuously supplied as Herbal Reference Standards of MFDS. Conclusion : As the result, the HPTLC results showed the same TLC patterns as compared with previous reports. Based on the all results that we will update the each certificate of analysis. We want to contribute for quality control of herbal medicines.

Background : The reference standards of herbal medicine is used to quality control for herbal medicines. It is important that National Reference Standards maintain high stability of herbal medicines during all periods from the manufacture to the storage. In order to control quality of herbal medicines, the control reference standards (CRSs) have been produced by Ministry of Food and Drug Safety, starting from 2002. The designated CRSs are essential tests and assays to be carried out in accordance with the official compendium such as the Korean Pharmacopoeia and the Korean Herbal Pharmacopoeia. Methods and Results : The aim of this study is to perform a stability testing for 80 national reference standards to ensure the reliability of standards. For example, there are reference standards of Sweroside, Liquiritin, Wogonin etc. First of all, We randomly select three samples of CRSs and weight them and mobile phase is made suitable for the experimental conditions. We analyzed the purity value of each CRSs in calculating absolute peak area percent, using High Performance Liquid Chromatography (HPLC) based on the method in the official compendium. And the result showed that 80 evaluted CRSs were revealed more than 95% purity value. The stability of the CRSs under storage condition (4℃) were tested annually for 3 randomly selected samples. Conclusion : There are no significant difference among observed contents. The results of stability assessment represent suitable for quantitative analysis: less than 5% uncertainty of measurement. Even though this statistical analysis identified that stability was maintained for most of the products, some of them still need to be continuously monitored.