Quality Standards Of The Chemical Composition Of Its New Drug Dioscorea Zingiberensis Amendments

Dioscorea zingiberensis Wright is a unique plant growing in China.The plant is mainly planted in the south part of Shaanxi province,Yunxi city of Hubei province, Anhua city of Hunan province and Nanyang city of Henan province. In order to enlarge the function of Huangjiang and make good use of the nature resourse of Shaanxi province ,we have studied the chemical constituents of HJ and developed it into HJS and its capsule,a kind of new drug for coronary heart disease and hyperlipidemia. This professional subject make basic study on the new drug research work. It is made of two parts. One part is studying on the chemical constituents of Dioscorea zingiberensis rhizoma. Another part is studying on the supplement of huangjiangsu capsule new drug.Part one In order to establish material base for the quality control.clinical medication and new drug exploitation of Dioscorea zingiberensis, we firstly made use of different kinds of pillar layer chromatogram method to carry out a systematic research on the chemical constituents of Huangjiang collected in Shaanxi province. Four compounds were achieved using several separation methods. Three of them were identified by the means of spectroscopy(UV,IR,NMR,MS etc.)assisted by comparing with standard substance and constants. Three constituents were: dioscin, zingiberensis newsaponin and huangjiangsu A. We also developed the method of HPLC-ELSD to make a series investigation on the content of huangjiangsu A which is the mark constituent in Dioscorea Zingiberensis growing in Shaanxi province .The result showed that Xunyang country is the best place to plant Huangjiang. The quality control method of using huangjiangsu A as mark constituent is more scientific and reasonable than before using diosgenin. Consequently it offered credibility foundation to control the quality of Dioscorea Zingiberensis medical material.Part tow Huang Jiang Su is the total steroid saponin extracted from Huangjiang(Dioscorea zingiberensis). According to the request of quality control of 5th category new drug ,it's not only need to control the content of the total components but also need to control the single component.In this subject we revised the former quality standard by setting up the HPLC-ELSD method to control the content of huangjiangsu A in huang jiang su and its capsule. The method did investigation on many aspects of technology(standard curve, degree of precision, recovery, stability, etc.). At the same time we carried out study on the tacho-stability and long-term stability of huang jiang su and its capsule. We choose three batches of Huangjiang su capsule and then placed them under the fixed temperature and relative humidity. Regularly we took samples from them to inspect different items requested. And then we compared the results with the original. The result certified that the product had good stability.