Gentian Concocted Pieces Of Raw Materials, Drug Screening And Quality Standards

In order to cooperate with the national high-tech "863" project - study on the standardization of Radix Gentianae tablet's quality control, we studied the recent literature of Radix Gentianae on its sources, original plants, producing areas, processing and function. The basis of our textual research is carried out according to: Radix Gentianae's species, resource distributing, morphology and histology, chemical composition, pharmacological effect and qualitative & quantitative analyses. We also screened the raw material medicines for the Radix Gentianae tablet and established its processing techniques and quality standards.The screening of raw material medicine is performed as follows: through the appearance discrimination, it's found that the difference between Radix Gentianae from different species and producing areas lies in their roots' thickness, length, superficial characteristics and section. The content of their water, extractive, total ash and acid-insoluble ash is also tested. The result shows the content of water ranging from 8% to 13% (except Baoshan's), extractive is above 33%; acid-insoluble ash is below 3% and the total ash is in accordance with pharmacopeia's standard (below 7%). Furthermore, the test of heavy metals, residual pesticides, microbes and aflatoxin B1 in Radix Gentianae from 5 different producing areas also show that all of them are in accordance with "Standards of Green importing and Exporting Medicinal Plants and Their Products". The content of gentiopicroside in Radix Gentianae from different producing areas is also tested with HPLC.The result shows Qingyuan's Radix Gentianae has highest gentiopicroside content. Taking into account that it's offered by the Qingyuan GAP base of Radix Gentianae, the quality consistency and controllability is guaranteed. Due also to its higher extractive content and that total ash content are in accordance with pharmacopeia and wild resource conservation, we choose Gentiana scabra from Qingyuan as raw materials to produce Radix Gentianae and Jiulongdan.Through the research of Jiulongdan's processing techniques, using the content of gentiopicroside and extractive as main index, combining with the tablet's appearance and water content, the best processing techniques should be as follows: take some Radix Gentianae and remove the useless parts, impurities and ashes;wash with water for 30 seconds, then marinate for 3 hours with 45% volume of water; cut into 10~15mm sections and desiccate 2 hours in the oven at 60 ℃; take the desiccated tablet out and add 10% volume of yellow wine; after the wine is absorbed, fry 10 minutes at 150℃～200℃, then take it out to dry.Through the study of quality standard, it's suggested that the content of water should not be more than 11% in Radix Gentianae tablet and 12% in Jiulongdan; extractive must not be less than 42% in Radix Gentianae tablet and 36% in Jiulongdan; total ash and acid-insoluble ash should not be more than 6.0% and 3.0% each; the gentiopicroside should not be less than 42mg/g in Radix Gentianae tablet and 45mg/g in Jiulongdan. The tests of heavy metals, residual pesticides, microbes and aflatoxin Bl also show all these items are in accordance with "Standards of Green importing and Exporting Medicinal Plants and Their Products".Our research specified the processing parameters of Radix Gentianae tablet, achieving a high quality standard and provided scientific proof and examples for the establishment of traditional Chinese medicine tablet quality standard .The attachments have 49 photographs and diagrams, including 11 histological and structural drawings, 24 HPLC drawings.