龙胆炮制饮片原料药筛选及质量标准研究

【作者】 刘薇；

【导师】 李敏；

【作者基本信息】 成都中医药大学 ， 生药学， 2006， 硕士

【摘要】 为配合国家863项目龙胆炮制饮片质量标准规范化研究，本文从龙胆的来源、原植物、产地、炮制和功能与主治等方面进行了本草考证。并且在文献查阅的基础上，对龙胆的品种研究、资源分布、形态组织学、化学成分、药理作用及定性和定量分析研究等方面进行了概括。并对龙胆炮制饮片的原料药进行了筛选研究，制定了炮制饮片的工艺和质量标准。 原料药筛选主要从以下几个方面进行：通过性状鉴别研究发现，不同品种、不同产地的龙胆药材在根的粗细及长短、表面和断面特征等方面有差异；经显微鉴别发现，龙胆药材的横切面特征主要通过外皮层、内皮层、裂隙和髓来加以区分，龙胆药材的粉末显微特征在外皮层碎片、内皮层碎片、草酸钙针晶、厚壁细胞和纤维这几个方面有区别，并绘制了清源产粗糙龙胆、玉溪产坚龙胆和河南产条叶龙胆的横切面组织详图、横切面简图及粉末图。测定了不同品种、不同产地龙胆药材的水分、浸出物、总灰分及酸不溶性灰分的含量，结果表明：龙胆药材水分含量均在8％～13％之间(保山产除外)，浸出物均在33％以上，酸不溶性灰分均在3％以下，而总灰分含量均符合药典标准(7％以下)。此外，测定了5种不同产地的坚龙胆，以及粗糙龙胆和条叶龙胆的重金属、砷盐、农药残留量、微生物和黄曲霉毒素B1含量，结果表明：龙胆药材样品的重金属、砷盐、农药残留量、微生物以及黄曲霉毒素B1均符合《药用植物及制剂外经贸绿色行业标准》。采用高效液相色谱法测定了不同产地的龙胆的有效成分龙胆苦苷的含量，结果表明：清源产粗糙龙胆的龙胆苦苷含量最高，且考虑此种龙胆是由辽宁清源龙胆GAP基地提供的，在质量稳定、可控等方面能得到保证，再加上该种浸出物较高、总灰分符合药典要求及从野生资源保护等方面的综合考虑，最后选择清源产粗糙龙胆Gentiana scabra作为龙胆饮片和酒龙胆的入选原料。 通过对龙胆炮制工艺的考查，以龙胆苦苷和浸出物含量为主要指标，并结合饮片的外观和水分，筛选出酒龙胆的最佳炮制工艺为：取一定量的龙胆药材，除去非药用部分、杂质及霉变品、虫蛀品、灰屑后，用水冲洗30秒，洗净后加入药材量45％的水润泡3小时至透心后，切制成10～15mm的短段，并于60℃烘箱中干燥2小时。取干燥后的龙胆饮片，加入相当于原料量10％的黄酒，拌润至黄酒被吸尽后，在150℃～200℃下炒10分钟，取出晾凉，即得。 通过对龙胆饮片和酒龙胆质量标准的研究，建议龙胆饮片的水分含量应不得过11％，酒龙胆的水分含量应不得过12％；龙胆饮片浸出物含量不得少于42％，酒龙胆浸出物不得少于36％；龙胆饮片和酒龙胆总灰分不得过6.0％，酸不溶性灰分不得过3.0％；龙胆饮片含龙胆苦苷不得少于42mg／g，酒龙胆含龙胆苦苷不得少于45mg／g。此外，还测定了龙胆饮片和酒龙胆的重金属、砷盐、农药残留量、微生物和黄曲霉毒素B1含量，结果表明，龙胆饮片和酒龙胆样品的重金属、砷盐、农药残留量、微生物和黄曲霉毒素B1含量均符合《药用植物及制剂外经贸绿色行业标准》。 本课题细化了酒龙胆的炮制参数，填补了龙胆炮制饮片无炮制参数的空白；完善了龙胆炮制饮片的质量标准；为中药材炮制品质量标准的制定提供了科学依据和可参照的范例。 论文共附图49幅：其中组织结构图11幅，高效液相色谱图24幅；照片图14幅。更多还原

【Abstract】 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.更多还原