摘要
为了促进穿心莲GAP基地的发展和满足临床用药需要，本课题按照药品注册管理办法有关技术要求，对穿心莲内酯原料药及其新制剂进行了研究。
穿心莲药材经提取分离、精制纯化后得到单体化合物，采用UV、IR、NMR和MS检测，并与穿心莲内酯对照品比对，鉴定为穿心莲内酯，其纯度大于97％；建立了穿心莲内酯含量的HPLC测定方法，提高了原有质量标准。
穿心莲内酯具有清热解毒、抗菌消炎的功效，广泛应用于临床。通过调研论证，拟将穿心莲内酯制备成栓剂，从肛门塞入给药以达到治疗上呼吸道感染的目的。栓剂制备工艺研究中，以溶出度为评价指标，筛选确定基质为SUPPOEIRE AM，增溶剂为聚山梨酯80，并优化了工艺条件。建立了栓剂的质量标准，并进行了初步稳定性研究。结果表明：制备工艺合理可行，质量稳定可控。
In order to improve the development of the GAP base and fulfil the demand of clinical medication, we have done a comprehensive research on the andrographolide and its preparation according to Examining and Approving Method of Medicine.
We gained a monomer by extraction, isolation, refinement and purification with advanced techniques and methods. This monomer was identified as andrographolide after being measured by UV, IR, NMR, MS and compared with standards. The purity of andrographolide is higher than 97%. We established a HPLC method for content determination. Moreover, we improved the quality standard of Andrographolide.
Andrographolide, an effective ingredient of andrographitis. is applied widely in clinic for its heat-clearing, detoxicating, antisepticise and dephlogisticate specialities. Further study of Andrographolide achieves a suppository, which can be administered from anus for treatment of upper respiratory tract infection. During the study, we used the index of dissolution to screen SUPPOCIRE AM as the basilaris substantia and tween-80 as the supplemental agent. Furthermore, we have done comprehensive researches to optimize the craft, set up methods of content determination, and dissolution determination. Studies of quality standard and preliminary stability show that the preparation technique is reasonable and practical, the standard is controllable, and the quality of the sample is steady as well.
引文
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