【作者】 张远远；

【导师】 郑国华；

【作者基本信息】 湖北中医药大学 ， 中药学， 2011， 硕士

【摘要】 理气消瘿片是以中药青皮、柴胡为主组成的复方制剂,具有疏肝解郁、理气消瘿之功效,临床上主要对痰气交阻型瘿病有较好的疗效。本课题是以中医药理论为指导,应用现代科学技术和方法,对该制剂的质量标准、初步稳定性进行了系统试验研究,确保药品制剂安全有效、稳定可控。1质量标准研究薄层定性研究:采用TLC法对制剂中所含的9味药材进行鉴别。结果表明,供试品色谱中,在对照品或对照药材色谱相应的位置上,均显相同颜色的斑点,阴性对照在相应位置无干扰,且经多次试验,重现性良好。含量测定研究：采用HPLC法测定制剂中橙皮苷的含量,色谱柱：Aichrom Bond-AQ C18(250mm×4.6 mm,5μm);流动相：甲醇-水(40：60)；流速1. OmL·min-1;柱温35℃；检测波长284nm。结果本品每片含橙皮苷不得少于6.653mg。2有机溶剂残留及指纹图谱研究有机溶剂残留研究：采用顶空气相色谱法测定理气消瘿片中间体中有机溶剂残留,其中苯残留量小于0.0002%,,正己烷、甲苯、二甲苯、苯乙烯、二乙烯苯均未检出。指纹图谱研究：首先,通过对10批理气消瘿片中间体指纹图谱的研究,建立了理气消瘿片中间体的HPLC指纹图谱,共有峰13个,相似度大于0.9,并对主要色谱峰进行了归属,4、7、10和12号峰分别为芥子碱硫氰酸盐、橙皮苷、土贝母苷甲和柴胡皂苷a；其次,通过对10批理气消瘿片制剂指纹图谱的研究,建立了理气消瘿片制剂的HPLC指纹图谱,共有峰13个,相似度大于0.9。3稳定性考察通过对制剂的初步稳定性考察,即对三批样品进行加速试验和正常室温试验研究考察,结果表明本品制备工艺合理、稳定性良好。更多还原

【Abstract】 Liqixiaoying tablet is totally of traditional Chinese medicine radix mainly composed of Citrus Veticulata Blanco and Bupleurum chinense DC,is an effective angent for treating Ying disease by reinforcing Qi,nourishing yin,,somthing liver,smothing pressuer.The author has made an experimental study on its quality standards and stability researchs.1. study of quality standardStudy on TLC qualitative:identify the nine kinds of crude drug in the preparation by TLC. Experimental results show that the product in reference substance chromatography corresponding control medicinal materials or position, all show the same color spots, and the negative control in the corresponding position is no interference. And after repeated experiments, the reproducibility is good.Study on determination:determined the content of Aurantiamarins in the preparation by HPLC;chromatographic column:Aichrom Bond -AQ C18 (250mm x 4.6 mm,5μm), Mobile phase:methanol-water (40:60); Velocity 1.0 mL·min-1; Column temperature 35℃; detected wavelength 284nm.The results of the content of Aurantiamarins isl not be less than 6.653 mg in each tablet2. study of organic solvent residual and HPLC fingerprintStudy on organic solvent residual:determination he content of organic solvent in the preparation by Headspace-GC;The results of Benzene is less than 0.0002%,and n-Hexane、Toluene、Xylene、Styrene and Divinyl benzene are not respectively detected in the preparation.Study on HPLC fingerprint:first,HPLC fingerprint of Liqixiaoying tablet intermediates are established by study on 10 batches of Liqixiaoying tablet intermediates, showing 13 common peaks and similarity>0.9,peak 4,7,10,and 12 as Sinapine thiocyanate、Aurantiamarins、Tubeimoside land Radix Stellaviae a. secondly,HPLC fingerprint of Liqixiaoying tablet preparations are established by study on 10 batches of Liqixiaoying tablet preparations,showing 13 common peaks and similarity>0.9.3. research on the stability of pharmaceuticalFor the sake of Preliminary stability of the mediaction,ensuring the satabilization of quality when the medication being leave in care.Overpass seeing about the fringe satabilization of the medication.The result of preliminary stability indicated that the result of characters,identifications, test.It showed that the quality is stabilized.更多还原