目的 建立能同时测定固本统血颗粒中水晶兰苷、去乙酰基车叶草苷酸、车叶草苷酸、朝藿定A、淫羊藿苷、宝藿苷Ⅰ和东莨菪苷含量的一测多评法(QAMS).方法 采用Agilent Zorbax SB-C18色谱柱(250 mm×4.6 mm,5 μm);柱温:30℃;乙腈-2 mL·L-1磷酸为流动相,梯度洗脱;流速:1.0 mL·min-1;检测波长:235 nm检测水晶兰苷、去乙酰基车叶草苷酸和车叶草苷酸,270 nm检测朝藿定A、淫羊藿苷和宝藿苷Ⅰ,346 nm检测东莨菪苷.以淫羊藿苷为内参物,建立其他6种成分的相对校正因子(RCFs),计算各成分含量.结果 7种成分分别在7.49~187.25(r1 = 0.999 6)、3.37~84.25(r2= 0.999 2)、0.78~19.50(r3 =0.999 8)、3.09~77.25(r4 = 0.999 4)、8.97~224.25(r5= 0.999 6)、4.66~116.50(r6= 0.999 7)、0.59~14.75μg·mL-1(r7=0.999 1)范围内线性关系良好.平均回收率(RSD 值)分别为99.67%(0.72%)、98.73%(1.06%)、96.98%(1.18%)、97.94%(1.25%)、100.14%(0.69%)、99.10%(0.75%)、97.37%(1.47%).QAMS法测得的7种成分含量与外标法实测值无明显差异.结论 所建立的QAMS法结果准确,操作便捷,可作为固本统血颗粒多指标成分的质量控制方法.
Objective:To explore the effect of different processing conditions on the content and variation of epimer and impurities in main components of Glycyrrhiza.Methods:Samples of 18α-Gly, 18β-Gly and impurities were sampled by RP-HPLC.The content of impurities, main components and 18α-Gly and 18β-Gly in the mixture of standard and liquorice pieces were compared.The effect of proportional changes.Results:Compared with licorice at 5 o'clock, the total content of the main components of Glycyrrhiza after processing was decreased.The increase of processing time would gradually increase the loss of the main components of the Glycyrrhiza pieces, and had no effect on the ratio of 18-alpha-Gly and 18-beta-Gly in the Glycyrrhiza slices.When the processing temperature is less than 90°C, the processing time and processing temperature had no obvious effect on the content of impurities, 18α-Gly and 18β-Gly in Glycyrrhiza slices.When the processing temperature was not less than 140°C, prolonging the processing time would decompose 18α-Gly and 18β-Gly, significantly reducing the main component content.Conclusion:The processing temperature of Glycyrrhiza slices should not be too high, and the brewing time should not be too long to prevent the loss of its active ingredients.The suitable conditions for the drying process are:temperature 65°C, time 1~2 h.Simple operation, controlled temperature and time, good sample stability and quality.
目的:探讨中药注射剂静脉滴注所致不良反应及预防.方法:在某医院2015年1月-2016年1月期间诊治的因中药注射剂静脉滴注所致不良反应患者中抽取85例作研究对象,对其不良反应累及部位、涉及药物等相关资料予以回顾性分析,并据此提出相应预防措施.结果:①本组85例患者因中药注射剂静脉滴注所致不良反应主要累及的器官系统按照所占比率依次是皮肤及其附件、肝脏系统、消化系统、血液循环系统及其他,其中以皮肤及其附件的不良反应发生率最高(P<0.05);②本组中药注射剂静脉滴注所致不良反应所涉及药品主要如下:生脉注射液所占比率是16.47%,双黄连注射液所占比率是14.12%,清开灵注射液、参附注射液、血必净注射液所占比率均是11.76%,参麦注射液所占比率是10.59%,复方丹参注射液、黄芪注射液所占比率均是8.24%,醒脑静注射液所占比率是7.06%.结论:中药注射剂以静脉滴注方式给药容易使患者产生不良反应,应严格掌握中药注射剂适应症、重视药物说明书、患者个体差异,从而保障用药安全.