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山苦荬标准提取物的制备与质量控制方法
引用本文:杨海明,李秀敏,孙宏冉,陈志强.山苦荬标准提取物的制备与质量控制方法[J].安徽农业科学,2016,44(21):104-106.
作者姓名:杨海明  李秀敏  孙宏冉  陈志强
作者单位:内蒙古华天制药有限公司,内蒙古赤峰,024070;内蒙古华天制药有限公司,内蒙古赤峰,024070;内蒙古华天制药有限公司,内蒙古赤峰,024070;内蒙古华天制药有限公司,内蒙古赤峰,024070
摘    要:目的]制定山苦荬标准提取物的制备工艺并建立其质量控制方法。方法]采用正交试验设计建立山苦荬标准提取物的制备工艺;采用紫外分光光度法、TCL、微生物法建立山苦荬提取物的质量控制指标。结果]制备工艺为原料药材的处方量用20倍量水连续提取3次,100℃,每次1 h,减压浓缩温度与干燥温度均为65℃;山苦荬提取物在30~70μg/m L的浓度与吸光度线性良好,回收率为98.4%,RSD为0.64%。标准提取物溶液在198与294 nm紫外波长最大吸光度比值为4.1,干燥失重为0.4%,灰分为0.8%,酸碱度为5.2,细菌菌落总数为12个/g,霉菌总数无,大肠杆菌无,沙门氏菌无。结论]优选溶剂水及相应的温度提取和控制是山苦荬标准提取物制备的安全有效方法。建立的检测项可以用于山苦荬标准提取物的指标控制。

关 键 词:山苦荬标准提取物  制备工艺  质量控制方法

Preparation and Quality Control of Standard Extracts from Ixeris denticulata
YANG Hai-ming,LI Xiu-min,SUN Hong-ran,CHEN Zhi-qiang.Preparation and Quality Control of Standard Extracts from Ixeris denticulata[J].Journal of Anhui Agricultural Sciences,2016,44(21):104-106.
Authors:YANG Hai-ming  LI Xiu-min  SUN Hong-ran  CHEN Zhi-qiang
Abstract:Objective] The aim was to develop standard extractive preparation technology of Ixeris denticulata and establish its quality control method. Method] The preparation technology of I.denticulata standard extractive was established by orthogonal experiment; quality control index of I.denticulata extractive was established by ultraviolet spectrophotometric method, TCL, microbial method. Result] The preparation technology was using 20 times water of raw material medicine to extract 3 times under 100 ℃, 1 hour each time, the reduced pressure concen-tration and drying temperature is 65 ℃; 30 -70 μg/mL I.denticulata extractive had good linearity with absorbance, recovery rate was 98.4%, RSD 0.64%.The maximum absorbance ratio of standard extract solution at 198 and 294 nm UV wavelength was 4.1, dry weight loss was 0.4%, ash content was 0.8%, pH value was 5.2, the total number of bacterial colonies was 12 ind/g, mould, Escherichia coli and Sal-monella were not got involved. Conclusion] The optimal solvent water and corresponding temperature are key points of safe and effective method for I.denticulata standard extractive.The established test items can be used to control the index of I.denticulata standard extractive.
Keywords:Standard extractive of Ixeris denticulata  Preparation technique  Quality control method
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