摘要
目的探讨电子加速器不同辐照剂量灭菌对肺热普清散质量的影响。方法采用电子加速器,分别以0,4,6,8,10,12kGy辐照剂量对样品进行辐照灭菌,比较样品性状、显微粉末特征,对去氢木香内酯、木香烃内酯进行薄层色谱鉴别,采用高效液相色谱法测定羟基红花黄色素A含量,参照2015年版《中国药典(四部)》通则检测细菌菌落总数、霉菌酵母菌菌落总数的变化。结果与0kGy比较,不同辐照剂量灭菌后的样品性状及粉末显微特征无明显变化;TLC图显相同颜色斑点,且阴性对照无干扰;羟基红花黄色素A含量无明显变化(P>0.05);细菌菌落总数、霉菌酵母菌菌落总数明显减少(P<0.05),当辐照剂量达8kGy时,霉菌酵母菌及细菌菌落均未检出。结论电子加速器辐照适用于藏药肺热普清散的灭菌。
Objective To investigate the effect of electron accelerator sterilization with different irradiation doses on the quality of Feirepuqing Powder.Methods The samples were irradiated and sterilized with irradiation doses of 0,4,6,8,10,and 12kGy by the electron accelerator.The appearance of the samples and the characteristics of microscopic powder were compared.The dehydrocostus lactone and costunolide in Feirepuqing Powder were identified by thin-layer chromatography(TLC).The content of hydroxysafflor yellow A was determined by the high-performance liquid chromatography(HPLC).The total number of bacterial colonies and the total number of mold and yeast colonies were determined according to the general rules of the Chinese Pharmacopoeia(2015 Edition,VolumeⅣ).Results Compared with sterilization by 0kGy of irradiation,there was no significant change in the sample appearance and powder microscopic characteristics after sterilization by different doses of irradiation.The TLC chromatogram showed that the test solution had the same color spots at the corresponding positions of the dehydrocostus lactone and costunolide reference solution,and the negative control has no interference.The content of hydroxysafflor yellow A did not change significantly(P>0.05).The total number of bacterial colonies and the total number of mold and yeast colonies decreased significantly(P<0.05).However,no mold,yeast or bacterial colonies were detected when the irradiation dose was 8kGy.Conclusion Electron accelerator irradiation is suitable for the sterilization of Tibetan medicine Feirepuqing Powder.
作者
采金金
谢和兵
尼玛次仁
白玛旦增
CAI Jinjin;XIE Hebing;NIMA Ciren;BAIMA Danzeng(College of Medicine,Anhui University of Chinese Medicine,Hefei,Anhui,China 230012;Yangtze Delta Drug Advanced Research Institute,Nantong,Jiangsu,China 226133;Jiangsu Shenhou Pharmaceutical Research Co.,Ltd.,Nantong,Jiangsu,China 226000;Xizang Shenhou Pharmaceutical Co.,Ltd.,Shigatse,Xizang,China 857000)
出处
《中国药业》
CAS
2023年第4期70-74,共5页
China Pharmaceuticals
基金
西藏自治区科技厅中央引导地方科技发展资金项目[XZ202202YD0020C]。
关键词
肺热普清散
电子加速器
辐照灭菌
性状鉴别
显微特征
薄层色谱
有效成分
含量测定
Feirepuqing Powder
electron accelerator
irradiation sterilization
character identification
microscopic characteristics
TLC
active ingredients
content determination
