小儿清热颗粒指标成分测定和水提工艺研究  

Determination of Index Component and Water Extraction Process of Xiaoer Qingre Granules

作　　者：余杨健 谢和兵 尼玛次仁 白玛旦增 YU Yangjian;XIE Hebing;NIMA Ciren;BAIMA Danzeng(School of Pharmacy,Anhui University of Chinese Medicine,Hefei,Anhui,China 230013;Yangtze Delta Drug Advanced Research Institute,Nantong,Jiangsu,China 226133;Jiangsu Shenhou Pharmaceutical Research Co.,Ltd.,Nantong,Jiangsu,China 226133;Tibet Shenhou Pharmaceutical Co.,Ltd.,Xigaze,Tibet,China 857000)

机构地区：[1]安徽中医药大学药学院,安徽合肥230013 [2]江苏省南通市海门长三角药物高等研究院,江苏南通226133 [3]江苏神猴医药研究有限公司,江苏南通226133 [4]西藏神猴药业有限责任公司,西藏日喀则857000

出　　处：《中国药业》2023年第7期64-68,共5页China Pharmaceuticals

摘　　要：目的建立小儿清热颗粒指标成分测定方法,并优选最佳水提工艺。方法采用高效液相色谱法测定羟基红花黄色素A含量,以加水量、提取次数、提取时间为考察因素,以提取液干膏得率、乙酸乙酯萃取部位得率和羟基红花黄色素A转移率为评价指标,设计L_(9)(3^(4))正交试验以优选最佳水提工艺。结果羟基红花黄色素A对照品溶液质量浓度在23.44~195.34 μg/mL范围内与峰面积线性关系良好(r=0.9996,n=6),精密度、稳定性和重复性试验结果的RSD均低于2.0%,平均加样回收率为100.69%,RSD为0.81%(n=6)。最佳水提工艺为加10倍水,提取3次,每次0.5 h。结论所建立的指标成分含量测定方法及优选的水提工艺稳定可靠、重复性好,可为藏药小儿清热颗粒的进一步开发奠定基础。Objective To establish a method for the determination of the index component of Xiaoer Qingre Granules,and to optimize its water extraction process.Methods The content of hydroxysafflor yellow A was determined by the high-performance liquid chromatography(HPLC)method.The water extraction process was optimized by the L9(34)orthogonal test with the amount of water added,extraction times and extraction time as the investigation factors,and with the yield of dry extract,the yield of ethyl acetate extract and the transfer rate of hydroxysafflor yellow A as the evaluation indexes.Results The linear range of hydroxysafflor yellow A reference solution was 23.44-195.34μg/mL(r=0.9996,n=6).The RSDs of precision,stability and repeatability tests were all lower than 2.0%,and the average recovery of hydroxysafflor yellow A was 100.69%with the RSD of 0.81%(n=6).The optimal water extraction process was as follows:adding 10 times amount of water,and extracting three times,0.5 h each time.Conclusion The established method for the determination of index component and the optimal water extraction process are stable,reliable and repeatable,which can lay a foundation for the further development of Tibetan medicine Xiaoer Qingre Granules.

关 键 词：小儿清热颗粒 :L_(9)(3^(4))正交试验 提取工艺 羟基红花黄色素A 

分 类 号：R932[医药卫生—生药学] R284.2[医药卫生—药学]