参麦咽舒口服液提取工艺优选及含量测定方法的建立  

Optimization of extraction process and establishment of content determination method for Shenmai Yanshu oral liquid

作　　者：孙琳 金文丽 王艳 谢静 王琼 方佳慧 贾君 SUN Lin;JIN Wenli;WANG Yan;XIE Jing;WANG Qiong;FANG Jiahui;JIA Jun(Jiayuguan Food and Medicine and Medical Equipment Inspection and Testing Center,Jiayuguan Gansu 735100,China;Jiugang Hospital of Gansu Province,Jiayuguan Gansu 735100,China)

机构地区：[1]嘉峪关市食品药品和医疗器械检验检测中心,甘肃嘉峪关735100 [2]酒钢医院,甘肃嘉峪关735100

出　　处：《中兽医医药杂志》2025年第2期85-92,共8页Journal of Traditional Chinese Veterinary Medicine

基　　金：嘉峪关市科技计划项目(23-B02)。

摘　　要：优选参麦咽舒口服液提取工艺并建立同时测定黄芩苷、牛蒡苷含量的高效液相色谱(HPLC)方法。采用Box-Behnken响应面法试验设计,以加水量(8~12倍)、提取时间(1.5~2.5 h)、提取次数(1~3次)为考察因素,以黄芩苷含量、牛蒡苷含量、出膏率的加权综合评分为指标进行工艺优选;建立HPLC法(色谱条件为CAPCELL PAK C18色谱柱,以乙腈-0.1%磷酸为流动相进行梯度洗脱,流速1.0 mL/min,检测波长280 nm)同步检测2种成分。结果显示,黄芩苷和牛蒡苷分别在0.0315~0.5040 mg/mL(r=0.9996)、0.0215~0.3430 mg/mL(r=0.9999)范围内线性关系良好;黄芩苷和牛蒡苷平均加样回收率分别为100.3%(RSD=1.04%,n=9)和101.3%(RSD=0.73%,n=9)。确定最优工艺为加12倍水、提取2次、每次2.0 h,验证试验显示综合评分(99.32)与预测值(98)偏差小于2%。本试验建立的HPLC法专属性强、重复性好,可有效控制制剂质量,优选的提取工艺稳定可控,工艺参数合理,为规模化生产提供了科学依据,研究方法对同类中药复方制剂开发具有参考价值。The objective was to optimize the extraction process for Shenmai Yanshu oral liquid and establish a high-performance liquid chromatography(HPLC)method for the simultaneous determination of baicalin and arctiin.Box-Behnken response surface methodology was employed to design experiments,with water addition(8-12 times),extraction time(1.5-2.5 h),and extraction frequency(1-3 times)as the factors under investigation.The comprehensive score based on the content of baicalin and arctiin,as well as the yield of extract,was used as the index to optimize the process.HPLC method was established(chromatographic conditions:CAPCELL PAK C18 column,gradient elution with acetonitrile-0.1%phosphoric acid,flow rate of 1.0 mL/min,detection wavelength of 280 nm)for the simultaneous detection of the two components.The results showed that baicalin and arctiin showed good linear relationships in the range of 0.0315-0.5040 mg/mL(r=0.9996)and 0.0215-0.3430 mg/mL(r=0.9999),respectively.The average recovery rates were 100.3%(RSD=1.04%,n=9)for baicalin and 101.3%(RSD=0.73%,n=9)for arctiin.The optimized process was determined to be adding 12 times water,extracting twice,each time for 2.0 h.Validation experiments showed that the comprehensive score(99.32)had a deviation of<2%from the predicted value(98).The established HPLC method is specific and reproducible,which can effectively control the quality of the preparation.The optimized extraction process is stable and controllable,with reasonable process parameters,providing a scientific basis for large-scale production.The research methods can provide reference for the development of similar traditional Chinese medicine compound preparations.

关 键 词：参麦咽舒口服液 提取工艺优选 Box-Behnken响应面法 高效液相色谱法 黄芩苷 牛蒡苷 

分 类 号：S853.7[农业科学—临床兽医学]