加味缩泉合剂制备工艺及质量标准研究  

Study on the preparation process and quality standards of Jiawei Suoquan mixture

作　　者：孟丽丽 黄飞翔 徐建兵 MENG Lili;HUANG Feixiang;XU Jianbing(Pharmacy Department,Hangzhou Women’s Hospital,Hangzhou 310008,Zhejiang,China;Department of Traditional Chinese Medicine,Hangzhou Women’s Hospital,Hangzhou 310008,Zhejiang,China;Research and Development Department,Huisong Pharmaceuticals,Hangzhou 310005,Zhejiang,China)

机构地区：[1]杭州市妇产科医院药剂科,浙江杭州310008 [2]杭州市妇产科医院中医科,浙江杭州310008 [3]浙江惠松制药有限公司研发部,浙江杭州310005

出　　处：《中国现代医生》2024年第30期61-65,125,共6页China Modern Doctor

基　　金：浙江省杭州市生物医药和健康产业发展扶持科技专项项目(2021WJCY183)。

摘　　要：目的优化加味缩泉合剂制备工艺,确定其质量标准。方法以出膏率、莫诺苷和马钱苷总量为指标,通过正交试验确定加味缩泉合剂的制备工艺。采用Diamonsil Plus 5μm C_(18)(250mm×4.6mm)色谱柱;流动相A为乙腈,流动相B为0.3%磷酸溶液,进行梯度洗脱;检测波长为240nm;流速为1.0ml/min;柱温为35℃。结果确定提取工艺的条件为提取2次,分别以10倍量水、8倍量水,提取1.5h、1.0h。建立的莫诺苷、马钱苷含量测定方法的专属性、重现性、准确度均较好;莫诺苷在进样量0.1962~0.9810μg范围内线性关系良好,平均加样回收率为100.83%、相对标准偏差(relative standard deviation,RSD)为1.26%,精密度、稳定性等均符合要求。马钱苷在进样量0.0995~0.7960μg范围内线性关系良好,平均加样回收率为97.10%、RSD为0.84%,精密度、稳定性等均符合要求。结论最终确定的加味缩泉合剂制备工艺简单,操作易行。含量测定方法专属性强、准确性可靠,可用于加味缩泉合剂的质量控制。Objective To optimize the preparation process of Jiawei Suoquan mixture and determine the quality standard.Methods The preparation technology of Jiawei Suoquan mixture was determined by orthogonal test with the yield of paste,the total amount of morroniside and loganin as indexes.The column was Diamonsil Plus 5μm C_(18)(250mm×4.6mm).Acetonitrile as mobile phase A,0.3%phosphoric acid solution as mobile phase B,gradient elution;The detection wavelength was 240nm;The flow rate was 1.0ml/min.The column temperature was 35℃.Results The determined extraction process conditions were extracted twice,with 10 times of water and 8 times of water,respectively,for 1.5h and 1.0h.The established methods for the determination of morroniside and loganin were specific,reproducibility and accurate.The linear relationship of morroniside was good in the range of 0.1962 to 0.9810μg,the average recovery was 100.83%,relative standard deviation(RSD)was 1.26%,and the precision and stability met the requirements.The linear relationship of loganin in the sample size range from 0.0995 to 0.7960μg was good.The average recovery was 97.10%and RSD was 0.84%.The precision and stability met the requirements.Conclusion The preparation process of Jiawei Suoquan mixture is simple and feasible.The content determination method is specific,accurate and reliable,and can be used for quality control of Jiawei Suoquan mixture.

关 键 词：加味缩泉合剂 制备工艺 质量标准 含量测定 莫诺苷 马钱苷 

分 类 号：R94[医药卫生—药剂学]