益龄精口服液中红景天苷的含量测定方法建立及其量值传递研究
Study on the Determination Method and Quality Value Transfer of Salidroside in Yilingjing Oral Liquid
罗菲菲 1叶惠煊 1唐梦香 1谭勇 1李敏 1袁莉 1袁利群 1吴崇乐 1胡丽彬 1黄胜1
作者信息
- 1. 九芝堂股份有限公司,湖南长沙 410205;湖南省中药固体制剂工程技术研究中心,湖南长沙 410205;中药验方湖南省工程研究中心,湖南长沙 410205
- 折叠
摘要
目的 建立益龄精口服液中红景天苷的含量测定方法,研究其从饮片至制剂成品生产过程中的量值传递关系.方法 采用高效液相色谱-二极管阵列检测器法(HPLC-DAD)对指标成分红景天苷进行含量测定,以乙腈-水(7∶93)为流动相,等度洗脱;流速为1.0mL·min-1;检测波长为220 nm;柱温为35 ℃;进样量为10 μL.结果 所建立的红景天苷含量测定方法的方法学验证均良好,红景天苷在56.109～3 591 ng范围内与峰面积呈良好的线性关系(r2=1.000 0),平均加样回收率为99.19％,RSD为0.27％(n=6),15批益龄精口服液中红景天苷从酒女贞子饮片到中间体和成品的平均转移率分别为(56.93±5.29)％、(47.60±4.32)％.结论 本研究建立了简便、准确、重现性好的指标成分定量方法,并进一步探讨了红景天苷在制剂生产过程中的量值传递规律,为完善益龄精口服液的质量标准和过程控制提供参考.
Abstract
OBJECTIVE To establish a method for the determination of salidroside in Yilingjing oral liquid,and to investigate the quality value transmitting of salidroside in the production process from decoction pieces to finished products.METHODS The content of the indicator component Salidroside was determined by high performance liquid chromatography-diode array detector(HPLC-DAD)with the mobile phase of acetonitrile-H2O(7∶93),using isocratic elution.The flow rate was 1.0 mL·min-1,and the detection wavelength was set at 220 nm.The column temperature was 35 ℃ and the injection volume was 10μL.RESULTS The methodological validation of theestablished method for the content determination of salidroside was good,which showed a good linear relationship between the injection amount and peak area in the range of 56.109-3 591 ng(r2=1.000 0),and the average recovery was 99.19％with RSD 0.27％(n=6).The average quality value transfer rates of salidroside in 15 batches of Yilingjing oral liquid from decoction pieces of wine steaming of Ligustri lucidi Fructus to extract intermediates and finished product were(56.93±5.29)％and(47.60±4.32)％,respectively.CONCLUSION This study established a simple,accurate and reproducible quantitative method of indicator components and further discussed the quantitative value transfer rule of salidroside in the production process,which provided references for improving the quality standard and process control of Yilingjing oral liquid.
关键词
益龄精口服液/红景天苷/酒女贞子/含量测定/量值传递/高效液相色谱Key words
Yilingjing oral liquid/salidroside/wine steaming of Ligustri Licidi Fructus/content determination/quantity value transfer/HPLC引用本文复制引用
基金项目
湖南省创新型省份建设专项(2022JJ80025)
出版年
2024
NETL
NSTL
万方数据