新催奶灵散的制备工艺及质量标准研究

Study on the optimization of processing technology and establishment of quality standard of the New cuinailing sanNING chen-xu1 ZHANG xiao-yan1 SU xiaojuan1 LV chen-zi1

关键词:  催奶灵散  响应曲面法  高效液相色谱法  含量测定  

Key words:  The New cuinailing san  Response surface method  High performance liquid chromatography  Content determination  

摘要:

目的：响应曲面法优选新催奶灵散的最佳制备工艺,并对新催奶灵散进行定性分析和定量分析,从而制定新催奶灵散的质量标准。方法：以过筛率为评价指标,以干燥温度A、干燥时间B、粉碎时间C为考察因素,采用响应曲面法优选新催奶灵散的最佳制备工艺。并通过HPLC法测定新催奶灵散中的阿魏酸、洋川芎内酯Ⅰ、绿原酸和藁本内酯的含量,对新催奶灵散的质量标准的建立进行升级。结果：新催奶灵散的最佳制备工艺为最佳工艺确定为干燥温度为60℃,干燥时间为4h,粉碎时间为5min；新催奶灵散中阿魏酸的含量0.526034 mg/g；洋川芎内酯Ⅰ的含量0.25353 mg/g；绿原酸的含量0.23975 mg/g；藁本内酯的含量为15.41618mg/g。结论：本实验采用响应曲面法建立的模型相对准确,优化的新催奶灵散制备工艺与各成分的含量测定方法切实可行,为制定新催奶灵散质量标准和现代研究提供了科学依据。

Abstract:

Objective: The response surface method was used to optimize the preparation process of the New cuinailing san, and the qualitative and quantitative analysis of the New cuinailing san was carried out, so as to establish the quality standard of the New cuinailing san. Methods: With the sieving rate as the evaluation index and drying temperature A, drying time B and comminution time C as the investigation factors, the response surface method was used to optimize the optimal preparation process of the New cuinailing san. And HPLC method was used for the determination of Ferulic acid , Senkyunolide I , the content of Chlorogenic acid and Ligustilide to upgrade the establishment of quality standard for the New cuinailing san. Results: The best preparation process of the New cuinailing san was determined as follows: the drying temperature was 60℃, the drying time was 4h and the crushing time was 5min.The content of Ferulic acid in the New cuinailing san was 0.526034 mg/g. The content of Senkyunolide I was 0.25353 mg/g;The content of Chlorogenic acid was 0.23975 mg/g. The Ligustilide content was 15.41618mg/g. Conclusion: The model established by response surface method in this experiment is relatively accurate, and the optimized preparation process and the content determination method of each component are feasible, which provides a scientific basis for the formulation of the new quality standard and modern research.