治带片质量标准的提高及质量评价研究

Specification improvement and quality evaluation of Zhidai Tablets

目的:对治带片的质量标准进行完善提高,对其质量进行整体评价。方法:采用薄层色谱法(TLC)对治带片中金樱子、苍术和知母药材进行定性鉴别;采用高效液相色谱(HPLC),以苍术素作为检测指标,进行定量测定。结果:薄层色谱法能清晰、有效的鉴别治带片中金樱子、苍术和知母药材,阴性无干扰;苍术素在1.0～104.7μg·mL^(-1)浓度范围内线性关系良好,回归方程为Y=131.9X+29.8,r=0.999 9;检测限为0.79μg·g^(-1),定量限为2.63μg·g^(-1);加标回收率为98.86%,RSD为0.91%(n=6)。结论:新建立的质量标准增加了检测药味,可控性、系统性更强;建立的实验方法简便快捷,准确可靠,适应性好,可用于该制剂的质量控制和质量评价。

Objective: To improve the specification and evaluate the quality of Zhidai Tablets. Methods: Rosae Laevigatae Fructus, Atractylodis Rhizoma and Anemarrhenae Rhizoma in Zhidai Tablets were identified by TLC. The content of atractylodin was determined by HPLC. Results: Rosae Laevigatae Fructus, Atractylodis Rhizoma and Anemarrhenae Rhizoma in Zhidai Tablets could be identified by TLC without the blank interference. The linearity equation between the concentrations and peak areas of atractylodin was Y=131.9X+29.8 in the range of 1.0-104.7 μg·mL-1(r=0.999 9). The limits of detection and quantification were 0.79 μg·g-1 and 2.63 μg·g-1 respectively. The spiked average recovery was 98.86% with RSD as 0.91%(n=6). Conclusion: The improved specification includes the identification of more crude drugs and has the better systematicness and controllability. The established methods are simple, fast, accurate, reliable, and adaptable. They can be used for quality control and quality evaluation of Zhidai Tablets.