正交试验法优选复方天麻控释胶囊的提取工艺研究

Study on optimizing the extraction process of Compound Tianma Controlled Release Capsules by orthogonal test

目的优选复方天麻控释胶囊的最佳提取工艺。方法以天麻素含量和提取物出膏率的综合评分为指标,天麻素含量采用高效液相色谱法(HPLC)进行测定,采用L_(9)(3^(4))正交试验法考察提取工艺的影响因素,优选提取工艺参数。结果天麻素在0.105~0.630μg(r=0.9998)范围内线性关系良好,平均回收率为99.40%(n=5),RSD=1.16%;正交试验法优选的最佳提取工艺为用60%乙醇回流提取3次,第1次用10倍量溶媒,提取1.5 h,第2、3次分别用8倍量溶媒,提取1 h。结论该含量测定方法简便易操作、且准确稳定,可用于该制剂及中间体中天麻素的含量测定;优选的提取工艺稳定可行,为该控释胶囊的开发奠定基础。

Objective To optimize the optimal extraction process of Compound Tianma Controlled-Release Capsule.Methods The effects of factors on extraction process were evaluated by L_(9)(3^(4))orthogonal test method,using the content of gastrodin and the quantity of alcohol extraction as the indexes,to optimize the optimal extraction parameter.the content of gastrodin was detected by HPLC.Results The content of gastrodin showed a good linear relationship within the range of 0.105-0.630μg(r=0.9998),and the average recovery was 99.40%(n=5),RSD=1.16%;The optimal extraction process was as follows:Reflux extraction with 60%alcohol for 3 times,1.5 hours and 10 times the amount of solvent for the first time,1 hour and 8 times the amount of solvent for the second and third times.Conclusion The determination method is simple and accurate and stable to detect the content of gastrodin in the preparations and intermediates;The optimal extraction process is stable and feasible to lay a foundation for the development of the Controlled Release Capsules.