摘要
目的:利用正交试验优化逍遥丸前处理方法,并建立逍遥丸HPLC指纹图谱,为其质量评价提供依据。方法:以逍遥丸为模型药物,选用L_9(3~4)正交试验表,对指纹图谱共有峰进行主成分分析(PCA)分析,以总因子得分为评价指标,采用正交试验法,对浸渍时间、甲醇浓度、溶剂倍量、提取时间等条件进行优化,筛选出其最佳提取工艺参数,并在此条件下建立逍遥丸指纹图谱。结果:在特征图谱研究中,共确定17个共有峰,利用主成分分析法从中筛选出的3个主成分累计贡献率达到84.937%,计算所有样本的综合得分指标。正交试验得出最优提取工艺为15倍70%甲醇,浸渍3 h后,再超声提取60 min。结论:所建立的方法简便有效,符合指纹图谱技术要求,可作为控制逍遥丸质量的分析方法。
Objective： To optimize the pretreatment technology of Xiaoyao pills by orthogonal test,and establish the HPLC fingerprint of Xiaoyao pills for the quality control. Methods： Taking Xiaoyao pills as the model drug,the fingerprints with different extraction conditions were established by HPLC,the areas of the common peaks were harvested,and the total factor scores were calculated by PCA. The technological parameters such as soaking time,methanol concentration,liquid-solid ratio and extraction time were optimized by L_9（ 3~4） orthogonal array design and the best extraction parameters were selected to establish the fingerprint under the relevant extraction conditions. Results： The common mode of fingerprint was set up with 17 common peaks,and three principle components with the accumulative contribution rate of 84. 937% were screened out to calculate the comprehensive score of each sample. The optimal water extraction technology was as follows： 15-fold amount of 70% methanol,soaking for 3 h,and ultrasonic extracting for 60 min. Conclusion： The present methodology meets the technical requirements of fingerprint with the suitable and feasible properties,which can be a basis for the establishment of intrinsic quality control standard for Xiaoyao pills.
作者
江雪欣
李建朋
Jiang Xuexin;Li Jianpeng(Yantai Center for Food and Drug Control and Test, Shandong Yantai 264000, Chin)
出处
《中国药师》
CAS
2018年第7期1150-1154,共5页
China Pharmacist
