用乘方指纹图谱评价双黄连胶囊质量的方法探讨  

Quality evaluation of Shuanghuanglian capsules by involution HPLC fingerprints

作　　者：孙国祥[1] 王建会[1] 吴玉[1] 李闫飞[1] 刘迎春[1] 

机构地区：[1]沈阳药科大学药学院,沈阳110016

出　　处：《中南药学》2013年第3期214-218,共5页Central South Pharmacy

基　　金：国家自然科学基金重大研究计划课题(No.90612002)

摘　　要：目的建立双黄连胶囊(Shuanghuanglian capsule,SHLC)280 nm HPLC指纹图谱,提出基于系统指纹定量法(SQFP)的4种乘方指纹图谱评价模型。方法采用RP-HPLC法,以黄芩苷(baicalin,BCL)为参照物峰,确定44个共有指纹峰,建立了280 nm SHLC-HPLC定量指纹图谱(N-FP)、开立方指纹图谱(CT-FP)、开平方指纹图谱(ST-FP)、1.5次方指纹图谱(1.5 PFP)和平方指纹图谱(S-FP),均采用SQFP评价12批双黄连胶囊质量。结果依据N-FP,用SQFP鉴别出12批次SHLCs的S1、S2、S4和S12质量很好(2级);S3、S6、S9、S10和S11质量好(3级);S8质量较好(4级),S7质量一般(6级),S5质量劣(8级),除S7外定性相似度都>0.9,只有S5的Pm相差很大,造成评级很大,结果表明11个不同批次的SHLC质量均一性很接近。N-FP能较好地反映SHLCs含量特征、指纹物质均一性及内在总质量变化状况,但忽视小指纹峰对评价的作用。CT-FPs和ST-FPs能拉平大小指纹峰信号而提高宏定性相似度,使宏定量相似度趋向100%,前者更能有效降低大峰掩蔽小峰来突出小指纹峰作用;对>1的乘方指纹图谱能突出大峰权重而增加大峰掩蔽小峰,当指纹峰信号比较接近时可采用高方次指纹图谱评价模式来实现突出大峰差异化。结论所建立SHLC-HPLC定量指纹图谱可清晰反映SHLC质量差异,开方指纹图谱和>1的乘方指纹图谱能分别增加小峰和差异化突出大峰对相似度贡献,但扭曲定量相似度。本文多维乘方指纹图谱评价模式为色谱指纹图谱评价方法提供了新思路。Objective To establish a 280 nm monitored HPLC fingerprint for Shuanghuanglian capsules （SHLC）, based on the systematically quantified fingerprint method （SQFM）, and to set up the 4 involution evaluation models for chro- matographic fingerprints （CFP）. Methods The CFPs were determined by RP-HPLC to obtain the 44 fingerprint peaks while choosing baicalin （BCL） peaks as the reference peak. The HPLC normal fingerprint （N-FP）, the cubic root fin- gerprint （CT-FP）, square root fingerprint （ST-FP）, 1.5 power of fingerprint （1.5 PFP） and squared fingerprint （S-FP）of SHLCs were thoroughly developed and all assessed by SQFM. Results In terms of SQFP, the quality of the 12 bathes of SHLCs was as follows： the quality of S1, S2, S4 and S12 was very good （grade 2）, that of S3, S6, S9, S10 and Sll was good （grade 3）, that of S8 was fine （grade 4）, while that of S7 was common （grade 6） and that of S5 was inferior （grade 8）. The macro qualitative similarity of the 11 batches of SHLCs was more than 0.9 except for that of S7, in which the quality grade of S5 was the largest because of its larger Pro. The assessment indicated that 11 batches of SHLCs had much closer quality grades and the N-FP better reflected the content characteristics, consistency of each fingerprint component and the total quality situation of SHLC; however, the results might have ignored the small fingerprint contribution. CT-FP and ST-FP could level the signals of both the small and big fingerprints to raise the qualitative similarity （Sin） of the samples and made the macro quantitative similarity （Pro） close to 100%, in which the former could further lower the effects of big peaks and uplift that of the small peaks. In involution fingerprints, if the involution value was more than 1, the weight ofbig peaks might be enhanced to lead the heavily masking effect of big peaks to small peaks, so the high involution finger- prints could protrude the difference resulting from the big peaks when all fi

关 键 词：双黄连胶囊 高效液相色谱定量指纹图谱 系统指纹定量法 开立方指纹图谱 开平方指纹图谱 1 5次方指纹图谱 平方指纹图谱 

分 类 号：O657.7[理学—分析化学] R284[理学—化学]