世界中医药

作者	单位
王燕鸽1，张志琴2，郭富礼1，贺卫国1	1 鹤壁煤业(集团)有限责任公司总医院药剂科,鹤壁,458000； 2 鹤壁市人民医院药学部,鹤壁,458030

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中文摘要:

目的:基于多指标成分定量评价分析复方鱼腥草胶囊,为复方鱼腥草胶囊的质量控制提供参考。方法:首先制备复方鱼腥草胶囊供试品溶液及槲皮苷、表告依春、绿原酸、连翘苷、黄芩苷对照品溶液,色谱条件采用CAPCELL-PAK-MG-C18色谱柱(5 μm,规格:4.6 mm×250 mm),柱温以35 ℃为宜,进样量为10 μL,流速为1.0 mL/min进行高效液相色谱(HPLC)检测,以流动相A(乙腈)和流动相B(水+0.01%磷酸)为条件进行梯度洗脱,优化高效液相(HPLC)的方法学严谨性,进行线性回归、精密度、重复性、稳定性、专属性试验和加样回收率试验,多指标成分定量分析样品中槲皮苷、表告依春、绿原酸、连翘苷和黄芩苷的含量。结果:1)采用HPLC色谱法对复方鱼腥草胶囊中鱼腥草、板蓝根、金银花、连翘、黄芩等进行专属性试验,结果显示复方鱼腥草胶囊中鱼腥草、板蓝根、金银花、连翘、黄芩专属性良好。2)线性范围考察结果显示槲皮苷对照品、连翘苷对照品、绿原酸对照品在4~201 μg/mL范围内、表告依春对照品、黄芩苷对照品在12~601 μg/mL范围内的线性关系均良好。3)精密度试验结果显示槲皮苷、连翘苷、绿原酸、表告依春对照品、黄芩苷峰面积相对标准偏差(RSD)分别是0.45%、0.52%、0.66%、0.59%、0.31%,结果表明此色谱条件下的HPLC仪器精密度良好。4)稳定性试验结果显示复方鱼腥草胶囊供试品溶液相对峰面积RSD是1.33%,表明24 h内复方鱼腥草胶囊供试品溶液基本稳定。5)重复性试验结果显示复方鱼腥草胶囊供试品溶液相对峰面积RSD为0.92%,表明该HPLC方法的重复性良好。6)结果显示槲皮苷、表告依春、绿原酸、连翘苷和黄芩苷的平均回收率分别为99.10%、99.26%、99.07%、98.05%、98.82%、98.32%,RSD为1.81%、1.49%、0.94%、1.58%、1.01%,表明回收率较好。7)基于多指标成分定量测定结果显示不同厂家不同批次的复方鱼腥草胶囊中有效成分槲皮苷、表告依春、绿原酸、连翘苷和黄芩苷的含量存在较大差异。结论:基于多指标成分定量测定结果显示不同厂家不同批次的复方鱼腥草胶囊中有效成分槲皮苷、表告依春、绿原酸、连翘苷和黄芩苷的含量存在较大差异。

English Summary:

Based on the quantitative evaluation and analysis of compound Houttuynia cordata capsule based on multi-index components,it provides a reference for the quality control of compound Houttuynia cordata capsule.Methods:First,the compound Houttuynia capsule sample solution and quercetin were prepared,including Yichun,chlorogenic acid,forsythrin,baicalin reference solution,The chromatographic conditions were determined by high performance liquid chromatography(HPLC) with CAPCELL-PAK-MG-C18 column (5 μm, specification: 4.6 mm × 250 mm),column temperature 35 ℃,injection volume 10 μL,flow rate 1.0 mL/min). Gradient eluting was carried out under the conditions of mobile phase A (acetonitrile) and mobile phase B (water 0.01% phosphate).Optimize the methodological rigour of high performance liquid phase (HPLC),carry out linear regression, precision, reproducibility,stability,specificity test and sample recovery test,quantitative analysis of quercetin in samples with multiple index components,Quercetin, chlorogenic acid,The contents of phillyrin and baicalin.Results:1)the specific tests of Houttuynia cordata, Radix Isatidis, Flos Lonicerae, Forsythia suspensa and Scutellaria baicalensis were carried out by HPLC chromatography. the results showed that Houttuynia cordata, Radix Isatidis, Flos Lonicerae and Forsythia suspensa were found in the compound Houttuynia cordata capsule. Scutellaria baicalensis Georgi has a good specificity.2) the linear range of quercetin, phillyrin and chlorogenic acid were within the range of 4≤201 μg/mL, and the linear range of baicalin and baicalin were 12 μg/mL and 601 μg/mL, respectively. the linear range of quercetin, phillyrin and chlorogenic acid was 4≤201 μg/mL.3) the results of precision test showed that the relative standard deviation (RSD) of quercetin, phillyrin, chlorogenic acid and baicalin peak area were 0.45%, 0.52%, 0.66%, 0.59%, 0.31%, 0.51%, 0.52%, 0.56%, 0.59%, 0.31%, 0.52%, 0.62%, 0.59% and 0.31%, respectively. The results show that the precision of HPLC instrument under this chromatographic condition is good.4) The results of stability test showed that the relative peak area RSD of compound Houttuynia capsule solution was 1.33%, which indicated that the solution of compound Houttuynia capsule was basically stable within 24 hours.5) The results of reproducibility test showed that the relative peak area RSD of compound Houttuynia capsule solution was 0.92%, which indicated that the HPLC method had good reproducibility.6) The results showed that the average recovery of quercetin, eichun, chlorogenic acid, phillyrin and baicalin were 99.10%, 99.26%, 99.07%, 98.05%, 98.82%, 98.32%, 1.81% and 1.49%, respectively. 0.94%, 1.58%, 1.01%, indicating that the recovery is good.7)The results of quantitative determination based on multi-index components showed that the contents of quercetin, chlorogenic acid, phillyrin and baicalin in different batches of compound Houttuynia cordata Thunb capsules from different manufacturers were quite different.Conclusion:The results of quantitative determination based on multi-index components showed that the contents of quercetin, chlorogenic acid, phillyrin and baicalin in different batches of compound Houttuynia cordata Thunb capsules from different manufacturers were quite different.

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