藿香正气制剂中和厚朴酚及总多糖快速测定分析
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摘要
目的建立HPLC双波长指纹图谱快速测定藿香正气制剂中和厚朴酚含量的方法,建立糖量计法快速测定其总多糖含量的方法,并分析其差异性。方法 HPLC采用XB-C18(HS)色谱柱(4.6 mm×250 mm,5μm),乙腈和0.1%磷酸水溶液等度洗脱,流速1.0 mL/min,进样量20μL,检测波长294、270 nm,柱温30℃;糖量计法以50%乙醇为阴性对照;聚类分析重复性样品,对比不同指标间的聚类结果。结果 HPLC测得和厚朴酚在1.40～0.14 mg/mL范围内与峰面积线性关系良好,线性方程为A=12182633C-217418,r~2=0.9995;藿香正气水中和厚朴酚浓度为(0.4008±0.0050)mg/mL,藿香正气滴丸中其浓度为(0.4879±0.0089)mg/mL。总多糖在0.91～0.29 g/mL范围内与其百分值线性关系良好,线性方程为Y=51.949X+0.868,r~2=0.9999;藿香正气水中总多糖浓度为(0.31±0.003)g/mL,藿香正气滴丸中其浓度为(1.12±0.005)g/mL。聚类分析筛选出和厚朴酚峰面积和总多糖百分值作为表现藿香正气水和藿香正气滴丸间差异的指标。结论本研究建立的HPLC及糖量计法能有效用于藿香正气制剂多类指标的质量控制及不同剂型间的差异考察;聚类分析筛选出的峰面积和总多糖百分值作为评价指标具有代表性和准确性。
Objective To establish a method for rapid determination of honokiol in Huoxiang Zhengqi Preparations by HPLC dual-wavelength fingerprint, and to establish a sugar meter for rapid determination of total polysaccharide in Huoxiang Zhengqi Preparations, and to analyze its differences. Methods HPLC was performed on an XB-C18(HS) column(4.6 mm × 250 mm, 5 μm), with acetonitrile and 0.1% phosphoric acid aqueous solution for isocratic elution. The flow rate was 1.0 mL/min; the injection volume was 20 μL; the detection wavelength was 294 and 270 nm; the column temperature was 30 ℃. Sugar meter method was performed with 50% ethanol as negative control. Cluster analysis was conducted to analyze repeated samples and comparison of clustering results among different indexes. Results The linear relationship between the concentration of honokiol and the peak area in the range of 1.40–0.14 mg/mL was good by HPLC. The linear equation was A=12182633C-217418, r~2=0.9995. The concentration of honokiol in Huoxiang Zhengqi Liquid was(0.4008±0.0050)mg/mL; the concentration of honokiol in Huoxiang Zhengqi Dropping Pills was(0.4879±0.0089)mg/mL. The linear relationship between the concentration of total polysaccharide and its percentage was good in the range of 0.91–0.29 g/mL; the linear equation was Y=51.949X+0.868, r~2=0.9999. The concentration of total polysaccharide in Huoxiang Zhengqi Liquid was(0.31±0.003)g/mL; the total polysaccharide in Huoxiang Zhengqi Dropping Pills was(1.12±0.005)g/mL. The area of honokiol peak and the percentage of total polysaccharide as indicators of Huoxiang Zhengqi Liquid and Huoxiang Zhengqi Dropping Pills showed significant differences between different formulations. Conclusion Established HPLC and sugar meter method can be effectively used for the quality control and investigation of differences between different dosage forms of Huoxiang Zhengqi Preparations; the selected peak area and total polysaccharide percentage as the evaluation index are representative and accurate.
Objective To establish a method for rapid determination of honokiol in Huoxiang Zhengqi Preparations by HPLC dual-wavelength fingerprint, and to establish a sugar meter for rapid determination of total polysaccharide in Huoxiang Zhengqi Preparations, and to analyze its differences. Methods HPLC was performed on an XB-C18(HS) column(4.6 mm × 250 mm, 5 μm), with acetonitrile and 0.1% phosphoric acid aqueous solution for isocratic elution. The flow rate was 1.0 mL/min; the injection volume was 20 μL; the detection wavelength was 294 and 270 nm; the column temperature was 30 ℃. Sugar meter method was performed with 50% ethanol as negative control. Cluster analysis was conducted to analyze repeated samples and comparison of clustering results among different indexes. Results The linear relationship between the concentration of honokiol and the peak area in the range of 1.40–0.14 mg/mL was good by HPLC. The linear equation was A=12182633C-217418, r~2=0.9995. The concentration of honokiol in Huoxiang Zhengqi Liquid was(0.4008±0.0050)mg/mL; the concentration of honokiol in Huoxiang Zhengqi Dropping Pills was(0.4879±0.0089)mg/mL. The linear relationship between the concentration of total polysaccharide and its percentage was good in the range of 0.91–0.29 g/mL; the linear equation was Y=51.949X+0.868, r~2=0.9999. The concentration of total polysaccharide in Huoxiang Zhengqi Liquid was(0.31±0.003)g/mL; the total polysaccharide in Huoxiang Zhengqi Dropping Pills was(1.12±0.005)g/mL. The area of honokiol peak and the percentage of total polysaccharide as indicators of Huoxiang Zhengqi Liquid and Huoxiang Zhengqi Dropping Pills showed significant differences between different formulations. Conclusion Established HPLC and sugar meter method can be effectively used for the quality control and investigation of differences between different dosage forms of Huoxiang Zhengqi Preparations; the selected peak area and total polysaccharide percentage as the evaluation index are representative and accurate.
引文
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[9]朱俊平,李龙,曾燕,等.野生与种植黄连不同部位蛋白质分析与评价[J].中国中医药信息杂志,2018,25(9):61-65.
[2]赵宏杰,郭利平,杨丰文,等.藿香正气方治疗胃肠型感冒有效性和安全性系统评价[J].中国中药杂志,2017,42(8):1495-1499.
[3]王姣,罗廷顺,孙钢,等.HPLC法同时测定藿香正气系列制剂中6种成分的含量[J].中国药师,2017,20(10):1741-1744.
[4]贺军成.因人制宜选用藿香正气类药物[N].中国中医药报,2012-07-04(005).
[5]黄雍,胡楚琦,李玉星,等.藿香正气方不同组方及剂型的临床应用[J].中国医药导刊,2017,19(12):1385-1388.
[6]张永志,佟玲,李东翔,等.藿香正气滴丸UFLC指纹图谱研究[J].中草药,2015,46(15):2246-2250.
[7]曹霞.藿香正气以“水”为先[N].卫生与生活报,2007-07-02(14).
[8]鲁劲松,王红芬,李云霞.藿香正气水中陈皮渗漉工艺的优化[J].中草药,2014,45(8):1096-1101.
[9]朱俊平,李龙,曾燕,等.野生与种植黄连不同部位蛋白质分析与评价[J].中国中医药信息杂志,2018,25(9):61-65.
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