世界中医药

作者	单位
邵琼1，张莹2，王艳梅1，严敢意1	1 湖北省鄂州市中心医院中草药房,鄂州,436000 2 湖北省鄂州市中心医院重症医学科,鄂州,436000

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中文摘要:

目的:采用高效液相色谱法对小青龙颗粒进行组方特点的研究,观察其组方是否具有预测小青龙颗粒制剂质量水平的特点。方法:首先制备小青龙颗粒供试品溶液、4种组方药材供试品溶液并优化色谱条件:进样量为2 μL,研究中选用250 mm×4.6 mm的C18色谱柱,柱温为35 ℃,而流动相A为0.1%磷酸水+0.02%庚烷磺酸钠;流动相B为82乙腈:10无水乙醇:8(水+0.24%磷酸),检测波长为220 nm。接着从考察精密度、重复性、稳定性、专属性、加样回收率等5个维度对HPLC的方法严谨性进行研究;最后建立小青龙颗粒的指纹图谱,并结合组方模式预测小青龙颗粒质量水平的特点。结果:1)精密度研究结果显示共有峰相对保留时间RSD为0.08%,重复性研究结果显示共有峰相对保留时间RSD为0.3%,稳定性结果显示共有峰相对保留时间RSD为0.4%,表明高效液相色谱仪具有良好的精密度、重复性和稳定性;2)专属性结果显示小青龙颗粒各味药物在相对保留时间内各个峰之间不存在杂质峰,具有良好的专属性;3)加样回收结果显示平均回收率的范围是96.52%～104.73%,RSD的范围是为0.67%～2.14%,表明高效液相色谱方法具有良好的准确度;4)22批小青龙颗粒供试品溶液指纹图谱共有40个共有峰,其中S13、S14、S19和S21等4个批次的小青龙颗粒质量相对较次;5)组方色谱中组方全相加模式比组方最大化模式质量较低;单位质量药物色谱中全相加模式比最大化模式质量等级低;组方色谱预测能力和单位质量药物色谱的预测能力相当,差异无统计学意义(P>0.05),进而从CMF和PMF的平均值2与RFP比较发现,2组间差异无统计学意义(P>0.05)。结论:可通过高效液相色谱检测方法对单位药物指纹图谱的分析预测小青龙颗粒制剂质量水平的组方特点。

English Summary:

To study the characteristics of Xiaoqinglong Granules by HPLC and to observe whether the formula has the characteristics of predicting the quality level of Xiaoqinglong Granules.Methods:First,prepare Xiaoqinglong Granules,and four kinds of medicinal materials for test solution and optimize chromatographic conditions.The injection volume was 2 uL.In the study,a C18 column of 250×4.6 mm was used,and the column temperature was 35 degrees Celsius,and the mobile phase A was 0.1% phosphoric acid water+0.02% sodium heptane sulfonate; the mobile phase B was 82 acetonitrile:10 Anhydrous ethanol:8 (water+0.24% phosphoric acid),and detection wavelength was 220 nm.Then,from the 5 dimensions of precision,repeatability,stability,specificity and sample recovery rate,we studied the rigor of HPLC.Finally,we established the fingerprints of Xiaoqinglong Granules and combined with the prescription mode to predict the quality level of Xiaoqinglong Granules.Results:1) The results of the precision study showed that the RSD of the shared peak relative retention time was 0.08%.The reproducibility study showed that the shared peak relative retention time RSD was 0.3%.The stability results showed that the shared peak relative retention time RSD was 0.4%,indicating HPLC has good precision,repeatability and stability.2) The results of specificity showed that there were no impurity peaks between the peaks of Xiaoqinglong Granules in the relative retention time,which indicated good specificity of Xiaoqinglong Granules.3) The results of sample recovery showed that the average recovery rate was 96.52%～104.73%,and the range of RSD was 0.67%～2.14%,indicating that the HPLC method had good accuracy.4) there were 40 common peaks in the 22 batches of Xiaoqinglong Granules,including 4 common batches of S13,S14,S19 and S21.5) The total additive pattern of group composition was lower than that of group maximization mode; the total additive mode in unit mass chromatography was lower than that in maximization mode; the prediction ability of the column chromatography and the quality of the unit chromatography were comparable,and there was no significantly statistical difference (P>0.05); and then from the comparison of the average value of CMF and PMF with 2 RFP,the difference between the two groups was very small (P>0.05).Conclusion:The quality level of Xiaoqinglong Granules preparation can be predicted by high performance liquid chromatography (HPLC).

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