基于制剂中多种内参物的一测多评法测定双香消食化积胶囊中5种成分的含量

Content determination of the 5 components in the preparation of Shuangxiang Xiaoshi Huaji Capsules quantitative analysis of multi-components by single-marker based on multiple internal reference substances

目的建立基于制剂中多种内参物的一测多评法(quantitative analysis of multi-components by single-marker,QAMS)以测定双香消食化积胶囊中5种成分的含量。方法色谱柱为Agilent Eclipse plus C18(250 mm×4.6 mm,5μm),流动相为乙腈-体积分数0.05%磷酸溶液(梯度洗脱),流速为1.0 mL·min^(−1),柱温为30℃,检测波长为283 nm。分别以芸香柚皮苷、柚皮苷、橙皮苷、和厚朴酚、厚朴酚为内参物,采用QAMS建立另外4个待测成分与内参物的相对校正因子,计算7批双香消食化积胶囊样品中5个成分的含量,并与用外标法(external standard method,ESM)测定的结果进行比较。结果用QAMS测得7批双香消食化积胶囊样品中芸香柚皮苷、柚皮苷、橙皮苷、和厚朴酚、厚朴酚的含量分别为1.353~1.845、5.865~6.417、8.150~9.539、1.088~1.241、3.321~4.455 mg·g^(−1),ESM测定结果分别为1.345~1.840、5.882~6.435、8.167~9.563、1.093~1.247、3.312~4.433 mg·g^(−1),用2种方法得到的结果的差异百分比≤1.00%,并通过统计比较ESM和QAMS测出的2组数据Pearson相关系数相似度较高,差异无统计学意义(P>0.05)。结论建立了基于制剂中多种内参物同时测定双香消食化积胶囊中5种成分含量的QAMS。该方法与ESM所得结果无明显差异,可用于双香消食化积胶囊的质量控制。

Objective To establish a determination method of the 5 components in the preparation of Shuangxiang Xiaoshi Huaji Capsules by quantitative analysis of multi-components by single-marker(QAMS)method based on multiple internal reference substances.Methods The chromatographic column was Agilent Eclipse plus C18(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.05%phosphoric acid(gradient elution),the flow rate was 1.0 mL·min^(−1),the column temperature was 30°C,and the detection wavelength was 283 nm.With narirutin,naringin,hesperidin,honokiol and magnolol as internal reference substances,the relative correction factors of the other 4 components were tested and the internal reference substances were established by using QAMS.Then,the contents of the 5 components in 7 batches of Shuangxiang Xiaoshi Huaji Capsules were calculated and compared with the results of external standard method(ESM).Results The contents of narirutin,naringin,hesperidin,honokiol and magnolol in the 7 batches of Shuangxiang Xiaoshi Huaji Capsules determined by QAMS were 1.353—1.845,5.865—6.417,8.150—9.539,1.088—1.241 and 3.321—4.455 mg·g^(−1),respectively.The results determined by ESM were 1.345—1.840,5.882—6.435,8.167—9.563,1.093—1.247 and 3.312—4.433 mg·g^(−1),respectively.The difference percentage of the results measured by the 2 methods was less than 1.00%,and the results obtained by the ESM method and QAMS method were statistically compared.The Pearson correlation coefficient similarity between the 2 sets of data was high,and there was no significant difference in the results.Conclusion A quantitative analysis of multi-components by QAMS method was established for the simultaneous determination of five components in Shuangxiang Xiaoshi Huaji Capsules based on multiple internal reference substances in the preparation.There was no significant difference between the results obtained by this method and the ESM.The method can be used for the quality control of Shuangxiang Xiaoshi Huaji Capsules.