目的:建立泽泻药材及其配方颗粒的HPLC指纹图谱。方法:色谱柱为ACQUITY HPLC BEH C18(2.1 mm × 100 mm, 1.7 μm),流动相为0.05%磷酸水溶液–乙腈,梯度洗脱,流速为0.1 mL/min;检测波长为210 nm;柱温为30℃;进样量为2 μL。建立泽泻及其配方颗粒指纹图谱,并采用中药色谱指纹图谱评价系统进行相似度分析。结果:20批泽泻药材及其配方颗粒的HPLC指纹图谱共确认13个共有峰,泽泻药材及配方颗粒指纹图谱相似度在0.502~0.989之间,两者化学成分存在一定差异。结论:建立了稳定、可行的泽泻药材及配方颗粒指纹图谱,可为泽泻药材及其配方颗粒质量与评价提供参考依据。 Objective: To establish HPLC fingerprint of Alisma plantago-aquatica Linn. and its formula granules. Methods: The chromatography was performed on ACQUITY HPLC BEH C18 (2.1 mm × 100 mm, 1.7 μm) column with mobile phase consisting of 0.05% phosphoric acid aqueous solution acetonitrile and gradient elution at the flow rate of 0.1 mL/min. The detection wavelength was 210 nm. The column temperature was 30˚C. The sample size was 2 μL. The fingerprint of Alisma plantago-aquatica Linn. and its formula granules was established, and the similarity analysis was carried out by the TCM chromatographic fingerprint evaluation system. Results: A total of 13 common peaks were identified by HPLC fingerprints of 20 batches of Alisma plantago-aquatica Linn. and its formula granules. The similarity of fingerprints of Alisma plantago-aquatica Linn. and formula granules ranged from 0.502 to 0.989, and there were certain differences in chemical components between them. Conclusion: A stable and feasible fingerprint of Alisma plant a go-aquatica Linn. and its formula granules was established, which can provide reference for the quality and evaluation of Alisma plantago-aquatica Linn. and its formula granules.
目的:建立泽泻药材及其配方颗粒的HPLC指纹图谱。方法:色谱柱为ACQUITY HPLC BEH C18(2.1 mm × 100 mm, 1.7 μm),流动相为0.05%磷酸水溶液–乙腈,梯度洗脱,流速为0.1 mL/min;检测波长为210 nm;柱温为30℃;进样量为2 μL。建立泽泻及其配方颗粒指纹图谱,并采用中药色谱指纹图谱评价系统进行相似度分析。结果:20批泽泻药材及其配方颗粒的HPLC指纹图谱共确认13个共有峰,泽泻药材及配方颗粒指纹图谱相似度在0.502~0.989之间,两者化学成分存在一定差异。结论:建立了稳定、可行的泽泻药材及配方颗粒指纹图谱,可为泽泻药材及其配方颗粒质量与评价提供参考依据。
泽泻,HPLC指纹图谱,配方颗粒
Yulan Liao1, Xiaosong Yang1, Xiangpei Wang2, Hongmei Wu1*
1School of Pharmacy, Guizhou University of Traditional Chinese Medicine, Guiyang Guizhou
2School of Chinese Ethnic Medicine, Guizhou Minzu University, Guiyang Guizhou
Received: Apr. 25th, 2024; accepted: May 23rd, 2024; published: May 30th, 2024
Objective: To establish HPLC fingerprint of Alisma plantago-aquatica Linn. and its formula granules. Methods: The chromatography was performed on ACQUITY HPLC BEH C18 (2.1 mm × 100 mm, 1.7 μm) column with mobile phase consisting of 0.05% phosphoric acid aqueous solution acetonitrile and gradient elution at the flow rate of 0.1 mL/min. The detection wavelength was 210 nm. The column temperature was 30˚C. The sample size was 2 μL. The fingerprint of Alisma plantago-aquatica Linn. and its formula granules was established, and the similarity analysis was carried out by the TCM chromatographic fingerprint evaluation system. Results: A total of 13 common peaks were identified by HPLC fingerprints of 20 batches of Alisma plantago-aquatica Linn. and its formula granules. The similarity of fingerprints of Alisma plantago-aquatica Linn. and formula granules ranged from 0.502 to 0.989, and there were certain differences in chemical components between them. Conclusion: A stable and feasible fingerprint of Alisma plantago-aquatica Linn. and its formula granules was established, which can provide reference for the quality and evaluation of Alisma plantago-aquatica Linn. and its formula granules.
Keywords:Alisma plantago-aquatica Linn., HPLC Fingerprint, Formula Granule
Copyright © 2024 by author(s) and beplay安卓登录
This work is licensed under the Creative Commons Attribution International License (CC BY 4.0).
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泽泻为泽泻科植物泽泻Alisma plantago-aquatica Linn.的干燥块茎,主产于福建和四川等地 [
ACQUITY HPLC(美国Waters公司);AL204-IC/万分之一分析天平(METTLE RTOLEDO仪器有限公司);KQ-100E型超声波清洗器(昆山市超声仪器有限公司)。
甲醇,乙腈为色谱纯(默克股份两合公司,德国),磷酸(国药集团化学试剂有限公司),水为哇哈哈纯净水(贵州娃哈哈集团有限公司),其余试剂均为分析纯。
10批泽泻药材经贵州民族大学民族医药学院王祥培教授鉴定,均为泽泻科植物泽泻Alisma plantago-aquatica Linn.的干燥块茎,20批泽泻药材及其配方颗粒均来源于广东一方制药有限公司,样品来源见表1。
NO | 类型 | 批号 | NO | 类型 | 来源 |
---|---|---|---|---|---|
S1 | 药材 | J2019010305-01 | S11 | 配方颗粒 | 广东一方制药有限公司 |
S2 | 药材 | J2019020101-01 | S12 | 配方颗粒 | 广东一方制药有限公司 |
S3 | 药材 | J2019020102-01 | S13 | 配方颗粒 | 广东一方制药有限公司 |
S4 | 药材 | J2019020101-02 | S14 | 配方颗粒 | 广东一方制药有限公司 |
S5 | 药材 | J2019020103-01 | S15 | 配方颗粒 | 广东一方制药有限公司 |
S6 | 药材 | J2019010304-01 | S16 | 配方颗粒 | 广东一方制药有限公司 |
S7 | 药材 | J2019020104-01 | S17 | 配方颗粒 | 广东一方制药有限公司 |
S8 | 药材 | J2018100303-01 | S18 | 配方颗粒 | 广东一方制药有限公司 |
S9 | 药材 | J2018100301-01 | S19 | 配方颗粒 | 广东一方制药有限公司 |
S10 | 药材 | J20181000302-01 | S20 | 配方颗粒 | 广东一方制药有限公司 |
表1. 泽泻药材及配方颗粒的来源
ACQUITY HPLC BEH C18(2.1 mm × 100 mm,1.7 μm)色谱柱;流速0.1 mL∙min−1;检测波长210 nm;柱温30℃;进样量2 μL;流动相0.05%磷酸水溶液(A)-乙腈(C),梯度洗脱程序见表2。
时间(t) | 0.05%磷酸水(A) | 乙腈(C) |
---|---|---|
0 | 95 | 5 |
5 | 90 | 10 |
15 | 85 | 15 |
20 | 65 | 35 |
30 | 45 | 55 |
35 | 30 | 70 |
40 | 25 | 75 |
65 | 25 | 75 |
表2. 流动相梯度洗脱程序
取10批泽泻药材,粉碎,过4号筛,各取约1 g,精密称定,置锥瓶中,加甲醇25 mL,称定重量,超声提取(功率250 W,频率35 kHz) 45 min,放冷,加甲醇补足减失的重量,摇匀,过滤,取续滤液经0.45 μm微孔滤膜滤过,即得泽泻药材供试品溶液;取10批泽泻配方颗粒,研细,各取约1.0 g,精密称定,置25 mL量瓶中,按药材供试品溶液制备方法制备泽泻配方颗粒供试品溶液。
取同一批次泽泻药材样品,按“3.2.”项下方法制备供试品,按“3.1.”项下色谱方法连续进样6次,并记录各共有峰的保留时间和峰面积,计算各共有峰的相对保留时间和相对峰面积的RSD均小于3.0%,表明仪器精密度良好。
取同一批次泽泻药材样品,按“3.2.”项下方法制备供试品,按“3.1.”项下色谱方法分别于0,2,4,8,12和24 h进样测定,并记录各共有峰的保留时间和峰面积,计算各共有峰的相对保留时间和相对峰面积的RSD均小于3.0%,表明样品溶液在24 h内稳定。
取同一批次泽泻药材样品6份,按“3.2.”项下方法平行制备供试品溶液6份,按“3.1.”项下色谱方法分别进样,并记录各共有峰的保留时间和峰面积,计算各共有峰的相对保留时间和相对峰面积的RSD均小于3.0%,表明该方法重复性良好。
指纹图谱的建立,按“3.2.”项下的方法制备分析样品,按“3.1.”项下的色谱条件分别对10批泽泻药材、10批泽泻配方颗粒进行测定,得到各批次样品HPLC色谱图,分别导入中药指纹图谱相似度评价系统(2004A),得到泽泻药材、泽泻配方颗粒、泽泻药材及配方颗粒色谱指纹图谱及对照色谱指纹图谱(见图1~6)。
图1. 10批泽泻药材HPLC指纹图谱
图2. 10批泽泻配方颗粒HPLC指纹图谱
图3. 20批泽泻药材及配方颗粒HPLC指纹图谱
图4. 泽泻药材HPLC对照图谱
图5. 泽泻配方颗粒HPLC对照图谱
图6. 泽泻药材与配方颗粒HPLC对照图谱
建立的泽泻药材及其配方颗粒的指纹图谱中,10批泽泻药材确定19个共有色谱峰,10批泽泻配方颗粒确定13个共有色谱峰,10批泽泻药材与10批配方颗粒确定13个共有峰。计算各共有峰的相对保留时间与相对峰面积,见表3、表4。
采用《中药色谱指纹图谱相似度评价系统软件》(2004版),以生成的对照谱图为参照,各批次供试品指纹图谱与对照谱图进行比较,分别计算10批药材、10批配方颗粒、10批药材及10批配方颗粒的相似度。S1~S10为泽泻药材、S11~S20为泽泻配方颗粒。结果见表5、表6。
共有峰 | S1 | S2 | S3 | S4 | S5 | S6 | S7 | S8 | S9 | S10 | S11 | S12 | S13 | S14 | S15 | S16 | S17 | S18 | S19 | S20 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | 0.1382 | 0.1384 | 0.1384 | 0.1391 | 0.1387 | 0.1382 | 0.1384 | 0.1386 | 0.1388 | 0.1382 | 0.0038 | 0.0038 | 0.0038 | 0.0038 | 0.0038 | 0.0038 | 0.0038 | 0.0038 | 0.0038 | 0.0038 |
2 | 0.1514 | 0.1513 | 0.1515 | 0.1521 | 0.1516 | 0.1513 | 0.1512 | 0.1515 | 0.1518 | 0.1512 | 0.0041 | 0.0041 | 0.0041 | 0.0041 | 0.0041 | 0.0041 | 0.0041 | 0.0041 | 0.0041 | 0.0041 |
3 | 0.1573 | 0.1569 | 0.1575 | 0.1581 | 0.1575 | 0.1572 | 0.1572 | 0.1575 | 0.1579 | 0.1571 | 0.0043 | 0.0043 | 0.0043 | 0.0043 | 0.0043 | 0.0043 | 0.0043 | 0.0043 | 0.0043 | 0.0043 |
4 | 0.1799 | 0.1797 | 0.1800 | 0.1804 | 0.1801 | 0.1799 | 0.1799 | 0.1801 | 0.1804 | 0.1799 | 0.0049 | 0.0049 | 0.0049 | 0.0049 | 0.0049 | 0.0049 | 0.0049 | 0.0049 | 0.0049 | 0.0049 |
5 | 0.2031 | 0.2028 | 0.2032 | 0.2037 | 0.2032 | 0.2031 | 0.2032 | 0.2032 | 0.2036 | 0.2032 | 0.0055 | 0.0055 | 0.0055 | 0.0055 | 0.0055 | 0.0055 | 0.0055 | 0.0055 | 0.0055 | 0.0055 |
6 | 0.2217 | 0.2214 | 0.2218 | 0.2224 | 0.2218 | 0.2216 | 0.2216 | 0.2216 | 0.2221 | 0.2216 | 0.0060 | 0.0060 | 0.0060 | 0.0060 | 0.0060 | 0.0060 | 0.0060 | 0.0060 | 0.0060 | 0.0060 |
7 | 0.2800 | 0.2803 | 0.2813 | 0.2819 | 0.2810 | 0.2807 | 0.2808 | 0.2805 | 0.2813 | 0.2808 | 0.0076 | 0.0076 | 0.0076 | 0.0077 | 0.0076 | 0.0076 | 0.0076 | 0.0076 | 0.0076 | 0.0076 |
8 | 0.2864 | 0.2867 | 0.2877 | 0.2885 | 0.2874 | 0.2871 | 0.2880 | 0.2868 | 0.2876 | 0.2872 | 0.0078 | 0.0078 | 0.0078 | 0.0078 | 0.0078 | 0.0078 | 0.0078 | 0.0078 | 0.0078 | 0.0078 |
9 | 0.3406 | 0.3404 | 0.3414 | 0.3421 | 0.3410 | 0.3409 | 0.3400 | 0.3407 | 0.3415 | 0.3408 | 0.0093 | 0.0093 | 0.0093 | 0.0093 | 0.0093 | 0.0093 | 0.0092 | 0.0093 | 0.0093 | 0.0093 |
10 | 0.9533 | 0.9541 | 0.9541 | 0.9541 | 0.9541 | 0.9527 | 0.9542 | 0.9531 | 0.9528 | 0.9530 | - | - | - | - | - | - | - | - | - | - |
11 | 0.9746 | 0.9754 | 0.9752 | 0.9753 | 0.9744 | 0.9744 | 0.9751 | 0.9741 | 0.9741 | 0.9742 | - | - | - | - | - | - | - | - | - | - |
12 (S) | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 |
13 | 1.0231 | 1.0234 | 1.0235 | 1.0234 | 1.0230 | 1.0233 | 1.0234 | 1.0234 | 1.0233 | 1.0233 | - | - | - | - | - | - | - | - | - | - |
14 | 1.0330 | 1.0332 | 1.0332 | 1.0332 | 1.0331 | 1.0331 | 1.0331 | 1.0333 | 1.0332 | 1.0332 | - | - | - | - | - | - | - | - | - | - |
15 | 1.0516 | 1.0518 | 1.0518 | 1.0516 | 1.0518 | 1.0516 | 1.0517 | 1.0518 | 1.0517 | 1.0516 | - | - | - | - | - | - | - | - | - | - |
16 | 1.0846 | 1.0858 | 1.0858 | 1.0854 | 1.0852 | 1.0847 | 1.0848 | 1.0846 | 1.0848 | 1.0847 | 0.0295 | 0.0295 | 0.0295 | 0.0295 | 0.0295 | 0.0295 | 0.0295 | 0.0295 | 0.0295 | 0.0295 |
17 | 1.1691 | 1.1691 | 1.1689 | 1.1688 | 1.1688 | 1.1690 | 1.1689 | 1.1692 | 1.1690 | 1.1690 | - | - | - | - | - | - | - | - | - | - |
18 | 1.2593 | 1.2594 | 1.2589 | 1.2589 | 1.2589 | 1.2587 | 1.2589 | 1.2589 | 1.2587 | 1.2589 | 0.0342 | 0.0342 | 0.0342 | 0.0342 | 0.0342 | 0.0342 | 0.0342 | 0.0342 | 0.0342 | 0.0342 |
19 | 1.4365 | 1.4364 | 1.4354 | 1.4358 | 1.4356 | 1.4352 | 1.4350 | 1.4353 | 1.4349 | 1.4354 | 0.0390 | 0.0391 | 0.0390 | 0.0390 | 0.0390 | 0.0390 | 0.0390 | 0.0390 | 0.0390 | 0.0390 |
表3. 20批泽泻药材及配方颗粒HPLC指纹图谱共有峰的相对保留时间
共有峰 | S1 | S2 | S3 | S4 | S5 | S6 | S7 | S8 | S9 | S10 | S11 | S12 | S13 | S1 | S15 | S16 | S17 | S18 | S19 | S20 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | 0.0213 | 0.0175 | 0.0134 | 0.0192 | 0.0286 | 0.0183 | 0.0166 | 0.0371 | 0.0258 | 0.0184 | 0.1580 | 0.1634 | 0.1695 | 0.1403 | 0.1133 | 0.1402 | 0.1473 | 0.1212 | 0.1126 | 0.1764 |
2 | 0.0161 | 0.0107 | 0.0124 | 0.0122 | 0.0103 | 0.0155 | 0.0110 | 0.0519 | 0.0108 | 0.0099 | 0.1064 | 0.1092 | 0.1130 | 0.0936 | 0.0762 | 0.0935 | 0.0983 | 0.1188 | 0.1118 | 0.1209 |
3 | 0.0151 | 0.0116 | 0.0112 | 0.0073 | 0.0115 | 0.0063 | 0.0120 | 0.0141 | 0.0116 | 0.0087 | 0.1756 | 0.1917 | 0.1970 | 0.1624 | 0.1339 | 0.1587 | 0.1722 | 0.1424 | 0.1335 | 0.2055 |
4 | 0.0342 | 0.0221 | 0.0181 | 0.0163 | 0.0169 | 0.0111 | 0.0329 | 0.0594 | 0.0420 | 0.0133 | 0.4767 | 0.4828 | 0.4963 | 0.4188 | 0.3363 | 0.4178 | 0.4388 | 0.3626 | 0.3405 | 0.5242 |
5 | 0.0249 | 0.0228 | 0.0117 | 0.0154 | 0.0124 | 0.0120 | 0.0260 | 0.0562 | 0.0135 | 0.0087 | 0.2004 | 0.2152 | 0.2232 | 0.1839 | 0.1508 | 0.1765 | 0.1929 | 0.1598 | 0.1483 | 0.2269 |
6 | 0.0495 | 0.0333 | 0.0525 | 0.0332 | 0.0238 | 0.0444 | 0.0334 | 0.1484 | 0.0313 | 0.0353 | 0.2265 | 0.2453 | 0.2506 | 0.2048 | 0.1667 | 0.1962 | 0.2166 | 0.1779 | 0.1662 | 0.2622 |
7 | 0.0110 | 0.0223 | 0.0222 | 0.0484 | 0.0149 | 0.0316 | 0.0194 | 0.1328 | 0.0132 | 0.0127 | 0.0976 | 0.1185 | 0.1259 | 0.0977 | 0.0812 | 0.0885 | 0.1057 | 0.0877 | 0.0805 | 0.1272 |
8 | 0.0178 | 0.0271 | 0.0189 | 0.0222 | 0.0080 | 0.0275 | 0.0163 | 0.1628 | 0.0080 | 0.0091 | 0.0833 | 0.1080 | 0.1100 | 0.0898 | 0.0745 | 0.0789 | 0.0939 | 0.0787 | 0.0719 | 0.1118 |
9 | 0.0547 | 0.0460 | 0.0544 | 0.0352 | 0.0182 | 0.0610 | 0.0395 | 0.2634 | 0.0201 | 0.0220 | 0.1954 | 0.2401 | 0.2455 | 0.2010 | 0.1607 | 0.1806 | 0.2092 | 0.1719 | 0.1582 | 0.2503 |
10 | 0.0233 | 0.0099 | 0.0068 | 0.0028 | 0.0015 | 0.0036 | 0.0142 | 0.0256 | 0.0013 | 0.0018 | - | - | - | - | - | - | - | - | - | - |
11 | 0.0046 | 0.0032 | 0.0026 | 0.0024 | 0.0080 | 0.0015 | 0.0034 | 0.0231 | 0.0188 | 0.0086 | - | - | - | - | - | - | - | - | - | - |
12 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 | 1.0000 |
13 | 0.0526 | 0.0284 | 0.0314 | 0.0222 | 0.0232 | 0.0235 | 0.0366 | 0.1004 | 0.0296 | 0.0208 | - | - | - | - | - | - | - | - | - | - |
14 | 0.0224 | 0.0233 | 0.0196 | 0.0205 | 0.0287 | 0.0191 | 0.0132 | 0.0515 | 0.0179 | 0.0127 | - | - | - | - | - | - | - | - | - | - |
15 | 0.0309 | 0.0105 | 0.0112 | 0.0046 | 0.0093 | 0.0074 | 0.0162 | 0.0234 | 0.0131 | 0.0083 | - | - | - | - | - | - | - | - | - | - |
16 | 0.0146 | 0.0093 | 0.0185 | 0.0080 | 0.0086 | 0.0066 | 0.0060 | 0.1789 | 0.0142 | 0.0112 | 0.0867 | 0.0897 | 0.0869 | 0.0771 | 0.0611 | 0.0732 | 0.0822 | 0.0660 | 0.0619 | 0.1006 |
17 | 0.1740 | 0.1263 | 0.0922 | 0.0449 | 0.0202 | 0.0436 | 0.1271 | 0.5067 | 0.0222 | 0.0208 | - | - | - | - | - | - | - | - | - | - |
18 | 0.3836 | 0.2572 | 0.1541 | 0.0686 | 0.0126 | 0.0566 | 0.2480 | 2.1285 | 0.0082 | 0.0087 | 0.1039 | 0.1011 | 0.1030 | 0.0832 | 0.0682 | 0.0876 | 0.0888 | 0.0734 | 0.0687 | 0.1094 |
19 | 0.2525 | 0.1494 | 0.1404 | 0.1968 | 0.0966 | 0.1299 | 0.1765 | 1.1875 | 0.0951 | 0.0845 | 0.1013 | 0.1048 | 0.1077 | 0.0874 | 0.0707 | 0.0912 | 0.0923 | 0.0752 | 0.0710 | 0.1139 |
表4. 20批泽泻药材及配方颗粒HPLC指纹图谱共有峰的相对峰面积
泽泻药材 | 相似度 | 泽泻配方颗粒 | 相似度 |
---|---|---|---|
S1 | 0.944 | S11 | 0.994 |
S2 | 0.979 | S12 | 0.998 |
S3 | 0.994 | S13 | 0.997 |
S4 | 0.996 | S14 | 1.000 |
S5 | 0.997 | S15 | 0.991 |
S6 | 0.995 | S16 | 0.997 |
S7 | 0.980 | S17 | 1.000 |
S8 | 0.500 | S18 | 0.994 |
S9 | 0.996 | S19 | 0.990 |
S10 | 0.996 | S20 | 0.996 |
表5. 泽泻药材、泽泻配方颗粒的相似度
泽泻药材 | 相似度 | 泽泻配方颗粒 | 相似度 |
---|---|---|---|
S1 | 0.865 | S11 | 0.954 |
S2 | 0.851 | S12 | 0.950 |
S3 | 0.833 | S13 | 0.946 |
S4 | 0.851 | S14 | 0.970 |
S5 | 0.502 | S15 | 0.988 |
S6 | 0.867 | S16 | 0.974 |
S7 | 0.862 | S17 | 0.965 |
S8 | 0.869 | S18 | 0.983 |
S9 | 0.843 | S19 | 0.989 |
S10 | 0.862 | S20 | 0.942 |
表6. 泽泻药材及配方颗粒的相似度
本文建立的泽泻药材指纹图谱,泽泻配方颗粒指纹图谱,其相似度分别在0.500~0.997、0.990~1.000之间,表明药材间和配方颗粒间其化学成分相关性良好;泽泻药材及配方颗粒指纹图谱相似度在0.502~0.989之间,说明泽泻药材到配方颗粒这一系列制备过程中会有一些化学成分含量发生变化。泽泻药材及配方颗粒指纹图谱中有13个共有峰,表明这13个特征成分在泽泻配方颗粒制备全过程中可以进行追溯。通过对泽泻药材、泽泻配方颗粒的HPLC指纹图谱进行相关性研究,阐明了泽泻药材、泽泻配方颗粒、泽泻药材及其配方颗粒在化学成分上的相关性,3者的指纹图谱特征峰变化较大,说明药材经过提取和浓缩等工艺制成配方颗粒后化学成分会有所改变,因此可以将指纹图谱用于中药配方颗粒全过程监控,可以反映生产过程各环节的量质传递变化规律,从而为泽泻的质量控制提供参考依据。
中药配方颗粒是以传统中药饮片为原料,运用现代技术制成的新型配方用药,具有能够满足临床医师按照病人的症状下药,方便使用和携带,并通过对病人症状的轻重缓急确定剂量的优点。泽泻配方颗粒是由泽泻饮片加工制成,且其现在被广泛应用于临床上,但是泽泻的来源复杂,故对泽泻配方颗粒的质量进行控制是有必要的,而中药指纹图谱的整体性、系统性特征为质量评价提供了新的方法。本研究建立了泽泻药材及其配方颗粒的HPLC指纹图谱,该方法稳定,信息量大,重复性好,操作简单且快速,从整体性和模糊性角度评价泽泻药材及其配方颗粒质量的一致性,以期为泽泻及其配方颗粒的质量控制与临床应用提供参考依据。
本研究得到的贵州省一流课程重点建设项目(项目合同编号:黔教高发[
廖玉兰,杨小松,王祥培,吴红梅. 泽泻及其配方颗粒的HPLC指纹图谱研究Study on HPLC Fingerprint of Alisma plantago-aquatica Linn. and Its Formula Granules[J]. 药物资讯, 2024, 13(03): 261-269. https://doi.org/10.12677/pi.2024.133031