六味地黄复方三种不同剂型之间的组分传递规律研究

The components transitive regularity of three dosage forms of Liuwei Dihuang Fufang

  • 摘要:
    目的本文旨在探讨六味地黄复方(LWDHF)原料粗片(MCS)至配方颗粒(FG)、方汤(FD)、浓缩片(CP)的整体组分传递规律。
    方法处理LWDHF不同剂型提取物后,得到LWDHF的MCS、FG、FD和CP样品。通过使用高效液相色谱(HPLC)建立指纹图谱数据库,使用XB-C18色谱柱分离各组分后,采用总量统计矩法(TQSM)计算各样品的总量零阶矩(AUCT)、总量一阶矩(MRTT)和总量二阶矩(VRTT),基于计算结果分析整体组分的传递规则及其相似性方法。基于LWDHF的FG、FD和CP的HPLC指纹图谱,计算各自的 AUCTMRTT VRTT
    结果LWDHF的FG、FD和CP的AUCT分别为71 804、46 553和144 646 μV·s,MRTT分别为14.43、14.54和18.85 min,VRTT分别为106.98、112.84和269.12 min2。通过比较LWDHF的FG/FD、FG/CP和FD/CP的相似性,得出TQSM相似性值分别为98.66%、76.62%和75.37%,而传统的相似性评估值分别为98.68%、 85.43%和85.60%。
    结论FG和FD的整体组分之间无明显区别,而FD和CP之间存在一定的差异。故六味地黄复方配方颗粒可以作为原料粗片的可替代物在临床应用中使用。

     

    Abstract:
    ObjectiveTo explore the transitive regularity of holistic constituents from the crude slices of the medicinal raw materials (MCS) to the formula granules (FG), fufang decoction (FD), and finally, the concentrated pills (CP) of Liuwei Dihuang Fufang (六味地黄复方, LWDHF).
    MethodsSamples for MCS, FG, FD, and CP of LWDHF were obtained, and a fingerprint database was established using high-performance liquid chromatography (HPLC), by separating the samples in an XB-C18 column and analyzing the transitive regularity of components using the total quantum statistical moment (TQSM), including total quantum zero moment (AUCT), total quantum first moment (MRTT), total quantum second moment (VRTT), and its similarity approach. The AUCT, MRTT, and VRTT were calculated based on the representative HPLC chromatograms of FG, FD, and CP of LWDHF.
    ResultsAUCT of FG, FD, and CP of LWDHF was 71 804, 46 553, and 144 646 µV·s, respectively; MRTT was 14.43, 14.54, and 18.85 min, respectively; and VRTT was 106.98, 112.84, and 269.12 min2, respectively. Comparing the similarity of FG/FD, FG/CP and FD/CP of LWDHF, the TQSM similarity values were 98.66%, 76.62%, and 75.37%, respectively, whereas the traditional similarity evaluation values were 98.68%, 85.43%, and 85.60%, respectively.
    ConclusionThe results perform little distinction in the total composition between FG and FD, whereas some distinction existed between FD and CP. Experimental evidence, therefore indicates that FG could be used as the alternative of MCS in clinical applications.

     

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