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Quality Control of Traditional Chinese Medicine (TCM) has been of priority and difficulty in modernization research of TCM. In this topic, Rhizoma Anemarrhenae (“Zhimu”in Chinese), Cortex Phellodendri (“Huangbai”in Chinese), and the standard extracts of them were taken into research, and their fingerprints were also analyzed, mainly focusing on the analytical metheds for the quality control of TCM. Because of the complicated chemical components in Herb Pair, and to ensure the stability and uniformity of the quality, it’s inevitable to establish an effective quality control method for comprehensive and systematic detection.Fingerprint of TCM can comparatively fully reflect the intrinsic quality of drugs, having the properties of integrity, stability and characteristic, and so on. When the chemical constituents of TCM isn’t elucidated completely, the fingerprint can reflect the population characteristic of herbs, and the establishment of fingerprint is useful for the effective and comprehensive quality control of Rhizoma Anemarrhenae, Cortex Phellodendri, and the herb pair, as well as their clinical use.“Herb Pair”, also called Drug Pair or Pair, specifically refers to prescription that consists of two fixed drugs in clinic, and it is the simplest, most basic and most common form of TCM compound recipe. Herb Pair provides the basic functions for indications, and its compatibility accords with“seven modes of emotion”, which is the theory of TCM compound recipe. As one of the prescription feature of TCM practitioner, it also has characteristics such as pathogenesis contacted, specific function, and significant effect.The regularity research of TCM compound recipe is one of the technical problems that are in urgent need of solution. Herb Pair, as the smallest unit of TCM compound recipe, is studied firstly, which accords with the idea that science research should advance step by step, and it is the basic theory of the TCM compound recipe study. Rhizoma Anemarrhenae, Cortex Phellodendri and the standard extracts of the pair were taken into study, taking their effective chemical constituents as main indicators. In order to enhance the effectiveness and comprehensiveness of the control over their preparations, and to improve the establishment of quality control standards, HPLC-DAD and HPLC-DAD-ELSD methods were developed, combining the corresponding fingerprint software. Those are useful to guide the practical production, control the production procedures, and effectively guarantee the stability of product and safety of medicament, providing good chance to the further study of TCM compound recipe.The fingerprints of Rhizoma Anemarrhenae, Cortex Phellodendri, and the standard extracts of the pair, were established using HPLC-DAD and HPLC-DAD-ELSD methods in this experiment, and their main active chemical constituents were also determined. Besides, more than 10 batches of the drugs and extracts of herb pairs were analyzed, and their similarity was evaluated by the TCM chromatographic fingerprint evaluation system 2004A similarity analysis software. In order to ensure the scientific validity and stability of the preparation, the correlation of the fingerprints was presented on the basis of the fingerprint of the drugs and their herb pair.Experimental result(1) Quality control of Cortex PhellodendriThe results showed that the average content of total active chemical constituents in Phellodendron chinense Schneid. was 4.93%, while 1.51% in Phellodendron amurense Rupr.. The content of berberine in P. chinense Schneid.was 4.37% on average, much higher than those (0.879%) of P. amurense Rupr., which was a 4.97-fold variation. But both of the contents of palmatine (0.025%) and limonin (0.25%) in P. chinense Schneid. were lower than those (0.38% and 1.2% respectively) in P. amurense Rupr., which were 15.03-fold and 5.12-fold variation, respectively. The average contents of jatrorrhizine in P. chinense Schneid. and P. amurense Rupr. were low, being 0.041% and 0.049%, respectively. Branch-bark, root-bark and twig-bark of P. amurense contained berberine, and moreover, root-bark had much higher contents of the compound among these different parts, followed by branch-bark and twig-bark. The experiment established a Cortex Phellodendri fingerprint by HPLC, and similarity was used as the fingerprint evaluation parameter, to evaluate the fingerprints similarity of drugs of different origin, as well as the similarity of control fingerprints, and then using SPSS software to do fingerprint analysis. Cortex Phellodendri fingerprint was established and 15 batch samples of different origin were clearly divided into P. chinense Schneid. and P. amurense Rupr. by this fingerprint analysis.(2) Quality control of Rhizoma AnemarrhenaeThe results of Rhizoma Anemarrhenae form 17 different areas showed that, the average content of flavonoids was 1.79%; and the average content of saponins was 5.79%, which was in the line with the result (6%) that was reported by literatures; but the contents of the six constituents in Rhizoma Anemarrhenae, especially of timosaponins, were in a large variation. Although large differences existed in contents among single constituent, the content differences of total flavonoids and saponins were relatively small. Rhizoma Anemarrhenae from Hebei province contains higher content of total saponins than others; and the contents difference of total flavonoids was relatively small. All drugs couldn’t simply and clearly clustered by SPSS software, but drugs which contains higher saponins contents (drugs from Hebei province) were categorized from those lower ones(drugs from Shandong, Liaoning, Ningxia, Heilongjiang, Shanxi provinces).(3) Quality control of standard extracts of Rhizoma Anemarrhenae and Cortex PhellodendriFirst of all, this experiment established a method to analyze the standard extracts of Rhizoma Anemarrhenae and Cortex Phellodendri by HPLC, determining 10 active chemical constituents from 10 batches, viz. mangiferin, neomangiferin, timosaponin-EⅠ, timosaponin-BⅡ, timosaponin-B, timosaponin-AⅢ, phellodendrine hydrochloride, jatrorrhizine hydrochloride, palmatine hydrochloride, and berberine hydrochloride. Secondly, the experiment established the standard drug extract fingerprint by HPLC, and similarity was used as the fingerprint evaluation parameter, to evaluate the fingerprints similarity of herb pairs of different batches, as well as the similarity of control fingerprints. The results showed that, although there was still some content variation among the standard drug extract of different batches, the total alkaloids, flavonoids and saponins were of small content difference. The similarity among the batches met with good result.Conclusion(1) The methods used in this experiment were scientific, reliable, and can be used in qualitative and quantitative research for Rhizoma Anemarrhenae, Cortex Phellodendri and their Drug Pair.(2) The results of this research are useful to establish a scientific method for the evaluation of Rhizoma Anemarrhenae, Cortex Phellodendri and their Herb Pair, guide the practical production, control the production procedures, and effectively guarantee the stability of product and safety of medicament.
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