| Evaluation of TCM's quality and study of compatible theory of compound prescriptions are the important subjects to TCM's modernization. In this paper Kuhuang injection was selected as an object for exploring the methodology of TCM's fingerprint. Additionally, the couple of Rhizoma Coptidis and Fructus Evodiae was selected for investigation of the influence of the proportions of Rhizoma Coptidis and Fructus Evodiae and extraction menstruum on the solubility of the main chemical constituents.The RP-HPLC methods for analyses of Kuhuang injection, Kuhuang semi-manufactured goods and their five original herbs were established and proved. Then the chromatographic fingerprints of Kuhuang injection and its semi-manufactured goods were established. In the chromatographic fingerprint, 14 mutual peaks were selected as fingerprint peaks because they were well reproducible, special to Kuhuang and reflect Kuhuang's quality. Additionally, the relationship about Kuhuang injection, Kuhuang semi-manufactured goods and their five original herbs were investigated. Assignments of 23 chromatographic peaks in Kuhuang injection were identified by comparing retention time and UV spectrum, and 12 chromatographic peaks' herbal origin was affirmed through absent comparison method. The researches laid a good foundation for investigating the quality relation between Kuhuang and its herbs and establishing a practical quality control method.There are several methods to determine the similarity between chromatographic fingerprints of Traditional Chinese Medicine. Cosine of angle was applied most frequently but it was defective. A new approach was proposed in the paper. According to close degree of its area from corresponding peak's area in standard fingerprint, the membership value of each peak was determined using a membership function. To obtain the similarity, the mean of all peaks' membership values was figured out, or special restriction was carried out if any peak was very important to the medicine's-4-quality. The simulative test and Kuhuang injection's analytical data were applied to verify the new method's applicability. The test results proved that the new method remedied the defects of cosine of angle and was practical and suitable to reflect the uniformity of TCM's quality.To study the relationship between the solubility of Rhizoma Coptidis' main chemical constituents and the proportion of Rhizoma Coptidis and Fructus Evodiae. 9 samples were selected in which proportion of Rhizoma Coptidis and Fructus Evodiae were 1:0, 6:1, 3:1, 2:1, 1:1, 1:2, 1:3 1:6 and 0:1, respectively. The samples' water-extracts were analyzed by RP-HPLC. Then solubility changes often chemical constituents were calculated, and the regression equations were established. Among ten chemical constituents, three were independent on the change of proportion of Rhizoma Coptidis and Fructus Evodiae, six having linear relationship. A new constituent was detected, and there was nonlinear relationship between its quantity and the proportion of the couple. Additionally, the influence of menstruum on solubility of protoberberinium alkaloids in the couple of Rhizoma Coptidis and Fructus Evodiae was investigated. The samples were extracted by water and hydrochloric acid-methanol, respectively. Then the contents of jatrorrhizine, palmatine, berberine were determined by reversed-phase high performance liquid chromatography, and the solubility was worked out. As a result, obvious difference was observed. Solubility of protoberberinium alkaloids in water decreased quickly as the ratio of Rhizoma Coptidis to Fructus Evodiae reduced, while the solubility in hydrochloric acid-methanol lessened little. Through this research, we can draw a conclusion that the solubility of protoberberinium alkaloids in the couple of Rhizoma Coptidis and Fructus Evodiae was remarkably influenced by menstruum.
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