| Traditional Chinese Medicine has a long history of use across the world, and there is consistently increasing interest in traditional and alternative systems of medicine in many countries as the primary healthcare of individuals and communities. The quality control of Traditional Chinese Medicine is more difficult than that of chemical drugs because of the complexity of chemical constituents. Kuhuang injection made from 5 crude drugs is a compound preparation of Traditional Chinese Medicine and contains many kinds of chemical compounds. This dissertation selects Kuhuang injection and some crude drugs for exploring the methodology for the quality analysis of Traditional Chinese Medicine. The research contents and achievements are included as follows:Chemical fingerprint technique is a powerful tool for the quality analysis of Traditional Chinese Medicine and has been widely accepted as a useful means for the quality assessment of medicinal materials and their preparations. However, there still are some technical problems unresolved in its application. In this dissertation, the relationships between the similarity and peak-area and number of chromatographic peak were investigated by simulation. The results suggested that contribution of large peak to the similarity is significant, whereas small peak is insignificant. These results are useful for selecting the conditions of fingerprint analysis. Information theory was firstly used in the selection of detection wavelength. This method can refrain from the subjectivity and give the objective result. The validation experiments carried out among several laboratories indicated that the analytical instrument could seriously affect the evaluation of fingerprint of Traditional Chinese Medicine.The identification of chemical compounds is important to the quality analysis of Traditional Chinese Medicine. According to our investigations, there are not saikosaponins, free indigo and indirubin and chlorogenic acid, and only little free anthraquinones is found in Kuhuang injection. In order to understand the chemical composition for improving its quality analysis method, Kuhuang injection was analyzed by high-performance liquid chromatography-diode array detection-mass spectrometry (HPLC-DAD-MS) and 17 chemical constituents were identified.In our opinions, combination between content determination and fingerprint analysis is the most effective approach to the quality control of Traditional Chinese Medicine. Therefore, the chemical analysis of the potent components or marker constituents is the important part of quality assessment of Traditional Chinese Medicine. In this dissertation, several analytical methods, such as high-performance liquid chromatography (HPLC), gas chromatography-mass spectrometry (GC-MS), high-performance capillary electrophoresis (HPCE) and high-performance liquid chromatography-mass spectrometry (HPLC-MS) were developed for the determination of anthraquinones and alkaloids. The HPLC, GC-MS and HPCE methods were applied to evaluate the quality of Kuhuang injection and its raw material, and HPLC-MS method was successfully applied for the pharmacokinetic study of sophoridine, sophocarpine and matrine in rabbit.Aiming at the multi-component in Kuhuang injection, two high-performance liquid chromatographic fingerprinting methods were established for detecting anthraquinones, flavonoids and alkaloids, respectively. Anthraquinones and flavonoids were characterized in fingerprint I, and alkaloids were analyzed in fingerprint II. Many batches of Kuhuang injection were determined, and batch-to-batch consistency was evaluated. The results demonstrated that the quality of Kuhuang injection was stable.Fingerprinting methods for analyzing the five raw materials of Kuhuang injection were also established and applied for comparing and selecting the raw materials from different locations. Moreover, relativity between fingerprints of raw material and its finished product was demonstrated by several methods.As a part of application of fingerprint analysis, high-performance liquid chromatography and gas chromatography fingerprinting method of Sarcandra Glabra Thunb were established. The two fingerprints characterized the water-soluble constituents and volatile components, respectively. The samples from different places, different seasons, wild and nursed, and different parts of the same plant were analyzed and compared by eyesight and evaluated by the software used for evaluating the similarity of fingerprint. Through the two approaches, the difference among fingerprints of different samples was observed. This method was convenient and reliable, it can be used for quality assessment of Sarcandra Glabra Thunb.The essential oil of Sarcandra Glabra Thunb mainly existed in the leaves and root, little in stem. The chemical constituents of essential oils from different parts were analyzed by GC-MS. Identification of components was done by comparison of MS with NIST mass spectra library. Relative percentage amounts of the identified componentswere calculated from the total ion current chromatograms by a computerized integrator. Cycloisolongifolene-8.9-dehydro-9-vinyl- (9.42%), cadina-3.9-diene (7.71 % ), P -elemene (6.82%), spathulenol (6.63%), terpineolacetate (4.98%), n-hexadecanoic acid (4.86%), acetic acid 1.7.7-trimethyl-bicyclol[2.2.1]hept-2-yl ester (4.84%) are the major components of essential oil from the root. The main constituents of the essential oil from stem are spathulenol (33.73%) and n-hexadecanoic acid (30.12%). Spathulenol (27.12%), longiverbenone (7.0%), 3-guaiene (5.71%), terpineolacetate (4.17%) are the principal compounds in the essential oil from the leaves.Traditional Chinese Medicine can be potentially toxic if used incorrectly. Toxic effects can be attributed to several factors including toxicity of constituents, contamination by pesticides, microorganisms, heavy metals or synthetic drugs. The best risk-benefit assessment before using any botanical drug product has to be made. Therefore, a GC-MS method for the simultaneous determination of 16 pesticides in crude drugs and botanical drug products was developed. The target pesticides involves cc-HCH, (3-HCH, Quintozene, Lindane, 5-HCH, Parathion-methyl, Aldrin, Chlorpyrifos, 2,4'-DDE, 4,4'-DDE, 4,4'-DDD, 4,4'-DDT, Tetramethrin, Fenpropathrin, Cypermethrin and Fenvalerate. The method was successfully used for the analysis of pesticide residues in 18 crude drugs.An HPLC-MS method for trace analysis of carbendazim in crude drugs and botanical drug products was developed and validated. The method was applied for residual analysis of carbendazim in several crude drugs and preparations, and also used to investigate the correlation between extraction method and residual content of carbendazim. The results indicated that the residue of carbendazim in water-extract was smaller than that in ethanol-extract. This research provided scientific basis for setting residual standard and controlling residual level of pesticides in Traditional Chinese Medicine.By the studies above, fingerprint analysis and quantitative methods of the main potent constituents for Kuhuang injection were established. The main chemical substances in Kuhuang injection were revealed. Quality assessment method of Sarcandra Glabra Thunb based on fingerprint analysis was developed as well. Trace analysis methods were developed for the determination of carbendazim, organochlorine, organophosphorus and pyrethriods. All the developed methods can be extended to quality analysis of other crude drugs and botanical drug products.
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