| The quality control is very important to modernization of TCM. In this thesis, Kuhuang injection was chosen as an object for exploring the methodology for TCM's quality control.The quality of Kuhuang injection should be based on its botanical raw materials' quality. So the HPLC methods for fingerprinting analysis of Dahuang, Kushen and Yinchen were established and the herbs from different habitats were analyzed. The results indicated that the fingerprinting method has potential of identifying the origin of the herbs.Kuhuang injection is a complicated preparation. It is difficult to characterize the whole chemical constituents with a chromatographic fingerprint. Therefore, two HPLC fingerprinting methods were developed according to the main chemical ingredients in Kuhuang injection. It was learned that the fingerprints could characterize the principal chemical components of Dahuang and Kushen. Subsequently, batch-to-batch consistency of Kuhuang injections and semi-manufactured products were evaluated by the multiple chemical fingerprints and the satisfactory results were obtained.An HPLC/MS fingerprinting method of Kuhuang injection was established. Five herbs' chemical components were simultaneously characterized in this fingerprintA new denoising method for HPLC analysis, named filtering algorithm based on computing analysis of spectra (FACAS), was proposed. The results of simulated and practical experiment both indicated that the proposed method could effectively filter noise and was a powerful denoising tool for HPLC/DAD data.Two RP-HPLC methods for analyzing the principal chemical compounds in Kuhuang injection were developed. Aloe-emodin, chein, emodin, chrysophanol, physcion, Matrine and Sophocarpine were determined. The results suggested that the methods are accurate, sensitive and reliable, and can be used to the quality control of Kuhuang injection. An HPLC method for identifying indigo and indirubin was proposed to indicate the Daqingye in Kuhuang injection. |
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