Study On Chemical Fingerprinting And Quality Control Of Yinzhihuang Injection

Yinzhihuang Injection, one of the well-sold Traditional Chinese Medicine (TCM) for treating heptatitis, was recorded in the Vol.14 of Patent TCM issued by State Administration of Health. Also it was one of the TCM injections required compulsorily by the National Pharmacopeia Committee to implement the regulation of TCM fingerprinting which has become an effective measure in the quality control for TCM. In this thesis , system studies on the chemical fingerprinting technology and standards of Yinzhihuang Injection were made.1. HPLC techniques and standards of Yinzhihuang Injection as well as Flos Lonicera, one of main medicinal materials, and its extract were established respectively.2. According to the molecularion peak information, combined with the coherent information of chemical controllers and related records, the chemical constituents of the common peaks in the fingerprintings of the extracts and injection had been confirmed by LC/MS technology .3. By the correlation analysis of the fingerprintings between the injection and each medicinal extracts, the original attribute was confirmed.4. Based on the studies of the above fingerprintings, unified and authentic prescription, manufacturing technique and quality standard were optimized and established.5. Meanwhile, pertinent analysis showed there is a correlation between the different fingerprintings and adverse drug reactions .In conclusion, more powerful technical supports for Yinzhihuang Injection in safety, effectiveness, stability and control will be provided. At the same time, it will be a model for other studies on the fingerprinting standardization of TCM injections.