Study On The X-ray Diffraction Pattern Of Chinese Patent Medicine

Chinese Patent Medicine(CPM) is the general term of Chinese herbal products prepared with different dosage forms using Traditional Chinese Medicine (TCM) as raw materials. It is history of medicine in China for thousands of years of medical practice through the creation and summed up effective prescription of essence, with the characteristic of readily available, adapt to badly need, convenience store and carry, easy to take and so on. It play an important role in promoting the development of motherland medicine and maintenance human health. But the Chinese medicine quality will directly affect their clinical efficacy and drug safety, thereby affecting the survival and development of the pharmaceutical industry. X-ray diffraction(XRD) pattern that would reflect the integrity of medicine, with the concept of integrated, objective analysis and quality control model evaluation the authenticity of the merits of proprietary products. This paper uses X-ray diffraction techniques combined with chemometric methods for the analysis of a variety of proprietary research, for the establishment of Chinese medicine quality control model provide scientific basis. This dissertation consists of five chapters.Chapter one:Introduction. The research progresses of infrared spectroscopy in XRD in recent years were summarized with 88 references. The objective and significance of this dissertation were described in brief.Chapter two:The optimization of experimental conditions of XRD. The experimental conditions of XRD for the analysis of CPM were optimized. The optimum experimental condition is as follows, particle size of 360 mesh, slit width of 1°, Scanning step length of 0.02, scanning speed of 0.2°/s. The experimental results show that the X-ray diffraction analysis has the good precision and reproducibity.Chapter three:Study on the XRD Patterns of Pill Chinese Patent Medicines. The XRD patterns of 4 pill CPM samples with the same batch number, different batch numbers from the same manufacture and different manufactures were determined, respectively. The consistency of XRD patterns of the 4 pill CPM samples was investigated using the similarity degree and cluster analysis, respectively, and the results show that the XRD patterns of 4 pill CPM samples with the same batch number, different batch numbers from the same manufacture and different manufactures were in good agreement. The XRD fingerprints of the 4 pill CPM samples were established by average method, respectively. The 4 pill CPM samples can be identified using the established XRD fingerprints.Chapter four:Study on the XRD Patterns of Capsule Chinese Patent Medicines. The XRD patterns of 4 capsule CPM samples with the same batch number, different batch numbers from the same manufacture and different manufactures were determined, respectively. The consistency of XRD patterns of the 4 capsule CPM samples was investigated with the similarity degree and cluster analysis, respectively, and the results show that the XRD patterns of CPM samples with the same batch number, different batch numbers from the same manufacture and different manufactures were in good agreement. The XRD fingerprints of the 4 capsule CPM samples were established by average method, respectively and the 4 capsule CPM samples can be identified using the established XRD fingerprints.Chapter five:Study on the XRD Patterns of Tablet Chinese Patent Medicines. The XRD patterns of 5 tablet CPM samples with the same batch number, different batch numbers from the same manufacture and different manufactures were determined, respectively. The investigation of the consistency of the XRD patterns of 5 kinds of tablet CPM samples was carried out with similarity degree and cluster analysis, respectively, and the results show that the XRD patterns of 5 kinds of tablet CPMs were in good agreement. The XRD fingerprints of 5 kinds of tablet CPMs were established using the average method, respectively and the 5 kinds of tablet CPMs can be identified using the established fingerprints.Chapter six:Study on the XRD Patterns of Powder Chinese Patent Medicines. The XRD patterns of 5 powder CPM samples with the same batch number, different batch numbers from the same manufacture and different manufactures were determined, respectively. The consistency of XRD patterns of the 5 powder CPM samples was investigated using similarity degree and cluster analysis, respectively, and the results show that the XRD patterns of CPM samples with the same batch number, different batch numbers from the same manufacture and different manufactures were in good agreement. The XRD fingerprints of the 5 powder CPM samples were established by average method, respectively. The 5 powder CPM samples can be identified using the established XRD fingerprints.