Study On The Infrared Fingerprints Of Several Kinds Of Chinese Patent Medicines For Children

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 has the characteristics of obvious curative effect and easy administration. The CPM plays an important role in promoting the development of TCM and maintenance of human health. The quality of CPM directly affects the clinical efficacy and the medication safety, and then affecting the survival and development of the cause of TCM. The infrared spectrogram can reflect the wholeness of CPM and the authenticity merits of CPM can be evaluated using integrated, objective analysis philosophy and quality control mode. Several kinds of CPMs were studied in this thesis by infrared spectroscopy combined with chemometrics methods. The results provide the scientific basis for the establishment of quality control model of CPMs. This dissertation consists of 7 chapters.Chapter one:Introduction. The research progresses of infrared spectroscopy in CPMs in recent years were summarized with 49 references. The objective and significance of this dissertation were described in brief.Chapter two:The optimization of experimental conditions and the methodological experiment. The experimental conditions of infrared spectroscopy for the analysis of CPM were optimized and the optimum experimental conditions were as follows, real-time deducting the blank background of KBr, scanning times of 10, particle size of 120 mesh, mixing ratio with KBr of 6:100, tablet pressing time of 20s, tablet pressing pressure of 70KN. The methodological experiments were carried out using the optimum conditions and the results show that the advantage aspects of infrared spectroscopy were found to be good precision, stability and reproducibility.Chapter three:Study on the infrared fingerprint of Xiao'er Ganmao Keli. The infrared spectrograms of 300 Xiao'er Ganmao Keli samples with the same batch number, different batch numbers from the same manufacture and different manufactures were determined, respectively. The consistency of the infrared spectrograms of Xiao'er Ganmao Keli samples was investigated by similarity degree, cluster analysis and projection discriminant based on principal component analysis and the results show that the infrared spectrograms of 300 Xiao'er Ganmao Keli samples were in good agreement. The infrared fingerprints of Xiao'er Ganmao Keli were established by average method.Chapter four:Study on the infrared fingerprints of granular Chinese Patent Medicines for children. The consistency of the infrared spectrograms of 4 kinds of granular CPMs was investigated by similarity degree and pattern recognition and the results show that the infrared spectrograms of 4 kinds of granular CPMs were in good agreement, respectively. The infrared fingerprints of 4 kinds of granular CPMs were established by average method, respectively.Chapter five:Study on the infrared fingerprints of pulvis Chinese Patent Medicines for children. The consistency of the infrared spectrograms of 3 kinds of pulvis CPMs was investigated by similarity degree and pattern recognition. The investigation results show that the infrared spectrograms of Ying'er Jianpi San and Xiao'er Ganmao San were in good agreement and the abnormal samples were observed in the experimental samples of Xiao'er FufangJineijin San. After the elimination of the abnormal samples, the infrared fingerprints of 3 kinds of pulvis CPMs were established by average method, respectively.Chapter six:Study on infrared fingerprints of tablet Chinese Patent Medicines for children. The investigation for the consistency of the infrared spectrograms of 3 kinds of tablet CPMs was carried out by similarity degree and pattern recognition and the results show that the infrared spectrograms of 3 kins of pulvis CPMs were in good agreement. The infrared fingerprints of 3 kinds of tablet CPMs were established by average method, respectively.Chapter seven:The comparison of the infrared fingerprints of 11 kinds of Chinese Patent Medicines for children. The calculation of similarity degrees and the t-test of the conventional and second derivative infrared fingerprints of CPMs for children were carried out. The significant difference was observed between different kinds of CPMs for children with the same dosage form and the difference in second derivative infrared fingerprints was greater than that in conventional infrared fingerprints, and the similarity degrees of the infrared fingerprints of CPMs with different dosage forms were smaller than that with the same dosage form. The results indicate that the difference in the composition of CPMs with the different formulations were greater than that with the same formulations. The results show that the qualitative identification of a variety of CPMs can be achieved with infrared spectroscopy.