| Shenzhiling oral liquid is China’s first approved compound of traditional Chinese medicine for mild-moderate Alzheimer’s disease, which causes the Heart-Qi Deficiency Syndrome, whose symptoms include palpitation, deficiency of Qi and hypologia, apathy, dizziness and fatigue, pale tongue and weak pulse, etc. The herbal formula consists of10kinds, such as Codonopsis Pilosula, Ramulus Cinnamomi, Wolfiporia Cocos and Paeonia Sterniana. Ramulus Cinnamomi and Paeonia Sterniana are the main crude drugs, for the main ingredients of the former are cinnamic acid and cinnamic aldehyde and those of the latter are paeoniflorin and albiflorin, which will play a key role in efficacy. Therefore, the quality of Shenzhiling oral liquid can be checked and controlled through the determination of cinnamic acid and paeoniflorin in the compound. The determination method used today is HPLC, which is complex and unfavourable for the line control. As a green, rapid and nondestructive analytic technique, NIR光谱has been widely applied in the research of traditional Chinese medicine, especially in the fields of authenticity and origin identification, quality qualification, and line quality control.Near infrared spectroscopy is mainly caused by the multiple frequency absorption and the combined frequency absorption of the groups containing hydrogen, contained by most organics, providing the structural basis for its wide application in agricultural products, food, medicine, petrochemicals and tobacco, etc. In addition, the development of stoichiometry and computer science in recent years gives renascence to the near infrared spectroscopy technology, and enriches the analytic technique. The near infrared spectroscopy technology is hailed as a green analytic technique for such advantages as rapidness, nondestructiveness, no pretreatment of the samples, low cost of analysis, and real-time online analysis of samples, etc. Meanwhile, we should fully realize the current limitations of the technology as well as being pleased with its development. On the one hand, with low sensitivity, NIR光谱usually requires that the componential content is higher than0.1%, which is only applicable for macroanalysis. On the other hand, NIR;光谱is an indirect analytic technique, requiring massive collection of the sample data for modeling, which will be long and costly, therefore not suitable for the analysis of samples with a small number.The experiment is divided into two parts. In the first part, with a collection of86samples of Shenzhiling oral liquid from four production batches, the following two are connected through PLS and the quantitative analysis model is established:the primary data of the content of the paeoniflorin, the main ingredient of Shenzhiling oral liquid, acquired through HPLC; and the near infrared spectroscopy of the samples, collected by the spectroscope ANTARIS II. The MSC spectroscopy becomes the final and best option for modeling in the full spectral interval after choosing the spectrum pretreatment method and optimizing the modeling interval. Such values as Rc, Rv, RMSEC and RMSEP taken as the evaluation index, the values of the best model in Rc, Rv, RMSEC and RMSEP are0.091,0.947,0.110and0.932respectively. The principal factor number adopted by the model is5. The model parameters can all meet the requirement of analysis. In the second part, with a collection of85samples of Shenzhiling oral liquid from four production batches, the following two are connected through PLS and the quantitative analysis model is established:the primary data of the content of the cinnamic acid, the main ingredient of Shenzhiling oral liquid, acquired through HPLC; and the near infrared spectroscopy of the samples, collected by the spectroscope ANTARIS II. The MSC spectroscopy becomes the final and best option for modeling in the full spectral interval after choosing the spectrum pretreatment method and optimizing the modeling interval. Such values as Rc, Rv, RMSEC and RMSEP taken as the evaluation index, the values of the best model in Rc, Rv, RMSEC and RMSEP are0.003,0.886,0.003and0.888respectively. The principal factor number adopted by the model is6. The model parameters can all meet the requirement of analysis.The experiment provides a new method for reference in the quality line control and the uniformity inspection of Shenzhiling oral liquid products. We believe that its line detection technology will be used thoroughly in the near future, when the traditional Chinese medicine production process will be controlled scientifically and reasonably, thus ensuring the homogeneity of the end products and promoting the modernization process of the traditional Chinese medicine in China. |
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