Near Infrared Spectroscopy Research In Monitoring The Mixed Process Of Miltiorrhiza, Puerarin And Hawthorn Extract

Traditional Chinese medicine (TCM) has a great development potential and has become one of the new important direction of the pharmaceutical development, due to its unique pharmacological activity by the general consumer recognition. However, medicinal materials occupy most of the whole exports in our country with low degree of processing, low added value. Comparing with chemical medicine, the effective components information is not clear and the product quality is not instable about TCM, leading to the poor clinical safety and effectiveness. These are mainly caused by the instability of the original medicinal materials and the uncontrolled TCM production process.TCM production generally includes the quality evaluation of original materials, crushing, sieving, extraction, enrichment, granulating, mixing and coating, etc, and most of them are still controlled by experience. However, differences among TCM materials quality and inevitable volatility of the process parameters lead to eventual differences between batches, which hindered the process of marketization, standardization and internationalization of TCM.Enrichment of extract of traditional Chinese medicine is one of the most important technology but time and energy consumption for TCM production process. There are many factors to limit the end point of concentration determination, which reduce the production efficiency and increase the cost of drug manufacturing. Production often relies on conventional physical parameters such as time, liquid level to control enrichment of the end. However, differences among TCM materials quality and inevitable volatility of the process parameters lead to eventual differences between batches. It is difficult to ensure concentrated creamwith good uniformity, which affects the subsequent granulating drying process in turn, and eventually lead to the instable quality of the products and differences among batches. Therefore, rapid development of effective monitoring enrichment method is imperative, and has operable and application value. Based on the above purpose, this topic takes the concentration process of mixed extract of the salvia miltiorrhiza, puerarin and hawthorn as the research object. The fast near infrared analytical technique are studied, the topic research contents are listed below:(1) We studied the standard method determining the content of the indicative components in the concentration process of the mixed extract of the salvia miltiorrhiza, puerarin and hawthorn, which was used to build PLS model. We optimized the model to improve the predictive ability of the model, mainly including the optimization of the spectral preprocessing methods and the intervals. Eventually, we built PLS regression models about tanshinol-Na, Protocatechuic aldehyde, puerarin, daidzein, danshinolic acid B and isoflavoues Aglycone. It could provide technical support for on-line monitoring solution concentration enrichment process to ensure product uniform and reliable.(2) We built the analytical model relating to the density in the concentration process of the mixed extract of the salvia miltiorrhiza, puerarin and hawthorn. We studied the different spectral preprocessing methods and used iPLS method to choose the useful variables. This could provide technical support to control the end point for the on-line concentration, and then to ensure the smooth progress of the subsequent granulating process.