| At present, the quality control of the Traditional Chinese Medicine (TCM) formula granule production process generally involves only the content ana-lysis at the end of the process, and on-line quality control of the process has been reported rarely. Production process of TCM formula granule is typical batch process, consist of a series units such as extraction, concentration, drying, etc., a change in parameter of each unit will affect the final product quality. Lack of effective on-line quality analysis method, production oper-ations often rely on experience, decision process is complete based on exp-erience, leading to product hard to reach for international drug quality stablility requirements, which seriously restricted the TCM formula granule industrialization and internationalization development.Near infrared spectroscopy (NIRS) is the most commonly used technology for process analysis, which is a new type of detection method, developing rapidly since the late 1980s, the samples does not need complex pretreatment can be directly tested, the testing process is usually done in a few minutes, and the whole testing process doesn't need to use any chemical reagent, it is a kind of environmental protection analysis and detection methods, it has been widely used in agricultural, petrochemical, life sciences and pharmaceutical analysis and other fields.Near infrared spectroscopy technology applied in TCM formula granule production process, establishing near infrared (NIR) on-line monitoring method in the production process key operation units such as extraction, concentra-tion, drying, etc., getting the material properties information from the actual production process timely, to understand the relationship between the key process parameters and the quality of the final product, thus to achieve production process parameter real-time control and optimization, making different batches of product achieve quality stablility requirements, and promoting the further development of TCM formula granule.In this paper, the application of NIRS technique to on-line monitor the production process of peony formula granule had been researched, and achieved satisfactory results.1. Quality control of herbal medicine in the whole production process of TCM formula granule plays an important role, the quality of medicinal materials which come from different areas and different batches exist certain differen-ces, which directly affects the subsequent operation process and the final product quality. Radix Paeoniae Alba selected in this paper come from different areas across the country, has certain representativeness, all samples were crushed under the same conditions, and pass 80 mesh pharmacopoeia sieve. Multivariate calibration models based on partial least squares (PLS) algorithm were developed to correlate the spectra and the corresponding values determ-ined by the reference method. The corelation coefficients (R2)of the calibra-tion models were 0.938,0.943 and 0.976, and the prediction average relative deviation for paeoniflori,albiflorin and moisture content were 6.46%,0.23% and 3.82%, respectively. The NIRS determination method was rapidly, accuracy, nondestructive and non-pollution. It can dispose the samples without compli-cated pretreatment. It is qualified to analyze TCM whose components are complex rapidly. NIRS can be used to control the quality of herbal material of paeony formula granule.2. Box-Behnken response surface method is a statistical method that use multiple quadratic equation to fit the relations between factors and the responses, through the analysis of the regression equation to find the optimum process parameters,to solve the multivariate problems. In this article, base on the results of single factor experiment, Box-Behnken experimental design combining with response surface methodology(RSM) was employed, with the soa-king time (X1), the water addition (X2), the extraction time (X3) as the inde-pendent variables. The response variable was the amount of Total Glucoside of Paeony. The optimization Processing Parameters was as follows:X1,X2and X3 levels of 98.4min,12 times and 69.8min, respectively. The observed responses are in close agreement with the predicted values of the mathematic models, and the Box-Behnken response surface method is suitable for optimizing the extraction of TCM.3. The extraction process of TCM is a key step in the production process, due to lack of on-line monitoring method, it is difficult to ensure the sta-bility of product quality. In this paper, the extraction process as the research object, multivariate calibration models based on partial least squares (PLS) algorithm were developed to correlate the spectra and the corresponding values determined by the reference method. The prediction average relative deviation for the content of albiflorin,paeoniflorin were 1.51%,-1.87%, respectively, the prediction average recovery were 100.48%,98.13%, respectively. That the established quantitative NIR calibration model can be used in the extraction process to on-line monitor the content changge of albiflorin and paeoniflorin.4. Extraction is an important step in the TCM production process, the quality of different batches extract exist differences, which directly affects the subsequent operation process and the final product quality. In this paper, the concentration process as the research object, multivariate calibration models based on PLS2 algorithm were developed to correlate the spectra and the corresponding values determined by the reference method. The prediction average relative deviation for the content of albiflorin,paeoniflorin were-1.16%,0.94%, respectively. That the use of near infrared spectroscopy reflect the enrichment process in real-time liquid state, to improve the quality of traditional Chinese medicine extract stability. Through using the NIRS technology, the situation of medicine liquid in the extraction process can be reflected, Therefore, the stability of the extract quality to obtain improved.5. The spray drying method has the characteristics such as fast-drying, heating time is short, less production processes, good mobility, homogeneous texture, good solubility,etc. In recent years, TCM industry has developed rapidly, the spray drying technology is widely used in many pharmaceutical enterprise. In this paper, the optimum technological conditions of the spray drying process of paeony extract were researched. According to the single factor experiment and the orthogonal test of 3 factors and 3 levels was ado-pted, and the optimum combination was obtained. the result showed the optimum conditions of spray drying process were as followed:inlet air temperature and outlet air temperature were 190℃and 90℃, the relative density of the extract was 1.08 (60℃), inlet flow rate was 7mL/min. 6.In this paper,NIRS technology applied in the spray drying process of paeony extract were researched, multivariate calibration models based on PLS and PCR algorithm were developed to correlate the spectra and the corresponding values determined by the reference method. The prediction average relative deviation for the content of moisture content,albiflorin,paeoniflorin were-1.38%,0.30%,0.12%, respectively, the prediction average recovery were 98.62%, 100.30%,100.12%, respectively. That the established quantitative NIR calibration model can be used in the spray drying process.The research results show that NIRS technology can be used to on-line monitor the major parts of production process of Paeony formula granule. If this research achievement and the characteristics of TCM formula granule production process are combined, set up a complete NIRS on-line detection system to monitor the production process, and improve the detection model of NIRS continually, This can control the quality of TCM formula granule effectively and ensure the stablility and repeatability of product quality.
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