Process Analysis Of Gingko Leaf Dispersible Tablets Using Near Infrared Diffuse Reflectance Spectroscopy

The Good manufacture practice (GMP) clearly points out that the quality problems of the drugs had to be eliminated in the production process, and it requires improving the quality control skills in the drug production process. In this study, with the Ginkgo biloba dispersible tablets produced by Jianmin Pharmaceutical Co., Ltd of Wuhan as example, according to the production procedure, the near-infrared spectroscopy analysis method was investigated to control the quality of the products in every part of the production process, and to monitor the whole production process. This method is simple, reliable and ensuring the stability and uniformity of the quality of the Chinese traditional medicine. And this method can also be applied in all the other Pharmaceuticals. The main works can be summarized as follows:(1)Using near-infrared spectroscopy and the least squares method to establish the calibration models, rapidly analysis total flavonol glycosides and terpene lactones content of gingko leaf dispersible tablets of semi-finished. The spetral bands had been assigned, the quantitative models for total flavonol glycosides and terpene lactones content of gingko leaf dispersible tablets of semi-finished were establ ished, and14batches samples that are not involved in the models were predicted. The result showed that the models had better prediction performances, the correlations between the NIRs predicted values and the actual values were good, the total flavonol glycosides and terpene lactones correlation coefficients were0.9708and0.9476, the predictions were better, and this methods can be used for routine testing of the content of the pharmaceutical manufacturing process control and high-volume products.(2)Using near-infrared spectroscopy and the least squares method to establish the calibration models, rapidly analysis the water of gingko leaf dispersible tablets of semi-finished. Aiming at the fluidized bed drying process of gingko leaf dispersible tablets, established the quantitative models for water, inspected the influences of the models by using different bands, different model ing methods and different pretreatment methods, and12batches samples that are not involved in the models were predicted. The results showed that the models had better prediction performances, the correlations between the NIRs predicted values and the actual values were good, the correlation coefficients were0.9729, and the predictions were better. The method is rapid and accurate, and can be used in the production process of ginkgo biloba dispersible tablets in water monitoring.(3)Using near-infrared quantitative model and the near-infrared spectra of the standard deviation combined with mahalanobis distance to control the mix uniformity, meanwhile, the results showed that the method is simple, reliable, and can be applied as an example in the other Pharmaceuticals. It is of great importance to improve the monitoring skills during the production process, ensure the uniformity of the product quality and enhance the management levels. This is consistence with the monitoring idea the product quality was produced, but not detected in GMP.