ABSTRACT
Objective: To investigate how to rapidly predict coating terminal point in the thin film coating of Tianshu Tablets by near-infrared spectroscopy (NIRS). Methods: Firstly, synergy interval partial least square (siPLS) was used to optimize the modeling intervals and the pretreatment methods were screened. Secondly, according to the optimal modeling parameters, the conformity test and similarity matching were used to establish calibration models based on the established reference spectra library. Subsequently, by comparing the similarities between the test spectra and the reference spectra, the threshold value was set. The relation among the similarities, threshold value and the coating end point was obtained. Finally, the performance of the calibration model was verified by the validation set. Results: During the coating process, the similarities between the test spectra and the reference spectra were gradually increasing until the similarities of continuous test spectra exceeded the threshold, thus, indicating the end point. Conclusion: Conformity test and similarity matching can sensitively monitor the change of similarities among spectra and the corresponding trend. Both models have high performance, which can accurately predict the coating terminal point. It’s of great significance to reduce batch-to-batch variation in film coating and the loss of coating materials, and improve the coating efficiency and the quality uniformity of solid preparation.
ABSTRACT
The quality uniformity of traditional Chinese medicine (TCM) preparation is the base for guaranteeing the safety and effectiveness of clinical medication. At present, the quality of TCM preparation is uneven. At present, the same TCM preparation in different manufacturers, TCM preparations in the same manufacturer, and even different batches of a same TCM preparation in the same manufacturer have great differences in quality, which can not reach stability and uniformity. This paper would discuss the possible factors that influence the uniformity of quality in the whole process of pharmacy by means of consulting relevant literature on quality control of Chinese herbal preparations and analyzing the present situation and problems of the quality of TCM preparation. In addition, some strategies such as standardization of cultivation of TCM, processing standardization, standardization of pharmaceutical equipment, mixed batch feeding, and Quality by Design would be also put forward to provide references for the quality uniformity of TCM preparation.