Development of an on-line Raman spectral analytical method for monitoring and endpoint determination of the Cornu Caprae Hircus hydrolysis process.

OBJECTIVES

Cornu Caprae Hircus (goat horn, GH), a medicinal animal horn, is frequently used in traditional Chinese medicine, and hydrolysis is one of the most important processes for GH pretreatment in pharmaceutical manufacturing. In this study, on-line Raman spectroscopy was applied to monitor the GH hydrolysis process by the development of partial least squares (PLS) calibration models for different groups of amino acids.

METHODS

Three steps were considered in model development. In the first step, design of experiments (DOE)-based preprocessing method selection was conducted. In the second step, the optimal spectral co-addition number was determined. In the third step, sample selection or reconstruction methods based on hierarchical clustering analysis (HCA) were used to extract or reconstruct representative calibration sets from the pool of hydrolysis process samples and investigated for their ability to improve model performance.

KEY FINDINGS

This study has shown the feasibility of using on-line Raman spectral analysis for monitoring the GH hydrolysis process based on the designed measurement system and appropriate model development steps.

CONCLUSIONS

The proposed Raman-based calibration models are expected to be used in GH hydrolysis process monitoring, leading to more rapid material information acquisition, deeper process understanding, more accurate endpoint determination and thus better product quality consistency.