Abstract:

The stability of coenzyme A solution was studied. It was found that the content of coenzyme A in the solution decreased with increasing storage time and increasing temperature，while it remained relatively constant for 24 h under conditions of temperature 1—5℃ and pH value 4.5. For this reason，the freeze-drying technology was introduced.  Using freeze-drying dosage-form and moisture content as qualitative indices，the return warming freeze-drying was proven superior to traditional ladder warming freeze-drying with respect of the product quality of coenzyme A. The characteristics and configuration of coenzyme A obtained from an ordinary drying process and different freeze-drying processes were further analyzed by optical image and X-ray diffraction. The findings demonstrated that the ladder warming freeze-drying process was better than the ordinary drying process with respect to the formation of the crystal structure of coenzyme A，while the return warming freeze-drying process further outweighed the ladder warming freeze-drying process.  Moreover，an optimized 16 h return warming freeze-drying process was finally proposed to obtain coenzyme A with high-purity(≥95%),high crystallinity and good stability，based on the research on the return warming freeze-drying process and also the acceleration stability test.