Study on co-processd excipient of microcrystalline cellulose and glycerol monostearate / 中草药

ABSTRACT

Objective: The co-processd excipient containing microcrystalline cellulose (MCC) and glycerol monostearate (GMS) was prepared. The humidity resistance of MCC used in Chinese materia medica (CMM) was improved and the possibility of this co-processd excipient used in the preparation of CMM tablet was explored. Methods: The co-processd excipient containing MCC and GMS was prepared by applying spray drying method. The moisture absorption, flow ability, compressibility, and disintegration were as the indexes to optimize the best preparation of co-processd excipient through uniform design methodology. The powder characteristic of co-processd excipient was investigated and the microstructures were studied by scanning electron microscope (SEM), differential scanning calorimeter (DSC), X-ray diffraction (XRD), and Flourier transform infra-red (FTIR) spectroscopy. The effect of co-processd excipient on the moisture absorption of spray drying power of Xinyueshu, epimedium total flavonoids, and wolfberry extracts was investigated. The in vitro dissolution of hyperside and ferulic acid in Xinyueshu Tablet was studied. Results: The results showed that the optimal conditions of the preparation consisted of 1 portion of GMS, 12 portions of MCC, and 200 portions of water, emulsionzing temperature of 66°C, and mixing time of 1 h. It was confirmed that the chemical constituents in co-processd excipient were not changed after spray drying with smaller particle size and better fluidity. The co-processd excipient can improve the moisture absorption of spray drying power of Xinyueshu, epimedium total flavonoids, and wolfberry extracts without affecting the disintegration of MCC. Conclusion: The co-processd excipient prepared has good humidity resistance and it is confirmed to have application prospect.