Preparation of Royal Jelly Effervescent Tablets and Determination of 10-HDA Dissolution

Objective: To solve the problem of low dissolution rate of 10-hydroxy-2-decenoic acid (10-HDA) in royal jelly effervescent tablets. Methods: The disintegration time and gas production were used as evaluation indexes. Single factor experiments and orthogonal test were used to optimize the amount of effervescent agent, the ratio of effervescent agent (citric acid:NaHCO₃), and the amount of sweetener added. Then different food additives were added to the formula. The effect of different food additives on the dissolution of 10-HDA was explored. And the optimum formula was obtained. Meanwhile, X-ray diffraction (XRD) was used to characterize the crystallinity of royal jelly effervescent tablets. Results: The optimum formula were royal jelly lyophilized powder 10%, effervescent agent 45%, best effervescent ratio (citric acid:NaHCO₃)=1.5:1, mannitol 10%, mogroside 1%, and magnesium stearate 0.8%, 15% calcium lactate or 0.5% polyglycerol fatty acid ester, and the rest was filled with lactose to 100%. The royal jelly effervescent tablets prepared by the formula had a good taste and rapid disintegration. In about 15 minutes, the cumulative dissolution rate of 10-HDA could reach 85% or more. Conclusion: Adding calcium lactate or polyglycerol fatty acid ester to the royal jelly effervescent tablets’ formulation could effectively improve the dissolution rate of 10-HDA. This study provided data reference for improving 10-HDA dissolution rate in royal jelly related products.