蜂王浆泡腾片的制备及王浆酸溶出的测定

目的:为解决蜂王浆泡腾片中难溶成分10-羟基-2-癸烯酸（10-HDA）溶出率低的问题。方法:采用单因素实验和正交试验，研究了泡腾剂添加量、泡腾剂比例（柠檬酸:碳酸氢钠）、甜味剂添加量对蜂王浆泡腾片崩解时间及产气量的影响，并探索了不同食品添加剂对蜂王浆泡腾片中10-HDA溶出度的影响，获得了最佳配方。同时，利用X射线衍射（XRD）表征蜂王浆泡腾片的结晶度。结果:最佳配方为蜂王浆冻干粉10%，泡腾剂添加量45%，泡腾剂最佳比例（柠檬酸:碳酸氢钠）=1.5:1，甘露醇10%，罗汉果甜苷1%，硬脂酸镁0.8%，15%乳酸钙或者0.5%聚甘油脂肪酸酯，剩余以乳糖填充至100%。该配方下制得的蜂王浆泡腾片，口感良好、崩解迅速，并有效提高了10-HDA的溶出率，10-HDA的累计溶出率在15 min左右可使达到85%以上。结论:在蜂王浆泡腾片配方中加入乳酸钙或聚甘油脂肪酸酯可以有效提高10-HDA的溶出率，为提高蜂王浆相关产品中10-HDA溶出率提供了数据参考。

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.