Optimization of Prescription of Lycii Fructus Polysaccharide Buccal Tablets by Central Composite Design-response Surface Methodology and Investigation of Its Immunomodulatory Effect / 中国实验方剂学杂志

ABSTRACT

Objective:To prepare Lycii Fructus polysaccharide buccal tablets and investigate its immunomodulatory effect. Method:Taking the appearance, taste, hardness and disintegration time of the tablets as comprehensive evaluation index, based on single factor tests, central composite design-response surface methodology was adopted to optimize the prescription of Lycii Fructus polysaccharide buccal tablets with mass ratio of dextrin to mannitol, mass ratio of cyclamate to malic acid and dosage of sodium carboxymethyl starch (CMS-Na) as factors. Kunming mice were randomly divided into 5 groups, namely the Lycii Fructus polysaccharide buccal tablets low (100 mg·kg-1·d-1), medium (200 mg·kg-1·d-1) and high (300 mg·kg-1·d-1) dose groups, the normal group (0.9% normal saline, 300 mg·kg-1·d-1) and the positive medicine group (Cinengsu group, 300 mg·kg-1·d-1). The immunomodulatory effect of the buccal tablets were investigated by calculating immune organ index, monocyte-macrophage phagocytic index, serum hemolysin antibody level, and the voix pedis thickness difference of delayed hypersensitivity (DTH) of mice. Result:Optimal prescription for the buccal tablets was 80% of Lycii Fructus extract, 11.5% of dextrin-mannitol (1.21), 1% of cyclamate-malic acid (11), 0.5% of cream essence, 6.5% of CMS-Na, 0.5% of magnesium stearate, and appropriate amount of 80% ethanol. Under the optimal condition, the hardness of the buccal tablets was 11.83 kg, its disintegration time was 13.21 min, both of which were in line with the relevant provisions of the 2015 edition of Chinese Pharmacopoeia, and the buccal tablets had good appearance and taste. Compared with the normal group, medium and high dose groups of Lycii Fructus polysaccharide buccal tablets significantly increased thymus index, spleen index and phagocytic index of mice (PPPPPConclusion:The formulation process of the buccal tablets optimized by central composite design-response surface methodology is stable and feasible, and Lycii Fructus polysaccharide buccal tablets can improve the immune regulation function of normal mice, and this study can provide experimental basis for the development, utilization and clinical application of Lycii Fructus and Lycii Fructus polysaccharides.