Preparing Glcyrrhetic-diphenhydramine Compound Salt And Preliminary Research On It's Preparation

Abstract: this study is to use the glycyrrhetic acid GTA and the diphenhydramin hydrochloric BHCL as two material for preparing a new anti-allergic compound salt drug :GTA - B. The GTA which come from the hydrolysis extracted from glycyrrhiza glabra, which is a special botanicals in xinjang indigenous plant. The BHCL is a classical anti-allergic medicine and is frequently employed in hospital. Purpose: this new prepared compound salt could modify the solubility of GTA or alter it's absorption properties or cooperate with two raw material drug pharmacological properties. We will make this new compound salt into ointment and study it's anti-inflammatory effect. This study has been done in two aspects with trial. The examination process as fellows:1 Preparing process and new compound salt identification. The new compound salt was investigated by using follow methods: First, the physic properties. for example, appearance, melting point m.p., solubility in different solvent ,crystal form and stability test; Second, structure identification: with thin layer chromatography TLC, ultra-violet spectrum UV, infra-red spectrum IR, element analysis and differential scanning calormetry DSC; Third, impurity check: with TLC, high performance liquid chromatography HPLC; Finally, content assay: with titrational and HPLC method. conclusion: the prepared compound salt is white, likes snow and as similar to crystal powder. m.p.=87~95℃;it can easy solved in methanol MeOH, ethanol EtOH, acetone and chloroform but solve in water less. At normal temperature , the new drug's solubility as follows : 80.2 μ g/ml in 20% EtOH, 2059 μ g/ml in 50% EtOH, 316 μ g/ml in 10% glycerin solution. Structure identification: with TLC;UV;IR;X-ray; element analysis and DSC date all have demonstrated that prepared compound salt structure is a new one. This result compared with the raw material structure. Impurity check conclusion: the impurity limit L