The Study On Production Process,Quality Standards And Stability Of Licorice Flavonoids Capsule

Licorice is one of the important and most commonly used Chinese traditional medicine. Its medicine part is the dry root and rhizone of licorice, Glycyrrhiza inflata Bat and Glycyrrhiza glabra L. Because of its effect,people usually has a tendency says"ten party nine grass",or called it "old kingdom". The medicine factory often extract glycyrrhizic acid from the licorice but often abandon. the flavonoids as liquids or industrial residues. Further research shows that the residues contain a lot of licorice flavonoids. The pharmocological study found it has obvious biological activity, such as antioxidant, antibacterial anti-inflammatory, antitumor, antivirus, protecting liver, etc. Licorice flavonoids have broad research and application prospect.The study of preliminary course showed that the licorice flavonoids have significant antioxidant and whitening effect.Therefore, this study extract and purify licorice flavonoids from licorice residues, then takes it as a raw material to product capsules, in order to realize exploitation of licorice residues.Fist, Production process researchAccording to the physical and chemical nature of licorice flavonoids, this study use ethanol to extract licorice flavonoids and polyamide resin purification. Based on a single factor experiment, we used the L9(34) orthogonal test to optimize the process of extraction flavonoids from licorice residue.The conclusion are: ethanol concentration is60%, temperature is80℃, material liquid proportion is1:30, extracting time is2h. Through comparation the adsorption and desorption rate, we choose screened mesh for30to60polyamide resin for purification of flavonoids. The conclusion are: sample concentration is1.42mg/mL, pH is3, the flow rate is1.5ml/min;Eluent is50%ethanol, elution rate is2.0BV/h, eluent volume is4BV.By comparing absorption rate and angle of rest for different auxiliary material and flavonoids,we selected microcrystalline cellulose as the auxiliary materials preparation licorice flavonoids capsules. Secondly, Quality standards and stability studiesAccording to the 《China pharmacopoeia》 of2010edition, the study of the licorice flavonoids capsules quality standard contains: character, identification, heavy metal, arsenic salt, the methed of assay, etc. By uv spectrophotometry, we used liquiritin as the reference substance to determine the assaybof licorice flavonoids capsules. The determination wavelength is335nm.The standard curve equation is y=0.0217x+0.1268,1=0.9991. The standard curve appeared linear is in range of2.63-26.34μg/mL. By HPLC method determined the assay of liquiritin, chromatography conditions are:Chromatography column is CAPCELL PAK MG C18(250mm x4.6mm,5μm); detector is PAD; In ice the mobile phase is acetonitrile-0.5%acetic acid (20:80); flow rate is1.0mL/min; Detected wavelength is276nm; The column temperature is25℃.The linear equation is:y=7.1429×105x+7.0138×104, r=0.9992. The investigation shows the method reproducible, reliable and simple which can be used for licorice flavonoids capsules quality control.By the acceleration testing and room temperature retention samples method, we observe and study the stability of three batch sample.The results show that all indicators come up to the standards in the study period.