Reseach On The Preparation Technology And Quality Standard Of Qidoufuzheng Granule

Objective: The prescription of Qidoufuzheng granules comes from the Gansu provincial hospital and is made up of Oxytropis kansuensis Bunge,Astragalus membranaceus(Fisch.)Bge.,Angellica sinensis(Oliv.)Diels and Ligustri Lucidi Ait..The preliminary pharmacodynamic experiment showed that the extraction had anti-tumor effects.This research is conducting the preparation process and quality standards of Qidoufuzheng Granules.This paper initially establish a quality standard for granules that can provide research materials for reporting hospital preparationsMethods: The type of excipients were preliminarily determined by consulting the literature,and the ratio of extract and excipients was optimized through single factor investigations,and granules were performed by centrifugal granulation technology;Refering to the “Chinese Pharmacopoeia”(2015 edition),Thin Layer Chromatography(TLC)was used to qualitatively identify the individual herb in the prescription.The total polysaccharide was used as the quantitative index,and it was determined by the phenol-sulfuric acid method.The draft quality standard of Qidoufuzheng Granule was formulated;Using High-speed countercurrent chromatography to separate compound with higher content in Oxytropis sinensis in order to provide a theoretical basis for improving the quality standard of the preparation.Results:(1)The single factor experiment results showed that the molding process of the preparation were 2 times maltodextrin as diluent,1 % micro silica gel as moisture absorber,and 50% ethanol as wetting agent.The WL-300 Centrifuge Pelletizer was used for granulation to obtain dry particles with uniform size,uniform color and good moisture resistance.(2)Ferulic acid in Angellica sinensis(Oliv.)Diels and oleanolic acid in Ligustri Lucidi Ait.were detected by TLC,determination of Total Polysaccharides in Preparations by Phenol-Sulfuric Acid Method,then draft quality standard.(3)Rhamnocitrin-3-O-?-D-galactopyranoside was extracted by high-speed counter-current chromatography.The flavonoid in Oxytropis kansuensis was analyzed by spectral analysis.Conclusions: On the one hand,the formulation process and quality standard experiments showed that the preparation process of Qidoufuzheng Granule is highly operative.The moisture resistance of the,granules can meet the quality requirements,and the quality standards are easy to implement.On the other hand,The processing technology of Qidoufuzheng Granule is operability,the moisture resistance of the excipients are good,the granules can meet the quality requirements;the quality standards are simple and feasible,easy to implement,and can meet and ensure the minimum requirements for the preparation quality;high speed countercurrent chromatography separation of the compound in Oxytropis kansuensis has high efficiency and repeatability,and it can provide the basis for the optimization of quality standards.