Study On Preparationtechnology And Quality Standard Of Bushen Gubiao Granules

Object:To establish the preparation process of Bushen Gubiao Granules,formulate its quality standards,and provide experimental basis for the development of preparations.Methods:1Six index components(cimicifugoside,calycosin glycoside,5-O-methylvisammioside,baicalin,psoralen and isopsoralen)in the prescription of Bushen Gubiao was simultaneously determined by HPLC.And its polysaccharide content was determined by anthrone-sulfuric acid method.Both were used to study the preparation process,quality standard and stability of Bushen Gubiao Granules2 According to the functions and indications of the of Bushen Gubiao prescription and the characteristics of active ingredients,the extraction process route with water as the solvent was determined.With the contents of 6 active ingredients and polysaccharides as indicators,orthogonal extraction experiments were used to optimize the extraction process parameters,and the single-factor experiment method was used to determine the extract drying process.Taking the moisture absorption rate as an index,the types and amounts of the auxiliary materials were preferably selected to determine the pellet forming process.According to the "Technical Guiding Principles for Pilot Study of Traditional Chinese Medicine and Natural Medicine",three batches of Pushen Gubiao Granules were tested for pilot technology.3 Thin-layer chromatography was used to identify psoraleae fructus and Saposhnikovia radix in Bushen Gubiao granules,and HPLC method was used to determine the content of 6 index components at the same time.The Bushen Gubiao granules were inspected according to the relevant requirements of the General Formulation Granules in the Chinese Pharmacopoeia(2015).4 Three batches of pilot products of Bushen Gubiao granules were studied for preliminary stability.Results:1 The established HPLC method could simultaneously determine the contents of six components in the prescription of Bushen Gubiao.Anthrone-sulfuric acid colorimetry could be used to determine its polysaccharide content.Methodological verification experiment results showed that the linear relationship,precision,stability,repeatability,and sample recovery were good.2 The preferred water extraction process and extract drying process were as follows: toke the decoction pieces according to the prescription,added 8 times the amount of water,and extract3 times by micro-boiling for 1 hour each time.The extract uses a vacuum of-0.085 MPa to-0.095 MPa at 60 ?,vacuum dried.The molding process is: mixed the dry paste powder and sucrose powder at a ratio of 1: 0.68,stirred with 88%(mL / mL)ethanol,granulate with a No.1 sieve,and dry at 70 ?.The results of the three batches of pilot process verification were:the extract yields were 64.1%,69.2%,and 64.7%,the dry paste yields were 34.9%,37.3%,and 33.1%,respectively,and the sucrose powder / dry paste ratios were 0.7,0.6 and 0.8,and the yields of finished particles are 95.2%,97.6%,and 98.8%,respectively.The characteristics,particle size,solubility,moisture,loading difference,qualitative identification,content determination,and microbial limit of the three batches of pilot products met the requirements of the quality standards..3 The established two methods of thin-layer chromatography identification and HPLC forsimultaneous determination of the content of six index components were feasible,and the content limits had been tentatively set.And each inspection item met the requirements of Chinese Pharmacopoeia(2015).4 The preliminary stability study showed that under three kinds of storage environments such as accelerated test,intermediate condition accelerated test,and long-term test,the eight investigation indexes of Bushen Gubiao granules all met the requirements of quality standards,indicating that the pilot test preparation process and Pure aluminum composite film packaging was feasible,and the effective period of Bushen Gubiao granules was initially determined to be 18 months.Conclusion:The analytical methods for the preparation of Bushen Gubiao Granules established in this paper were scientific and reasonable,easy to operate,the preferred preparation process was stable and feasible,the established quality standards were controllable,and the pilot product was stable,which provided experimental basis for the development and research of the preparation.