The Study On Preparation Process And Quality Control Of Baoshenjiedu Enema Granules

ObjectiveBaoshenjiedu Granules is a traditional Chinese medicine prescription whitch is mainly composed of Chinese rhubarb and calcined oyster. Is used to treat the Chronic Renal Faliure, This article evaluated preparation routes, drug quality control and fingerprint analysis under the Chinese medicine theory of dialectical theory guidance. It optimized a better preparation, researched and established a more comprehensive quality control and fingerprint analysis whitch provided a new experimental and theoretical basis for the development of safe and effective Baoshenjiedu Granules.Methods1,The extraction process of rhubarb on several factors whitch includ the acid solution concentration, temperature and time, extraction method, extraction solvents were investigated and optimized by orthogonal test method of extracting with the total anthraquinone content evaluation. Preparation of the use of theoretical preparation, preparation of new kidneys, Granules.2,Five anthraquinones was selected as the index of components witch was analyzed the comprehensive quality of the Baoshenjiedu granules and developed a more comprehensive quality control with TLC and HPLC.3,Baoshenjiedu granules were compound Chinese medicine preparations which were composed of medicinal rhubarb and calcined oyster. The active ingredients were synergistic with each other in kidneys detoxification. It was studied fingerprint experimental of the and raw materials witch conducted to Aloe-emodin peak as the reference peak by HPLC/PDA detection and explored the conditions of HPLC chromatographic fingerprint analysis in the Baoshenjiedu granules for the establishment of the granules the quality of HPLC fingerprint analysis.Results1, The preparation process of Baoshenjiedu granules:1.0 g calcined oyster dilute in 5 mL HC1 solution, filtered, the filtrate obtained. Take 10 g of dry extract of rhubarb powder dissolved in 100 mL ethanol, mixing the two solutions, concentrated to the relative density of 1.30-1.35 (60℃measured) of the thick paste, extract and accessories by adding lactose 1:1 Mixed, made of soft material, over 4 orders, drug screening pellet, placed in drying oven at 45℃for 1 h, whole (taken by No.2 sieve sieve but not through 5, the particle as a product), after the release of whole Into the drying oven at 55℃, that may protect kidneys detoxification particles.2, It was established the quality control of the Baoshenjiedu granules with the TLC test, purity test control, impurity limits, high performance liquid chromatography determination of 5 anthraquinones.3,It was established the Baoshenjiedu granules and rhubarb herbs HPLC/PDA fingerprint analysis.ConclusionUnder the guidance of the theory of Chinese medicine, Chinese medicine formulations developed optimized compound preparation of granules extract better, to overcome the disadvantage of taking large doses, made of granules, the easy to use, easy to store. To achieve the industrialization of traditional Chinese medicine, modernization of new ideas and methods. The Baoshenjiedu granules are excellent in using and storing.The preparation have supply the modernization of new ideas and methods which would achieve the industrialization of traditional Chinese medicine.Granules was established to identify, Quantitative analysof 5 anthraquinones was determinated; granules fingerprint analysis method was established, the comprehensive quality of granules was worked out; safe and effective for the study provided new granules Experimental and theoretical basis.