Study On Preparation Technology And Quality Standard Of The Mixture Of Acute Mastitis

Objective:This topic is a study of acute mastitis mixture preparation process. The preparation process was optimized by orthogonal experiment design,which is verified by pilot test. Through the medium test, we made it into a mixture, and completed the quality standard draft of formulation and study stability.Methods:1 Study on Preparation Technology The preparation technology includes three parts:preparation technology of volatile component extraction, preparation technology of water extraction and preparation technology of clarification. For the optimizing of extraction process of volatile component, methods Orthogonal design was adopted. Extraction content of ligustilide was used as the index to investigate the extraction time, pressure, temperature of volatile component. For the optimizing of extraction process of water, methods Orthogonal design was adopted. Contents of chlorogenic acid and Baicalin was used as the comprehensive evaluation index to investigate the quantity of adding water, the frequency and time of extract of water. For the optimizing of concentration of alcohol precipitation, single-factor test was adopted. Contents of chlorogenic acid and Baicalin was still used as the index to comprehensively investigate clarification process and experiment with 50% alcohol precipitation,60% alcohol precipitation, and 70% alcohol precipitation. The amount of surfactant, preservatives and other additives is determined by the optimizing of the molding process.2 Preparetion of quality standard draft and preliminary stability test TLC was adopted for qualitative identification of Rhizome, licorice and honeysuckle in Acute Mastitis Mixture to determine their TLC identification method. HPLC was adopted to determine the contenchlorogenic acid to establish a HPLC method of determination. Preliminary stability test was conducted according to inspection items and methods in the quality standard draft regulation.Results:The optimal extraction process is screened and determined as follows by orthogonal test:1 The optimal extraction process of volatile components is smashing the Bupleurum, Loulu, Chuan Xiong and separating in by the 20 mesh bolt, then extracting volatile components for 2 hours using supercritical-CO2 in the condition of 25 MPa,35 degrees.2 The optimal extraction process of baicalin and chlorgenic acid is twice extraction by 2.5h, to add 8 times of water.3 Adding ethanol to 70% alcohol Concentration works best in the alcohol precipitation process.4 Volatile components could be totally dissolved when the dosage of surface active agent Twain-80 doubled the amount of volatile components; The corrosion protection effect was achieved when the amount of potassium potassium was 0.2%.ConsLusion:This paper has prepared quality standard draft of the Acute Mastitis Mixture. The method is simple, stable and reliable and can be determined accurately and quantitatively, which can be used for the quality control of acute mastitis.