Study On Preparation Technology, Quality Standard And Main Pharmacodynamics

QiBai Granules is a new traditional compound preparation of pure Traditional Chinese Medicine, which consist of Astragali Radix, Macrocephalae Rhizoma, Scutellariae Radix, Ligustri lucidi Fructus, Ecliptae Herba, Spatholobi Caulis, Coicis Semen, Cuscurae Semen, Poria, Trichosanthis Radix, Notoginseng Radix Et Rhizoma, Glyscyrrhizea Radix Et Rhizoma. It always be used for the treatment of leukopenia in clinically. This topic put Chinese medicine theory as theoretical basis, put orthogonal test as design methods, aim to determine the best preparation process, study the quality standard and investigate the role of elevated white blood cell of QiBai Granuels.The main contents of this topic are as follows:The prescription of QiBai Granuels are divided into two categories, which Poria, Trichosanthis Radix, Notoginseng Radix Et Rhizoma as a class, they are added into medicine by original powder after crushing, the rest which are added into medicine mainly by aqueous extraction of active ingredients.1. Study on preparation process of QiBai GranulesThis part put orthogonal test as design methods, investigate the extraction process of remaining nine flavor prescription drugs of QiBai Granuels. The extraction solvent are water, the investigate factor are solvent consumption, extraction times and extraction time, the investigate indexes are extract yield and the content of baicalin. The best extraction process as follows:the amount of solvent is 8 times the amount of water, extracted for 2 times, the extraction time for the first extract is two hours {Scutellariae Radix added after boiling), the extraction time for the second extract is one hours, filtration, combined filtrate and set aside.This part put orthogonal test as design methods, inspect the alcohol precipitation of water extract. The investigate factors are the alcohol content and the relative concentration of the liquid, the investigate indexes are extract yield and the content of baicalin. The best alcohol precipitation as follows:concentrate the filtrate to a relative density of 1.18-1.22 (60℃) by using evaporated method, add some ethanol to the alcohol content is 60%, stoping and stiring. After the liquid was allowed to stand 12h, take the supernatant and set aside.This part put comparison test as design methods, inspect the molding process. The investigate factors are the amount of powdered sugar and dextrin, the investigate indexes are moisture resistance and taste of granules. The best molding process as follows:recover ethanol solution by vacuum method, continue concentrat to a certain density of thick manuscript, add Poria, Trichosanthis Radix, Notoginseng Radix Et Rhizoma powder, sugar and dextrin(thick paste:dextrin:sucrose powder=1:1:1), mixing, Granulated with 75% ethanol, pellets were dried at 60℃,2. Study on quality standards of QiBai GranulesAccording to "Granules" General granules preparation, check the particle size, moisture, melting resistance, load difference and microbial limit of QiBai Granules.Using microscopic identification method identity TCS and Poria two flavor ingredients; using TLC identification method identity Astragali Radix, Notoginseng Radix Et Rhizoma, Glyscyrrhizea Radix Et Rhizoma three flavor ingredients; adopting HPLC identification method identity Scutellariae Radix. The test results show that identification method is simple, safe and effective, can identificate six herbs which contained in QiBai Granules.Adopting HPLC to determine the content of baicalin in QiBai Granules. Column: Prevail C18 (4.6mmx250mm,5μm), Mobile phase:methanol-0.2%phosphoric acid water liquid(50:50), flow rate:1.0mL-min-1, detection wavelength was set at 280nm; column temperature:25℃. The method is scientific, sensitive, rapid, reliable, and can accurately detect the content of Baicalin in Qibai Granules.3. HPLC Simultaneous Determination of Five Active Constituents in Qibai GranulesUsing Mult-index control mode to establish an HPLC method for simultaneous determination of five active constituents. HPLC analysis was performed on a Prevail Ci8 column (4.6mm×250mm,5μm) with methanol-0.2 phosphoric acid as mobile phase by gradient elution. The flow rate was 1.0 mL·min-1 column temperature was maintained at 25℃, and the detection wavelength was set at 203nm. The test results show that this method can evaluate the quality of QiBai Granules fully and accurately to ensure clinical efficacy.4. Study on Pharmacodynamic of QiBai GranulesTo research the effects of QiBai Granules on mice leukopenia models. Experimental results show that QiBai Granules could obviously raise the counts of white blood cell, bone marrow karyocyte, organ coefficient, body weight and swimming time of the leukopenia model. These results suggest that QiBai Granules can elevated white blood cell.