Preparation Of The "BAO GAN HU SHEN TUO MEI SU" Granules

This study was for the mycotoxins in the veterinary clinic with the main symptom of liver,kidney and immune damage on the livestock and poultry. It was the principle that "protect liver and enhance immunity", made the Bupleurum chinense,Astragali,et.al to be the Chinese medicine granules of "Baoganhushentuomeisu" from the view of traditional Chinese veterinary medicine theories and the Modern Chinese drugs pharmaceutics theories, screening the optimum conditions by using orthogonal test method, and appraising its quality control method、stability.1. In oder to achieve the optimal preparation process of "Baoganhushentuomei-su",choose the decoction time、decoction frequency, ratio of material to liquid soak period content to be the main influential factors, The optimum conditions were obtained by an orthogonal design of L₉（4-3）, the optimal technology were soaking1.5hour with20times water and decocting for2times,once a hour. The decoction was concentrated to extract at70degrees.As evaluation index of granule appearance,melting agent and hygroscopicity,the best molding process:lactose as accessories, the humid soft material was made of extract and accessories at the ratio of1:4. Then pelletizing,stoving at50degrees,screen-ing. Granules was uniform,brownish red,good solubility and low moisture absorption rate.2. For establishing the quality control standard, identify Saikosaponin a, Astragal-oside,Baicalin and Schisandra using the thin layer chromatography.The chromatographic conditions were stable and reliable.Detected the Saikosaponin a, Baicalin in "baoganhus hentuomeishu" Granules by high performance liquid chromatography （HPLC）. The chro matographic condition as follows, Saikosaponin a:Mobile phase:Methanol-water （70:30,V/V）; Flow number:1mL/min; Column temperature:35℃; UV Detect W/L:208nm; S ample size:10μL;Baicalin:Mobile phase:Methanol-water-phosphoric acid（47:53:0.2,V/V）; Flow number:0.8mL/min; Column temperature:35℃; UV Detect W/L:280nm; Sa mple size:10μL The methods could be used for the content detection for "baoganhushen tuomeishu"Granules with the char-acteristic of highly stabilization, reliability, reproduci bility. recovery rate and accurate consequence.3. In order to determine the optimal storage conditions and period of validity of th"Bao Gan Hu Shen TuoMei Su",Granules was stable at room temperature,and effect- ive for a period of two years,through the temperature accelerated test, light accelerated test, high humidity test and long-term placement test.