Studies On Preparation Technology And Quality Standard Of Bushenpaidu Granules

Bushenpaidu Granules are a compound preparation which contains 10 Chinese medicinal herbs, such as Astragalus, Codonopsis pilosula, Salvia miltiorrhiza, Leonurus japonicus, Achyranthes bidentata, and so on. It has an efficacy with invigorating spleen and reinforcing kidney, invigorating qi and nourishing yin, removing blood stasis and purgation turbid urine. It is mainly used for the treatment of the chronic renal failure because of deficiency of both qi and yin on the spleen and kidney. Based on the results of literatures investigation and the active ingredients of the different Chinese medicinal materials, refer to the established extract technology of the same active ingredients from the same Chinese medicinal materials as to preparaing other Chinese patent medicine, the extract processes of the main active ingredients were defined respectively and the extraction technology parameters were optimized, thus the scientific and reasonable extraction and preparation technology were determined. Using modern analysis technologies such as the thin layer chromatography (TLC) method and the high performance liquid chromatography-evaporative light scattering device (HPLC-ELSD), quality standards of the preparation were set up. The preliminary stability studies of the preparation were carried out accoring the official study methods.To obtain the best preparation technology, orthogonal test L9 (34) was used to excellent choose the extraction and preparation parameters of the Bushenpaidu Pellets. The Salvia miltiorrhiza was added to 85% alcohol of eightfold volume and returning extraction methods for 3 times (1.5,1.5,1.5 h) was applied. The mixture was filtrated, and the extracting juice was combined. The concentrated extract was obtain by removing the excessive alcohol. Then the concentrated extract was dried by vacuum drying. This was labelled as extractⅠ. The residual of Salvia miltiorrhiza and other seven Chinese medicinal herbs including Astragalus membranaceus, Broussonetia papyrifera, Codonopsis pilosula, Polygonatum kingianum, Leonurus japonicus, Alisma orientalis, Plantago asiatica were added to water of twelvefold volume, decocted and boiled 2 times (2,2 h), filtrated and concentrated to suitable volume. Then 95% alcohol of double volume was added slowly into the extract, mixed for 20 min, placed for 48 h to precipited completely. Finally, the extracting juice was filtrated and the concentrated extract was obtain by removing the excessive alcohol. This was labelled as extractⅡ. Furthermore, Rheum palmatum and Achyranthes bidentata were acceded to 75% alcohol of eightfold volume and returning extraction methods for 3 times (2,1.5,1.5 h) was applied. The mixture was filtrated, and the extracting juice was combined. The concentrated extract was obtain by removing the excessive alcohol. This was labelled as extract III.The extract II and the extract III was combined added suitable amount dextrin, mixed, dryed and grinded. Then, the extract I and 1.0% stevioside was added and mixed. Finally,1000 g granules was get by pelletizing all the material metioned above. The obtained franules was divided by 10 g per bag, packed and sterilized, then stored for further use.The TLC method was selected to establish the quality standards. The standard tanshinone-ⅡA, stachydrine, oleanolic and emodin were used as control. The TLC were carried out to identify the 4 herbs such as Salvia miltiorrhiza, Leonurus japonicas, Achyranthes bidentata, and Rheum palmatum. The relevant spots were clear and specific strong compared with their control. These illuminated that the 4 herbs were valid. The content of astragalosideⅣthat was contained in Astragalus was determined using the HPLC-ELSD method. The mobile phase was Acetonitrile-water (35:65), as a result, the regression equation of the astragalosideⅣ was y=0.9836 x+8.9452, r= 0.9996, and the calibration curve was linear within a range of 2-30μg. The average recovery rate was 97.5%, and the RSD was 1.2%. The astragaloside IV content were controlled between 1.753～1.953 mg each bag (10 g). The stability studies including the accelerated tests for 3-month and the long term stability tests for 6-month had been done.In one word, the preparation method was applicable, and the quality of the preparations could be controlled. Further studies was value to be carried out to develop Bushenpaidu Granules as a new Chinese Traditional Medicine.