Alchemy Capsule Pharmacy Part Of The Study

Danzhu capsule is a kind of Chinese medicine compose preparation, which consist of six herbs such as Zedoray Rhizome and Danshen Root. It possesses the action and indication of removing blood stasis and dispersing masses , strengthening body resistance and eliminating pathogens. It is indicated for the treatment of malignant tumor main for lung cancer of qi-stagnancy and blood stasis or qi-deficiency and blood stasis. Under the guidance of Traditional Chinese Medicine theories, and with the help of the modern pharmaceutical technology, Danzhu capsule was studied on pre-clinical pharmaceutical reasearch.Base on the clinic demand, the dosage form was chosen as capsule. On the basis of the action and indications as well as the character of the ingredients included in the herbs, the optimum extract conditions about alchohol-extract and water-extract were selected by using orthogonal design which use quite a few assessing norms to evaluate them comprehensively. The optimum extract conditions were all herbs made by processing and extracted with 75% ethanol under reflux twice, using 6 volumes of ethanol for 1.5 hours both times. Residue decocted with water twice for 1 hour each time, using 8 volumes of water for the first time, and 6 volumes of water for the second time. The purifying technology were ethanol-extract filtered with filter cloth and water-extract separated by high speed centrifugal filter. The concentrate technology were ethanol-extract filtrates recovered under reduced pressure, concentrated to a clear extract with a relative density of 1. 10 (60℃) respectively, combined them and dryed by spray. Added some adjuvant to the clear extract to make granulation, then made capsule.At the same time, the quality standard of the drug product for clinical trail had been made, studing the ingredients such as Danshen Root, Ginseng Root and Tuber Fleeceflower Root respectively by using TLC. Meanwhile, by means of HPLC to determine the content of Danshensu and accomplished the systematic methodology.Preliminary stability research had kept on 3 months, the further research is in progress, the results indicated that Danzhu capsule was stable and the packing was suitable.The results indicate that the preparation process is reasonable and practical, the standard is controllable, the quality of the sample is steady on the whole as well.