Study on the Preparation Technology and Quality Standard of Danggui Dropping Pills
|Keywords||Danggui Dropping Pills Ligustilide Supercritical Fluid Extraction Quality Standard Preparation Technology|
Angelica sinensis(Oliv.)Diels is one of conventional Chinese medicines. There are many kinds of chemical compositions existed in it, mainly including volatile oil, phenolic acids and polysaccharides, etc. As the active fraction of Angelica sinensis(Oliv.)Diels, the volatile oil exhibits remarkable therapeutic effects in promoting blood circulation and removing blood stasis. Phthalides are main chemical substances in the volatile oil. Especialy, ligustilide, which has the highest amount in it, has been patented for treating cardiovascular and cerebral vascular diseases. In order to develop the new drug, the preparation and quality standard of Danggui dropping pills were sestematically researched in this dissertation.Firstly, we achieved quality evaluation of A. sinensis(Oliv.)Diels. The method of simultaneous detecting the content of ligustilide and ferulic acid was established by HPLC. Using this method, we measured and evaluated the quality of some samples (including crude drugs and processed pieces) of A. sinensis(Oliv.) Diels from different regions. Results showed that the quality of A. sinensis(Oliv.)Diels. was very different. To guarantee the quality stability of A. sinensis(Oliv.)Diels., the medicinal materials from Min town, gansu province was determined in our research.Secondly, the supercritical fluid extraction process of A. sinensis(Oliv.)Diels was studied and optimized. In this part, using the average transfer rate and purity of ligustilide as evaluating indexes, the optimal extraction conitions were determined by single factor test and orthogonal test. The detailed extration conditions were as follows: extraction pressure 10MPa, extraction temperature 45℃, extraction time 20min and drug particle size 40-60 mesh. After extracting, the purity and transfer rate of A. sinensis phthalides were both up to more than 80%.Thirdly, the preperation technology of Danggui dropping pills was researched. Taking the roundness, hardness and dripping status as evaluating indexes, the optimal dropping pills conditions were optimized by screening matrix sorts, dosage, and dropping temperature, etc. Because the dropping pills was sensitive to air, light and heat, which would affect the taste characteristic and internal quality, we optimized the coating process by screening coating materials, ethanol concentration, coating plasma concentration, the wind temperature and the flow rate of coating liquid,etc. experimental data indicated the conditions were feasible.At last, we studied and established quality specification of the Danggui dropping pills, including the TLC identification method and HPLC assaying method of ligustilide. This quality control method was specific, accurate and repeatable. We inspected the detection items, which were conformed with Chinese Pharmacopoeia(2010). In addition, we studied the initial stability of the preparation obtainded, including impact factors test, six months acceleration stability test and six months room temperature stability test. It turned out that the product should be stored in cool, dry space away from light.