| Xiangbai rupi Granule is a Prescription with years of experience in clinical. It is consists of seven Chinese herbs(Curcuma, White peony root, Cyperus rotundus Etc.),with promoting qi circulation to relieve pain, soothing liver-qi stagnation, removing stasis, blood menstruation, mainly for the treatment of qi depression to blood stasis breast cystic hyperplasia and Precancerous lesions of breast cancer. This issue is under the guidance of TCM theory, according to the State Administration of Drug Registration, with the application of modern pharmaceutical technology. Preparation techniques of formulations, quality standards and stability tests were carried out systematic research and conducted a preliminary study to some question on extraction of volatile oil of Chinese medicine.Treatment under the prescription and Physical and Chemical Properties of Pharmaceutical active ingredients contained in herbs.The single factor method, and orthogonal multi-index comprehensive used to optimization of various process parameters. Ultimate, determine the conditions were:Takewhite peony root, Prunella vulgaris in 70% ethanol plus 10 times, refluxing three times every 1.5 hours at a time, filter through, combining filtration, recycling ethanol and vacuum concentration. Obtaining concentrated solution have relative density. Cyperus rotundus and other herbs were added in 10 times the amount of water, extracting volatile oil for 3 hours and collecting it. Then each volatile oil 1ml add 8gβ-CD and 80ml water. They were grinded for 30 minutes by Colloid mill, taking the suction filtration after refrigeration, dry and comminute. The volatile oil after extracted of herbs and tuckahoe were added in 10 times the amount of water, soaked 1 hour, boiled three times every 45 min at a time, filteration, combining filtrate and the water after extracting volatile oil, off center. The liquid medicine evaporated to the relative density. Mixing it with concentrated solution after Recycled ethanol,take sponging drying, and collection of spray-dried powder, through 80 mesh sieve, addingβ-CD inclusion volatile oil and steviosin, blending, using dry granulating, split charging. This study lays down the product quality standards, taking the TLC distinguished Cyperus rotundus, white peony root and other four drugs. The TLC is clear and have good separation, negative non-interference. Using HPLC to determine the content of paeoniflorin and ferulic acid, take methodology research. And tentative bag containing has the product of paeoniflorin not less than 60mg, ferulic acid not 1 ferulic acid ess than 1.8mg.Adopt accelerating test and Long term test investigated the stability of the test product. The results show that:The preparation is reasonably practicable, quality standards easily controlled, stable product quality.In a related study of volatile oil, to unstable quality of the bulk drug, large-scale production yield is low, the inclusion of volatile oil industrialization level is low, inclusion metabolism is not clear, conducted a preliminary exploration. Transformation through the device, screening method for inclusion of industrial, Pharmacokinetic studies, and other related research, preliminary solve the above problem. This study provide a reference for future study and reference. |
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