Studies On Processing Technology And Studies On The Quality Control Of Siwu Granules

Objective:Siwu Decoction is composed of Radix rehmanniae, Angelicae sinensis, Radix paeoniaea abla and Rhizoma chuanxiong. It is a famous traditional Chinese medical formula for enriching and regulating the blood, as a good medicine for gynecologic, the medication history is glorious, has obvious curative effect, and extensive in clinical application, and an enormous market requirements, The former prescription is medicinal broth, Pharmacopoeia of china record it as a mixture, now there are capsule, tablets and so on. But these formulation still face large dosage and poor stability, Siwu mixture will appear phenomenons such as turbidity or precipitation, to transport and to take is unconvenient, therefore it is necessary to improve dosage form of Siwu mixture, to achieve the goal that both retains effectiveness of the original prescription and reduces the dosage, simultaneously improve the stability, easy to take and transport. With the guidance of the theories of traditional Chinese medicine, Siwu granules was studied with modern pharmaceutical technology. On the basis of differences of effective parts as well as different characters of them, traditional decoction was transformed into granules by the optimum extracting and processing technologies.Methods:This research studied on the preparing technology of Siwu granules. Orthogonal design is applied to research the best extracting conditions of ethanol extraction effective fraction (glycoside, organic acids, Alkaloids), the influencing factors of macroporous resin purification of ethanol extraction were investigated and the optimum experimental condition was determined. The optimum extracting technology of Polysaccharides in Siwu decoction was also determined, the optimum processing technology was selected by orthogonal design which used several assessing norms to research factors of auxiliary material, etc. at last quality standard of Siwu granules were performed.Results:The preparation of Siwu granules:extracting technology is:add 95% of the ethanol of quantity of 8 times and 6 times respectively, reflux extraction twice (1.5h and 1.0h). The extracts were collected together and concentrated as 0.7g/mL of raw herbs, then passed through a column containing macroporous absorption resin and use 80% ethanol as eluation, then the 80% ethanol eluation was collacted and concentrated under reduced pressure, ethanol extraction effective fraction was obtained, the herb residue was added 8 and 6 times of water respectively, reflux extraction twice (1.0h and 0.5h respectively). The extracts were collected together and concentrated under reduced pressure, water extraction effective fraction was also obtained. Two effective fractions were combined together so as to prepare granules. The optimum processing technology was that use 90% ethanol as wetting agent, the ratio of assistance materials(soluble starch:dextrin=7:1), the amount of assistance materials was 0.4:1, drying temperature was 50℃. In order to control the quality of Siwu granules, angelica sinensis, white peony roots, Ligusticum chuanxiong Hort were identified by TLC. Establish a method for content determination of paeoniflorin and ferulic acid by HPLC.Conclusion:The research indicated that the technology of preparation was reasonable and practical, the standard of quality was controllable.