| Objective: Xiaoyao Powder Formula originate from the "Taiping Huiming Heji Jufang ",composed of Chaihu,Danggui, Fuling,Shaoyao,Baizhu,Gancao,Shengjiang and Bohe and it is a frequently used formula by practitioners throughout ages.And as the modern reaserch developing deeply,it is possible to explain the science bases and actional mechanism of Xiaoyao Powder more detail and the use scope of Xiaoyao Powder will be continue to enlarge .But based on the ancient and modern literature,we find that the series of Xiaoyao preparations defect normalizational techonology of research and qualitation standard . So the purpose of the studytries is to offer a new trend and method towards the standardization in dealing with the Xiaoyao Granule. And to standardizate the preparing conditions and quality standard of Xiaoyao Granule in order to provide a basis for mass production.Methods: The guidance of the theories of TCM and pharmacy, the related statutes to new TCM products in the "Examining and Approviizg Method of New Medicine", and the function of the prescription and properties of active agents in the herbs were all taken into consideration during the design and practice of the research. Adopting modern pharmaceutical techniques and methods of comparison and orthogonal design with multifactor evaluation comprehensively, this paper administration focused on the preparation procedure, the quality standard, the preliminary stability.At the same time,the reaserch of IR and NIR related to the Chinese herbs which composed Xiaoyao Powder were offerd and to primarily establish a analysis method.In the appreciation of crude herbs , to add the assaying standard of Chaihu;at the same time ,the results suggest that the crude herbs ,complex prescription extracta and granula's infrared spectrums are all have conspicuous characteristic absorption bands .For the Fuling and Fuling polycose, they are hard to qualitatived and quantitived ,so their infrared spectrum were to study and research.And in this paper ,their characteristic absorption bands were determined for the first time .In the normative preparation technology research ,we considerated the extract method of essential oil in complex prescription at first , by contrasting three method and based on the yield of essential oil and component ,then optimizating better techonology ofindustrialization ,adopting orthogonality to design the experiment ,then optimizate the best parameter.Secondly,according to the Traditional Chinese Medicine priniciple,we use water to decode herbs;adopting orthogonality to design the esperiment and optimizate the best parameter of extraction.Based on the active component and pharmacodynamics ,contrasting the centrifugalization technology of precipitation with ethanol. Last,optimizing the best parameter of condense,dry and granulate to offer the reasonable ,normative and scientific data for industrialized production .In the research of normative quality specification ,the indentification methods and conditions of Chaihu,Danggui,Baishao and Gancao were offered ,and we also establish the assaying method of Chaihu,Baishao,Danggui.All of this is to establish a reasonable,normative and scientific quality control systerm.Results: To specify the optimum preparing conditions of Xiaoyao Granules is using 8 timeswater to decocte the herbs for 3times,each time for 1 hour. Than the water was concentratedto extract tatio in the range of 1:1, precipitation with ethanol containing35%water ,centrifugal separate 10 min by 3000r/min,refining ,then the supemate is todecompress and condense to the density 1.10,add 15% Dextrin of herbs ,then stiruniformly .Aopting " Drying Spray - One step Granulate" technology todry and shape theextract.Throughing the physico-description investigation granule's quality specification isqualification.Conclusions: The results suggest that the preparation procedure is reasonable andpractical, the standard is controllable, and the quality is stable on the wholepaper. |
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