| Modified Guilu Erxian Gao was modified Cistanches Herba and Hippocampal two chinese medicine on the base of the traditional classics party. Modified Guilu Erxian Gao were a compound preparation which contains six Chinese medicine, such as Testudinis Carapacis Et Plastri, Cervi Cornus, Changii Radix, Lycii Fructus, Cistanches Herba and Hippocampal. It had an efficacy with warming and recuperating kidney, invigorating qi and tonifying blood for the body. It was mainly used for the treatment of lumbar debility, and inadequate JingXie disease and so no, especially suitable for office for a long time, working pressure was big, exercise less white-collar regulate body, enhanced physique, enhance immunity, to overcome the sub-health. The preparation proeedure, quality standard and preliminary stability of the Modified Guilu Erxian Gao were Studied in this thesis.1Literature ReviewThis thesis on the research progress of paste which including production method, modern production technology, quality control and the clinical application. as so as summarized research progress about the Modified Guilu Erxian Gao of the source, the solution and each single herbs on chemical constituents, pharmacology.2The preparation process of Modified Guilu Erxian GaoThe optimal extraction process is determined according to the physicochemical properties of drugs. Because the modified Guilu Erxian paste is based in Guilu Erxian paste on modified cistanche and hippocampus and become, China Pharmacopoeia Reference ""(2010version a) method of Guilu Erxian paste, combined with the actual production conditions, tortoise shell, antler, hippocampus and other drugs to total nitrogen content as the index, the orthogonal test to optimize the extraction process, the optimal extraction process was:tortoise shell, antler, hippocampus, adding30times amount of water, decocting for4times, each time10hours. Cistanche, medlar, Radix Codonopsis, medicine to chrysanthemum glycosides and betaine content of pineal as index, orthogonal test was used to optimize the extraction technology, the optimum extraction process was as follows:Cistanche, fruit of Chinese wolfberry, party in15times of water decocting for4times, each time1hours. The filtrate with the filtrate and tortoise shell, antler, hippocampus, concentrated to a relative density of1.25(60℃), after the study on the forming process, choose Paste with honey ratio is1:0.5.3. The quality standard of Modified Guilu Erxian GaoIn order to effectively control the quality of modified Guilu Erxian paste, on the study of quality standard, TLC identification of the prescription of Cistanche, medlar, Radix Codonopsis, tortoiseshell and glycine betaine content by thin layer chromatography; main components by high performance liquid chromatography method for the determination of main components in Herba cistanches prescription of echinacoside content and medlar. Echinacoside in8.0546～56.3822μg showed a good linear relationship (r=0.9997), the average recovery was97.27%(RSD=1.20); Betaine in10.4606～104.6064μg showed a good linear relationship (r=0.9997), the average recovery was97.57%(RSD=1.41). Provisional echinacoside content shall not be less than2000μ g/g; Betaine Content shall not be less than6000μg/g; using the Kjeldahl total amount of this product contains the Kjeldahl method, the total nitrogen content is37.5%, the provisional total nitrogen content shall not be less than30%.4. The preliminary safety of Modified Guilu Erxian GaoTo study and preliminary safety on the3batch of modified Guilu two products, check the third month traits, relative density, insoluble, microbial limit, load difference, and according to the relevant provisions of examination of the tortoise shell, Codonopsis pilosula, Cistanche, fruit of Chinese wolfberry, glycine TLC and the3batch of modified Guilu Erxian paste echinacoside determination, betaine content, nitrogen content determination, the results are in accordance with the relevant provisions. |
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