| The FuFangTongLuo capsule is made up of 5 kinds of Chinese Materia Medica, which contains Huangqi, Sanqi, Chuanqiong, Xijiancao, Dannanxing, etc. FuFangTongLuo capsule is an experience clinical composite prescription of the 3rd subordinate hospital of Nanjing university of TCM, It has the function of nourishing qi and activating blood, removing extrav asted blood passes. It is mainly used in the anemic stroke and the stroke sequela, which belong to the lacking in vital energy and blood stasis phlegm. The symptom can be seen the body unable to move voluntarily, the mouth eye slanting, the language disadvantageous and so on. This study mainly is on pharmacy for the FuFangTongLuo capsule.First, the origin of medical material and appraisal: the FuFangTongLuo capsule contain radix astragali, radix Notoginseng, chuanxiong, common St. Paulswort, bile arisaema. According to Pharmacopoeia of People’s Republic of China 2005 yearsâ… part, study the medical material of the FuFangTongLuo capsule on the habitat, micro, the thin layer chromatograpy distinction and the partial content determination. All the results of Chinese Materia Medica test are in accordance with Pharmacopoeia of People’s Republic of China2005 yearsâ… partSecond, study for the production process of the FuFangTongLuo Capsule:â‘ The optimization of ethanol extraction process of radix astragali, radix Notoginseng, Chuanxiong was investigated using L9 (34) orthogonal design with the contents of Astragaloside and ginsenoside Rg1 as the indices. The result is that adding 20 fold of 60% alcohol to medicinal herb for 3 times and 1.5h per time as the best extraction technology.â‘¡The optimization of boiling water technology of common St. Paulswort, bile arisaema was investigated using orthogonal design with the contents of total polysaccharides and alkaloid as the indices. The result is that adding 20 fold of water solution to medicinal herb for 2 times and 1.5h per time as the best extraction technology. To reduce the capsules’ dosage, with the contents of total polysaccharides and alkaloid as the indices, precipitation using different concentrations of ethanol to depurate aqueous extract, The findings have confirmed that the aqueous extract is concentrated then ethanol is added to 50% alcohol content for the best.â‘¢inspection of concentration: the contents of Astragaloside and ginsenoside Rg1 as the indices, The t-test comparison of the content of films before enrichment, and no significant difference.â‘£the inspection of drying methods and conditions: the contents of Astragaloside and ginsenoside Rg1 as the indices, The result: spray drying conditions to extract medicines by filtration, condensed to the relative density 1.10~1.15 (60℃), increase by 10% on radix Notoginseng powder, mixed on the import of 165~175℃temperature, vacuum 300~350Pa column. export under the conditions of temperature spray drying, spray-dried powder present the solid yellow loose powder, moisture content below 5%.⑤granulation conditions options: adding 95% ethanol to determine appropriate conditions for granulating granulation, the effect of granulationis easy.Third, the quality standard of the FuFangTongLuo Capsule: determining content of Astragaloside and ginsenoside Rg1 by HPLC., and to study assaying method. To carry out lamellar analysis on radix Notoginseng, chuanxiong, common St. Paulswort, bile arisaema and for the Control of Pharmaceutical by TLC method. As a quality standard of the FuFangTongLuo Capsule, the result shows that the separate effect is good and easy to control. Besides, the check of water, capacity volume variance, time of disintegration, and the microorganism limitation are all in accordance with Pharmacopoeia of People’s Republic of China 2005 sectionâ… . Heavy metals and Arsenic test results are all in accordance with the safety requirements of examine and endorse of new drug of Chinese Materia Medica.Fourth, inspection of the FuFangTongLuo Capsule stability: through inspection at room temperature and accelerated test inspections, Results: The sample product which was lay up at room temperature 12 months and accelerated tests 6 months are investigated, the characters, properties, content adhere to quality standards. |