| ObjectiveTo investigate the extraction processes, formation technologies, experimental enlargement and related quality control of Compound Shenqi Wuwei chewable Tablets, which provides basic medical to new drug approval in the market, establishes the best extraction process and accurate the quality control standard of Compound Shenqi Wuwei chewable Tablets.MethodsWith content of Schisandrin, ginsenoside Rg1 and AstragalosideⅣfor idex, combining the extraction yield of ethanol extract and water extract, The orthogonal design L9 (34) was used to optimize the extraction process and the optimize formation technologies; Thin layer chromatography (TLC) was used to identify ginsenoside Rg1, ginsenoside Re, ginsenoside Rb1, Schizandrin, AstragalosideⅣand ophiopogon japonicus medicinal materials; While high performance liquid chromatography (HPLC) was used to determine the cotent of Ginsenoside Rg1, Schisandrin and AstragalosideⅣintablets. The HPLC conditions for Schisandrin: Dikma Diamonsil-C18 (250mm×4.6mm, 5μm) column was used. The mobile phase consisted of Methanol-water (57.5:42.5), with a flow rate of 1.0mL·min-1 and detection wavelength at 250nm under room temperature; For Ginsenoside Rg1: Dikma Diamonsil-C18 (200mm×4.6mm, 5μm) column was used. The mobile phase consisted of acetonitrile-water (20:80), with a flow rate of 1.0mL·min-1 and detection wavelength at 203nm under room temperature; For Astragaloside IV: Dikma Diamonsil-C18 (250mm×4.6mm, 5μm) column was used. The mobile phase consisted of Acetonitrile-water (32:68), with a flow rate of 1.0mL·min-1 and detection evaporative light-scattering detector (ELSD) under room temperature. ResultsTo determine the best preparation technology of Compound Shenqi Wuwei chewable Tablets: Schisandra chinensis and Ginseng was as follows: 10 fold of 90%ethanol, reflux extracting for 1.5 hours in heating mantles, 3 times. Merging the extract, filtering, filtrate recovery ethanol and the thick paste could be concentrated to relative density 1.301.35 (60℃), reserving it; adding medical slag and shenqi in 10 fold of the boiling water for 1.5 hours, 3 times. merging filtrate, filtering, filtrate could be concentrated to plaster of relative density 1.301.35 (60℃) , reserving it; then adding 80% ethanol to 40%, stirring, and leaving for 24 hour and filtering. filtrate recovery ethanol and the thick paste could be concentrated to relative density 1.301.35 (60℃), combining with the above thick paste, spraying dry to fines, adding sucrose (15%), Mannitol (15%) as bottom fraction, using amylin (20%), protein sugar (2%), essence (1%), magnesium stearate (1%) and an appropriate amount of water into paste and then spray and granulate, fluidifying for 15 min, with the addition of appropriate magnesium stearate, after sieved to 16 meshes, compression 1.8g/ tablet. The dapples in the TLC plate are clean and the result of Separation is good ; The Ginsenoside Rg1, Schizandrin, Astragaloside IV had a linear range of 2.517.5μg·mL-1, 2.412μg·mL-1, 4.632.2μg·mL-1, and the average recovery rate of Ginsenoside Rg1, Schizandrin, Astragaloside IV were 98.1%, RSD=2.0%; 97.2%, RSD=1.4%; 97.71%, RSD=1.2%, respectively.ConclusionsThe systematic research on the ethanol extract and water extract process of Shenqi Wuwei chewable Tablets was performed. The quality control indices was chosen to the quality assessment. And the extraction ratio of ethanol extract and water extract were used to screen new drug development and pilot scale production for the best process condition, which is very important for basis; This method is accurate, reproducible and sensitive, and it can be used for the quality control of Compound Shenqi Wuwei chewable Tablets. |
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