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The Di'ao Xinxuekang capsules Quality Evaluation Method

Author: RanZuo
Tutor: ChenXiaoHui;BiKaiShun
School: Shenyang Pharmaceutical University
Course: Pharmaceutical Analysis
Keywords: Of Diao Xinxuekang capsule Chromatographic fingerprint Quality evaluation methods
CLC: R286.0
Type: Master's thesis
Year: 2008
Downloads: 236
Quote: 0
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Abstract


This study to ground Austrian effort Kang capsule of raw herbs extraction and separation and purification of five monomer compounds; established Di'ao effort Kang Capsule effective ingredient of HPLC content determination method, at the same time establish a HPLC and CE chromatographic fingerprint map, the system to its quality evaluation method were studied. Using a variety of chromatographic separation technology of Dioscorea effective parts carry out separation and purification, Five compounds, by spectroscopic analysis and combination of physical and chemical identification to determine its structure, respectively, as: Dioscorea nipponica saponins (dioscin), raw potato nipponica saponins (protodioscin), extension Age asiatica (trillin), methyl protodioscin (methylprotodioscin) and slender saponins (gracillin). Established in this study by HPLC-ELSD simultaneous determination ground Olympic Xinxuekang capsule in three kinds of active ingredient content. Shim-pack VP-ODS column (250 mm × 4.6 mm, μm), gradient elution with water and acetonitrile at a flow rate of 0.8 mL · min -1 , the column temperature was 35 ° C. Using evaporative light scattering detector drift tube temperature of 105 ° C, gas (air) flow rate of 2.7 L · min -1 . The linear range 1.021 0.21 μg (r = 0.9999),, 1.029 ~ 10.29μg (r = 0.9995) and 1.074 to 10.74μg (r = 0.9998), the average recoveries were 99.2% (RSD of = 2.0%), 101.9% (RSD of = 1.5%) and 100.7% (RSD of = 2.0%); same method Di'ao effort Kang capsule Trillium grass glycosides of content carried determination, its linear range of 0.8032 ~ 5.020μg (0.9991 ), the average recovery was 99.4% (RSD = 2.4%). The method was successfully applied to the 12 land grant the Austrian Xinxuekang capsules four effective components protodioscin, methyl protodioscin, diosgenin and Trillium glycosides Determination. The method is simple, accurate, reproducible, and provides methods for the Di'ao Xinxuekang capsule quality control. This study to establish the ground Olympic effort Kang capsule of HPLC chromatography fingerprinting using Shim-pack VP-ODS column (250 mm × 4.6 mm, 5 μm), to acetonitrile (A) - water (B) (0 ~~ 15 min, B: 75% → 71%; 15 ~ 25 min, B: 71%; 25 ~ 45 min, B: 71% → 65%; 45 ~ 65 min, B: 65% → 40%; 66min, B: 30%; 66 ~ 75 min, B: 30% → 0%) as the mobile phase gradient elution with a flow rate of 0.8 mL · min -1 column temperature was 35 ° C. Using evaporative light scattering detector drift tube temperature of 105 ° C, gas (air) flow rate of 2.7 L · min -1 . 12 batches Austrian Xinxuekang capsule chromatographic fingerprint analysis, the establishment of the capsule's Total mode the angle cosine measure to calculate the similarity between the samples with a total of mode. HPLC Fingerprint of 0.95 or more for qualified products. This study to establish the the Di'ao Xinxuekang capsules CE fingerprint, not coated fused silica capillary (50μm × 50 cm, effective length 42 cm), 20 mmol · L -1 borax -200 mmol · L -1 boric acid as background electrolyte, operating voltage 18 kV, UV detection wavelength 205 nm, and pressure injection 50 mbar · s -1 × 10 s chuck temperature 25 ° C 12 batches Austrian Xinxuekang capsule chromatographic fingerprint analysis, the establishment of a shared model of the capsule, and the cosine of the angle calculated measure of similarity between the samples with a total of mode. CE fingerprint similarity above 0.95 is qualified. In this study, the chromatographic fingerprinting Determination of multi-component combination, provide the basis for the Di'ao Xinxuekang capsule of quality control.

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CLC: > Medicine, health > Chinese Medicine > Of Pharmacy > In drugs > Drug identification
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