| OBJECTIVEThe study is aim to control the Quality of ShenFuShu Granules.METHODS1.Content determination1.1 Agilent TC-C18 Column (4.6 mm×250 mm,5μm) was used to determine the Gallic acid in ShenFuShu Granules, the mobile phase was acetonitrile-0.05% phosphoric acid (5:95), the flow rate was 1.0 mL/min,λ1=273 nm,and the column temperature was at 30℃.1.2 Agilent TC-C18 Column (4.6 mm×250 mm,5μm) was used in the determination of chrysophanol, liquiritin and naringin in ShenFuShu Granules (Rheum offcinale Baillon, Radix Glycyrrhizae and fructus aurantii) by HPLC-DAD. The mobile phase was methanol-0.1% glacial acetic acid for gradient elution (0-20min,methanol from 40% to 60%,0.1% glacial acetic acid from 60% to 40%;20-40min, methanol from 60% to 85%,0.1% glacial acetic acid from 40% to 15%; 40-45min,methanol 85%,0.1% glacial acetic acid 15%). The flow rate was 1.0 mL/min,λ1=276 nm(detect the liquiritin),λ2= 283 nm (detect the naringin),λ3=254 nm(detect the chrysophanol). The column temperature was at 30℃.2. Fingerprint12 batches of ShenFuShu Granules were extracted in 50% methanol ultrasonic extraction, respectively. Subsequently, the samples solution was separated on an Agilent TC-C18 column(4.6 mm×250 mm,5μm)and detected by DAD Mobile phase was composed of aqueous phosphoric acid(0.05%)and acetonitrile using a gradient elution. Analysis was performed a 30℃with a flow rate of 1 mL-min-1 and UV detection at 254 nm. 3.Study on dissloutionThe dissolution of the of chrysophanol, liquiritin and naringin in ShenFuShu Granules was determined by performed with plasma method, O.lmol/L hydrochloric acid 500 mL at a speed of 100 r-min-1.RESULTS1.Content determination1.1 The linear ranges for gallic acid were 11.60-116.00μg/mL (r=1).The average recovery of Gallic acid were 99.9% with RSD of 0.46%.And the content of Gallic acid is:1.55mg/g.1.2 The linear range of chrysophanol was within 13.64μg/mL-136.4μg/mL, r=0.9999, the recovery was 99.5%(n=9). The linear range of naringin was within 5.52μg/mL-55.2μg/mL, r=0.9999, the recovery was 99.4%(n=9). The linear range of liquiritin was within 17.52μg/mL-175.2μg/mL, r=1, the recovery was 99.5%(n=9). And the content of chrysophanol is:0.36 mg/g,the content of naringin is: 1.90mg/g, the content of liquiritin is:3.53mg/g.2. FingerprintThere were 39 common peaks in ShenFuShu Granules and peaks identified. The fingerprints peaks were defined by software which were published by the committee of pharmacopeia of China(2004A), The similarity degree was above 0.90.3. Study on dissloutionThe dissolution of chrysophanol, liquiritin and naringin in ShenFuShu Granules in 45min is:chrysophanol 86.7%(RSD=1.6%), 86.3%(RSD=1.6%),85.7%(RSD=2.3%); liquiritin 88.9%(RSD=1.2%), 87.2%(RSD=1.2%),86.9%(RSD=1.7%); naringin 86.4%(RSD=1.1%), 87.4%(RSD=1.3%),85.3%(RSD=1.5%).CONCLUSIONS1. The HPLC method is simple, accurate, stable, and has good reproducibility. It can be used for quality control in the production of ShenFuShu Granules.2. The fingerprint of ShenFuShu Granules could be applied to the intrinsic quality control of ShenFuShu Granules.3. The dissolution rate of three active components from ShenFuShu Granules was fast and the analytic methods established in this study could be used to evaluate the quality of the preparation.
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