Sponsor(s): Tianjin Institute of Pharmaceutical Research；Chinese Pharmaceutical Association
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Current Issue: Issue 22, 2020
Chinese Traditional and Herbal Drugs is supervised by Chinese Pharmaceutical Association and sponsored by Tianjin Institute of Pharmaceutical Research and Chinese Pharmaceutical Association. Launched in 1970, the journal is an academic journal with a broad scope in publishing research papers, brief reports, reviews, dissertations, and special treatises on the recent achievements of basic study, production, quality control, and clinic application on traditional Chinese medicine and Chinese materia medica. The journal is included in CA, JST and CSCD.
Overall quality control of Jinzhen Oral Liquid based on HPLC-UVD-ELSD fingerprint and simultaneous determination of 13 main representative components
Chinese Traditional and Herbal Drugs,2020,Vol 51,No. 22
Objective To establish the fingerprint of Jinzhen Oral Liquid (JOL) by HPLC-UVD-ELSD and determine the main 13 representative components (gallic acid, liquiritin, aloe-emodin-8- O-β- D-glucopyranoside, liquiritigenin, baicalin, chrysin-7- O-β- D-glucoronide, oroxyloside, wogonoside, chrysophal-1- O-β- D-glucopyranoside, chrysophal-8- O-β- D-glucopyranoside, rhein, glycyrrhizic acid, hyodeoxycholic acid and cholic acid) simultaneously, in order to provide reference for the overall quality control of JOL. Methods The separation was performed on Cosmosil-C 18 column (250 mm × 4. 6 mm, 5 μm) via gradient elution with methanol–water [containing 0. 1% formic acid] at 254 nm; the temperature of the drift tube was maintained at 115 °C and the carrier gas flow rate was 2. 0 L/min. An HPLC-UVD-ELSD fingerprint of JOL was established, and 15 batches of JOL were evaluated by similarity assay. Furthermore, the contents of the main 13 representative components were determined on the premise of small disparities among batches. Results The HPLC-UVD-ELSD fingerprint of JOL was established with good separation, and 13 chemical components were determined simultaneously. Fifteen main characteristic peaks [gallic acid (peak 1), liquiritin (peak 5), aloe-emodin-8- O-β- D-glucopyranoside (peak 7), liquiritigenin (peak 11), baicalin (peak 13), chrysin-7- O-β- D-glucoronide (peak 16), oroxyloside (peak 17), wogonoside (peak 18), chrysophal-8- O-β- D-glucopyranoside (peak 19), chrysophal-1- O-β- D-glucopyranoside (peak 20), rhein (peak 24), glycyrrhizic acid (peak 26), (18β, 20α)-glycyrrhizic acid (peak 27), hyodeoxycholic acid (peak 28), and cholic acid (peak 29)] from four Chinese medicinals of JOL were chemically identified. Twenty-nine main characteristic peaks were assigned to individual Chinese medicinals (peaks 8, 12, 13, and 15–18 from Radix Scutellariae, peaks 3–5, 10, 11, and 25–27 from Radix Glycyrrhizae, peaks 1, 6, 7, 9, 14, 19, 20, and 24 from Radix et Rhizoma Rhei, peak 2 from Bulbus Fritillariae Ussuriensis, peaks 28 and 29 from Calculus Bovis Artifactus, and peaks 21–23 from excipients). The similarity among 15 batches of JOL was about 0.968 to 1.000. Moreover, good linear relationships were found ( R2 = 0.999 0–0.999 9), and the average recovery rates were 96.90%–102.84%. The mass concentrations of quantitative components in 15 batches of JOL were determined as follows: gallic acid 51.82–148.27 μg/mL, liquiritin 75.04–130.00 μg/mL, aloe-emodin-8- O-β- D-glucopyranoside 31.72–39.84 μg/mL, liquiritigenin 14.24–43.65 μg/mL, baicalin 610.37–867.40 μg/mL, chrysin-7- O-β- D-glucoronide 12.87–34.09 μg/mL, oroxyloside 62.45–101.48 μg/mL, wogonoside 155.41–205.86 μg/mL, chrysophal-1- O-β- D-glucopyranoside 11.56–23.72 μg/mL, chrysophal-8- O-β- D-glucopyranoside 16.14–36.87 μg/mL, glycyrrhizic acid 222.97–310.32 μg/mL, hyodeoxycholic acid 177.48–239.70 μg/mL, and cholic acid 98.54–132.85 μg/mL. Conclusion The HPLC-UVD-ELSD qualitative and quantitative methods mentioned above have provided important evidence for further improving the overall quality standard of JOL.