Quaily Analysis of Weiling Granules
- VernacularTitle:胃灵颗粒质量分析
- Author:
Jinmiao TIAN
1
;
Lingfeng KONG
;
Jing CHEN
Author Information
1. 辽宁省药品检验检测院 沈阳110036
- Keywords:
Weiling granules;
Quality analysis;
Fingerprint;
Paeoniflorin;
Tetrahydropalmatine;
Ammonium glycyrrhizinate
- From:
China Pharmacist
2018;21(10):1874-1878
- CountryChina
- Language:Chinese
-
Abstract:
Objective: To analyze 167 batches of Weiling granules according to the quality standard and exploratory research, and evaluate the overall quality and standard condition of the preparation. Methods: A TLC method was established for the identification of Atractylodis macrocephalae Rhizoma;an HPLC method was established for the fingerprint and the content determination of paeoniflorin, tetrahydropalmatine and ammonium glycyrrhizinate. An Agilent Poroshell120,SB-C18analytical column (100 mm×4. 6 mm, 2. 7 μm) was employed with gradient elution of acetonitrile-0. 1% phosphoric acid as the mobile phase at the flow rate of 1. 8 ml·min-1, and the sample size was 3 μl. Acid base titration method was used for measuring acid-neutralizing capacity. Results: No interference from the negative controls was shown to the TLC identification of Atractylodis macrocephalae Rhizoma. The fingerprint exhibited better separation of each peak. The precision, reproducibility and stability of the method were good,and the RSDs of the relative retention time and rela-tive peak area were less than 3. 0% . The linear range of paeoniflorin, tetrahydropalmatine and ammonium glycyrrhizinate was 0. 057-0. 568 μg(r=0. 999 9), 0. 035-0. 353 μg(r=0. 999 9)and 4. 244×10 -3-42. 44×10 -3μg(r=0. 999 9), respectively, and the av-eragerecoverywas99.3%(RSD=1.0%,n=6),100.0%(RSD=0.8%,n=6) and99.8%(RSD=1.2%,n=6),respectively. The average recovery of acid-neutralizing capacity was 99. 5% (RSD=0. 5% ,n=6). Conclusion: Exploratory research increases the specificity, controllability and safety of the standards, which provides reference for the further drug standards revision and the drug quality control.
