Study on the Quality Standard of Banlangen Dispensing Granules
10.6039/j.issn.1001-0408.2015.18.32
- VernacularTitle:板蓝根配方颗粒的质量标准研究
- Author:
Wei GONG
;
Xu SUN
;
Qinghua ZHAO
;
Xingdong LI
;
Mei ZHAO
;
Kun ZHANG
;
Xinxin ZHANG
- Publication Type:Journal Article
- Keywords:
Banlangen dispensing granules;
Quality standard;
TLC;
HPLC;
(R,S)-goitrin
- From:
China Pharmacy
2015;(18):2541-2543,2544
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To establish the quality standard of Banlangen dispensing granules. METHODS:Thin layer chroma-tography(TLC)was used to identify Isatis indigotica,leucine and arginine,the items according to granules preparations and the ex-traction were detected. HPLC was conducted to determine the content of (R,S)-goitrin. The Shimadzu VP-ODS C18 column was used with the mobile phase of methanol-0.05% phosphoric acid (7∶93,V/V) at the flow rate of 1.0 ml/min. The detection wave-length was set at 245 nm,and the column temperature was room temperature. The sample size was 10 μl. RESULTS:TLC showed clear spots and good resolution. Particle size,moisture,dissolubility and microbial limit test were all conformed to the specifica-tion. The extraction limit was no less than 25.0%.(R,S)-goitrin showed a good linear relationship in the range of 1.565 9-50.109 8μg/ml(r=0.999 9,n=6). The average recovery was 99.25%(RSD=2.08%,n=9);the RSDs of precision,stability and repeatabili-ty tests were no more than 1.12%. The content of(R,S)-goitrin was initially determined as 0.35 mg/g. CONCLUSIONS:The estab-lished quality standard has increased content determination,and the control programs are more comprehensive and reasonable. It can be used for the quality control of Banlangen dispensing granules.
