Study on the Stability of Fuke Zhidai Capsule
10.6039/j.issn.1001-0408.2016.12.26
- VernacularTitle:妇科止带胶囊的稳定性考察
- Author:
Yuanchun XIE
;
Lin ZHENG
;
Yongjun LI
;
Li'na LIU
;
Ye YUAN
- Publication Type:Journal Article
- Keywords:
Fuke zhidai capsule;
Berberine hydrochloride;
Accelerated testing;
Long-term testing;
Stability
- From:
China Pharmacy
2016;27(12):1661-1663
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To study the stability of Fuke zhidai capsule at accelerated testing and room temperature. METHODS:HPLC was conducted to determine the content of berberine hydrochloride in the preparation:the column was Diamonsil C18 with mobile phase of B methanol-0.7% triethylamine(pH adjusted to 3 by phosphate)(50:50,V/V)at a flow rate of 1 ml/min;detec-tion wavelength was 265 nm,with a column temperature at 45 ℃,and the injection volume was 5 μl;its moisture,disintegration time,accelerated stability and long-term stability were studied according to the 2015 edition of Chinese Pharmacopoeia. RE-SULTS:The linear range of berberine hydrochloride was 0.0217-0.1736 mg/ml(r=0.9999);RSDs of precision,stability and re-producibility tests were lower than 2%;recovery was 97.24%-101.73%(RSD=1.72%,n=6). CONCLUSIONS:The moisture,dis-integration time,accelerated stability and long-term stability were all in line with the quality standards.
