[Quality evaluation of Salvianolate for Injection by quantitative analysis of multi-components with single-marker].
Zhongguo Zhong Yao Za Zhi
; 45(7): 1670-1675, 2020 Apr.
Article
en Zh
| MEDLINE
| ID: mdl-32489048
Developing high-quality standard is useful for promoting the quality of traditional Chinese medicine injections, which could be evaluated by establishing the comprehensive quality control method. A method for simultaneous determination of salvianolic acid B, rosmarinic acid and lithospermic acid in Salvianolate for Injection was developed for quantitative analysis of multi-components with single-marker(QAMS). ZORBAX Eclipse Plus C_(18) chromatographic column was adopted, with 0.1% phosphoric acid and acetonitrile as mobile phase. The flow rate was set at 1 mL·min~(-1). The column temperature was set at 20 â, and the detection wavelength was 286 nm. Salvianolic acid B was used as internal reference. The relative correction factors of rosmarinic acid and lithospermic acid(f_(s/i)) were 0.58 and 0.94, respectively. About 85% of substances in Salvianolate for Injection were quantified by the established QAMS method. The analysis of different batches of intermediates and preparations during four years showed that the contents of salvianolic acid B were 77.1%-81.5% in intermediates and 70.5%-80.1% in preparations; The total content of rosmarinic acid and lithospermic acid was about 6%. The ratio of rosmarinic acid to lithospermic acid was(3.4â¶1-10â¶1) and(2.5â¶1-5â¶1), respectively, which showed that the ratio was more stable in preparation. The QAMS method established is feasible for comprehensive quality control of multiple components of in Salvianolate for Injection.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Medicamentos Herbarios Chinos
/
Extractos Vegetales
Tipo de estudio:
Diagnostic_studies
Idioma:
Zh
Revista:
Zhongguo Zhong Yao Za Zhi
Asunto de la revista:
FARMACOLOGIA
/
TERAPIAS COMPLEMENTARES
Año:
2020
Tipo del documento:
Article
País de afiliación:
China
Pais de publicación:
China