Quality evaluation and stability investigation of asarone submicro emulsion injection / 中国中药杂志
China Journal of Chinese Materia Medica
;
(24): 3945-3949, 2014.
Artículo
en Chino
| WPRIM
| ID: wpr-310961
ABSTRACT
The content of the asarone submicro emulsion injection was determind by HPLC method, and thereby a quality evaluation method was established based on indexes of pH value, particle size, peroxide value, methoxy aniline values, free fatty acid, lysophosphatidylcholine, visible foreign substances, insoluble particle, sterility, bacterial endotoxin and impurities, etc. The results showed that the injection exhibited uniform physical appearance and all the products were in milkwhite liquid. The content of the three batches products were respectively 102.9%, 100.8%, 97.70% of the labeled amount, with mean particle size of 210-250 nm, and other indexes all met with the standards. The reserved samples showed no obvious change in terms of detection indexes and indicated good stability after the accelerated stability test and long-term stability for 12 months. The quality evaluation method established in this study could be applied to quality control and stability investigation of asarone submicron emulsion injection, which laid a basis for further clinical research and application.
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Asunto principal:
Tamaño de la Partícula
/
Control de Calidad
/
Medicamentos Herbarios Chinos
/
Química
/
Cromatografía Líquida de Alta Presión
/
Estabilidad de Medicamentos
/
Emulsiones
/
Anisoles
Tipo de estudio:
Guía de Práctica Clínica
Idioma:
Chino
Revista:
China Journal of Chinese Materia Medica
Año:
2014
Tipo del documento:
Artículo
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