[Physical fingerprint for quality control of Reduning injection].
摘要
The method of physical fingerprint spectrum for Reduning injection (RI) was proposed in this paper to improve its quality standards based on the strong correlation between physicochemical properties of drugs, their safety, effectiveness and stability. The quality of RI was studied by the thought and method of physical chemistry. The physical fingerprint spectrum was visually showed by the radar map, and consisted of eight indexes (pH, conductivity, turbidity, refractive index, osmolarity, surface tension, relative density, and kinematic viscosity). Then 12 batch of samples were verified. It was found that the physical fingerprint spectra of 3 batches of RI were in line with the standards within their validity time, with similarity above 0.999; in addition for the expired 9 batches of RI, their physical fingerprint spectra did not meet the standards. The results showed that physical fingerprint spectrum can be used for the quality control of RI, with a certain exemplary role in the quality evaluation of traditional Chinese medicine injection.