[Physical fingerprint for quality control of Reduning injection]

Area of Science:

• Physical Chemistry
• Pharmaceutical Analysis
• Traditional Chinese Medicine

Background:

• Current quality standards for Reduning injection (RI) require enhancement.
• Physicochemical properties are strongly correlated with drug safety, effectiveness, and stability.

Purpose of the Study:

• To develop and validate a physical fingerprint spectrum method for RI quality control.
• To establish improved quality standards for RI based on physical chemistry principles.

Main Methods:

• Utilized physical chemistry principles to analyze RI quality.
• Developed a physical fingerprint spectrum comprising eight indexes: pH, conductivity, turbidity, refractive index, osmolarity, surface tension, relative density, and kinematic viscosity.
• Visualized the spectrum using a radar map.

Main Results:

• Verified 12 batches of RI samples.
• Three batches within their validity period met the physical fingerprint spectrum standards, showing similarity above 0.999.
• Nine expired batches failed to meet the standards, indicating degradation.

Conclusions:

• The physical fingerprint spectrum method is effective for Reduning injection quality control.
• This approach demonstrates potential as an exemplary method for evaluating traditional Chinese medicine injections.