Objective To investigate the quality standard and stability of Agkistrodon acutus venom(AAV).

Methods Seventeen batches of AAV from different sources were collected, and its were identified by two-way immunodiffusion and ultraviolet absorption spectrometry; potency and loss on drying were examined; the protein content of its were determined by bis-urea; the distribution of molecular weights of the proteins and peptides in AAV were investigated by SDS-PAGE; and the stability of its were examined by accelerated and long term tests.

RESULTS In the two-way immunodiffusion experiment, all 17 batches of AAV could produce precipitation lines with Agkistrodon acutus antivenin, indicating that this method could accurately identify AAV. In addition, ultraviolet absorption spectroscopy could assist in the identification of AAV, and the absorbance of this product at the wavelength of 278~280 nm should be between 1.30 and 1.70; loss of weight on drying of its should ≤ 10.0%; the enzyme activity per 1 mg of protein, its potency should be between 40 and 100 units; the bands of its were distributed within the range of 10~130 KDa; the protein content of its should ≥ 90.0% when human serum albumin was used as the control; three batches of AAV were examined in 6-month accelerated test and 12-month long-term test, and all the indexes met the requirements of quality standard.

Conclusion The method established in this study is exclusive, accurate and reliable, and can be used for the quality control of AAV, which provides a scientific basis for standardizing the quality control of AAV.