Aluminum hydroxide adjuvant exhibits a poorly crystalline boehmite(PCB)structure,which demonstrates instability during prolonged storage.In the present study,we systematically investigated the quality alterations of t...Aluminum hydroxide adjuvant exhibits a poorly crystalline boehmite(PCB)structure,which demonstrates instability during prolonged storage.In the present study,we systematically investigated the quality alterations of the adjuvant stored at roo m temperature by analyzing its crystal structure,particle size distribution,electron microscopic characteristics,pH,isoelectric point(pI),and adsorption capacity.These assessments aimed to ensure the effectiveness and safety of vaccine production.Three batches of adjuvants were stored at room temperature for 15 months,and their changes were monitored using X-ray diffraction patterns,transmission electron microscopy(TEM),pH measurements,pI determination,and adsorption capacity analysis.X-ray diffraction revealed that the crystalline phases of aluminum hydroxide initially exhibited a PCB structure,which became progressively more ordered during storage.Notably,after 12 months,a new diffraction peak emerged at 18.2°2θ,with its intensity increasing over time.This corresponded to the formation of highly crystalline gibbsite and bayerite,which compromised the stability of the adjuvant.Furthermore,the pH and pI values decreased during storage,reflecting a decline in the chemical stability of the adjuvant.Comprising nanoparticles with a mean diameter of 130 nm,the adjuvant maintained a high surface area and excellent adsorption capacity.The adsorption rate at 8 mg BSA/mg Al3+consistently exceeded 97%,with no statistically significant differences observed between the adsorption capacities at 1 and 15 months(P>0.05).This indicated that the nanoparticle aluminum hydroxide adjuvant sustained high adsorption efficiency throughout the storage period,underscoring its reliability as a vaccine adsorbent.However,in the later stages of storage,the emergence of highly crystalline gibbsite and bayerite,coupled with declines in pH and pI,negatively impacted the adjuvant’s stability.Based on these findings,we recommended that aluminum hydroxide adjuvants should not be stored at room temperature for longer than 12 months to preserve their quality and efficacy.展开更多
The aluminum hydroxide adjuvant possesses a poorly crystalline boehmite (PCB) structure, the stability of which is significantly affected by storage conditions. In the present study, we conducted a comprehensive inves...The aluminum hydroxide adjuvant possesses a poorly crystalline boehmite (PCB) structure, the stability of which is significantly affected by storage conditions. In the present study, we conducted a comprehensive investigation into the structural and quality alterations of aluminum hydroxide adjuvants under varying temperature conditions over time. Three batches of the adjuvant were stored at 2–8℃, 18–25℃, and 37℃, respectively, for 6 months. Key parameters, including X-ray diffraction patterns, pH, isoelectric point (pI), adsorption capacity, and average particle size, were analyzed to assess the impact of storage temperatures. X-ray diffraction analysis confirmed the PCB structure of the aluminum hydroxide adjuvant. Notably, after 1 month of storage at 37℃, new diffraction peaks emerged at 18.2 °2θ, with their intensity increasing progressively over time. Concurrently, the largest decreases in pI and pH were observed, measuring 0.78 and 1.33, respectively. In contrast, adjuvants stored at 2–8℃ for 6 months exhibited only faint diffraction peaks at 18.2 °2θ, indicating minor structural changes. Under these conditions, the reductions in pI and pH were comparatively smaller, at 0.43 and 0.80, respectively. The average particle size of the adjuvants remained within 110–140 nm across all storage conditions. Additionally, the aluminum hydroxide adjuvant consistently demonstrated a high protein adsorption capacity, approximately 8 mg BSA/mg Al^(3+), with no statistically significant differences in adsorption rates observed among the different temperature conditions (P > 0.05). These findings highlighted the remarkable adsorption efficiency of nanoparticle aluminum hydroxide adjuvants throughout storage, reinforcing their potential as superior vaccine adsorbents. However, elevated storage temperatures were shown to accelerate structural aging, promoting the formation of highly crystalline phases such as gibbsite or bayerite, which could compromise the stability and quality of the adjuvant.展开更多
文摘Aluminum hydroxide adjuvant exhibits a poorly crystalline boehmite(PCB)structure,which demonstrates instability during prolonged storage.In the present study,we systematically investigated the quality alterations of the adjuvant stored at roo m temperature by analyzing its crystal structure,particle size distribution,electron microscopic characteristics,pH,isoelectric point(pI),and adsorption capacity.These assessments aimed to ensure the effectiveness and safety of vaccine production.Three batches of adjuvants were stored at room temperature for 15 months,and their changes were monitored using X-ray diffraction patterns,transmission electron microscopy(TEM),pH measurements,pI determination,and adsorption capacity analysis.X-ray diffraction revealed that the crystalline phases of aluminum hydroxide initially exhibited a PCB structure,which became progressively more ordered during storage.Notably,after 12 months,a new diffraction peak emerged at 18.2°2θ,with its intensity increasing over time.This corresponded to the formation of highly crystalline gibbsite and bayerite,which compromised the stability of the adjuvant.Furthermore,the pH and pI values decreased during storage,reflecting a decline in the chemical stability of the adjuvant.Comprising nanoparticles with a mean diameter of 130 nm,the adjuvant maintained a high surface area and excellent adsorption capacity.The adsorption rate at 8 mg BSA/mg Al3+consistently exceeded 97%,with no statistically significant differences observed between the adsorption capacities at 1 and 15 months(P>0.05).This indicated that the nanoparticle aluminum hydroxide adjuvant sustained high adsorption efficiency throughout the storage period,underscoring its reliability as a vaccine adsorbent.However,in the later stages of storage,the emergence of highly crystalline gibbsite and bayerite,coupled with declines in pH and pI,negatively impacted the adjuvant’s stability.Based on these findings,we recommended that aluminum hydroxide adjuvants should not be stored at room temperature for longer than 12 months to preserve their quality and efficacy.
文摘The aluminum hydroxide adjuvant possesses a poorly crystalline boehmite (PCB) structure, the stability of which is significantly affected by storage conditions. In the present study, we conducted a comprehensive investigation into the structural and quality alterations of aluminum hydroxide adjuvants under varying temperature conditions over time. Three batches of the adjuvant were stored at 2–8℃, 18–25℃, and 37℃, respectively, for 6 months. Key parameters, including X-ray diffraction patterns, pH, isoelectric point (pI), adsorption capacity, and average particle size, were analyzed to assess the impact of storage temperatures. X-ray diffraction analysis confirmed the PCB structure of the aluminum hydroxide adjuvant. Notably, after 1 month of storage at 37℃, new diffraction peaks emerged at 18.2 °2θ, with their intensity increasing progressively over time. Concurrently, the largest decreases in pI and pH were observed, measuring 0.78 and 1.33, respectively. In contrast, adjuvants stored at 2–8℃ for 6 months exhibited only faint diffraction peaks at 18.2 °2θ, indicating minor structural changes. Under these conditions, the reductions in pI and pH were comparatively smaller, at 0.43 and 0.80, respectively. The average particle size of the adjuvants remained within 110–140 nm across all storage conditions. Additionally, the aluminum hydroxide adjuvant consistently demonstrated a high protein adsorption capacity, approximately 8 mg BSA/mg Al^(3+), with no statistically significant differences in adsorption rates observed among the different temperature conditions (P > 0.05). These findings highlighted the remarkable adsorption efficiency of nanoparticle aluminum hydroxide adjuvants throughout storage, reinforcing their potential as superior vaccine adsorbents. However, elevated storage temperatures were shown to accelerate structural aging, promoting the formation of highly crystalline phases such as gibbsite or bayerite, which could compromise the stability and quality of the adjuvant.
