Trehalose Dihydrate Excipient is a non-reducing sugar composed of two glucose molecules connected by a 1,1-glycosidic bond. It has three isomers: trehalose (α,α), isotrehalose (β,β), and neotrehalose (α,β), which have non-specific protective effects on various bioactive substances. Trehalose is widely present in many edible plants, animals, and microorganisms in nature, such as mushrooms, algae, beans, shrimp, bread, beer, and yeast-fermented foods commonly consumed in daily life.
Trehalose is a stable non-reducing disaccharide composed of two glucose molecules connected by an α,α,1,1-glycosidic bond. Trehalose Dihydrate was initially extracted from ergot fungus found in rye, and it has since been discovered to be widely present in plants, animals, and microorganisms, especially fungi, algae, mosses, and invertebrates. Trehalose is a white crystalline substance, each molecule containing two molecules of crystallization water. It is soluble in water, glacial acetic acid, and hot ethanol but insoluble in ether and acetone. When heated to 130°C, trehalose loses its crystallization water and becomes anhydrous crystal.
Trehalose has a remarkable protective effect on biological entities: under extreme conditions such as high temperature, freezing, high osmotic pressure, and desiccation, it can form a unique protective film on the cell surface, effectively protecting cells, protein molecules, and other entities from denaturation and inactivation. Unlike other sugars like sucrose and glucose that do not have this function, trehalose is often referred to in the scientific community as the "Sugar of Life."
Due to its unique biological properties, trehalose has found extensive applications in the pharmaceutical field. It is mainly used as a lyoprotectant in biological preparations, a protein protectant in monoclonal antibody injections, and a preservation protectant in blood products. It enhances the stability of biological membranes and protein structures. Compared to common sugars like sucrose, trehalose has unique advantages and is increasingly used in vaccines, diagnostic reagents, and other bioproducts.
The application of trehalose in vaccines is becoming more extensive. Trehalose replaces serum albumin as a protectant, significantly improving the stability of vaccine products. This allows many vaccines to be stored at room temperature, reducing the high costs associated with cold chain transportation. More importantly, it helps prevent the transmission of fatal diseases such as hepatitis B and AIDS caused by blood contamination.
The protective effects of trehalose on enzymes and proteins have been widely verified. Literature reports that adding 8-12wt% of trehalose to enzyme conjugate diluents in certain diagnostic test kits helps maintain the stability of the enzyme conjugate diluents using trehalose as a stabilizer. Some data also show that after adding Trehalose Dihydrate Excipient, enzyme-labeled antibodies show no significant activity change after 37°C for 4d, while the activity of enzyme-labeled antibodies without trehalose stabilizer is almost completely lost.
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