트레할로스 2수화물

그림문자(GHS)

• 그림문자(GHS)

  

• 신호 어

  Warning

• 유해·위험 문구

  H315：피부에 자극을 일으킴

  H319：눈에 심한 자극을 일으킴

  H335：호흡 자극성을 일으킬 수 있음

• 예방조치문구

  P261：분진·흄·가스·미스트·증기·...·스프레이의 흡입을 피하시오.

  P305+P351+P338：눈에 묻으면 몇 분간 물로 조심해서 씻으시오. 가능하면 콘택트렌즈를 제거하시오. 계속 씻으시오.

트레할로스 2수화물 화학적 특성, 용도, 생산

• 개요

  Trehalose is a natural non-reducing disaccharide composed of two α-glucose units. It is found in all major groups of organisms except vertebrates, has biological functions as an osmolyte, storage reserve, and stress protectant, and has diverse commercial applications. Trehalose can also induce or enhance autophagy.

• 용도

  D(+)-Trehalose dihydrate is used in many processed foods as well as in biopharmaceutical monoclonal antibody formulations, it is also used as a protein stabilize.

• 생산 방법

  Trehalose is prepared from liquefied starch by a multistep enzymatic process. The commercial product is the dihydrate.

• Pharmaceutical Applications

  D(+)-Trehalose dihydrate is used for the lyoprotection of therapeutic proteins, particularly for parenteral administration. Other pharmaceutically relevant applications include use as an excipient for diagnostic assay tablets; for stabilization during the freeze–thaw and lyophilization of liposomes; and for stabilization of blood cells, cosmetics, and monoclonal antibodies. Trehalose may also be used in formulations for topical application.

• Safety

  Trehalose is used in cosmetics, foods, and parenteral and nonparenteral pharmaceutical formulations. It is generally regarded as a relatively nontoxic and nonirritant material when used as an excipient.
  In the gut, trehalose is rapidly metabolized to glucose by the specific enzyme trehalase. A small minority of the population exhibits a primary (hereditary) or secondary (acquired) trehalase deficiency and thus may experience intestinal discomfort after ingestion of excessive amounts of trehalose owing to the osmotic activity of undigested trehalose in the gut. However, smaller amounts of trehalose are tolerated by such individuals without any symptoms.
  Trehalose is used as a sweetener and is reported to have substantially less cariogenic potential than sucrose.
  LD50 (dog, IV): >1 g/kg
  LD50 (dog, oral): >5 g/kg
  LD50 (mouse, IV): >1 g/kg
  LD50 (mouse, oral): >5 g/kg
  LD50 (rat, IV): >1 g/kg
  LD50 (rat, oral): >5 g/kg

• 저장

  Trehalose is a relatively stable material. At 60°C for 5 hours it loses not more than 1.5% w/w of water (the dihydrate water of crystallization is retained). Open stored powder may liquefy at high relative humidity (≥90%).
  Trehalose should be stored in a cool, dry place in a well-sealed container.

• Purification Methods

  α,α-D(+)-Trehalose crystallises (as the dihydrate) from aqueous EtOH. Dry it at 13o. For the anhydrous compound dissolve 10g in pyridine (200mL) and distil off this solvent at atmospheric pressure, and when the temperature rises to 115.3o all the H2O is removed and 73mL of distillate is collected. Most of the anhydrous material crystallises out at this stage. The crystals are collected (6.8g), washed with Et2O to give 6.1g of anhydrous product. Higher yields are obtained by slightly more prolonged distillation. [Birch J Chem Soc 3489 1965, X-ray cryst: Brown et al. Acta Cryst 28 3145 1972, Beilstein 17/8 V 3.]

• 비 호환성

  D(+)-Trehalose dihydrate is incompatible with strong oxidizing agents, especially in the presence of heat.

• Regulatory Status

  GRAS listed. In the UK trehalose may be used in certain food applications. Included in parenteral and nonparenteral investigational formulations.

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