Octadecanoic acid, 12-hydroxy-, polymer with .alpha.-hydro-.omega.-hydroxypoly(oxy-1,2-ethanediyl)

危険有害性情報のコード(GHS)

• 絵表示(GHS)

  

• 注意喚起語

  Warning

• 危険有害性情報

  H317：アレルギー性皮膚反応を起こすおそれ

• 注意書き

  P280：保護手袋/保護衣/保護眼鏡/保護面を着用するこ と。

Octadecanoic acid, 12-hydroxy-, polymer with .alpha.-hydro-.omega.-hydroxypoly(oxy-1,2-ethanediyl) 価格

Octadecanoic acid, 12-hydroxy-, polymer with .alpha.-hydro-.omega.-hydroxypoly(oxy-1,2-ethanediyl) 化学特性,用途語,生産方法

• 化学的特性

  Yellowish, waxy mass.

• 使用

  Non-ionic surfactant.

• 調製方法

  Macrogol 15 hydroxystearate is produced by reacting 15 moles of ethylene oxide with 1 mole of 12-hydroxystearic acid.

• 応用例（製薬）

  Macrogol 15 hydroxystearate is frequently used in preclinical testing of drugs, mainly for IV and other parenteral applications. The solubilizing capacity for some tested drugs (clotrimazole, carbamazepine, 17 β-estradiol, sulfathiazole, and piroxicam) increases almost linearly with increasing concentration of solubilizing agent. This is due to the formation of spherical micelles even at high concentrations of macrogol 15 hydroxystearate. Similarly, tests have revealed that viscosity increases with increasing amount of solubilizer, but the amount of solubilized drugs does not have any additional influence on the kinematic viscosity. Lipid nanocapsules comprising macrogol 15 hydroxystearate and soybean phosphatidylcholine containing 3% docetaxel have been successfully prepared by a solvent-free inversion process.
  Macrogol 15 hydroxystearate has been used in the manufacture of aqueous parenteral preparations with vitamin A, D, E and K, and a number of other lipophilic pharmaceutical active agents, such as propanidid, miconazole, alfadolone, and alfaxalone. It is very efficient at solubilizing substances like fat-soluble vitamins and active ingredients of hydrophobic nature. It is also an excellent solubilizer for parenteral use, at a concentration of 20%, and the water solubility of different drugs may be enhanced by a factor of 10–100, depending on the structure of the drug molecule.

• 安全性

  Macrogol 15 hydroxystearate is used in parenteral pharmaceutical preparations in concentrations up to 50% to solubilize diclofenac, propanidid, and vitamin K1. It has also been used in preclinical formulations in preparing supersaturated injectable formulations of water-insoluble molecules. It is generally regarded as a relatively nontoxic and nonirritant excipient.
  Macrogol 15 hydroxystearate is reported not to be mutagenic in bacteria, mammalian cell cultures and mammals.
  LD50 (dog, IV): >3.10 g/kg
  LD50 (mouse, IP): >0.0085 g/kg
  LD50 (mouse, IV): >3.16 g/kg
  LD50 (rabbit, IV): 1.0–1.4 g/kg
  LD50 (rat, oral): >20 g/kg
  LD50 (rat, IV): 1.0–1.47 g/kg

• 貯蔵

  Macrogol 15 hydroxystearate has a high chemical stability. The prolonged action of heat may induce physical separation into a liquid and a solid phase after cooling, which can be reversed by subsequent homogenization. Macrogol 15 hydroxystearate is stable for at least 24 months if stored in unopened airtight containers at room temperature (maximum 25 °C). Aqueous solutions of macrogol 15 hydroxystearate can be heat-sterilized (121°C, 0.21 MPa). The pH may drop slightly during heating, which should be taken into account. Separation into phases may also occur, but agitating the hot solution can reverse this. Aqueous solutions can be stabilized with the standard preservatives used in pharmaceuticals.
  Macrogol 15 hydroxystearate should be stored in tightly sealed containers in a dry place.

• 規制状況(Regulatory Status)

  Included in the Canadian List of Acceptable Non-medicinal Ingredients.

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Octadecanoic acid, 12-hydroxy-, polymer with .alpha.-hydro-.omega.-hydroxypoly(oxy-1,2-ethanediyl) 生産企業

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