aluminium magnesium silicate(2:1:2) 化学特性,用途語,生産方法
定義
本品は、天然の鉱物から得られる複合ケイ酸塩である。
化粧品の成分用途
不透明化剤、滑沢剤、抗ケーキング剤、親水性増粘剤、吸着剤、増量剤
化学的特性
Almost white powder, granules or plates.
使用
Aluminium magnesium silicate is used as an Antacid Raw material in a specific antacid formulations, Ceramics, Suspending Agent, Thickning agent etc.
調製方法
Aluminium magnesium silicate is obtained from silicate ores of the
montmorillonite group, which show high magnesium content. The
ore is blended with water to form a slurry to remove impurities and
separate out the colloidal fraction. The refined colloidal dispersion
is drum-dried to form a small flake, which is then micro-atomized to
form various powder grades.
応用例(製薬)
Aluminium magnesium silicate has been used for many years in the
formulation of tablets, ointments, and creams. It is used in oral and
topical formulations as a suspending and stabilizing agent either
alone or in combination with other suspending agents. The
viscosity of aqueous dispersions may be greatly increased by
combination with other suspending agents, such as xanthan gum,
owing to synergistic effects; see Xanthan Gum. In tablets,
magnesium aluminum silicate is used as a binder and disintegrant
in conventional or slow-release formulations.
Magnesium aluminum silicate may cause bioavailability problems
with certain drugs.
安全性
Aluminium magnesium silicate is generally regarded as nontoxic and
nonirritating at the levels employed as a pharmaceutical excipient.
Subacute animal feeding studies in rats and dogs fed magnesium
aluminum silicate at 10% of the diet, for 90 days, were negative,
including autopsy and histopathological examinations.
LD50 (rat, oral): > 16 g/kg
貯蔵
Magnesium aluminum silicate is stable indefinitely when stored
under dry conditions. It is stable over a wide pH range, has baseexchange
capacity, absorbs some organic substances, and is
compatible with organic solvents.
Magnesium aluminum silicate should be stored in a well-closed
container, in a cool, dry place.
不和合性
Owing to its inert nature, magnesium aluminum silicate has few
incompatibilities but is generally unsuitable for acidic solutions
below pH 3.5. Magnesium aluminum silicate, as with other clays,may adsorb some drugs. This can result in low bioavailability if
the drug is tightly bound or slowly desorbed, e.g. amfetamine
sulfate, tolbutamide, warfarin sodium, diazepam, and
diclofenac sodium.
規制状況(Regulatory Status)
Included in the FDA Inactive Ingredients Database (oral granules,
solutions, suspensions and tablets; rectal; and topical preparations;
vaginal preparations). Included in nonparenteral medicines licensed
in the UK. Included in the Canadian List of Acceptable Nonmedicinal
Ingredients.
aluminium magnesium silicate(2:1:2) 上流と下流の製品情報
原材料
準備製品