ラクトース一水和物 化学特性,用途語,生産方法
定義
本品は、次の化学式で表される二糖類である。
解説
ラクトース
乳糖ともいう．D-グルコースの4位にD-ガラクトースがβ-グリコシド結合した還元性の二糖．すべてのほ乳動物の乳汁中に5％ 前後含まれており，モクセイ科植物，ナツメヤシなど2，3の植物にも存在する．牛乳から脂肪およびチーズをとった残りの乳清を濃縮して，結晶化させて製造する．α-アノマーの一水和物は融点202 ℃．＋85→＋52.6°(水)．β-アノマーは融点252 ℃．＋34.9→＋55.4°(水)．前者は常温で，後者は93 ℃ 以上で晶出させると得られる．生体中ではUDP-ガラクトースのガラクトシル基がグルコースに転移して合成される．特殊なラクトース酵母で発酵されて乳酸を生じ，各種の乳酸菌の栄養源となる．散薬の希釈剤や錠剤の賦形剤などの薬用，乳製品添加剤，乳酸発酵用などの食用として広く用いられる．
用途
培養基剤、食品添加物
化粧品の成分用途
保湿.湿潤剤
効能
錠・カプセル希釈剤
化学的特性
Anhydrous lactose occurs as white to off-white crystalline particles
or powder. Several different brands of anhydrous lactose are
commercially available which contain anhydrous b-lactose and
anhydrous a-lactose. Anhydrous lactose typically contains 70–80%
anhydrous b-lactose and 20–30% anhydrous a-lactose.
使用
Lactose is a disaccharide carbohydrate that occurs in mammalian
milk except that of the whale and the hippopotamus. it is princi-
pally obtained as a cows’ milk derivative. it is also termed milk sugar
and it is a reducing sugar consisting of glucose and galactose. its
most common commercial form is alpha-monohydrate, with the
beta-anhydride form available to a lesser extent. all forms in solution
will equilibrate to a beta:alpha ratio of 62.25:37.75 at 0°c. it is about
one-sixth as sweet as sugar and is less soluble. it functions as a flow
agent, humectant, crystallization control agent, and sweetener. it is
used in baked goods for flavor, browning, and tenderizing and in
dry mixes as an anticaking agent.
定義
A sugar found in milk. It is a disaccharide
composed of glucose and galactose units.
調製方法
There are two anhydrous forms of lactose: a-lactose and b-lactose.
The temperature of crystallization influences the ratio of a- and blactose.
The anhydrous forms that are commercially available may
exhibit hygroscopicity at high relative humidities. Anhydrous
lactose is produced by roller drying a solution of lactose above
93.5°C. The resulting product is then milled and sieved. Two
anhydrous a-lactoses can be prepared using special drying
techniques: one is unstable and hygroscopic; the other exhibits
good compaction properties. However, these materials are not
commercially available.
生物活性
ラクトースの分解はラクターゼによって行われるが、一方、生合成は乳腺(にゅうせん)内でUDP（ウリジン二リン酸）-ガラクトースからガラクトースを転移する反応により生成される。この転移反応を触媒する酵素は、乳汁や乳腺中にみいだされるガラクトシルトランスフェラーゼで、アロステリックタンパク質の一種である。この酵素はα(アルファ)-ラクトアルブミン（血清タンパク質の一種）を結合するときにグルコースを受容体としてラクトースを合成するが、この酵素だけの場合はグルコースではなく、N-アセチルグルコサミンにガラクトースが転移されてN-アセチルラクトサミンが生成される。これは生物のもつ調節機構の一例であり、出産後にはα-ラクトアルブミンが増加して、乳児に必要なラクトースの合成が促進される。なお、ラクトースは腸のラクターゼによって加水分解されたのち吸収される。
一般的な説明
Pharmaceutical secondary standards for application in quality control, provide pharma laboratories and manufacturers with a convenient and cost-effective alternative to the preparation of in-house working standards.
空気と水の反応
Water soluble.
反応プロフィール
Flammable and/or toxic gases are generated by the combination of alcohols with alkali metals, nitrides, and strong reducing agents. They react with oxoacids and carboxylic acids to form esters plus water. Oxidizing agents convert them to aldehydes or ketones. Alcohols exhibit both weak acid and weak base behavior. They may initiate the polymerization of isocyanates and epoxides.
健康ハザード
ACUTE/CHRONIC HAZARDS: Lactose should be considered toxic.
応用例（製薬）
Anhydrous lactose is widely used in direct compression tableting
applications, and as a tablet and capsule filler and binder.
Anhydrous lactose can be used with moisture-sensitive drugs due
to its low moisture content. It may also be used in intravenous
injections.
安全性
Lactose is widely used in pharmaceutical formulations as a diluent
and filler-binder in oral capsule and tablet formulations. It may also
be used in intravenous injections. Adverse reactions to lactose are
largely due to lactose intolerance, which occurs in individuals with a
deficiency of the intestinal enzyme lactase, and is associated with
oral ingestion of amounts well over those found in solid dosage
forms.
貯蔵
Mold growth may occur under humid conditions (80% RH and
above). Lactose may develop a brown coloration on storage, the
reaction being accelerated by warm, damp conditions. At 80°C and 80% RH, tablets containing anhydrous lactose
have been shown to expand 1.2 times after one day.
Lactose anhydrous should be stored in a well-closed container in
a cool, dry place.
純化方法
-Lactose crystallises from water below 93.5o as the hydrate which can be dried at 80o/14mm. [Horst Recl Trav Chim, Pays-Bas 72 878 1953, Beilst 17 III/IV 3066.]
不和合性
Lactose anhydrous is incompatible with strong oxidizers. When
mixtures containing a hydrophobic leukotriene antagonist and
anhydrous lactose or lactose monohydrate were stored for six
weeks at 40°C and 75% RH, the mixture containing anhydrous
lactose showed greater moisture uptake and drug degradation.
Studies have also shown that in blends of roxifiban acetate
(DMP-754) and lactose anhydrous, the presence of lactose
anhydrous accelerated the hydrolysis of the ester and amidine
groups.
Lactose anhydrous is a reducing sugar with the potential to
interact with primary and secondary amines (Maillard reaction)
when stored under conditions of high humidity for extended
periods.
規制状況(Regulatory Status)
GRAS listed. Included in the FDA Inactive Ingredients Database
(IM, IV: powder for injection solution; IV and sublingual preparations;
oral: capsules and tablets; powder for inhalation; vaginal).
Included in nonparenteral and parenteral medicines licensed in the
UK. Included in the Canadian List of Acceptable Non-medicinal
Ingredients.
ラクトース一水和物 上流と下流の製品情報
原材料
準備製品