カルボキシメチルセルロースナトリウム 化学特性,用途語,生産方法
外観
白色～わずかにうすい褐色, 粉末
定義
本品は、セルロース(*)のカルボキシメチルエーテルのナトリウム塩である。参照表示名称：セルロース
溶解性
水に可溶。水に溶け、エタノール及びアセトンにほとんど溶けない。
用途
乳化剤、安定剤、増粘剤。
化粧品の成分用途
結合剤、皮膜形成剤、親水性増粘剤、乳化安定剤
効能
下剤, 懸濁剤, 賦形剤, 増粘剤
商品名
カルメロースナトリウム (丸石製薬); バルコーゼ (サンノーバ)
確認試験
(１) 本品0.2gを温湯20mLにかき混ぜながら加えて溶かし，
冷後，これを試料溶液とする．試料溶液1mLに水を加えて
5mLとし，その1滴に濃クロモトロープ酸試液0.5mLを加え，
水浴中で10分間加熱するとき，液は赤紫色を呈する．
(２) (1)の試料溶液10mLに硫酸銅(Ⅱ)試液1mLを加えると
き，青色綿状の沈殿を生じる．
(３) 本品3gにメタノール20mL及び希塩酸2mLを加え，水
浴上で5分間穏やかに煮沸した後，ろ過する．ろ液を蒸発乾
固し，残留物に水20mLを加えた液はナトリウム塩の定性反
応を呈する．
ｐＨ 本品1.0gを少量ずつ温湯100mLにかき混ぜなが
ら溶かし，冷却した液のpHは6.0～8.0である．
定量法
本品を乾燥し，その約0.5gを精密に量り，酢酸
(100)80mLを加え，還流冷却器を付けて130℃の油浴中で2
時間加熱する．冷後，0.1mol/L過塩素酸で滴定する
(電位差滴定法)．同様の方法で空試験を行い，補正する．
0.1mol/L過塩素酸1mL＝2.299mg Na
純度試験
(１) 溶状 高さ250mm，内径25mm，厚さ2mmのガラス
円筒の底に厚さ2mmの良質ガラス板を密着させたものを外
管とし，高さ300mm，内径15mm，厚さ2mmのガラス円筒
の底に厚さ2mmの良質ガラス板を密着させたものを内管と
し，その外管に，本品1.0gを水100mLに溶かした液を入れ，
これを幅1mm，間隔1mmの15本の平行線を黒色で書いた白
紙の上に置き，内管を上下して，その上部から観察し，線が
区別できなくなったときの内管の下端までの液の高さを測定
する．この操作を3回繰り返して得た平均値は，次の比較液
を用いて，同様に操作して得た平均値より大きい．
比較液：0.005mol/L硫酸5.50mLに希塩酸1mL，エタノー
ル(95)5mL及び水を加えて50mLとし，これに塩化バリ
ウム試液2mLを混和し，10分間放置した後，よく振り
混ぜて用いる．
(２) 塩化物 本品0.5gを水50mLに溶かし，試料溶
液とする．試料溶液10mLに希硝酸10mLを加えて振り混ぜ，
水浴中で綿状の沈殿を生じるまで加熱し，冷却した後，遠心
分離する．上澄液をとり，沈殿を水10mLずつで3回洗い，
毎回遠心分離し，上澄液及び洗液を合わせ，更に水を加えて
200mLとする．この液50mLを検液とし，試験を行う．比較
液には0.01mol/L塩酸0.45mLを加える(0.640％以下)．
(３) 硫酸塩 (2)の試料溶液10mLに塩酸1mLを加
えてよく振り混ぜ，水浴中で綿状の沈殿を生じるまで加熱し，
冷却した後，遠心分離する．上澄液をとり，沈殿を水10mL
ずつで3回洗い，毎回遠心分離し，洗液を先の上澄液に合わ
せ，更に水を加えて50mLとし，この液10mLに水を加えて
50mLとする．これを検液とし，試験を行う．比較液には
0.005mol/L硫酸0.40mLを加える(0.960％以下)．
(４) ケイ酸塩 本品約1gを精密に量り，白金皿に入れ，
強熱灰化した後，希塩酸20mLを加え，時計皿でふたをして，
30分間穏やかに煮沸する．時計皿をとり，空気を送りなが
ら水浴上で加熱し，蒸発乾固する．更に1時間加熱を続けた
後，熱湯10mLを加え，よくかき混ぜ，定量分析用ろ紙を用
いてろ過する．残留物を熱湯で洗い，洗液に硝酸銀試液を加
えても混濁しなくなったとき，ろ紙とともに乾燥し，更に恒
量になるまで強熱するとき，その量は0.5％以下である．
(５) 重金属 本品1.0gをとり，第2法により操作し，
試験を行う．比較液には鉛標準液2.0mLを加える(20ppm以
下)．
(６) ヒ素 本品1.0gに硝酸20mLを加え，流動状と
なるまで弱く加熱する．冷後，硫酸5mLを加え，白煙が発
生するまで加熱する．必要ならば，冷後，更に硝酸5mLを
加えて加熱する．この操作を液が無色～淡黄色となるまで繰
り返す．冷後，シュウ酸アンモニウム飽和溶液15mLを加え，
再び白煙が発生するまで加熱する．冷後，水を加えて25mL
とする．この液5mLを検液とし，試験を行うとき，次の標
準色より濃くない．
標準色：本品を用いないで同様に操作した後，この液
5mLを発生瓶に入れ，ヒ素標準液2mLを正確に加え，
以下検液の試験と同様に操作する(10ppm以下)．
(７) でんぷん (2)の試料溶液10mLをとり，ヨウ素試液2
滴を滴加するとき青色を呈しない．
貯法
容器 気密容器．
乾燥減量
10.0％以下(1g，105℃，4時間)．
使用上の注意
吸湿性あり
化学的特性
Carboxymethylcellulose sodium occurs as a white to almost white,
odorless, tasteless, granular powder. It is hygroscopic after drying.
使用
In drilling muds, in detergents as a soil-suspending agent, in resin emulsion paints, adhesives, printing inks, textile sizes, as protective colloid in general. As stabilizer in foods. Pharmaceutic aid (suspending agent; tablet excipient; viscosity-increasing agent).
定義
A semisynthetic, water-soluble polymer in which
CH
2
COOH groups are substituted on the glucose
units of the cellulose chain through an ether link-
age. Mw ranges from 21,000 to 500,000. Since the
reaction occurs in an alkaline medium, the prod-
uct is the sodium salt of the carboxylic acid R-O-
CH
2
COONa.
調製方法
Alkali cellulose is prepared by steeping cellulose obtained from
wood pulp or cotton fibers in sodium hydroxide solution. The
alkaline cellulose is then reacted with sodium monochloroacetate to
produce carboxymethylcellulose sodium. Sodium chloride and
sodium glycolate are obtained as by-products of this etherification.
一般的な説明
Sodium carboxymethyl cellulose (CMC) belongs to the class of anionic linear structured cellulose. Its components consist of polysaccharide composed of fibrous tissues of plants. It is a water soluble polymer which can be used as a polyelectrolyte cellulose derivative.
応用例（製薬）
Sodium carboxymethyl cellulose (NaCMC) is the sodium salt of carboxymethyl cellulose, an anionic derivative.It is widely used in oral and topical pharmaceutical formulations, primarily for its viscosity-increasing properties. Viscous aqueous solutions are used to suspend powders intended for either topical application or oral and parenteral administration. Carboxymethylcellulose sodium may also be used as a tablet binder and disintegrant, and to stabilize emulsions.
Higher concentrations, usually 3–6%, of the medium-viscosity grade are used to produce gels that can be used as the base for applications and pastes; glycols are often included in such gels to prevent them drying out. Carboxymethylcellulose sodium is also used in self-adhesive ostomy, wound care, and dermatological patches as a muco-adhesive and to absorb wound exudate or transepidermal water and sweat. This muco-adhesive property is used in products designed to prevent post-surgical tissue adhesions; and to localize and modify the release kinetics of active ingredients applied to mucous membranes; and for bone repair. Encapsulation with carboxymethylcellulose sodium can affect drug protection and delivery. There have also been reports of its use as a cyto-protective agent.
Carboxymethylcellulose sodium is also used in cosmetics, toiletries, surgical prosthetics, and incontinence, personal hygiene, and food products.
安全性プロファイル
Mildly toxic by ingestion. Experimental reproductive effects. Questionable carcinogen with experimental neoplastigenic data. It migrates to food from packagmg materials. When heated to decomposition it emits toxic fumes of NazO. See also POLYMERS, SOLUBLE.
安全性
Carboxymethylcellulose sodium is used in oral, topical, and some
parenteral formulations. It is also widely used in cosmetics,
toiletries, and food products, and is generally regarded as a
nontoxic and nonirritant material. However, oral consumption of
large amounts of carboxymethylcellulose sodium can have a
laxative effect; therapeutically, 4–10 g in daily divided doses of the
medium- and high-viscosity grades of carboxymethylcellulose
sodium have been used as bulk laxatives.
The WHO has not specified an acceptable daily intake for
carboxymethylcellulose sodium as a food additive since the levels
necessary to achieve a desired effect were not considered to be a
hazard to health. However, in animal studies, subcutaneous
administration of carboxymethylcellulose sodium has been found to
cause inflammation, and in some cases of repeated injection
fibrosarcomas have been found at the site of injection.
Hypersensitivity and anaphylactic reactions have occurred in
cattle and horses, which have been attributed to carboxymethylcellulose
sodium in parenteral formulations such as vaccines and
penicillins.
LD
50 (guinea pig, oral): 16 g/kg
LD
50 (rat, oral): 27 g/kg
貯蔵
Carboxymethylcellulose sodium is a stable, though hygroscopic
material. Under high-humidity conditions, carboxymethylcellulose
sodium can absorb a large quantity (>50%) of water. In tablets, this
has been associated with a decrease in tablet hardness and an
increase in disintegration time.
Aqueous solutions are stable at pH 2–10; precipitation can occur
below pH 2, and solution viscosity decreases rapidly above pH 10.
Generally, solutions exhibit maximum viscosity and stability at pH
7–9.
Carboxymethylcellulose sodium may be sterilized in the dry state
by maintaining it at a temperature of 1608℃ for 1 hour. However,
this process results in a significant decrease in viscosity and some
deterioration in the properties of solutions prepared from the
sterilized material.
Aqueous solutions may similarly be sterilized by heating,
although this also results in some reduction in viscosity. After
autoclaving, viscosity is reduced by about 25%, but this reduction is
less marked than for solutions prepared from material sterilized in
the dry state. The extent of the reduction is dependent on the
molecular weight and degree of substitution; higher molecular
weight grades generally undergo a greater percentage reduction in
viscosity. Sterilization of solutions by gamma irradiation also
results in a reduction in viscosity.
Aqueous solutions stored for prolonged periods should contain
an antimicrobial preservative.
The bulk material should be stored in a well-closed container in a
cool, dry place.
純化方法
Dialyse it for 48hours against distilled water and freeze-dry if a solid is required.
不和合性
Carboxymethylcellulose sodium is incompatible with strongly
acidic solutions and with the soluble salts of iron and some other
metals, such as aluminum, mercury, and zinc. It is also incompatible
with xanthan gum. Precipitation may occur at pH < 2, and also
when it is mixed with ethanol (95%).
Carboxymethylcellulose sodium forms complex coacervates
with gelatin and pectin. It also forms a complex with collagen
and is capable of precipitating certain positively charged proteins.
規制状況(Regulatory Status)
GRAS listed. Accepted as a food additive in Europe. Included in the
FDA Inactive Ingredients Database (dental preparations; intraarticular,
intrabursal, intradermal, intralesional, and intrasynovial
injections; oral drops, solutions, suspensions, syrups and tablets;
topical preparations). Included in nonparenteral medicines licensed
in the UK. Included in the Canadian List of Acceptable Nonmedicinal
Ingredients.
カルボキシメチルセルロースナトリウム 上流と下流の製品情報
原材料
準備製品