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순도시험
(1) 액성 : 이 품목 1g을 물 100mL에 녹인 액의 pH는 5.0～8.0이어야 한다
(2) 프로필렌클로로히드린 : 이 품목 1g을 정밀히 달아 디에틸에테르 5mL를 가해 주고 마개를 한 후 10분간 초음파 추출한다. 이 액을 원심분리하여 상등액을 시험용액으로 한다. 따로, 프로필렌클로로히드린[Aldrich 292087(1-Chloro-2-propanol 70%와 2-Chloro-1-propanol 25%의 혼합물) 또는 이와 동등한 것] 0.1g을 정밀히 달아 디에틸에테르를 가하여 100mL로 하고, 이 액 일정량을 취해 디에틸에테르로 희석하여 1mL당 6～25ng의 프로필렌클로로히드린을 함유하도록 조제한 액을 각 표준용액으로 한다. 시험용액 및 각 표준용액 1μL씩을 다음의 조작조건으로 가스크로마토그래피에 주입한다. 이어서 각 표준용액의 농도(ng/mL)에 대한 표준용액의 피크면적을 측정하여 검량선을 작성한다. 시험용액 중의 프로필렌클로로히드린의 피크면적을 측정하여 미리 작성한 검량선으로부터 시험용액 중의 프로필렌클로로히드린 함량을 구할 때, 그 양은 0.1ppm 이하이어야 한다.
조작조건
캐필러리칼럼 : DB-WAX(30m×0.53mm, 1μm) 또는 이와 동등한 것
검 출 기 : 전자포획검출기(ECD)
주입구온도 : 200℃
칼럼온도 : 35℃에서 7분간 머무른 후 8℃/min의 비율로 온도를 상승시켜 200℃에서 5분간 유지한다.
검출기온도 : 230℃
캐리어가스 : 질소 또는 헬륨
유 량 : 1-클로로-2-프로판올의 유지시간은 약 11.7분, 2-클로로-1-프로판올의 유지시간은 약 12.5분이 되도록 조정한다.
(3) 납 : 이 품목 5.0g을 취하여 원자흡광광도법 또는 유도결합플라즈마발광광도법에 따라 시험할 때, 그 양은 2.0ppm 이하이어야 한다.
(4) 카드뮴 : 이 품목 5.0g을 취하여 원자흡광광도법 또는 유도결합플라즈마발광광도법에 따라 시험할 때, 그 양은 1.0ppm 이하이어야 한다.
(5) 수은 : 이 품목을 수은시험법에 따라 시험할 때, 그 양은 1.0ppm 이하이어야 한다.
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확인시험
(1) 이 품목의 수용액(0.1→100)을 심하게 흔들면 거품층이 생긴다.
(2) 이 품목의 수용액(0.5→100) 5mL에 5% 황산동용액 또는 5% 황산알루미늄용액 5mL를 가하면, 침전이 생기지 않는다.
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정량법
이 품목 약 65mg을 정밀히 달아 분해병(5mL 내압마개 유리병)에 넣고 아디프산 65mg, 내부표준용액 2.0mL 및 요오드화수소산(취급시 주의할 것) 2.0mL를 넣고 마개를 하고 그 무게를 정밀히 단다. 분해병을 30초간 흔들어 섞고 가열기를 사용하여 150℃, 20분간 가열한 다음 조심스럽게 흔들어 섞고 다시 40분간 가열한다. 45분간 식힌 다음 그 무게를 정밀히 달고 감량이 10mg 이하의 것의 상층을 시험용액으로 한다. 따로 아디프산 65mg, 내부표준용액 2.0mL, 요오드화수소산 2.0mL를 분해병에 취하여 마개를 하고 그 무게를 정밀히 달고 요오드화이소프로필 15μL를 넣고 무게를 정밀히 달아 같은 방법으로 요오드화메틸 45μL를 넣고 무게를 정밀히 단다. 분해병을 30초간 흔들어 섞은 다음 상층을 표준용액으로 한다. 시험용액과 표준용액 1μL를 각각 가스크로마토그래피에 주입하고 다음 식에 따라 메톡실기와 히드록시프로폭실기의 함량(%)을 구한다.
WSa : 표준용액중의 요오드화메틸의 양(mg)
WSb : 표준용액중의 요오드화이소프로필의 양(mg)
QSa, QSb : 표준용액중 내부표준물질의 피크면적에 대한 요오드화메틸 및 요오드화이소프로필의 피크면적비
QTa, QTb : 시험용액중 내부표준물질의 피크면적에 대한 요오드화메틸 및 요오드화이소프로필의 피크면적비
조작조건
칼 럼 : 가스크로마토그래피용 규조토(Chromosorb WHP 또는 이와 동등한 것)에 10% 메틸실리콘오일을 입힌 것 또는 이와 동등한 것
검 출 기 : 열전도도검출기(TCD) 또는 수소염이온화검출기(FID)
주입구온도 : 200℃
칼럼온도 : 50℃
검출기온도 : 200℃
캐리어가스 : 헬륨 또는 질소
유지시간 : 요오드화메틸, 요오드화이소프로필, 톨루엔 순이다.
내부표준용액 : 톨루엔 0.25g을 정밀히 취하여 ο-크실렌으로 50mL로 한다.
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강열잔류물
이 품목의 강열잔류물은 점도가 50cps이상일 경우에는 1.5% 이하, 50cps미만일 경우에는 3.0% 이하이어야 한다. 점도는「메틸셀룰로스」의 순도시험 (1)에 따라 시험한다.
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개요
Hydroxypropyl methyl cellulose is a propylene glycol ether of methylcellulose in which both hydroxypropyl and methyl groups are bound to the anhydrous glucose ring of cellulose by ether linkages. Hydroxypropyl methyl cellulose is synthesized from methyl cellulose by the action of alkali and propylene oxide. The resultant product is a water soluble ether derivative of cellulose containing both methoxy and hydroxypropyl groups. The degree of substitution is 1.08 to 1.83 with the hydroxypropyl groups as the minor constituent. White to off-white fibrous powder or granules. Soluble in water and some organic solvents. Insoluble in ethanol, the aqueous solution has surface activity, forms a thin film after drying, and undergoes a reversible transition from sol to gel in turn by heating and cooling.
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화학적 성질
Hypromellose is an odorless and tasteless, white or creamy-white fibrous or granular powder. This product is soluble in water (10 mg/ml). However, it is very important to thoroughly disperse the particles in water with agitation before they will dissolve. Otherwise, they will lump and form a gelatinous membrane around the internal particles, preventing them from wetting completely. There are four dispersion techniques commonly used to prepare solutions of hydroxypropylmethylcellulose: dispersion in hot water, dry blending, dispersion in non-solvent medium, and dispersion of surface-treated powders.
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주요 응용
Hydroxypropyl methyl cellulose is used as an ophthalmic lubricant, an emulsifier and a thickening and suspending agent. It is widely used as an excipient in pharmaceutical formulations. It acts as a food additive. Its eye drops are known as artificial tears, which are used to relieve eye dryness and soreness. It finds applications in various fields as emulsifier, film former, protective colloid, stabilizer, suspending agent, or thickener in foods. Pharmaceutic aid (suspending agent; tablet excipient; demulcent; viscosity increasing agent); hydrophilic carrier in drug delivery systems. In adhesives, asphalt emulsions, caulking compounds, tile mortars, plastic mixes, cements, paints.
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Indications
Hydroxypropyl methylcellulose belongs to the group of medicines known as artificial tears. It is used to relieve dryness and irritation caused by reduced tear flow. It helps prevent damage to the eye in certain eye diseases. Hydroxypropyl methylcellulose may also be used to moisten hard contact lenses and artificial eyes. In addition, it may be used in certain eye examinations.
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생산 방법
A purified form of cellulose, obtained from cotton linters or wood
pulp, is reacted with sodium hydroxide solution to produce a
swollen alkali cellulose that is chemically more reactive than
untreated cellulose. The alkali cellulose is then treated with
chloromethane and propylene oxide to produce methyl hydroxypropyl
ethers of cellulose. The fibrous reaction product is then
purified and ground to a fine, uniform powder or granules.
Hypromellose can then be exposed to anhydrous hydrogen chloride
to induce depolymerization, thus producing low viscosity grades.
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일반 설명
Hydroxypropylmethylcelluloses are water soluble polymers derived from cellulose. They are typically used as thickeners, binders, film formers, and water retention agents. They also function as suspension aids, surfactants, lubricants, protective colloids, and emulsifiers. In addition, solutions of these polymers thermally gel.
These polymers are prepared by reacting wood or cotton cellulose fibers with propylene oxide and methyl chloride in the presence of caustic soda. This product has a methoxyl content of 28-30% and a hydroxypropoxyl content of 7-12%.
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부작용
Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug.
Major & minor side effects for Hydroxypropyl Methylcellulose
Blurred vision
Decrease/loss of vision
Eye pain
Excessive tearing of the eye
Redness in and around the eyes
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Safety
Hypromellose is widely used as an excipient in oral, opthalmic,
nasal, and topical pharmaceutical formulations. It is also used
extensively in cosmetics and food products.
Hypromellose is generally regarded as a nontoxic and nonirritating
material, although excessive oral consumption may have a
laxative effect. The WHO has not specified an acceptable daily
intake for hypromellose since the levels consumed were not
considered to represent a hazard to health. In fact, high dosages
of hypromellose are being investigated for treating various
metabolic syndromes.
LD50 (mouse, IP): 5 g/kg(20)
LD50 (rat, IP): 5.2 g/kg
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저장
Hypromellose powder is a stable material, although it is hygroscopic
after drying.
Solutions are stable at pH 3–11. Hypromellose undergoes a
reversible sol–gel transformation upon heating and cooling,
respectively. The gelation temperature is 50–90°C, depending
upon the grade and concentration of material. For temperatures
below the gelation temperature, viscosity of the solution decreases
as temperature is increased. Beyond the gelation temperature,
viscosity increases as temperature is increased.
Aqueous solutions are comparatively enzyme-resistant, providing
good viscosity stability during long-term storage. However,
aqueous solutions are liable to microbial spoilage and should be
preserved with an antimicrobial preservative: when hypromellose is
used as a viscosity-increasing agent in ophthalmic solutions,
benzalkonium chloride is commonly used as the preservative.
Aqueous solutions may also be sterilized by autoclaving; the
coagulated polymer must be redispersed on cooling by shaking.
Hypromellose powder should be stored in a well-closed
container, in a cool, dry place.
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비 호환성
Hypromellose is incompatible with some oxidizing agents. Since it is
nonionic, hypromellose will not complex with metallic salts or ionic
organics to form insoluble precipitates.
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Regulatory Status
GRAS listed. Accepted for use as a food additive in Europe.
Included in the FDA Inactive Ingredients Database (ophthalmic and
nasal preparations; oral capsules, suspensions, syrups, and tablets;topical and vaginal preparations). Included in nonparenteral
medicines licensed in the UK. Included in the Canadian List of
Acceptable Non-medicinal Ingredients.
