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순도시험
(1) 비선광도 : 이 품목 1g(무수물로 환산한 것)을 초산 100mL에 녹여서 비선광도를 측정할 때, 
=+250°～+295° 이어야 한다.
(2) 액성 : 이 품목의 현탁액(1→100)의 pH는 5.0～7.5이어야 한다.
(3) 납 : 이 품목 5.0g을 취하여 원자흡광광도법 또는 유도결합플라즈마발광광도법에 따라 시험할 때, 그 양은 2.0ppm 이하이어야 한다.
(4) 비소 : 이 품목을 비소시험법에 따라 시험할 때, 그 양은 4.0ppm 이하이어야 한다.
(5) 수은 : 이 품목을 수은시험법에 따라 시험할 때, 그 양은 1.0ppm 이하이어야 한다.
(6) 세균수 : 이 품목은 「식품의 기준 및 규격」 일반시험법의 미생물시험법 중 세균수(일반세균수)에 따라 시험할 때, 제품 1g 당 100 이하이어야 한다.
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확인시험
(1) 이 품목 1mg에 염산 1mL를 가해 혼합할 때, 이 액은 청자색을 나타낸다.
(2) 이 품목 5mg에 초산메탄올용액(1→1,000) 1,000mL를 가하여 녹인 액은 파장 290nm 부근, 303nm 부근 및 318nm 부근에 극대흡수부가 있다.
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정량법
이 품목 및 나타마이신 표준품(미리 수분함량을 측정한다) 0.02g을 정밀히 달아 테트라하이드로퓨란 5mL을 가하고 10분간 초음파 조사한 후 메탄올 60mL를 가해 녹인 후 이에 물 25mL를 가하여 실온에서 방치한다. 여기에 물을 가하여 정확히 100mL로 하여 시험용액과 표준용액으로 한다. 표준용액 및 시험용액을 각각 20μL씩을 취하여 다음의 조작조건에 서 액체크로마토그래피를 행하고 얻어진 피크의 높이 또는 면적으로 다음 계산식에 따라 나타마이신의 함량을 구한다. 다만, 조작은 직사일광을 피해, 차광한 용기를 이용하여 행한다.
조작조건
검 출 기 : UV 303nm
칼럼충전제 : 5～10μm의 액체크로마토그래피용 옥타데실시릴화실리카겔
칼 럼 관 : 내경 4.6mm, 길이 25cm의 스텐인레스관
칼 럼 온 도 : 실온
이 동 상 : 초산암모늄 3.0g 및 염화암모늄 1.0g을 물 760mL에 녹여 테트라 하이드로퓨란 5.0mL 및 아세토나이트릴 240mL를 가한다.
유 량 : 2mL/min
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강열잔류물
이 품목 2g을 취하여 강열잔류물 실험을 할 때, 그 양은 0.5% 이하이어야 한다.
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개요
Natamycin is a naturally occurring macrolide polyene antifungal agent produced during fermentation by the bacterium S. natalensis, commonly found in soil. With minimal inhibitory concentrations ranging from 4-64 μM, natamycin is used to treat fungal infections, including Candida, Aspergillus, Cephalosporium, Fusarium, and Penicillium. Natamycin blocks fungal growth by binding specifically to ergosterol with an apparent affinity of ~100 μM, but it does not permeabilize cell membranes as other polyene antibiotics are known to do. Natamycin is also used in the food industry as a preservative.
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화학적 성질
Natamycin (more commonly known as pimaricin) belongs to the polyene macrolide group of antifungal antibiotics. It was derived from Streptomyces natalensis or S. chattanoogensis. In therapeutic use, it is prescribed for a variety of fungal infections, mainly topically, but some ophthalmic applications as well. In addition to therapeutic and food use, pimaricin has applications including use as an agricultural chemical and wood preservative.
In the dry state, pimaricin is very stable, as long as it is protected from light and heat, and stability is maintained for a minimum of 1 to 2 years. As long as aqueous suspensions are stored in a cooland dark place, they can be kept for at least six months. Once placed on the surface of the cheese (pimaricin does not penetrate the surface of cheese as do sorbic acid salts), the antimycotic decomposes in about six weeks.
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용도
Natamycin (l), from Streptomyces nataIensis and Streptomyces chat tanoogensis,
is used for the control of diseases of bulbs.
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Biological Functions
Natamycin, also known as pimaracin, belongs to the polyene family of antibiotics; (a group of antifungal agents which target and bind to eukaryotic sterols and specifically ergosterol), and it is a secondary metabolite of Streptomyces natalensis . Very low levels (10–20 ppm) are needed to inhibit almost all yeasts and molds, while no amount of natamycin is sufficient to inhibit most bacteria, as they lack the sterol targeted by natamycin (some gram-positive types may be susceptible). Thus, natamycin may be used to retard the growth of fungi in meat products to which fermentative cultures are added, and is typically applied as a surface treatment (i.e., dip or spray). Resistant organisms are not typically encountered even though natamycin has been used as a food preservative for more than three decades. Unlike most bacteriocins, natamycin is toxic to eukaryotes. Acceptable daily intake of natamycin for humans is 0–0.3 mg/kg of body weight.
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Antimicrobial activity
The spectrum of Natamycin's activity is somewhat narrower than that of amphotericin and nystatin,
but at the same time, it is less toxic. It exhibits especially pronounced activity against a few
strains of Fusarium and Cefalosporium. Natamycin is a drug for treating superficial fungal infections, and it is used only for ophthalmologic purposes. Synonyms of this drug are
pimafucin, pimaricin, tennecetin, and others.
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일반 설명
Natamycin (pimaricin; Natacyn) is a polyene antibiotic obtainedfrom cultures of Streptomyces natalensis.The natamycin structure consists of a 26-membered lactonering containing a tetraene chromophore, an α,β-unsaturatedlactone carbonyl group, three hydroxyl groups, a carboxyl group, a trans epoxide, and a glycosidically joined mycosamine.Like the other polyene antibiotics, natamycin isamphoteric.The smaller polyenes are fungistatic and fungicidal within thesame concentration range.Natamycin possesses in vitro activity against severalyeasts and filamentous fungi, including Candida,Aspergillus, Cephalosporium, Penicillium, and Fusariumspp. The drug is supplied as a 5% ophthalmic suspension intendedfor the treatment of fungal conjunctivitis, blepharitis,and keratitis.
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부작용
Side effects that you should report to doctor as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips or tongue
changes in vision
eye pain
severe burning, stinging, or swelling of the eyelids
Side effects that usually do not require medical attention:
blurred vision for a few moments after application
temporary redness or stinging for a few moments after application
temporary watering of eyes
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Safety Profile
Poison by intravenous,
intramuscular, subcutaneous, and
intraperitoneal routes. Moderately toxic by
ingestion. When heated to decomposition it emits toxic fumes of NOx. Used as an
antibacterial agent.
