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通用名
BP: Microcrystalline cellulose
JP: Microcrystalline cellulose
PhEur: Cellulosum microcristallinum
USPNF: Microcrystalline cellulose
别名
cellulose-gel; crystalline cellulose;cellulose microgranulare
化学名和CAS注册号
cellulose [9004-34-6]
分子式 分子量
(C6H10O5)n ≈36 000
n≈220
制法
微晶纤维素可用稀无机酸溶液将α-纤维素控制水解制得,α-纤维素可从含纤维素的植物的纤维浆制得。水解后,水解纤维素经过滤、提纯,水浆喷雾干燥形成干的,粒径布广泛的多孔颗粒。
类别
吸附剂;助悬剂;片剂和胶囊的稀释剂;片剂的崩解剂。
制剂应用
微晶纤维素广泛用于药物制剂,主要是在口服片剂和胶囊剂中作为黏合剂或稀释剂,不仅可用于湿法制粒而且可用于直接压片。除了用于黏合剂或稀释剂,微晶纤维素还有一定的润滑和崩解性,故其在片剂的制备中非常有用。
微晶纤维素还可以被用于化妆品和食品;见表Ⅰ。
表Ⅰ:微晶纤维素用途
用途
浓度(%)
吸附剂
20~90
抗黏着剂
5~20
胶囊黏合剂或稀释剂
20~90
片剂崩解剂
5~15
片剂黏合剂或稀释剂
20~90
性状
微晶纤维素是一种纯化的、部分非聚合的纤维素,白色、无臭、无味、由多孔微粒组成的晶体粉末。不同的微粒大小和含水量有不同的特性和应用范围。
药典标准
见表Ⅱ
表Ⅱ 微晶纤维素的药典标准
测试项目
JP 2001
PhEur 2002, Suppl 4.2
USPNF 20
鉴别
+
+
+
性状
+
+
-
pH
5.0~7.0
5.0~7.5
5.0~7.0
松密度
+
-
+
干燥失重
≤7.0%
≤6.0%
≤7.0%
炽灼残渣
≤0.05%
-
≤0.05%
电导率
+
-
+
硫酸灰分
-
≤0.1%
-
醚溶物
≤0.05%
≤0.05%
≤0.05%
水溶物
+
≤0.25%
≤0.24%
重金属
≤10 ppm
≤10 ppm
≤0.001%
淀粉
-
+
-
挥发性有机杂质
-
-
+
微生物限度
+
+
+
一般性质
松密度:0.337g/cm3
轻敲密度:0.478g/cm3
真密度:1.512~1.668g/cm3
熔点:260~270℃炭化
水分:一般小于5% w/w,不同规格的微晶纤维素含水量不同。本品有吸水性。
粒度分布:一般平均粒径是20~200μm。不同规格的微晶纤维素有着不同的中间平均粒径。
溶解度:微溶于5%氢氧化钠溶液;尤其不溶于水,稀酸和多数有机溶剂。
稳定性和贮藏条件
本品有吸湿性,而稳定的物质。大批量贮藏须在阴凉干燥的环境置于密闭性容器中。
配伍禁忌
微晶纤维素对强氧化剂有配伍禁忌
安全性
本品广泛应用在口服药物制剂和食品中,是相对无毒和无刺激性的物质。
本品口服后不吸收,几乎没有潜在的毒性。大量使用可能会引起轻度腹泻,作为药剂辅料无困难。
滥用含有纤维素的某些片剂,如吸入或注射给药,都会导致纤维素肉芽肿。
操作注意事项
遵守材料操作的环境和数量相应的注意事项,本品能刺激眼睛。推荐使用护眼镜和防尘面具。英国,长期暴露(8小时,TWA)在可吸入纤维素粉尘中的职业环境的极限浓度不得超过10mg/m3,而在可呼吸的粉尘纤维素极限浓度不得超过4mg/m3;短期暴露不得超过20 mg/m3。
法规
已列入GRAS。欧洲准许作为食品添加剂。已收载于FDA的<非活性组分指南>中 (吸入剂;口服胶囊;颗粒剂;混悬剂;糖浆剂;片剂;局部和阴道给药)。英国准许用于非注射制剂。
同类物质
微晶纤维素和角叉胶,微晶纤维素和羧甲纤维素钠,微晶纤维素和瓜耳胶,粉状纤维素;硅化微晶纤维素
微晶纤维素和角叉胶
微晶纤维素和羧甲纤维素钠
外观:白色,无臭、无味,吸湿性粉末
酸碱性: 1.2 %的水溶液pH=6~8
含水量:不高于6.0 %
溶解度:在稀酸和有机溶剂中几不溶。部分溶于稀碱和水(羧甲纤维素钠部分)。
注释:微晶纤维素和羧甲基纤维素钠的混合物可以在水中可分散并形成触变胶,在药剂中适于做助悬剂。羧甲纤维素的用量可根据物料的规格在8.3%和18.8%之间变动。
18 注释
上市的几种不同规格的微晶纤维素的不同之处在于它们的生产方法,粒径大小,水分,流动性,以及其他物理性质。大粒径品种流动性较好。低水分的品种可以和湿敏感物质一起配伍使用。高密度的品种改善了流动性。
几种微晶纤维素与其他辅料如角叉胶、羧甲纤维素钠或瓜耳胶等的共加工的混合物都已上市。
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NITIKA PHARMACEUTICAL SPECIALITIES PVT. LTD. ( NITIKA CHEMICALS ) was found in 1991 as a small manufacturing unit has grown today into a dynamic production center for range of products finding applications in various Industry Verticals.
While achieving this growth we are still maintaining it as a family owned enterprise to make best of the advantages of being a closely held company.
15 years after its foundation the company has been able to adapt to the fast growing technological changes to have an edge in the global market place.
Our focus is on the customer and achieving the high degree of customer satisfaction by providing quality products at a reasonable cost backed by timely deliveries and after sales support.
In 1991 NITIKA PHARMACEUTICAL SPECIALITIES PVT. LTD. ( NITIKA CHEMICALS ) was started to Manufacture Fine Chemicals for the Pharmaceutical and Allied Industries.
In 1993 received the Indian FDA Approval.
In 1996 the Production of Metallic Stearates was started utilizing the totally Home-Grown technologies.
In 2000 first Export for USA
n 2003 received ISO 9001:2000 from Bureau Veritas Quality International (Holding) S.A. London.
In 2005 we started building the plant as per WHO-GMP and US-FDA requirements and also received US-DMF no.18912 for our product Magnesium Stearate.
In 2006 we received KOSHER Certificate
In 2007 EDMF No.1252 from European authorities.
In 2008 received ISO 14001:2004.
In 2009 received WHO – GMP Approval.
NITIKA PHARMACEUTICAL SPECIALITIES PVT. LTD. ( NITIKA CHEMICALS ) wishes to maintain a profitable competitive and continuing organization where challenging and rewarding environment encourages employees to work with pride, enthusiasm and commitment.
We acknowledge that the present and future well-being of the company and its employees depends on our pharmaceutical and chemical products meeting statutory, regulatory and customer requirements. We support this by implementing Good Manufacturing and good laboratory practices.
Why Nitika?
Only company in Asia and second in world have Active US-DMF No.18912 for Magnesium Stearate
All the major global players producing Magnesium Stearate are chemical companies having a small Pharma division where as NITIKA PHARMACEUTICAL SPECIALITIES PVT. LTD. ( NITIKA CHEMICALS ) is a purely Pharma focused company and a step further we are focusing on only Pharmaceutical specialized Excipients.
Being strategically located in Central India, provides us with immense benefits like availability of pool of technically qualified personnel, low cost manpower, ready availability of various raw material and utilities.
We stand to gain from the fact that, India is being projected as the future pharmaceutical hub in the global knowledge economy.
India’s first International Multi-model Cargo Hub ‘MIHAN’ is coming up at a distance of about 15 miles from our plant.
Vision
We see Nitika Chemicals as a research based integrated chemical and pharmaceutical company of tomorrow having presence all over the globe with its focus on pharmaceutical excipients and specialties by providing its customers high quality products and backing them with technical, documentation and other supports.