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通用名
BP: Stearic acid
JP: Stearic acid
PhEur: Acidum stearicum
USPNF: Stearic acid
别名
十八烷酸;脂蜡酸;octadecanoic acid;stearophanic acid
化学名和CAS注册号
Octadecanoic acid [57-11-4]
分子式 分子量
C18H36O2, 284.47(纯物质)
USPNF20描述硬脂酸为(C18H36O2)和棕榈酸(C16H32O2)的混合物。USPNF规定含两种酸的总量在40.0~90.0%。USPNF有一个品目列为纯硬脂酸。PhEur2002收载硬脂酸单个品目,但将硬脂酸50,硬脂酸70及硬脂酸95定义为特定含量的硬脂酸 (C18H36O2)。
制造工艺
本品由脂肪在高压釜中持续与高温蒸气逆流接触水解制得。所得的混合物通过减压蒸馏提纯,用选择性溶剂进一步分离。
本品也可由氢化棉籽油或其他菜籽油,通过氢化、皂化、乙醇重结晶制得;或由食用脂肪或油脂与氢氧化钠共煮沸,分离甘油,加入硫酸或盐酸与形成的皂进一步反应。以后采用冷榨法,将硬脂酸与油酸分离。
外用硬脂酸则由不能食用的脂肪制得。硬脂酸可含有抗氧剂,如0.005% w/w丁羟甲苯。
类别
乳化剂;增溶剂、片剂及胶囊剂的润滑剂。
制剂应用
硬脂酸广泛用于口服、局部药剂中。主要用作片剂、胶囊剂的润滑剂。见表Ι,也可作为黏合剂,与虫胶合用用于片剂包衣。也可用于缓释制剂载体。
表Ι 硬脂酸的用途
用途 浓度(%)
软膏剂及乳膏剂 1~20
片剂润滑剂 1~3
在局部用制剂中,硬脂酸用作乳化剂与增溶剂。用碱或三乙醇胺部分中和时,硬脂酸用于乳膏制备。部分中和的硬脂酸加入5~15倍水性液体形成乳膏基质;乳膏外观和塑性决定于碱的用量。
硬脂酸可加到甘油栓剂中作为硬化剂。
硬脂酸广泛用于食品和化妆品中。
性状
本品为硬的、白色或微黄色,有光泽的结晶固体;或白色,黄白色粉末。稍有气味,有动物脂肪味道。
药典标准
见表Ⅱ
表Ⅱ 硬脂酸的药典标准
测试项目
JP 2001
PhEur 2002 (增补本 4.1)
USPNF 20
酸度
-
+
-
酸值
194~210
194~212
-
外观
性状
-
-
+
+
-
-
硬脂酸含量
-
-
≥40.0%
硬脂酸 50
硬脂酸 70
硬脂酸 95
-
-
-
40~60%
60~80%
≥90.0%
-
-
-
硬脂酸和软脂酸含量
-
-
≥90.0%
硬脂酸 50
硬脂酸 70
硬脂酸 95
-
-
-
≥90.0%
≥90.0%
≥96.0%
-
-
-
凝结温度
56.0~72.0℃
-
≥54℃
凝固点
+
硬脂酸 50
硬脂酸 70
硬脂酸 95
-
-
-
53~59℃
57~64℃
64~69℃
-
-
-
碘值
≤4.0
+
≤4.0
硬脂酸 50
硬脂酸 70
硬脂酸 95
-
-
-
≤4.0%
≤4.0%
≤1.5%
-
-
-
镍
-
≤1 ppm
-
炽灼残渣
≤0.1%
-
≤0.1%
重金属
≤20ppm
-
≤0.001%
中性脂肪或石蜡
+
-
+
无机酸
+
-
+
有机挥发性杂质
-
-
+
一般性质
酸值:200~212
松密度:≈0.537 g/cm3
轻敲密度:≈0.571 g/cm3
真密度:≈0.980 g/cm3
熔点:≥54℃
含水量:不含水。
皂化值:200~220
溶解度:易溶于苯,四氯化碳,氯仿,乙醚;溶于乙醇,正己烷,丙二醇;水中不溶解。
表面积:0.51~0.53 m2/g
稳定性和贮藏条件
本品稳定,可加入抗氧剂,散装材料应保存于密闭容器中,置阴凉、干燥处。
配伍禁忌
硬脂酸与金属氢氧化物、氧化剂有配伍禁忌。
与许多金属形成水不溶性的硬脂酸盐;用硬脂酸制得的软膏基质与锌盐或钙盐反应可变成黏稠的胶块。
差热分析方法可被用来研究硬脂酸与一些药物的相容性,据报道,硬脂酸与萘普生不相容。
文献报道,采用水性薄膜包衣技术用于片剂包衣时能引起衣层膜麻面,硬脂酸熔点是形成此缺陷的原因。
安全性
硬脂酸广泛用于口服及局部用制剂中,也用于化妆品和食品中。硬脂酸无毒、无刺激性。
口服过量也可能有害。
LD50( 小鼠,IV): 23 g/kg
LD50( 大鼠,IV): 21.5 g/kg
操作注意事项
遵守材料操作环境和数量相适应的注意事项, 硬脂酸细粉对皮肤、眼睛、黏膜有刺激性,应防护眼睛,带防尘口罩。硬脂酸有燃烧性。
法规
已列入GRAS。欧洲许可作为食品添加剂(脂肪酸),收载在FDA<非活性组分指南>中 (舌下片,口服胶囊剂,溶液剂,混悬剂,片剂,局部用制剂,阴道制剂),英国许可用于非注射药物制剂。
同类物质
硬脂酸钙,硬脂酸镁,硬脂酸钙,棕榈酸,纯化硬脂酸和硬脂酸锌。
棕榈酸
分子式:C16H32O2
分子量:256.42
CAS注册号:[57-10-3]
外观:纯品为白色,结晶性粉末。
沸点:215℃
密度:0.853 g/cm3 ,62℃
熔点:63~64℃
折射率: 1.4273
溶解度:易溶于四氯化碳,乙醚,异丙醇,热乙醇(95%);在乙醇(95%)中略溶,水中不溶解。
注释:EINECS号为200-312-9。
精制硬脂酸
分子式: C18H32O2
分子量:284.47
CAS注册号:[57-11-4]
酸值:195~200
沸点:361℃
密度:0.847 g/cm3 (70℃)
闪点:196℃
碘值:≤1.5
熔点:66~69 ℃
折射率: 1.4299
溶解度:易溶于苯(1:5),四氯化碳(1:6),氯仿(1:2),乙醇(1:15),乙醚(1:3);水中不溶。
相对蒸汽密度:9.80 (空气为1)
注释:精制硬脂酸含硬脂酸和棕榈酸不低于96.0%,硬脂酸不低于总量90.0%。
注释
EINECS号为200-313-4。
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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.