通用名

BP: Magnesium stearate

JP: Magnesium stearate

PhEur: Magnesii stearas

USPNF: Magnesium stearate

化学名和CAS注册名

Octadecanoic acid magnesium salt（十八酸镁盐）[557-04-0]

分子式      分子量

C₃₆H₇₀MgO₄    591.34

USPNF 20 载：硬脂酸镁为镁的多种固态有机酸的化合物，主要由不定比例的硬脂酸镁和棕榈酸镁（C₃₂H₆₂MgO₄）组成。PhEur 2002 描述硬脂酸镁为不同脂肪酸（主要组成为硬脂酸、棕榈酸和少量的其他脂肪酸）的镁盐。

制造工艺

硬脂酸镁由氯化镁与硬脂酸钠的水溶液相互作用制得，或由氧化镁、氢氧化镁、碳酸镁与硬脂酸在高温下相互作用制得。

类别

片剂和胶囊剂的润滑剂。

制剂应用

硬脂酸镁广泛用于化妆品、食品和药物制剂中。在胶囊剂和片剂生产中，它主要用作润滑剂，使用浓度为0.25～5.0% w/w。它也用于护肤乳膏中。

性状

硬脂酸镁为白色、沉降而得的或磨细的、不易触摸而感知的细粉，松密度低，有硬脂酸的微臭并有异味。触摸粉末有细腻感，易粘到皮肤上。

药典标准

见表Ⅰ。

表Ⅰ： 硬脂酸镁的药典标准

一般性质

结晶形式：高纯度的硬脂酸镁有三水化合物、二水化合物、无水化合物。

松密度：0.159g/cm³

轻敲密度：0.286g/cm³

真密度：1.092g/cm³

闪点：250℃

流动性：流动性差，黏性粉末。

熔距：117～150℃（商业样品）

          126～130℃（高纯度硬脂酸镁）

溶解度：不溶于乙醇、95%乙醇、醚和水；微溶于热的苯和95%乙醇中。

比表面积：1.6～14.8m²/g

稳定性和贮藏条件

硬脂酸镁稳定，应贮藏于密闭容器中，置于阴凉、干燥处保存。

配伍禁忌

与强酸、强碱和铁盐配伍禁忌。避免与强氧化物混合。硬脂酸镁在含有阿司匹林、一些维生素、大多数生物碱盐的产品中不得使用。

安全性

硬脂酸镁是广泛应用的药物辅料，通常认为口服无毒。然而，大量口服会引起腹泻或黏膜刺激。

有关正常的职业性接触毒性，未见报告资料。硬脂酸镁中重金属限度，系按硬脂酸镁品质最差者最大的日摄入量和重金属组成来评价。

硬脂酸镁对大鼠的实验表明对皮肤无刺激性，口服及吸入也无毒。

硬脂酸镁植入小鼠的膀胱中，无致癌性。

LD₅₀（大鼠，吸入）：> 2mg/L

 LD₅₀（大鼠，口服）：> 10mg/L

操作注意事项

遵守材料操作环境和数量相应的常规注意事项。注意保护眼睛，戴手套。过量吸入硬脂酸镁粉尘会引起上呼吸道不适，咳嗽和窒息。硬脂酸镁应在通风处操作；戴防尘呼吸设备。

法规

已列入GRAS中。英国准许作为食品添加剂。收载于FDA《非活性组分指南》（口服胶囊剂、散剂和片剂；口含片和阴道用片剂；局部用制剂）。英国准许用于在肠胃道制剂。

同类物质

硬脂酸钙；硬脂酸；硬脂酸锌。

注释

硬脂酸镁呈疏水性，并能阻滞药物从固体剂型中溶出；因此，在处方中使用可能最低的浓度。处方中硬脂酸镁的含量和混合时间对胶囊剂的溶出度敏感；硬脂酸镁用量过高和长时间混合将形成疏水粉末床，致使胶囊壳溶解后内容物不能分散。

在硬脂酸镁和片剂颗粒混合时，混合的变异系数增加，溶出速度降低。混合时间增加，片剂溶出速度和破碎强度降低；硬脂酸镁也可能增加片剂的脆碎度。因此，硬脂酸镁的混合时间应谨慎控制。

已确定硬脂酸镁有多种晶型的存在。有三水合物、二水合物和无水物，无定形形式也已发现。水合物在潮湿的环境中稳定，无水物在相对湿度达到50%以上时有吸湿性，更高湿度下二水合物转化成三水合物。在105℃干燥任何一种水合物能形成无水物。

现在还没有确定纯的硬脂酸镁哪种晶型拥有最好的润滑特性。工业生产的硬脂酸镁是各种晶型的混合物。在加热过程中，晶型有可能转化，所以确定硬脂酸镁粉末的物理特性，例如比表面积，应考虑预处理条件。

硬脂酸镁的物理特性会随生产厂商、不同批号变化而异，因为粉末的固态性质受生产变因的影响。同一生产厂商生产的不同批号的硬脂酸镁物理特性的变化已有研究报道。也许因这些可变因素，就不能武断地说溶出速度降低与其观察到的润滑作用相关。

然而，不同批号的硬脂酸镁各种物理特性，例如比表面积、粒度、晶体结构、含湿量、脂肪酸组成等与润滑效果有关。在某些情况下，因硬脂酸镁的作用引起溶出速度的降低，可在处方中加入高膨胀性的崩解剂来解决。

据报道，硬脂酸镁疏水的特性会随批号变化，由于存在水溶性、表面活性杂质，例如硬脂酸钠。含有低浓度的这类杂质的批号，比使用含有更高浓度这类杂质的批号能更大地阻滞药物的溶出。有研究报道认为润滑作用与片剂处方润滑剂的脂肪酸组成（硬脂酸：棕榈酸）有关。根据严密的数据和片剂所用材料特性。然而，其他有些报道表明脂肪酸组成对润滑剂活性无影响，高纯度的硬脂酸镁与市售的商品润滑效果一样。

硬脂酸镁EINECS号为209-150-3

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.