The USP32-NF27 describes magnesium stearate as a compound of magnesium with a mixture of solid organic acids that consists chiefly of variable proportions of magnesium stearate and magnesium palmitate (C_(32)H_(62)MgO_(4))\left(\mathrm{C}_{32} \mathrm{H}_{62} \mathrm{MgO}_{4}\right). The PhEur 6.5 describes magnesium stearate as a mixture of solid organic acids consisting mainly of variable proportions of magnesium stearate and magnesium palmitate obtained from sources of vegetable or animal origin. USP32-NF27 将硬脂酸镁描述为镁与固体有机酸混合物的化合物，该混合物主要由不同比例的硬脂酸镁和棕榈酸镁 (C_(32)H_(62)MgO_(4))\left(\mathrm{C}_{32} \mathrm{H}_{62} \mathrm{MgO}_{4}\right) 组成。PhEur 6.5 将硬脂酸镁描述为固体有机酸的混合物，主要由不同比例的硬脂酸镁和棕榈酸镁组成，这些酸镁来自植物或动物来源。
7 Applications in Pharmaceutical Formulation or Technology 7 在药物制剂或技术中的应用
Magnesium stearate is widely used in cosmetics, foods, and pharmaceutical formulations. It is primarily used as a lubricant in capsule and tablet manufacture at concentrations between 0.25%0.25 \% and 5.0%w//w5.0 \% \mathrm{w} / \mathrm{w}. It is also used in barrier creams. See also Section 18. 硬脂酸镁广泛用于化妆品、食品和药物配方中。它主要用作胶囊和片剂制造中的润滑剂，浓度在 0.25%0.25 \% 和 5.0%w//w5.0 \% \mathrm{w} / \mathrm{w} 之间。它也用于隔离霜。另见第 18 节。
8 Description 8 详情描述
Magnesium stearate is a very fine, light white, precipitated or milled, impalpable powder of low bulk density, having a faint odor of stearic acid and a characteristic taste. The powder is greasy to the touch and readily adheres to the skin. 硬脂酸镁是一种非常细的浅白色，沉淀或研磨，难以捉摸的粉末，体积密度低，具有微弱的硬脂酸气味和特有的味道。粉末摸起来很油腻，很容易粘附在皮肤上。
9 Pharmacopeial Specifications 9 药典规格
See Table I. See also Section 18. 见表 I。另见第 18 节。
10 Typical Properties 10 典型特性
Crystalline forms High-purity magnesium stearate has been isolated as a trihydrate, a dihydrate, and an anhydrate. 结晶形式 高纯度硬脂酸镁已被分离为三水合物、二水合物和无水物。
Density (bulk) 0.159g//cm^(3)0.159 \mathrm{~g} / \mathrm{cm}^{3} 密度（体积） 0.159g//cm^(3)0.159 \mathrm{~g} / \mathrm{cm}^{3}
Density (tapped) 0.286g//cm^(3)0.286 \mathrm{~g} / \mathrm{cm}^{3} 密度（振实） 0.286g//cm^(3)0.286 \mathrm{~g} / \mathrm{cm}^{3}
Density (true) 1.092g//cm^(3)1.092 \mathrm{~g} / \mathrm{cm}^{3} 密度 （true） 1.092g//cm^(3)1.092 \mathrm{~g} / \mathrm{cm}^{3}
Flash point 250^(@)C250^{\circ} \mathrm{C} 闪点 250^(@)C250^{\circ} \mathrm{C}
Flowability Poorly flowing, cohesive powder. 流动性 流动性差，粘性强的粉末。
Melting range 熔融范围 117-150^(@)C117-150^{\circ} \mathrm{C} (commercial samples); 117-150^(@)C117-150^{\circ} \mathrm{C} （商业样品）;
SEM 1: Excipient: magnesium stearate; magnification: 600 xx600 \times. SEM 1：赋形剂：硬脂酸镁;放大倍率： 600 xx600 \times .
SEM 2: Excipient: magnesium stearate; magnification: 2400 xx2400 \times. SEM 2：赋形剂：硬脂酸镁;放大倍率： 2400 xx2400 \times . 126-130^(@)C126-130^{\circ} \mathrm{C} (high purity magnesium stearate). 126-130^(@)C126-130^{\circ} \mathrm{C} （高纯度硬脂酸镁）。
NIR spectra see Figure 1. NIR 光谱见图 1。
Solubility Practically insoluble in ethanol, ethanol (95%), ether and water; slightly soluble in warm benzene and warm ethanol (95%). 溶解度 几乎不溶于乙醇、乙醇（95%）、乙醚和水;微溶于温苯和温乙醇 （95%）。
Specific surface area 1.6-14.8m^(2)//g1.6-14.8 \mathrm{~m}^{2} / \mathrm{g} 比表面积 1.6-14.8m^(2)//g1.6-14.8 \mathrm{~m}^{2} / \mathrm{g}
11 Stability and Storage Conditions 11 稳定性和储存条件
Magnesium stearate is stable and should be stored in a well-closed container in a cool, dry place. 硬脂酸镁是稳定的，应储存在密闭容器中，置于阴凉干燥处。
Table I: Pharmacopeial specifications for magnesium stearate. 表 I：硬脂酸镁的药典规范。
Incompatible with strong acids, alkalis, and iron salts. Avoid mixing with strong oxidizing materials. Magnesium stearate cannot be used in products containing aspirin, some vitamins, and most alkaloidal salts. 与强酸、强碱和铁盐不相容。避免与强氧化性物质混合。硬脂酸镁不能用于含有阿司匹林、某些维生素和大多数生物碱的产品。
13 Method of Manufacture 13 制造方法
Magnesium stearate is prepared either by the interaction of aqueous solutions of magnesium chloride with sodium stearate or by the interaction of magnesium oxide, hydroxide, or carbonate with stearic acid at elevated temperatures. 硬脂酸镁是通过氯化镁与硬脂酸钠的水溶液相互作用或通过氧化镁、氢氧化物或碳酸盐在高温下与硬脂酸相互作用来制备的。
14 Safety 14 治理
Magnesium stearate is widely used as a pharmaceutical excipient and is generally regarded as being nontoxic following oral administration. However, oral consumption of large quantities may produce a laxative effect or mucosal irritation. 硬脂酸镁被广泛用作药用辅料，通常认为口服后无毒。然而，大量口服可能会产生通便作用或粘膜刺激。
No toxicity information is available relating to normal routes of occupational exposure. Limits for heavy metals in magnesium stearate have been evaluated in terms of magnesium stearate worstcase daily intake and heavy metal composition. ^((1)){ }^{(1)} 没有关于正常职业暴露途径的毒性信息。硬脂酸镁中重金属的限值是根据硬脂酸镁最坏情况下的每日摄入量和重金属成分进行评估的。 ^((1)){ }^{(1)}
Toxicity assessments of magnesium stearate in rats have indicated that it is not irritating to the skin, and is nontoxic when administered orally or inhaled. ^((2,3)){ }^{(2,3)} 硬脂酸镁在大鼠体内的毒性评估表明，它对皮肤无刺激性，口服或吸入时无毒。 ^((2,3)){ }^{(2,3)}
Magnesium stearate has not been shown to be carcinogenic when implanted into the bladder of mice. ^((4)){ }^{(4)} 硬脂酸镁在植入小鼠膀胱时尚未显示具有致癌性。 ^((4)){ }^{(4)}
{:[LD_(50)(" rat, inhalation "):>2mg//L^((2))],[LD_(50)(" rat, oral "):>10g//kg]:}\begin{aligned}
& \mathrm{LD}_{50}(\text { rat, inhalation }):>2 \mathrm{mg} / \mathrm{L}^{(2)} \\
& \mathrm{LD}_{50}(\text { rat, oral }):>10 \mathrm{~g} / \mathrm{kg}
\end{aligned}
15 Handling Precautions 15 处理注意事项
Observe normal precautions appropriate to the circumstances and quantity of material handled. Eye protection and gloves are recommended. Excessive inhalation of magnesium stearate dust may cause upper respiratory tract discomfort, coughing, and choking. Magnesium stearate should be handled in a well-ventilated environment; a respirator is recommended. In the USA, the OSHA limit is 10mg//m^(3)10 \mathrm{mg} / \mathrm{m}^{3} TWA for magnesium stearate. 遵守适合所处理物料情况和数量的正常预防措施。建议佩戴护目镜和手套。过量吸入硬脂酸镁粉尘可引起上呼吸道不适、咳嗽和窒息。硬脂酸镁应在通风良好的环境中处理;建议使用呼吸器。在美国，OSHA 限值为 10mg//m^(3)10 \mathrm{mg} / \mathrm{m}^{3} 硬脂酸镁的 TWA。
16 Regulatory Acceptance 16 监管接受
GRAS listed. Accepted as a food additive in the USA and UK. Included in the FDA Inactive Ingredients Database (oral capsules, powders, and tablets; buccal and vaginal tablets; topical prepara- 列入 GRAS 列表。在美国和英国被接受为食品添加剂。包含在 FDA 非活性成分数据库中（口服胶囊、粉末和片剂;口腔和阴道片剂;局部制剂-
Figure 1: Near-infrared spectrum of magnesium stearate measured by reflectance. 图 1：通过反射率测量的硬脂酸镁的近红外光谱。
tions; intravitreal implants and injections). Included in nonparenteral medicines licensed in the UK. Included in the Canadian List of Acceptable Non-medicinal Ingredients. Listed on the US TSCA inventory. tions;玻璃体内植入物和注射剂）。包含在 UK 许可的非肠外药物中。包含在加拿大可接受的非药用成分清单中。列入美国 TSCA 库存。
Magnesium stearate is one of the materials that have been selected for harmonization by the Pharmacopeial Discussion Group. For further information see the General Information Chapter <1196> in the USP32-NF27, the General Chapter 5.8 in PhEur 6.0, along with the ‘State of Work’ document on the PhEur EDQM website, and also the General Information Chapter 8 in the JP XV. 硬脂酸镁是药典讨论组选择进行协调的材料之一。有关更多信息，请参阅 USP32-NF27 中的一般信息章 <1196>、PhEur 6.0 中的通则 5.8，以及 PhEur EDQM 网站上的“工作状态”文件，以及 JP XV 中的一般信息第 8 章。
Magnesium stearate is hydrophobic and may retard the dissolution of a drug from a solid dosage form; the lowest possible concentration is therefore used in such formulations. ^((5-10)){ }^{(5-10)} Capsule dissolution is also sensitive to both the amount of magnesium stearate in the formulation and the mixing time; higher levels of magnesium stearate and long mixing times can result in the formation of hydrophobic powder beds that do not disperse after the capsule shell dissolves. ^((11,12)){ }^{(11,12)} 硬脂酸镁具有疏水性，可能会延缓药物从固体剂型中的溶解;因此，在此类配方中使用尽可能低的浓度。 ^((5-10)){ }^{(5-10)} 胶囊溶解对制剂中硬脂酸镁的量和混合时间也很敏感;较高水平的硬脂酸镁和较长的混合时间会导致形成疏水性粉末床，胶囊壳溶解后不会分散。 ^((11,12)){ }^{(11,12)}
An increase in the coefficient of variation of mixing and a decrease in the dissolution rate have been observed following blending of magnesium stearate with a tablet granulation. Tablet dissolution rate and crushing strength decreased as the time of blending increased; and magnesium stearate may also increase tablet friability. Blending times with magnesium stearate should therefore be carefully controlled. ^((13-29)){ }^{(13-29)} A variety of online analytical techniques have been investigated to monitor magnesium stearate in powder blends and tablets. ^((30-32)){ }^{(30-32)} Inverse gas chromatography has been used to examine the surface coverage of magnesium stearate on powder blends. ^((33)){ }^{(33)} Magnesium stearate also affects the flow properties of blends. ^((34)){ }^{(34)} 在硬脂酸镁与片剂造粒混合后，观察到混合变异系数的增加和溶出速率的降低。片剂溶解速率和粉碎强度随着混合时间的增加而降低;硬脂酸镁也可能增加片剂的脆性。因此，应仔细控制与硬脂酸镁的混合时间。 ^((13-29)){ }^{(13-29)} 已经研究了各种在线分析技术来监测粉末混合物和片剂中的硬脂酸镁。 ^((30-32)){ }^{(30-32)} 反相气相色谱法已用于检查粉末混合物上硬脂酸镁的表面覆盖率。 ^((33)){ }^{(33)} 硬脂酸镁也会影响共混物的流动特性。 ^((34)){ }^{(34)}
The existence of various crystalline forms of magnesium stearate has been established. ^((35-39)){ }^{(35-39)} A trihydrate, a dihydrate, and an anhydrate have been isolated, ^((5,37,38,40)){ }^{(5,37,38,40)} and an amorphous form has been observed. ^((41)){ }^{(41)} While the hydrated forms are stable in the presence of moisture, the anhydrous form adsorbs moisture at relative humidity up to 50%50 \%, and at higher humidities rehydrates to form the trihydrate. The anhydrate can be formed by drying either of the hydrates at 105^(@)C.^((38))105^{\circ} \mathrm{C} .^{(38)} 已经确定了硬脂酸镁的各种结晶形式的存在。 ^((35-39)){ }^{(35-39)} 分离出一种三水合物、一种二水合物和一种无水物， ^((5,37,38,40)){ }^{(5,37,38,40)} 并观察到无定形形式。 ^((41)){ }^{(41)} 虽然水合形式在水分存在下是稳定的，但无水形式在相对湿度高达 50%50 \% 时吸附水分，在较高的湿度下再水化形成三水合物。可以通过在 105^(@)C.^((38))105^{\circ} \mathrm{C} .^{(38)}
It has not been conclusively established which form of pure magnesium stearate possesses the best lubricating properties. ^((36,37,41-43)){ }^{(36,37,41-43)} Commercial lots of magnesium stearate generally 尚未最终确定哪种形式的纯硬脂酸镁具有最佳润滑性能。 ^((36,37,41-43)){ }^{(36,37,41-43)} 硬脂酸镁的商业批次通常
consist of mixtures of crystalline forms. ^((37,39,41,42,44-46)){ }^{(37,39,41,42,44-46)} Because of the possibility of conversion of crystalline forms during heating, consideration should be given to the pretreatment conditions employed when determining physical properties of magnesium stearate powders such as surface area. (47,48)(47,48) 由结晶形式的混合物组成。 ^((37,39,41,42,44-46)){ }^{(37,39,41,42,44-46)} 由于在加热过程中可能会转化结晶形式，因此在确定硬脂酸镁粉末的物理性质（如表面积）时应考虑所采用的预处理条件。 (47,48)(47,48)
Physical properties of magnesium stearate can vary among batches from different manufacturers ^((46)){ }^{(46)} because the solid-state characteristics of the powder are influenced by manufacturing variables. ^((36)){ }^{(36)} Variations in the physical properties of different lots of magnesium stearate from the same vendor have also been observed. ^((46)){ }^{(46)} Presumably because of these variations, it has not been possible to conclusively correlate the dissolution rate retardation with observed lubricity. ^((49)){ }^{(49)} 硬脂酸镁的物理特性可能因不同制造商 ^((46)){ }^{(46)} 的批次而异，因为粉末的固态特性受制造变量的影响。 ^((36)){ }^{(36)} 还观察到来自同一供应商的不同批次硬脂酸镁的物理性质差异。 ^((46)){ }^{(46)} 据推测，由于这些变化，无法最终地将溶出速率延迟与观察到的润滑性相关联。 ^((49)){ }^{(49)}
However, various physical properties of different batches of magnesium stearate, such as specific surface area, particle size, crystalline structure, moisture content, and fatty acid composition, have been correlated with lubricant efficacy. ^((37,41,45,46,50-55)){ }^{(37,41,45,46,50-55)} Due to variations in the specific surface area, the labeling states that specific surface area and the method specified for its determination should be listed on the label. Reduction in dissolution caused by the effects of magnesium stearate in some cases can be overcome by including a highly swelling disintegrant in the formulation. ^((56)){ }^{(56)} 然而，不同批次的硬脂酸镁的各种物理性质，如比表面积、粒径、晶体结构、水分含量和脂肪酸组成，都与润滑剂的功效相关。 ^((37,41,45,46,50-55)){ }^{(37,41,45,46,50-55)} 由于比表面积的变化，标签上应列出比表面积和指定的测定方法。在某些情况下，硬脂酸镁作用引起的溶出减少可以通过在配方中加入高溶胀崩解剂来克服。 ^((56)){ }^{(56)}
The impact of magnesium stearate levels on tablet compaction properties and performance of roller compacted granulations has been examined. ^((57-59)){ }^{(57-59)} In other compaction studies performed with granules, magnesium stearate has been shown to exert an influence on granule relaxation and may help to prevent capping. ^((60)){ }^{(60)} 已经研究了硬脂酸镁水平对片剂压实性能和辊压制颗粒性能的影响。 ^((57-59)){ }^{(57-59)} 在对颗粒进行的其他压实研究中，硬脂酸镁已被证明对颗粒松弛有影响，可能有助于防止加帽。 ^((60)){ }^{(60)}
There is evidence to suggest that the hydrophobic nature of magnesium stearate can vary from batch to batch owing to the presence of water-soluble, surface-active impurities such as sodium stearate. Batches containing very low concentrations of these impurities have been shown to retard the dissolution of a drug to a greater extent than when using batches that contain higher levels of impurities. ^((49)){ }^{(49)} One study related lubricity to the fatty acid composition (stearate: palmitate) of lubricant lots for tablet formulations based on compaction data and tablet material properties. ^((54)){ }^{(54)} However, other studies have indicated that fatty acid composition has no influence on lubricant activity ^((37)){ }^{(37)} and highpurity magnesium stearate was as effective a lubricant as the commercial material. ^((10)){ }^{(10)} Moisture sorption at different relative humidities can result in morphological changes in the magnesium stearate. ^((61,62)){ }^{(61,62)} 有证据表明，由于存在水溶性、表面活性杂质（如硬脂酸钠），硬脂酸镁的疏水性可能因批次而异。研究表明，与使用杂质含量较高的批次相比，含有极低浓度这些杂质的批次可以更大程度地延缓药物的溶解。 ^((49)){ }^{(49)} 一项研究根据压实数据和片剂材料特性，将润滑性与片剂配方润滑剂批次的脂肪酸组成（硬脂酸盐：棕榈酸酯）联系起来。 ^((54)){ }^{(54)} 然而，其他研究表明，脂肪酸成分对润滑剂活性 ^((37)){ }^{(37)} 没有影响，高纯度硬脂酸镁是一种与商业材料一样有效的润滑剂。 ^((10)){ }^{(10)} 不同相对湿度下的水分吸附会导致硬脂酸镁的形态发生变化。 ^((61,62)){ }^{(61,62)}
Magnesium stearate has been investigated for use in inhalation powders to control their performance. ^((63)){ }^{(63)} 硬脂酸镁已被研究用于吸入粉末以控制其性能。 ^((63)){ }^{(63)}
A specification for magnesium stearate is included in the Food Chemicals Codex (FCC). ^((64)){ }^{(64)} The EINECS number for magnesium stearate is 209-150-3. 硬脂酸镁的规格包含在食品化学法典 （FCC） 中。 ^((64)){ }^{(64)} 硬脂酸镁的 EINECS 编号为 209-150-3。
19 Specific References 19 具体参考资料
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