通用名

BP: Purified talc

JP: Talc

PhEur: Talcum

USP: Talc

化学名和CAS注册号

Talc（滑石粉） [14807-96-6]

分子式 分子量

滑石粉是经过纯化的含水硅酸镁，分子式近似为： Mg₆(Si₂O₅)₄(OH)₄。其中可能含有少量不定量硅酸铝和铁。

制造工艺

滑石粉是一种天然存在的含水硅酸盐矿物，藏于全球很多地方，如澳大利亚、中国、意大利、印度、法国和美国。

滑石粉的纯度随原产地的国家而改变。如：据报道意大利产的含有硅酸钙杂质；印度产的含有氧化铝和氧化铁杂质；法国产的含有氧化铝杂质；美国产品中含有碳酸钙（加州产）、氧化铁（蒙大纳州产）、氧化铁和氧化铝（卡罗莱纳州产）或氧化铝（阿拉巴马州产）等杂质。

天然存在的滑石粉开采出来后被研成粉末，然后经浮选处理除去各种杂质，如石棉（透闪石）、碳、白云石、氧化铁和各种其他的铝盐和碳酸盐矿物。这些工艺之后，再被制成细粉，用稀盐酸处理，用水洗净，然后干燥。块状滑石粉的加工工艺不同对其物理性质的影响很大。

类别

抗黏结剂；助流剂；片剂和胶囊稀释剂；片剂和胶囊润滑剂。

制剂应用

滑石粉一度是广泛应用的口服固体制剂的润滑剂和稀释剂（见表Ⅰ），不过目前较少应用。但是，作为控释制剂的溶出阻滞剂，滑石粉得到广泛应用。

在局部用制剂中，滑石粉可用作扑粉，但它不可以用于手术手套的防黏。滑石粉是天然物质，可能会含有微生物，所以作为扑粉应用前应灭菌。

滑石粉可以使液体澄清，还作为润滑剂用于化妆品和食品中。

表Ⅰ：滑石粉的用途

性状

滑石粉粒径很小，呈白色或灰白色，无臭无味，润滑性、结晶性粉末。易附着于皮肤，触感柔软，无颗粒感。

药典标准

见表Ⅱ。

一般性质

酸碱度：pH=7～10(20%w/v水分散液)

硬度（摩尔）:1.0～1.5

含水量：在25℃和相对湿度90％时，滑石粉吸收的水分可忽略不计。

粒径分布: 随原料的来源和级别而异。两种一般的级别为≥99%可通过74μm(200目)或≥99%可通过44μm(325目)。

折射率:n²⁰_D=1.54～1.59

溶解度: 几乎不能溶解于稀酸和碱、有机溶剂和水。

比重:2.7～2.8

比表面积:2.41～2.42m²/g

表Ⅱ：滑石粉的药典标准。

稳定性和贮藏条件

滑石粉是稳定的物质，可以在160℃加热灭菌1小时以上。也可以环氧乙烷灭菌或γ射线灭菌。

滑石粉应密闭存放于凉爽、干燥处。

配伍禁忌

与季铵化合物有配伍禁忌。

安全性

滑石粉主要用在片制与胶囊剂中。滑石粉经口食入后不会被吸收，而且被认为是一种无毒的物质。鼻内和静脉内大量使用含有滑石粉的产品可导致体内组织产生肉芽肿，特别在肺中。伤口和体腔内被滑石粉污染同样可产生肉芽肿，因此它不能涂在外科手术手套上。吸入后会产生刺激反应而且幼儿吸入且会导致肺部疼痛。

滑石粉的致癌性曾被广泛地研究，结果显示妇女使用滑石粉后患卵巢癌的机率上升，但是其证据却是不确定的。不过含有石棉杂质的滑石粉被证明对人类是有致癌性的，因此在药物制剂中应该使用不含石棉的滑石粉。

含有大量六氯酚杂质的滑石粉偶然被幼儿接触后，其长期毒性可导致严重的不可逆的神经毒作用。

操作注意事项

遵守材料操作的数量和相应的常规注意事项。滑石粉吸入后有刺激性，而且长期的大量接触会导致肺尘症。

在英国，职业性的极限浓度为：长期（8-hour TWA）吸入为1mg/m³。应使用护眼镜、手套或呼吸器。

法规

在欧洲准许用于食品添加剂；已列入FDA《非活性组分指南》（口腔片剂；口服胶囊剂和片剂；直肠和局部的剂型）》；在英国准许用于非注射用制剂中

注释

各种级别的滑石粉均有商品上市，它们的来源与制备不同其化学成分也有不同。

由含有石棉的沉积岩中得到的滑石粉不适合用于药剂中。必须对闪石和蛇纹石等矿石进行检验以防止产品中夹有石棉。

滑石粉的EINECS号为238－877－9。

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.