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小木虫论坛-学术科研互动平台 » 生物医药区 » 药学 » 药典 » 第四版药用辅料手册中的同类物质
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dcc2010

铜虫 (小有名气)

[求助] 第四版药用辅料手册中的同类物质 已有1人参与

请教各位高手，我有药用辅料第四版的中文版。在前言后面有个同类物质的目录，只有名字，没有页码，但是在目录中找不到相关的物质，请问下各位高手我应该怎么去查呢？
我要查硅酸钙，在同类物质表中有但目录没有。
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1楼 2012-07-30 17:20:57
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Tadalafil

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【答案】应助回帖

感谢参与，应助指数 +1
查附录，如果没有的话，就没收载在这本书里。
第六版里有，第四版里应该也有的。

Calcium Silicate
1 Nonproprietary Names
USP-NF: Calcium Silicate
2 Synonyms
Calcium hydrosilicate; calcium metasilicate; calcium monosilicate;
calcium polysilicate; Micro-Cel; okenite; silicic acid, calcium salt;
tobermorite.
3 Chemical Name and CAS Registry Number
Calcium silicate [1344-95-2]
4 Empirical Formula and Molecular Weight
CaSiO3 116.2
5 Structural Formula
See Section 4.
6 Functional Category
Adsorbent; anticaking agent; opacifier; tablet filler.
7 Applications in Pharmaceutical Formulation or
Technology
Calcium silicate is used as a filler aid for oral pharmaceuticals. It has
also been used in pharmaceutical preparations as an antacid.
The main applications of calcium silicate relate to its anticaking
properties, and it has therefore been used in dusting powders and a
range of different cosmetic products (e.g. face powders, eye
shadow).(1)
C
Calcium Silicate 101
8 Description
Calcium silicate occurs as a crystalline or amorphous white or offwhite
material, and often exists in different hydrate forms.
9 Pharmacopeial Specifications
The USP32–NF27 describes the material as containing not less than
4% of calcium oxide and not less than 35% of silicon dioxide.
See Table I.
Table I: Pharmacopeial specifications for calcium silicate.
Test USP32–NF27
Identification þ pH 8.4–11.2
Loss on ignition 420%
Heavy metals 20 mg/g
Fluoride 50 mg/g
Lead 40.001%
Assay for silicon dioxide 90–110%
Assay for calcium oxide 90–110%
Ratio of silicon dioxide to calcium oxide 0.5 : 20
Sum of calcium oxide, silicon dioxide and loss on ignition 590%
10 Typical Properties
Acidity/alkalinity pH= 8.4–10.2 (5% w/v aqueous solution)
Density 2.10 g/cm3
Melting point 15408C
Solubility Practically insoluble in water; forms a gel with mineral
acids. It can absorb up to 2.5 times its weight of liquids and still
remain a free-flowing powder.
11 Stability and Storage Conditions
Calcium silicate is chemically stable and nonflammable, but it
should be protected from moisture. Store in airtight containers in a
cool, dry place.
12 Incompatibilities
—
13 Method of Manufacture
Calcium silicate is a naturally occurring mineral, but for commercial
applications it is usually prepared from lime and diatomaceous
earth under carefully controlled conditions.
14 Safety
When used in oral formulations, calcium silicate is practically
nontoxic. Inhalation of the dust particles may cause respiratory
tract irritation.
15 Handling Precautions
Observe normal precautions appropriate to the circumstances and
quantity of the material handled. In large quantities, calcium silicate
is irritating to eyes, the respiratory system and skin. Gloves, eye
protection, a respirator, and other protective clothing should be
worn. In the UK, the long-term (8-hour TWA) workplace exposure
standards for calcium silicate are 10 mg/m3 for total inhalable dust
and 4 mg/m3 for respirable dust.(2)
16 Regulatory Status
GRAS listed. Included in the FDA Inactive Ingredients Database
(oral dosage forms). Included in nonparenteral (oral, orodispersible,
effervescent and enteric-coated tablets) formulations licensed in the
UK.
17 Related Substances
Calcium diorthosilicate; calcium trisilicate.
Calcium diorthosilicate
Empirical formula Ca2SiO4
Molecular weight 172.2
CAS number [10034-77-2]
Synonyms Dicalcium silicate; belite
Comments The EINECS number for calcium diorthosilicate is
233-107-8.
Calcium trisilicate
Empirical formula Ca3SiO5
Molecular weight 228.3
CAS number [12168-85-3]
Synonyms Tricalcium silicon pentaoxide
Comments The EINECS number for calcium trisilicate is 235-
336-9.
18 Comments
Studies utilizing the porous properties of calcium silicate granules
have shown their ability to form floating structures, giving rise to
potentially gastroretentive formulations.(3,4)
A specification for calcium silicate is contained in the Food
Chemicals Codex (FCC).(5)
The EINECS number for calcium silicate is 215-710-8. The
PubChem Compound ID (CID) for calcium silicate is 518851.
19 Specific References
1 Gottschalck TE, McEwen GN, eds. International Cosmetic Ingredient
Dictionary and Handbook, 11th edn. Washington, DC: The Cosmetic,
Toiletry, and Fragrance Association, 2006; 325.
2 Health and Safety Executive. EH40/2005:Workplace Exposure Limits.
Sudbury: HSE Books, 2005 (updated 2007). http://www.hse.gov.uk/
coshh/table1.pdf (accessed 5 February 2009).
3 Jain AK et al. Controlled release calcium silicate based floating granular
delivery system of ranitidine hydrochloride. Curr Drug Deliv 2006;
3(4): 367–372.
4 Jain SK et al. Calcium silicate based microspheres of repaglinide for
gastroretentive floating drug delivery: preparation and in vitro
characterization. J Control Release 2005; 107(2): 300–309.
5 Food Chemicals Codex, 6th edn. Bethesda, MD: United States
Pharmacopeia, 2008; 149.
20 General References
Sigma-Aldrich. Material safety data sheet, version 1.2: Calcium silicate, 13
March 2004.
21 Author
MA Pellett.
22 Date of Revision
25 February 2009.
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2楼2012-07-30 20:15:55
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ronpharm

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【答案】应助回帖

罗辅医药进口药用级硅酸钙，有DMF，替代二氧化硅
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