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[求助]
第四版药用辅料手册中的同类物质 已有1人参与
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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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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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3楼2017-12-26 10:31:01
