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Sodium stearyl fumarate is a widely used and important pharmaceutical and food excipient. During the metabolism of sodium stearyl fumarate in animals, most of it can be absorbed and hydrolysed to produce stearyl alcohol and stearic acid, and a small part of it can be metabolised directly and rapidly, which is non-toxic and non-irritating.
In the pharmaceutical field, sodium stearate fumarate is added to pharmaceutical preparations, which can be used as a lubricant for tablets and capsules, and can also form a protective film in effervescent tablets, which can solve the problems of stearate lubricants, and can improve the disintegration of the drug, and promote the dissolution of the drug. In the food field, the FDA permits sodium stearate to be added directly to food for human consumption as a regulator and stabiliser.
Uses and functions of Sodium Stearyl Fumarate.
Sodium stearate fumarate: used as a lubricant for tablets and capsules, the common amount is 0.5~2.0%, it is also used in some foods. It is a hydrophilic lubricant, soluble in water, but its solubility is significantly affected by the water temperature, and its solubility is very small in 25℃ water, and white floating matter (sodium stearic fumarate) will appear on the surface of the effervescent solution with a slightly larger dosage, which affects the appearance of the solution and the taste.
Uses of Sodium Stearyl Fumarate.
Sodium Stearyl Fumarate (C22H39NaO4) is a widely used and important pharmaceutical food excipient. During the metabolism of sodium stearyl fumarate in animals, most of it can be absorbed and hydrolysed to produce stearyl alcohol and stearic acid, and a small portion of it can be metabolised directly and rapidly, with non-irritating properties.
In the field of pharmaceuticals, sodium stearate fumarate is added to pharmaceutical preparations, can be used as a lubricant for the agent and capsule, but also in the effervescent tablets to form a protective film, which can solve the problems of stearate lubricants, coltan play a role in improving the disintegration of the drug to promote the role of drug dissolution.
Preparation of Bulk Sodium Stearyl Fumarate.
A method of preparing an excipient of sodium stearic fumarate, comprising the following steps: S1, mixing maleic anhydride, octadecanol and a reaction solvent, and carrying out a ring-opening reaction at a temperature of 80°C and above; S2, adding a conversion agent to the reaction system, and carrying out a conversion reaction; S3, lowering the temperature to 40-50°C, dropping a sodium-containing alkali solution to the reaction system, and stirring the reaction to finish After cooling down and precipitating crystals, the crude product of sodium stearate fumarate is obtained; S4, the crude product of sodium stearate fumarate is refined, and the product of sodium stearate fumarate is obtained
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