Main efficacy and function of pharmaceutical grade sorbitan trioleate

 Main functions and functions of pharmaceutical grade Sorbitan Trioleate Sorbitan Trioleate Sanyousuan ShanlitanSorbitan Trioleate [26266-58-0] This product is a mixture of sorbitan and three molecules of oleic acid to form an ester.
It is a dehydration of sorbitol.
It is obtained by esterification with three molecules of oleic acid
.

Or by direct esterification of sorbitol and trimolecular oleic acid at 180～280℃
.

【Properties】 This product is light yellow to yellow oily liquid with a slight special smell
.

This product is slightly soluble in ethanol and insoluble in water
.

Acid value The acid value of this product (general rule 0713) should not be greater than 17
.

Hydroxyl Value The hydroxyl value of this product (general rule 0713) should be 50 to 75
.

Iodine value The iodine value of this product (general rule 0713) should be 77 to 85
.

Peroxide value The peroxide value of this product (general rule 0713) should not be greater than 10
.

Saponification value The saponification value (general rule 0713) of this product should be 169-183
.

　　[Identification] Take about 2g of this product, put it in a 250ml flask, add 100ml of ethanol and 3.
5g of potassium hydroxide, and mix well
.

Heat to reflux for 2 hours, add about 100ml of water, transfer to a 250ml beaker while still hot, evaporate on a water bath and add water continuously, continue to evaporate until there is no ethanol smell, add 100ml of hot water, and slowly add sulfuric acid solution (1→ 2) Until the litmus paper is neutral, record the consumed volume, and continue to drop the sulfuric acid solution (1→2) (about 10% of the above consumed volume) until the lower liquid is clear
.

The above solution was extracted three times with n-hexane, 100 ml each time, the n-hexane layer was discarded, the aqueous layer solution was adjusted to pH 7.
0 with 10% potassium hydroxide solution, evaporated to dryness in a water bath, 150 ml of anhydrous ethanol was added to the residue, and a glass rod was used.
Stir, if necessary, pulverize the residue, put it in a water bath and boil for 3 minutes, place the above solution in a funnel covered with diatomaceous earth, filter, evaporate the filtrate to dryness, add 2 ml of methanol to the residue to dissolve, and use it as the test solution; In addition, 33 mg of isosorbide, 25 mg of 1,4-sorbitol and 25 mg of sorbitol were respectively weighed, and dissolved in 1 ml of methanol as a reference solution
.

According to the test of thin layer chromatography (general rule 0502), draw 2 μl of each of the above two solutions, point them on the same silica gel G thin layer plate, use acetone-glacial acetic acid (50:1) as the developing agent, develop, take out, and dry.
, spray with sulfuric acid ethanol solution (1→2) until it is just wet, heat until the spots are clear and check immediately
.

The position and color of the spots in the test solution should be the same as those in the reference solution
.

　　[Check] Take this product from water, use anhydrous methanol-dichloromethane (1:1) as a solvent, and measure it according to the moisture determination method (General Rule 0832 First Method 1), and the moisture content should not exceed 0.
7%
.

　　Take 1.
0g of this product for the residue on ignition, check it according to the law (General Rule 0841), and the residual residue should not exceed 0.
25%
.

　　Heavy metals and residues left under residue on ignition shall be inspected in accordance with the law (the second method of General Rule 0821), and the heavy metals shall not exceed 10 parts per million
.

　　Fatty acid composition Take 0.
1g of this product, put it in a 50ml round-bottomed flask, add 4ml of 0.
5mol/L potassium hydroxide methanol solution, heat to reflux in a 65°C water bath for 10 minutes, let it cool, add 5ml of 14% methanol solution, at 65°C Heat and reflux in a water bath for 2 minutes, let cool, add 5 ml of n-hexane, continue to heat and reflux in a 65°C water bath for 1 minute, let cool, add 10 ml of saturated sodium chloride solution, shake well, let stand for stratification, take the upper liquid, Dry over anhydrous sodium sulfate
.

According to gas chromatography (General 0521) test
.

The capillary column with polyethylene glycol as the fixed solution was used as the chromatographic column, the initial temperature was 150 °C, maintained for 3 minutes, and the temperature was increased to 220 °C at a rate of 5 °C per minute, maintained for 10 minutes; the inlet temperature was 240 °C, and the detection The temperature of the device is 280℃
.

Take appropriate amounts of methyl myristate, methyl palmitate, methyl palmitoleate, methyl stearate, methyl oleate, methyl linoleate, and methyl linolenic acid, respectively, add n-hexane to dissolve and dilute Prepare a solution containing about 1mg per 1ml, inject 1μl into the gas chromatograph, record the chromatogram, the theoretical plate number is not less than 20,000 calculated according to the methyl oleate peak, and the resolution of each chromatographic peak should meet the requirements
.

Take 1 μl of the upper layer liquid and inject it into a gas chromatograph, record the chromatogram, and calculate according to the area normalization method.
6.
0%, oleic acid should be 65.
0% to 88.
0%, linoleic acid should not exceed 18.
0%, linolenic acid should not exceed 4.
0%, and other fatty acids should not exceed 4.
0%
.

　　【Category】Pharmaceutical excipients, emulsifiers and defoamers,
etc.

　　【Storage】Sealed and stored in a dry place
.