Pharmaceutical grade soybean lecithin pc80 injection grade standard registration A

Pharmaceutical grade soybean lecithin pc80 injection grade standard registration A [Determination of content] Take 0.
1g of this product for nitrogen, accurately weigh it, measure it according to the nitrogen determination method (the second method of general rule 0704), and calculate it
.

Preparation of Phosphorus Reference Substance Solution Precisely weigh 0.
0439g of potassium dihydrogen phosphate reference substance dried at 105°C to constant weight, put it in a 50ml measuring bottle, add water to dissolve and dilute to the mark, shake well, accurately measure 10ml, and place it in a 50ml measuring bottle , dilute to volume with water, and shake well (equivalent to 0.
04 mg of phosphorus per 1 ml)
.

Preparation of the test solution Take about 0.
15g of this product, accurately weigh it, put it in a Kjeldahl flask, add 20ml of sulfuric acid and 50ml of nitric acid, slowly heat it until the solution is light yellow, carefully add concentrated hydrogen peroxide solution dropwise to make the solution Faded, continue to heat for 30 minutes, after cooling, transfer to a 100ml measuring bottle, dilute with water to the mark, and shake well
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Determination method Precisely measure 2ml each of the reference solution and the test solution, put them in 50ml measuring flasks, respectively add 4ml of ammonium molybdate sulfuric acid test solution, 2ml of sodium sulfite test solution and freshly prepared hydroquinone solution (take the pair of 0.
5g of hydroquinone, add an appropriate amount of water to dissolve, add 1 drop of sulfuric acid, dilute to 100ml with water) 2ml, dilute to the mark with water, shake well, place in a dark place for 40 minutes, according to UV-Vis spectrophotometry (General rule 0401), in Measure the absorbance at the wavelength of 620nm respectively, and calculate the amount of phosphorus (P), that is
.

Phosphatidylcholine and phosphatidylethanolamine were determined by high performance liquid chromatography (general rule 0512)
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The chromatographic conditions and system suitability tests were performed with silica gel as the filler (chromatographic column Alltima Sillica, 250mm×4.
6mm, 5μm or a chromatographic column with equivalent performance), and the column temperature was 40°C; methanol-water-glacial acetic acid-triethylamine ( 85:15:0.
45:0.
05) as mobile phase A, and n-hexane-isopropanol-mobile phase A (20:48:32) as mobile phase B; the flow rate is 1ml per minute; the gradient elution is carried out according to the following table; The detector is an evaporative light scattering detector (reference conditions: drift tube temperature is 72°C; carrier gas flow rate is 2.
0L per minute)
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　　　　Take appropriate amount of phosphatidylethanolamine, phosphatidylinositol, lysophosphatidylethanolamine, phosphatidylcholine, and lysophosphatidylcholine reference substance, dissolve and dilute with -methanol (2:1) to make each 1ml containing the above reference substance The mixed solutions of 50 μg, 100 μg, 100 μg, 200 μg and 200 μg, respectively, were taken and 20 μl were injected into the liquid chromatograph.
Each component was eluted in the above order, and the separation degree of each component should meet the requirements.
The calculated peaks of phosphatidylethanolamine and phosphatidylinositol are not lower than 1500
.

　　Determination method Take appropriate amounts of phosphatidylethanolamine and soybean phosphatidylcholine reference substance, accurately weigh them, add -methanol (2:1) to dissolve and quantitatively dilute to make each 1ml containing soybean phosphatidylcholine respectively 50μg, 100μg, 150μg, 200μg, 300μg, 400μg, containing 5μg, 10μg, 15μg, 20μg, 30μg, 40μg solution of phosphatidylethanolamine, respectively, as the reference solution
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Precisely measure 20 μl of the above-mentioned reference solution and inject it into the liquid chromatograph, record the chromatogram, and calculate the regression equation with the logarithm of the concentration of the reference solution and the corresponding logarithm of the peak area.
In the measuring flask, add methanol (2:1) to dissolve and dilute to the mark, shake well, and use it as the test solution
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Precisely measure 20 μl of the test solution and inject it into the liquid chromatograph, and record the chromatogram
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Calculate the content of phosphatidylcholine and phosphatidylethanolamine by the regression equation, that is,
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　　【Category】 Pharmaceutical excipients, emulsifiers, solubilizers,
etc.

　　【Storage】 Sealed, protected from light, and stored at low temperature (below -18℃)
.