Preparation method and instructions for use of sodium glycerophosphate_Industrial additives

Background and overview^[1]

As a nutritional medicine, sodium glycerophosphate is a mixture of α-sodium glycerophosphate and β-sodium glycerophosphate. Among them, sodium β-glycerophosphate is the active part, while sodium α-glycerophosphate does not have pharmaceutical activity. Sodium glycerophosphate is an intravenous phosphorus supplement. Phosphorus is involved in the formation of bone and the composition of cell membranes in the form of phospholipids. At the same time, phosphorus is related to the activity of many enzymes in metabolism and plays a crucial role in energy metabolism. It is suitable for supplementing the human body’s daily need for phosphorus and for the treatment of people with phosphorus deficiency.

Preparation^[1]

Preparation method of sodium glycerol reverse osmosis fungicide:

(1) Salt formation and esterification

Put a certain amount of phosphoric acid and glycerol into the esterification reaction tank, and then add sodium carbonate. The three by weight are 53g sodium carbonate, 98g phosphoric acid, and 184g glycerol;

Introduce steam; in the reaction cylinder, phosphoric acid reacts with sodium carbonate to form sodium dihydrogen phosphate, and then sodium dihydrogen phosphate reacts with glycerol to form an esterification sodium glycerol phosphate; the pH value of the reaction process is controlled to 4.6, Keep the vapor pressure at 0.4-0.5MPa and the reaction temperature at 135°C; after the reaction, add an appropriate amount of purified water to dilute it;

(2)Hydrolysis

After esterification, add 45ml of 30% sodium hydroxide solution; the sodium diglyceryl phosphate and sodium hydroxide undergo a hydrolysis reaction to generate sodium glycerophosphate and glycerol; this reaction process requires boiling and refluxing for 10 hours, and the pH value is controlled at 9.5, 2ml of NaOH should be added; after hydrolysis, 2g of MgO should be added according to the free phosphate content detected in the medium to remove the free phosphate after the reaction;

(3) Concentrate and separate free glycerin

Concentrate the crude sodium glycerophosphate and separate the free glycerol;

(4) Finished product decolorization

Decolorize the crude sodium glycerophosphate after passing the separation. After passing the sampling inspection, it can be packaged as a liquid finished product, or as a solid package through crystallization;

(5) Crystallization, spin drying, and drying

Crystallization, spin-drying, drying, sampling and inspection, and packaging and storage after passing the test.

Usage and precautions^[2]

For adults, add 2.16g per day to compound amino acid injection or 5% to 10% glucose injection into 500mL and infuse slowly intravenously within 4 to 6 hours. Patients receiving intravenous nutrition therapy may increase or decrease the amount as needed. This product should be used up within 24 hours after dilution to avoid contamination. This product cannot be infused without dilution; pay attention to control the speed of administration.

Adverse reactions, contraindications and drug effects^[2]

Long-term medication may cause changes in blood phosphorus and blood calcium concentrations. It is prohibited for those with severe renal insufficiency, shock and dehydration; it is prohibited for those allergic to this product. People with renal dysfunction should use with caution; during long-term use, attention should be paid to monitoring of blood phosphorus and blood calcium concentrations.

Detection of phosphate^[3]

Detection method of free phosphate:

Chemical test solution: Precisely weigh 1.00g of sodium glycerophosphate into a 100ml volumetric flask, add water to dissolve and dilute to the mark, accurately pipette 10ml into a 100ml volumetric flask, add 50ml of water, shake well, and add ammonium molybdate solution (Take 2.5g of ammonium molybdate, add 20ml of water, heat to dissolve, take 28ml of sulfuric acid and dilute with 50ml of water, let cool, mix the two liquids, and dilute with water to 100ml) 4ml, shake well, add stannous chloride solution (take chlorine 3.3g of stannous, add 1ml of hydrochloric acid to dissolve, add water to 10ml, measure 1ml and add 9ml of 2mol/L hydrochloric acid solution, mix to get) 0.1ml, shake well, add water to dilute to the mark, shake well, and leave it for 10 minutes.

Reference solution: Precisely measure phosphate standard solution (precisely weigh 0.716g of potassium dihydrogen phosphate into a 1000ml volumetric flask, add water to dissolve and dilute to the mark, shake well; accurately measure 1.0ml into a 100ml volumetric flask , dilute with water to the mark, shake well, and get) 20ml or appropriate amount into a 100ml volumetric flask, add 50ml of water, shake well, add 4ml of ammonium molybdate solution, shake well, add 0.1ml of stannous chloride solution, shake well, and add water Dilute to volume, shake well, and leave for 10 minutes.

Blank solution: Take a 100ml volumetric flask, add 50ml of water, 4ml of ammonium molybdate solution, shake well, add 0.1ml of stannous chloride solution, shake well, add water to the mark, shake well, and leave it for 10 minutes.

Measurement method: According to UV-visible spectrophotometry (Chinese Pharmacopoeia 2005 edition Appendix IVA), measure the absorbance at a wavelength of 707nm, and calculate.