The lysine hydrochloride contained in this product is one of the essential amino acids for human body, especially for children in the development period, recovery period after illness, pregnancy and lactation period. Lack of lysine hydrochloride can cause dysplasia, anorexia, weight loss and hypoproteinemia.
indication
It is used for malnutrition and anorexia caused by lysine deficiency.
Usage and dosage
Oral.Adult, 300 mg each time.For children under 2 years of age, 100mg each time, 200mg each time for 2-9 years of age, and the same dose for adults over 10 years of age, all of them are taken once or twice a day, dissolved in water, milk, milk cake or porridge.
Adverse reactions
Mild nausea, vomiting and allergic reaction were occasionally seen.
taboo
1. It is forbidden for those allergic to this product.
2. It is forbidden for patients with severe liver and kidney dysfunction.
Drug interaction
If you are taking other drugs, please consult a doctor or pharmacist before using this product.
matters needing attention
1. It is forbidden to take this product when its properties change.
2. Children must be used under adult supervision.
3. Please keep this medicine away from children.
Pharmacopoeia information
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source
This product is L-2,6-diaminohexanoic acid hydrochloride, calculated as dry product, containing CsixHfourteenNtwoOtwo• HCI shall not be less than 98.5%.
character
This product is white crystal or crystalline powder, odorless.
This product is easily soluble in water, very slightly soluble in ethanol, and almost insoluble in ether.
Specific curl
Take this product, weigh it precisely, add 6mol/L hydrochloric acid solution to dissolve it and dilute it quantitatively to make a solution containing about 80mg per 1mL. Determine according to the law (general rule 0621), and the specific rotation is+20.4 ° to+21.5 °.
identify
1. Take an appropriate amount of this product and the lysine hydrochloride control, add water to dissolve and dilute them respectively to make a solution containing about 0.4 mg per 1mL, which is used as the test solution and the control solution.According to the method under other amino acids, the position and color of the main spot of the test solution should be the same as that of the control solution.
2. The infrared absorption spectrum of this product should be consistent with that of the reference sample (General Rule 0402). If not, take an appropriate amount of this product and the reference sample, add water to dissolve them respectively, evaporate them in a 60 ° C water bath, and determine them in the same way.
3. Identification reaction of chlorides in the aqueous solution of this product (general rule 0301).
inspect
acidity
Take 1.0g of this product, add 10mL of water to dissolve it, and then measure it according to the law (general rule 0631). The pH value should be 5.0~6.0.
Transmittance of solution
Take 0.50g of this product, add 10mL of water to dissolve it, and then measure the transmittance at the wavelength of 430nm according to the ultraviolet visible spectrophotometry (general rule 0401), which shall not be less than 98.0%.
sulfate
Take 1.0g of this product and check it according to the law (general rule 0802). Compared with the control solution made of 2.0mL of standard potassium sulfate solution, it should not be more concentrated (0.02%).
ammonium salt
Take 0.10g of this product and check it according to the law (general rule 0808). It should not be deeper (0.02%) than the control solution made of 2.0mL standard chlorination solution.
Other amino acids
Test according to thin layer chromatography (general rule 0502).
Test solution: take a proper amount of this product, add water to dissolve and dilute it to make a solution containing about 20mg per 1mL.
Reference solution: precisely measure 1mL of the test solution, place it in a 200mL volumetric flask, dilute it with water to the scale, and shake it up.
System suitability solution: Take appropriate amount of lysine hydrochloride control and arginine control, place them in the same measuring bottle, add water to dissolve and dilute them to make a solution with 0.4mg per 1mL.
Chromatographic conditions: silica gel G thin layer plate is used, and n-propanol concentrated ammonia solution (2:1) is used as developing agent.
Determination method: take 5 µ L of each of the above three solutions, dab them on the same thin-layer plate, develop them, dry them, spray ninhydrin acetone solution (1 → 50), heat them at 80 ℃ until spots appear, and inspect them immediately.
System suitability requirements: the reference solution should show a clear spot, and the system suitability solution should show two completely separated spots.
Limit: If the test solution shows impurity spots, its color shall not be deeper (0.5%) than the main spot of the control solution.
Loss on drying
Take this product and dry it at 105 ℃ for 3 hours. The weight loss shall not exceed 0.4% (general rule 0831).
Ignition residue
Not more than 0.1% (general rule 0841).
ferric salt
Take 0.50g of this product and check it according to the law (general rule 0807). Compared with the control solution made of 1.5mL of standard iron solution, it should not be deeper (0.003%).
heavy metal
Take 2.0g of this product, add 23mL of water to dissolve it, add 2mL of acetate buffer solution (pH 3.5), and check according to the law (General Rule 0821, Method 1). The content of heavy metals should not exceed 10% per million.
Arsenite
Take 2.0g of this product, add 23mL of water to dissolve it, add 5mL of hydrochloric acid, and check according to the law (the first method of general rule 0822), which should meet the requirements (0.0001%).
Bacterial endotoxin
Take this product and check it according to the law (general rule 1143). The amount of endotoxin in every 1g of lysine hydrochloride should be less than 10EU.(for injection)
Chlorine content
Take about 0.35g of this product, precisely weigh it, add 20mL of water to dissolve it, add 2mL of dilute acetic acid and 8-10 drops of bromophenol blue indicator solution, and titrate it with silver nitrate titrant (0.1mol/L) until it is blue purple.Every 1mL of silver nitrate titrant (0.1mol/L) is equivalent to 3.545mg of Cl.The chlorine content shall be 19.0%~19.6% based on the dry product.
Assay
Take about 90mg of this product, precisely weigh it, add 3mL of anhydrous formic acid to dissolve it, add 50mL of glacial acetic acid and 10mL of mercury acetate test solution, titrate with perchloric acid titrant (0.1mol/L) according to the potentiometric titration method (General Rule 0701), and correct the titration results with a blank test.Every 1mL perchloric acid titrant (0.1mol/L) is equivalent to 9.133mg CsixHfourteenNtwoOtwo·HCl。
category
Amino acid drugs.
Storage
Shading, sealed storage.[2]
security information
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Safety terminology
S26：In case of contact with eyes, rinse immediately with plenty of water and seek medical advice.
After eye contact, immediately flush with plenty of water and seek medical advice.
S36/37/39：Wear suitable protective clothing, gloves and eye/face protection.
Wear appropriate protective clothing, gloves and eye/face protection.
S45：In case of accident or if you feel unwell, seek medical advice immediately (show the lable where possible).
In case of an accident or feeling unwell, seek medical advice immediately (show the label if possible).
