Element
This product is a compound preparation, and its components are vitamin B, riboflavin sodium phosphate, vitamin 6, nicotinamide, and calcium d-pantothenate.
Traits
This product is a yellow or almost clear liquid with green fluorescence.
Indications
This product is suitable for the auxiliary treatment of malnutrition and diseases caused by lack of vitamin B, such as anorexia, beriberi, pellagra, etc.
Specification
2ml.
Dosage
Intramuscular or subcutaneous injection. The usual amount is 2ml once, or follow the doctor's advice.
Adverse reactions
Occasionally, reactions such as headache, dizziness, vertigo, abdominal pain, nausea, and rash may occur.
Taboo
still uncertain.
Precautions
1. Use with caution in patients with liver and kidney dysfunction.
2. It is forbidden to use the drug when its properties change.
3. Medication for pregnant women and lactating women: pregnant women should use it with caution; large quantities of pregnant women may cause teratogenicity.
4. Children's medication: The experiment has not been carried out and there is no reliable reference.
5. Elderly medication: The experiment has not been carried out and there is no reliable reference.
6. Drug overdose: The above-mentioned adverse reactions can occur due to overdose.
medicine interactions
Vitamin B1 is easy to decompose in alkaline solution, and when compatible with alkaline drugs such as sodium bicarbonate and sodium citrate, it is easy to cause deterioration.
Pharmacological action
Vitamin B complex is involved in the body's metabolism process, is a coenzyme necessary for various metabolic links in the body and an important coenzyme that provides tissue breathing. Vitamin B1 is an important component of coenzymes required for carbohydrate metabolism. Vitamin B2 is an important coenzyme component required for tissue respiration. Vitamin B6 is the prosthetic group of many enzymes, and it is involved in the metabolism of amino acids and fats. Nicotinamide is a component of coenzyme , which is necessary for lipid metabolism, oxygenation of tissue respiration, and glycogen decomposition. Sodium pantothenate is the precursor of coenzyme A and participates in the metabolism of carbohydrates, fats, and proteins.
Pharmacokinetics
B vitamins, including nicotinamide, are distributed in various tissues after being absorbed, metabolized in the liver, and excreted by the kidneys, and a small amount of the original form is eliminated from the urine. After absorption, calcium pantothenate is distributed in various tissues, and is not metabolized in the body. 70% is eliminated with urine in its original form, and 30% is eliminated with feces.
storage
Shade and store in airtight (10-30ºC).
Valid period
24 months
Executive standard
State Food and Drug Administration National Drug Standard WS-10001-(HD-0029)-2002.
Identify
1. Take an appropriate amount of this product (approximately equivalent to 15mg of vitamin B), add 25ml sodium hydroxide test solution, add 0.5ml potassium ferricyanide test solution and 5ml n-butanol, shake vigorously for 2 minutes, place it to separate, and the alcohol layer gradually It shows strong blue fluorescence. Add acid to make it acidic, and the fluorescence disappears. Add alkali to make it alkaline, and the fluorescence appears again.
2. Take an appropriate amount of this product (approximately equivalent to 21mg of vitamin B), dilute with water, the solution will appear light yellow-green under transmitted light, and has strong yellow-green fluorescence. Add mineral acid or alkali, and the fluorescence will disappear.
3. Take 1ml of this product, dilute 10 times with water, take 1ml each of the diluent, separate into two test tubes of A and B, add 4ml of sodium acetate (1-5) to each, add 1ml of water to tube A, and add boric acid to tube B Solution (1-25) 1ml, mix well, quickly add 1ml of chlorimino-2,6-dichloroquinone ethanol solution (1-200), the blue-green color gradually appears in tube A, and after a few minutes, it becomes slightly Red, does not change color in tube B.
4. Take 1ml of this product, add 5ml of sodium hydroxide test solution, and boil slowly, then ammonia odor will occur.
5. Take 2ml of this product, heat and evaporate to dryness, and then burn it to produce the odor of pyridine.
an examination
1. pH value: should be 3.5-5.5 (Chinese Pharmacopoeia 2000 edition two appendix VIH).
2. Others: In addition to the slight turbidity allowed by the clarity inspection, it should comply with the relevant regulations under the injections (Chinese Pharmacopoeia 2000 Edition Two Appendix IB).
Assay
1. Vitamin B1: Precisely measure 5ml of this product and dilute it with water to 50ml, add 2ml of hydrochloric acid, boil, immediately add 4ml of silicotungstic acid test solution dropwise, continue to boil for 2 minutes, filter with a weighed vertical melting glass crucible, and precipitate First wash with boiled hydrochloric acid solution (1-20) twice, 10ml each time, then 10ml hot water, and finally wash twice with acetone, 5ml each time. The precipitate is dried at 80°C to constant weight and accurately weighed. Multiply by 0.1929 to get the weight of C12H17ClN4OS·HCl in the test product (approximately equivalent to 150mg of vitamin B), add 50ml of water, follow the method under vitamin B1 (page 784 of the Chinese Pharmacopoeia 2000 edition) from "Add 2ml of hydrochloric acid "Starting, determined in accordance with the law.
2. Vitamin B2: operate in the dark, accurately measure an appropriate amount of this product (approximately equivalent to 210mg of vitamin B), put it in a 100ml measuring flask, add 2ml of 10% acetic acid solution and 7ml of 14% sodium aldehyde solution, dilute to the mark with water, shake Evenly, according to the spectrophotometric method (Chinese Pharmacopoeia 2000 edition two appendix IVA), the absorbance is measured at a wavelength of 444nm, and the absorption coefficient (E1%1cm) of C17H20N4O6 is calculated as 323.
3. This product is a sterile aqueous solution made by mixing 5 kinds of vitamins. Vitamin B1 (C12H17ClN4OS·HCl) should be 90.0%-110.0% of the labeled amount. Vitamin B2 (C17H20N4O6) is 90.0%-110.0% of the labeled amount.
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