| Application: | Internal Medicine |
|---|---|
| Usage Mode: | For oral administration |
| Suitable for: | Adult |
| State: | Solid |
| Shape: | Tablet |
| Type: | Biological Products |
| Customization: |
|---|
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It is a composition preparation which contains 100mg of vitamin B1, 100mg of vitamin B6 and 200mg
of vitamin B12.
Description
Film coating or sugar tablets with pink-read core.
Pharmacodynamics and Toxicity
Vitamin B1 is formed phosphorylated thiamine which is important integrant of enzyme acid of carbohydrate metabolism and maintains the normal function of heart , nerve and digestive systerm.
Vitamin B1 may inhibit hte activity of cholinesterase that may enhance the activity of it and hasten hydrolytic of acetylcholine and effect gastrointestinal tract and myocardial function when lack it.
Vitamin B6 is converted to pyridoxal phosphate in erythrocyte. As coenzym , pyridoxine enters into metabolisms of protein , carbohydrate and lipid , and also the metabolism of amino acids.
Vitamin B12 participates in transformation of methylium and metobolism of folic acid to promote the change tetrahydrafolic acid by 5-methy-tetrahydrafolic acid. When lack it , it should be lead the disturbance of DNA synthesis and maturation of erythrocyte.
Used in the treatment of Vitamin B1 , Vitamin B6 and Vitamin B12. Also used for mononeuropathy or polyneuritis caused by different of etiopathogenesis.
Administration and dosage
Orally, 1-2 tablets once, 3 times daily.
Adverse reaction
There aren't any reports about it.
Precaution
1. To disturb diagnosis: qualitative test of urobilinogen is false positive.
2. Large-dose used may disturb the concentration of serum theocin: pseudorise of uric acid concentration; the urobilinogen occur false positive.
3. Lacking intrinsic factor , malignant anemia patients may occur malabsorption of Vitamin B12 after administration by oral.
Pregnancy and lactation Use
Pregnant women receive a large quantity of Vitamin B6 , it may cause pyridoxine dependence synadrome of newborn. It has not adverse effect to infant while intake normal breast milk.
Drug interaction
Studies have indicated that pyridoxin was take with the following medicines at same time , the effect of pyridoxine may be antagonized. They are chloramphenicol, cycloserine , ethionamide, hydralazine hydrochloride and immuno suppressants. Including adrenocortical hormone , , cyclosporin, and penicillamine.
Levodopa use with small dose of Vitamin B6 (5mg every day), it may reduce the antiparkinson action of levodopa.
Storage
Preserver in well closed containers , protected from light.
Certificate of Drug Analysis
| Name of Drug | Trivitamins B tablets | Batch No. | 160725 |
| Mfg. Date | 25/07/2016 | Exp. Date | 06/2019 |
| Specification | Compound | Quantity | 1704000 Tablets |
| Standards | WS-10001-(HD-0206)-2002 |
| ITEM | STANDARDS | RESULTS |
| Appearance | This film coating or coating film, after removal of the coat , pink colour. | Complies |
| Identification | Positive reaction | Complies |
| Uniformity of content | Meet the specification | Complies |
| Weight difference | Meet the specification | Complies |
| Microbial limits | Meet the specification | Complies |
| Disintegration time | ≤30 Mins | 10 Mins |
| Assay Vitamin B1 | 93.0%-107.0% | 94.6% |
| Assay Vitamin B6 | 93.0%-107.0% | 98.8% |
| Assay Vitamin B12 | 85.0%-115.0% | 100.3% |
Conclusion: The above product confirms to WS-10001-(HD-0206)-2002 Standards.
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