What Is Betamethasone Sodium Phosphate?

Betamethasone sodium phosphate is an adrenal corticosteroid, and the main dosage forms include injections, drops and the like. It is suitable for the treatment of eczema, contact dermatitis, neurodermatitis, solar dermatitis and senile pruritus.

Betamethasone sodium phosphate

Betamethasone sodium phosphate is an adrenal corticosteroid, and the main dosage forms include injections, drops and the like. It is suitable for the treatment of eczema, contact dermatitis, neurodermatitis, solar dermatitis and senile pruritus.

Chinese name

Betamethasone sodium phosphate

Main dosage form

Injections, drops, etc.

Apply

Eczema, contact dermatitis, neurodermatitis

Dosage and usage

Intramuscular or intravenous

This product is highly water soluble and suitable for first aid. Drops are used to treat allergic inflammation of the eyes, ears, nose, and skin. Betnesol-N drops imported from the United Kingdom, containing 0.1% of this product and 0.5% of neomycin sulfate, in addition to anti-allergy, and has anti-infective effects, the effect is more ideal. [Specifications] Injection: 5.2mg / 1ml; powder injection: 1.3mg, 6.5mg; drops: 0.1%. ^[1]

Intramuscular or intravenous injection: 5.2 to 15.6 mg (equivalent to 4 to 12 mg of betamethasone) for each initial dose. Intra-articular injection: 0.2 to 1 ml / time. Drops for external use.

Application of corticosteroids in large doses for a long time can cause iatrogenic adrenocortical hyperfunction (Cushing-like syndrome), manifested as full moon face, buffalo back, centripetal obesity, thin and purple skin, and muscle atrophy. , Osteoporosis, hyperglycemia, diabetes, hypertension, hypokalemia, virilization of women such as hair, beard, amenorrhea, rough voice, etc. (metabolites have a weak androgenic effect), inhibition of child growth and development, fetal malformations, induction Infection spread, ulcers, psychosis, diabetes, hypertension, pancreatitis; withdrawal syndrome (myalgia, myotonia, joint pain, etc.);

Bounce phenomenon (decreasing too fast or abruptly discontinuing the drug, the original symptoms may appear quickly or worsen);

Iatrogenic adrenal insufficiency (adrenal crisis): During long-term high-dose application, due to negative feedback, endogenous glucocorticoid secretion is reduced, and even adrenal cortex atrophy. After sudden withdrawal, In the case of stress, due to insufficient secretion of endogenous hydrocortisone, adrenal insufficiency may occur. In severe cases, adrenal crisis may occur, such as hypotension, hypoglycemia, coma, shock, etc. The patient may suddenly faint. Hydrocortisone should be used in a first aid in a timely manner, 300 mg on the first day, 100-200 mg on the second day, intravenously, supplemented with fluid replacement, anti-shock and symptomatic treatment, and replaced with alternative therapy when the condition improves. Adrenal hyperfunction, hypertension, arteriosclerosis, edema, glaucoma, congestive heart failure, diabetes, ulcer, psychosis, epilepsy, osteoporosis, early pregnancy, puerperium, child growth period, trauma, postoperative recovery Period, general viral infection, bacterial infection and active tuberculosis patients are contraindicated. Bacterial infections must be accompanied by large doses of effective antibacterial drugs. Should enter a low salt, low sugar, high protein diet, potassium, calcium and vitamin D. For more than 2 weeks, the drug should be gradually reduced and slowly discontinued. If necessary, ACTH25U / day can be injected.

(1) Take an appropriate amount of this product and a reference substance of betamethasone sodium phosphate, add methanol to make a solution containing 1mg per 1ml, and perform a test according to thin layer chromatography (Appendix V B). Take 10l of each of the two solutions, respectively. Point on the same silica gel G thin plate, use dilute hydrochloric acid-saturated butanol solution as the developing agent. After unfolding, dry, spray with sulfuric acid-methanol-nitric acid (10: 10: 1), and heat at 105 ° C for 10 minutes. The main spot of the test solution should be the same as the main spot of the reference solution. (2) Take about 40mg of this product, put it in a porcelain crucible, add 2ml of sulfuric acid, heat at low temperature until the sulfuric acid vapor is removed, let it cool, add 0.5ml of nitric acid dropwise, continue heating until the nitrogen oxide vapor is removed, at 500 Burn to complete ashing, let cool, add 5ml of water to dissolve (if necessary, neutralize with ammonia test solution to reach a neutral reaction with litmus paper), filter, and identify the filtrate as sodium salt and phosphate (Appendix III) reaction. (3) Take this product and dry it at 105 for 3 hours. The infrared light absorption spectrum should be the same as that of the control (spectrum set 659).

Take this product for alkalinity, add water to make a solution containing 5mg per 1ml, and measure it according to law (Appendix VI H). The pH value should be 7.0 to 9.0. Free phosphate was accurately weighed 20 mg of this product, and the absorbance was measured according to the method of dexamethasone sodium phosphate. The absorbance of the test product should not exceed that of the control solution. Take the appropriate amount of free betamethasone and other steroids, add methanol to make a solution containing 10mg per 1ml, as a test solution, take a precise amount, add methanol to make a solution containing 0.2mg per 1ml as a control The solution was tested by thin-layer chromatography (Appendix V B), and 10 l of each of the two solutions was pipetted onto the same silica gel GF254 thin-layer plate, methanol was used as a developing agent, and after being developed, it was dried and placed in an ultraviolet light ( 254nm). If the solution of the test product exhibits impurity spots, its color must not be darker than the main spots of the control solution. Take this product for weight loss and dry it under reduced pressure at 100 for 4 hours. The weight loss should not exceed 8.0% (Appendix L).