What Is Galantamine Hydrobromide?

This product is an anti-cholinesterase drug, which has a weak anti-cholinesterase effect and can penetrate the blood-brain barrier, so it has a stronger effect on the central nervous system. Restores blocked neuromuscular conduction and improves paralysis of various peripheral neuromuscular disorders. It has a wide range of treatment, less toxicity, and is easier for patients to tolerate. Clinically, it is mainly used to treat the sequelae of polio (poliomyelitis), muscle atrophy, and myasthenia gravis. It can also be used in children with cerebral palsy, traumatic sensory dyskinesia, polyneuritis and spinal radiculitis.

Galantamine hydrobromide

This product is an anti-cholinesterase drug, which has a weak anti-cholinesterase effect and can penetrate the blood-brain barrier, so it has a stronger effect on the central nervous system. Restores blocked neuromuscular conduction and improves paralysis of various peripheral neuromuscular disorders. It has a wide range of treatment, less toxicity, and is easier for patients to tolerate. Clinically, it is mainly used to treat the sequelae of polio (poliomyelitis), muscle atrophy, and myasthenia gravis. It can also be used in children with cerebral palsy, traumatic sensory dyskinesia, polyneuritis and spinal radiculitis.

Chinese name

Galantamine hydrobromide

Foreign name

Galantamine Hydrobromide Lycoremine

Chinese alias

Bromogalantamine

Extract source

Lycoris radiata

Chinese name: Galantamine hydrobromide ^[1]

Method name:

Determination of galantamine hydrobromide-neutralization titration

Application:

This method uses titration to determine the content of galantamine hydrobromide.

This method is applicable to galantamine hydrobromide.

Method principle:

Put the test product in a conical flask, add glacial acetic acid and mercury acetate test solution to dissolve, add crystal violet indicator solution, and titrate with perchloric acid titration solution (0.1mol / L) until the solution becomes blue-green. Read out the amount of perchloric acid titrant used to calculate the content of galantamine hydrobromide.

Reagent:

1. Water (newly boiled to room temperature)

2. Perchloric acid titrant (0.1mol / L)

3. Crystal violet indicator liquid

Acetic anhydride

5. Anhydrous glacial acetic acid

6. Mercury acetate test solution

7. Reference Potassium Phthalate

equipment:

Sample preparation:

1. Perchloric acid titration solution (0.1mol / L)

Preparation: Take 750mL of anhydrous glacial acetic acid (calculated with water content, add 5.22mL acetic anhydride per 1g of water), add 8.5mL perchloric acid (70% -72%), shake well, and slowly add acetic anhydride dropwise at room temperature. 23mL, shake while adding, shake evenly after adding, let cool, add an appropriate amount of anhydrous glacial acetic acid to 1000mL, shake well, and leave for 24 hours. If the test sample is easily acetylated, the water content on this page must be determined by moisture measurement, and then the water content of this solution should be adjusted to 0.01% -0.2% with water and acetic anhydride.

Calibration: Take about 0.16g of standard potassium hydrogen phthalate dried to constant weight at 105 , accurately weigh, add 20mL of anhydrous glacial acetic acid to dissolve, add 1 drop of crystal violet indicator solution, and titrate slowly with Blue, and the results of the titration are corrected with a blank test. Each 1mL of perchloric acid titration solution (0.1mol / L) is equivalent to 20.42mg of potassium hydrogen phthalate. Calculate the concentration of this solution based on the consumption of this solution and the amount of potassium hydrogen phthalate taken.

Storage: Place in a brown glass bottle and keep tightly closed.

Crystal violet indicator liquid

Take 0.5g of crystal violet, add 100mL of glacial acetic acid to dissolve, and get.

3. Mercury acetate test solution

Take 5g of mercury acetate, grind it fine, add warm glacial acetic acid to dissolve it into 100mL, and get it. This solution should be placed in a brown bottle and kept tightly closed.

Steps:

Accurately weigh about 0.3g of this product, put it in a conical flask, add 20mL of glacial acetic acid and 5mL of mercury acetate test solution, add 1 drop of crystal violet indicator solution, and titrate with perchloric acid titration solution (0.1mol / L) The solution was blue-green and the titration results were corrected with a blank test. Record the volume (mL) of perchloric acid titrant consumed. Each 1mL of perchloric acid titrant (0.1mol / L) is equivalent to 36.83mg of C17H21NO3 · HBr.

Note 1: "Precision weighing" means that the weighed weight should be accurate to one thousandth of the weight. Precision requirements.

references:

Pharmacopoeia of the People's Republic of China, compiled by the National Pharmacopoeia Committee, Chemical Industry Press, 2005 edition, Part Two, p.410.

Galantamine hydrobromide update

The specific rotation is taken from this product, accurately weighed, dissolved in water and quantitatively diluted to make a solution containing about 20 mg per 1 ml, and measured according to law (Appendix VI E). The specific rotation is -90 ° to -100 °.

[ Identification ] (2) Take this product and Galantamine hydrobromide reference substance, dissolve and dilute with the mobile phase of the relevant substance and make a solution containing about 0.1mg per 1ml as the test solution and reference substance. Solution, according to the test under the relevant substance, the retention time of the main peak of the test solution should be consistent with the retention time of the main peak of the reference solution.

[ Check ]

Relevant substances are taken from this product, dissolved in mobile phase and quantitatively diluted to make a solution containing 1mg per 1ml as the test solution; 1ml is precisely measured, placed in a 100ml measuring flask, diluted with mobile phase to the mark, shaken, as Control solution. Determined according to high performance liquid chromatography (Appendix VD), using octadecylsilane bonded silica as a filler, methanol-triethylamine phosphate buffer solution (take 7ml of triethylamine, put in 900ml of water, and use 0.5mol / L phosphoric acid The solution was adjusted to pH 6.0, water was added to 1000 ml) (25:75) as the mobile phase, and the detection wavelength was 228 nm. Weigh the appropriate amount of clarithin hydrobromide and dilute with the test solution above to make a mixed solution containing 0.1mg clarithin hydrobromide and 1mg galantamine hydrobromide per 1ml, and take 20l of the mixed solution. For a phase chromatograph, the resolution of the claratamine peak and the main peak should meet the requirements. Take 20l of the control solution and inject it into the liquid chromatograph, adjust the sensitivity of the instrument so that the peak height of the main component peak is about 20% of the full range; precisely measure 20l each of the above reference solution and the test solution, and inject them into the liquid chromatograph respectively. Record the chromatogram to 3 times the peak retention time of the main component. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak must not be greater than the area of the main peak of the control solution (1.0%), and the sum of the area of each impurity peak must not be more than twice the area of the main peak of the control solution (2.0%).

Revised Galantamine Hydrobromide

[ Content determination ] Take about 0.3g of this product, accurately weigh, add 10ml of anhydrous formic acid to dissolve, add 50ml of acetic anhydride, according to potentiometric titration method (Appendix VII A), use perchloric acid titration solution (0.1mol / L) Titrate and correct the results of the titration with a blank test. Each 1ml of perchloric acid titration solution (0.1mol / L) is equivalent to 36.83mg of C17H21NO3 · HBr.