ELANTAN
1,4:3,6-dianhydro-D-glucitol 5-nitrate
CAS: 16051-77-7
Molecular Formula: C6H9NO6
ELANTAN - Names and Identifiers
| Name | 1,4:3,6-dianhydro-D-glucitol 5-nitrate |
| Synonyms | ELAN IMDUR IS-5-MN ELANTAN CORANGIN ISOSORBIDE 5-NITRATE Isosorbide mononitrate ISOSORBIDE MONONITRATE Isosorbide 5-mononitrate ISOSORBIDE 5-MONONITRATE |
| CAS | 16051-77-7 |
| EINECS | 240-197-2 |
| InChI | InChI=1/C6H7NO6/c8-3-1-11-6-4(13-7(9)10)2-12-5(3)6/h4-6H,1-2H2/t4-,5+,6+/m1/s1 |
| InChIKey | YWXYYJSYQOXTPL-SLPGGIOYSA-N |
ELANTAN - Physico-chemical Properties
| Molecular Formula | C6H9NO6 |
| Molar Mass | 191.14 |
| Density | 1.5784 (rough estimate) |
| Melting Point | 88-93 °C |
| Boling Point | 326.86°C (rough estimate) |
| Specific Rotation(α) | 170 º (c=1, EtOH) |
| Water Solubility | soluble |
| Solubility | Undiluted isosorbide mononitrate is freely soluble in water, in acetone, in ethanol (96 per cent) and in methylene chloride. The solubility of the diluted product depends on the diluent and its concentration. |
| Appearance | White crystalline powder |
| Color | White to Off-White |
| Merck | 5225 |
| pKa | 13.09±0.40(Predicted) |
| Storage Condition | -20°C Freezer |
| Refractive Index | 145 ° (C=5, H2O) |
| MDL | MFCD00143462 |
| Physical and Chemical Properties | Melting point 88-93°C specific optical rotation 170 ° (c = 1, EtOH) water-soluble solution |
ELANTAN - Risk and Safety
| Hazard Symbols | Xi - Irritant F,Xi,F - |
| Risk Codes | R36/37/38 - Irritating to eyes, respiratory system and skin. R11 - Highly Flammable |
| Safety Description | S37/39 - Wear suitable gloves and eye/face protection S16 - Keep away from sources of ignition. S15 - Keep away from heat. |
| UN IDs | 3251 |
| RTECS | LZ4386500 |
| HS Code | 2932999000 |
| Hazard Class | 4.1 |
| Toxicity | LD50 oral in rat: 2010mg/kg |
ELANTAN - Preparation Method
Open Data Verified Data
with sorbitol as raw material, by dehydration ring synthesis of Sorbitan, and nitric acid and acetic anhydride reaction, isosorbide mononitrate ester.
Last Update：2024-01-02 23:10:35
ELANTAN - Use
Open Data Verified Data
The active metabolite of isosorbide dinitrate. Oral administration is not affected by the effect of liver metabolism, and the prototype drug enters the systemic circulation with high bioavailability. For long-term treatment of coronary heart disease and prevention of angina attacks, also for the treatment after myocardial infarction.
Last Update：2022-01-01 09:10:17
ELANTAN - Standard
Authoritative Data Verified Data
This product is 1,4:3, 6-dianhydro-d-sorbitol-5-mononitrate. The content of C6H9NO6 shall be between 98.0% and 102.0% based on the dry product.
Last Update：2024-01-02 23:10:35
ELANTAN - Trait
Authoritative Data Verified Data
- This product is white needle-like crystal or crystalline powder; Odorless.
- This product is soluble in methanol or acetone, dissolved in chloroform or water, and almost insoluble in hexane.
- This product is susceptible to explosion by heat or impact.
specific rotation
take this product, precision weighing, plus absolute ethanol dissolution and quantitative dilution of about 10 mg per lml solution, according to the law (General 0621), the specific rotation was 170 ° to 176 °.
Last Update：2022-01-01 13:37:39
ELANTAN - Differential diagnosis
Authoritative Data Verified Data
- in the chromatogram recorded under the content determination item, 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.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 776).
Last Update：2022-01-01 13:37:40
ELANTAN - Exam
Authoritative Data Verified Data
Related substances
take the solution containing 1 mg per 1 ml prepared under the content determination item as the test solution; Take the appropriate amount of isosorbide dinitrate reference and 2-isosorbide mononitrate reference, add the mobile phase to dissolve and quantitatively dilute to make a mixed solution containing about 0.25mg each in 1 ml, take 2ml with precision, put it in a 200ml measuring flask, and then add 1 ml of the test solution with precision, dilute to the scale with the mobile phase, shake, and serve as a control solution. According to the chromatographic conditions under the content determination item, 20ul of the test solution and the control solution are respectively injected into the human liquid chromatograph, and the chromatogram is recorded to 1.1 times of the retention time of the isosorbide dinitrate peak. In the chromatogram of the test solution, if there are chromatographic peaks that are consistent with the retention time of the isosorbide dinitrate peak and the isosorbide mononitrate peak, the peak area shall not exceed 0.25% based on the external standard method; the Peak area of other single impurities shall not be greater than 0.5 times (0.25%) of the peak area of isosorbide mononitrate in the control solution, and the total amount of impurities shall not exceed 0.5%.
chloride
take 0.20g of this product and check it according to law (General rule 0801). Compared with the control solution made of 6.0 ml of standard sodium chloride solution, it should not be more concentrated (0.03%).
loss on drying
take this product, put the phosphorus pentoxide dryer under reduced pressure to dry to constant weight, the weight loss should not exceed 0.5% (General rule 0831).
Heavy metals
This product lg, inspection according to law (General Principles 0821 The first law), containing heavy metals shall not exceed 10 parts per million.
Last Update：2022-01-01 13:37:41
ELANTAN - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with eighteen alkyl silane was used as the filler; Methanol-water (25:75) was used as the mobile phase; The detection wavelength was 210Nm. Appropriate amount of isosorbide mononitrate reference substance and 2-isosorbide mononitrate reference substance were dissolved and diluted with mobile phase to prepare solutions containing about 5ug in each lml, and 20ul was injected into human liquid chromatograph, the theoretical plate number is not less than 3000 based on the isosorbide mononitrate peak, and the separation degree of the isosorbide mononitrate peak and the isosorbide mononitrate peak should be greater than 2.0.
assay
take about 25mg of this product, precision weighing, put in 25ml measuring flask, add mobile phase to dissolve and dilute to the scale, shake, take 5ml precision, put in 50ml measuring flask, dilute to scale with mobile phase, shake, as test solution, take 20 u1 with precision, inject human liquid chromatograph, record chromatogram; Take isosorbide mononitrate reference substance, same method for determination. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 13:37:41
ELANTAN - Category
Authoritative Data Verified Data
vasodilators.
Last Update：2022-01-01 13:37:42
ELANTAN - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 13:37:42
ELANTAN - Isosorbide Mononitrate Tablets
Authoritative Data Verified Data
This product contains isosorbide mononitrate (C6H9NO6) should be labeled the amount of 90.0% to 110.0%.
trait
This product is white tablet.
identification
- Take appropriate amount of fine powder of this product (about 60mg of isosorbide mononitrate), add chloroform 10ml, fully shake, filter, and the filtrate is evaporated to dryness on a water bath. Take about 20mg of the residue and put it in a test tube, add 1 ml of water and 2ml of concentrated sulfuric acid, mix well, dissolve and cool. Slowly add 3ml of ferrous sulfate test solution along the tube wall to make two liquid layers, and connect the interface to appear brown.
- in the chromatogram recorded under the content determination item, 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.
examination
- isosorbide dinitrate and 2-isosorbide mononitrate filtrate under the item of content determination as test solution; Isosorbide dinitrate reference and 2-isosorbide mononitrate reference, precision weighing, the mobile phase was added to dissolve and quantitatively dilute to prepare a mixed solution containing about 5ug each per 1 ml as a reference solution. The solution was measured according to the method under isosorbide mononitrate related substances. In the chromatogram of the test solution, if there are chromatographic peaks with the same retention time as the isosorbide dinitrate peak and the isosorbide dinitrate peak, the peak area shall be calculated according to the external standard method, and 0.5% of the labeled amount of isosorbide mononitrate shall not be passed.
- Content uniformity take 1 tablet of this product, put it in a measuring flask of lOOml(lOmg specification) or 200ml(20mg specification), add appropriate amount of mobile phase, shake for about 20 minutes to dissolve isosorbide mononitrate, dilute to the scale with mobile phase, shake, filter, take the filtrate as the test solution; Take the isosorbide mononitrate reference substance, precision weighing, the mobile phase was added for dissolution and quantitative dilution to make about 0.1 mg solution, as a control solution. Determination of content according to the method under the content determination item, should comply with the provisions (General 0941).
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), with water as the dissolution medium, the speed is 100 rpm, according to the law, after 30 minutes, the solution was filtered, and the continuous filtrate 20 u1 was accurately measured according to the chromatographic conditions under the content determination item, and injected into the liquid chromatograph to record the chromatogram. Another reference substance of isosorbide mononitrate was accurately weighed, dissolved with water and quantitatively diluted to make a solution containing about 20ug(10mg specification) or 40ug(20mg specification) per 1 ml, and the solution was determined by the same method. The dissolution amount of each tablet was calculated by the peak area according to the external standard method. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
Take 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about 25mg Isosorbide mononitrate), put it in a 250ml measuring flask, add an appropriate amount of mobile phase, shake for about 20 minutes to dissolve Isosorbide Mononitrate, dilute to scale with mobile phase, shake well, filter, Take 5ml of continuous filtrate precisely, put it in 50ml measuring flask, dilute to scale with mobile phase, shake well, as a test solution. According to the isosorbide mononitrate content determination method under the item, that is obtained.
category
isosorbide mononitrate.
specification
(l)10mg (2)20mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 13:37:43
ELANTAN - Isosorbide Mononitrate Injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of isosorbide mononitrate, containing isosorbide mononitrate (C6H9N06) should be 90.0% to 110.0% of the label amount.
trait
This product is a clear colorless liquid.
identification
- take an appropriate amount of this product (containing about 20mg of isosorbide mononitrate), put it in a test tube, add 2ml of sulfuric acid, mix well, cool, slowly add 5ml of ferrous sulfate test solution along the tube wall, and make it into two layers, the interface was brown.
- in the chromatogram recorded under the content determination item, 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.
examination
- the pH value should be 4.0 to 6.0 (2ml:25mg specification) or 6.0 to 8.0 (General 0631).
- isosorbide dinitrate and 2-Isosorbide mononitrate precision quantity take the appropriate amount of this product, quantitative dilution with the mobile phase to make a solution containing about 1 mg of isosorbide mononitrate per 1 ml, as a test solution; in addition, isosorbide dinitrate reference and 2-isosorbide mononitrate reference were precisely weighed, dissolved and quantitatively diluted with mobile phase to prepare a mixed solution containing about 5ug each in 1 ml, which was used as a reference solution. If there are chromatographic peaks with the same retention time as the isosorbide dinitrate peak and the isosorbide mononitrate peak in the chromatogram of the test solution, the peak area shall be calculated according to the external standard method, not 0.5% of the labeled amount of isosorbide mononitrate.
- bacterial endotoxin take this product, check according to law (General 1143), each 1 mg of isosorbide mononitrate containing endotoxin should be less than 14EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
precision take the appropriate amount of this product, quantitative dilution with mobile phase made of isosorbide mononitrate in about each lml 0.1 mg of the solution was obtained as a test solution according to the method described in the item of isosorbide mononitrate content measurement.
category
isosorbide mononitrate.
specification
(l)lml:lOmg (2)2ml:20mg (3)2ml:25mg(4)5ml:20mg
storage
sealed and stored in a cool place.
Last Update：2022-01-01 13:37:44
ELANTAN - Isosorbide Mononitrate Capsules
Authoritative Data Verified Data
This product contains isosorbide mononitrate (C6H9N06) should be labeled the amount of 90.0% to 110.0%.
trait
The content of this product is white or off-white powder.
identification
- take an appropriate amount of fine powder of the content of this product (about 60mg of isosorbide mononitrate), add 10ml of chloroform, fully shake, filter, and the filtrate is evaporated to dryness on a water bath. Take about 20mg of the residue, put it in a test tube, add water (1 ml) and concentrated sulfuric acid (2ml), mix well, dissolve, cool, slowly add ferrous sulfate test solution (3ml) along the tube wall to form two layers, the interface was brown.
- in the chromatogram recorded under the content determination item, 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.
examination
- isosorbide dinitrate and 2-isosorbide mononitrate the filtrate under the content measurement was taken as a test solution. In addition, isosorbide dinitrate control and 2-isosorbide mononitrate control were precisely weighed, dissolved and quantitatively diluted with mobile phase to prepare a mixed solution containing about 5ug each in 1 ml as a reference solution. Determination according to the method under isosorbide mononitrate related substances. In the chromatogram of the test solution, if there are chromatographic peaks with the same retention time as the isosorbide dinitrate peak and the isosorbide dinitrate peak, the peak area shall be calculated according to the external standard method, and 0.5% of the labeled amount of isosorbide mononitrate shall not be passed.
- Content uniformity: Take 1 capsule of this product, place the content in a lOOml(lOmg specification) or 200ml( 20mg specification) measuring flask, and wash the capsule shell with a small amount of mobile phase, in the washing liquid and measuring flask, an appropriate amount of mobile phase is added, and isosorbide mononitrate is dissolved by shaking for about 20 minutes. The mobile phase is diluted to the scale, shaken, filtered, and the continued filtrate is taken as the test solution. Determination of content according to the method under the content determination item, should comply with the provisions (General 0941).
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 second method), water 500ml as the dissolution medium, the speed of 50 rpm, according to the law, after 30 minutes, the solution was filtered, and according to the chromatographic conditions under the content determination item, the continuous filtrate 50 u1 was accurately measured and injected into the liquid chromatograph, and the chromatogram was recorded, water was added to dissolve and quantitatively diluted to prepare a solution containing about 20ug(10mg specification) or 40ug(20mg specification) per 1 ml, which was determined by the same method. According to the external standard method, the dissolution amount of each particle was calculated by the peak area. The limit is 80% of the labeled amount and shall be in accordance with the provisions.
- others should comply with the relevant provisions under the capsule (General 0103).
Content determination
take the contents of 20 capsules of this product, precision weighing, mixing evenly, precision weighing an appropriate amount (about 25mg Isosorbide mononitrate), put it in a 25ml measuring flask, add an appropriate amount of mobile phase, shake for about 20 minutes to dissolve Isosorbide Mononitrate, dilute to scale with mobile phase, shake well, filter, Take 5ml of continuous filtrate precisely, put it in 50ml measuring flask, dilute to scale with mobile phase, shake well, as a test solution. According to the isosorbide mononitrate content determination method under the item, that is obtained.
category
isosorbide mononitrate.
specification
(l)10mg (2)20mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 13:37:45
ELANTAN - Isosorbide Mononitrate Sustained Release Tablets
Authoritative Data Verified Data
This product contains isosorbide mononitrate (C6H9N06) should be labeled the amount of 90.0% to 110.0%.
trait
This product is white-like tablets or film-coated tablets, white or white-like after removing the coating.
identification
- take an appropriate amount of fine powder of this product (about 60mg of isosorbide mononitrate), add 10ml of chloroform, fully shake, filter, the filtrate is evaporated to dryness on a water bath, take about 20mg of residue, put it in a test tube, add 1 ml of water and 2ml of concentrated sulfuric acid, mix well, dissolve and cool down. Slowly add 3ml of ferrous sulfate test solution along the pipe wall to make two liquid layers, and the interface is brown.
- in the chromatogram recorded under the content determination item, 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.
examination
- isosorbide dinitrate and 2-Isosorbide mononitrate take an appropriate amount of fine powder of this product (about 50mg equivalent to isosorbide mononitrate), weigh it accurately, put it in a 50ml measuring flask, add about 35ml of mobile phase, shake it for about 20 minutes, dilute to scale with mobile phase, shake, centrifuge, take supernatant, filter, take filtrate as test solution; Take isosorbide dinitrate control and 2-isosorbide mononitrate control, precision weighing, the mobile phase was added to dissolve and quantitatively dilute to prepare a mixed solution each containing about 1 ml as a control solution. If there are chromatographic peaks with the same retention time as the isosorbide dinitrate peak and the isosorbide mononitrate peak in the chromatogram of the test solution, the peak area shall be calculated according to the external standard method, not 0.5% of the labeled amount of isosorbide mononitrate.
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 The first method), water 500ml as the dissolution medium, the speed of 50 rpm, according to the law, after 1 hour, 4 hours and 8 hours, take 5ml of the solution respectively, filter, and immediately add the same temperature, the same volume of dissolution medium, according to the chromatographic conditions under the content determination item, 20ul of continuous filtrate was accurately measured respectively, and human was injected into liquid chromatograph to record chromatogram. Another reference substance of isosorbide mononitrate was accurately weighed, dissolved by adding water and quantitatively diluted to prepare about 60ug (30mg specification) per lml, 80ug(40mg specification), 100g (50mg specification) or 120UG (60mg specification) of the solution, as a reference solution, the same method. According to the external standard method, the dissolution amount of each tablet at different times was calculated by peak area. The dissolution amount of each tablet at 1 hour, 4 hours and 8 hours shall be 15% ~ 40%, 40% ~ 75% and more than 75% of the labeled amount respectively, and shall comply with the regulations.
- others shall be in accordance with the relevant provisions under the item of tablets (General rule 0101).
Content determination
Take 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about 25mg Isosorbide mononitrate), put it in a 250ml measuring flask, add an appropriate amount of mobile phase, isosorbide mononitrate was dissolved by shaking for about 20 minutes, diluted to scale with mobile phase, shaken, filtered, and the filtrate was taken as a test solution. According to the isosorbide mononitrate content determination method under the item, that is obtained.
category
isosorbide mononitrate.
specification
(l)30mg (2)40mg (3)50mg (4)60mg
storage
light shielding, sealed storage.
Last Update：2022-01-01 13:37:46
ELANTAN - Isosorbide mononitrate and glucose injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of isosorbide mononitrate and glucose, containing isosorbide mononitrate (C6H9NO6) should be 90.0% ~ 110.0% of label; Containing glucose (C6H9N06 • H20) should be 95.0% ~ 105.0% of label.
trait
This product is a clear colorless liquid.
identification
- take 5ml of this product, slowly drop warm alkaline copper tartrate test solution, which generates red precipitate of cuprous oxide.
- in the chromatogram recorded under the content determination item, 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.
examination
- the pH value should be 4.0 to 6.0 (General 0631).
- isosorbide dinitrate and 2-Isosorbide mononitrate to take the test solution under the content determination item as the test solution; Another isosorbide dinitrate reference and 2-Isosorbide mononitrate reference, precision weighing, the mobile phase was added to dissolve and quantitatively dilute to prepare a mixed solution containing about 0.4ug each in 1 ml as a control solution. Determination according to the method under isosorbide mononitrate related substances. In the chromatogram of the test solution, if there are chromatographic peaks that are consistent with the retention time of the isosorbide dinitrate peak and the isosorbide mononitrate peak, the peak area shall be calculated by the external standard method, and 0.5% of the labeled amount of isosorbide mononitrate shall not be passed.
- 5-hydroxymethyl furfural precision take the right amount of this product (about equivalent to glucose l.Og), put in a 100ml measuring flask, dilute to the scale with water, shake well, according to UV-visible spectrophotometry (General 0401), measured at the wavelength of 284nm, absorbance shall not be greater than 0.32.
- take an appropriate amount of heavy metal (equivalent to 3g of glucose), put it on a water bath and evaporate it to about 20ml, let it cool, add 2ml of acetate buffer (PH 3.5) and an appropriate amount of water to make it 25ml, inspection by law (General Principles 0821, law I), the content of heavy metals must not exceed 5 parts per million of the amount of glucose marked.
- The osmolality shall be 0632 ~ 320mOsmol/ kg when the product is taken for inspection according to law (General Rule 260).
- bacterial endotoxin this product, according to the law to check (General 1143), the amount of endotoxin per lml should be less than 0.50EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- isosorbide mononitrate precision: take an appropriate amount of this product and quantitatively dilute it with mobile phase to prepare a solution containing about 80% of isosorbide mononitrate per 1 ml as a test solution, the mobile phase was added to dissolve and quantitatively dilute to prepare a solution containing about 80ug per 1 ml as a control solution. According to the isosorbide mononitrate content determination method under the item, that is obtained.
- glucose the optical rotation of the product was measured at 25 ° C. According to the law (General rule 0621), and multiplied by 2.0852 to obtain a Weight (g) containing C6H1206 · H20 in of the sample.
category
isosorbide mononitrate.
specification
- 100ml: isosorbide mononitrate 20mg with glucose 5G
- 250ml: isosorbide mononitrate 20mg with glucose 12.5g
storage
sealed, stored in a cool and dry place.
Last Update：2022-01-01 13:37:47
ELANTAN - Isosorbide Mononitrate Sodium Chloride Injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of isosorbide mononitrate and sodium chloride, containing isosorbide mononitrate (C6H9N06) shall be 90.0% ~ 110.0% of label amount; Containing sodium chloride (NaCl) shall be 95.0% ~ 105.0% of label amount.
trait
This product is a clear colorless liquid.
identification
- Take 40ml of this product into an evaporation dish, evaporate to 1-2ml on a water bath, transfer to a test tube, add 2ml sulfuric acid, mix well, cool, slowly add 3ml ferrous sulfate test solution along the tube wall, two liquid layers were formed, and the interface was brown.
- in the chromatogram recorded under the content determination item, 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.
- This product sodium salt identification (1) of the reaction and gasification identification (1) of the reaction (General 0301).
examination
- the pH value should be 4.0 to 7.0 (General 0631).
- isosorbide mononitrate and isosorbide dinitrate, the test solution under the content determination item was taken as the test solution, and the isosorbide dinitrate and the isosorbide dinitrate control were taken as the test solution, precision weighing, adding mobile phase dissolution and quantitative dilution to make a mixed solution containing about 0.4ug per 1 ml, as a reference solution. Determination according to the method under isosorbide mononitrate related substances. In the chromatogram of the test solution, if there are chromatographic peaks that are consistent with the retention time of the isosorbide dinitrate peak and the isosorbide mononitrate peak, the peak area shall be calculated by the external standard method, and 0.5% of the labeled amount of isosorbide mononitrate shall not be passed.
- take 50ml of heavy metal, evaporate to about 3.5, let it cool, add 2ml of acetate buffer (pH 0821) and an appropriate amount of water to make 25ml, and check it according to law (General rule first law), heavy metals should not exceed three million.
- The osmolality shall be 0632 ~ 320mOsmol/kg when the product is taken for inspection according to law (General Rule 260).
- bacterial endotoxin this product, according to the inspection (General 1143), the amount of endotoxin per lm l should be less than 0.50EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
- isosorbide mononitrate precision: take an appropriate amount of this product and quantitatively dilute it with mobile phase to prepare a solution containing about 80% of isosorbide mononitrate per 1 ml as a test solution, the mobile phase was added to dissolve and quantitatively dilute to prepare a solution containing about 80% per 1 ml as a control solution. According to the isosorbide mononitrate content determination method under the item, that is obtained.
- Take 20ml of sodium chloride, Add 30ml of water, 5ml of 2% dextrin solution, 2 @ 1 of 2.5% borax solution and 5~8 drops of fluorescein indicator solution, with silver nitrate titration solution (0.lmol/L) titration. Each 1 ml of silver nitrate titration solution (0.1 mol/L) corresponds to 5.844mg of NaCl.
category
isosorbide mononitrate.
specification
- 100ml: isosorbide mononitrate 20mg with sodium chloride 0.9g
- 100ml: isosorbide mononitrate 25mg with sodium chloride 0.85g
- 250ml: isosorbide mononitrate 20mg with sodium chloride 2.25g
- 250ml: isosorbide mononitrate 50mg with sodium chloride 2.25g
storage
sealed and stored in a cool place.
Last Update：2022-01-01 13:37:48
ELANTAN - Reference Information
| EPA chemical information | Information provided by: ofmpub.epa.gov (external link) |
| introduction | isosorbide mononitrate (Isosorbide Mononitrate) is the common name of 1,4:3, 6-dianhydro-D-sorbitum-5 mononitrate, also known as isosorbide 5-dinitrate, is the main bioactive metabolite of isosorbide dinitrate. The main pharmacological effect is to relax vascular smooth muscle. The clinical dosage forms are: ordinary tablets, sustained-release preparations and injections, mainly used for: long-term treatment of coronary disease; prevention of angina pectoris; treatment of persistent colic after myocardial infarction; Combined application with digitalis or diuretics to treat chronic congestive heart failure; treatment of elderly simple systolic hypertension, hypertensive crisis and perioperative acute hypertension. |
| clinical application | 1. in cardiovascular and cerebrovascular diseases, the drug has the effects of improving myocardial ischemia, reducing myocardial oxygen consumption, improving cardiac function, etc., with few and mild adverse reactions. 2. In the treatment of liver cirrhosis, isosorbide mononitrate is added to the treatment of hepatic ulcer on the basis of peptic ulcer treatment. The results show that its healing rate and efficiency are significantly better than those without isosorbide mononitrate. |
| pharmacology | 5-isosorbide mononitrate binds to the intracellular Ryukyu group in vascular smooth muscle to produce NO or S-nitrosothiol compounds, both of which can activate guanylate cyclase, increase cyclic guanylate (cGMP), accelerate the release of calcium ions from the cell, inhibit the influx of calcium ions, reduce intracellular calcium ions, and relax vascular smooth muscle. The vasodilation effect of isosorbide 5-mononitrate was dose-dependent. With the increase of dose, it dilated venous vessels, coronary arteries and resistance arterioles in turn. Its main mechanism of action is: ①Venous dilation causes blood retention in the periphery, reduces the necessary blood volume, reduces the necessary preload, and reduces the ventricular wall tension; dilates arterial blood vessels, reduces peripheral vascular resistance, and reduces systolic arterial pressure and mean arterial pressure (afterload). Decrease, reduce myocardial oxygen consumption, and increase the amount of necessary discharge; ②Expand coronary arteries to redistribute coronary blood flow, improve myocardial blood supply, enhance myocardial load compliance and contractility, promote functional recovery of failing myocardial cells, and increase cardiac output; within the range of clinically commonly used doses, do not dilate the arterioles to avoid the phenomenon of "coronary artery bleeding"; ③Expand pulmonary blood vessels, reduce pulmonary vascular bed pressure, reduce pulmonary capillary compression, improve pulmonary congestion, and reduce systemic circulation resistance, Improve heart function; ④ it can effectively promote the synthesis of prostaglandin (PG) by vascular endothelial cells, inhibit the synthesis of platelet thromboxane A2, inhibit the function of platelets, avoid the formation of atherosclerotic plaque in blood vessels, and further reduce the occurrence of vascular stenosis. The above effects jointly promote the reduction of myocardial oxygen consumption, increase oxygen supply, enhance myocardial contractility, improve the perfusion of ischemic tissues and organs, and significantly relieve the symptoms of angina, heart failure and hypertension. |
| pharmacokinetics | isosorbide mononitrate for injection is a powerful and long-acting anti-angina drug, which is administered intravenously and quickly distributed to the whole body, has no liver or intestinal adverse reactions, has complete and absolute bioavailability, its t1/2 is 4-5h, and the effective blood drug concentration time is as long as 8-9h, it is more than 10 times that of nitroglycerin. The oral absorption of ordinary tablets is fast, the blood drug concentration reaches a peak value 1 hour after taking the medicine, the gastrointestinal absorption is complete, there is no liver first pass effect, and the bioavailability can reach 90%-100%, which is consistent with intravenous medication. The blood drug concentration value can be accurately predicted, t1/2 is 4-5h, and the plasma protein binding rate |
| toxicology | mice ig, intravenous injection and intraperitoneal injection, LD50 is 3231.7, 2215.5 and 2224.6 mg/kg respectively. In the long-term toxicity test of dogs, isosorbide mononitrate was taken orally at 50mg/kg per day for 6 months without any toxic symptoms. 500mg/kg per day is the toxic dose for dogs. |
| use | is the active metabolite of isosorbide dinitrate. Oral administration is not affected by liver metabolic effects, and the original drug enters the systemic circulation. Long-acting, half-life of about 5h, high bioavailability. It is clinically used for the prevention and treatment of angina pectoris. Long-term treatment of coronary heart disease, prevention of vasospasm and mixed heart strangulation, is also suitable for the treatment of myocardial infarction and long-term treatment of chronic heart failure. |
| production method | sorbitol is used as raw material, dehydrated sorbitol is produced by dehydration cyclizing, and then reacted with nitric acid and acetic anhydride at 10~15 ℃ for 2.5h to obtain isosorbide mononitrate. |
Last Update：2024-04-10 22:29:15
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