trihydroxyethylrutin - Names and Identifiers
Name | trihydroxyethylrutin
|
Synonyms | Troxerutin Factor-P-zyma Trihydroxylrutin trihydroxyethylrutin Trihydroxyethylrutoside 3',4',7-Tris(hydroxyethyl)rutin 3',4',7-Tris[O-(2-hydroxyethyl)]rutin 3μ,4μ,7-Tris[O-(2-hydroxyethyl)]rutin, Troxerutin 3,5-Dihydroxy-3',4',7-tris(2-hydroxyethoxy)flavone 3-rutinoside 2-[3,4-bis(2-hydroxyethoxy)phenyl]-5-hydroxy-7-(2-hydroxyethoxy)-4-oxo-4H-chromen-3-yl 6-O-(6-deoxyhexopyranosyl)hexopyranoside 2-[3,4-bis(2-hydroxyethoxy)phenyl]-5-hydroxy-7-(2-hydroxyethoxy)-4-oxo-4H-chromen-3-yl 6-O-(6-deoxy-alpha-L-mannopyranosyl)-D-glucopyranoside 2-[3,4-bis(2-hydroxyethoxy)phenyl]-5-hydroxy-7-(2-hydroxyethoxy)-4-oxo-4H-chromen-3-yl 6-O-(6-deoxy-alpha-L-mannopyranosyl)-beta-D-glucopyranoside 2-[3,4-BIS(2-HYDROXYETHOXY)PHENYL]-3-[[6-O-(6-O-DEOXY-A-L-MANNOPYRANOSYL)-BETA-D-GLUCOPYRANOSYL]OXY]-5-HYDROXY-7-(2-HYDROXYETHOXY)-4H-1-BENZOPYRAN-4-ONE
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CAS | 7085-55-4
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EINECS | 230-389-4 |
InChI | InChI=1/C33H42O19/c1-14-23(38)26(41)28(43)32(49-14)48-13-21-24(39)27(42)29(44)33(51-21)52-31-25(40)22-17(37)11-16(45-7-4-34)12-20(22)50-30(31)15-2-3-18(46-8-5-35)19(10-15)47-9-6-36/h2-3,10-12,14,21,23-24,26-29,32-39,41-44H,4-9,13H2,1H3/t14-,21+,23-,24+,26+,27-,28+,29+,32+,33?/m0/s1 |
InChIKey | KMPBUGGPUQOWMJ-NXPSPVSKSA-N |
trihydroxyethylrutin - Physico-chemical Properties
Molecular Formula | C33H42O19
|
Molar Mass | 742.68 |
Density | 1.65±0.1 g/cm3(Predicted) |
Melting Point | 181°C |
Boling Point | 1058.4±65.0 °C(Predicted) |
Flash Point | 332°C |
Solubility | DMSO, Pyridine, Methanol, Ethanol, etc. |
Vapor Presure | 0mmHg at 25°C |
Appearance | Yellow, yellow-green or light brown yellow powder |
Color | Light Yellow to Yellow |
Merck | 14,9789 |
BRN | 4778232 |
pKa | 5.92±0.40(Predicted) |
Storage Condition | Sealed in dry,Store in freezer, under -20°C |
Refractive Index | 1.689 |
MDL | MFCD00153058 |
Use | Used as anticoagulant, has the effect of preventing thrombosis, suitable for cerebral thrombosis and cerebral embolism caused by hemiplegia, aphasia and myocardial infarction, arteriosclerosis |
trihydroxyethylrutin - Risk and Safety
Safety Description | S22 - Do not breathe dust.
S24/25 - Avoid contact with skin and eyes.
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WGK Germany | 3 |
RTECS | LK8331500 |
trihydroxyethylrutin - Standard
Authoritative Data Verified Data
This product is troxerutin (7,3 ', 4'-Three Hydroxyethyl rutin)-based Hydroxyethyl rutin mixture. Troxerutin (C33H42O19), calculated as anhydrous, shall not be less than 80.0% (for oral use) or 88.0% (for injection).
Last Update:2024-01-02 23:10:35
trihydroxyethylrutin - Trait
Authoritative Data Verified Data
- This product is yellow or yellow-green powder; Odorless; With hygroscopicity.
- This product is soluble in water, slightly soluble in methanol, slightly soluble in ethanol, insoluble in chloroform.
Last Update:2022-01-01 11:44:59
trihydroxyethylrutin - Introduction
This product is a hydroxyethyl rutin mixture based on troxerutin (7,3 ',4'-trihydroxyethyl rutin). The main impurities are tetrahydroxyethyl rutin, one hydroxyethyl rutin, rutin and dihydroxyethyl rutin peaks
Last Update:2022-10-16 17:28:07
trihydroxyethylrutin - Differential diagnosis
Authoritative Data Verified Data
- take about 20mg of this product, add 20ml of water, lml of hydrochloric acid and a small amount of zinc powder, and put it on a water bath for heating, showing a persistent red color.
- take about 20mg of this product, add 20ml of water and a small amount of aluminum trichloride, and the solution is bright yellow.
- take this product, add water to make a solution containing 20ug per lml, according to UV-visible spectrophotometry (General 0401), there is a maximum absorption at the wavelength of 254nm and MN, there is minimal absorption at a wavelength of 283Mn.
- 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 reference product (for injection) (General rule 0402).
Last Update:2022-01-01 11:44:59
trihydroxyethylrutin - Differential diagnosis
Authoritative Data Verified Data
acidity
take this product, add water to dissolve and dilute the solution containing 50mg per lml, according to the law (General 0631 ),pH value should be 5.0~7.0.
clarity of the solution
take this product, add water to dissolve and dilute to make a solution containing 50mg per lml, and the solution should be clear; If it is turbid, compare it with No. 1 turbidity standard solution (General rule 0902 first method), not more concentrated. (For injection)
Other components
take this product, add solvent [mobile phase A- mobile phase B(8020)] to dissolve and dilute to prepare A solution containing 1 mg per 1 ml as A test solution; the appropriate amount of the sample solution was taken and quantitatively diluted with a solvent to prepare a solution containing 0.5ug of troxerutin per 1 ml as a sensitivity solution. According to the test of high performance liquid chromatography (General rule 0512), silica gel bonded with eighteen alkyl silane is used as the filler (VenusilMP 4.6, 250mm,5um or the performance equivalent column); mobile phase A was phosphate buffer (O. 1 mol / L sodium dihydrogen phosphate solution, adjusted to pH 4.4 with phosphoric acid), mobile phase B was acetonitrile; Flow rate was 0.5ml per minute. The gradient elution was carried out according to the following table and the detection wavelength was 254nm. Take the appropriate amount of troxerutin system suitability reference, dissolve with solvent and dilute to make a solution containing 50ug per lml as the system suitability solution, take the system suitability solution L01, inject it into the liquid chromatograph, record the chromatogram, the retention time of troxerutin peak is about 18 minutes, and the relative retention times of tetrahydroxyethyl rutin peak, Hydroxyethyl rutin peak, rutin peak, troxerutin peak and dihydroxyethyl rutin peak are about 0.5, 0.8, 0.9, 1.0 and 1.1, the separation between the above peaks should meet the requirements. Take the sensitivity of Louli solution injection liquid chromatography, troxerutin peak signal-to-noise ratio should be greater than 10. l0ul of the sample solution is taken and injected into the human Liquid Chromatograph. The chromatogram is recorded and calculated according to the peak area normalization method. Except the troxerutin peak, the peak area of the single largest component shall not be more than 10.0% of the total peak area, the Peak area of other individual components shall not be greater than 5.0% of the total peak area, and the sum of the peak areas of each component shall not be greater than 20.0% of the total peak area (for oral use), the peak areas of dihydroxyethylrutin and tetrahydroxyethylrutin shall not be more than 5.0% of the total peak area, the peak areas of other individual unknown components shall not be more than 1.0% of the total peak area, and the sum of the peak areas of unknown components shall not be more than 4.0% of the total peak area, the sum of the peak areas of each component shall not be greater than 12.0% of the total peak area (for injection).
residual solvent
take this product l. Log, precision weighing, in the top empty bottle, precision add water lml to dissolve, sealed, as a test solution; Respectively, precision weigh the appropriate amount of epoxy Agent B, methanol, quantitative dilution with water was made to contain 0.02mg of ethylene oxide and methanol per 1 mL 3.0 mg of the mixed solution was accurately measured and 1 ml was placed in the headspace bottle, sealed and used as a reference solution. According to the determination method of residual solvent (General 0861 second method), the capillary column with 14% cyanopropyl phenyl-86% dimethyl polysiloxane (or similar polar) as stationary liquid is used as the column; The initial temperature is 30°C, it was maintained for 5 minutes and heated to 20°C at a rate of every minute for 3 minutes; The inlet temperature was 150°C; The detector temperature was 250°C; And the equilibrium temperature of the headspace bottle was 45 minutes. The Headspace sampling of the reference solution shall be taken, and the separation degree between the ethylene oxide peak and the methanol peak shall meet the requirements. The sample solution and the reference solution shall be taken respectively in the headspace, and the chromatogram shall be recorded. According to the external standard method, the residual amount of methanol shall be in accordance with the regulations, and the residual amount of ethylene oxide shall not pass Lom.
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the water content shall not exceed 4.0%.
ignition residue
This product l.Og, according to the law inspection (General 0841), residue shall not exceed 0.4% (for oral use) or 0.2% (for injection).
Heavy metals
The residue left under the item of taking the ignition residue shall not contain more than 20 parts per million of heavy metals (for oral use) after examination by law (General Principles 0821 second law). Or 10 parts per million (for injection).
abnormal toxicity
take this product, plus sodium chloride injection made of troxerutin solution containing 50mg per lml, according to inspection (General rule 1141), should comply with the provisions. (For injection)
Last Update:2022-01-01 11:45:00
trihydroxyethylrutin - Content determination
Authoritative Data Verified Data
measured by high performance liquid chromatography (General 0512).
chromatographic conditions and system suitability test
silica gel bonded with octanoalkylsilane as a filler (Venusil MPC18 4.6mm X 4.4, 5um or equivalent column); Phosphate buffer (pH)(0.1 mol / L sodium dihydrogen phosphate solution, adjusted to pH 4.4 with phosphoric acid)-acetonitrile (80:20) as mobile phase; The detection wavelength was 254mn. Take 10ul of the system applicable solution under other components and inject it into human liquid chromatograph, and record the chromatogram. The retention time of troxerutin peak is about 18 minutes, and the relative retention times of tetrahydroxyethyl rutin peak, Hydroxyethyl rutin peak, rutin peak, troxerutin peak and dihydroxyethyl rutin peak are about 0.5, 0.8, 0.9, 1.0 and 1.1, the separation degree between troxerutin peak and Two Hydroxyethyl rutin peak and rutin peak shall meet the requirements.
assay
take this product, precision weighing, add mobile phase dissolution and quantitative dilution to make a solution containing about 0.2mg per 1 ml, as a test solution, take 10ul of precision, inject into the liquid chromatograph, record the chromatogram and weigh the appropriate amount of troxerutin reference substance accurately. According to the external standard method to calculate the peak area, that is.
Last Update:2022-01-01 11:45:01
trihydroxyethylrutin - Category
Authoritative Data Verified Data
capillary protective drugs.
Last Update:2022-01-01 11:45:01
trihydroxyethylrutin - Storage
Authoritative Data Verified Data
shade, seal, and store in a cool place.
Last Update:2022-01-01 11:45:01
trihydroxyethylrutin - Troxerutin Tablets
Authoritative Data Verified Data
This product contains troxerutin (C33H42019) should be the label amount of 90.0% ~ 110.0%.
trait
This product is sugar-coated tablet or film-coated tablet, yellow or yellow-green after removing the coating.
identification
- take an appropriate amount of fine powder under the content determination item, add water to dissolve and dilute to prepare a solution containing about 15ug of troxerutin per lml, according to ultraviolet-visible spectrophotometry (General rule 0401) it was determined that there was a maximum absorption at a wavelength of 254mn and 347nm and a minimum absorption at a wavelength of 283nm.
- 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
- appropriate amount of fine powder under the content determination item of other components is taken, and the mobile phase under the content determination item is added to dissolve and dilute to prepare a solution containing about 1 mg of troxerutin per 1 ml, shake well, filter, the continued filtrate was taken as the test solution, which was determined according to the method under the item of other components of troxerutin, and calculated according to the peak area normalization method, except the troxerutin peak, the Peak area of a single maximum component shall not be greater than 10.0% of the total peak area, the peak area of other individual components shall not be greater than 5.0% of the total peak area, and the sum of the peak areas of each component shall not be greater than 20.0% of the total peak area.
- the dissolution of this product, according to the dissolution and release determination method (General rule 0931 second method), water 900ml as the dissolution medium, the speed of 75 rpm, according to the law, after 45 minutes, take the appropriate amount of the solution, filter, take the appropriate amount of the filtrate, and dilute it quantitatively with water to make a solution containing about 66ug of troxerutin per lml, as a test solution (in addition, an appropriate amount of troxerutin reference substance was accurately weighed, dissolved with water and quantitatively diluted to a solution containing about 66ug troxerutin per 1 ml, as a reference solution. The sample solution and the reference solution are respectively 10UL for precision measurement, measured according to the method under the content determination item, and the dissolution amount of each tablet is 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
- measured by high performance liquid chromatography (General 0512).
- chromatographic conditions and system suitability test using eighteen alkyl silane bonded silica gel as filler (Venusil MP Cl8,4.6mm X 250mm, 5um or performance equivalent column); Phosphate buffer (pH 4.4)(0.1 mol/L sodium dihydrogen phosphate solution, adjusted to pH 4.4 with phosphoric acid)-acetonitrile (80:20) as mobile phase; The detection wavelength was 254nm. Take the system applicable solution l0ul under other components, inject human liquid chromatograph, record chromatogram. The retention time of troxerutin peak is about 18 minutes, and the relative retention times of tetrahydroxyethyl rutin peak, Hydroxyethyl rutin peak, rutin peak, troxerutin peak and dihydroxyethyl rutin peak are about 0.5, 0.8, 0.9, 1.0 and 1.1, the separation degree between troxerutin peak and Two Hydroxyethyl rutin peak and rutin peak shall meet the requirements.
- determination Method: Take 20 tablets of this product (remove coating of sugar-coated tablets), weigh them precisely, grind them finely, take an appropriate amount of fine powder (about equivalent to troxerutin lOOmg), weigh them precisely, and put them in a 100ml measuring flask, add appropriate amount of mobile phase, shake to dissolve troxerutin, dilute to scale with mobile phase, shake well, filter, Take 5ml of continuous filtrate in precise volume, put it in 25ml measuring flask, dilute to scale with mobile phase, shake well, as a test solution, take 10 u1 with precision, inject human liquid chromatograph, record chromatogram. Another troxerutin reference substance was precision weighed, dissolved and quantitatively diluted with mobile phase to make a solution containing about 0.2mg per 1 ml, which was determined by the same method. According to the external standard method to calculate the peak area, that is.
category
troxerutin.
specification
(1) 60mg (2) 180mg
storage
light-shielded, sealed, and stored in a dry place.
Last Update:2022-01-01 11:52:59