Pyrithioxin Dihydrochloride
pyrithioxin dihydrochloride
CAS: 10049-83-9
Molecular Formula: C16H22Cl2N2O4S2
Pyrithioxin Dihydrochloride - Names and Identifiers
| Name | pyrithioxin dihydrochloride |
| Synonyms | bonifen Pyritinol HCl Pyrithioxine hcl Pyritinol hydrochloride PYRITINOL HYDROCHLORIDE PYRITINOL DIHYDROCHLORIDE pyritinol dihydrochloride Pyrithioxine hydrochloride PYRITHIOXIN DIHYDROCHLORIDE pyrithioxin dihydrochloride pyridin-2(1H)-one hydrochloride 3,3'-(dithiodimethylene)bis(5-hydroxy-6-methyl-4-pyridinemethanodihydrochl 5,5'-dithiodimethylenebis(2-methyl-3-hydroxy-4-hydroxymethylpyridine)dihydro 3,3'-dithiodimethylenebis(5-hydroxy-6-methyl-4-pyridinemethanol)dihydrochlor 5,5'-(disulfanediyldimethanediyl)bis[4-(hydroxymethyl)-2-methylpyridin-3-ol] 3,3'-dithiobis(methylene)bis(5-hydroxy-6-methyl-4-pyridinemethanol)dihydroch 5,5'-(disulfanediyldimethanediyl)bis[4-(hydroxymethyl)-2-methylpyridin-3-ol] dihydrochloride |
| CAS | 10049-83-9 |
| EINECS | 233-178-5 |
| InChI | InChI=1/C5H5NO.ClH/c7-5-3-1-2-4-6-5;/h1-4H,(H,6,7);1H |
| InChIKey | HRZWYHGGJOWGRI-UHFFFAOYSA-N |
Pyrithioxin Dihydrochloride - Physico-chemical Properties
| Molecular Formula | C16H22Cl2N2O4S2 |
| Molar Mass | 441.39 |
| Melting Point | 184 °C |
| Boling Point | 330.9°C at 760 mmHg |
| Flash Point | 153.9°C |
| Vapor Presure | 0.000117mmHg at 25°C |
| Appearance | neat |
| Storage Condition | Sealed in dry,Room Temperature |
Pyrithioxin Dihydrochloride - Risk and Safety
| WGK Germany | 2 |
| RTECS | UT4900000 |
Pyrithioxin Dihydrochloride - Standard
Authoritative Data Verified Data
This product is 3,3 '-(dithiomethylene) BIS (5-hydroxy-6-methyl-4-pyridinmethanol) dihydrochloride monohydrate. The content of C16H20N204S2 · 2HC1 should be between 97.0% and 103.0% based on the water content.
Last Update：2024-01-02 23:10:35
Pyrithioxin Dihydrochloride - Trait
Authoritative Data Verified Data
- This product is white or off-white crystalline powder; Odorless.
- This product is soluble in water, slightly soluble in ethanol, insoluble in acetone, chloroform or ether.
Last Update：2022-01-01 15:04:53
Pyrithioxin Dihydrochloride - Preparation solution concentration reference
| 1mg | 5mg | 10mg | |
|---|---|---|---|
| 1 mM | 2.266 ml | 11.328 ml | 22.656 ml |
| 5 mM | 0.453 ml | 2.266 ml | 4.531 ml |
| 10 mM | 0.227 ml | 1.133 ml | 2.266 ml |
| 5 mM | 0.045 ml | 0.227 ml | 0.453 ml |
Last Update：2024-01-02 23:10:35
Pyrithioxin Dihydrochloride - Differential diagnosis
Authoritative Data Verified Data
- take about 50mg of this product, put it in a test tube, and pay attention to slowly heating with direct fire to melt, that is, the odor of hydrogen sulfide occurs.
- The infrared absorption spectrum of this product should be consistent with that of the control (Spectrum set 356).
- the aqueous solution of this product was chloride identification (1) of the reaction (General 0301).
Last Update：2022-01-01 15:04:54
Pyrithioxin Dihydrochloride - Exam
Authoritative Data Verified Data
acidity
take 0.10g of this product, Add 10ml of water to dissolve, check according to law (General 0631) ,pH value should be 2.0~3.5 (for injection).
clarity and color of solution
take l.Og of this product, add 10ml of water to dissolve, the solution should be clear and colorless. If it is turbid, it should not be more concentrated compared with No. 1 turbidity standard solution (General 0902 method 1), orange or yellow-green standard colorimetric solution No. 5 (for oral use or comparison with yellow or yellow-green standard colorimetric solution No. 2 (for injection) (General rule 0901 method 1), shall not be deeper.
Related substances
take this product, add water to dissolve and dilute to make a solution containing about 0.2 mg per lml as a test solution; Take lml for precision measurement and put it in a 100ml measuring flask, as a control solution, it was diluted to the scale with water and shaken. Test according to high performance liquid chromatography (General 0512). Silica gel was bonded with eighteen alkyl silane as filler; The mobile phase was perchloric acid solution (0.82 -1000, adjusted to pH 3.0 with triethylamine)-methanol (75:25); The detection wavelength was 295mn. The number of theoretical plates shall not be less than 2000 based on the calculation of pyritinol peak, and the separation degree between pyritinol peak and adjacent impurity peak shall meet the requirements. 20ul of the test solution and the control solution were respectively injected into the liquid chromatograph, and the chromatogram was recorded to 2 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than 0.5 times (0.5%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
moisture
take this product, according to the moisture determination method (General 0832 first method 1), the moisture content should be 3.5% ~ 4.5%.
ignition residue
take l.Og of this product and check it according to law (General rule 0841). The residue left shall not exceed 0.1%.
Heavy metals
The residue left under the item of taking the ignition residue shall not contain more than 10 parts per million of heavy metal when examined by law (General Principles 0821, Law II).
sterile
take this product, according to the law inspection (General 1101), should comply with the provisions. (For aseptic dispensing)
Last Update：2022-01-01 15:04:55
Pyrithioxin Dihydrochloride - Content determination
Authoritative Data Verified Data
take an appropriate amount of this product, precision weighing, add 0.01mol/ L hydrochloric acid solution to dissolve and quantitatively dilute to prepare a solution containing about 10ug per lml, the absorbance was measured at a wavelength of 0401 NM according to ultraviolet-visible spectrophotometry (General Rule 403), and the absorption coefficient of C16H20N204S2 · 2HC1 was calculated.
Last Update：2022-01-01 15:04:55
Pyrithioxin Dihydrochloride - Category
Authoritative Data Verified Data
cerebral metabolism improving drugs.
Last Update：2022-01-01 15:04:55
Pyrithioxin Dihydrochloride - Storage
Authoritative Data Verified Data
light shielding, sealed storage.
Last Update：2022-01-01 15:04:55
Pyrithioxin Dihydrochloride - Pithiol hydrochloride tablets
Authoritative Data Verified Data
This product contains pyritinol hydrochloride (C16H20N204S2 • 2HCI • H20) should be 93.0% ~ 107.0% of the label amount.
trait
This product is white or white-like tablets or sugar-coated tablets, white or white after removing the coating.
identification
take an appropriate amount of the fine powder of this product, and show the same reaction according to the tests (1) and (3) under the item of pyritinol hydrochloride.
examination
should be in accordance with the relevant provisions under The tablet item (General rule 0101).
Content determination
Take 20 tablets of this product (sugar-coated tablets should be removed from the coating), finely grind, accurately weigh appropriate amount (about equivalent to pyritinol hydrochloride 0.lg), put it in a 100ml measuring flask, and add O.Olmol/L hydrochloric acid solution to pyritinol hydrochloride dissolved and diluted to the scale, shake, filter, precision volume filtrate 2ml, 200ml flask, with 0.01mol/L hydrochloric acid solution to the scale, shake, UV-visible spectrophotometry (General 0401), at the wavelength of 295nm absorbance, the absorption coefficient of C16H20N204S2 · 2HC1 · H20 was calculated as 388.
category
with pyritinol hydrochloride.
specification
0.lg
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:04:56
Pyrithioxin Dihydrochloride - Pyritinol hydrochloride injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of pyritinol hydrochloride. Pyritinol hydrochloride, calculated as C16H20N2O4S2 • 2HC1, shall be 93.0% ~ 107.0% of the labeled amount.
trait
This product is colorless to yellowish clear liquid.
identification
- take 5ml of this product and add lmol/L sodium hydroxide solution Dropwise, which means white flocculent precipitate is produced, filtered, and the precipitate is slowly heated by direct fire to melt, that is, the odor of hydrogen sulfide occurs.
- This product chloride identification (1) of the reaction (General 0301).
examination
- the pH value should be 2.0 to 3.5 (General 0631).
- color this product should be clear and colorless; If the color is colored, it should not be deeper compared with the yellow or yellow-green 2# crutaneously colorimetric liquid (General rule 0901 first method).
- appropriate amount of related substances of this product is diluted with water to make a solution containing about 0.2mg of pyritinol gallate (as calculated by C16H20N204S2 • 2HC1) per 1ml, which is used as a test solution; take 1ml accurately, put it in a 200ml measuring flask, dilute it with water to HB, shake it well, and use it as a control solution. According to high performance liquid chromatography (General 0512). Silica gel was bonded with eighteen alkyl silane as filler; Perchloric acid was used to dissolve phosphonium (0.82-1000, pH was adjusted to 3.0 with triethylamine)-methanol (75:25), mobile phase; Detection wavelength was 295nm. The number of theoretical plates shall not be less than 2000 based on the calculation of pyritinol peak, and the separation degree between pyritinol peak and adjacent impurity peak shall meet the requirements. The sample solution and the control solution were respectively injected with human liquid chromatograph, and the chromatogram was recorded to 3 times of the retention time of the main component peak. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than the area of the main peak of the control solution (0.5% ) , the sum of each impurity peak area shall not be greater than 2 times (1.0%) of the main peak area of the control solution.
- bacterial endotoxin this product is taken and diluted with inspection water to make a solution containing 1143 mg of pyritinol hydrochloride (calculated as C16H20N204S2 • 2HC1) per 1 ml, which is inspected according to law (general rule), the amount of endotoxin contained in each 1 mg of pyritinol hydrochloride (calculated as C16H20N2O4S2 · 2HC1) should be less than 0.75EU.
- sterile take this product, by membrane filtration method, with 0.1% sterile peptone aqueous solution washing (each membrane is not less than 300ml), with Staphylococcus aureus as positive control bacteria, inspection in accordance with the law (General rule 1101), should comply with the provisions.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
precision take the right amount of this product, with O.Olmol/L hydrochloric acid solution is quantitatively diluted to prepare a solution containing about 10ug of pyritinol hydrochloride (based on Cl6H20N204S2 • 2HC1) per 1 ml, which is obtained by the method under the item of pyritinol hydrochloride content determination.
category
with pyritinol hydrochloride.
specification
calculated by C16H20N204S2 • 2HC1 (l)2ml:0.1g(2)2ml:0.2g (3)5ml:0.2g
storage
light shielding, closed storage.
Last Update：2022-01-01 15:04:57
Pyrithioxin Dihydrochloride - Pyritinol hydrochloride capsules
Authoritative Data Verified Data
This product contains pyritinol hydrochloride (C16H20N204S2 • 2HCl • H20) should be 93.0% ~ 107.0% of the label amount.
trait
The content of this product is white or white powder.
identification
- take the content of this product, according to the item of pyritinol hydrochloride identification (1) test, showed the same reaction.
- take an appropriate amount of the contents of this product, add water, shake, filter, filtrate chloride identification (1) of the reaction (General 0301).
examination
should comply with the relevant provisions under the capsule (General rule 0103).
Content determination
take the contents under the difference of loading amount, mix evenly, weigh an appropriate amount (about 0.1g of pyritinol hydrochloride) accurately, put it in a 100ml measuring flask, and add 0.Olmol/L hydrochloric acid solution to pyritinol hydrochloride dissolved and diluted to the scale, shake, filtered, precision volume of filtrate continued 2ml, 200ml flask, with O.Olmol/L hydrochloric acid solution to the scale, shake, according to UV-visible spectrophotometry (General 0401), at the wavelength of 295nm absorbance, the absorption coefficient of C16H20N204S2 · 2HC1 · H20 was calculated as 388.
category
with pyritinol hydrochloride.
specification
O.lg
storage
light shielding, sealed storage.
Last Update：2022-01-01 15:04:58
Pyrithioxin Dihydrochloride - Pyritinol Hydrochloride for Injection
Authoritative Data Verified Data
This product is pyritinol hydrochloride sterile powder or sterile lyophilized. Based on the average loading, pyritinol hydrochloride shall be calculated as C16H20N204S2 • 2HC1 and shall be 93.0% ~ 107.0% of the labeled amount.
trait
This product is white or off-white crystalline powder or freeze-dried loose lumps; Odorless.
identification
take this product, according to the item of pyritinol hydrochloride identification (1), (3) test, show the same reaction.
examination
- the clarity and color of the solution take 5 bottles of this product, each bottle of water lml(0.lg specification) or 2ml (0902G specification) to dissolve, the solution should be clear and colorless; If it is turbid, it should not be more concentrated compared with No. 1 turbidity standard solution (general rule); If it is colored, no deeper than the yellow or yellow-green No. 2 Standard Colorimetric solution (General rule 0901 method 1).
- acidity: take several bottles of this product and add water to make a solution containing anhydrous pyritinol Hydrochloride 1%, which is measured according to law (General rule 0631). The pH value should be 2.0~3.5.
- appropriate amount of contents under the item of difference in loading amount of related substances, add water to dissolve and dilute to prepare a solution containing about 0.2mg of pyritinol hydrochloride (calculated as C16H20N204S2 • 2HC1) per 1ml, as a test solution; 1ml was accurately measured, placed in a 100ml measuring flask, diluted with water to scale, and shaken to serve as a control solution. According to the method of pyritinol hydrochloride related substances. If there are impurity peaks in the chromatogram of the test solution, the area of a single impurity peak shall not be greater than 0.5 times (0.5%) of the area of the main peak of the control solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
- the moisture content of this product shall not exceed 0832 as determined by the method for determination of moisture (General rule 5.0%, first method 1).
- bacterial endotoxin this product shall be inspected according to law (General rule 1143), and the amount of endotoxin contained in 1 mg pyritinol hydrochloride (calculated as C16H20N204S2 • 2HC1) shall be less than 0.75EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
take the contents under the difference of loading amount, mix evenly, weigh the appropriate amount accurately, and add O.Olmol/L hydrochloric acid solution is dissolved and quantitatively diluted to prepare a solution containing about 10ug of pyritinol hydrochloride (as calculated by C16H20N2O4S2 • 2HC1) per 1 ml, which is obtained according to the method under the item of pyritinol hydrochloride content determination.
category
with pyritinol hydrochloride.
specification
calculated as C16H20N2O4S2 • 2HC1 (l)0.1g (2)0.2g
storage
light shielding, closed storage.
Last Update：2022-01-01 15:04:58
Pyrithioxin Dihydrochloride - Reference Information
| central stimulant | pyritinol hydrochloride, also known as naofuxin, is a central stimulant. This product is a derivative of vitamin B6, which can promote the metabolism of glucose and amino acids in the brain, increase carotid blood flow, increase cerebral blood flow, and improve systemic assimilation. Mainly used for the improvement of symptoms such as headache, dizziness, insomnia, memory loss, inattention, and emotional changes in cerebral concussion syndrome, brain trauma sequelae, encephalitis and meningitis sequelae; also used for cerebral arteriosclerosis, Alzheimer's psychosis, etc. |
| traits | white crystalline powder, odorless. Easily soluble in water, high temperature, alkaline solution, sunlight are easy to destroy. |
| pharmacokinetics | oral administration is rapidly and completely absorbed, plasma protein binding rate is very low, and it quickly enters brain tissue and other body organs and tissues. It is mainly metabolized in the liver and excreted by the kidneys. |
| pharmacological action | pyritinol hydrochloride is a derivative of vitamin B6, which is formed by connecting two molecules of vitamin B6 with disulfide bonds and has the effects of promoting intelligence and brain activation. This drug can activate the cholinergic system in the brain, increase the activity of postsynaptic cholinergic neurons in the cerebral cortex, increase the second messenger cGMP, reduce γ-aminobutyric acid, and activate dopamine in the brain to enhance the brain Tolerance to hypoxia. It can also promote glucose and amino acid metabolism in the brain and improve systemic assimilation. It can also increase carotid blood flow, improve cerebral blood flow and brain bioelectrical activity. |
| clinical application | 1. it is used to improve symptoms such as dizziness, pain, insomnia, memory loss, inattention, mood changes, etc. caused by sequelae of brain trauma, encephalitis and meningitis. It is also used to improve cerebral arteriosclerosis and senile dementia mental symptoms. 2. For rheumatoid arthritis. |
| adverse reactions | 1. the nervous system can occasionally cause dizziness, dizziness and headache. 2. Gastrointestinal tract can occasionally cause nausea. 3. Skin can occasionally cause rash. 4. Phlebitis and pain may occur at other injection sites, which can disappear after drug withdrawal. |
| precautions | 1. contraindications are allergic to this drug. 2. Use with caution ① Liver insufficiency. ② Diabetic patients. 3. Special population (1) Children: There is still a lack of research data on children's medication. Not recommended for children. (2) the elderly: elderly patients with no special medication. (3) Pregnant women: In animal experiments, this medicine has the tendency to cause cleft lip in offspring animals, so pregnant women should use it with caution. (4) lactating women: this medicine in the milk concentration is higher, lactating women should be used with caution. |
Last Update：2024-04-09 02:00:05
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View History
Pyrithioxin Dihydrochloride
5,7-dichloro-1H-pyrrolo[2,3-c]pyridine
2-[4-(溴甲基)苯基]丙酸
二乙二醇单十六醚
三氟甲烷硫醇亚铜
布美他尼杂质D
2-ethoxyoxane
枸橼酸氢氧化钠
TRIETHYL NITRILOTRICARBOXYLIC ACID
3-IODO- 4-PYRIDINECARBONITRILE
5,7-dichloro-1H-pyrrolo[2,3-c]pyridine
2-[4-(溴甲基)苯基]丙酸
二乙二醇单十六醚
三氟甲烷硫醇亚铜
布美他尼杂质D
2-ethoxyoxane
枸橼酸氢氧化钠
TRIETHYL NITRILOTRICARBOXYLIC ACID
3-IODO- 4-PYRIDINECARBONITRILE