脑复康
Piracetam
CAS: 7491-74-9
Molecular Formula: C6H10N2O2
脑复康 - Names and Identifiers
脑复康 - Physico-chemical Properties
| Molecular Formula | C6H10N2O2 |
| Molar Mass | 142.16 |
| Density | 1.2298 (rough estimate) |
| Melting Point | 151-152,5 C |
| Boling Point | 259.72°C (rough estimate) |
| Flash Point | 200.8°C |
| Solubility | Freely soluble in water, soluble in ethanol (96 per cent). It shows polymorphism (5.9). |
| Vapor Presure | 7.06E-07mmHg at 25°C |
| Appearance | neat |
| Color | Crystals from isopropanol |
| pKa | 15.67±0.40(Predicted) |
| Storage Condition | 2-8°C |
| Refractive Index | 1.5010 (estimate) |
| Physical and Chemical Properties | White crystalline powder. Melting point 151.5-152.5 °c. Soluble in water, slightly soluble in ethanol, almost insoluble in ether. No odor, slightly bitter taste. |
| Use | For the treatment of cerebral arteriosclerosis and cerebral vascular accident caused by memory and thinking function decline |
脑复康 - Risk and Safety
| Hazard Symbols | Xi - Irritant |
| Risk Codes | 36/37/38 - Irritating to eyes, respiratory system and skin. |
| Safety Description | S26 - In case of contact with eyes, rinse immediately with plenty of water and seek medical advice. S37/39 - Wear suitable gloves and eye/face protection S24/25 - Avoid contact with skin and eyes. |
| WGK Germany | 2 |
| RTECS | UX9660500 |
| HS Code | 29339900 |
| Toxicity | LD50 oral in mouse: 2gm/kg |
脑复康 - Standard
Authoritative Data Verified Data
This product is 2-oxo-1-pyrrolidinylacetamide. The content of C6H10N2O2 shall be between 98.0% and 102.0% based on the dry product.
Last Update：2024-01-02 23:10:35
脑复康 - Trait
Authoritative Data Verified Data
- This product is white or white crystalline powder; Odorless.
- This product is soluble in water, slightly soluble in ethanol, almost insoluble in ether.
melting point
The melting point of this product (General 0612) is 151~154°C.
Last Update：2022-01-01 11:56:48
脑复康 - Differential diagnosis
Authoritative Data Verified Data
- take 0.lg of this product, place it on a dropping plate, add several drops of water to dissolve, add 1 drop of potassium permanganate test solution and 1 drop of sodium hydroxide test solution, stir and place, the solution should be purple, gradually turning blue, finally, it was green.
- 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 185).
Last Update：2022-01-01 11:56:49
脑复康 - Exam
Authoritative Data Verified Data
clarity and color of solution
take this product 2. G, add water 10ml to dissolve, the solution should be clear and colorless; If it is turbid, compared with No. 1 turbidity standard solution (General Principles 0902 The first method), not more concentrated.
acidity
take this product l.Og, add water 20ml to dissolve, according to the law (General 0631),pH value should be 5.0~7.0.
Related substances
take this product, add the mobile phase to dissolve and dilute to make a solution containing about 0.5mg per lml, as a test solution; Take the appropriate amount of precision, A solution containing about 5ug per 1 ml was prepared as a control solution by quantitative dilution with mobile phase. According to the chromatographic conditions under the content determination item, 10 u1 of the test solution and 10 u1 of the control solution are accurately measured and injected into the human liquid chromatograph respectively, and the chromatogram is 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 sum of each impurity peak area shall not be greater than 0.5 times (0.5%) of the main peak area of the control solution.
loss on drying
take this product, dry to constant weight at 105°C, weight loss shall not exceed 0.5% (General rule 0831).
ignition residue
not more than 0.1% (General rule 0841).
Heavy metals
take 1.0g of this product, add 25ml of water to dissolve, and check according to law (General rule 0821 first law), containing heavy metals should not exceed 20 parts per million.
Last Update：2022-01-01 11:56:49
脑复康 - 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 (10:90) was used as the mobile phase, and the detection wavelength was 210Nm. The number of theoretical plates is not less than 2000 based on the piracetam peak.
assay
take the right amount of this product, precision weighing, plus mobile phase dissolution and quantitative dilution made in each lml containing about 0.lmg solution was used as the test solution, and 10ul was injected into the human liquid chromatograph for precise measurement, and the chromatogram was recorded. Another reference substance of piracetam was used for precise weighing and determination by the same method. According to the external standard method to calculate the peak area, that is.
Last Update：2022-01-01 11:56:50
脑复康 - Category
Authoritative Data Verified Data
cerebral metabolism improving drugs.
Last Update：2022-01-01 11:56:50
脑复康 - Storage
Authoritative Data Verified Data
light shielding, sealed storage port
Last Update：2022-01-01 11:56:50
脑复康 - Piracetam oral solution
Authoritative Data Verified Data
This product contains Piracetam (C6H10N2O2) should be labeled the amount of 95.0% to 105.0%.
trait
This product is an orange-yellow to yellow-brown clear liquid.
identification
- take an appropriate amount of this product (about 0.5g equivalent to piracetam), add chloroform 10ml, shake extraction, static to make the layer, take the three gas methane solution 2ml, add 5 drops of potassium permanganate test solution and 5 drops of sodium hydroxide test solution, shake, the upper layer is green.
- 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 relative density shall not be less than 1.10 (General 0601).
- the pH value should be 4.0 to 6.5 (General 0631).
- Related Substances: take this product and dilute it with mobile phase to make a solution containing about 0.5mg of piracetam per lm l as a test solution; Take appropriate amount with precision, A solution containing about 5ug of piracetam per 1 ml was prepared as a control solution by quantitative dilution with mobile phase. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area shall not be greater than 1.5 times (1.5%) of the main peak area of the control solution.
- others should comply with the relevant provisions under the item of oral solution (General rule 0123).
Content determination
precision take the right amount of this product, quantitative dilution with mobile phase made of each lml containing about 0. The solution of 1 mg was obtained as a test solution by measurement according to the method described in the item of piracetam content measurement.
category
Same as piracetam.
specification
10ml:0.8g
storage
light shielding, closed storage.
Last Update：2022-01-01 11:56:51
脑复康 - Piracetam Tablets
Authoritative Data Verified Data
This product contains Piracetam (C6H10N2O2) should be 95.0% to 105.0% of the label.
trait
This product is white or off-white.
identification
- take an appropriate amount of fine powder of this product (equivalent to 0.5g of piracetam), add 10ml of water, shake, dissolve piracetam, filter, take 2ml of filtrate and place it on the dropping plate, add 1 drop of potassium permanganate test solution and 1 drop of sodium hydroxide test solution, stir, place, the solution should be purple, gradient to blue, and finally green.
- 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
should be in accordance with the relevant provisions under The tablet item (General rule 0101).
Content determination
Take 20 tablets of this product, precision weighing, fine grinding, precision weighing an appropriate amount (about equivalent to piracetam 0.lg ), put it in a 100ml measuring flask, add an appropriate amount of mobile phase, shake to dissolve piracetam, dilute to scale with mobile phase, shake, filter, Take 5ml of filtrate accurately, put it in 50ml measuring flask, dilute to scale with mobile phase, shake well, as test solution, the content of piracetam was determined according to the method under the item of determination.
category
Same as piracetam.
specification
0.4g
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:56:52
脑复康 - Piracetam injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of piracetam. Piracetam-containing (C6H10N2O2) shall be between 95.0% and 105.0% of the labeled amount.
trait
This product is a clear colorless liquid.
identification
- take an appropriate amount of this product (approximately equivalent to piracetam O.lg), place on the dropping plate, add 1 drop of potassium permanganate test solution and 1 drop of sodium hydroxide test solution, stir well, place, the solution gradually changes from purple to blue, and finally shows green.
- 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 7.0 (General 0631).
- appropriate amount of related substances should be taken and diluted with mobile phase to prepare a solution containing about 0.5mg of piracetam per 1 ml as a sample solution, A solution containing about 5ug of piracetam per 1 ml was prepared as a control solution by quantitative dilution with mobile phase. Determination of related substances of piracetam according to the method. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (1.0%).
- bacterial endotoxin this product is taken and checked according to law (General rule 1143). The amount of endotoxin contained in piracetam per 1 mg should be less than 0.04EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
precision take the right amount of this product, and quantitative dilution of mobile phase is made to contain about 0. The solution of 1 mg was obtained as a test solution by measurement according to the method described in the item of piracetam content measurement.
category
Same as piracetam.
specification
(l ) 5ml:lg (2)20ml:4g (3)20ml:8g
storage
light shielding, closed storage.
Last Update：2022-01-01 11:56:52
脑复康 - Piracetam capsules
Authoritative Data Verified Data
This product contains Piracetam (C6H10N2O2) should be labeled the amount of 95.0% to 105.0%.
trait
The content of this product is white or white granular powder or powder.
identification
- take an appropriate amount of the content of this product (about 0.5g equivalent to piracetam), add 10ml of water, shake, dissolve piracetam, filter, take 2ml of filtrate and put it on the dropping plate, add 1 drop of potassium permanganate test solution and 1 drop of sodium hydroxide test solution, stir, place, the solution should be purple, gradient to blue, and finally green.
- 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
should comply with the relevant provisions under the capsule (General rule 0103).
Content determination
take the contents under the difference of loading amount, mix well, weigh appropriately (about 0.1g equivalent to piracetam), put them in a 100ml measuring flask, add appropriate amount of mobile phase, and shake to dissolve piracetam, dilute to scale with mobile phase, shake, filter, Take 5ml of filtrate accurately, put it in 50ml measuring flask, dilute to scale with mobile phase, shake well, as test solution, the content of piracetam was determined according to the method under the item of determination.
category
Same as piracetam.
specification
(1)0.2g (2)0.4g
storage
light shielding, sealed storage.
Last Update：2022-01-01 11:56:53
脑复康 - Piracetam and sodium chloride injection
Authoritative Data Verified Data
This product is a sterile aqueous solution of piracetam and sodium chloride. The content of Piracetam (C6H10N202) and sodium chloride (NaCl) should be 95.0% to 105.0% of the labeled amount.
trait
This product is a clear colorless liquid.
identification
- take an appropriate amount of this product (approximately equivalent to piracetam O.lg), place on the dropping plate, add 1 drop of potassium permanganate test solution and 1 drop of sodium hydroxide test solution, stir well, place, the solution gradually changes from purple to blue, and finally shows green.
- 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.
- identification reaction of sodium salt of this product and chloride identification (1) reaction (General rule 0301).
examination
- the pH value should be 4.0 to 7.0 (General 0631).
- appropriate amount of related substances should be taken and diluted with mobile phase to prepare a solution containing about 0.5mg of piracetam per 1 ml as a sample solution, A solution containing about 5ug of piracetam per 1 ml was prepared by quantitative dilution with mobile phase and used as a control solution. The solution was determined according to the method under the item of related substances of piracetam, except for the sodium chloride peak, if there are impurity peaks, the sum of the peak areas of each impurity shall not be greater than 1.5 times (1.5%) of the area of the main peak of the control solution.
- Heavy Metal take 3.5 of this product, add 2ml of acetate buffer (pH 0821) and an appropriate amount of water to make 25ml, and check according to law (General Principles first law), heavy metals should not exceed 10 per million.
- 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
piracetam precision take an appropriate amount of this product, and quantitatively dilute with mobile phase to prepare a solution containing about 0.1 mg piracetam per 1 ml as a test solution. The content of piracetam was determined according to the method under the item of determination.
Sodium chloride precision take this product 10ml, add water 30ml, add 2% dextrin solution 5ml, 2.5% borax solution 2ml and fluorescent yellow indicator solution 5~8 drops, 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
Same as piracetam.
specification
250ml: piracetam 8G with sodium chloride 2.25g
storage
light shielding, closed storage.
Last Update：2022-01-01 11:56:54
脑复康 - Piracetam For Injection
Authoritative Data Verified Data
This product is a sterile powder of piracetam, a sterile lyophilized product or a sterile lyophilized product prepared by adding an appropriate amount of excipients. The content of Piracetam (C6Hl0N202) shall be between 95.0% and 105.0% of the labeled amount calculated as the average loading.
trait
This product is white or off-white powder or crystalline powder, or loose lumps.
identification
- take an appropriate amount of this product (about 0.lg of piracetam), place it on a dropping plate, add several drops of water to dissolve, add 1 drop of potassium permanganate solution and 1 drop of sodium hydroxide solution, stir well, and stand still, the solution gradually changed from magenta to blue, and finally appeared green.
- 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
- acidity: Take appropriate amount of this product, add water to dissolve and dilute to prepare a solution containing about 50mg of piracetam per 1 ml, and determine it according to law (General rule 0631). The pH value should be 5.0~7.0.
- clarity and color of the solution take appropriate amount of this product, add water to dissolve and dilute to make a solution containing 0.2g of piracetam per 1 ml, and the solution should be clear and colorless.
- Related substances take this product, add mobile phase to dissolve piracetam and dilute it to prepare a solution containing about 0.5mg piracetam per 1 ml as a test solution, A solution containing about 2.5ug of piracetam per 1 ml was prepared as a control solution by quantitative dilution with mobile phase. Determination of related substances of piracetam according to the method. If there are impurity peaks in the chromatogram of the test solution, the sum of each impurity peak area shall not be greater than the main peak area of the control solution (0.5%).
- weight loss on drying this product shall be dried to constant weight at 105°C, and the weight loss shall not exceed 3.0% (General rule 0831)o
- take 1.0g of heavy metal, add water to dissolve 0821, and check according to law (General rule first law), containing heavy metals shall not exceed 10 parts per million.
- bacterial endotoxin take this product, according to the law inspection (General 1143), each 1 mg of piracetam containing endotoxin amount should be less than 0.012EU.
- others should comply with the relevant provisions under injection (General 0102).
Content determination
take the contents under the difference of loading amount, mix evenly, accurately weigh appropriate amount, add mobile phase to dissolve and quantitatively dilute to make piracetam 0. The solution of 1 mg was obtained as a test solution by measurement according to the method described in the item of piracetam content measurement.
category
Same as piracetam.
specification
(l)l.Og (2 )2.0g (3 )4.0g (4 )6.0g(5)8.Og
storage
light shielding, closed storage.
Last Update：2022-01-01 11:56:55
脑复康 - Reference Information
| NIST chemical information | information provided by: webbook.nist.gov (external link) |
| Central nervous stimulant | piracetam, also known as piracetam, piracetam, acetamide, it is a kind of brain metabolism improving drug, which belongs to the cyclic derivative of gamma-aminobutyric acid. It has strong central selectivity and is limited to the improvement of brain function (memory, consciousness, etc.), no side effects of psychotropic drugs, no dependence. Can prevent or protect the animal due to hypoxia caused by retrograde amnesia, but also can significantly antagonize the inhibitory effect of barbiturate on the central nervous system, can promote brain cell metabolism, increase brain amino acids, protein, the absorption and utilization of glucose can activate, protect and repair the brain nerve cells, promote the conversion of ADP into ATP in the brain, and improve the metabolic energy supply in the brain. It affects the Excitatory Transmission of cholinergic neurons and promotes the synthesis of acetylcholine. Piracetam can resist the damage of brain function caused by physical and chemical factors, and improve the ability of learning, memory and recall. Retrograde amnesia caused by hypoxia can be improved. Oral absorption, 30~40 minutes after the peak blood concentration, protein binding rate of 30%, the elimination half-life of 4~6 hours, easy to penetrate the blood-brain barrier, reaching the brain and cerebrospinal fluid. After oral administration can not be decomposed by the liver, in the form of the original form of excretion from the urine and feces. It is mainly used for memory and thinking disorders caused by brain diseases, Organic dementia and mental retardation in children have a certain effect on mild to moderate senile dementia, but it is invalid for severe patients. To improve the symptoms of functional brain function decline syndrome also has a certain effect. Piracetam can also be used for encephalitis, carbon monoxide, pesticide and alcohol poisoning consciousness recovery, can be used by intravenous injection or drip. |
| pharmacology and toxicology | piracetam is a derivative of γ-aminobutyric acid, which can promote thinking and memory, and can directly act on the cerebral cortex, enhance protein synthesis, protect nerve cells, promote information transmission, improve learning and memory ability, improve brain damage or degenerative diseases caused by various reasons, and improve brain function. Animal experiments confirmed that this product can improve the ability to learn, against hypoxic memory disorders, improve the brain's utilization of glucose and energy reserves, improve brain function. It has a certain effect on the cognitive and directional ability of mild and moderate senile dementia, but it has no obvious effect on severe patients. It also has a therapeutic effect on brain functional decline syndrome, such as slow response, disturbance of consciousness and other symptoms, so that it can be improved to a certain extent. It has curative effect on brain dysfunction caused by trauma, stroke and carbon monoxide poisoning. It can also be used to improve the intelligence of mentally retarded children and the treatment of nocturia. This product has a strong central selective effect, limited to the improvement of memory and consciousness function, no side effects of psychotropic drugs such as mental excitement, and no dependence. The acute toxicity test of animal experiment showed that the mice had no death when the dose of gavage was more than 10g/kg. The LD50 of intravenous administration was 9.2g/kg, and the subacute and chronic toxicity tests did not show any adverse effects on the growth and development of rats and dogs. Blood, heart, liver, kidney, brain and other important internal organs and functions have no adverse effects. |
| pharmacokinetics | This product is quickly absorbed from the digestive tract and enters the blood after oral administration, and through the blood-brain barrier to reach the brain and cerebrospinal fluid, cerebral cortex and olfactory bulb concentration is higher than the brain stem concentration. This product easily passes through the placental barrier. After oral administration, the plasma concentration reached a peak at 30 to 45 minutes, the plasma protein binding rate was 30%, the half-life t1/2 was 5 to 6 hours, and the apparent volume of distribution (Vd) was 0.6L/kg. Piracetam can not be broken down by the liver after oral administration, it is excreted in the urine and feces in prototype form. The renal clearance rate was 86ml/min. Stool output is about 1% ~ 2%. |
| indication | It is mainly used for memory and thinking disorders caused by brain diseases, organic dementia and mental retardation in children, it has a certain effect on mild to moderate senile dementia, but has no effect on severe patients. To improve the symptoms of functional brain function decline syndrome also has a certain effect. For brain injury drug poisoning, can be used for intravenous injection or drip. |
| usage and dosage | oral: 800~1600 mg, 3 times a day, 3~6 weeks for a course of treatment, children half the dosage. intramuscular injection: 1 g every time, 2-3 times a day. intravenous injection: 4 g each time, 1 time per day. intravenous drip: 4-8g every time, once a day. Dilute to 0.9% with 5% dextrose injection or 250 sodium chloride injection. The dosage of the elderly and children was halved. |
| adverse reactions | common gastrointestinal adverse reactions are Nausea, abdominal discomfort, anorexia, abdominal distension, Abdominal Pain, etc, the severity of symptoms is directly related to the dose of the drug. The adverse reactions of the central nervous system include excitement, excitability, dizziness, Head Pain and Sleep Initiation and Maintenance Disorders, but the symptoms are mild and have nothing to do with the dose, the symptoms disappeared after drug withdrawal. Occasionally mild liver function damage, manifested as mild transaminase elevation, but not related to drug dose. |
| drug interaction | when combined with warfarin, this product can prolong prothrombin time and induce inhibition of platelet aggregation. In patients receiving anticoagulant therapy, simultaneous application of piracetam should pay special attention to the clotting time, prevent the risk of bleeding, and adjust the dosage and usage of anticoagulant therapy. |
| note | 1. This product is easy to pass through the blood-brain barrier, placental barrier. In the body does not degrade is not transformed, directly by the kidney excretion, so pregnant women, newborns, liver, renal dysfunction disabled. 2. Individual patients had dry mouth, loss of appetite, urticaria and memory and thinking loss. 3. Extrapyramidal diseases, Huntington's chorea is contraindicated to avoid worsening of symptoms. |
| Use | early use of timber as anti-vertigo and anti-emetic drugs, currently used as nervous system drugs, it can promote and enhance the function of brain memory B, and is effective for senile memory impairment. For some low intelligence children's intelligence to improve the glue, the Alzheimer's disease, brain injury caused by memory and thinking disorders also have a certain effect. for cerebral arteriosclerosis and cerebrovascular accident caused by memory and thinking function decline treatment medicine used for cooling oil, painkillers, etc., also used for toothpaste, tooth powder, candy, beverage, fragrance |
| production method | 2-pyrrolidone is used as the starting material to form a salt with sodium methoxide in toluene, it is obtained by condensation with ethyl chloroacetate followed by ammonification. |
| toxic substance data | information provided by: pubchem.ncbi.nlm.nih.gov (external link) |
Last Update：2024-04-09 02:00:11
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View History
脑复康
2-苄基-2-(二甲氨基)-1-[4-(吗啉代)苯基]-1-丁酮
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GZD 824
7-Ethoxycarbonylisoquinoline
1597440-03-3
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40400-13-3
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2-苄基-2-(二甲氨基)-1-[4-(吗啉代)苯基]-1-丁酮
1-P-CHLOROPHENYL-1-PHENYLACETONE
O-METHYLISOUREA SULFATE SALT
GZD 824
7-Ethoxycarbonylisoquinoline
1597440-03-3
2-(氧代-苯基甲基)-5-苯并呋喃羧酸
40400-13-3
4-[(Phenyloxycarbonyl)oxy]benzoic acid methyl ester