CN106420598A - Low-impurity levorotatory oxiracetam injection and preparation method thereof - Google Patents
Low-impurity levorotatory oxiracetam injection and preparation method thereof Download PDFInfo
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- CN106420598A CN106420598A CN201510511617.4A CN201510511617A CN106420598A CN 106420598 A CN106420598 A CN 106420598A CN 201510511617 A CN201510511617 A CN 201510511617A CN 106420598 A CN106420598 A CN 106420598A
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Abstract
The invention provides a low-impurity levorotatory oxiracetam injection, which is characterized by comprising the following original auxiliary materials: levorotatory oxiracetam, glycerol, glycine, vitamin C, and ethylene diamine tetraacetic acid. The above materials are subjected to concentration proportion, dilution proportion, embedment, disinfection, examination, packaging and the like to prepare the levorotatory oxiracetam injection. The prepared levorotatory oxiracetam injection is not easily oxidized during the storage process, and the increased amount of impurities during the sterilization process is only 0.03%. Therefore, the levorotatory oxiracetam injection is good in stability and the validity period of the levorotatory oxiracetam injection is as long as 18 months. Within the validity period of the levorotatory oxiracetam injection, the levorotatory oxiracetam injection has fewer impurities and the total impurity content of the levorotatory oxiracetam injection is smaller than 0.26%. The obtained product is good in clarity and the clarity of the product is smaller than that of a No. 0.5 standard turbidity solution. The product is good in main drug solubility, and the sizes of insoluble particles in the product are smaller than 25 mum. The preparation process of the product is simple and feasible, thus being worthy of market promotion.
Description
Technical field
The invention mainly relates to pharmaceutical technology field is and in particular to a kind of few levo-oxiracetam injection of impurity and its system
Preparation Method.
Background technology
Nootropics are a kind of promotion study also known as cereboactive drug, the new medicine for central nervous system of memory reinforcing.Promote
Intelligence medicine requires selection in cerebral cortex, has and selects activation, protection and promote damaged nerve cell functional rehabilitation
Feature.Different from other neurologic agents be a little their above-mentioned effect not by reticular system or olfactory bulb, but directly
Connect and act on cortex.Neither affect behavior, also no calm excitation, therefore such medicine has caused the extensive pass of people
Note and interest, also grow with each passing day to the demand of such medicine.
Oxiracetam (S-oxiracetam) is a kind of hydroxy-amino-butyric acid of synthesis (BABOB) cyclic derivatives, only
For central nervous system, it is mainly distributed on cerebral cortex, Hippocampus, have activation, protection or the function of promoting neurocyte
Recover, improve the mnemonic learning function of disturbance of intelligence patient, and medicine does not have direct vasoactive in itself, in not having yet
Pivot excitation, the impact to ability of learning and memory is a kind of lasting facilitation.
Existing levo-oxiracetam injection its be primarily present that stability is poor, sterilization process is oxidizable so that product impurity increases
Greatly, the problems such as product principal agent dissolubility is bad, clarity is bad.
Content of the invention
It is an object of the invention to provide the few levo-oxiracetam injection of a kind of good stability, impurity.
Another object of the present invention is to providing the preparation method of above-mentioned levo-oxiracetam injection.
The purpose of the present invention is realized by following technical measures：
A kind of few levo-oxiracetam injection of impurity it is characterised in that it is with levo-oxiracetam as raw material, then
A certain amount of additives are added to be obtained；Wherein said additives are glucose, sodium chloride, Mannitol, glycerol, L- silk ammonia
Acid, sodium glutamate, alanine, glycine, lecithin, propylene glycol, benzyl alcohol, chlorobutanol, sodium sulfite,
In sodium sulfite, sodium pyrosulfite, one or more of vitamin C, ethylenediaminetetraacetic acid.
Inventor finds in research process, selects a certain proportion of glycerol, glycine, vitamin C and ethylenediamine tetrem
The compound additives of acid composition, then coordinate specific preparation technology, and total impurities increase is relatively in sterilization process can to make product
Little, product stability is good, and product principal agent dissolubility is good, and clarity significantly improves；Above-mentioned levo-oxiracetam injection,
It is characterized in that：It is with levo-oxiracetam, glycerol, glycine, vitamin C, ethylenediaminetetraacetic acid as supplementary material,
By dense join, dilute join, embedding, sterilizing, test package step be obtained；The consumption of wherein said supplementary material is weight percent
The levo-oxiracetam 55%～75% of ratio, glycerol 10%～30%, glycine 8%～25%, vitamin C 3%～8%, second
Ethylenediamine tetraacetic acid (EDTA) 2%～5%；Described dense step of joining is to add supplementary material in material-compound tank, adds sterilized water for injection immediately,
Stirring, dissolving, obtain concentrated wiring liquid；Described dilute step of joining is to take concentrated wiring liquid, adds 0.1mol/L～0.5mol/L sodium hydroxide
Solution, adjusts pH to 6.5～7.0, adds the shitosan of cumulative volume 0.2%～0.6% (g/ml), stir in above-mentioned solution
Mix, mix, stand 30～50min, with 0.8 μm of filter membrane filtration, add cumulative volume 0.1%～0.3% (g/ml)
Activated carbon, adsorption bleaching, with 0.45 μm of filter membrane filtration, collect filtrate, add sterilized water for injection to recipe quantity,
It is qualified to test through middle product examine, you can；Described sterilization steps are canned peace to be cutd open semi-finished product send into steam sterilization pan sterilizing,
121 DEG C of sterilizing 15min, sterilizing program：10 DEG C/min, rise to 121 DEG C, keep 15min at 121 DEG C；Compressed air
3～5 DEG C/min of air blast lowers the temperature, and 8～12min is cooled to 70～80 DEG C, and 2～3 DEG C/min of cooling water lowers the temperature, and 15～18min is cold
But to 30 DEG C, sterilizing completes.
Most preferably, above-mentioned levo-oxiracetam injection is it is characterised in that it is former auxiliary by following significant percentage
Material is obtained：Levo-oxiracetam 60%～66%, glycerol 15%～20%, glycine 12%～18%, vitamin C 3%～5%,
Ethylenediaminetetraacetic acid 2%～4%, above-mentioned supplementary material is added in material-compound tank, adds the sterile injection of 1/3 recipe quantity to use immediately
Water, stirring, dissolving, obtain concentrated wiring liquid；Take concentrated wiring liquid, add 0.1mol/L sodium hydroxide solution, adjust pH to 6.5～7.0,
Add the shitosan of cumulative volume 0.2%～0.6% (g/ml), stirring in above-mentioned solution, mix, stand 30～50min,
With 0.8 μm of filter membrane filtration, add the activated carbon of cumulative volume 0.1%～0.3% (g/ml), adsorption bleaching, use 0.45
μm filter membrane filtration, collect filtrate, add sterilized water for injection to recipe quantity, it is qualified to test through middle product examine, you can；
Canned peace is cutd open semi-finished product and sends into steam sterilization pan sterilizing, 121 DEG C of sterilizing 15min, sterilizing program：10 DEG C/min,
Rise to 121 DEG C, keep 15min at 121 DEG C；3～5 DEG C/min of compressed air air blast lowers the temperature, and 8～12min is cooled to 70～80
DEG C, 2～3 DEG C/min of cooling water lowers the temperature, and 15～18min is cooled to 30 DEG C, and sterilizing completes.
A kind of preparation method of the few levo-oxiracetam injection of impurity is it is characterised in that it is to be obtained as follows
's：
1. dense join：Supplementary material is added in material-compound tank, adds the sterilized water for injection of 1/3 recipe quantity immediately, stirring,
Dissolving, obtains concentrated wiring liquid；
2. dilute join：Take concentrated wiring liquid, add 0.1mol/L sodium hydroxide solution, adjust pH to 6.5～7.0, to above-mentioned
Add the shitosan of cumulative volume 0.2%～0.6% mass volume ratio, stirring in solution, mix, stand 30～50min,
With 0.8 μm of filter membrane filtration, add the activated carbon of cumulative volume 0.1%～0.3% mass volume ratio, adsorption bleaching, use
0.45 μm of filter membrane filtration, collects filtrate, adds sterilized water for injection to recipe quantity, it is qualified to test through middle product examine,
?；
3. embedding：Intermediate is filtered with 0.22 μm of filter after the assay was approved, checks visible foreign matters, antibacterial endogenous toxin
After element is qualified, upper streamline carries out fill, and the nitrogen that pouring process need to be filled with purity 99.99% makes injection in tank
Oxygen content in water is less than 0.01%, seals after inflated with nitrogen；
4. sterilize：Canned peace is cutd open semi-finished product and sends into steam sterilization pan sterilizing, 121 DEG C of sterilizing 15min, sterilizing
Program：10 DEG C/min, rise to 121 DEG C, keep 15min at 121 DEG C；3～5 DEG C/min of compressed air air blast lowers the temperature,
8～12min is cooled to 70～80 DEG C, and 2～3 DEG C/min of cooling water lowers the temperature, and 15～18min is cooled to 30 DEG C, has sterilized
Become, by rated condition leak detection；
5. check：After sterilizing, sample checks visible foreign matters, the sample checking qualified is packed, full inspection, warehouse-in.
The present invention has following beneficial effect：
Levo-oxiracetam injection of the present invention is only difficult in oxidized, sterilization process impurity incrementss during having storage
For 0.03%, good stability, it is valid up to more than 18 months, in effect duration, product impurity is few, its total impurities is less than
0.26%, product clarity is good, and clarity is less than No. 0.5 standard turbidity solution, and product principal agent dissolubility is good, insoluble micro-
Grain is respectively less than 25 μm, and preparation process is simple is feasible, worth marketing.
Specific embodiment
Below by embodiment, the present invention is specifically described it is necessary to it is pointed out here that be that following examples are served only for
The present invention is further described it is impossible to be interpreted as limiting the scope of the invention, without departing substantially from present invention spirit
In the case of essence, the modification that the inventive method, step or condition are made or replacement, belong to the scope of the present invention.
Embodiment 1
A kind of few levo-oxiracetam injection of impurity, is obtained according to the following steps：
Preparation process：
1. dense join：Supplementary material is added in material-compound tank, adds the sterilized water for injection of 1/3 recipe quantity immediately, stirring,
Dissolving, obtains concentrated wiring liquid；
2. dilute join：Take concentrated wiring liquid, add 0.1mol/L sodium hydroxide solution, adjust pH to 6.5～7.0, to above-mentioned
Add the shitosan of cumulative volume 0.2%～0.6% mass volume ratio, stirring in solution, mix, stand 30～50min,
With 0.8 μm of filter membrane filtration, add the activated carbon of cumulative volume 0.1%～0.3% mass volume ratio, adsorption bleaching, use
0.45 μm of filter membrane filtration, collects filtrate, adds sterilized water for injection to recipe quantity, it is qualified to test through middle product examine,
?；
3. embedding：Intermediate is filtered with 0.22 μm of filter after the assay was approved, checks visible foreign matters, antibacterial endogenous toxin
After element is qualified, upper streamline carries out fill, and the nitrogen that pouring process need to be filled with purity 99.99% makes injection in tank
Oxygen content in water is less than 0.01%, seals after inflated with nitrogen；
4. sterilize：Canned peace is cutd open semi-finished product and sends into steam sterilization pan sterilizing, 121 DEG C of sterilizing 15min, sterilizing
Program：10 DEG C/min, rise to 121 DEG C, keep 15min at 121 DEG C；3～5 DEG C/min of compressed air air blast lowers the temperature,
8～12min is cooled to 70～80 DEG C, and 2～3 DEG C/min of cooling water lowers the temperature, and 15～18min is cooled to 30 DEG C, has sterilized
Become, by rated condition leak detection；
5. check：After sterilizing, sample checks visible foreign matters, the sample checking qualified is packed, full inspection, warehouse-in.
In order to be better understood from the present invention, invention medicine beneficial is expanded on further below by way of stability test of the present invention
Effect, rather than limitation of the present invention.
Experiment one：A kind of few levo-oxiracetam injection stability experiment of impurity of the present invention
Experiment material：
Levo-oxiracetam injection sample：It is obtained for embodiment 1
Acceleration study method：The levo-oxiracetam injection that embodiment 1 is obtained presses listing packaging, puts Acceleration study case
In, certain time samples, and investigation project is tested.
Acceleration study temperature：40±2℃
Humidity：RH75% ± 5%
The investigation time：0th, 1,2,3, June
Inspection target：Character, visible foreign matters, clarity, particulate matter, pH, relevant material, content, aseptic inspection
Look into
Accelerated test stability record：
Acceleration study result shows：Accelerate June sample suitable with 0 month sample items Testing index quality, show that this product adds
In speed experiment June, quality keeps stable, and this product stability is preferable.
Long-term experiment method：The levo-oxiracetam injection that embodiment 1 is obtained presses listing packaging, puts the case that keeps sample for a long time
In, certain time samples, and investigation project is tested.
Acceleration study temperature：25±2℃
Humidity：RH60% ± 10%
The investigation time：0th, 3,6,9,12,18 months
Inspection target：Character, visible foreign matters, clarity, particulate matter, pH, relevant material, content, aseptic inspection
Look into
Long term test stability record：
Long term test shows：18 months character of this product long term test, visible foreign matters, clarity, particulate matter, pH,
Relevant material, content and sterility test indices all no significant changes, all meet each of production quality standard draft
Item relevant regulations.18 months steady qualities of this product long term test, therefore minimum 18 months of this product effect duration, long term test is still
During continuing to investigate.
Experiment two：The impact that a kind of few levo-oxiracetam injection sterilization process of impurity of the present invention increases to impurity
1. experiment material：
Levo-oxiracetam injection sample：Prepare by embodiment 1.
Levo-oxiracetam injection control sample 1：For lacking the sample of vitamin C and ethylenediaminetetraacetic acid, its preparation
Technique is with embodiment 1.
Levo-oxiracetam injection control sample 2：For the prescription of embodiment 1, sterilising temp is 115 DEG C, during sterilizing
Between be 32 minutes, obtained product.
2. experimental technique：In embodiment 1 preparation process, sample afterwards before sterilization respectively, detect that it, about material, is investigated
To the impact about material before and after sterilizing.Meanwhile, take the prescription lacking vitamin C and ethylenediaminetetraacetic acid as comparison at
Side, by the preparation method preparation of embodiment 1, equally sampling detects that it, about material, investigates sterilization process afterwards before sterilization
To the impact about material.Meanwhile, the prescription of Example 1, is changed to 115 DEG C according to sterilising temp, and sterilization time is
Prepare within 32 minutes sample, sampling detects relevant material afterwards before sterilization respectively, investigate sterilization process to the impact about material.
3. experimental result see table：
4. experiment conclusion：The prescription of embodiment 1, the specific sterilization process of cooperation, relevant material increase only 0.03%, bright
Show better than other two control samples.
Experiment three：A kind of few levo-oxiracetam injection clarity comparative experimental research of impurity of the present invention
1. experiment material：
Levo-oxiracetam injection sample：It is obtained for embodiment 1
Levo-oxiracetam injection control sample：Monofactorial respectively change pH adjusting agent, pH value and be not added with shitosan
After factor, the levo-oxiracetam sample of the injection being obtained by embodiment 1 is as control sample.
2. experimental technique：Test according to version pharmacopeia annex IXB clarity inspection technique in 2010.
3. experimental result see table：
| Sample survey | Result |
| Embodiment 1 sample | ≤ 0.5 standard turbidity solution |
| Control sample 1：Using sodium bicarbonate as sample obtained by pH adjusting agent | 0.5 standard turbidity solution≤clarity≤1.0 standard turbidity solution |
| Control sample 2：PH regulator is to 7.5～8.0 | 0.5 standard turbidity solution≤clarity≤1.0 standard turbidity solution |
| Control sample 3：PH regulator is to 6.0～6.5 | 0.5 standard turbidity solution≤clarity≤1.0 standard turbidity solution |
| Control sample 4：Not plus treatment with chitosan sample | ≥1.0 |
4. experiment conclusion：Sample clarity obtained by embodiment 1 is better than each control sample.
Embodiment 2
A kind of few levo-oxiracetam injection of impurity, is obtained according to the following steps：
Preparation process：Preparation technology according to embodiment 1 is obtained.
By the test method of embodiment 1, carry out stability test investigation respectively, impact that sterilization process increases examination to impurity
Test and clarity contrast test, stability test result shows to accelerate June sample quality stable, long-term 18 months quality
Stable, therefore minimum 18 months of this product effect duration.Sterilization process shows embodiment 2 to the impact result of the test that impurity increases
Prescription, coordinate specific sterilization process, relevant material increase is substantially better than its control sample.Clarity contrast test is tied
Fruit shows that the sample clarity that embodiment 2 is produced is less than No. 0.5 standard turbidity solution, and this product clarity is good.
Embodiment 3
A kind of few levo-oxiracetam injection of impurity, is obtained according to the following steps：
Preparation process：Preparation technology according to embodiment 1 is obtained.
By the test method of embodiment 1, carry out stability test investigation respectively, impact that sterilization process increases examination to impurity
Test and clarity contrast test, stability test result shows to accelerate June sample quality stable, long-term 18 months quality
Stable, therefore minimum 18 months of this product effect duration.Sterilization process shows embodiment 3 to the impact result of the test that impurity increases
Prescription, coordinate specific sterilization process, relevant material increase is substantially better than its control sample.Clarity contrast test is tied
Fruit shows that the sample clarity that embodiment 3 is produced is less than No. 0.5 standard turbidity solution, and this product clarity is good.
Embodiment 4-6：A kind of levo-oxiracetam injection, is prepared by the supplementary material of following weight, preparation method
With embodiment 1：
| Embodiment | Levo-oxiracetam | Glycerol | Glycine | Vitamin C | Ethylenediaminetetraacetic acid | Sterilized water for injection |
| 4 | 100g | 26g | 24g | 6g | 5g | Add water to 1000ml |
| 5 | 100g | 27g | 25g | 5g | 6g | Add water to 1000ml |
| 6 | 100g | 28g | 26g | 7g | 5g | Add water to 1000ml |
By the test method of embodiment 1, carry out stability test investigation respectively, impact that sterilization process increases examination to impurity
Test and clarity contrast test, embodiment 4,5,6 stability test result shows to accelerate June sample quality stable, long
18 months phases steady quality, therefore minimum 18 months of this product effect duration.The impact result of the test that sterilization process increases to impurity
Show the prescription of embodiment 4,5,6, coordinate specific sterilization process, relevant material increase is substantially better than its control sample.
Clarity comparative test result shows that the sample clarity that embodiment 4,5,6 is produced is less than No. 0.5 standard turbidity solution,
This product clarity is good.
Claims (3)
1. a kind of few levo-oxiracetam injection of impurity it is characterised in that：It is with levo-oxiracetam, glycerol, glycine, vitamin C, ethylenediaminetetraacetic acid as supplementary material, by dense join, dilute join, embedding, sterilizing, test package step be obtained；The levo-oxiracetam 55% ~ 75% that the consumption of wherein said supplementary material is weight percentage, glycerol 10% ~ 30%, glycine 8% ~ 25%, vitamin C 3% ~ 8%, ethylenediaminetetraacetic acid 2% ~ 5%；Described dense step of joining is to add in material-compound tank by supplementary material, adds sterilized water for injection, stirring, dissolving immediately, obtains concentrated wiring liquid；Described dilute step of joining is to take concentrated wiring liquid, adds 0.1mol/L ~ 0.5mol/L sodium hydroxide solution, adjusts pH to 6.5 ~ 7.0, adds cumulative volume 0.2% ~ 0.6% in above-mentioned solution（g/ml）Shitosan, stirring, mix, stand 30 ~ 50min, with the filtration of 0.8 μm of filter membrane, add cumulative volume 0.1% ~ 0.3%（g/ml）Activated carbon, adsorption bleaching, with the filtration of 0.45 μm of filter membrane, collect filtrate, add sterilized water for injection to recipe quantity, it is qualified to test through middle product examine, you can；Described sterilization steps are canned peace to be cutd open semi-finished product send into steam sterilization pan sterilizing, 121 DEG C of sterilizing 15min, sterilizing program：10 DEG C/min, rise to 121 DEG C, keep 15min at 121 DEG C；3 ~ 5 DEG C/min of compressed air air blast lowers the temperature, and 8 ~ 12min is cooled to 70 ~ 80 DEG C, and 2 ~ 3 DEG C/min of cooling water lowers the temperature, and 15 ~ 18min is cooled to 30 DEG C, and sterilizing completes.
2. levo-oxiracetam injection as claimed in claim 1 is it is characterised in that it is to be obtained by the supplementary material of following significant percentage：Levo-oxiracetam 60% ~ 66%, glycerol 15% ~ 20%, glycine 12% ~ 18%, vitamin C 3% ~ 5%, ethylenediaminetetraacetic acid 2% ~ 4%, above-mentioned supplementary material is added in material-compound tank, adds the sterilized water for injection of 1/3 recipe quantity immediately, stirring, dissolving, obtain concentrated wiring liquid；Take concentrated wiring liquid, add 0.1mol/L sodium hydroxide solution, adjust pH to 6.5 ~ 7.0, add cumulative volume 0.2% ~ 0.6% in above-mentioned solution（g/ml）Shitosan, stirring, mix, stand 30 ~ 50min, with the filtration of 0.8 μm of filter membrane, add cumulative volume 0.1% ~ 0.3%（g/ml）Activated carbon, adsorption bleaching, with the filtration of 0.45 μm of filter membrane, collect filtrate, add sterilized water for injection to recipe quantity, it is qualified to test through middle product examine, you can；Canned peace is cutd open semi-finished product and sends into steam sterilization pan sterilizing, 121 DEG C of sterilizing 15min, sterilizing program：10 DEG C/min, rise to 121 DEG C, keep 15min at 121 DEG C；3 ~ 5 DEG C/min of compressed air air blast lowers the temperature, and 8 ~ 12min is cooled to 70 ~ 80 DEG C, and 2 ~ 3 DEG C/min of cooling water lowers the temperature, and 15 ~ 18min is cooled to 30 DEG C, and sterilizing completes.
3. the preparation method of levo-oxiracetam injection as claimed in claim 1 or 2 is it is characterised in that it is obtained as follows：
A. dense join：Supplementary material is added in material-compound tank, adds the sterilized water for injection of 1/3 recipe quantity immediately, stirring, dissolving, obtain concentrated wiring liquid；
B. dilute join：Take concentrated wiring liquid, add 0.1mol/L sodium hydroxide solution, adjust pH to 6.5 ~ 7.0, add the shitosan of cumulative volume 0.2% ~ 0.6% mass volume ratio, stirring in above-mentioned solution, mix, standing 30 ~ 50min, with 0.8 μm of filter membrane filtration, adds the activated carbon of cumulative volume 0.1% ~ 0.3% mass volume ratio, adsorption bleaching, with 0.45 μm of filter membrane filtration, collect filtrate, add sterilized water for injection to recipe quantity, it is qualified to test through middle product examine, you can；
C. embedding：Intermediate is filtered with 0.22 μm of filter after the assay was approved, check visible foreign matters, after bacterial endotoxin is qualified, upper streamline carries out fill, the nitrogen that pouring process need to be filled with purity 99.99% makes the oxygen content in water for injection in tank be less than 0.01%, seals after inflated with nitrogen；
D. sterilize：Canned peace is cutd open semi-finished product and sends into steam sterilization pan sterilizing, 121 DEG C of sterilizing 15min, sterilizing program：10 DEG C/min, rise to 121 DEG C, keep 15min at 121 DEG C；3 ~ 5 DEG C/min of compressed air air blast lowers the temperature, and 8 ~ 12min is cooled to 70 ~ 80 DEG C, and 2 ~ 3 DEG C/min of cooling water lowers the temperature, and 15 ~ 18min is cooled to 30 DEG C, and sterilizing completes, by rated condition leak detection；
E. check：After sterilizing, sample checks visible foreign matters, the sample checking qualified is packed, full inspection, warehouse-in.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510511617.4A CN106420598A (en) | 2015-08-19 | 2015-08-19 | Low-impurity levorotatory oxiracetam injection and preparation method thereof |
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| CN201510511617.4A CN106420598A (en) | 2015-08-19 | 2015-08-19 | Low-impurity levorotatory oxiracetam injection and preparation method thereof |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101766597A (en) * | 2008-12-31 | 2010-07-07 | 北京利乐生制药科技有限公司 | Injection preparation with levo-oxiracetam as active component |
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2015
- 2015-08-19 CN CN201510511617.4A patent/CN106420598A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101766597A (en) * | 2008-12-31 | 2010-07-07 | 北京利乐生制药科技有限公司 | Injection preparation with levo-oxiracetam as active component |
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