CN107260659A - A kind of injection containing levetiracetam medicinal composition and preparation method thereof - Google Patents
A kind of injection containing levetiracetam medicinal composition and preparation method thereof Download PDFInfo
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K9/00—Medicinal preparations characterised by special physical form
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
- A61K31/4015—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil having oxo groups directly attached to the heterocyclic ring, e.g. piracetam, ethosuximide
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
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- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
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Abstract
This application discloses injection containing levetiracetam medicinal composition of a kind of stabilization and preparation method thereof.Said preparation contains Levetiracetam and other pharmaceutically acceptable auxiliary materials, using special preparation method, can effectively improve the stability of Levetiracetam injection, the treatment for epilepsy.
Description
Technical field
The application belongs to technical field of medicine, and in particular to a kind of injection containing levetiracetam medicinal composition
Agent and preparation method thereof.
Background technology
Global annual about 2,000,000 epilepsies of kainogenesis.The incidence of disease of epilepsy is about annual every ten wherein in developed country
Wan Renzhong has 50 people.Equally, the incidence of disease of epilepsy also significantly increases in developing country, is to have 100 people in every 100,000 people.
China there are about 9,000,000 epileptics, wherein 6,000,000 patients still have breaking-out every year, and 400,000 neopathies can all occurs every year
Example.The mortality prediction of epileptic is about two to four times of general population(Death may and underlying diseases, commit suiside, accident
Or Status Epilepticus is relevant).According to international anti-epileptic alliance(ILAE)Investigation, the death rate of the young man with epilepsy is just
4 times of normal young man.
Levetiracetam(Levetiracetam)Chemical entitled (-)-(S)-[α]-ethyl -2- oxo -1- pyrroles
Alkyl acetamide is coughed up, is a kind of new combination SV2A(Synaptophysin 2A)Isotype cholinergic agonist anti-epileptic
Medicine, different from the structure of other antiepileptics, its definite anti-epileptic mechanism is still failed to understand, but is acted on Antiepileptic drugs
It is different in ion channel or excitability, inhibitory neurotransmitter system.Levetiracetam almost possesses preferable antiepileptic
All pharmaco-kinetic properties of thing:Bioavilability height, linearity curve, low protein binding rate, without liver enzyme inducing action.Many animals
Model shows that Levetiracetam has anti-epileptic characteristic.
A kind of new antiepileptic drugs that Levetiracetam is researched and developed by Belgian UCB. S.A. (BE) Bruxelles Belgium, trade name KEPPRA®, in
Levetiracetam tablet in 1999 obtains FDA approvals, and listing formulation includes injection, tablet, oral administration solution, sustained release tablets.In U.S.
State, the product is represented as complementary oral medication, the part breaking-out of adult and children for treating 1 monthly age and greater age
Property epilepsy, wherein with epilepsy, myoclonic seizure and age in adult are teenager's myoclonic of 12 years old and the above
Epilepsy(JME)Broken out with the primary generalized tonic-clonic of 6 years old and above adult and Childhood idiopathic systemic epilepsy.
Impurity C is one of synthesis material of Levetiracetam in EP.Control of Impurities is the important component of drug quality,
Thus, when preparing parenteral solution, the impurity is removed to greatest extent, is conducive to improving the product quality of Levetiracetam injection
And security, it is of great importance to improving patient clinical drug safety.
The content of the invention
The purpose of the application is to provide that a kind of technique is simple, cost is low, the preferable Levetiracetam injection of stability
And impurity C is one of synthesis material of Levetiracetam in preparation method EP.The Levetiracetam quality standard of multinational pharmacopeia is equal
It is limited the quantity and is controlled, illustrates that impurity C can influence the quality of Levetiracetam, so as to influence the matter of Levetiracetam injection
Amount and security.Therefore the application uses special preparation technology, i.e., PAMA is added in preparation process, due to
Impurity C is in electropositivity in the solution, and the strong suction-operated using PAMA to cation can be removed effectively
The impurity C that bulk drug in injection is brought into;It is several in the Levetiracetam injection finally given not contain impurity C.
Injection containing levetiracetam medicinal composition provided herein, including by Levetiracetam, acidity
Compound, alkali compounds, the levetiracetam medicinal composition and water for injection of osmotic pressure regulator composition.Levetiracetam
The concentration of Levetiracetam is 90 ~ 110mg/mL in parenteral solution;Acid compound is one kind in acetic acid, citric acid, phosphate
Or it is several;Alkali compounds is the one or more in sodium acetate, sodium hydroxide, potassium hydroxide, sodium citrate, phosphate;Its
PH adjusting agent is acid compound solution, or alkaline compound solution, such as acetum, citric acid solution, phosphate solution, vinegar
Acid sodium solution, sodium hydroxide solution, potassium hydroxide solution, sodium citrate solution;Osmotic pressure regulator be sodium chloride, glucose,
One or more in mannitol.
Injection containing levetiracetam medicinal composition provided herein, wherein including:Levetiracetam 90 ~
110mg/mL, 0.5 ~ 6mg/mL of acid compound, 0.5 ~ 6mg/mL of alkali compounds, 5 ~ 150mg/mL of osmotic pressure regulator and note
Penetrate and use water;The pH values of the parenteral solution are 4.5 ~ 6.5.
Injection containing levetiracetam medicinal composition provided herein, wherein including:Levetiracetam 95 ~
105mg/mL, 1 ~ 3mg/mL of acid compound, 1 ~ 3mg/mL of alkali compounds, 9 ~ 50mg/mL of osmotic pressure regulator and injection
Water;The pH value of the parenteral solution is 5.0 ~ 6.0.
The preparation method of levetiracetam injection provided herein is as follows:
(1)Weigh 60% note that recipe quantity acid compound, alkali compounds and osmotic pressure regulator add about recipe quantity
Penetrate with water, stirring dissolves it, and/or, the pH scopes that solution system is controlled with pH adjusting agent are 4.5 ~ 6.5, obtain solution I;
(2)The Levetiracetam for weighing recipe quantity is added in solution I, obtains solution II;
(3)0.5 ~ 3.0mg/mL activated carbons are added into solution II, 10 ~ 30min is stirred, 10-30min is stood, carried out at decarburization
Reason, obtains solution III;
(4a)Solution III is adsorbed using polyacrylamide resin, solution IV is obtained;
(5)Solution IV is mended and added to the full amount of water for injection, and/or, the pH values of solution are adjusted with pH adjusting agent to 4.5 ~ 6.5;
Then aseptic filtration is carried out to solution with ultrafiltration apparatus, filtrate is filled into vial, sealed, pressure sterilizing is produced.
The preparation method of levetiracetam injection provided herein, in addition to:
(4b)Polyacrylamide resin is added in solution III, stirring and/or shaking table vibrate 10 ~ 30min;And/or by polypropylene
Amide resin is packed into post, adds solution III and carries out adsorption treatment, obtains solution IV;
Preparation method according to claim 8-9, its polyacrylamide resin be PAMA resin, sun from
Sub- polyacrylamide resin, amphiprotic polyacrylamide resin, preferred anionic polyacrylamide resin.
Levetiracetam injection preparation method described herein, the filter plant aperture of its pre-filtering processing is 0.22
~0.45μm;Ultrafiltration apparatus aperture is 0.001 ~ 0.02 μm.
In levetiracetam injection preparation method described herein, by adding PAMA, utilize
Its suction-operated to electropositive impurity C is presented in water, removes the impurity C in Levetiracetam injection.
The levetiracetam injection that the application is provided, it is several not contain impurity C.
Embodiment
Following examples further describe beneficial effects of the present invention, and embodiment is only used for the purpose of illustration, and this is not limited
The scope of invention, while obvious change and modification that those of ordinary skill in the art are made according to the present invention are also contained in
Within the scope of the invention.
(One)The preparation of Levetiracetam injection
Embodiment 1
。
Note:PH adjusting agent is the acid compound and/or alkaline compound solution used in the present embodiment, specific consumption
Adjusted according to pH, therefore consumption is appropriate, the following examples are ibid.
Preparation technology
(1)Weigh 60% water for injection that recipe quantity potassium dihydrogen phosphate, dipotassium hydrogen phosphate and sodium chloride add about recipe quantity
In, stirring dissolves it, with 1mol/L dipotassium hydrogen phosphate solution adjust solution pH value to 6.5 solution I;
(2)The Levetiracetam for weighing recipe quantity is added in solution I, obtains solution II;
(3)2.5mg/mL activated carbons are added into solution II, 30min is stirred, 30min is stood, carbonization treatment is carried out, obtains solution
Ⅲ;
(4)0.05% PAMA is added, 10min is stirred, pre-filtering processing is carried out, obtains solution IV;
(5)Solution IV is mended and added to the full amount of water for injection, the pH values of solution are adjusted with 1mol/L dipotassium hydrogen phosphate to 6.5,
Then aseptic filtration is carried out to solution with ultrafiltration apparatus, filtrate is filled into vial, sealed, pressure sterilizing is produced.
Embodiment 2
。
Preparation technology
(1)Weigh recipe quantity glacial acetic acid, potassium hydroxide and sodium chloride to add in about 60% water for injection of recipe quantity, stirring
Dissolve it, with 1mol/L glacial acetic acid adjust solution pH value to 4.5 solution I;
(2)The Levetiracetam for weighing recipe quantity is added in solution I, obtains solution II;
(3)0.5mg/mL activated carbons are added into solution II, 10min is stirred, 20min is stood, carbonization treatment is carried out, obtains solution
Ⅲ;
(4)0.3% PAMA is added, 10min is stirred, pre-filtering processing is carried out, obtains solution IV;
(5)Solution IV is mended and added to the full amount of water for injection, the pH values of solution are adjusted with 1mol/L glacial acetic acid to 4.5, then
Aseptic filtration is carried out to solution with ultrafiltration apparatus, filtrate is filled into vial, sealed, pressure sterilizing is produced.
Embodiment 3
。
Preparation technology
(1)Weigh recipe quantity citric acid, sodium citrate and glucose to add in about 60% water for injection of recipe quantity, stirring
Dissolve it, with 1mol/L citric acid solution adjust solution pH value to 5.6 solution I;
(2)The Levetiracetam for weighing recipe quantity is added in solution I, obtains solution II;
(3)3.0mg/mL activated carbons are added into solution II, 20min is stirred, 30min is stood, carbonization treatment is carried out, obtains solution
Ⅲ;
(4)0.25% PAMA is added, shaking table vibration 20min carries out pre-filtering processing, obtains solution IV;
(5)Solution IV is mended and added to the full amount of water for injection, the pH values of solution are adjusted with 1mol/L citric acid solution to 5.0,
Then aseptic filtration is carried out to solution with ultrafiltration apparatus, filtrate is filled into vial, sealed, pressure sterilizing is produced.
Embodiment 4
。
Preparation technology
(1)Weigh 60% water for injection that recipe quantity dipotassium hydrogen phosphate, potassium dihydrogen phosphate, sodium chloride add about recipe quantity
In, stirring dissolves it, with 1mol/L dipotassium hydrogen phosphate solution adjust solution pH value to 5.8 solution I;
(2)The Levetiracetam for weighing recipe quantity is added in solution I, obtains solution II;
(3)2.0mg/mL activated carbons are added into solution II, 15min is stirred, 20min is stood, decarburization is carried out, obtains solution III;
(4)0.1% PAMA is added, shaking table vibration 15min carries out pre-filtering processing, obtains solution IV;
(5)Solution IV is mended and added to the full amount of water for injection, adjusted with 1mol/L potassium dihydrogen phosphate the pH values of solution to
5.5, aseptic filtration then is carried out to solution with ultrafiltration apparatus, filtrate is filled into vial, sealed, pressure sterilizing is produced.
Embodiment 5
。
Preparation technology
(1)Weigh recipe quantity glacial acetic acid, sodium acetate and mannitol to add in about 60% water for injection of recipe quantity, stirring makes
It dissolves, with 1mol/L sodium acetate adjust solution pH value to 5.6 solution I;
(2)The Levetiracetam for weighing recipe quantity is added in solution I, obtains solution II;
(3)1.0mg/mL activated carbons are added into solution II, 30min is stirred, 10min is stood, carbonization treatment is carried out, obtains solution
Ⅲ;
(4)0.2% PAMA is added, 1min is stirred, polyacrylamide resin is then packed into post, is added molten
Liquid III carries out adsorption treatment, carries out pre-filtering processing, obtains solution IV;
(5)Solution IV is mended and added to the full amount of water for injection, the pH values of solution are adjusted with 1mol/L sodium acetate solution to 5.8,
Then aseptic filtration is carried out to solution with ultrafiltration apparatus, filtrate is filled into vial, sealed, pressure sterilizing is produced.
Embodiment 6
。
Preparation technology
(1)Weigh recipe quantity glacial acetic acid, sodium hydroxide and sodium chloride to add in about 60% water for injection of recipe quantity, stirring
Dissolve it, with 1mol/L glacial acetic acid solution adjust solution pH value to 5.7 solution I;
(2)The Levetiracetam for weighing recipe quantity is added in solution I, obtains solution II;
(3)1.5mg/mL activated carbons are added into solution II, 15min is stirred, 30min is stood, carbonization treatment is carried out, obtains solution
Ⅲ;
(4)0.15% PAMA is added, 20min is stirred, pre-filtering processing is carried out, obtains solution IV;
(5)Solution IV is mended and added to the full amount of water for injection, the pH values of solution are adjusted with 1mol/L acetum to 5.5, so
Aseptic filtration is carried out to solution with ultrafiltration apparatus afterwards, filtrate is filled into vial, sealed, pressure sterilizing is produced.
Comparative example 1
。
Preparation technology
(1)Weigh recipe quantity glacial acetic acid, sodium hydroxide and sodium chloride to add in about 60% water for injection of recipe quantity, stirring
Dissolve it, with 1mol/L citric acid solution adjust solution pH value to 5.7 solution I;
(2)The Levetiracetam for weighing recipe quantity is added in solution I, obtains solution II;
(3)2.0mg/mL activated carbons are added into solution II, 30min is stirred, 30min is stood, carbonization treatment is carried out, obtains solution
Ⅲ;
(4)Solution III is mended and added to the full amount of water for injection, the pH values of solution are adjusted with 1mol/L sodium hydroxide solutions to 6.5,
Then with 0.22 μm of poly tetrafluoroethylene membrane filtration, filtrate is filled into vial, and sealing, pressure sterilizing is produced.
Comparative example 2
。
Preparation technology
(1)Weigh recipe quantity citric acid, sodium citrate and sodium chloride to add in about 60% water for injection of recipe quantity, stirring
Dissolve it, with 1mol/L citric acid solution adjust solution pH value to 5.7 solution I;
(2)The Levetiracetam for weighing recipe quantity is added in solution I, obtains solution II;
(3)2.0mg/mL activated carbons are added into solution II, 30min is stirred, 30min is stood, carbonization treatment is carried out;Add
0.01% PAMA, stirs 10min, carries out pre-filtering processing, obtains solution III;
(4)Solution III is mended and added to the full amount of water for injection, the pH values of solution are adjusted with 1mol/L glacial acetic acid to 7.0, Ran Houyong
0.22 μm of poly tetrafluoroethylene membrane filtration, filtrate is filled into vial, and sealing, pressure sterilizing is produced.
Comparative example 3
。
Preparation technology
(1)Weigh recipe quantity citric acid, sodium citrate and sodium chloride to add in about 60% water for injection of recipe quantity, stirring
Dissolve it, with 1mol/L citric acid solution adjust solution pH value to 5.7 solution I;
(2)The Levetiracetam for weighing recipe quantity is added in solution I, obtains solution II;
(3)2.0mg/mL activated carbons are added into solution II, 30min is stirred, 30min is stood, carbonization treatment is carried out;Add
0.4 % PAMAs, stir 20min, carry out pre-filtering processing, obtain solution III;
(4)Solution III is mended and added to the full amount of water for injection, the pH values of solution are adjusted with 1mol/L glacial acetic acid to 7.0, Ran Houyong
0.22 μm of poly tetrafluoroethylene membrane filtration, filtrate is filled into vial, and sealing, pressure sterilizing is produced.
(Two)Criteria of quality evaluation
Drug content and impurity C content in the parenteral solution prepared using USP standard test various embodiments above.
。
。
By comparative example 1-3 and the Levetiracetam content and impurity C content result of embodiment 1 ~ 6, preparing
The PAMA of 0.05 ~ 0.3% consumption is added in journey, the impurity C in injection can be effectively removed, while not
Influence the content of Levetiracetam;If the addition of PAMA is less than 0.05%, it can not reach and remove note completely
The impurity C penetrated in agent;If the addition of PAMA is higher than 0.3%, although can remove the impurity C in injection,
But the content to Levetiracetam generates significant impact.To sum up, the left side obtained using preparation method described herein
It is several in etiracetam parenteral solution not contain impurity C.
Embodiment described above is only the preferred embodiment to absolutely prove the present invention and being lifted, protection model of the invention
Enclose not limited to this.Equivalent substitute or conversion that those skilled in the art are made on the basis of the present invention, in the present invention
Protection domain within.Protection scope of the present invention is defined by claims.
Claims (9)
1. the injection containing levetiracetam medicinal composition, it includes levetiracetam medicinal composition and water for injection,
But its is several not to contain impurity C in EP, wherein the levetiracetam medicinal composition include Levetiracetam, acid compound,
Alkali compounds, osmotic pressure regulator.
2. with according to the injection described in claim 1, wherein the concentration of the Levetiracetam is 90 ~ 110mg/mL.
3. with according to the injection described in claim 1 or 2, wherein the acid compound is in acetic acid, citric acid, phosphate
One or more;The alkali compounds in sodium acetate, sodium hydroxide, potassium hydroxide, sodium citrate, phosphate one
Plant or several;One or more of the osmotic pressure regulator in sodium chloride, glucose, mannitol.
4. the parenteral solution according to claim 1-3 any claims, wherein 90 ~ 110mg/mL of Levetiracetam, acidity
0.5 ~ 6mg/mL of compound, 0.5 ~ 6mg/mL of alkali compounds, 5 ~ 150mg/mL of osmotic pressure regulator and water for injection;The injection
The pH value of liquid is 4.5 ~ 6.5.
5. the parenteral solution according to claim 1-4 any claims, wherein 95 ~ 105mg/mL of Levetiracetam, acidity
1 ~ 3mg/mL of compound, 1 ~ 3mg/mL of alkali compounds, 9 ~ 50mg/mL of osmotic pressure regulator and water for injection;The parenteral solution
PH value is 5.0 ~ 6.0.
6. the preparation method of the injection described in claim 1, it includes:
(1)Weigh 60% note that recipe quantity acid compound, alkali compounds and osmotic pressure regulator add about recipe quantity
Penetrate with water, stirring dissolves it, and/or, the pH scopes that solution system is controlled with pH adjusting agent are 4.5 ~ 6.5, obtain solution I;
(2)The Levetiracetam for weighing recipe quantity is added in solution I, obtains solution II;
(3)0.5 ~ 3.0mg/mL activated carbons are added into solution II, 10 ~ 30min is stirred, 10-30min is stood, carried out at decarburization
Reason, obtains solution III;
(4a)Solution III is adsorbed using polyacrylamide resin, solution IV is obtained;
(5)Solution IV is mended and added to the full amount of water for injection, and/or, the pH values of solution are adjusted with pH adjusting agent to 4.5 ~ 6.5;
Then aseptic filtration is carried out to solution with ultrafiltration apparatus, filtrate is filled into vial, sealed, pressure sterilizing produces the note
Penetrate agent.
7. preparation method according to claim 6, in addition to:
(4b)Polyacrylamide resin is added in solution III, stirring and/or shaking table vibrate 10 ~ 30min;And/or by polypropylene
Amide resin is packed into post, adds solution III and carries out adsorption treatment, obtains solution IV;
Preparation method according to claim 6-7, wherein polyacrylamide resin be selected from PAMA resin,
PAMC resin, amphiprotic polyacrylamide resin, preferred anionic polyacrylamide resin.
8. the preparation method according to claim 6-7, wherein the consumption of the PAMA be 0.05 ~
0.3%, preferably 0.1 ~ 0.2%.
9. the preparation method according to claim 6-8, wherein pH adjusting agent are acid compound solution, or alkali compounds
Solution, such as acetum, citric acid solution, phosphate solution, sodium acetate solution, sodium hydroxide solution, potassium hydroxide solution, lemon
Lemon acid sodium solution.
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Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101919811A (en) * | 2009-06-09 | 2010-12-22 | 北京博时安泰液体制剂科技有限公司 | Levetiracetam injection and preparation method thereof |
CN102525900A (en) * | 2012-01-19 | 2012-07-04 | 南京恒道医药科技有限公司 | Levetiracetam injection and preparation method thereof |
CN103432070A (en) * | 2013-09-13 | 2013-12-11 | 四川鼎诺泰宸科技有限公司 | Levetiracetam injection and preparation method thereof |
CN106344562A (en) * | 2016-11-01 | 2017-01-25 | 上海秀新臣邦医药科技有限公司 | Production method for levetiracetam injection and product prepared by production method |
-
2017
- 2017-05-19 CN CN201710356475.8A patent/CN107260659A/en active Pending
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN101919811A (en) * | 2009-06-09 | 2010-12-22 | 北京博时安泰液体制剂科技有限公司 | Levetiracetam injection and preparation method thereof |
CN102525900A (en) * | 2012-01-19 | 2012-07-04 | 南京恒道医药科技有限公司 | Levetiracetam injection and preparation method thereof |
CN103432070A (en) * | 2013-09-13 | 2013-12-11 | 四川鼎诺泰宸科技有限公司 | Levetiracetam injection and preparation method thereof |
CN106344562A (en) * | 2016-11-01 | 2017-01-25 | 上海秀新臣邦医药科技有限公司 | Production method for levetiracetam injection and product prepared by production method |
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Application publication date: 20171020 |