CN1398635A - Piracetam medicine composition with function of promoting thinking and memory and its prepn - Google Patents

Piracetam medicine composition with function of promoting thinking and memory and its prepn Download PDF

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Publication number
CN1398635A
CN1398635A CN 02123539 CN02123539A CN1398635A CN 1398635 A CN1398635 A CN 1398635A CN 02123539 CN02123539 CN 02123539 CN 02123539 A CN02123539 A CN 02123539A CN 1398635 A CN1398635 A CN 1398635A
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China
Prior art keywords
piracetam
function
derivant
injection
thinking
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CN 02123539
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Chinese (zh)
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CN1186094C (en
Inventor
蔡海德
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Hunan Kangyuan Pharmaceutical Co Ltd
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Individual
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  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The present invention is Piractetam medicine composition with the function of promoting thinking and memory and its preparation process. The composition consists of Piracetam and reductive glutathione in the weight ratio of 10-100 to 6-12 as well as pharmaceutically acceptable supplementary material. It has high curative effect, high stability, less adverse reaction and high safety.

Description

Has piracetam pharmaceutical composition of function of promoting thinking and memory and preparation method thereof
Technical field
The present invention relates to a kind of medicine, particularly relate to a kind of piracetam pharmaceutical composition and preparation method thereof with function of promoting thinking and memory with function of promoting thinking and memory.
Technical background
There are many deficiencies in existing piracetam medicine aspect component, dosage form and the production technology, the defective of the poor stability when making the piracetam medicine exist weak curative effect, not high, the untoward reaction side effect of stability to reach more greatly the hepatic and kidney function obstacle person used.
Summary of the invention
The objective of the invention is to overcome the above-mentioned shortcoming of prior art, a kind of good effect, stability is strong, the untoward reaction side effect is little and safety the is good piracetam pharmaceutical composition with function of promoting thinking and memory are provided; The present invention also aims to provide the preparation method of this invention medicine.
For achieving the above object, the piracetam pharmaceutical composition of the present invention with function of promoting thinking and memory contains following materials of weight proportions component:
Piracetam 10-100
Reduced glutathion 6-12
Other auxiliary material of acceptable on the pharmaceutics.
As optimization, its auxiliary material comprises alpha-cyclodextrin and derivant, beta-schardinger dextrin-and derivant thereof.
As optimization, its auxiliary material consumption be:
Alpha-cyclodextrin and derivant thereof are 1-5 times of the smooth molal quantity of pyrrole hila
Beta-schardinger dextrin-and derivant thereof are 1-5 times of the smooth molal quantity of pyrrole hila
As optimization, described alpha-cyclodextrin and derivant thereof and beta-schardinger dextrin-and derivant thereof can replace with gamma-cyclodextrin and derivant thereof.
As optimization, its auxiliary material also comprises sodium chloride for injection.
As optimization, the consumption of sodium chloride for injection is to account for 0.9% of solution total amount.
As optimization, its dosage form is small-volume injection, bulk capacity injection and lyophilized injectable powder, the water content of lyophilized injectable powder≤2%.
The piracetam preparation of drug combination method that the present invention has function of promoting thinking and memory comprises the following steps:
(1) piracetam is dissolved with water for injection, make saturated solution, under agitation be added drop-wise to again in the cyclodextrin aqueous solution, stir under the last lucifuge room temperature and further make piracetam cyclodextrin saturated solution.
(2) add sodium chloride solution and the reduced glutathion of handling through decolouring, stir, further this solution is filtered again.
As optimization, the mixing time of described (1) step is 3-5 hour; The filtration branch two-stage of described step (2) three times: the first order is the filter membrane of 0.45 μ m, and the second level is the filter membrane of 0.22 μ m, and be the membrane filtration with water for injection dilution back reuse 0.22 μ m the partial second time.
As optimization, the preparation method of lyophilized injectable powder also comprises carries out lyophilization to water content≤2% with above-mentioned medicinal liquid.
After adopting technique scheme, the indication of piracetam pharmaceutical composition of the present invention is:
(1) promotes reviving of coma patient after the neurosurgery;
(2) treatment oligophrenia.
Medicine of the present invention is compared with existing piracetam medicine, has following outstanding advantage:
(1) the crude drug inner quality standard is higher than national standard, has guaranteed the quality of the pharmaceutical preparations, has improved curative effect.
(2) by production technology of the present invention, make alpha-cyclodextrin and derivant thereof comprise the five-membered ring part of piracetam molecule, beta-schardinger dextrin-and derivant thereof comprise the amide groups part of piracetam molecule.Alpha-cyclodextrin and derivant thereof and β-Cyclodextrin and derivant thereof are worked in coordination with and are comprised the five no loop sections that the piracetam effect is better than only comprising with alpha-cyclodextrin and derivant thereof the piracetam molecule, the latter makes its amide groups exposed, is subject to light, heat, acid, alkali or other factor effects and decomposes; Also be better than only comprising with beta-schardinger dextrin-and derivant thereof the amide groups part of piracetam molecule, the latter allows heterocycle and carbonyl expose, and medicine easily produces qualitative change.Like this because above-mentioned two kinds of synergism that comprise make the piracetam molecule keep stable when pharmaceutical preparation manufacturing, storage, use.
(3) owing to improved crude drug purity, guaranteed that piracetam is high pure degree crude drug, adopted the collaborative simultaneously piracetam molecule that comprises of alpha-cyclodextrin and beta-schardinger dextrin-again, make the piracetam medicine in making, store, using, keep high stability, thereby make drug dose keep high stability, reduced impurity of the drug content like this, thereby reduce untoward reaction of medicine own and side effect, strengthened medicine and in human body, discharged stability, created conditions for keeping medicine to stablize curative effect.
(4), make medicine slighter, because glutathion protects the liver, kidney reaches antiradiation drug toxic action in Liver and kidney to human liver, the slight toxic action of kidney in the adding of reductive glutathione.
(4) the present invention makes the piracetam medicine have better social benefit for people provide more effective, safer piracetam formulation.
Therefore, it has the advantage that curative effect of medication is good, stability is strong, the untoward reaction side effect is little and safety is good.
Clinical efficacy
(1) piracetam compositions of the present invention is to neurosurgery coma patient consciousness recovery effect observation of curative effect
The treatment back is average before the treatment improves
GCS scoring GCS scoring mark
Piracetam composition injection 6.7 ± 2.1 13.6 ± 2.2 6.9
The smooth one pack system injection 7.9 in west, pyrrole position ± 3.5 11.9 ± 4.7 4.0
(2) piracetam combination treatment oligophrenia observation of curative effect of the present invention
The effective number total effective rate of case sum produce effects number
Piracetam composition injection 30 5 (18%) 17 (56%) 74%
Piracetam one pack system injection 30 4 (13%) 14 (48%) 61%
(3) side effect that causes of invention piracetam compositions is observed
The uncomfortable number side reaction of the nauseating number vomiting of case sum number liver rate
Piracetam composition injection 30 1 (3.5%) 1 (3.5%) 1 (2.9%) 9.9%
Piracetam one pack system injection 30 2 (6.5%) 2 (6.5%) 2 (6.7%) 20.8%
The specific embodiment
Embodiment one
1, the small-volume injection compositions is divided and content
Piracetam 1000g
Reduced glutathion 600g
Sodium chloride (injection is used) 45g
Water for injection adds to 5000ml
1000 small-volume injections of packing
2, small-volume injection preparation method
(1) piracetam 1000g is dissolved in the 1000ml water for injection, adds the injection water while stirring until just dissolving is complete;
(2) dissolve good alpha-cyclodextrin, beta-schardinger dextrin-with 1000ml, while stirring the piracetam saturated solution is added in above-mentioned alpha-cyclodextrin, the beta-schardinger dextrin-solution, after adding, restir 3.5 hours;
(3) add and to have sterilized and to have stirred through 15% sodium chloride solution of activated carbon decolorizing;
(4) medicinal liquid adds the sterilized water for injection standardize solution behind 0.45 μ m and 0.22 μ m two-stage membrane filtration, surveys pyrrole and draws west load content qualified, carries out fill, with 1000 of peace berkelium packing, seals simultaneously;
(5) through 121 ℃/25min steam sterilization, lamp inspection, up-to-standard back packing, warehouse-in.
Embodiment two
1, amount injection composition component and content
Piracetam 10000g
Reduced glutathion 6000g
Sodium chloride (injection is used) 900g
Water for injection adds to 10000ml
1000 bottles of packing
2, high capacity injection preparation method
(1)~(5) step is with embodiment one small-volume injection preparation method, and difference is the adjustment of fill amount and ampule sealing is changed into the pressure butyl rubber plug and bundle is moulded aluminium lid.
Embodiment three
1, dry powder injection composition component and content
Piracetam 1000g
Reduced glutathion 600g
Sodium chloride (injection is used) 90g
Water for injection adds to 2000ml
1000 of packing
2, lyophilized injectable powder preparation method
(1)~(5) step is with embodiment one small-volume injection preparation method, and difference is that ampoule bottle changes 7ml cillin bottle packaging solution into every fill 2ml of fill amount, and ampule sealing changes false add plug butyl rubber plug into.
(6) in the freeze dryer drying baker in-48 ℃~30 ℃, vacuum pressure 1Pa~15Pa, lyophilization is to moisture≤2%, tamponade, Zha Gai, the qualified warehouse-in of detection.
The proportioning raw materials of the foregoing description can also be:
Piracetam 10g, 50g, 100g
Reduced glutathion 6g, 9g, 12g
Alpha-cyclodextrin and derivant thereof are 1-5 times of the smooth molal quantity of pyrrole hila
Beta-schardinger dextrin-and derivant thereof are 1-5 times of the smooth molal quantity of pyrrole hila
Sodium chloride accounts for 0.9% of solution total amount.

Claims (10)

1, a kind of piracetam pharmaceutical composition with function of promoting thinking and memory is characterized in that it contains following materials of weight proportions component:
Piracetam 10-100
Reduced glutathion 6-12
Other auxiliary material of acceptable on the pharmaceutics.
2, the piracetam pharmaceutical composition with function of promoting thinking and memory according to claim 1 is characterized in that its auxiliary material comprises alpha-cyclodextrin and derivant, beta-schardinger dextrin-and derivant thereof.
3, the piracetam pharmaceutical composition with function of promoting thinking and memory according to claim 2, it is characterized in that its auxiliary material consumption be:
Alpha-cyclodextrin and derivant thereof are 1-5 times of the smooth molal quantity of pyrrole hila
Beta-schardinger dextrin-and derivant thereof are 1-5 times of the smooth molal quantity of pyrrole hila
4, the piracetam pharmaceutical composition with function of promoting thinking and memory according to claim 1 and 2 is characterized in that described alpha-cyclodextrin and derivant thereof and beta-schardinger dextrin-and derivant thereof can replace with gamma-cyclodextrin and derivant thereof.
5, the piracetam pharmaceutical composition with function of promoting thinking and memory according to claim 4 is characterized in that its auxiliary material also comprises sodium chloride for injection.
6, the piracetam pharmaceutical composition with function of promoting thinking and memory according to claim 5, the consumption that it is characterized in that sodium chloride for injection is to account for 0.9% of solution total amount.
7, according to claim 1,2 or 3 described piracetam pharmaceutical compositions with function of promoting thinking and memory, its dosage form is small-volume injection, bulk capacity injection and lyophilized injectable powder, the water content of lyophilized injectable powder≤2%.
8, the present invention has the piracetam preparation of drug combination method of function of promoting thinking and memory, it is characterized in that comprising the following steps:
(1) piracetam is dissolved with water for injection, make saturated solution, under agitation be added drop-wise to again in the cyclodextrin aqueous solution, stir under the last lucifuge room temperature and further make piracetam cyclodextrin saturated solution.
(2) add sodium chloride solution and the reduced glutathion of handling through decolouring, stir, further this solution is filtered again.
9, the piracetam preparation of drug combination method with function of promoting thinking and memory according to claim 8 is characterized in that the mixing time of described (1) step is 3-5 hour; The filtration branch two-stage of described step (2) three times: the first order is the filter membrane of 0.45 μ m, and the second level is the filter membrane of 0.22 μ m, and be the membrane filtration with water for injection dilution back reuse 0.22 μ m the partial second time.
10, the piracetam preparation of drug combination method with function of promoting thinking and memory according to claim 9, the preparation method that it is characterized in that lyophilized injectable powder also comprises carries out lyophilization to water content≤2% with above-mentioned medicinal liquid.
CN 02123539 2002-07-01 2002-07-01 Piracetam medicine composition with function of promoting thinking and memory and its prepn Expired - Fee Related CN1186094C (en)

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Application Number Priority Date Filing Date Title
CN 02123539 CN1186094C (en) 2002-07-01 2002-07-01 Piracetam medicine composition with function of promoting thinking and memory and its prepn

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CN1398635A true CN1398635A (en) 2003-02-26
CN1186094C CN1186094C (en) 2005-01-26

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Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101856493A (en) * 2010-06-09 2010-10-13 白求恩医科大学制药厂二分厂 Compound piracetam brain protein hydrolysate tablet and preparation method thereof
CN102008430A (en) * 2010-12-17 2011-04-13 张家港市华菱化工机械有限公司 Piracetam-containing oral liquid
CN104013585A (en) * 2014-06-18 2014-09-03 海南通用康力制药有限公司 Piracetam freeze-dried powder injection for injection and preparation method thereof
CN104083328B (en) * 2009-01-29 2017-04-12 Ucb生物制药私人有限公司 Pharmaceutical Compositions Comprising 2-Oxo-1-Pyrrolidine Derivatives
CN113230216A (en) * 2021-05-26 2021-08-10 海南通用康力制药有限公司 Piracetam freeze-dried powder injection for injection and preparation method thereof

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104083328B (en) * 2009-01-29 2017-04-12 Ucb生物制药私人有限公司 Pharmaceutical Compositions Comprising 2-Oxo-1-Pyrrolidine Derivatives
CN101856493A (en) * 2010-06-09 2010-10-13 白求恩医科大学制药厂二分厂 Compound piracetam brain protein hydrolysate tablet and preparation method thereof
CN102008430A (en) * 2010-12-17 2011-04-13 张家港市华菱化工机械有限公司 Piracetam-containing oral liquid
CN104013585A (en) * 2014-06-18 2014-09-03 海南通用康力制药有限公司 Piracetam freeze-dried powder injection for injection and preparation method thereof
CN113230216A (en) * 2021-05-26 2021-08-10 海南通用康力制药有限公司 Piracetam freeze-dried powder injection for injection and preparation method thereof
CN113230216B (en) * 2021-05-26 2023-04-07 海南通用康力制药有限公司 Piracetam freeze-dried powder injection for injection and preparation method thereof

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Publication number Publication date
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Assignee: Hunan Kangyuan Pharmacy Co., Ltd.

Assignor: Cai Dehai

Contract record no.: 2011430000208

Denomination of invention: Piracetam medicine composition with function of promoting thinking and memory and its prepn

Granted publication date: 20050126

License type: Exclusive License

Open date: 20030226

Record date: 20111008

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Owner name: HUNAN KANGYUAN PHARMACY CO., LTD.

Free format text: FORMER OWNER: CAI HAIDE

Effective date: 20120306

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Free format text: CORRECT: ADDRESS; FROM: 330009 NANCHANG, JIANGXI PROVINCE TO: 410329 CHANGSHA, HUNAN PROVINCE

TR01 Transfer of patent right

Effective date of registration: 20120306

Address after: 410329 No. 36, link road, A District, Liuyang biomedical industry park, Hunan

Patentee after: Hunan Kangyuan Pharmacy Co., Ltd.

Address before: 330009, room 11, 201 Bai Yi lane, Xiangshan South Road, Nanchang, Jiangxi

Patentee before: Cai Haide

CF01 Termination of patent right due to non-payment of annual fee

Granted publication date: 20050126

Termination date: 20140701

EXPY Termination of patent right or utility model