CN1390543A - Oxiracetam injection - Google Patents
Oxiracetam injection Download PDFInfo
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- CN1390543A CN1390543A CN 02114302 CN02114302A CN1390543A CN 1390543 A CN1390543 A CN 1390543A CN 02114302 CN02114302 CN 02114302 CN 02114302 A CN02114302 A CN 02114302A CN 1390543 A CN1390543 A CN 1390543A
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Abstract
An oxiracetam injection for the first aid of cerebral anoxia is prepared from oxiracetam (20-40 wt%), mannitol (5-45) and water for injection (25-65) through proportioning, adding part of water for injection, decolouring with activated carbon, stirring at 40-60 deg.C for 10-20 min, coarse filtering, adding rest of water for injection, stirring, fine filtering, loading in bottles and freeze drying. Its advantages are sure curative effect, and high stability.
Description
Technical field
The present invention relates to a kind of piracetam class nootropics and manufacture method thereof, especially the lyophilized injectable powder of injection oxiracetam and manufacture method thereof.
Background technology
Injection oxiracetam (Oxiracetam for injection), chemical name: 4-hydroxyl-2-OXo-1-pyrrolidine acetamide, the Chinese phonetic alphabet: Zhushengyong Aolaxitan.The nomenclature principle of the formal name of an article of preparation: (revision in 1986 replenishes " the English-Chinese Chinese-English medicine name vocabulary " that office of the raw materials used oxiracetam naming basis of preparation Pharmacopoeia Commission of the Ministry of Public Health tissue is compiled and edit, the first draft of version in 1984), this preparation is the injection freeze-dried powder, so injection oxiracetam by name, it is the cyclic derivatives of a new hydroxy-amino-butyric acid (GABOB), be piracetam (Piracetam) class nootropics, Italian ISF company was synthetic in 1974,1987 in Italian Initial Public Offering, went on the market in Portugal in 1991, at present, in Japan, Korea S, Greece, it is clinical that Brazil has finished the III phase, China is in approval on February 28th, 1997, Shijiazhuang first pharmaceutical factory and Tianjin Medicine Research Academy Pharmaceutical Co., Ltd's raw materials for production and capsule.Tianjin Inst. of Materia Medica has transferred our Pharmaceutical Factory No.3, Yueyang City, Hunan Prov. in December in 1997 31 days with raw material and capsule manufacture qualification.
This medicine can make half senile cell vigor strengthen, and significantly improves brain memory, and is effective to senile memory and mental deterioration.Be applicable to that clinically brain function is incomplete, memory disorder, especially senile dementia in addition, are used for neurosis, cerebral trauma, the rehabilitation of diseases such as encephalitis.In recent years, the foreign study personnel have found the anti-platelet aggregation of oxiracetam ex hoc genus anne medicine again and to erythrocytic pharmacological property, and have detoxifcation and immunization.Can predict, oxiracetam will have more wide prospect than present piracetam salable.This medicine social need amount is bigger at present, and dosage form is single, can not meet the need of market.
Summary of the invention
The purpose of this invention is to provide a kind of injection oxiracetam, it is a kind of injection-lyophilized injectable powder, satisfies the demand of people to different dosage form, is mainly used in the cerebral anoxia first aid, some severe cases is rescued immediately, for the patient removes slight illness.
For achieving the above object, technical scheme of the present invention is as follows: a kind of oxiracetam injection is characterized in that: it is made by oxiracetam, mannitol and water for injection, and its percentage by weight is: oxiracetam 20%～40%, mannitol 5%～45%, water for injection 25%～65%.
Make the described oxiracetam of claim 1, it is characterized in that: accurately take by weighing each component by proportioning, add 85% preparation of injection water, decolour with needle-use activated carbon, under 40～60 ℃ of temperature, stirred 10～20 minutes, coarse filtration is added into residue water for injection, is stirred, and surveys pH value, oxiracetam content, after qualified, fine straining is sub-packed in the bottle to clear and bright, and lyophilizing promptly.
Quality research general introduction: we have carried out the research of content limit, character, discriminating, acidity, moisture, related substance, pyrogen, aseptic, content uniformity, clarity, assay to this product.Concrete research situation is as follows: the determining of (1) content limit, and three batch sample content after measured, labelled amount is 90.0%～110.0%, so definite this product contains oxiracetam (C as a result
6H
10N
2O
3) should be 90.0%～110.0% of labelled amount.(2) character, according to the outward appearance actual measurement situation of three batch samples, describing this product is " white or off-white powder or loose block ".(3) differentiate, formulate with reference to the discrimination method of oxiracetam.(4) acidity, this product raw material are nearly neutral chemical compound soluble in water, and institute adds adjuvant also for neutral, and the pH value of formulating this product is 4.5～6.5.The pH value of three batch samples after measured is all in this scope.(5) clarity of solution and color, this product character are white or loose block, in order to control the quality of product, need the color of control sample solution, and the color of the aqueous solution of this product must not be deeper than yellow No. 5; Because of this product is a chemical compound soluble in water, in order to control other insoluble chemical compound, the aqueous solution of regulation this product should be clarified.(6) adopt two appendix aquametries of Chinese Pharmacopoeia version in 2000, first method-Ka Shi aquametry to measure the moisture of this product, the moisture of three batch samples does not all surpass 2.0% after measured.(7) related substance, adopt high effective liquid chromatography for measuring, system suitability test and acid, alkali, oxidation destructive testing show that this system can make impurity separate with principal agent effectively, and adjuvant is noiseless to measuring, adopt Self-control method quantitative to impurity, need testing solution is as showing impurity peaks, and the peak area at maximum contaminant peak must not be greater than 1.5 times of contrast solution main peak peak area.(8) pyrogen, because of this product is the sterile preparation of injection, so need carry out pyrogen test, according to the method inspection under two appendix XID of Chinese Pharmacopoeia version in 2000 item, should (9) up to specification aseptic, because of this product is the sterile preparation of injection, so need carry out sterility test to it, according to the method inspection under the aseptic item of two appendix of Chinese Pharmacopoeia version in 2000, three batch samples are all up to specification.(10) content uniformity is checked through three batch sample content uniformity, and is all up to specification.(11) clarity, according to the regulation under two appendix injections of Chinese Pharmacopoeia version in 2000 item, reply this product is carried out the inspection of clarity, check three batches of test samples with reference to the method under two second clarity test items of Ministry of Public Health ministry standard, (12) all up to specification assay according to the content assaying method of crude drug and capsule, adopts N2 method, through investigating these methods of demonstration of method such as blank adjuvant, recovery test, repeatability is feasible, and adjuvant does not disturb assay.
The stability study general introduction: we have carried out influence factor's test (strong illumination 4800Lx to the injection oxiracetam, 60 ℃ of high temperature and high humidity RH92.5%), accelerated test (40 ℃ ± 2 ℃ of temperature, humidity RH75% ± 5%), the research of long term test (25 ℃ ± 2 ℃ of temperature, humidity RH60% ± 10%), specifically investigation project has appearance color, acidity, the clarity of solution and color; Related substance, assay.Result of the test is as follows: (1) this product is tested 10 days results of investigation through the influence factor and shown: under each influence factor's condition, every index is all stable.(2) this product shows through 6 months result of accelerated test investigation: every index is all stable, with this product shading, airtight, in shady and cool dry place placement, can preserve 2 years.(3) this product is investigated 9 months through long term test, and every quality standard all meets declares the quality standard draft.
The main pharmacodynamics research overview: the drug effect of relevant oxiracetam, the existing a large amount of reports of foreign literature may be utilized.From the visible oxiracetam of foreign literature data to normally, aged animal, the learning and memory of cerebrovascular trauma and cerebral dysgenesis animal all has clear improvement, curative effect is better than similar medicine piracetam.This product toxicity is extremely low, and side effect is minimum, no teratogenesis, mutagenic action.Drug oral absorbs good, the bioavailability height, mainly through kidney by homaluria, be difficult for accumulation in the body, be suitable for long-term prescription.
The result of the oxiracetam raw material of declaring according to Tianjin Inst. of Materia Medica, the research of capsular main pharmacodynamics and foreign literature is as follows:
(1) learning and memory is obtained bad improvement effect.Test causes dysmnesia model with mice with Anisodine, found that 25,50 and the oxiracetam oral administration of 100mg/Kg dosage, the errors number of three dosage groups is all less than the pathology matched group, train the 2nd, 3 time, 3 groups errors number becomes dose-effect relevant with dosage, errors number increases with dosage and reduces, and the 4th is trained 3 groups of levels that all reach the intact animal.Step down test and water maze test prove that all oxiracetam has the improvement effect to the learning and memory acquisition is bad, and are better than similar medicine piracetam.
(2) to the improvement effect of memory represents.Mice is used in test, causes the bad model of memory represents with ethanol.Proof oxiracetam 50mg and 100mg/kg intraperitoneal administration all can make the animal errors number reduce in step down test, incubation period significant prolongation, and similar medicine piracetam 100mg/kg errors number reduces to some extent, and prolong incubation period to some extent, but effect is far away from oxiracetam 50mg and 100mg/kg.The result shows that oxiracetam can significantly improve memory represents, and its effect is better than piracetam.
(3) facilitation that active avoidance response is formed.Use shuttle box test at normal rat (female), oxiracetam 25mg/kg dosage forms no facilitation to active avoidance response, and 50mg/kg dosage is formed with certain promotion to active avoidance response, and its response rate is higher than matched group.Piracetam 100mg/kg dosage only had facilitation in first day in training, all do not show facilitation in 2-5 days, with Anisodine pathological model rat (female), oxiracetam 25 and 50mg/kg dosage show certain promotion, and piracetam does not then have any facilitation.
Local application's toxicity research general introduction:
(1) injection oxiracetam blood vessel irritation test.Behind the injection oxiracetam rabbit ear edge intravenous administration, tangible venous congestion, edema, degeneration, scleroma and necrosis are not seen in perusal after 24 hours and 7 days, with the apparent in view difference of matched group; Histopathologic examination does not have obvious pathological changes.This shows that the injection oxiracetam does not have tangible zest to blood vessel, can be used for intravenous administration.
(2) injection oxiracetam hemolytic test.The injection oxiracetam does not produce hemolytic effect and cohesion to erythrocyte.Can be used safely in intravenous injection.
(3) injection oxiracetam anaphylaxis test.These product do not have irritated effect to Cavia porcellus, and anaphylaxis is negative.
Our the oxiracetam injection of Yueyang, Hunan Province pharmacy three factories development is Western medicine four kind new medicines.The formulation and technology of its injection is rationally feasible, and steady quality is reliable, and drug action is definite, and local application's toxicity research shows that clinical drug safety is reliable.Be mainly used in the cerebral anoxia first aid.
The specific embodiment
Embodiment 1: get oxiracetam crude drug (our factory's production and sales) 1000g, it is 1000 bottles of every bottle of freeze-dried powder injections that contains oxiracetam 1 gram that mannitol 200g, water for injection 2000ml make specification.Preparation technology: take by weighing each component by recipe quantity, add 85% preparation of injection water, 15 minutes (50 ℃) are stirred in the needle-use activated carbon decolouring with 0.05%, and coarse filtration is added into residue water for injection, stirred.Survey PH, oxiracetam content, qualified after, fine straining is sub-packed in the 10ml bottle to clear and bright, lyophilizing promptly.
Claims (2)
1, a kind of oxiracetam injection is characterized in that: it is made by oxiracetam, mannitol and water for injection, and its percentage by weight is: oxiracetam 20%～40%, mannitol 5%～45%, water for injection 25%～65%.
2, make the described oxiracetam of claim 1, it is characterized in that: accurately take by weighing each component by proportioning, add 85% preparation of injection water, decolour with needle-use activated carbon, under 40～60 ℃ of temperature, stirred 10～20 minutes, coarse filtration is added into residue water for injection, is stirred, and surveys pH value, oxiracetam content, after qualified, fine straining is sub-packed in the bottle to clear and bright, and lyophilizing promptly.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02114302 CN1390543A (en) | 2002-07-25 | 2002-07-25 | Oxiracetam injection |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 02114302 CN1390543A (en) | 2002-07-25 | 2002-07-25 | Oxiracetam injection |
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| CN1390543A true CN1390543A (en) | 2003-01-15 |
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Cited By (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102204904A (en) * | 2010-03-31 | 2011-10-05 | 重庆润泽医疗器械有限公司 | Application of levorotatory oxiracetamto preparation of medicaments for preventing or treating cognitive dysfunction |
| CN101396358B (en) * | 2007-09-25 | 2011-10-12 | 广东世信药业有限公司 | Oxiracetam injection |
| CN102274195A (en) * | 2011-07-18 | 2011-12-14 | 石药集团欧意药业有限公司 | Oxiracetam freeze-dried powder preparation and preparation method thereof |
| EP2061471A4 (en) * | 2006-08-31 | 2012-02-01 | Univ Alberta | Method of inhibition of respiratory depression using positive allosteric ampa receptor modulators |
| CN102512363A (en) * | 2011-12-23 | 2012-06-27 | 重庆药友制药有限责任公司 | Oxiracetam injection and preparation method thereof |
| CN102670527A (en) * | 2012-05-28 | 2012-09-19 | 南京优科生物医药研究有限公司 | Freeze-dried powder injection of L-oxiracetam and process for preparing freeze-dried powder injection |
| CN103417534A (en) * | 2013-08-01 | 2013-12-04 | 李鹏坤 | Medicinal composition and application thereof |
| CN103536543A (en) * | 2013-10-15 | 2014-01-29 | 海南卫康制药(潜山)有限公司 | Oxiracetam composition freeze-dried powder for injection |
| CN104069074A (en) * | 2013-03-29 | 2014-10-01 | 重庆药友制药有限责任公司 | Oxiracetam for injection and preparation method thereof |
| CN104739760A (en) * | 2015-04-09 | 2015-07-01 | 山东罗欣药业集团股份有限公司 | Pharmaceutical composition for treating encephaledema and preparation of pharmaceutical composition |
| CN105434373A (en) * | 2016-01-11 | 2016-03-30 | 青岛辰达生物科技有限公司 | Oxiracetam freeze-drying preparation for injection and preparation method thereof |
| CN106389349A (en) * | 2015-07-30 | 2017-02-15 | 重庆东泽医药科技发展有限公司 | L-oxiracetam freeze drying powder for injection, and preparation method thereof |
| CN106943361A (en) * | 2016-03-31 | 2017-07-14 | 重庆润泽医药有限公司 | It is a kind of（S）Oxo-1-pyrrolidine ethanamide aseptic powdery of -4- hydroxyls -2 and preparation method thereof |
| CN106943360A (en) * | 2016-03-31 | 2017-07-14 | 重庆润泽医药有限公司 | A kind of levo-oxiracetam aseptic powdery and preparation method thereof |
| CN113476412A (en) * | 2021-07-02 | 2021-10-08 | 海南通用康力制药有限公司 | Preparation method of piracetam freeze-dried powder injection for injection |
-
2002
- 2002-07-25 CN CN 02114302 patent/CN1390543A/en active Pending
Cited By (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2061471A4 (en) * | 2006-08-31 | 2012-02-01 | Univ Alberta | Method of inhibition of respiratory depression using positive allosteric ampa receptor modulators |
| CN101396358B (en) * | 2007-09-25 | 2011-10-12 | 广东世信药业有限公司 | Oxiracetam injection |
| CN102204904B (en) * | 2010-03-31 | 2014-10-01 | 重庆润泽医药有限公司 | Application of levorotatory oxiracetamto preparation of medicaments for preventing or treating cognitive dysfunction |
| CN102204904A (en) * | 2010-03-31 | 2011-10-05 | 重庆润泽医疗器械有限公司 | Application of levorotatory oxiracetamto preparation of medicaments for preventing or treating cognitive dysfunction |
| CN102274195A (en) * | 2011-07-18 | 2011-12-14 | 石药集团欧意药业有限公司 | Oxiracetam freeze-dried powder preparation and preparation method thereof |
| CN102512363A (en) * | 2011-12-23 | 2012-06-27 | 重庆药友制药有限责任公司 | Oxiracetam injection and preparation method thereof |
| CN102670527A (en) * | 2012-05-28 | 2012-09-19 | 南京优科生物医药研究有限公司 | Freeze-dried powder injection of L-oxiracetam and process for preparing freeze-dried powder injection |
| CN104069074A (en) * | 2013-03-29 | 2014-10-01 | 重庆药友制药有限责任公司 | Oxiracetam for injection and preparation method thereof |
| CN104069074B (en) * | 2013-03-29 | 2018-04-17 | 重庆药友制药有限责任公司 | A kind of injection Oxiracetam and preparation method thereof |
| CN103417534A (en) * | 2013-08-01 | 2013-12-04 | 李鹏坤 | Medicinal composition and application thereof |
| CN103536543A (en) * | 2013-10-15 | 2014-01-29 | 海南卫康制药(潜山)有限公司 | Oxiracetam composition freeze-dried powder for injection |
| CN104739760B (en) * | 2015-04-09 | 2018-03-06 | 山东罗欣药业集团股份有限公司 | A kind of pharmaceutical composition and its preparation for treating encephaledema |
| CN104739760A (en) * | 2015-04-09 | 2015-07-01 | 山东罗欣药业集团股份有限公司 | Pharmaceutical composition for treating encephaledema and preparation of pharmaceutical composition |
| CN106389349A (en) * | 2015-07-30 | 2017-02-15 | 重庆东泽医药科技发展有限公司 | L-oxiracetam freeze drying powder for injection, and preparation method thereof |
| CN105434373A (en) * | 2016-01-11 | 2016-03-30 | 青岛辰达生物科技有限公司 | Oxiracetam freeze-drying preparation for injection and preparation method thereof |
| CN105434373B (en) * | 2016-01-11 | 2018-06-22 | 所秀艳 | A kind of injection Oxiracetam lyophilized preparation and preparation method thereof |
| CN106943361A (en) * | 2016-03-31 | 2017-07-14 | 重庆润泽医药有限公司 | It is a kind of（S）Oxo-1-pyrrolidine ethanamide aseptic powdery of -4- hydroxyls -2 and preparation method thereof |
| CN106943360A (en) * | 2016-03-31 | 2017-07-14 | 重庆润泽医药有限公司 | A kind of levo-oxiracetam aseptic powdery and preparation method thereof |
| CN113476412A (en) * | 2021-07-02 | 2021-10-08 | 海南通用康力制药有限公司 | Preparation method of piracetam freeze-dried powder injection for injection |
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