CN104800151A - Oxiracetam oral liquid and preparation method thereof - Google Patents
Oxiracetam oral liquid and preparation method thereof Download PDFInfo
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- CN104800151A CN104800151A CN201410036388.0A CN201410036388A CN104800151A CN 104800151 A CN104800151 A CN 104800151A CN 201410036388 A CN201410036388 A CN 201410036388A CN 104800151 A CN104800151 A CN 104800151A
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Abstract
An oxiracetam oral liquid is prepared from the following raw materials and accessories by weight: 1 part of oxiracetam, 0.006-0.012 part of a preservative, 0.13-0.38 part of a cosolvent, 0.03-0.25 part of a flavoring agent and 0.006-0.03 part of a fragrance. The prepared oxiracetam oral liquid has the advantages of convenient medication, quick absorption, high bioavailability, good stability and shelf life of up to 24 months. The product is convenient for administration, carrying, transportation and storage; the process is simple, applicable to mechanized production, high in yield and low in cost, and reaches the annual production capacity of 8 million; and the product has good taste and can be easily accepted by patients.
Description
Technical field
The present invention relates generally to pharmaceutical technology sectors, and being specifically related to a kind of main component is oral administration solution of oxiracetam and preparation method thereof.
Background technology
Oxiracetam (oxiracetam, CAS No.:62613-82-5) chemistry Esomeprazole by name, for the anti-hypoxia class nootropics (compound is disclosed in US4118396) that Italian ISFS.P.A company synthesized first in 1974, it is ring GABOB derivant, Phosphorylcholine and phosphatidyl ethanolamine synthesis can be promoted, promote brain metabolism, through blood brain barrier, stimulation is had to specificity nervus centralis road, intelligence and memory can be improved, to cerebrovascular, cerebral trauma, cerebroma, intracranial infection, brain degenerative diseases etc. also have good curative effect, and this drug toxicity is extremely low, without mutagenesis and carcinogenesis and genotoxicity.The people such as Giorgio disclose chemical constitution and the preparation method of oxiracetam in US4118396, the people such as Chiodini disclose in WO9306826A, clinical effectiveness proves that the drug effect of oxiracetam of S configuration (left-handed) is better than R configuration (dextrorotation), oxiracetam and oxiracetam structure as follows.
Existing oxiracetam oral formulations is mainly capsule, and it exists mouthfeel difference, and absorb slow, bioavailability is not high, has placed of a specified duration simultaneously and has also easily occurred the phenomenon that the moisture absorption is rotten.
Summary of the invention
The object of the present invention is to provide a kind of medication convenience, absorb soon, the oxiracetam oral administration solution that bioavailability is high.
Another object of the present invention is to the preparation method that above-mentioned oxiracetam oral administration solution is provided.
The object of the invention is to be realized by following technical measures:
A kind of oxiracetam oral administration solution, obtained by the supplementary material of following weight proportion, it is characterized in that: oxiracetam 1 part, antiseptic 0.008 ~ 0.018 part, cosolvent 0.78 ~ 1.61 part, correctives 0.03 ~ 0.25 part, aromatic 0.006 ~ 0.03 part, wherein said antiseptic is one or more in benzoic acid, sorbic acid, chlorocresol, ethyl hydroxybenzoate, propyl hydroxybenzoate; Described cosolvent is one or more in the smooth class of fatty acid Pyrusussuriensis, poly yamanashi esters, polyoxyethylene fatty acid ester class, polyoxyethylene-poiyoxypropylene copolymer; Described correctives is Mel, sucrose, stevioside, saccharin sodium, one or more in aspartame; Described aromatic is one or more in ethyl maltol, Oleum Cinnamomi, Oleum menthae, orange peel oil, flavoring banana essence, flavoring pineapple essence.
Inventor finds that above-mentioned oral administration solution is in storage process, if control, bad easily to cause bacterium to be examined defective, makes oral administration solution product unstable, though the good drug efficacy shelf-life is not long.In order to address this problem, above-mentioned oxiracetam oral administration solution comprises oxiracetam 1 part, ethyl hydroxybenzoate 0.004 ~ 0.006 part, the propyl hydroxybenzoate 0.003 ~ 0.005 part of weighing scale, sodium benzoate 0.001 ~ 0.007, tween200.18 ~ 0.31 part, aspartame 0.08 ~ 0.22 part, flavoring pineapple essence 0.008 ~ 0.016 part.
Further be preferably above-mentioned oxiracetam oral administration solution and comprise oxiracetam 1 part, ethyl hydroxybenzoate 0.005 ~ 0.006 part, propyl hydroxybenzoate 0.0035 ~ 0.0045 part, the sodium benzoate 0.003 ~ 0.005 part of weighing scale, tween200.18 ~ 0.31 part, aspartame 0.08 ~ 0.22 part, flavoring pineapple essence 0.008 ~ 0.016 part.
Inventor also finds that above-mentioned oral administration solution easily produces floccule in storage process, causes product defective.In order to address this problem, above-mentioned oxiracetam oral administration solution comprises the oxiracetam 1 part of weighing scale, ethyl hydroxybenzoate 0.005 ~ 0.006 part, propyl hydroxybenzoate 0.0035 ~ 0.0045 part, sodium benzoate 0.003 ~ 0.005 part, tween200.18 ~ 0.31 part, glycerol 0.5 ~ 0.8 part, paregal O 0.1 ~ 0.5 part, aspartame 0.08 ~ 0.22 part, flavoring pineapple essence 0.008 ~ 0.016 part.
Further be preferably above-mentioned oxiracetam oral administration solution and comprise the oxiracetam 1 part of weighing scale, ethyl hydroxybenzoate 0.005 ~ 0.006 part, propyl hydroxybenzoate 0.0035 ~ 0.0045 part, sodium benzoate 0.003 ~ 0.005 part, tween200.22 ~ 0.29 part, glycerol 0.68 ~ 0.72 part, paregal O 0.3 ~ 0.4 part, aspartame 0.08 ~ 0.22 part, flavoring pineapple essence 0.008 ~ 0.016 part.
Those skilled in the art are not difficult to learn, oxiracetam oral administration solution mouthfeel is poor, and seasoning difficulty is large.Inventor finds to select a certain proportion of correctives and aromatic with the use of solving taste poor by great many of experiments.Above-mentioned oxiracetam oral administration solution comprises the oxiracetam 1 part of weighing scale, ethyl hydroxybenzoate 0.005 ~ 0.006 part, propyl hydroxybenzoate 0.0035 ~ 0.0045 part, sodium benzoate 0.003 ~ 0.005 part, tween200.22 ~ 0.29 part, glycerol 0.68 ~ 0.72 part, paregal O 0.3 ~ 0.4 part, aspartame 0.11 ~ 0.18 part, flavoring pineapple essence 0.010 ~ 0.015 part, ethyl maltol 0.001 ~ 0.006 part.
Further be preferably above-mentioned oxiracetam oral administration solution and comprise the oxiracetam 1 part of weighing scale, ethyl hydroxybenzoate 0.005 ~ 0.006 part, propyl hydroxybenzoate 0.0035 ~ 0.0045 part, sodium benzoate 0.003 ~ 0.005 part, tween200.22 ~ 0.29 part, glycerol 0.68 ~ 0.72 part, paregal O 0.3 ~ 0.4 part, aspartame 0.13 ~ 0.15 part, flavoring pineapple essence 0.012 ~ 0.013 part, ethyl maltol 0.003 ~ 0.005 part.
The preparation method of oxiracetam oral administration solution, carry out as follows:
1. appropriate for oxiracetam purified water is dissolved, make oxiracetam concentrated solution, for subsequent use;
2. foregoing preservatives, above-mentioned cosolvent, above-mentioned correctives, above-mentioned aromatic are added Purified Water q. s,
For subsequent use;
3., by the solution mix and blend in above-mentioned 1 step and 2 steps, mixing, filters;
4. by the filled with solution in 3 steps, sterilizing and get final product.
The present invention has following beneficial effect:
Oxiracetam oral administration solution is a kind of oral liquid being used for treating brain injury and the neurological deficit caused, memory and disturbance of intelligence.This product medication is convenient, absorption is fast, and bioavailability is high, good stability, and shelf life reaches 24 months.This product is taken, and carries, and transports and stores all more convenient; Technique is simple, is applicable to mechanization production, and output is large, and cost is low, and year output can reach 8,000,000; And this product excellent taste, is easily easily accepted by the patient.
Detailed description of the invention
Below by embodiment, the present invention is specifically described; what be necessary to herein means out is that following examples are only used to further illustrate the present invention; limiting the scope of the invention can not be interpreted as; without departing from the spirit and substance of the case in the present invention; the amendment do the inventive method, step or condition or replacement, all belong to scope of the present invention.
Embodiment 1
A kind of oxiracetam oral administration solution, obtains according to the following steps:
Prescription forms:
| Composition | Consumption |
| Oxiracetam | 1 part |
| Ethyl hydroxybenzoate | 0.005 part |
| Propyl hydroxybenzoate | 0.0045 part |
| Sodium benzoate | 0.0035 part |
| Tween20 | 0.22 part |
| Glycerol | 0.68 part |
| Paregal O | 0.3 part |
| Aspartame | 0.13 part |
| Flavoring pineapple essence | 0.012 part |
| Ethyl maltol | 0.003 part |
| Purified water | Add water to 10 liters |
Make 10000
1. appropriate for oxiracetam purified water is dissolved, make oxiracetam concentrated solution, for subsequent use;
2. foregoing preservatives, above-mentioned cosolvent, above-mentioned correctives, above-mentioned aromatic are added Purified Water q. s, for subsequent use;
3., by the solution mix and blend in above-mentioned 1 step and 2 steps, mixing, filters;
4. by the filled with solution in 3 steps, sterilizing and get final product.
Embodiment 2
A kind of oxiracetam oral administration solution, obtains according to the following steps:
Prescription forms:
| Composition | Consumption |
| Oxiracetam | 1 part |
| Ethyl hydroxybenzoate | 0.006 part |
| Propyl hydroxybenzoate | 0.0035 part |
| Sodium benzoate | 0.005 part |
| Tween20 | 0.29 part |
| Glycerol | 0.72 part |
| Paregal O | 0.4 part |
| Aspartame | 0.15 part |
| Flavoring pineapple essence | 0.013 part |
| Ethyl maltol | 0.005 part |
| Purified water | Add water to 10 liters |
Make 10000
Preparation process: the preparation technology according to embodiment 1 obtains.
Embodiment 3
A kind of oxiracetam oral administration solution, obtains according to the following steps:
Prescription forms:
| Composition | Consumption |
| Oxiracetam | 1 part |
| Ethyl hydroxybenzoate | 0.006 part |
| Propyl hydroxybenzoate | 0.0045 part |
| Sodium benzoate | 0.004 part |
| Tween20 | 0.29 part |
| Glycerol | 0.70 part |
| Paregal O | 0.35 part |
| Aspartame | 0.15 part |
| Flavoring pineapple essence | 0.012 part |
| Ethyl maltol | 0.004 part |
| Purified water | Add water to 10 liters |
Make 10000
Preparation process: the preparation technology according to embodiment 1 obtains.
Embodiment 4-8: the present invention, be a kind of oral liquid being used for treating brain injury and the neurological deficit caused, memory and disturbance of intelligence, by following medicine material, other are all identical with embodiment 1, all in weight proportion.Obtained oxiracetam oral administration solution absorbs fast, and bioavailability is high, good stability, and shelf life reaches 24 months.This product is taken, and carries, and transports and stores all more convenient; Technique is simple, is applicable to mechanization production, and output is large, and cost is low, and year output can reach 8,000,000; And this product excellent taste, is easily easily accepted by the patient.
| Embodiment | 4 | 5 | 6 | 7 | 8 |
| Oxiracetam | 1 part | 1 part | 1 part | 1 part | 1 part |
| Ethyl hydroxybenzoate | 0.005 | 0.005 | 0.006 | 0.006 | 0.005 |
| Propyl hydroxybenzoate | 0.005 | 0.005 | 0.006 | 0.006 | 0.005 |
| Sodium benzoate | 0.003 | 0.005 | 0.003 | 0.004 | 0.003 |
| Tween20 | 0.0035 | 0.0037 | 0.0037 | 0.0038 | 0.0042 |
| Glycerol | 0.69 | 0.70 | 0.70 | 0.72 | 0.71 |
| Paregal O | 0.30 | 0.35 | 0.35 | 0.40 | 0.30 |
| Aspartame | 0.13 | 0.13 | 0.15 | 0.15 | 0.14 |
| Flavoring pineapple essence | 0.012 | 0.012 | 0.013 | 0.013 | 0.012 |
| Ethyl maltol | 0.003 | 0.004 | 0.003 | 0.005 | 0.005 |
| Purified water | Add water to 10 liters | Add water to 10 liters | Add water to 10 liters | Add water to 10 liters | Add water to 10 liters |
For a better understanding of the present invention, set forth the beneficial effect of invention medicine below by way of drug study of the present invention further, experiment is below intended to the effect further illustrating medicine, but not limitation of the present invention.
Experiment 1: oxiracetam oral administration solution stability experiment
Experiment material:
Oxiracetam oral administration solution sample: be the oxiracetam oral administration solution that embodiment 1 is obtained.
Acceleration study method: by oxiracetam oral administration solution obtained for embodiment 1 by listing packaging, put in Acceleration study case, certain hour samples, and tests to investigation project.
Acceleration study temperature: 40 ± 2 DEG C
Humidity: RH75% ± 5%
The investigation time: 0,1,2,3, June
Inspection target: character, oxiracetam content, related substance, clarity, discriminating and limit test of microbe
Investigation the results are shown in subordinate list 1:
Table 1 oxiracetam oral administration solution Acceleration study result
| Accelerate | Character | Clarity | Differentiate | Related substance (%) | Content (%) | Microbial check |
| 0 month | Conform with the regulations | Conform with the regulations | In positive reaction | 0.06 | 100.1 | Conform with the regulations |
| January | Conform with the regulations | Conform with the regulations | In positive reaction | 0.08 | 100.5 | Conform with the regulations |
| February | Conform with the regulations | Conform with the regulations | In positive reaction | 0.11 | 99.9 | Conform with the regulations |
| March | Conform with the regulations | Conform with the regulations | In positive reaction | 0.15 | 100.2 | Conform with the regulations |
| June | Conform with the regulations | Conform with the regulations | In positive reaction | 0.19 | 100.0 | Conform with the regulations |
Acceleration study result shows: it is suitable with 0 month every Testing index quality of sample to accelerate June sample, and show this product Acceleration study June, quality keeps stablizing, and this product stability is better.
Long-term experiment method: by oxiracetam oral administration solution obtained for embodiment 1 by listing packaging, put and keep sample in case for a long time, certain hour samples, and tests to investigation project.
Acceleration study temperature: 25 ± 2 DEG C
Humidity: RH60% ± 10%
The investigation time: 0,3,6,9,12,18,24 months
Inspection target: character, oxiracetam content, related substance, clarity, discriminating and limit test of microbe
Investigation the results are shown in subordinate list 2:
Table 2 oxiracetam oral administration solution long-term experiment result
| For a long time | Character | Clarity | Differentiate | Related substance (%) | Content (%) | Microbial check |
| 0 month | Conform with the regulations | Conform with the regulations | In positive reaction | 0.06 | 100.1 | Conform with the regulations |
| March | Conform with the regulations | Conform with the regulations | In positive reaction | 0.07 | 100.3 | Conform with the regulations |
| June | Conform with the regulations | Conform with the regulations | In positive reaction | 0.08 | 99.9 | Conform with the regulations |
| JIUYUE | Conform with the regulations | Conform with the regulations | In positive reaction | 0.12 | 100.2 | Conform with the regulations |
| December | Conform with the regulations | Conform with the regulations | In positive reaction | 0.16 | 100.0 | Conform with the regulations |
| 18 months | Conform with the regulations | Conform with the regulations | In positive reaction | 0.19 | 100.5 | Conform with the regulations |
| 24 months | Conform with the regulations | Conform with the regulations | In positive reaction | 0.23 | 100.3 | Conform with the regulations |
Long-term experiment result shows: long-term 24 months samples are suitable with 0 month every Testing index quality of sample, show this product long-term experiment 24 months, and quality keeps stable, and this product stability is better, therefore this product shelf life can reach 24 months.Long-term experiment is still in continuation is investigated.
Two. taste, mouthfeel market survey
Oxiracetam oral administration solution of the present invention is through strict supplementary material compatibility, makes through repeatedly seasoning.There is mouthfeel fabulous, have a sweet taste, can accept by extensive patients, there is good market prospect.
Method: crowd 1000 people of Stochastic choice more than 18 years old, carries out taste trial test, and existing result statistics of tasting is as table 3:
Table 3 oxiracetam oral administration solution taste is investigated
| Very good | Better | Generally | Difference |
| 798 | 122 | 77 | 3 |
Taste market survey according to taste, this product is easy to accepted by extensive patients, according to incompletely statistics, think that taste is extraordinary and account for whole crowd's 79.8%, think that taste is reasonable and account for 12.2%, feel general and account for 7.7%, think that distasteful accounts for 0.3%.Therefore this product to have mouthfeel good, be subject to the feature that extensive patients colony accepts.
Claims (4)
1. an oxiracetam oral administration solution, is that the supplementary material comprising following weight proportion obtains, it is characterized in that: oxiracetam 1 part, antiseptic 0.006 ~ 0.012 part, cosolvent 0.13 ~ 0.38 part, correctives 0.03 ~ 0.25 part, aromatic 0.006 ~ 0.03 part.
2. oral administration solution as claimed in claim 1, is characterized in that: described antiseptic is one or more in benzoic acid, sorbic acid, chlorocresol, ethyl hydroxybenzoate, propyl hydroxybenzoate; Described cosolvent is one or more in the smooth class of fatty acid Pyrusussuriensis, poly yamanashi esters, polyoxyethylene fatty acid ester class, polyoxyethylene-poiyoxypropylene copolymer; Described correctives is Mel, sucrose, stevioside, saccharin sodium, one or more in aspartame; Described aromatic is one or more in ethyl maltol, Oleum Cinnamomi, Oleum menthae, orange peel oil, flavoring banana essence, flavoring pineapple essence.
3. oral administration solution as claimed in claim 1, it is characterized in that: oxiracetam 1 part, ethyl hydroxybenzoate 0.004 ~ 0.006 part, propyl hydroxybenzoate 0.003 ~ 0.005 part, sodium benzoate 0.001 ~ 0.007, tween20 0.18 ~ 0.31 part, aspartame 0.08 ~ 0.22 part, flavoring pineapple essence 0.008 ~ 0.016 part.
4. the preparation method of oxiracetam tablet as described in any one of claim 1 ~ 3, carry out as follows:
A. appropriate for oxiracetam purified water is dissolved, make oxiracetam concentrated solution, for subsequent use;
B. foregoing preservatives, above-mentioned cosolvent, above-mentioned correctives, above-mentioned aromatic are added Purified Water q. s, for subsequent use;
C. by the solution mix and blend in above-mentioned step A and step B, mixing, filters;
D. by the filled with solution in step C, sterilizing and get final product.
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Citations (4)
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| CN102846600A (en) * | 2012-09-06 | 2013-01-02 | 石药集团欧意药业有限公司 | Oxiracetam drug activity composition and preparation method thereof |
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2014
- 2014-01-24 CN CN201410036388.0A patent/CN104800151B/en active Active
Patent Citations (4)
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|---|---|---|---|---|
| US20080045583A1 (en) * | 2006-08-18 | 2008-02-21 | David Delmarre | Stable levetiracetam compositions and methods |
| CN101766565A (en) * | 2008-12-31 | 2010-07-07 | 北京利乐生制药科技有限公司 | Oral liquid preparation with levo-oxiracetam as active component |
| 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 |
| CN102846600A (en) * | 2012-09-06 | 2013-01-02 | 石药集团欧意药业有限公司 | Oxiracetam drug activity composition and preparation method thereof |
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