CN104546682A - Piracetam composition freeze-dried tablets and preparation method thereof - Google Patents
Piracetam composition freeze-dried tablets and preparation method thereof Download PDFInfo
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- CN104546682A CN104546682A CN201410829331.6A CN201410829331A CN104546682A CN 104546682 A CN104546682 A CN 104546682A CN 201410829331 A CN201410829331 A CN 201410829331A CN 104546682 A CN104546682 A CN 104546682A
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Abstract
The invention provides piracetam composition freeze-dried tablets and a preparation method thereof, and relates to the technical field of medicines and medicine production. The aspirin composition freeze-dried tablets comprise piracetam, starch and sucrose, wherein starch and sucrose are used as accessories. Ordinary corn starch is treated by a heating process, so that the bonding and disintegration effects of starch in the tablets can be improved, and the forming property of the tablets can be improved; only starch and sucrose are required to be used as the accessories of the piracetam composition freeze-dried tablets. A two-cooling two-heating freeze-drying process is adopted for the piracetam composition freeze-dried tablets, and by twice cooling and twice heating, better forming property of the tablets can be achieved, and the dissolubility of the tablets is improved, so that the bioavailability of the tablets is improved. According to the tablets, the defects of ordinary piracetam tablets are overcome, the sort and using amounts of the accessories in the piracetam tablets are reduced, the tablets are high in dissolubility and bioavailability, and the curative effects and safety of clinical mediation are ensured.
Description
Technical field
The present invention relates to medicine and medical production technical field, be specifically related to a kind of piracetam composition freeze-drying sheet and preparation method thereof.
Background technology
This product is for being applicable to hypomnesis caused by the many reasons such as acute and chronic cerebrovascular, cerebral trauma, various toxic encephalopthys and light, moderate disordered brain function.Also can be used for child intelligence hypoevolutism.Molecular formula: C
6h
10n
2o
2.
molecular weight: 142.16
This product is nootropic agents, belongs to the annular derivant of r aminobutyric acid.There is resistance against physical factor, act on like the injury of brain function caused by chemical factor.ATP in brain can be promoted, acetylcholine can be promoted to synthesize and just strengthening the conduction of neural excitation, have and promote the effect of brain intracellular metabolite.The injury of brain function caused by physical factor, chemical factor can be resisted.Improved action is had to the antidromicity caused by anoxia is forgetful.Can hypermnesis, improve learning capacity.Zooperal acute toxinology experiment shows, mouse stomach dosage is greater than 10g/kg, has no dead.The median lethal dose(LD 50) LD50 of intravenously administrable is 9.2g/kg.Subacute and chronic toxicity does not all find there is any harmful effect to the growth promoter of rat, Canis familiaris L..On the important internal organs such as blood, the heart, liver, kidney, brain and function all without impact.
In common piracetam containing supplementary product kind and quantity more, generally will use filler, lubricant, disintegrating agent, adhesive, correctives etc., its disintegration time reaches 12 minutes, and bioavailability is lower.And increasing research shows that impurity in the incompatibility of the toxic and side effects of adjuvant itself, adjuvant and principal agent, adjuvant etc. all can have an impact to the safety of medicine.
Therefore, provide one can overcome above-mentioned shortcoming, select suitable adjuvant and technique, reduce supplementary product kind and consumption in piracetam, improve piracetam bioavailability, ensure that the safety of clinical application all has positive effect.
Traditional lyophilizing tablet can improve bioavailability, but still need use the adjuvant such as mannitol, gelatin.And mannitol has certain biological activity, gelatin resource-constrained and perishable.
Starch is the basic adjuvant of oral solid formulation, it is polymerized by glucose molecule, and be commonly used for adhesive, diluent and disintegrating agent in tablets, it is cheap and easy to get, to human-body safety, but being used alone starch has no report as adjuvant freeze-dry process production piracetam lyophilizing sheet.
Summary of the invention
Technical problem to be solved by this invention is the defect overcoming prior art, and propose a kind of piracetam composition freeze-drying sheet and preparation method thereof further, said preparation adjuvant is few, good stability, and bioavailability is high.
Technical problem to be solved by this invention realizes by the following technical solutions:
A kind of piracetam composition freeze-drying sheet, adjuvant is done with starch and sucrose, produce with freeze-dry process, this tablet overcomes the shortcoming of above-mentioned common piracetam, decrease supplementary product kind and consumption in piracetam, this sheet dissolution is large, and bioavailability is high, ensure that curative effect and the safety of clinical application.
A kind of piracetam composition freeze-drying sheet, is prepared from by following raw material:
A preparation method for piracetam composition freeze-drying sheet, comprises step as follows:
A, take the starch of component amount, add a certain amount of purified water and stir, by pH adjusting agent, the pH value of solution is controlled between 4-5, be then heated to 72 DEG C, be incubated 20 minutes, make the corn starch solution of 5 ~ 15% (W/V);
B, measure purified water 45ml, boil, add 85g sucrose, stir, after dissolving, continue to be heated to 100 DEG C, filter with purified cotton, the appropriate hot distilled water of filter is cleaned, and washing liquid and filtrate merge, and let cool, add appropriate distilled water, make full dose become 100mL, stir evenly, obtain B solution;
The solution that C, the solution and the step B that steps A are obtained obtain mixes, and fully stirs 30 minutes, is down to room temperature and obtains Semen Maydis-sucrose solution;
D, take piracetam 400 grams, add in 1L Semen Maydis-sucrose solution, stir 25 ~ 35 minutes;
Medicinal liquid is sub-packed in drug-containing dish after measuring piracetam content by E, medicinal liquid, each drug-containing dish dress 1.0ml;
F, the drug-containing dish that medicinal liquid is housed is put into vacuum freezing drying oven, be cooled to subzero 45 DEG C, keep 2 hours, evacuation, then 0 DEG C is warming up to gradually, keep 2 hours, then be cooled to subzero 45 DEG C, keep 2 hours, be warming up to 0 DEG C gradually again, keep 2 ~ 4 hours, then be warming up to 28 ~ 32 DEG C of dryings 4 ~ 6 hours gradually, whole process vacuum remains on 10 handkerchiefs; Finally the drug-containing dish lid of powder charge is covered tightly, and load aluminium foil bag and carry out sealing and obtain piracetam composition freeze-drying sheet.
Described starch selects corn starch, preferably the corn starch solution of 10% (W/V).
Beneficial effect of the present invention is:
The preparation method of a kind of piracetam composition freeze-drying sheet of the present invention, heating process process is carried out to common corn starch, starch bonding in tablets, disintegration can be improved, improve the mouldability of tablet, in piracetam composition freeze-drying sheet, dosage of sucrose is 8.5% (W/V), it is the hardness reinforcer of this tablet, and plays flavored action.Piracetam composition freeze-drying sheet only needs starch and sucrose two kinds of adjuvants.The freeze-dry process of two liters falls in piracetam composition freeze-drying sheet employing two, and twice cooling, twice intensification can make sheet mouldability better, and shorten the disintegration time of tablet, improve the bioavailability of tablet.
Detailed description of the invention
The technological means realized to make the present invention, creation characteristic, reaching object and effect is easy to understand, below in conjunction with specific embodiment, set forth the present invention further, but following embodiment being only the preferred embodiments of the present invention, and not all.Based on the embodiment in embodiment, those skilled in the art under the prerequisite not making creative work obtain other embodiment, all belong to the protection domain of this patent.
Embodiment 1
A, take the corn starch of 100g, the purified water adding 900ml stirs, and controls 6.5, is then heated to 72 DEG C, keep 120 minutes, make the corn starch solution of 9% (W/V) by pH adjusting agent by the pH value of solution.
B, measure purified water 45ml, boil, add 85g sucrose, stir, after dissolving, continue to be heated to 100 DEG C, filter with purified cotton, the appropriate hot distilled water of filter is cleaned, and washing liquid and filtrate merge, and let cool, add appropriate distilled water, make full dose become 100mL, stir evenly, obtain B solution.
The solution that C, the solution and the step B that steps A are obtained obtain mixes, and fully stirs 30 minutes, after solution be down to room temperature obtain Semen Maydis-sucrose solution.
D, take piracetam 400g, add in 1L Semen Maydis-sucrose solution, stir 30 minutes.
Medicinal liquid is sub-packed in drug-containing dish after measuring piracetam content by E, medicinal liquid, each drug-containing dish dress 1.0ml.
F, the drug-containing dish that medicinal liquid is housed is put into vacuum freezing drying oven, be cooled to subzero 45 DEG C, keep 2 hours, evacuation, then 0 DEG C is warming up to gradually, keep 2 hours, then be cooled to subzero 45 DEG C, keep 2 hours, be warming up to 0 DEG C gradually again, keep 2 ~ 4 hours, then be warming up to 28 ~ 32 DEG C of dryings 4 ~ 6 hours gradually, whole process vacuum remains on 10 handkerchiefs.Finally the drug-containing dish lid of powder charge is covered tightly, and load aluminium foil bag and carry out sealing and obtain piracetam composition freeze-drying sheet.
Embodiment 2
A, take the corn starch of 130g, the purified water adding 900ml stirs, and controls at 4-5, is then heated to 72 DEG C, keep 120 minutes, make the corn starch solution of 13% (W/V) by pH adjusting agent by the pH value of solution.
B, measure purified water 45ml, boil, add 85g sucrose, stir, after dissolving, continue to be heated to 100 DEG C, filter with purified cotton, the appropriate hot distilled water of filter is cleaned, and washing liquid and filtrate merge, and let cool, add appropriate distilled water, make full dose become 100mL, stir evenly, obtain B solution.
The solution that C, the solution and the step B that steps A are obtained obtain mixes, and fully stirs 30 minutes, after solution be down to room temperature obtain Semen Maydis-sucrose solution.
D, take piracetam 400 grams (by 1000 calculations), add 1L Semen Maydis-sucrose solution, stir 30 minutes.
Medicinal liquid is sub-packed in drug-containing dish after measuring piracetam content by E, medicinal liquid, each drug-containing dish dress 1.0ml.
F, the drug-containing dish that medicinal liquid is housed is put into vacuum freezing drying oven, be cooled to subzero 45 DEG C, keep 2 hours, evacuation, then 0 DEG C is warming up to gradually, keep 2 hours, then be cooled to subzero 45 DEG C, keep 2 hours, be warming up to 0 DEG C gradually again, keep 2 ~ 4 hours, then be warming up to 28 ~ 32 DEG C of dryings 4 ~ 6 hours gradually, whole process vacuum remains on 10 handkerchiefs.Finally the drug-containing dish lid of powder charge is covered tightly, and load aluminium foil bag and carry out sealing and obtain piracetam composition freeze-drying sheet.
Experimental data
The piracetam composition freeze-drying sheet that above-described embodiment is obtained carries out following quality research test:
1, hardness, friability contrast test
Get piracetam composition freeze-drying sheet prepared by above-described embodiment respectively and piracetam ordinary tablet (commercially available) detects friability and hardness by " Chinese Pharmacopoeia " version in 2010 two annex X G inspection techniques, contrast, the results are shown in following table:
| Sample | Hardness/N | Friability |
| Embodiment 1 | 67 | <1％ |
| Embodiment 2 | 68 | <1％ |
| Ordinary tablet | 70 | <1％ |
Experimental data shows, piracetam composition freeze-drying sheet and ordinary tablet without significant difference, meet " Chinese Pharmacopoeia " version in 2010 to the requirement of tablet on friability and hardness.
2, disintegration contrast test
Get piracetam composition freeze-drying sheet prepared by above-described embodiment respectively and piracetam ordinary tablet (commercially available) operates by Chinese Pharmacopoeia (2010 editions) second annex X A, its disintegration is checked.Result is as follows:
One, piracetam ordinary tablet (commercially available)
Two, piracetam composition freeze-drying sheet (No. 1 to No. 3 is embodiment 1, and No. 4 to No. 6 is embodiment 2)
Result judges:
Judge about the bioassay standard in disintegration of tablet time limit according to Chinese Pharmacopoeia (2010 editions) second piracetam quality standard and Chinese Pharmacopoeia (2010 editions) second annex X A, piracetam is no more than 12 minutes for qualified disintegration, actual measurement is 12 minutes, and piracetam composition freeze-drying sheet (embodiment 1 and embodiment 2) disintegration is 6 minutes.It can thus be appreciated that piracetam composition freeze-drying sheet disintegration is than reducing by 50% (6 minutes) piracetam (commercially available) disintegration, so piracetam composition freeze-drying sheet absorption of human body is faster, the blood drug level peaking time is shorter than piracetam ordinary tablet (commercially available), its bioavailability is higher, better efficacy.
More than show and describe ultimate principle of the present invention, principal character and advantage of the present invention.The technical staff of the industry should understand; the present invention is not restricted to the described embodiments; what describe in above-described embodiment and description is only preference of the present invention; be not used for limiting the present invention; without departing from the spirit and scope of the present invention; the present invention also has various changes and modifications, and these changes and improvements all fall in the claimed scope of the invention.Application claims protection domain is defined by appending claims and equivalent thereof.
Claims (2)
1. a piracetam composition freeze-drying sheet, is characterized in that, is prepared from by following raw material:
2. a preparation method for piracetam composition freeze-drying sheet according to claim 1, is characterized in that, comprise step as follows:
A, take the starch of component amount, add a certain amount of purified water and stir, by pH adjusting agent, the pH value of solution is controlled between 4-5, be then heated to 72 DEG C, be incubated 20 minutes, make the corn starch solution of 5 ~ 15% (W/V);
B, measure purified water 45ml, boil, add 85g sucrose, stir, after dissolving, continue to be heated to 100 DEG C, filter with purified cotton, the appropriate hot distilled water of filter is cleaned, and washing liquid and filtrate merge, and let cool, add appropriate distilled water, make full dose become 100mL, stir evenly, obtain B solution;
The solution that C, the solution and the step B that steps A are obtained obtain mixes, and fully stirs 30 minutes, is down to room temperature and obtains Semen Maydis-sucrose solution;
D, take piracetam 400 grams, add in 1L Semen Maydis-sucrose solution, stir 25 ~ 35 minutes;
Medicinal liquid is sub-packed in drug-containing dish after measuring piracetam content by E, medicinal liquid, each drug-containing dish dress 1.0ml;
F, the drug-containing dish that medicinal liquid is housed is put into vacuum freezing drying oven, be cooled to subzero 45 DEG C, keep 2 hours, evacuation, then 0 DEG C is warming up to gradually, keep 2 hours, then be cooled to subzero 45 DEG C, keep 2 hours, be warming up to 0 DEG C gradually again, keep 2 ~ 4 hours, then be warming up to 28 ~ 32 DEG C of dryings 4 ~ 6 hours gradually, whole process vacuum remains on 10 handkerchiefs; Finally the drug-containing dish lid of powder charge is covered tightly, and load aluminium foil bag and carry out sealing and obtain piracetam composition freeze-drying sheet.
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| CN201410829331.6A CN104546682A (en) | 2014-12-25 | 2014-12-25 | Piracetam composition freeze-dried tablets and preparation method thereof |
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| CN201410829331.6A CN104546682A (en) | 2014-12-25 | 2014-12-25 | Piracetam composition freeze-dried tablets and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112022816A (en) * | 2020-07-31 | 2020-12-04 | 河北君临药业有限公司 | Piracetam tablet and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS61242556A (en) * | 1985-04-19 | 1986-10-28 | Hatoya Seika:Kk | Preparation of snack using fruits |
| US20020173016A1 (en) * | 2001-03-27 | 2002-11-21 | Helmut Wurst | High-throughput nucleic acid polymerase devices and methods for their use |
| CN102125524A (en) * | 2010-01-16 | 2011-07-20 | 青岛科技大学 | Piracetam orally disintegrating tablets |
-
2014
- 2014-12-25 CN CN201410829331.6A patent/CN104546682A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS61242556A (en) * | 1985-04-19 | 1986-10-28 | Hatoya Seika:Kk | Preparation of snack using fruits |
| US20020173016A1 (en) * | 2001-03-27 | 2002-11-21 | Helmut Wurst | High-throughput nucleic acid polymerase devices and methods for their use |
| CN102125524A (en) * | 2010-01-16 | 2011-07-20 | 青岛科技大学 | Piracetam orally disintegrating tablets |
Non-Patent Citations (1)
| Title |
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| 刘晓睿: "《口腔速溶片的研究进展》", 《中南药学》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN112022816A (en) * | 2020-07-31 | 2020-12-04 | 河北君临药业有限公司 | Piracetam tablet and preparation method thereof |
| CN112022816B (en) * | 2020-07-31 | 2022-08-12 | 河北君临药业有限公司 | Piracetam tablet and preparation method thereof |
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Application publication date: 20150429 |