CN102688216A - Gabapentin tablet and preparation method thereof - Google Patents

Gabapentin tablet and preparation method thereof Download PDF

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Publication number
CN102688216A
CN102688216A CN2012101102770A CN201210110277A CN102688216A CN 102688216 A CN102688216 A CN 102688216A CN 2012101102770 A CN2012101102770 A CN 2012101102770A CN 201210110277 A CN201210110277 A CN 201210110277A CN 102688216 A CN102688216 A CN 102688216A
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gabapentin
less
granularity
tablets
hydroxypropyl cellulose
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Inventor
王建芳
杨理镇
曲艳玲
俞波
何有凤
戴微微
宋小叶
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HANGZHOU TIANCHENG PHARMACEUTICAL CO Ltd
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HANGZHOU TIANCHENG PHARMACEUTICAL CO Ltd
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Abstract

The invention belongs to the field of medicine preparation and relates to a gabapentin tablet which is prepared by wet granulation and prepared mainly from the following raw materials by weight percentage: 80.0% or more of gabapentin, 4.0-17.0% of low-substituted hydroxypropyl cellulose, 0.5-2.5% of adhesive, 0.1-2.5% of stabilizer and 0.5-1.5% of lubricant. The invention further provides a preparation method of the gabapentin tablet. The gabapentin raw material adopted in the invention has good formability and high physical strength after being crushed. Besides, the gabapentin raw material can be prepared by adopting an ordinary wet granulation method and has the characteristics of simple preparation and low cost. The gabapentin tablet provided by the invention has the advantages of very high dissolution in vitro, high content of gabapentin, less application auxiliary materials and high convenience for use, thus meeting modern medicine's requirements of 'small in three aspects' and 'convenient in three aspects', and can be prepared by adopting an ordinary wet granulation method and has the characteristics of simple preparation and low cost.

Description

A kind of gabapentin tablets and preparation method thereof
Technical field
The invention belongs to field of pharmaceutical preparations, relate to a kind of gabapentin tablets and preparation method thereof.
Background technology
Gabapentin tablet quality standard is recorded in American Pharmacopeia 32 editions (USP32), and in American-European countries's listing and be widely used, domestic also have a listing of gabapentin sheet.These article were the epilepsy therapy medicine originally, single drug: be applicable to and suffer from simple or the adult of complexity partial seizures and the child's more than 12 years old (comprising new diagnosing patients) treatment, can with or without the Secondary cases generalized seizures; Drug combination: suffer from partial seizures with or without the child more than 3 years old and 3 years old and the adult of Secondary cases generalized seizures.Found afterwards that gabapentin had definite curative effect to various neuralgias, existing this product has become the neuralgic standard medicine of treatment.
The gabapentin sheet is at first gone on the market by Pfizer, and prescription is except that active ingredient, and adjuvant is made up of corn starch, hyprolose, poloxamer, copolyvidone, magnesium stearate; Wherein gabapentin content about 75%; Copolyvidone is a dry adhesives, and hyprolose is dissolved in the ethanol as the wet granulation binding agent, for increasing the mouldability and the physical strength of slice, thin piece; So added more binding agent, but dissolution rate reduced.Domestic listing product gabapentin sheet, product gabapentin content is about 62%, and external dissolution rate is also slower.U.S. Pat 6,294,198B1 discloses a kind of prescription and method for preparing of high-load gabapentin sheet; Its slice, thin piece contains gabapentin more than 76%, and this patent thinks that it is the main cause of high content tablets insufficient formability that the gabapentin raw material exists with crystal form, so adopt the spraying semar technique to prepare granule; Main purpose is to improve the physical strength of slice, thin piece, a kind of comparatively ideal method for preparing of can yet be regarded as, but to use spray granulation equipment; Equipment requirements is high; The more important thing is: according to United States pharmacopoeia specifications, the stripping in 45 minutes of gabapentin sheet gets final product greater than 80%, and patent is because will increase slice, thin piece intensity; Used more a large amount of celluloses and drug particle is embedded in the macromolecular material, so can't propose requirements at the higher level the product stripping; In addition, raw material granularity is also studied in this patent the change of product physical property.Chinese patent discloses that (publication number: CN1720025A) a kind of wet granulation method is primarily characterized in that the part binding agent adds to earlier in the medicated powder with solid form, the binding agent granulation liquid that reuse is remaining; Carry out pelletizing press sheet; Though solved the wet granulation subproblem, its used adjuvant is more, and gabapentin content is also lower in the finished product; The external stripping of medicine is not very good yet, its method in essence with wet granulation zero difference repeatedly (just adding part binding agent dry method earlier); Chinese patent discloses (publication number: CN1321083A) a kind of method for preparing of gabapentin coated granule and application thereof; Relate to the gabapentin sheet with this publication method pelletizing press sheet, though extraordinary dissolution in vitro is arranged, maximum not enough tablet Chinese traditional medicine content is very few; And application accessory is (greater than 45%) too much; Use very inconvenience, do not meet the requirement of modern medicinal agents " three is little ", " three convenience ", also possibly cause stability of drug to change.
Because of the gabapentin safety is good, drug use dosage big (maximum consumption per day can reach 2.4g), too many like adjuvant in the product, certainly will cause the patient tolerability variation; According to reported in literature, gabapentin stripping outside intestinal absorbs desirable more than the enteral stripping again.A kind of gabapentin content is high, (0.06N hydrochloric acid), the easy gabapentin sheet of preparation are necessary to good, the external stripping of physical strength soon so provide.
Summary of the invention
Shortcoming and defect to above-mentioned prior art existence; The object of the invention at first is to provide a kind of can use the preparation of common wet granulation method, gabapentin content is high, physical strength is good, stripping gabapentin tablets fast, and second purpose provides the method for preparing of said gabapentin tablets.
Particularly, the inventor provides following technical scheme:
A kind of gabapentin tablets is mainly obtained through wet granulation by following weight percentages:
Gabapentin >=80.0%,
Low-substituted hydroxypropyl cellulose 4.0%~17.0%,
Binding agent 0.5%~2.5%,
Stabilizing agent 0.1%~2.5%,
Lubricant 0.5%~1.5%.
As preferably, according to a kind of gabapentin tablets of the present invention, wherein, the powder size of described gabapentin meets following requirement: granularity is no less than 50% less than 80 μ m, and granularity is no less than 80% less than 120 μ m.
Discover that the granularity of gabapentin raw material has a significant effect to formed product property and physical strength, but gabapentin is difficult to sieve after pulverizing; The way of prior art is: generally raw material is not pulverized; Directly use as raw material with crystallization, so, slice, thin piece mouldability variation; Strengthen slice, thin piece intensity so generally will increase the method for binding agent or coating raw material, thereby dissolution rate is slowed down.
Key character of the present invention is that raw material granularity is carried out strictness control.Being difficult to sieve after the gabapentin raw material pulverizing, is the reason that directly adopts drug crystallization in numerous public informations.Raw material process of the present invention is pulverized, but does not sieve, and the particle size range (by technology controlling and process) of regulation raw material, has saved the trouble of sieving, and makes the particle diameter of raw material be able to control again.Raw material can carry out the raw material pre-treatment with the method for mechanical activation comminution, and grinding mode can be modes such as shearing, grinding, and powder size meets following requirement: granularity is no less than 50% less than 80 μ m, and granularity is no less than 80% less than 120 μ m; More preferably granularity is no less than 60% less than 80 μ m, and granularity is no less than 90% less than 120 μ m.
Another key character of the present invention is to adopt the novel auxiliary material low-substituted hydroxypropyl cellulose, and in composition of raw materials, plays multiple function.Low-substituted hydroxypropyl cellulose (L-HPC) is insoluble in water and organic solvent, but in water swellable, and do not have much relations with pH value of solution, be its outstanding feature.On the one hand,, cohesive force is strengthened, so can be used as forming agent, make the slice, thin piece easy-formation, and outward appearance is bright and clean beautiful according to owing between its coarse structure and medicated powder and granule bigger tessellation is arranged; On the other hand, because powder has very big surface area and porosity, so quickened the moisture absorption degree, having increased swellability, is a kind of excellent disintegrating agent, can make the slice, thin piece disintegrate fast, thereby quickens the medicine stripping.The present invention prescription contains that low to get low hydroxypropyl cellulose be 4%~17%, is preferably 6.0%~11%.Described low-substituted hydroxypropyl cellulose, containing hydroxypropyl is 7.0%~16.0%, preferably containing hydroxypropyl is 10.0%~14.0%.
As preferably, according to a kind of gabapentin tablets of the present invention, wherein, described binding agent is dissolvable in water in the ethanol, is selected from: polyvidone and derivant thereof or cellulose derivative.Binder dosage is 0.5%~2.5%, is preferably 1.0%~2.0%.Described polyvidone and derivant thereof comprise: 30 POVIDONE K 30 BP/USP 15,30 POVIDONE K 30 BP/USP 25,30 POVIDONE K 30 BP/USP 30,30 POVIDONE K 30 BP/USP 60,30 POVIDONE K 30 BP/USP 90,30 POVIDONE K 30 BP/USP 120 and copolyvidone etc. are preferably 30 POVIDONE K 30 BP/USP 30 (K29/32); Described cellulose derivative comprises: ethyl cellulose, hydroxypropyl cellulose etc., be preferably hydroxypropyl cellulose, and the amount that contains hydroxypropyl is 53.4%~77.8%, its viscosity is: 1000cps~50000cps is preferably: 4000cps~15000cps.Relatively two types of binding agents are excellent with polyvidone and derivant thereof again.
As preferably, according to a kind of gabapentin tablets of the present invention, wherein; Described stabilizing agent is the oxirane base polymer; Comprise poloxamer (poloxamer), castor oil derivatives, be preferably poloxamer, poloxamer has the multiple type product can be through selecting for use; As 401,407,338,237,188,108 etc., preferred model is: 407 (F127).Stabilizing agent dosage is 0.1%~2.5%, is preferably 0.5%~1.5%.Castor oil derivatives comprises: glycerol polyethylene glycol Oleum Ricini, glycerol polyethylene glycol castor oil hydrogenated (RH40, RH60) etc.
As preferably, according to a kind of gabapentin tablets of the present invention, wherein, described lubricant is selected from one or more in magnesium stearate, stearic acid, Pulvis Talci, the micropowder silica gel etc.Consumption is a conventional amount used, is 0.5%~1.5%.
As preferably, according to a kind of gabapentin tablets of the present invention, wherein, the friability of described gabapentin tablets before coating not is not more than 0.5%.Friability in the optimization of C all is not more than 0.2%.
As preferably, according to a kind of gabapentin tablets of the present invention, wherein, described gabapentin tablets also comprises the gastric solubility coating material, is selected from hydroxypropyl cellulose, hypromellose, polyvidone etc.Hydroxypropyl cellulose more preferably.
As preferably, according to a kind of gabapentin tablets of the present invention, wherein, described gabapentin dissolution is that stripping in 15 minutes is not less than 85.0%.Another key character of the present invention is: described gabapentin tablets, and stripping in 15 minutes is not less than 85.0%, is preferably stripping in 15 minutes and is not less than 90.0%, and stripping in more preferably 15 minutes is not less than 95.0%.
Dissolution determination method: getting these article, is solvent according to dissolution method (two X C second methods of Chinese Pharmacopoeia version in 2010) with 0.06mol/L hydrochloric acid (51ml hydrochloric acid is diluted to 10L) 900ml; Revolution Per Minute 50 changes, and measures in accordance with the law, and it is an amount of to get solution; Filter, filtrating is as need testing solution.It is an amount of that other gets the gabapentin reference substance, and the solution suitable with need testing solution concentration is processed in the hydrochloric acid solution and the dilution that add 0.06mol/L, as reference substance solution.Draw each 50 μ l~100 μ l of above-mentioned reference substance solution and need testing solution, measure by following liquid phase chromatogram condition:
Use eight alkyl silane bonded silica gels to be filler; With pH6.9 phosphate buffer (get potassium dihydrogen phosphate 1.2g and add water to 940ml, stir and make dissolving, regulate medicinal liquid pH to 6.9 with the 5mol/L potassium hydroxide solution)-acetonitrile (940:60), flow velocity is 1.2ml/min; The detection wavelength is 210nm.
As preferably, according to a kind of gabapentin tablets of the present invention, wherein, described gabapentin tablets is 40 ℃, RH75% condition held 3 months, in the lactams content of gabapentin less than 0.2%.
The present invention also provides the method for preparing of above-mentioned a kind of gabapentin tablets, comprising: taking adhesive, add dissolve with ethanol, and process 5%~25% solution; Other gets gabapentin, pulverizes, and granularity is met the requirements, and with stabilizing agent and low-substituted hydroxypropyl cellulose mix homogeneously, adds the binding agent alcoholic solution and processes soft material; Cross 10 orders~20 orders, in 45 ℃~60 ℃ dryings, granulate adds lubricant; Mix homogeneously, tabletting, or bag film-coat promptly get.Gabapentin tablets of the present invention adopts common wet granulation method to prepare, and technology is simple, and cost is low.
Compared with prior art, the present invention has the following advantages:
The gabapentin raw material that the present invention adopts is through pulverizing, and tablet good moldability, physical strength are good, and can adopt common wet granulation method just can prepare, and prepares simple and easyly, has the low characteristics of cost.
Gabapentin tablets of the present invention has extraordinary dissolution in vitro, and the gabapentin medicament contg is high in the tablet, and application accessory is few, and is very easy to use, meets the requirement of modern medicinal agents " three is little ", " three convenience ".
The specific embodiment
Below in conjunction with embodiment, content of the present invention is described more specifically.Should be appreciated that enforcement of the present invention is not limited to following embodiment, all will fall into protection domain of the present invention any pro forma accommodation and/or the change that the present invention made.
In the present invention, if not refer in particular to, all part, percentage ratios are unit of weight, and all equipment and raw material etc. all can be buied from market or the industry is commonly used.Method among the following embodiment if no special instructions, is the conventional method of this area.
Reference examples
With external listing gabapentin tablets as reference examples (pfizer).Heavy and the specification calculating according to sheet, external product gabapentin content is 75%.
Embodiment 1
Per 1000 slice prescriptions:
Gabapentin 800.0 g (80.00%)
Low-substituted hydroxypropyl cellulose 170.0g (17.00%)
Hyprolose 10.0g (1.00%)
Poloxamer 10.0g (1.00%)
Magnesium stearate 10.0g (1.00%)
Preparation technology:
Get hyprolose, use dissolve with ethanol, process about 10% solution; Other gets gabapentin, pulverizes, and granularity is met the requirements, and (granularity is 52% less than 80 μ m; Granularity is 82% less than 120 μ m), with mistake 80 mesh sieve poloxamers and low-substituted hydroxypropyl cellulose mix homogeneously, add the soft material that the binding agent alcoholic solution is processed appropriateness; Cross 16 orders, in 55 ℃ of dryings, granulate; Add an amount of magnesium stearate, mix homogeneously, tabletting.
Result of the test:
1, friability: 0.07%.
2, lactams content: 0 day, ND (not detecting); 40 ℃, RH (60% ± 10%) 3 months, 0.076%.
Embodiment 2
Per 1000 slice prescriptions:
Gabapentin 800.0g (89.09%)
Low-substituted hydroxypropyl cellulose 71.3g (7.94%)
Hyprolose 8.9g (0.99%)
Poloxamer 8.9g (0.99%)
Magnesium stearate 8.9g (0.99%)
Preparation technology:
Get hyprolose, use dissolve with ethanol, process about 10% solution; Other gets gabapentin, pulverizes, and makes granularity meet the requirements (granularity is 61% less than 80 μ m, and granularity is 91% less than 120 μ m); With cross 80 mesh sieve poloxamers and low-substituted hydroxypropyl cellulose mix homogeneously, add the soft material that the binding agent alcoholic solution is processed appropriateness, mistake 16 orders; In 55 ℃ of dryings, granulate adds an amount of magnesium stearate; Mix homogeneously, tabletting, coating.
Result of the test:
1, uncoated tablets friability: 0.18%.
2, lactams content: 0 day, ND; 40 ℃, RH (60% ± 10%) 3 months, 0.10%.
3, dissolution table as a result
Figure 332676DEST_PATH_IMAGE003
Embodiment 3
Per 1000 slice prescriptions:
Gabapentin 800.0 g (80.00%)
Low-substituted hydroxypropyl cellulose 170.0g (17.00%)
30 POVIDONE K 30 BP/USP 30 10.0g (1.00%)
Poloxamer 10.0g (1.00%)
Magnesium stearate 10.0g (1.00%)
Preparation technology:
Get 30 POVIDONE K 30 BP/USP 30, use dissolve with ethanol, process about 10% solution; Other gets gabapentin, pulverizes, and granularity is met the requirements, and (granularity is 52% less than 80 μ m; Granularity is 82% less than 120 μ m), with mistake 80 mesh sieve poloxamers and low-substituted hydroxypropyl cellulose mix homogeneously, add the soft material that the binding agent alcoholic solution is processed appropriateness; Cross 16 orders, in 55 ℃ of dryings, granulate; Add an amount of magnesium stearate, mix homogeneously, tabletting.
Result of the test:
1, friability: 0.03%.
2, lactams content: 0 day, ND; 40 ℃, RH (60% ± 10%) 3 months, 0.082%.
Embodiment 4
Per 1000 slice prescriptions:
Gabapentin 800.0 g (89.09%)
Low-substituted hydroxypropyl cellulose 71.3g (7.94%)
30 POVIDONE K 30 BP/USP 30 4.5g (0.50%)
Poloxamer 8.9g (0.99%)
Magnesium stearate 13.3g (1.48%)
Preparation technology:
Get 30 POVIDONE K 30 BP/USP 30, use dissolve with ethanol, process about 10% solution; Other gets gabapentin, pulverizes, and makes granularity meet the requirements (granularity is 61% less than 80 μ m, and granularity is 91% less than 120 μ m); With cross 80 mesh sieve poloxamers and low-substituted hydroxypropyl cellulose mix homogeneously, add the soft material that the binding agent alcoholic solution is processed appropriateness, mistake 16 orders; In 55 ℃ of dryings, granulate adds an amount of magnesium stearate; Mix homogeneously, tabletting, coating.
Result of the test:
1, uncoated tablets friability: 0.09%.
2, lactams content: 0 day, ND; 40 ℃, RH (60% ± 10%) 3 months, 0.068%.
Figure 882737DEST_PATH_IMAGE005
Embodiment 5
Per 1000 slice prescriptions:
Gabapentin 800.0 g (85.02%)
Low-substituted hydroxypropyl cellulose 103.4g (10.99%)
Hyprolose 18.8g (2.00%)
Poloxamer 14.1g (1.50%)
Pulvis Talci 4.7g (0.50%)
Preparation technology:
Get hyprolose, use dissolve with ethanol, process about 20% solution; Other gets gabapentin, pulverizes, and makes granularity meet the requirements (granularity is 61% less than 80 μ m, and granularity is 91% less than 120 μ m); With cross 80 mesh sieve poloxamers and low-substituted hydroxypropyl cellulose mix homogeneously, add the soft material that the binding agent alcoholic solution is processed appropriateness, mistake 16 orders; In 55 ℃ of dryings, granulate adds Pulvis Talci; Mix homogeneously, tabletting, coating.
Result of the test:
1, uncoated tablets friability: 0.11%.
2, lactams content: 0 day, ND; 40 ℃, RH (60% ± 10%) 3 months, 0.084%.
Figure 406122DEST_PATH_IMAGE006
Embodiment 6
Per 1000 slice prescriptions:
Gabapentin 800.0 g (85.02%)
Low-substituted hydroxypropyl cellulose 103.4 g (10.99%)
30 POVIDONE K 30 BP/USP 30 18.8g (2.00%)
Poloxamer 4.7g (0.50%)
Magnesium stearate 14.1g (1.50%)
Preparation technology:
Get 30 POVIDONE K 30 BP/USP 30, use dissolve with ethanol, process about 20% solution; Other gets gabapentin, pulverizes, and makes granularity meet the requirements (granularity is 61% less than 80 μ m, and granularity is 91% less than 120 μ m); With cross 80 mesh sieve poloxamers and low-substituted hydroxypropyl cellulose mix homogeneously, add the soft material that the binding agent alcoholic solution is processed appropriateness, mistake 16 orders; In 55 ℃ of dryings, granulate adds an amount of magnesium stearate; Mix homogeneously, tabletting, coating.
Result of the test:
1, uncoated tablets friability: 0.09%.
2, lactams content: 0 day, ND; 40 ℃, RH (60% ± 10%) 3 months, 0.13%.
Embodiment 7
Per 1000 slice prescriptions:
Gabapentin 800.0g (90.91%)
Low-substituted hydroxypropyl cellulose 53.6g (6.09%)
30 POVIDONE K 30 BP/USP 30 17.6g (2.00%)
Poloxamer 4.4g (0.50%)
Magnesium stearate 4.4g (0.50%)
Preparation technology
Get 30 POVIDONE K 30 BP/USP 30, use dissolve with ethanol, process about 20% solution; Other gets gabapentin, pulverizes, and makes granularity meet the requirements (granularity is 61% less than 80 μ m, and granularity is 91% less than 120 μ m); With cross 80 mesh sieve poloxamers and low-substituted hydroxypropyl cellulose mix homogeneously, add the soft material that the binding agent alcoholic solution is processed appropriateness, mistake 16 orders; In 55 ℃ of dryings, granulate adds an amount of magnesium stearate; Mix homogeneously, tabletting, coating.
Result of the test:
1, uncoated tablets friability: 0.17%.
2, lactams content: 0 day, ND; 40 ℃, RH (60% ± 10%) 3 months, 0.11%.
Figure 649016DEST_PATH_IMAGE007
Embodiment 8
Per 1000 slice prescriptions:
Gabapentin 800.0g (90.99%)
Low-substituted hydroxypropyl cellulose 44.0g (5.00%)
30 POVIDONE K 30 BP/USP 30 22.0g (2.50%)
Poloxamer 8.8g (1.00%)
Magnesium stearate 4.4g (0.50%)
Preparation technology
Get 30 POVIDONE K 30 BP/USP 30, use dissolve with ethanol, process about 20% solution; Other gets gabapentin, pulverizes, and makes granularity meet the requirements (granularity is 61% less than 80 μ m, and granularity is 91% less than 120 μ m); With cross 80 mesh sieve poloxamers and low-substituted hydroxypropyl cellulose mix homogeneously, add the soft material that the binding agent alcoholic solution is processed appropriateness, mistake 16 orders; In 55 ℃ of dryings, granulate adds an amount of magnesium stearate; Mix homogeneously, tabletting, coating.
Result of the test:
1, uncoated tablets friability: 0.10%.
2, lactams content: 0 day, ND; 40 ℃, RH (60% ± 10%) 3 months, 0.091%.
Above-mentioned preferred embodiment just is used for explanation and explains content of the present invention not constituting the restriction to content of the present invention.Although the inventor has done in more detail the present invention and has enumerated; But; The content that those skilled in the art is disclosed according to summary of the invention part and embodiment can be made various modifications or/and additional or to adopt similar mode to substitute be obvious to described specific embodiment, and can realize technique effect of the present invention; Therefore, give unnecessary details no longer one by one here.The term that occurs among the present invention is used for the elaboration of technical scheme of the present invention and understanding are not construed as limiting the invention.

Claims (10)

1. gabapentin tablets is characterized in that mainly being obtained through wet granulation by following weight percentages:
Gabapentin >=80.0%,
Low-substituted hydroxypropyl cellulose 4.0%~17.0%,
Binding agent 0.5%~2.5%,
Stabilizing agent 0.1%~2.5%,
Lubricant 0.5%~1.5%.
2. a kind of gabapentin tablets according to claim 1 is characterized in that, the powder size of described gabapentin meets following requirement: granularity is no less than 50% less than 80 μ m, and granularity is no less than 80% less than 120 μ m.
3. a kind of gabapentin tablets according to claim 1 is characterized in that, described binding agent is dissolvable in water in the ethanol, is selected from: polyvidone and derivant thereof or cellulose derivative.
4. a kind of gabapentin tablets according to claim 1 is characterized in that, described stabilizing agent is the oxirane base polymer.
5. a kind of gabapentin tablets according to claim 1 is characterized in that described lubricant is selected from one or more in magnesium stearate, stearic acid, Pulvis Talci, the micropowder silica gel.
6. a kind of gabapentin tablets according to claim 1 is characterized in that, the friability of described gabapentin tablets before coating not is not more than 0.5%.
7. a kind of gabapentin tablets according to claim 1 is characterized in that described gabapentin tablets also comprises the gastric solubility coating material, is selected from hydroxypropyl cellulose, hypromellose, polyvidone.
8. a kind of gabapentin tablets according to claim 1 is characterized in that, described gabapentin dissolution is that stripping in 15 minutes is not less than 85.0%.
9. a kind of gabapentin tablets according to claim 1 is characterized in that, described gabapentin tablets is 40 ℃, RH75% condition held 3 months, in the lactams content of gabapentin less than 0.2%.
10. according to the method for preparing of one of claim 1-9 described a kind of gabapentin tablets, it is characterized in that described method for preparing comprises: taking adhesive, add dissolve with ethanol, process 5%~25% solution; Other gets gabapentin, pulverizes, and granularity is met the requirements, and with stabilizing agent and low-substituted hydroxypropyl cellulose mix homogeneously, adds the binding agent alcoholic solution and processes soft material; Cross 10 orders~20 orders, in 45 ℃~65 ℃ dryings, granulate adds lubricant; Mix homogeneously, tabletting, or bag film-coat promptly get.
CN2012101102770A 2012-04-16 2012-04-16 Gabapentin tablet and preparation method thereof Pending CN102688216A (en)

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CN103976966A (en) * 2014-05-20 2014-08-13 朱金强 Indomethacin tablet and preparation method thereof
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Publication number Priority date Publication date Assignee Title
CN103976966A (en) * 2014-05-20 2014-08-13 朱金强 Indomethacin tablet and preparation method thereof
CN114028352A (en) * 2021-11-30 2022-02-11 上海汉维生物医药科技有限公司 Gabapentin soft chewable tablet preparation as well as preparation method and application thereof

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Application publication date: 20120926