CN104352476A - Gabapentin capsule and preparation method thereof - Google Patents
Gabapentin capsule and preparation method thereof Download PDFInfo
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- CN104352476A CN104352476A CN201410562196.3A CN201410562196A CN104352476A CN 104352476 A CN104352476 A CN 104352476A CN 201410562196 A CN201410562196 A CN 201410562196A CN 104352476 A CN104352476 A CN 104352476A
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Abstract
The invention relates to a gabapentin capsule and a preparation method thereof. The gabapentin capsule comprises the following components: 150-300 g of gabapentin, 100-600 g of low substituted hydroxy propyl cellulose, 50-100 g of cross-linking polyvidone, 20-50 g of dodecyl sodium sulphate, 10-50 g of hydroxypropyl methylcellulose and 2-8 g of magnesium stearate. The gabapentin capsule disclosed by the invention is reasonable in recipe, feasible in technology, stable and reliable in quality, better in stability, better in dissolution and better in bioavailability. The method which comprises the steps of adopting a wet granulation technology and adding solubilizer, i.e., the dodecyl sodium sulphate for preparing the gabapentin capsule is proper, the concentration of an adhesive is proper, the gabapentin belongs to powder with better flowability, and the requirement for filling the capsule with gabapentin can be satisfied. The production cycle is short, the production cost is low, and the industrialized production is facilitated.
Description
Invention field
The present invention relates to a kind of pharmaceutical preparation for the treatment of epilepsy and preparation method thereof, belong to neurosurgery or department of general surgery's class disease medication, be specifically related to a kind of gabapentin capsule and preparation method thereof.
Background of invention
Gabapentin tablet quality standard is recorded in American Pharmacopeia 32 editions (USP32), goes on the market and widely use in American-European countries, and domestic also have gabapentin sheet to go on the market.This product was epilepsy therapy medicine originally, single drug: be applicable to suffer from simple or the adult of complexity partial seizures and child's (comprise and newly diagnose patient) of more than 12 years old treatment, can with or without secondary generalized seizures; Drug combination: suffer from partial seizures with or without the child of more than 3 years old and 3 years old of secondary generalized seizures and adult.Found that gabapentin had definite curative effect to various neuralgia afterwards, this product existing has become the neuralgic standard pharmaceutical for the treatment of.
First gabapentin sheet is gone on the market by Pfizer, prescription is except active ingredient, adjuvant is made up of corn starch, hyprolose, poloxamer, copolyvidone, magnesium stearate, wherein gabapentin content about 75%, copolyvidone is dry adhesives, and hyprolose is dissolved in as wet granulation binding agent in こ alcohol, for increasing mouldability and the physics Strong degree of slice, thin piece, therefore add more bonding drug, but dissolution rate is reduced.Domestic commercialized product gabapentin sheet, product gabapentin content is about 62%, and In vitro dissolution rate is also slower.US Patent No. 6, 294, the prescription of the gabapentin sheet of 198B1 Gong Kai ー kind high-load and preparation method, its slice, thin piece is containing gabapentin more than 76%, this patent thinks that gabapentin material is the main cause of high content tablets insufficient formability with crystal form existence, therefore adopt spraying semar technique to prepare granule, main purpose improves the physical strength of slice, thin piece, to can yet be regarded as a kind of ideal preparation method, but 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 is greater than 80%, and patent is because will increase slice, thin piece intensity, employ relatively large cellulose and make drug particle be embedded in macromolecular material, therefore to product stripping, requirements at the higher level cannot be proposed, in addition, the change of raw material granularity to product physical property is also studied in that patent.Chinese patent discloses (publication number: CN1720025A)-kind of wet granulation method, be primarily characterized in that some adhesive first adds in medicated powder in solid form, again by remaining binding agent granulation liquid, carry out pelletizing press sheet, though solve wet granulation subproblem, but its adjuvant used is more, in finished product, gabapentin content is also lower, vitro Drug stripping is not very good yet, its method in essence with repeatedly wet granulation zero difference (just first some adhesive dry method being added); The preparation method of Chinese patent discloses (publication number: CN1321083A) a kind of gabapentin coated granule and application thereof, relate to the gabapentin sheet with the disclosure patented method pelletizing press sheet, although there is extraordinary dissolution in vitro, but maximum not enough tablet Chinese traditional medicine content is very few, and application accessory too much (being greater than 45%), it is very inconvenient to use, and does not meet the requirement of modern medicinal agents " three is little ", " three convenience ", and the stability of medicine also may be caused to change.
Because gabapentin safety is good, drug use dosage large (maximum consumption per day can reach 2.4g), as adjuvant in product is too many, patient tolerability certainly will be caused to be deteriorated; Again according to reported in literature, comparatively enteral stripping absorption is more desirable in the outer stripping of intestinal for gabapentin.Therefore Ti Gong ー kind gabapentin content is high, physical strength good, In Vitro Dissolution fast (0.06N hydrochloric acid), to prepare easy gabapentin capsule be necessary.
Therefore, be necessary to provide a kind of applicable industrialized, the Peroral solid dosage form capsule of pharmaceutical composition stability can be improved.
Gabapentin material is crystalloid powder particle, owing to there is poor compressibility, makes not easily to set up the techniques such as industrialized, that cost is low tabletting or dry granulation.
Prior art improves the stripping of gabapentin usually by the kind of the consumption or increase disintegrating agent that increase disintegrating agent.The first object of the present invention is to provide a kind of gabapentin capsule, this capsule only uses a kind of disintegrating agent, product is not only made to have good stability, guarantee that product is after accelerated test, its disintegrating property is good, the dissolution of product also improves a lot, and has better bioavailability.
Summary of the invention
The first object of the present invention is to provide a kind of gabapentin capsule, this capsule only uses a kind of disintegrating agent, product is not only made to have good stability, guarantee that product is after accelerated test, its disintegrating property is good, the dissolution of product also improves a lot, and has better bioavailability.
The second object of the present invention is the preparation method providing described gabapentin capsule, and its preparation technology is simple, convenient, feasible, favorable reproducibility, and said composition has stronger practicality.
The object of the present invention is to provide a kind of can the capsule preparations improving gabapentin stability and preparation method thereof, and through repetition test by each component screening to weight ratio of the present invention, be surprised to find that the dispersible tablet steady quality obtained, stripping is fast, distribution in vivo is rapid, and bioavailability is high.
On the one hand, the invention provides a kind of gabapentin capsule, wherein, described gabapentin capsule is made up of following component:
Gabapentin 150 ~ 300g
Low-substituted hydroxypropyl cellulose 100 ~ 600g
Polyvinylpolypyrrolidone 50 ~ 100g
Sodium lauryl sulphate 20 ~ 50g
Hypromellose 10 ~ 50g
Magnesium stearate 2 ~ 8g
Make 1000.
Some embodiments wherein, gabapentin capsule of the present invention, wherein, described gabapentin capsule is made up of following component:
Gabapentin 300g
Low-substituted hydroxypropyl cellulose 600g
Polyvinylpolypyrrolidone 60g
Sodium lauryl sulphate 40g
Hypromellose 40g
Magnesium stearate 5g
Make 1000.
Some embodiments wherein, gabapentin capsule of the present invention, wherein, described gabapentin capsule is made up of following component:
Gabapentin 300g
Low-substituted hydroxypropyl cellulose 500g
Polyvinylpolypyrrolidone 100g
Sodium lauryl sulphate 50g
Hypromellose 30g
Magnesium stearate 7.5g
Make 1000.
On the other hand, the present invention relates to a kind of preparation method of gabapentin capsule, described method comprises the steps: 1) binding agent preparation: the sodium lauryl sulphate and the hypromellose that take described consumption, be dissolved in water, and is mixed with the solution of 10% hypromellose; 2) sieve: adjuvant low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone and magnesium stearate cross 60 mesh sieves respectively; 3) granulate with dry: the gabapentin material medicine taking described consumption is put in mixer, adds above-mentioned binding agent soft material, then granulates with granulator; Wet granular at 40 DEG C ~ 45 DEG C after dry 1 ~ 3 hour, granulate; 4) mix: above-mentioned granule is put in mixer, adds the low-substituted hydroxypropyl cellulose of described consumption, polyvinylpolypyrrolidone and magnesium stearate, mix 30 minutes, sampling and measuring content and loss on drying; 5) filling: calculate average loading amount by particle content measuring result, filling, controls content uniformity within scholar 5%; 6) pack: intermediate products after testing content uniformity, content and dissolution qualified after, aluminum-plastic packaged, then through outer package, obtain above-mentioned gabapentin capsule.
Some embodiments wherein, preparation method of the present invention, wherein, described sodium lauryl sulphate is dissolved in hypromellose, adds in wet-granulation process; Described low-substituted hydroxypropyl cellulose adopts outside granule and adds.
Some embodiments wherein, preparation method of the present invention, wherein, described method also comprises carries out pretreated process to gabapentin, described pretreatment refers to that gabapentin first carries out following pretreatment before inserting mixer: i) be dissolved in ethanol by gabapentin, obtains gabapentin alcoholic solution; Ii) get that hypromellose is soluble in water is made into hypromellose aqueous solution; Iii) by step I i) hypromellose aqueous solution insert in ice-water bath, under ultrasonic condition, gabapentin alcoholic solution Uniform speed is added dropwise in hypromellose aqueous solution, becomes muddy to solution system, leave standstill, filter, dry, pulverize and sieve.
In other embodiments, preparation method of the present invention, wherein, step I) in the concentration of gabapentin alcoholic solution be 0.01g/ml.
In other embodiments, preparation method of the present invention, wherein, step I i) concentration of hypromellose cellulose solution is 5%.
In other embodiments, preparation method of the present invention, wherein, step I ii) described in ultrasonic frequency be 0.4KW; The temperature of described ice-water bath is 0-5 DEG C, and the speed that described Uniform speed drips is 1.5ml/min, describedly leaves standstill as leaving standstill 6 hours at 0-5 DEG C, described in sieve as crossing 80 mesh sieves.
In the component of gabapentin capsule of the present invention, wherein, described sodium lauryl sulphate is dissolved in hypromellose, adds in wet-granulation process.
Crude drug gabapentin is almost insoluble in water, in prescription of the present invention, select adjuvant sodium lauryl sulphate as solubilizing agent, its consumption is 20 ~ 50 parts, consumption is relatively less, if adopt powder directly to add, its solubilizing effect is very poor, if be dissolved in binding agent, add in wet-granulation process, then can ensure that it is well dispersed in crude drug surface, solve the shortcoming that gabapentin material medicine hydrophobicity is excessively strong, thus medicated powder fully contacts with dissolution medium after ensureing capsule shells disintegrate, reach the object accelerating drug-eluting.Therefore, the present invention adopts wet granulation technology, and is dissolved in binding agent by sodium lauryl sulphate and adds.
In the component of gabapentin capsule of the present invention, wherein, described low-substituted hydroxypropyl cellulose adopts the mode added outside granule to add.
Gabapentin capsule of the present invention is adopted and is prepared with the following method:
1) binding agent preparation: the sodium lauryl sulphate and the hypromellose that take described consumption, be dissolved in water, and is mixed with the solution of 10% hypromellose;
2) sieve: adjuvant low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone and magnesium stearate cross 60 mesh sieves respectively;
3) granulate with dry: the gabapentin material medicine taking described consumption is put in mixer, adds above-mentioned binding agent soft material, then granulates with granulator; Wet granular at 40 DEG C ~ 45 DEG C after dry 1 ~ 3 hour, granulate;
4) mix: above-mentioned granule is put in mixer, adds the low-substituted hydroxypropyl cellulose of described consumption, polyvinylpolypyrrolidone and magnesium stearate, mix 30 minutes, sampling and measuring content and loss on drying;
5) filling: calculate average loading amount by particle content measuring result, filling, controls content uniformity within ± 5%;
6) pack: intermediate products after testing content uniformity, content and dissolution qualified after, aluminum-plastic packaged, then through outer package, obtain above-mentioned gabapentin capsule.
The process in leaching of oral insoluble drug is the key factor limiting its absorption and bioavailability, and in general, the dissolution rate of medicine and the particle diameter of drug particles are inverse relation, so the particle diameter of reduction insoluble drug granule is to improve its dissolution rate.Therefore in the preparation process of oral tablet and capsule, all certain requirement is had to crude drug phase analyzed laser-light scattering.The method of conventional reduction drug particles granularity mainly contains: the methods such as low-temperature airflow comminuting method, ball-milling method, solid dispersion method.In preparation method of the present invention, gabapentin first carries out as above pretreatment before inserting mixer, by gabapentin pretreatment in hypromellose cellulose solution, and carry out stripping contrast experiment and bioavailability experiment, surprisingly find that gabapentin all has significant difference in stripping and bioavailability after above-mentioned preprocess method process.Analyze reason, possibility gabapentin release in vitro quickening after pretreatment in surfactant solution on the one hand may be that SURFACTANT ADSORPTION, on hydrophobic drug surface, adds the wettability of medicine in preprocessing process.Observe in stripping experiment, untreated gabapentin swims in solution surface, and the gabapentin processed then wetted being distributed in dissolution medium soon goes; On the other hand may because gabapentin material medicine be under ultrasonic condition, after surfactant solution process, its particle diameter diminishes, and this may be the another kind of reason improving dissolution and bioavailability.
Also comprise in the preferred preparation method of the present invention and carry out pretreated process to gabapentin, described pretreatment refers to that gabapentin first carries out following pretreatment before inserting mixer:
I) gabapentin is dissolved in ethanol, obtains gabapentin alcoholic solution;
Ii) get that hypromellose is soluble in water is made into hypromellose aqueous solution;
Iii) by step I i) hypromellose aqueous solution insert in ice-water bath, under ultrasonic condition, gabapentin alcoholic solution is at the uniform velocity added dropwise in hypromellose aqueous solution, becomes muddy to solution system, leave standstill, filter, dry, pulverize and sieve.
According to aforesaid preparation method, wherein, step I) in the concentration of gabapentin alcoholic solution be 0.12g/ml.
According to aforesaid preparation method, wherein, step I i) in the concentration of hypromellose cellulose solution be 5%.
According to aforesaid preparation method, wherein, step I ii) described in ultrasonic frequency be 0.4KW; The temperature of described ice-water bath is 0-5 DEG C, and the described speed at the uniform velocity dripped is 1.5ml/min, described leave standstill at 0-5 DEG C leave standstill 6 hours, described in sieve into cross 80 mesh sieves.
In preferred version provided by the present invention, before inserting mixer, first adopted by gabapentin the method for the invention to carry out as above pretreatment, namely under ultrasonic condition, by the pretreatment in hypromellose cellulose solution of gabapentin material medicine, by stripping contrast experiment and bioavailability experiment, surprisingly find that gabapentin all has significant difference in dissolution and bioavailability after above-mentioned preprocess method process.
Detailed description of the invention
Explain the present invention further below in conjunction with embodiment, but embodiment does not limit in any form to the present invention.
Embodiment 1
Prescription:
Gabapentin 300g
Low-substituted hydroxypropyl cellulose 600g
Polyvinylpolypyrrolidone 60g
Sodium lauryl sulphate 40g
Hypromellose 40g
Magnesium stearate 5g
Make 1000.
Preparation method:
(1) binding agent preparation: the sodium lauryl sulphate and the hypromellose that take recipe quantity, be dissolved in water, and is mixed with the solution of 10% hypromellose;
(2) sieve: adjuvant low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone and magnesium stearate cross 60 mesh sieves respectively;
(3) granulate with dry: take recipe quantity and put in mixer through pretreated gabapentin material medicine, add above-mentioned binding agent soft material, then granulate with granulator; Wet granular at 40 DEG C ~ 45 DEG C after dry 1 ~ 3 hour, granulate;
(4) mix: above-mentioned granule is put in mixer, adds the low-substituted hydroxypropyl cellulose of recipe quantity, polyvinylpolypyrrolidone and magnesium stearate, mix 30 minutes, sampling and measuring content and loss on drying;
(5) filling: calculate average loading amount by particle content measuring result, filling, controls content uniformity within ± 5%;
(6) pack: intermediate products after testing content uniformity, content and dissolution qualified after, aluminum-plastic packaged, then through outer package, obtain above-mentioned gabapentin capsule.
Embodiment 2
Prescription:
Gabapentin 300g
Low-substituted hydroxypropyl cellulose 500g
Polyvinylpolypyrrolidone 100g
Sodium lauryl sulphate 50g
Hypromellose 30g
Magnesium stearate 7.5g
Make 1000.
Preparation method is with embodiment 1.
Embodiment 3
Prescription:
Gabapentin 300g
Low-substituted hydroxypropyl cellulose 600g
Polyvinylpolypyrrolidone 100g
Sodium lauryl sulphate 30g
Hypromellose 50g
Magnesium stearate 8g
Make 1000.
Preparation method is with embodiment 1.
Biological test
Test example 1
Check the gabapentin capsule prepared by the embodiment of the present invention, its result is as follows:
Table 1 embodiment assay
Above-mentioned assay shows, embodiment sample all conforms to quality requirements, show gabapentin capsule prescription of the present invention rationally, feasible process, stable, product quality is controlled, show simultaneously, gabapentin capsule dissolubility obtained after preprocess method pretreatment of the present invention is high, and single mixing is less than undressed with total assorted content, and active component content is high.
Test example 2
The mensuration of dissolution
1, reagent
By test preparation 1: the gabapentin capsule of the embodiment of the present invention 1.
By test preparation 2: the gabapentin capsule of the embodiment of the present invention 2.
Reference preparation: commercially available gabapentin capsule (the permanent auspicious medicine in Jiangsu, specification: 300mg).
2, assay method
Get this product, according to dissolution method (China's coastal port two annex) (C first method), with the phosphate buffer 900ml of pH6.8 for solvent, rotating speed is 100 turns per minute, operate in accordance with the law, 5, 10, 15, 30, 45, 60 minutes, get solution 10ml to filter, and supplement the phosphate buffer 1 0ml of the pH6.8 of identical temperature, precision measures subsequent filtrate 2ml and puts in 10ml measuring bottle, add the phosphate buffer of pH6.8 to scale, shake Uniform, according to spectrophotography (China's coastal port two annex IV A), trap is measured at the wavelength place of 251nm, separately get gabapentin reference substance appropriate, accurately weighed, dissolve with the phosphate buffer of pH6.8 and be diluted to the solution about containing 20 μ g in every 1ml, being measured in the same method, calculating accumulation stripping quantity.Measurement result is in table 2.
Table 2 gabapentin capsule accumulation dissolution (%)
Product | 5min | 10min | 15min | 20min | 30min | 45min |
By test preparation 1 | 85.3 | 86.7 | 91.3 | 93.2 | 96.4 | 99.0 |
By test preparation 2 | 82.5 | 85.6 | 90.2 | 92.4 | 95.7 | 98.2 |
Reference preparation | 50.5 | 61.3 | 70.6 | 83.6 | 90.0 | 98.5 |
As can be seen from the above results, by test preparation 1 and by the accumulation dissolution of the test preparation 2 i.e. gabapentin capsule of the embodiment of the present invention 1 and embodiment 2 apparently higher than reference preparation.
Also carried out above-mentioned identical test to the gabapentin capsule of the embodiment of the present invention 3, its result obtained is similar.
Claims (9)
1. a gabapentin capsule, wherein, described gabapentin capsule is made up of following component:
2. gabapentin capsule according to claim 1, wherein, described gabapentin capsule is made up of following component:
3. gabapentin capsule according to claim 1, wherein, described gabapentin capsule is made up of following component:
4. the preparation method of the gabapentin capsule described in an any one of claim 1-3, described method comprises the steps: 1) binding agent preparation: the sodium lauryl sulphate and the hypromellose that take described consumption, be dissolved in water, be mixed with the solution of 10% hypromellose; 2) sieve: adjuvant low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone and magnesium stearate cross 60 mesh sieves respectively; 3) granulate with dry: the gabapentin material medicine taking described consumption is put in mixer, adds above-mentioned binding agent soft material, then granulates with granulator; Wet granular at 40 DEG C ~ 45 DEG C after dry 1 ~ 3 hour, granulate; 4) mix: above-mentioned granule is put in mixer, adds the low-substituted hydroxypropyl cellulose of described consumption, polyvinylpolypyrrolidone and magnesium stearate, mix 30 minutes, sampling and measuring content and loss on drying; 5) filling: calculate average loading amount by particle content measuring result, filling, controls content uniformity within scholar 5%; 6) pack: intermediate products after testing content uniformity, content and dissolution qualified after, aluminum-plastic packaged, then through outer package, obtain above-mentioned gabapentin capsule.
5. preparation method according to claim 4, wherein, described sodium lauryl sulphate is dissolved in hypromellose, adds in wet-granulation process; Described low-substituted hydroxypropyl cellulose adopts outside granule and adds.
6. preparation method according to claim 4, wherein, described method also comprises carries out pretreated process to gabapentin, and described pretreatment refers to that gabapentin first carries out following pretreatment before inserting mixer: i) be dissolved in ethanol by gabapentin, obtains gabapentin alcoholic solution; Ii) get that hypromellose is soluble in water is made into hypromellose aqueous solution; Iii) by step I i) hypromellose aqueous solution insert in ice-water bath, under ultrasonic condition, gabapentin alcoholic solution Uniform speed is added dropwise in hypromellose aqueous solution, becomes muddy to solution system, leave standstill, filter, dry, pulverize and sieve.
7. preparation method according to claim 6, wherein, step I) in the concentration of gabapentin alcoholic solution be 0.01g/ml.
8. preparation method according to claim 6, wherein, step I i) concentration of hypromellose cellulose solution is 5%.
9. preparation method according to claim 6, wherein, step I ii) described in ultrasonic frequency be 0.4KW; The temperature of described ice-water bath is 0-5 DEG C, and the speed that described Uniform speed drips is 1.5ml/min, describedly leaves standstill as leaving standstill 6 hours at 0-5 DEG C, described in sieve as crossing 80 mesh sieves.
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Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN112843015A (en) * | 2021-04-08 | 2021-05-28 | 海南鑫开源医药科技有限公司 | Gabapentin capsule preparation and preparation method thereof |
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CN1449750A (en) * | 2003-05-12 | 2003-10-22 | 徐州恩华药业集团有限责任公司 | Gabapentin slow -released composition |
CN103385869A (en) * | 2012-05-09 | 2013-11-13 | 鲁南制药集团股份有限公司 | Medical application of gabapentin |
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2014
- 2014-10-21 CN CN201410562196.3A patent/CN104352476A/en active Pending
Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
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CN1300213A (en) * | 1998-05-15 | 2001-06-20 | 沃尼尔·朗伯公司 | Gamma-contained aminobutyric acid derivatives solid compositions and preparation process thereof |
CN1449750A (en) * | 2003-05-12 | 2003-10-22 | 徐州恩华药业集团有限责任公司 | Gabapentin slow -released composition |
CN103385869A (en) * | 2012-05-09 | 2013-11-13 | 鲁南制药集团股份有限公司 | Medical application of gabapentin |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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CN112843015A (en) * | 2021-04-08 | 2021-05-28 | 海南鑫开源医药科技有限公司 | Gabapentin capsule preparation and preparation method thereof |
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