CN105434395B - Pregabalin capsule and preparation method thereof - Google Patents
Pregabalin capsule and preparation method thereof Download PDFInfo
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- CN105434395B CN105434395B CN201511014568.XA CN201511014568A CN105434395B CN 105434395 B CN105434395 B CN 105434395B CN 201511014568 A CN201511014568 A CN 201511014568A CN 105434395 B CN105434395 B CN 105434395B
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- pregabalin
- lactose
- capsule
- partial size
- meshes
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- AYXYPKUFHZROOJ-ZETCQYMHSA-N pregabalin Chemical compound CC(C)C[C@H](CN)CC(O)=O AYXYPKUFHZROOJ-ZETCQYMHSA-N 0.000 title claims abstract description 71
- 229960001233 pregabalin Drugs 0.000 title claims abstract description 63
- 239000002775 capsule Substances 0.000 title claims abstract description 38
- 238000002360 preparation method Methods 0.000 title claims abstract description 8
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims abstract description 32
- 239000008101 lactose Substances 0.000 claims abstract description 32
- 230000036961 partial effect Effects 0.000 claims abstract description 32
- 239000000314 lubricant Substances 0.000 claims abstract description 8
- 239000000853 adhesive Substances 0.000 claims abstract description 7
- 230000001070 adhesive effect Effects 0.000 claims abstract description 7
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims abstract description 6
- 239000003937 drug carrier Substances 0.000 claims abstract description 6
- 239000000843 powder Substances 0.000 claims description 16
- 239000002245 particle Substances 0.000 claims description 12
- 239000008187 granular material Substances 0.000 claims description 6
- 239000002994 raw material Substances 0.000 claims description 6
- 239000000463 material Substances 0.000 claims description 3
- 239000000945 filler Substances 0.000 claims 1
- 239000000203 mixture Substances 0.000 abstract description 10
- 238000004519 manufacturing process Methods 0.000 abstract description 3
- 238000007873 sieving Methods 0.000 abstract description 3
- 238000005516 engineering process Methods 0.000 abstract description 2
- 230000000052 comparative effect Effects 0.000 description 14
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 description 10
- 229920002472 Starch Polymers 0.000 description 5
- 235000019359 magnesium stearate Nutrition 0.000 description 5
- 239000008107 starch Substances 0.000 description 5
- 235000019698 starch Nutrition 0.000 description 5
- BTCSSZJGUNDROE-UHFFFAOYSA-N gamma-aminobutyric acid Chemical compound NCCCC(O)=O BTCSSZJGUNDROE-UHFFFAOYSA-N 0.000 description 3
- 208000004296 neuralgia Diseases 0.000 description 3
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 description 2
- 125000003178 carboxy group Chemical group [H]OC(*)=O 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 238000009833 condensation Methods 0.000 description 2
- 230000005494 condensation Effects 0.000 description 2
- 229960003692 gamma aminobutyric acid Drugs 0.000 description 2
- 125000002924 primary amino group Chemical group [H]N([H])* 0.000 description 2
- 238000005550 wet granulation Methods 0.000 description 2
- OGNSCSPNOLGXSM-UHFFFAOYSA-N (+/-)-DABA Natural products NCCC(N)C(O)=O OGNSCSPNOLGXSM-UHFFFAOYSA-N 0.000 description 1
- 108090000312 Calcium Channels Proteins 0.000 description 1
- 102000003922 Calcium Channels Human genes 0.000 description 1
- BHPQYMZQTOCNFJ-UHFFFAOYSA-N Calcium cation Chemical compound [Ca+2] BHPQYMZQTOCNFJ-UHFFFAOYSA-N 0.000 description 1
- 239000001856 Ethyl cellulose Substances 0.000 description 1
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 description 1
- 208000001640 Fibromyalgia Diseases 0.000 description 1
- 208000011688 Generalised anxiety disease Diseases 0.000 description 1
- 229920002153 Hydroxypropyl cellulose Polymers 0.000 description 1
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical compound C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 description 1
- 206010036376 Postherpetic Neuralgia Diseases 0.000 description 1
- 229920003081 Povidone K 30 Polymers 0.000 description 1
- -1 acyl Amine Chemical class 0.000 description 1
- 238000009098 adjuvant therapy Methods 0.000 description 1
- 239000002269 analeptic agent Substances 0.000 description 1
- 239000005557 antagonist Substances 0.000 description 1
- 230000000903 blocking effect Effects 0.000 description 1
- 229910001424 calcium ion Inorganic materials 0.000 description 1
- 239000006071 cream Substances 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 206010012601 diabetes mellitus Diseases 0.000 description 1
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 238000007908 dry granulation Methods 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000001037 epileptic effect Effects 0.000 description 1
- 235000019325 ethyl cellulose Nutrition 0.000 description 1
- 229920001249 ethyl cellulose Polymers 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 208000029364 generalized anxiety disease Diseases 0.000 description 1
- 239000008172 hydrogenated vegetable oil Substances 0.000 description 1
- 239000001863 hydroxypropyl cellulose Substances 0.000 description 1
- 235000010977 hydroxypropyl cellulose Nutrition 0.000 description 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 description 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 description 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 description 1
- 229960003943 hypromellose Drugs 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- 230000003902 lesion Effects 0.000 description 1
- 238000000034 method Methods 0.000 description 1
- 229920000609 methyl cellulose Polymers 0.000 description 1
- 239000001923 methylcellulose Substances 0.000 description 1
- 235000010981 methylcellulose Nutrition 0.000 description 1
- 238000002156 mixing Methods 0.000 description 1
- 201000006417 multiple sclerosis Diseases 0.000 description 1
- 239000002858 neurotransmitter agent Substances 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 239000000377 silicon dioxide Substances 0.000 description 1
- 208000020431 spinal cord injury Diseases 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/195—Carboxylic acids, e.g. valproic acid having an amino group
- A61K31/197—Carboxylic acids, e.g. valproic acid having an amino group the amino and the carboxyl groups being attached to the same acyclic carbon chain, e.g. gamma-aminobutyric acid [GABA], beta-alanine, epsilon-aminocaproic acid or pantothenic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention discloses a kind of Pregabalin capsules and preparation method thereof, it is made of Pregabalin, lactose and pharmaceutically acceptable carrier.The D50 partial size of the Pregabalin is 180 μm~220 μm, and D90 partial size is 250 μm~280 μm；The D50 partial size of the lactose is 120 μm~140 μm, and D90 partial size is 160 μm~180 μm.In the Pregabalin capsule, the weight percent of Pregabalin is 5%~50%, and the weight percent of lactose is 10%~60%.Pregabalin and lactose are first passed through sieving technology respectively and partial size appropriate are made by the present invention, the pharmaceutically acceptable carriers such as adhesive and lubricant are cooperated to prepare Pregabalin capsule again, the preferable Pregabalin capsule of mobility and stability and mixture homogeneity can be obtained, to be suitble to industrialized production.
Description
Technical field
The invention belongs to technical field of medicine, and in particular to a kind of Pregabalin capsule and preparation method thereof.
Background technique
Pregabalin belongs to non-γ-aminobutyric acid (GABA) receptor stimulating agent or antagonist, is that a kind of novel agents of calcium ion is logical
Road regulator, energy blocking voltage dependent calcium channel, reduces the release of neurotransmitter.Clinic is mainly used for Diabetic Peripheral mind
Through the related neuralgia of lesion, postherpetic neuralgia and adjuvant treatment the epileptic attack of adult partial's property, generalized anxiety disorder, in
Pivot neuralgia (including spinal cord injury, stroke and the adjoint neuralgia of multiple sclerosis) and fibromyalgia.
On the one hand, since there are primary amino groups and carboxyl for Pregabalin intramolecular, intramolecular condensation easily occurs and generates interior acyl
Amine, this intramolecular condensation phenomenon is more obvious especially under wet heat condition.And the primary amino group in Pregabalin is damp and hot
Under the conditions of be also easy to and mailland reaction occurs for carboxyl in lactose molecule.Therefore, wet granulation (is especially filling with lactose
The wet granulation of agent) be not suitable for preparing Pregabalin capsule.
On the other hand, the very poor compressibility of Pregabalin is but also dry granulation is difficult to reach to form particle improvement mobility
Purpose prepares Pregabalin capsule to be not suitable for use in.
Summary of the invention
The purpose of the present invention is to solve the above problem, provides one kind and has preferable mobility and stability and mixing
The uniformity, the Pregabalin capsule for being suitble to industrialized production and preparation method thereof.
Realizing the technical solution of above-mentioned purpose of the present invention is: a kind of Pregabalin capsule, it be by Pregabalin, lactose with
And pharmaceutically acceptable carrier is made.
It has been found that the particle size of Pregabalin and lactose for Pregabalin capsule mobility and stability with
And mixture homogeneity is affected, for this purpose, applicant finally found that by a large number of experiments: when the D50 partial size of Pregabalin is 180
μm~220 μm, D90 partial size is 250 μm~280 μm and the D50 partial size of lactose is 120 μm~140 μm, D90 partial size is 160 μm
At~180 μm, obtained Pregabalin capsule is had preferable mobility and stability and mixture homogeneity.
Above-mentioned pharmaceutically acceptable carrier is mainly adhesive and lubricant.
Applicant further found that in Pregabalin capsule otherwise the content of Pregabalin will affect Puri bar no more than 50%
The mobility and stability and mixture homogeneity of woods capsule, therefore, in above-mentioned Pregabalin capsule, the weight hundred of Pregabalin
Divide than being 5%~50%, preferably 20%~30%.
In above-mentioned Pregabalin capsule, the weight percent of lactose is 10%~60%, preferably 25%~35%.
In above-mentioned Pregabalin capsule, the weight percent of adhesive is 20%~80%, preferably 32%~48%；It is described viscous
Mixture is in starch, PVP K30, hydroxypropyl cellulose, hypromellose, methylcellulose and ethyl cellulose
One or two kinds of, preferably starch.
In above-mentioned Pregabalin capsule, the weight percent of lubricant is 1%~10%, preferably 3%~7%；The lubrication
Agent is selected from one of magnesium stearate, talcum powder, silica and hydrogenated vegetable oil or two kinds, preferably magnesium stearate.
The preparation method of above-mentioned Pregabalin capsule has follow steps:
1. Pregabalin raw material is crossed 30 mesh (600 μm of aperture) sieve on oscillating granulator, the Puri of 30 meshes will be crossed
Bahrain's raw material successively crosses 60 mesh (250 μm of aperture) sieve and 80 mesh (180 μm of aperture) sieve again, took 60 meshes and did not crossed 80 mesh
The pregabaline particles powder of sieve, it is spare；
2. being taken 80 mesh (180 μm of aperture) sieve and 120 mesh (120 μm of aperture) sieve is successively crossed on lactose earthquake sieve
It crosses 80 meshes and does not cross the lactose granule powder of 120 meshes, it is spare；
3. (D50 partial size is 180 μm~220 μm to the pregabaline particles powder for first 1. obtaining step, and D90 partial size is 250
μm~280 μm) be uniformly mixed on Mixers with Multi-direction Movement with adhesive, the cream that then 2. addition lubricant and step obtain
Sugared particle powder (D50 partial size is 120 μm~140 μm, and D90 partial size is 160 μm~180 μm), continuess to mix uniformly, will finally mix
It closes uniform material and directly filling obtains Pregabalin capsule on fully-automatic capsule filling machine.
The good effect that the present invention has: Pregabalin and lactose are first passed through sieving technology respectively and are made appropriate by the present invention
Partial size, then the pharmaceutically acceptable carriers such as adhesive and lubricant is cooperated to prepare Pregabalin capsule, can be flowed
Property and stability and the preferable Pregabalin capsule of mixture homogeneity, to be suitble to industrialized production.
Specific embodiment
(embodiment 1)
The Pregabalin capsule of the present embodiment contains Pregabalin 0.025g, lactose 0.030g, the starch as adhesive
0.040g and magnesium stearate 0.005g as lubricant.
The preparation method of the Pregabalin capsule of the present embodiment has follow steps:
1. Pregabalin raw material is crossed 30 mesh (600 μm of aperture) sieve on oscillating granulator, the Puri of 30 meshes will be crossed
Bahrain's raw material successively crosses 60 mesh (250 μm of aperture) sieve and 80 mesh (180 μm of aperture) sieve again, took 60 meshes and did not crossed 80 mesh
The pregabaline particles powder of sieve, it is spare.
2. being taken 80 mesh (180 μm of aperture) sieve and 120 mesh (120 μm of aperture) sieve is successively crossed on lactose earthquake sieve
It crosses 80 meshes and does not cross the lactose granule powder of 120 meshes, it is spare.
3. (D50 partial size is 180 μm~220 μm to the pregabaline particles powder for first 1. obtaining 250g step, D90 partial size
It is 250 μm~280 μm) 5min, revolving speed 30rpm are mixed on Mixers with Multi-direction Movement with 400g starch (crossing 80 meshes)；So
Be added afterwards 2. lactose granule powder that 50g magnesium stearate (sieving with 100 mesh sieve) and 300g step obtain (D50 partial size is 120 μm~
140 μm, D90 partial size is 160 μm~180 μm), 10min, revolving speed 30rpm are continuesd to mix, is uniformly mixed；It will finally mix equal
Even material is directly filling on fully-automatic capsule filling machine to obtain Pregabalin capsule, and 10000 (1000g in total) are made,
Every 0.1g.
(2~embodiment of embodiment 3)
Each embodiment is substantially the same manner as Example 1, and difference is shown in Table 1.
Table 1
| Embodiment 1 | Embodiment 2 | Embodiment 3 | |
| Pregabalin | 0.025g | 0.020g | 0.030g |
| Lactose | 0.030g | 0.025g | 0.035g |
| Starch | 0.040g | 0.048g | 0.032g |
| Magnesium stearate | 0.005g | 0.007g | 0.003g |
(1~comparative example of comparative example 4)
Each comparative example is substantially the same manner as Example 1, and difference is shown in Table 2.
Table 2
| Embodiment 1 | Comparative example 1 | Comparative example 2 | Comparative example 3 | Comparative example 4 | |
| Pregabalin D50 partial size | 180 μm~220 μm | 180 μm~220 μm | 180 μm~220 μm | 120 μm~150 μm | 250 μm~280 μm |
| Pregabalin D90 partial size | 250 μm~280 μm | 250 μm~280 μm | 250 μm~280 μm | 180 μm~200 μm | 380 μm~400 μm |
| Lactose D50 partial size | 120 μm~140 μm | 180 μm~200 μm | 80 μm~100 μm | 120 μm~140 μm | 120 μm~140 μm |
| Lactose D90 partial size | 160 μm~180 μm | 230 μm~250 μm | 110 μm~130 μm | 160 μm~180 μm | 160 μm~180 μm |
Wherein:
The lactose of comparative example 1 was 60 meshes and the D50 partial size of 80 meshes excessively is not 180 μm~200 μm, D90 partial size is
230 μm~250 μm of lactose granule powder.
The lactose of comparative example 2 was 120 meshes and the D50 partial size of 160 meshes excessively is not 80 μm~100 μm, D90 partial size is
110 μm~130 μm of lactose granule powder.
The Pregabalin of comparative example 3 was 80 meshes and did not crossed the D50 partial size of 120 meshes to be 120 μm~150 μm, D90
The pregabaline particles powder that diameter is 180 μm~200 μm.
The Pregabalin of comparative example 4 was 40 meshes and did not crossed the D50 partial size of 60 meshes to be 250 μm~280 μm, D90
The pregabaline particles powder that diameter is 380 μm~400 μm.
(test example)
Mobility, mixture homogeneity and Detection of Stability are carried out to Pregabalin capsule made from embodiment 1, as a result seen
Table 3.
(comparative experimental example)
Mobility, mixture homogeneity and stability inspection are carried out to Pregabalin capsule made from 1~comparative example of comparative example 4
It surveys, is as a result equally shown in Table 3.
Table 3
Claims (3)
1. a kind of Pregabalin capsule, it is made of Pregabalin, lactose and pharmaceutically acceptable carrier；Its feature exists
In: the D50 partial size of the Pregabalin is 180 μm~220 μm, and D90 partial size is 250 μm~280 μm；The D50 grain of the lactose
Diameter is 120 μm~140 μm, and D90 partial size is 160 μm~180 μm；
In the Pregabalin capsule, the weight percent of Pregabalin is 5%~50%, the weight percent of lactose is 10%~
60%。
2. Pregabalin capsule according to claim 1, it is characterised in that: in the Pregabalin capsule, Pregabalin
Weight percent be 20%~30%, the weight percent of lactose is 25%~35%.
3. a kind of preparation method of Pregabalin capsule described in claim 1, it is characterised in that have follow steps:
1. Pregabalin raw material is crossed 30 mesh screens on oscillating granulator, the Pregabalin raw materials of 30 meshes successively mistake again will be crossed
60 mesh screens and 80 mesh screens took 60 meshes and did not crossed the pregabaline particles powder of 80 meshes, spare；
2. taking 80 meshes by 80 mesh screens and 120 mesh screens are successively crossed on lactose earthquake sieve and not crossing the lactose of 120 meshes
Particle powder, it is spare；
3. first 1. pregabaline particles powder that step obtains is uniformly mixed on Mixers with Multi-direction Movement with adhesive, then
2. lactose granule powder that addition lubricant and step obtain continuess to mix uniformly, finally by uniformly mixed material complete
It is directly filling on automatic capsule filler to obtain Pregabalin capsule；
In the Pregabalin capsule, the weight percent of Pregabalin is 5%~50%, the weight percent of lactose is 10%~
60%。
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201511014568.XA CN105434395B (en) | 2015-12-31 | 2015-12-31 | Pregabalin capsule and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201511014568.XA CN105434395B (en) | 2015-12-31 | 2015-12-31 | Pregabalin capsule and preparation method thereof |
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| Publication Number | Publication Date |
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| CN105434395A CN105434395A (en) | 2016-03-30 |
| CN105434395B true CN105434395B (en) | 2018-12-11 |
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Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2019238068A1 (en) | 2018-06-13 | 2019-12-19 | 北京泰德制药股份有限公司 | Sustained-release pregabalin composition and preparation method therefor |
| CN110613694A (en) * | 2019-10-18 | 2019-12-27 | 杭州百诚医药科技股份有限公司 | Pregabalin capsule and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2002078747A2 (en) * | 2001-03-30 | 2002-10-10 | Warner-Lambert Company Llc | Pregabalin lactose conjugates |
| CN102793685A (en) * | 2012-08-14 | 2012-11-28 | 浙江华海药业股份有限公司 | Oral capsule containing pregabalin and preparation method thereof |
| CN103494796A (en) * | 2013-09-30 | 2014-01-08 | 浙江华义医药有限公司 | Stable pharmaceutical composition of pregabalin and preparation method thereof |
-
2015
- 2015-12-31 CN CN201511014568.XA patent/CN105434395B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2002078747A2 (en) * | 2001-03-30 | 2002-10-10 | Warner-Lambert Company Llc | Pregabalin lactose conjugates |
| CN102793685A (en) * | 2012-08-14 | 2012-11-28 | 浙江华海药业股份有限公司 | Oral capsule containing pregabalin and preparation method thereof |
| CN103494796A (en) * | 2013-09-30 | 2014-01-08 | 浙江华义医药有限公司 | Stable pharmaceutical composition of pregabalin and preparation method thereof |
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