CN107998074A - Pregabalin oral administration solution and preparation method thereof - Google Patents
Pregabalin oral administration solution and preparation method thereof Download PDFInfo
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- CN107998074A CN107998074A CN201711327161.1A CN201711327161A CN107998074A CN 107998074 A CN107998074 A CN 107998074A CN 201711327161 A CN201711327161 A CN 201711327161A CN 107998074 A CN107998074 A CN 107998074A
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- Prior art keywords
- pregabalin
- oral administration
- administration solution
- solution according
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- 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
- A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
- A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
-
- 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, pantothenic acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
Abstract
The present invention relates to a kind of Pregabalin oral administration solution and preparation method thereof, oral liquid of the present invention contains the components such as Pregabalin, preservative, buffer and flavouring, the present invention is using water as solvent, pass through the quantitative proportioning and synergistic effect of each component, the stability with oral liquid of the present invention, the improvement that taste is got well at the same time, the life quality and medication compliance of patient is also improved, and oral liquid bioavilability is more suitable for old man or children taking apparently higher than solid pharmaceutical preparation.
Description
Technical field
The present invention relates to a kind of oral liquid containing Pregabalin, belong to field of pharmaceutical preparations.
Background technology
Neurogenic pain refers to the pain caused by nervous system is damaged or produces lesion, with dull pain,
Scorching hot, shouting pain is main feature.One of epilepsy-nervous system common disease, is a kind of chronic, recurrent exerbation of short duration brain function
Imbalance syndrome, no matter in developed country or developing country, epilepsy is all an important public health problem.Banding blister
Rash is a kind of disease of acute skin mucosa infection, is to be caused by varicella virus, causes skin blister gathering, easily
Fester infection, and postherpetic neuralgia is the complication of herpes zoster most serious, with tear, acupuncture sample pain during breaking-out
Bitterly, the difficult peace of patient's sleeping and eating is made, and more with depressed or anxiety symptom.Tension headache is the most common type headache type,
Illness rate is higher, and patient usually feels dull pain, can concurrently have a sleepless night, depressed and other intracranial complications, more with irritated, mood
The symptom such as low.Above-mentioned disease seriously affects the physical and mental health and quality of life of patient, in work, in life cannot usually play
Normal function.
Pregabalin obtained European Drug Administration by Pfizer on July 6th, 2004（EMA）Approval listing, after
December in 2004 30 Huo FDA (Food and Drug Adminstration)s（FDA）Approval is as treatment diabetic neuralgia and herpes zoster god
The medicine listing of dysmenorrhoea.Pregabalin is first of US and European accreditation while the medicine suitable for treating above two pain
Thing.In June, 2005, Pregabalin is granted to be used for auxiliary treatment adult partial onset epilepsy, and approval treatment is wide successively afterwards
General sexual anxiety obstacle and fibromyalgia syndrome etc..Novel agents of calcium ion channel modulators Pregabalin can effectively treat above-mentioned
Disease, improves the pain of patient, improves the symptom such as sleep quality, fatigue-relieving.
Although Pregabalin and γ-aminobutyric acid（GABA）Structure is similar, but it is affine with GABAA and GABAB acceptors
Power is weaker.Pregabalin will not be metabolized as the antagonist of GABA or GABA acceptors in vivo, therefore nor affect on the suction of GABA
Receive or degrade.Research finds, the α of the voltage-gated calcium channel of Pregabalin and presynaptic neuron2- delta-subunit combines, from
And cause the neurotransmitter regulators such as glutamic acid and norepinephrine to reduce, by suppressing neuronal excitation, neurotransmitter regulator
So as to produce therapeutic effect.
Zoopery and clinical trial show that Pregabalin to neurogenic pain and additional treatment epilepsy, has aobvious
The therapeutic effect of work, and tolerance is good, adverse reaction is slight.A kind of neurotransmitter-ammonia of the Pregabalin as chemical synthesis
The analog of base butyric acid, presently mainly mouth have good bioavilability to medication.In addition Pregabalin is also to social burnt
Consider obstacle, restless leg syndrome, rapid-action all with preferable therapeutic effect, security is good.
Worldwide, the commercialized product formulation of Pregabalin has capsule, oral administration solution and tablet, wherein compared to
Oral solid formulation, oral administration solution is good in taste, and patient's compliance is more preferable, the elderly preferably and children taking.
Therefore, it is necessary to provide, one kind is safe and stable, mouthfeel is suitable, the wider array of Pregabalin liquid oral of the scope of application
Preparation method.
The content of the invention
The technical problems to be solved by the invention be to provide a kind of stable quality, safely and effectively, strong general of patient's compliance
Auspicious Bahrain's oral administration solution, the oral administration solution add following one or more additives by Pregabalin：Preservative, buffer,
Sweetener and aromatic composition.
A kind of Pregabalin oral liquid, is prepared from the following components：Pregabalin 10-50g, preservative 0.1-1g, phosphorus
Hydrochlorate 0.1-50g, Sucralose 1-10g, acesulfame potassium 2-10g, sorbierite 20-45g, maltitol 20-45g, food flavor
0.1-10g。
Preparation process of the present invention is as follows：Flavouring and preservative are added into dispensing containers, addition purifies water-soluble in right amount
Solution, adds pH adjusting agent, adds Pregabalin and aromatic adds purified water to measure pH values, scope is in pH5.0- to full dose
Between 7.0.
Brief description of the drawings
The situation curve map that Fig. 1 is 1 group of embodiment with pregabalin concentration changes over time in commercially available group of rat plasma.
Embodiment
The present invention is further illustrated by following embodiments, including but is not limited only to following implementation
Example.
Embodiment 1：
Prescription：
Pregabalin 20g
Sodium dihydrogen phosphate 25.8g
Disodium hydrogen phosphate 0.4g
Methyl hydroxybenzoate 0.13g
Nipasol 0.0163g
Sucralose 5g
Strawberry essence 2g
Add water to 1000ml
Sucralose 5g, methyl hydroxybenzoate 0.13g, Nipasol 0.0163g are added into dispensing containers, addition purifies water-soluble in right amount
Solution, adds sodium dihydrogen phosphate 25.8g, disodium hydrogen phosphate 0.4g, adds Pregabalin 20g and strawberry essence 2g, adds purified water
To full dose, pH value is measured, scope is between pH5.0-7.0.
Embodiment 2：
Prescription：
Pregabalin 20g
Sodium dihydrogen phosphate 25.8g
Disodium hydrogen phosphate 0.4g
Methyl hydroxybenzoate 0.13g
Nipasol 0.0163g
Acesulfame potassium 5g
Strawberry essence 1g
Add water to 1000ml
Acesulfame potassium 5g, methyl hydroxybenzoate 0.13g, Nipasol 0.0163g are added into dispensing containers, addition purifies water-soluble in right amount
Solution, adds sodium dihydrogen phosphate 25.8g, disodium hydrogen phosphate 0.4g, adds Pregabalin 20g and strawberry essence 1g, adds purified water
To full dose, pH value is measured, scope is between pH5.0-7.0.
Embodiment 3：
Prescription：
Pregabalin 20g
Sodium dihydrogen phosphate 25.8g
Disodium hydrogen phosphate 0.4g
Methyl hydroxybenzoate 0.13g
Nipasol 0.0163g
Sorbierite 40g
Strawberry essence 2g
Add water to 1000ml
Sorbierite 40g, methyl hydroxybenzoate 0.13g, Nipasol 0.0163g are added into dispensing containers, addition purifies water-soluble in right amount
Solution, adds sodium dihydrogen phosphate 25.8g, disodium hydrogen phosphate 0.4g, adds Pregabalin 20g and strawberry essence 2g, adds purified water
To full dose, pH value is measured, scope is between pH5.0-7.0.
Embodiment 4：
Prescription：
Pregabalin 20g
Sodium dihydrogen phosphate 25.8g
Disodium hydrogen phosphate 0.4g
Methyl hydroxybenzoate 0.13g
Nipasol 0.0163g
Maltitol 20g
Strawberry essence 2g
Add water to 1000ml
Maltitol 20g is added into dispensing containers, methyl hydroxybenzoate 0.13g, Nipasol 0.0163g, add appropriate purified water
Dissolving, adds sodium dihydrogen phosphate 25.8g, disodium hydrogen phosphate 0.4g, adds Pregabalin 20g and strawberry essence 2g, adds purifying
Water measures pH value, scope is between pH5.0-7.0 to full dose.
Effete test embodiment
Technique effect to illustrate the invention, the high bioavilability Pregabalin oral administration solution that embodiment 1-4 is prepared
Do following detection：
1 study on the stability
1.1 Pregabalin oral administration solution influence factors are tested, and the results are shown in Table 1：
1 influence factor result of the test of table
As can be seen from the above table, sample made from embodiment 1-4, solution is without layering, aggregation, precipitation in factors influencing
Phenomena such as, illustrate to have good stability in Pregabalin oral administration solution influence factor experiment produced by the present invention.
1.2 Pregabalin oral administration solution accelerated tests
Pregabalin oral administration solution produced by the present invention under 40 DEG C of ± 2 DEG C of temperature conditionss, respectively at 0 month, January, 2 months, March,
Respectively sampling once, carried out accelerated test investigation, the results are shown in Table 2 June：
2 accelerated test result of table
As can be seen from the above table, to be investigated by the accelerated test of 6 months, Pregabalin oral administration solution face shaping is relatively stable,
It is faint yellow supernatant liquid, pH stable, content has no obvious decay, and related material, which has no, to rise appreciably, and shows the present invention
Oral liquid it is safe and stable, reliable.
1.3 Pregabalin oral administration solution long term tests
The Pregabalin oral administration solution of the present invention carries out long-term steady under the conditions of 25 DEG C ± 2 DEG C of temperature, relative humidity 60% ± 10%
Qualitative investigation, the results are shown in Table 3：
3 long-term test results of table
As can be seen from the above table, in experiment for long-term stability, oral administration solution stable content produced by the present invention, is not decreased obviously,
Stability is high, is effectively guaranteed the security of drug quality and patient medication.
Blood concentration is tested after the administration of 2 rats
Using Self-control method, 50 rats are taken, are randomly divided into 5 groups, every group 10, numbering is embodiment 1-4 groups and original respectively
Grind Pregabalin capsule " diazepam ".Correspond to respectively after giving the pregabaline formulation of 30mg/kg, measure Puri in rat plasma
The situation of Bahrain's concentration changes with time.Record respectively to rat be administered after 30min, 60min, 90min, 120min, 180min,
The blood plasma pregabalin concentration of 240min, 360min, 480min, 720min, the results are shown in Table 4 for it.By 1 Zu Yu cities of embodiment
Sell Pregabalin oral administration solution group and measure the situation that pregabalin concentration in rat plasma changes over time and be plotted as curve map,
As shown in Figure 1.
After the administration of 4 each preparation of table in different time blood plasma Pregabalin concentration（Unit：ng/ml）
As can be seen from Table 4, Pregabalin oral administration solution of the invention has good bioavilability, in rat serum after administration
The concentration of active ingredient Pregabalin is significantly higher in slurry, ensure that its higher bioavilability.As seen from Figure 1, it is real
The peak time reach of Pregabalin in example 1 is applied, highest blood concentration significantly increases, and shows the Pregabalin oral liquid of the present invention
Body preparation can realize very fast preferable absorption in vivo.
Claims (10)
1. a kind of Pregabalin oral administration solution, it is characterised in that be prepared from the following components：Pregabalin, preservative, buffering
Agent, sweetener, aromatic, solvent.
2. a kind of Pregabalin oral administration solution according to claim 1, it is characterised in that 10-50g containing Pregabalin, prevent
Rotten agent 0.1-1g, phosphate 0.1-50g, Sucralose 1-10g, acesulfame potassium 2-10g, sorbierite 20-45g, maltitol 20-
45g, food flavor 0.1-10g.
3. a kind of Pregabalin oral administration solution according to claim 1, it is characterised in that the preservative is oxybenzene first
One or more of mixtures in ester, ethyl hydroxy benzoate, Nipasol, butyl hydroxybenzoate, preferably methyl hydroxybenzoate and Nipasol.
4. a kind of Pregabalin oral administration solution according to claim 1, it is characterised in that the buffer refers to phosphoric acid hydrogen
Disodium-sodium dihydrogen phosphate buffer, dipotassium hydrogen phosphate-potassium dihydrogen phosphate buffer solution, disodium hydrogen phosphate-potassium dihydrogen phosphate delay
Solution is rushed, its dosage, which should control, can make the pH value of oral administration solution between 5.0-7.0.
A kind of 5. Pregabalin oral liquid according to claim 1, it is characterised in that the sweetener refer to sucrose,
Glucose, fructose, Sucralose, acesulfame potassium, sorbierite, preferably maltitol one or more mixture, Sucralose.
6. a kind of Pregabalin oral administration solution according to claim 1, it is characterised in that the aromatic refers to strawberry
Essence, orange essence, lemon extract, flavoring apple essence, preferably Cranberry essence one or more mixture, strawberry essence.
7. a kind of Pregabalin oral administration solution according to claim 1, it is characterised in that the solvent refers to water.
8. a kind of Pregabalin oral administration solution according to claim 1, it is characterised in that give an oral account and take the pH value of solution and be
5.0-7.0。
9. a kind of Pregabalin oral administration solution according to claim 1, it is characterised in that the oral administration solution is very molten
Liquid, syrupy shape are runny colourless to weak yellow liquid.
10. a kind of Pregabalin oral administration solution according to claim 1, it is characterised in that its preparation method is as follows：To with
Put and flavouring and preservative are added in container, add appropriate purified water dissolving, add pH adjusting agent, add Pregabalin and fragrance
Agent adds purified water to measure pH value, scope is between pH5.0-7.0 to full dose.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711327161.1A CN107998074A (en) | 2017-12-13 | 2017-12-13 | Pregabalin oral administration solution and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201711327161.1A CN107998074A (en) | 2017-12-13 | 2017-12-13 | Pregabalin oral administration solution and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN107998074A true CN107998074A (en) | 2018-05-08 |
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ID=62058428
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201711327161.1A Withdrawn CN107998074A (en) | 2017-12-13 | 2017-12-13 | Pregabalin oral administration solution and preparation method thereof |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110693820A (en) * | 2018-07-10 | 2020-01-17 | 北京万全德众医药生物技术有限公司 | Pregabalin oral solution and preparation method thereof |
| CN111855828A (en) * | 2020-02-28 | 2020-10-30 | 中国人民解放军军事科学院军事医学研究院 | Method for simultaneously determining content of pregabalin and hydroxyphenyl bacteriostatic agent |
| CN112107537A (en) * | 2019-06-19 | 2020-12-22 | 北京万全德众医药生物技术有限公司 | Pregabalin oral solution and preparation method thereof |
| CN112891303A (en) * | 2021-03-24 | 2021-06-04 | 广州大光制药有限公司 | Pregabalin oral solution and preparation method thereof |
| CN113616591A (en) * | 2021-09-03 | 2021-11-09 | 贝克诺顿(浙江)制药有限公司 | Pregabalin oral solution and preparation method thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1893938A (en) * | 2003-12-18 | 2007-01-10 | 辉瑞有限公司 | Pregabalin composition |
| CN104840443A (en) * | 2015-05-27 | 2015-08-19 | 齐鲁制药有限公司 | Medicine composition containing active ingredients of pregabalin |
-
2017
- 2017-12-13 CN CN201711327161.1A patent/CN107998074A/en not_active Withdrawn
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1893938A (en) * | 2003-12-18 | 2007-01-10 | 辉瑞有限公司 | Pregabalin composition |
| CN104840443A (en) * | 2015-05-27 | 2015-08-19 | 齐鲁制药有限公司 | Medicine composition containing active ingredients of pregabalin |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110693820A (en) * | 2018-07-10 | 2020-01-17 | 北京万全德众医药生物技术有限公司 | Pregabalin oral solution and preparation method thereof |
| CN112107537A (en) * | 2019-06-19 | 2020-12-22 | 北京万全德众医药生物技术有限公司 | Pregabalin oral solution and preparation method thereof |
| CN111855828A (en) * | 2020-02-28 | 2020-10-30 | 中国人民解放军军事科学院军事医学研究院 | Method for simultaneously determining content of pregabalin and hydroxyphenyl bacteriostatic agent |
| CN112891303A (en) * | 2021-03-24 | 2021-06-04 | 广州大光制药有限公司 | Pregabalin oral solution and preparation method thereof |
| CN113616591A (en) * | 2021-09-03 | 2021-11-09 | 贝克诺顿(浙江)制药有限公司 | Pregabalin oral solution and preparation method thereof |
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