CN112089698A - Amisulpride tablet and preparation method thereof - Google Patents
Amisulpride tablet and preparation method thereof Download PDFInfo
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- CN112089698A CN112089698A CN202011147962.1A CN202011147962A CN112089698A CN 112089698 A CN112089698 A CN 112089698A CN 202011147962 A CN202011147962 A CN 202011147962A CN 112089698 A CN112089698 A CN 112089698A
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
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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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
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Abstract
The invention belongs to the technical field of medicines, particularly relates to the field of pharmacy, and more particularly relates to an amisulpride tablet and a preparation method thereof, wherein the amisulpride tablet consists of 39.6-43.8% of amisulpride, 0.1-2.0% of surfactant and the balance of auxiliary materials in percentage by mass. By adding the surfactant, the in-vivo release rate of amisulpride in use can be remarkably improved, and drug absorption is ensured. Meanwhile, the preparation method disclosed by the invention is based on a dry granulation process, and through the material adding sequence design, the problem of poor flowability of the amisulpride tablet raw material is effectively solved, the problems of bitter taste of amisulpride and the like in the preparation process are effectively solved, and the medicine taking compliance of patients is remarkably improved.
Description
Technical Field
The invention belongs to the technical field of medicines, particularly relates to the field of pharmacy, and more particularly relates to amisulpride tablets and a preparation method thereof.
Background
Amisulpride, its chemical name is: 4-amino-N- [ (1-ethyl-2-pyrrolidinyl) methyl ] -5- (ethylsulfonyl) -2-methoxybenzamide. The structural formula is as follows:
amisulpride is an aniline substitute for psychosedatives, and can be selectively administered to the peripheral system2、D3Dopamine receptor binding is an atypical antipsychotic. It is mainly used for the treatment of acute or chronic schizophrenia, mainly with positive symptoms (such as delirium, hallucinations, cognitive disorders) and/or negative symptoms (such as delayed response, apathy and social withdrawal), and also schizophrenia characterized by negative symptoms.
Because amisulpride is a substance that is poorly soluble in water, controlling the release process of the drug in vivo is a major method of affecting the absorption of amisulpride in vivo, and the in vivo release capacity also becomes the rate-limiting factor of the absorption capacity of amisulpride in vivo. Clinically, the amisulpride preparation is expected to take effect quickly after being taken, so that the preparation is required to adopt a proper formula and a preparation process to improve the dissolution rate of the medicament and the dissolution rate of the medicament after reaching the body.
Oral dosage forms such as amisulpride tablets, amisulpride granules, amisulpride capsules and the like have been developed in the prior art. The preparation process adopts wet granulation method. As is known, wet granulation has a complex preparation process, low production efficiency and high production cost.
Disclosure of Invention
The invention aims to solve the technical problem of providing a new amisulpride tablet and a preparation method thereof. Thereby not only improving the in vivo release rate of amisulpride in use and ensuring drug absorption; meanwhile, the bitter taste of oral administration can be reduced, and the medication compliance of patients is improved.
In order to solve the technical problem, the invention discloses an amisulpride tablet, which consists of 39.6-43.8% of amisulpride, 0.1-2.0% of surfactant and the balance of auxiliary materials in percentage by mass, wherein the mass percentage of the amisulpride tablet is pharmaceutically acceptable.
More preferably, the surfactant is preferably an anionic surfactant, and more preferably the surfactant is sodium lauryl sulfate.
Further preferably, the invention further discloses that the pharmaceutically acceptable auxiliary materials comprise 40-60% of filler, 5-10% of disintegrant, 0.5-5% of flavoring agent and 0.5-2% of lubricant by mass.
More preferably, the filler is composed of a filler I and a filler II, wherein the filler I is a filler which is not static electricity and water-soluble and is easily soluble in water or soluble in water, the filler II is a filler which is static electricity and water-soluble and is insoluble in water or insoluble in water, and the weight ratio of the filler I to the filler II is 1: 1.
As a preferable technical scheme, the filler I is selected from mannitol, and the filler II is selected from microcrystalline cellulose or lactose.
Further, as a preferred technical scheme, the disintegrating agent is selected from one or more of sodium carboxymethyl starch, croscarmellose sodium and crospovidone; and/or the flavoring agent is selected from one or more of aspartame, strawberry essence and orange essence, wherein aspartame is the most preferable, and/or the lubricating agent is selected from one or more of magnesium stearate, talcum powder, silicon dioxide and stearic acid, wherein magnesium stearate is the most preferable.
Further, the invention also discloses a preparation method of the amisulpride tablet, which comprises the following steps:
s1: crushing amisulpride;
s2: uniformly mixing amisulpride and a filler I under the stirring condition to obtain a mixture A;
s3: uniformly mixing the mixture A obtained in the step S2 with a surfactant under the stirring condition to obtain a mixture B;
s4: uniformly mixing the mixture B with the filler II and the flavoring agent under the stirring condition to obtain a dry powder mixture;
s5: granulating the dry powder mixture to obtain mixture granules;
s6: uniformly mixing the mixture particles with a disintegrating agent, and then uniformly mixing the mixture particles with a lubricating agent to obtain a total mixed material;
s7: tabletting to obtain amisulpride tablet.
Surprisingly, the inventor discovers that the flowability of the medicine can be effectively improved by adjusting the adding mode and the adding sequence of the filler and utilizing the stepwise adding mode of the filler I and the filler II, and the feasibility of dry granulation of the amisulpride tablet is realized.
As a preferred technical solution, the mixing in S2 adopts an equal incremental mixing mode, specifically, amisulpride is added to mannitol in a small amount for multiple times.
In a preferred embodiment, the mixing in S3 is performed by an equal incremental mixing method, specifically, the surfactant is mixed with an equal amount of the mixture a to form a mixture a', and then mixed with an equal amount of the mixture a to form a mixture a ″, and the above steps are repeated until the mixture a is completely added to obtain a mixture B.
As a preferred technical solution, the mixing in S4 is performed by an equal incremental mixing method, specifically, filler II and flavoring agent are mixed first, then mixed together with an equal amount of mixture B to form mixture B', then mixed with an equal amount of mixture B to form mixture B ", and the above steps are repeated until all of mixture B is added to obtain a dry powder mixture.
In a preferred technical scheme, a circular punch with the diameter of 12mm is adopted for tabletting in S7.
By adding the surfactant, the in-vivo release rate of amisulpride in use can be remarkably improved, and drug absorption is ensured. Meanwhile, the preparation method disclosed by the invention is based on a dry granulation process, and through the material adding sequence design, the problem of poor flowability of the amisulpride tablet raw material is effectively solved, the problems of bitter taste of amisulpride and the like in the preparation process are effectively solved, and the medicine taking compliance of patients is remarkably improved. The amisulpride tablet disclosed by the invention is simple in preparation process. The product has good patient compliance in the using process, and the influence factor test shows that the tablet is stable under the conditions of high temperature, high humidity and illumination.
Detailed Description
In order that the invention may be better understood, we now provide further explanation of the invention with reference to specific examples.
The tablets prepared in the following examples were all prepared using the same type of equipment, unless otherwise specified, and were tabletted with a punch of Φ 12mm to a tablet weight of 480mg and controlled to have a hardness of 50 to 100N.
In addition, the following preparation method is adopted in each embodiment, and the preparation method specifically comprises the following steps:
the method comprises the following steps:
s1: crushing amisulpride;
s2: uniformly mixing amisulpride and a filler I under the stirring condition to obtain a mixture A; preferably, it means that amisulpride is added to mannitol in small amounts multiple times.
S3: uniformly mixing the mixture A obtained in the step S2 with a surfactant under the stirring condition to obtain a mixture B; preferably, the surfactant and an equal amount of the mixture A are mixed together to form a mixture A ', then the mixture A' is mixed with an equal amount of the mixture A to form a mixture A ", and the steps are repeated until the mixture A is completely added to obtain a mixture B;
s4: uniformly mixing the mixture B with the filler II and the flavoring agent under the stirring condition to obtain a dry powder mixture; preferably, an equal progressive mixing mode is adopted, specifically, the filler II and the flavoring agent are mixed firstly, then the filler II and the flavoring agent are mixed together with an equal amount of the mixture B to form a mixture B ', then the mixture B' is mixed with an equal amount of the mixture B to form a mixture B ", and the steps are repeated until the mixture B is completely added to obtain a dry powder mixture;
s5: granulating the dry powder mixture to obtain mixture granules;
s6: uniformly mixing the mixture particles with a disintegrating agent, and then uniformly mixing the mixture particles with a lubricating agent to obtain a total mixed material;
s7: tabletting to obtain amisulpride tablet.
The following examples 1 to 6 were each formulated in 1000 tablets.
Example 1
The prescription composition is as follows:
example 2
The prescription composition is as follows:
example 3
The prescription composition is as follows:
example 4
The prescription composition is as follows:
example 5
The prescription composition is as follows:
example 6
The amisulpride tablet tablets obtained in examples 1 to 5 and the reference formulation were respectively tested for their dissolution profile in water.
The dissolution conditions were: 900mL of medium, paddle method, 50 rpm.
The sampling time is as follows: 5. 10, 15, 30, 45 and 60 min.
The detection method comprises the following steps: the cumulative dissolution at each time point was calculated and the results are shown in table 1.
TABLE 1 examples 1-5 and reference formulations cumulative dissolution in aqueous medium
| Time of sampling | 5min | 10min | 15min | 30min | 45min | 60min |
| Reference formulation | 33.42 | 72.29 | 87.04 | 91.07 | 91.88 | 92.13 |
| Example 1 | 35.14 | 77.84 | 89.63 | 93.33 | 94.25 | 93.39 |
| Example 2 | 25.34 | 68.12 | 84.87 | 90.84 | 94.20 | 95.59 |
| Example 3 | 37.11 | 78.64 | 91.59 | 94.57 | 95.42 | 95.95 |
| Example 4 | 41.12 | 82.27 | 92.21 | 96.86 | 97.22 | 97.17 |
| Example 5 | 46.20 | 85.90 | 94.91 | 98.58 | 99.88 | 100.45 |
The dissolution of the samples of the examples was similar to the reference formulation and the disintegration time was within 5 minutes. It is demonstrated that the method disclosed in the present invention can obtain an excellent elution effect.
Example 7
The mouth feel after administration of the samples of examples 1-5 and the reference formulation was tested by 3 panelists who contained the tablets in their mouths for 10 seconds and recorded a mouth feel description for each of the participants for amisulpride tablets. The taste grade is 4 grades, which are bitter, slightly sweet and very sweet respectively. The test results are shown in Table 2.
TABLE 2 taste evaluation results of examples 1 to 5 and reference formulations
| Examples | Test person 1 | Test person 2 | Test person 3 |
| Reference formulation | Has bitter taste | Has bitter taste | Has bitter taste |
| Example 1 | Slightly bitter | Slightly bitter | Slightly bitter |
| Example 2 | Has bitter taste | Has bitter taste | Has bitter taste |
| Example 3 | Slightly bitter | Slightly sweet | Slightly bitter |
| Example 4 | Slightly sweet | Slightly sweet | Slightly sweet |
| Example 5 | Slightly sweet | Slightly sweet | Slightly sweet |
As can be seen from table 2, the amisulpride tablets prepared by the invention have obviously improved mouth feel, the reference preparation and the example 2 do not contain a sweetening agent and have bitter taste when being taken, and the examples 1 and 3-5 have weak bitter taste and are acceptable by patients, so that the compliance of the patients is improved to a certain extent.
Example 8
The influencing factors of example 3, example 4 and the original bare chip are tested.
The influence factor tests of example 3, example 4 and the original preparation are carried out according to the guiding principle 9001 of the four parts of the Chinese pharmacopoeia of 2015 edition on the stability of the raw material drug and the pharmaceutical preparation, samples are placed under the conditions of high temperature of 60 ℃, high humidity of 75% RH and illumination, and samples are taken when the samples are placed for 5 days and 10 days respectively to carry out detection according to the key stability investigation items. The results are shown in tables 3 to 5.
TABLE 3 test results of the influence factors of the original developer
Table 4 example 3 influencing factor test results
Table 5 example 4 influencing factor test results
As can be seen from the data in tables 3-5, both examples 3 and 4, using the formulation process of the present invention, produce stable tablets of consistent quality with the original formulation.
What has been described above is a specific embodiment of the present invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principle of the present invention, and such improvements and modifications are also considered to be within the scope of the present invention.
Claims (10)
1. Amisulpride tablets, characterized in that: the amisulpride tablet consists of 39.6-43.8% of amisulpride, 0.1-2.0% of surfactant and the balance of auxiliary materials, wherein the mass percentage of the amisulpride tablet is pharmaceutically acceptable.
2. Amisulpride tablets according to claim 1, characterized in that: the surfactant is preferably an anionic surfactant, more preferably the surfactant is sodium lauryl sulfate.
3. Amisulpride tablets according to claim 1, characterized in that: the pharmaceutically acceptable auxiliary materials comprise 40-60% of filler, 5-10% of disintegrant, 0.5-5% of flavoring agent and 0.5-2% of lubricant in percentage by mass.
4. Amisulpride tablets according to claim 3, characterized in that: the filler is composed of a filler I and a filler II, wherein the filler I is a filler which is not static, water-soluble and soluble in water, the filler II is a filler which is static, water-soluble and insoluble in water or insoluble in water, and the weight ratio of the filler I to the filler II is 1: 1.
5. Amisulpride tablets according to claim 4, characterized in that: the filler I is selected from mannitol, and the filler II is selected from microcrystalline cellulose or lactose.
6. Amisulpride tablets according to claim 3, characterized in that: the disintegrating agent is selected from one or more of sodium carboxymethyl starch, croscarmellose sodium and crospovidone; and/or the flavoring agent is selected from one or more of aspartame, strawberry essence and orange essence, wherein aspartame is the most preferable, and/or the lubricating agent is selected from one or more of magnesium stearate, talcum powder, silicon dioxide and stearic acid, wherein magnesium stearate is the most preferable.
7. A process for the preparation of amisulpride tablets according to any one of claims 1 to 6, characterised by comprising the steps of:
s1: crushing amisulpride;
s2: uniformly mixing amisulpride and a filler I under the stirring condition to obtain a mixture A;
s3: uniformly mixing the mixture A obtained in the step S2 with a surfactant under the stirring condition to obtain a mixture B;
s4: uniformly mixing the mixture B with the filler II and the flavoring agent under the stirring condition to obtain a dry powder mixture;
s5: granulating the dry powder mixture to obtain mixture granules;
s6: uniformly mixing the mixture particles with a disintegrating agent, and then uniformly mixing the mixture particles with a lubricating agent to obtain a total mixed material;
s7: tabletting to obtain amisulpride tablet.
8. The method for preparing amisulpride tablets according to claim 7, characterized by comprising the steps of:
the mixing in S2 adopts an equal progressive mixing mode, specifically, amisulpride is added into mannitol for multiple times in a small amount.
9. The method for preparing amisulpride tablets according to claim 7, wherein the mixing in S3 is performed in an equal incremental mixing manner, specifically, the surfactant and an equal amount of the mixture A are mixed together to form a mixture A ', and then the mixture A' is mixed with an equal amount of the mixture A to form a mixture A ", and the steps are repeated until the mixture A is completely added to obtain a mixture B;
and/or the presence of a gas in the gas,
and S4, mixing in an equal progressive mixing mode, namely mixing the filler II and the flavoring agent, mixing the filler II and the flavoring agent together with an equal amount of the mixture B to form a mixture B', mixing the mixture B with an equal amount of the mixture B to form a mixture B ", and repeating the steps until the mixture B is completely added to obtain a dry powder mixture.
10. A process for the preparation of amisulpride tablets according to claim 7, characterized in that: s7, the tablets are pressed by a circular punch with the diameter of 12 mm.
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| CN202011147962.1A CN112089698A (en) | 2020-10-23 | 2020-10-23 | Amisulpride tablet and preparation method thereof |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20060153925A1 (en) * | 2003-07-09 | 2006-07-13 | Sanofi-Aventis | Novel solid pharmaceutical composition comprising amisulpride |
| CN107049981A (en) * | 2017-04-11 | 2017-08-18 | 深圳市泛谷药业股份有限公司 | A kind of quick-release Amisulpride pharmaceutical composition and preparation method thereof |
| CN107126422A (en) * | 2017-03-02 | 2017-09-05 | 河北龙海药业有限公司 | A kind of Amisulpride tablet and preparation method thereof |
| CN109010300A (en) * | 2018-10-24 | 2018-12-18 | 湖南洞庭药业股份有限公司 | A kind of Amisulpride piece and preparation method thereof |
-
2020
- 2020-10-23 CN CN202011147962.1A patent/CN112089698A/en active Pending
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20060153925A1 (en) * | 2003-07-09 | 2006-07-13 | Sanofi-Aventis | Novel solid pharmaceutical composition comprising amisulpride |
| CN107126422A (en) * | 2017-03-02 | 2017-09-05 | 河北龙海药业有限公司 | A kind of Amisulpride tablet and preparation method thereof |
| CN107049981A (en) * | 2017-04-11 | 2017-08-18 | 深圳市泛谷药业股份有限公司 | A kind of quick-release Amisulpride pharmaceutical composition and preparation method thereof |
| CN109010300A (en) * | 2018-10-24 | 2018-12-18 | 湖南洞庭药业股份有限公司 | A kind of Amisulpride piece and preparation method thereof |
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