CN109589310A - Racecadotril Dried Suspension and preparation method thereof - Google Patents
Racecadotril Dried Suspension and preparation method thereof Download PDFInfo
- Publication number
- CN109589310A CN109589310A CN201710923690.1A CN201710923690A CN109589310A CN 109589310 A CN109589310 A CN 109589310A CN 201710923690 A CN201710923690 A CN 201710923690A CN 109589310 A CN109589310 A CN 109589310A
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- Prior art keywords
- racecadotril
- dried suspension
- dried
- preparation
- adhesive
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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
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
- A61K9/1605—Excipients; Inactive ingredients
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/265—Esters, e.g. nitroglycerine, selenocyanates of carbonic, thiocarbonic, or thiocarboxylic acids, e.g. thioacetic acid, xanthogenic acid, trithiocarbonic acid
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
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Abstract
This application involves medicine fields, specially Racecadotril Dried Suspension and preparation method thereof.The Racecadotril Dried Suspension first pelletizes to racecadotril using adhesive, and then addition sucrose, corrigent and mix lubricant are uniform, obtains Racecadotril Dried Suspension.The preparation method can reduce contact of the bulk pharmaceutical chemicals with other auxiliary materials, and impurity is stablized.
Description
Technical field
The invention belongs to pharmaceutical technology fields, and in particular to a kind of Racecadotril Dried Suspension and preparation method thereof.
Background technique
Racecadotril (racecadotril) is developed by French Bioproject company, in 1993 with commodity
Name Tiorfan listing, dosage form is capsule.Racecadotril is a kind of novel anti diar rhea medicine, pair suitable for various diarrhea
Disease treatment.Compared with other anti diar rhea medicines, racecadotril has curative effect height, rapid-action, oral not enter central nervous system
System, does not generate dependence, on respiratory system, cardiovascular system without influence, does not generate the secondary effects such as constipation, abdominal distension, abdominal pain, youngster
The characteristics of child can also use safely.
Racecadotril is an enkephalinase inhibitor, alternative, reversible inhibition enkephalinase, to protect
Endogenous enkephalins extend the physiological activity of alimentary canal endogenous enkephalins from degradation.In peripheral tissues, racecadotril
Fast hydrolyzing is more effective enkephalins inhibitor acetorphan.Acetorphan increases opioids to the inhibiting effect of enkephalinase
Utilization, have activated the opiate receptor of enteron aisle, cAMP mucous membrane level caused to reduce, thus reduce water and electrolyte excessively point
It secretes.And the medicine acts on periphery enkephalins, does not influence the enkephalinase activity of central nervous system, and to gastrointestinal motility and intestines
Road basal secretion has no significant effect, quickly effective, takes safety.In addition, racecadotril can take together with food, water or breast milk
With using convenient.
Summary of the invention
This application involves medicine fields, specially Racecadotril Dried Suspension and preparation method thereof.The racemization card is more
Bent dry suspensoid agent first pelletizes to racecadotril using adhesive, and sucrose, corrigent and mix lubricant is then added
Uniformly, Racecadotril Dried Suspension is obtained.The preparation method can reduce contact of the bulk pharmaceutical chemicals with other auxiliary materials, and impurity is steady
It is fixed.
In certain embodiments, Racecadotril Dried Suspension, the supplementary material including following parts by weight:
In certain embodiments, Racecadotril Dried Suspension preparation method includes the following steps:
(1) recipe quantity racecadotril is weighed, using adhesive softwood, obtains wet granular after sieving；
(2) wet granular is dry, obtain dry particl；Moisture < 3.0% is dried at 45 DEG C ~ 50 DEG C；
(3) sucrose of recipe quantity, lubricant and corrigent are added in the dry particl, dispenses after mixing.
In certain embodiments, the preparation method of Racecadotril Dried Suspension further include:
(1) a weighs recipe quantity racecadotril, using adhesive softwood, obtains wet granular after crossing 30 meshes；
(2) a dries the wet granular at 45 DEG C ~ 50 DEG C to moisture < 3.0%；
(3) sucrose of recipe quantity, lubricant and corrigent is added in a in the dry particl, dispenses after mixing, the sucrose
It should can pass through 30 meshes.
In certain embodiments, Racecadotril Dried Suspension, which is characterized in that described adhesive be Utech NE30D,
The mixture of one or both of hydroxypropyl cellulose K4M, PVP K30 composition described above.
In certain embodiments, the Racecadotril Dried Suspension, which is characterized in that described adhesive is hydroxypropyl
Cellulose K4M.
In certain embodiments, the Racecadotril Dried Suspension, which is characterized in that described adhesive is hydroxypropyl
Cellulose K4M, concentration are 4% ~ 8%
In certain embodiments, the Racecadotril Dried Suspension, it is characterised in that the lubricant is colloidal silica
The mixture of one or more of silicon, magnesium stearate, talcum powder.
In certain embodiments, the Racecadotril Dried Suspension, which is characterized in that the corrigent is that strawberry is fragrant
The mixture of one or more of essence, apricot taste essence, flavoring apple essence, Hami melon essence.
Specific embodiment
The invention discloses a kind of Racecadotril granules agent and its preparation process, those skilled in the art can use for reference this
Literary content, is suitably modified realization of process parameters.In particular, it should be pointed out that all similar substitutions and modifications are to art technology
It is it will be apparent that they are considered as being included in the present invention for personnel.Method and application of the invention has passed through preferably
Embodiment is described, related personnel obviously can not depart from the content of present invention, in spirit and scope to side as described herein
Method and application are modified or appropriate changes and combinations, carry out implementation and application the technology of the present invention.
Embodiment 1:
Preparation process:
(1) bulk pharmaceutical chemicals are weighed, using 4% hydroxypropyl cellulose K4M softwood, cross the granulation of 30 meshes.
(2) baking oven is used, is dried to moisture < 3.0% at 45 DEG C ~ 50 DEG C.
(3) collator is waved into crystalline saccharose use and crosses 30 sieve whole grains, to reduce partial size.
(4) crystalline saccharose of recipe quantity, lubricant and essence, three-dimensional mixer mixing are added in bulk pharmaceutical chemicals dry particl
5min。
Embodiment 2:
Preparation process:
(1) bulk pharmaceutical chemicals are weighed, using 6% hydroxypropyl cellulose K4M softwood, cross the granulation of 30 meshes.
(2) baking oven is used, is dried to moisture < 3.0% at 45 DEG C ~ 50 DEG C.
(3) collator is waved into crystalline saccharose use and crosses 30 sieve whole grains, to reduce partial size.
(4) crystalline saccharose of recipe quantity, lubricant and essence, three-dimensional mixer mixing are added in bulk pharmaceutical chemicals dry particl
5min。
Comparative example 1:
Preparation process:
(1) bulk pharmaceutical chemicals are weighed, using 10% hydroxypropyl cellulose K4M softwood, cross the granulation of 40 meshes.
(2) baking oven is used, is dried to moisture < 3.0% at 45 DEG C ~ 50 DEG C.
(3) the sucrose powder of recipe quantity, lubricant and essence, three-dimensional mixer mixing are added in bulk pharmaceutical chemicals dry particl
5min。
Comparative example 2:
Preparation process:
(1) bulk pharmaceutical chemicals are weighed, using 5% Utech NE30D softwood, cross the granulation of 30 meshes.
(2) baking oven is used, is dried to moisture < 5.0% at 45 DEG C ~ 50 DEG C.
(3) collator is waved into crystalline saccharose use and crosses 30 sieve whole grains, to reduce partial size.
(4) crystalline saccharose of recipe quantity, lubricant and essence, three-dimensional mixer mixing are added in bulk pharmaceutical chemicals dry particl
5min。
Related material result:
Embodiment 1,2 is miscellaneous in relation to substance list, always miscellaneous to be significantly better than that comparative example compared with comparative example 1,2.
Racecadotril is prepared as dry suspensoid agent, uses the hydroxypropyl cellulose K4M of 4% ~ 8% concentration for adhesive, it is first
First pelletize to bulk pharmaceutical chemicals, after drying, crystalline saccharose be added, lubricant and essence are mixed, greatly reduce bulk pharmaceutical chemicals with
The contact area of other auxiliary materials, related substance are more excellent.
Claims (8)
1. a kind of Racecadotril Dried Suspension, which is characterized in that the supplementary material including following parts by weight:
。
2. Racecadotril Dried Suspension preparation method described in claim 1 includes the following steps:
Recipe quantity racecadotril is weighed, using adhesive softwood, obtains wet granular after sieving；
The wet granular is dry, obtain dry particl；Moisture < 3.0% is dried at 45 DEG C ~ 50 DEG C；
The sucrose of recipe quantity, lubricant and corrigent are added in the dry particl, dispenses after mixing.
3. the preparation method of Racecadotril Dried Suspension as claimed in claim 2 further include:
(1) a weighs recipe quantity racecadotril, using adhesive softwood, obtains wet granular after crossing 30 meshes；
(2) a dries the wet granular at 45 DEG C ~ 50 DEG C to moisture < 3.0%；
(3) sucrose of recipe quantity, lubricant and corrigent is added in a in the dry particl, dispenses after mixing, the sucrose
It should can pass through 30 meshes.
4. Racecadotril Dried Suspension according to claim 1 to 3, which is characterized in that described
Adhesive is the mixing of one or both of Utech NE30D, hydroxypropyl cellulose K4M, PVP K30 composition described above
Object.
5. Racecadotril Dried Suspension described in -4 according to claim 1, which is characterized in that described adhesive is that hydroxypropyl is fine
Tie up element K4M.
6. Racecadotril Dried Suspension described in -5 according to claim 1, which is characterized in that described adhesive is that hydroxypropyl is fine
Element K4M is tieed up, concentration is 4% ~ 8%.
7. Racecadotril Dried Suspension described in -6 according to claim 1, it is characterised in that the lubricant is colloidal state dioxy
The mixture of one or more of SiClx, magnesium stearate, talcum powder.
8. according to Racecadotril Dried Suspension described in claim 1-7, which is characterized in that the corrigent be strawberry essence,
The mixture of one or more of apricot taste essence, flavoring apple essence, Hami melon essence.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710923690.1A CN109589310A (en) | 2017-10-01 | 2017-10-01 | Racecadotril Dried Suspension and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201710923690.1A CN109589310A (en) | 2017-10-01 | 2017-10-01 | Racecadotril Dried Suspension and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN109589310A true CN109589310A (en) | 2019-04-09 |
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ID=65956778
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201710923690.1A Pending CN109589310A (en) | 2017-10-01 | 2017-10-01 | Racecadotril Dried Suspension and preparation method thereof |
Country Status (1)
| Country | Link |
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| CN (1) | CN109589310A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110840848A (en) * | 2019-10-21 | 2020-02-28 | 健民药业集团股份有限公司 | Racecadotril granules and preparation method thereof |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20030166718A1 (en) * | 2000-06-23 | 2003-09-04 | Jeanne-Marie Lecomte | Formulation |
| CN101103960A (en) * | 2006-07-14 | 2008-01-16 | 海南盛科生命科学研究院 | Dry mixed suspension containing racecadotril and preparation method thereof |
| CN102008469A (en) * | 2010-11-16 | 2011-04-13 | 武汉武药科技有限公司 | Method for preparing telmisartan amlodipine tablets |
| CN102166197A (en) * | 2011-04-25 | 2011-08-31 | 四川百利药业有限责任公司 | Racecadotril granules and production process thereof |
| EP2749270A1 (en) * | 2012-12-26 | 2014-07-02 | ILKO Ilac Sanayi ve Ticaret A.S. | Racecadotril and pharmaceutical compositions thereof |
| CN104224724A (en) * | 2013-06-08 | 2014-12-24 | 北京韩美药品有限公司 | Racecadotril granules and preparation technology thereof |
-
2017
- 2017-10-01 CN CN201710923690.1A patent/CN109589310A/en active Pending
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20030166718A1 (en) * | 2000-06-23 | 2003-09-04 | Jeanne-Marie Lecomte | Formulation |
| CN101103960A (en) * | 2006-07-14 | 2008-01-16 | 海南盛科生命科学研究院 | Dry mixed suspension containing racecadotril and preparation method thereof |
| CN102008469A (en) * | 2010-11-16 | 2011-04-13 | 武汉武药科技有限公司 | Method for preparing telmisartan amlodipine tablets |
| CN102166197A (en) * | 2011-04-25 | 2011-08-31 | 四川百利药业有限责任公司 | Racecadotril granules and production process thereof |
| EP2749270A1 (en) * | 2012-12-26 | 2014-07-02 | ILKO Ilac Sanayi ve Ticaret A.S. | Racecadotril and pharmaceutical compositions thereof |
| CN104224724A (en) * | 2013-06-08 | 2014-12-24 | 北京韩美药品有限公司 | Racecadotril granules and preparation technology thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110840848A (en) * | 2019-10-21 | 2020-02-28 | 健民药业集团股份有限公司 | Racecadotril granules and preparation method thereof |
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| PB01 | Publication | ||
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Application publication date: 20190409 |