CN110448538A - N-acetylglucosamine capsule preparations and preparation method thereof - Google Patents
N-acetylglucosamine capsule preparations and preparation method thereof Download PDFInfo
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- CN110448538A CN110448538A CN201910846210.5A CN201910846210A CN110448538A CN 110448538 A CN110448538 A CN 110448538A CN 201910846210 A CN201910846210 A CN 201910846210A CN 110448538 A CN110448538 A CN 110448538A
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- acetylglucosamine
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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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7008—Compounds having an amino group directly attached to a carbon atom of the saccharide radical, e.g. D-galactosamine, ranimustine
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/485—Inorganic compounds
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P19/00—Drugs for skeletal disorders
- A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
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Abstract
The invention belongs to technical field of medicine, a kind of N-acetylglucosamine capsule preparations and preparation method thereof are disclosed.N-acetylglucosamine capsule preparations of the invention include the component of following parts by weight: 25-35 parts of N-acetylglucosamines, 20-30 parts of precipitated calcium carbonates, 7-15 portions of disintegrating agents, 10-15 parts of adhesives, 9-12 portions of mannitol, 4-7 portions of glidants and 2-5 parts of lubricants, said preparation passes through the combination of N-acetylglucosamine and precipitated calcium carbonate, mannitol and specific disintegrating agent, adhesive, glidant, lubricant, so that not only stability is good for gained capsule preparations, and dissolution is very fast, is convenient for absorption of human body.
Description
Technical field
The present invention relates to technical field of medicine, be specifically related to a kind of N-acetylglucosamine capsule preparations and its
Preparation method.
Background technique
2-acetylamino-2-deoxy-D-glucose is the basic composition unit of many important polysaccharide in biological cell, especially crust
The ectoskeleton content highest of class animal.It is the important prerequisite for synthesizing bifidus factor, has many important physiology in vivo
Function.It is clinically the drug for treating rheumatic and rheumatoid arthritis.It can also be used as food antioxidant and
Infant food additive, diabetic's sweetener.It is mainly used for clinical enhancing function of the human immune system, inhibits cancer thin
The undue growth of born of the same parents or fibrocyte, plays an inhibitory and therapeutic role in cancer and malignant tumor;For various inflammation, can play
Effective treatment, also has therapeutic effect to osteoarthritis and arthralgia.
Glucosamine itself belongs to BSC classification 1 class drug (high-dissolvability, high osmosis), but due to first pass effect,
Bioavilability after this product is oral is less than 30%.Capsule has as common pharmaceutical preparation form and covers drug not
Good smell reduces medicine irritation, improves the advantages such as drug bioavailability.It is commonly used in the preparation process of capsule directly filling
Filling method after method and granulation, wherein directly filling method simple process, but if for active constituent compressibility itself or mobility,
The drug of bad dispersibility is needed to screen suitable auxiliary material and carries out compatibility, and processed using suitable technique, just can be prepared into
It is suitble to the capsule preparations of clinical application.
Summary of the invention
N-acetylglucosamine raw material is acicular crystal, and chance water is easy to change after which mixes with auxiliary material, in addition raw material
Granular pile density itself is low, poor fluidity.The purpose of the invention is to for capsule preparations and N-acetylglucosamine
Feature screens suitable auxiliary material combination, provides a kind of N-acetylglucosamine capsule preparations.
To achieve the object of the present invention, N-acetylglucosamine capsule preparations of the invention include N- acetylamino Portugal
Grape sugar, precipitated calcium carbonate, disintegrating agent, adhesive, mannitol, glidant and lubricant.
Further, N-acetylglucosamine capsule preparations of the invention include the component of following parts by weight: 25-35
Part N-acetylglucosamine, 20-30 parts of precipitated calcium carbonates, 7-15 portions of disintegrating agents, 10-15 parts of adhesives, 9-12 parts of sweet dews
Alcohol, 4-7 portion glidant and 2-5 parts of lubricants.
Further, the disintegrating agent is one of low-substituted hydroxypropyl cellulose, sodium carboxymethyl starch.
Further, described adhesive is one of polyvinylpyrrolidone, sodium carboxymethylcellulose, starch.
Further, the glidant is superfine silica gel powder or talcum powder.
Further, the lubricant is sodium stearyl fumarate, magnesium laurylsulfate or magnesium stearate.
Further, when the glidant is superfine silica gel powder, the lubricant is not magnesium laurylsulfate.
On the other hand, the present invention also provides a kind of preparation method of N-acetylglucosamine capsule preparations, institutes
State method the following steps are included:
(1) micronization processes N-acetylglucosamine;
(2) precipitated calcium carbonate and disintegrating agent is added, is mixed in batch mixer with the N-acetylglucosamine of micronization processes
It closes;
(3) adhesive is added into mixture obtained by step (2) and mannitol mixes in batch mixer;
(4) into mixture obtained by step (3), addition glidant and lubricant use Full-automatic glue after mixing in batch mixer
Capsule filling machine is packed into capsule shells.
Further, micronization processes N-acetylglucosamine is the N- second so that 80% or more in the step (1)
Acylamino- glucose can pass through 500 meshes.
Further, precipitated calcium carbonate and disintegrating agent micronization processes described in the step (2), make it cross 200 meshes.
N-acetylglucosamine capsule preparations of the invention pass through N-acetylglucosamine and precipitated calcium carbonate, sweet dew
The combination of pure and mild specific disintegrating agent, adhesive, glidant, lubricant, so that not only stability is good for gained capsule preparations, Er Qierong
It is very fast out, it is convenient for absorption of human body.
Specific embodiment
In order to make the objectives, technical solutions, and advantages of the present invention clearer, with reference to embodiments, to the present invention
It is further elaborated.Additional aspect and advantage of the invention will be set forth in part in the description, partially will be under
Become obvious in the description in face, or practice through the invention is recognized.It is only used to explain this hair it should be appreciated that being described below
It is bright, it is not intended to limit the present invention.
Term "comprising" used herein, " comprising ", " having ", " containing " or its any other deformation, it is intended that covering
Non-exclusionism includes.For example, composition, step, method, product or device comprising listed elements are not necessarily limited to those and want
Element, but may include not expressly listed other elements or such composition, step, method, product or device it is intrinsic
Element.
Equivalent, concentration or other values or parameter are excellent with range, preferred scope or a series of upper limit preferred values and lower limit
When the Range Representation that choosing value limits, this should be understood as specifically disclosing by any range limit or preferred value and any range
Any pairing of lower limit or preferred value is formed by all ranges, regardless of whether the range separately discloses.For example, when open
When range " 1 to 5 ", described range should be interpreted as including range " 1 to 4 ", " 1 to 3 ", " 1 to 2 ", " 1 to 2 and 4 to
5 ", " 1 to 3 and 5 " etc..When numberical range is described herein, unless otherwise stated, otherwise the range is intended to include its end
Value and all integers and score in the range.Moreover, technical characteristic involved in each embodiment of the present invention is only
Not constituting a conflict with each other can be combined with each other.
Embodiment 1
Prepare raw material: 30 parts of N-acetylglucosamines, 25 parts of precipitated calcium carbonates, 11 parts of disintegrations by following parts by weight
Agent, 12 parts of adhesives, 11 portions of mannitol, 6 portions of glidants and 4 parts of lubricants.
The disintegrating agent is low-substituted hydroxypropyl cellulose.
Described adhesive is polyvinylpyrrolidone.
The glidant is superfine silica gel powder.
The lubricant is sodium stearyl fumarate.
The preparation methods of the N-acetylglucosamine capsule preparations the following steps are included:
(1) micronization processes N-acetylglucosamine, so that 80% or more N-acetylglucosamine can pass through 500
Mesh;
(2) precipitated calcium carbonate and disintegrating agent that micronization processes cross 200 meshes, the N- acetyl ammonia with micronization processes is added
Base glucose mixes in batch mixer;
(3) adhesive is added into mixture obtained by step (2) and mannitol mixes in batch mixer;
(4) into mixture obtained by step (3), addition glidant and lubricant use Full-automatic glue after mixing in batch mixer
Capsule filling machine is packed into capsule shells.
Embodiment 2
Prepare raw material: 25 parts of N-acetylglucosamines, 20 parts of precipitated calcium carbonates, 7 parts of low substitutions by following parts by weight
Hydroxypropyl cellulose, 10 parts of polyvinylpyrrolidones, 9 portions of mannitol, 4 portions of glidants and 2 parts of lubricants.
The disintegrating agent is sodium carboxymethyl starch.
Described adhesive is sodium carboxymethylcellulose.
The glidant is talcum powder.
The lubricant is magnesium stearate.
The preparation methods of the N-acetylglucosamine capsule preparations the following steps are included:
(1) micronization processes N-acetylglucosamine, so that 80% or more N-acetylglucosamine can pass through 500
Mesh;
(2) precipitated calcium carbonate and disintegrating agent that micronization processes cross 200 meshes, the N- acetyl ammonia with micronization processes is added
Base glucose mixes in batch mixer;
(3) adhesive is added into mixture obtained by step (2) and mannitol mixes in batch mixer;
(4) into mixture obtained by step (3), addition glidant and lubricant use Full-automatic glue after mixing in batch mixer
Capsule filling machine is packed into capsule shells.
Embodiment 3
Prepare raw material by following parts by weight: 35 parts of N-acetylglucosamines, 30 parts of precipitated calcium carbonates, 15 parts low take
For hydroxypropyl cellulose, 15 parts of polyvinylpyrrolidones, 12 portions of mannitol, 7 portions of glidants and 5 parts of lubricants.
The disintegrating agent is low-substituted hydroxypropyl cellulose.
Described adhesive is polyvinylpyrrolidone.
The glidant is superfine silica gel powder.
The lubricant is magnesium stearate.
The preparation methods of the N-acetylglucosamine capsule preparations the following steps are included:
(1) micronization processes N-acetylglucosamine, so that 80% or more N-acetylglucosamine can pass through 500
Mesh;
(2) precipitated calcium carbonate and disintegrating agent that micronization processes cross 200 meshes, the N- acetyl ammonia with micronization processes is added
Base glucose mixes in batch mixer;
(3) adhesive is added into mixture obtained by step (2) and mannitol mixes in batch mixer;
(4) into mixture obtained by step (3), addition glidant and lubricant use Full-automatic glue after mixing in batch mixer
Capsule filling machine is packed into capsule shells.
Embodiment 4
Prepare raw material: 30 parts of N-acetylglucosamines, 25 parts of precipitated calcium carbonates, 11 parts of disintegrations by following parts by weight
Agent, 12 parts of adhesives, 11 portions of mannitol, 6 portions of glidants and 4 parts of lubricants.
The disintegrating agent is low-substituted hydroxypropyl cellulose.
Described adhesive is polyvinylpyrrolidone.
The glidant is talcum powder.
The lubricant is magnesium laurylsulfate.
The preparation methods of the N-acetylglucosamine capsule preparations the following steps are included:
(1) micronization processes N-acetylglucosamine, so that 80% or more N-acetylglucosamine can pass through 500
Mesh;
(2) precipitated calcium carbonate and disintegrating agent that micronization processes cross 200 meshes, the N- acetyl ammonia with micronization processes is added
Base glucose mixes in batch mixer;
(3) adhesive is added into mixture obtained by step (2) and mannitol mixes in batch mixer;
(4) into mixture obtained by step (3), addition glidant and lubricant use Full-automatic glue after mixing in batch mixer
Capsule filling machine is packed into capsule shells.
Embodiment 5
Prepare raw material: 30 parts of N-acetylglucosamines, 25 parts of precipitated calcium carbonates, 11 parts of disintegrations by following parts by weight
Agent, 12 parts of adhesives, 11 portions of mannitol, 6 portions of glidants and 4 parts of lubricants.
The disintegrating agent is low-substituted hydroxypropyl cellulose.
Described adhesive is polyvinylpyrrolidone.
The glidant is superfine silica gel powder.
The lubricant is magnesium laurylsulfate.
The preparation methods of the N-acetylglucosamine capsule preparations the following steps are included:
(1) micronization processes N-acetylglucosamine, so that 80% or more N-acetylglucosamine can pass through 500
Mesh;
(2) precipitated calcium carbonate and disintegrating agent that micronization processes cross 200 meshes, the N- acetyl ammonia with micronization processes is added
Base glucose mixes in batch mixer;
(3) adhesive is added into mixture obtained by step (2) and mannitol mixes in batch mixer;
(4) into mixture obtained by step (3), addition glidant and lubricant use Full-automatic glue after mixing in batch mixer
Capsule filling machine is packed into capsule shells.
Embodiment 6
Prepare raw material: 30 parts of N-acetylglucosamines, 25 parts of precipitated calcium carbonates, 11 parts of disintegrations by following parts by weight
Agent, 12 parts of adhesives, 11 portions of mannitol, 6 portions of glidants and 4 parts of lubricants.
The disintegrating agent is crospovidone.
Described adhesive is starch.
The glidant is superfine silica gel powder.
The lubricant is sodium stearyl fumarate.
The preparation methods of the N-acetylglucosamine capsule preparations the following steps are included:
(1) micronization processes N-acetylglucosamine, so that 80% or more N-acetylglucosamine can pass through 500
Mesh;
(2) precipitated calcium carbonate and disintegrating agent that micronization processes cross 200 meshes, the N- acetyl ammonia with micronization processes is added
Base glucose mixes in batch mixer;
(3) adhesive is added into mixture obtained by step (2) and mannitol mixes in batch mixer;
(4) into mixture obtained by step (3), addition glidant and lubricant use Full-automatic glue after mixing in batch mixer
Capsule filling machine is packed into capsule shells.
Embodiment 7
Prepare raw material: 30 parts of N-acetylglucosamines, 25 parts of microcrystalline celluloses, 11 parts of disintegrations by following parts by weight
Agent, 12 parts of adhesives, 11 portions of mannitol, 6 portions of glidants and 4 parts of lubricants.
The disintegrating agent is low-substituted hydroxypropyl cellulose.
Described adhesive is polyvinylpyrrolidone.
The glidant is superfine silica gel powder.
The lubricant is sodium stearyl fumarate.
The preparation methods of the N-acetylglucosamine capsule preparations the following steps are included:
(1) micronization processes N-acetylglucosamine, so that 80% or more N-acetylglucosamine can pass through 500
Mesh;
(2) microcrystalline cellulose and disintegrating agent that micronization processes cross 200 meshes, the N- acetyl ammonia with micronization processes is added
Base glucose mixes in batch mixer;
(3) adhesive is added into mixture obtained by step (2) and mannitol mixes in batch mixer;
(4) into mixture obtained by step (3), addition glidant and lubricant use Full-automatic glue after mixing in batch mixer
Capsule filling machine is packed into capsule shells.
Embodiment 8
Prepare raw material: 30 parts of N-acetylglucosamines, 25 parts of precipitated calcium carbonates, 11 parts of disintegrations by following parts by weight
Agent, 12 parts of adhesives, 11 portions of mannitol, 6 portions of glidants and 4 parts of lubricants.
The disintegrating agent is low-substituted hydroxypropyl cellulose.
Described adhesive is polyvinylpyrrolidone.
The glidant is superfine silica gel powder.
The lubricant is sodium stearyl fumarate.
The preparation methods of the N-acetylglucosamine capsule preparations the following steps are included:
(1) precipitated calcium carbonate and disintegrating agent that micronization processes cross 200 meshes is added, with the N- second without micronization processes
Acylamino- glucose mixes in batch mixer;
(2) adhesive is added into mixture obtained by step (1) and mannitol mixes in batch mixer;
(3) into mixture obtained by step (2), addition glidant and lubricant use Full-automatic glue after mixing in batch mixer
Capsule filling machine is packed into capsule shells.
Stability and dissolution are investigated
It investigates capsule obtained by embodiment and places 3 for (40 DEG C ± 2 DEG C of temperature, humidity 75% ± 5%) under the conditions of accelerated test
A month total miscellaneous, and investigating to the dissolved corrosion of capsule obtained by each embodiment, wherein dissolved corrosion, which is investigated, mainly investigates
Capsule obtained by being is in the acetate buffer solution medium of pH4.5, the citrate buffer solution medium of pH6.5 after 30min
Dissolution rate, as a result as shown in the table.
As it will be easily appreciated by one skilled in the art that the foregoing is merely illustrative of the preferred embodiments of the present invention, not to
The limitation present invention, any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should all include
Within protection scope of the present invention.
Claims (10)
1. a kind of N-acetylglucosamine capsule preparations, which is characterized in that the N-acetylglucosamine capsule preparations packet
Containing N-acetylglucosamine, precipitated calcium carbonate, disintegrating agent, adhesive, mannitol, glidant and lubricant.
2. N-acetylglucosamine capsule preparations according to claim 1, which is characterized in that N- acetylamino Portugal
Grape carbohydrate gum capsule preparation include following parts by weight component: 25-35 parts of N-acetylglucosamines, 20-30 parts of precipitated calcium carbonates,
7-15 portions of disintegrating agents, 10-15 parts of adhesives, 9-12 portions of mannitol, 4-7 portions of glidants and 2-5 parts of lubricants.
3. N-acetylglucosamine capsule preparations according to claim 1, which is characterized in that the disintegrating agent is low takes
For one of hydroxypropyl cellulose, sodium carboxymethyl starch.
4. N-acetylglucosamine capsule preparations according to claim 1, which is characterized in that described adhesive is poly- second
One of alkene pyrrolidone, sodium carboxymethylcellulose, starch.
5. N-acetylglucosamine capsule preparations according to claim 1, which is characterized in that the glidant is micro mist
Silica gel or talcum powder.
6. N-acetylglucosamine capsule preparations according to claim 1, which is characterized in that the lubricant is tristearin
Fumaric acid sodium, magnesium laurylsulfate or magnesium stearate.
7. N-acetylglucosamine capsule preparations according to claim 1, which is characterized in that the glidant is micro mist
When silica gel, the lubricant is not magnesium laurylsulfate.
8. the preparation method of N-acetylglucosamine capsule preparations described in claim 1, which is characterized in that the method includes
Following steps:
(1) micronization processes N-acetylglucosamine;
(2) precipitated calcium carbonate and disintegrating agent is added, is mixed in batch mixer with the N-acetylglucosamine of micronization processes;
(3) adhesive is added into mixture obtained by step (2) and mannitol mixes in batch mixer;
(4) it is filled out after into mixture obtained by step (3), addition glidant and lubricant mix in batch mixer with fully-automatic capsule
It fills machine and is packed into capsule shells.
9. the preparation method of N-acetylglucosamine capsule preparations according to claim 9, which is characterized in that the step
(1) micronization processes N-acetylglucosamine is so that 80% or more N-acetylglucosamine can be by 500 meshes in.
10. the preparation method of N-acetylglucosamine capsule preparations according to claim 9, which is characterized in that the step
Suddenly precipitated calcium carbonate described in (2) and disintegrating agent micronization processes, make it cross 200 meshes.
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