CN108159015A - A kind of chondroitin sulfate natrium capsule and preparation method thereof - Google Patents
A kind of chondroitin sulfate natrium capsule and preparation method thereof Download PDFInfo
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- CN108159015A CN108159015A CN201810018404.1A CN201810018404A CN108159015A CN 108159015 A CN108159015 A CN 108159015A CN 201810018404 A CN201810018404 A CN 201810018404A CN 108159015 A CN108159015 A CN 108159015A
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- chondroitin sulfate
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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
- A61K9/4866—Organic macromolecular compounds
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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
- A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
- A61K31/737—Sulfated polysaccharides, e.g. chondroitin sulfate, dermatan sulfate
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Abstract
The invention discloses a kind of chondroitin sulfate natrium capsule and preparation method thereof, a kind of raw material of chondroitin sulfate natrium capsule includes sodium chondroitin sulfate, cornstarch, low-substituted hydroxypropyl cellulose, silica and talcum powder, and parts by weight recipe ratio is：15 parts of 50 60 parts of sodium chondroitin sulfate, 30 40 parts of cornstarch, 38 parts of low-substituted hydroxypropyl cellulose, 5 parts of silica 1 and talcum powder；The preparation method includes the following steps：(1) it is dry；(2) it mixes；(3) it fills；(4) bubble-cap fills moisture barrier bag.The present invention solves the hygroscopicity problems of chondroitin sulfate natrium capsule, makes product quality stability more preferable, it is made to can guarantee before the deadline up-to-standard.
Description
Technical field
The present invention relates to pharmaceutical technology field, particularly a kind of chondroitin sulfate natrium capsule and preparation method thereof.
Background technology
Sulphation chain made from sodium chondroitin sulfate system from the cartilaginous tissues such as bone, tracheae in the larynx bone, nose of pig extraction glues
Polysaccharide sodium salt is reducing blood lipid and bone and joint diseases medicine.Since the hygroscopicity of chondroitin sulfate sodium raw materials is superpower, in granulation
Wet granular is made, since the moisture absorption can lead to medicinal powder softening, capsule deformation during storage, so as to cause quality testing unqualified.Cause
This, sodium chondroitin sulfate on the market is commonly tablet.
Publication number CN105399864A, the invention of entitled " preparation process of high purity and low molecular weight sodium chondroitin sulfate "
Patent discloses a kind of preparation process of high purity and low molecular weight sodium chondroitin sulfate, under certain condition, by low point of crude product
High purity and low molecular weight sulphur is made in the preparation of son amount sodium chondroitin sulfate and the purifying of crude product low-molecular weight chondroitin sulfate sodium
Aching and limp ossein sodium.The preparation process that the patent only discloses sodium chondroitin sulfate does not relate to the system of sodium chondroitin sulfate capsule
It is standby.
Invention content
To solve the problems, such as the bibulous of chondroitin sulfate sodium raw materials, the present invention provides a kind of sodium chondroitin sulfate glue
Capsule and preparation method thereof, the present invention improve traditional handicraft, and the suction of chondroitin sulfate natrium capsule can be solved after improvement
Damp sex chromosome mosaicism makes product quality stability more preferable, it is made to can guarantee before the deadline up-to-standard.
The present invention provides a kind of chondroitin sulfate natrium capsule, and capsule includes sodium chondroitin sulfate, cornstarch, low substitution hydroxyl
Third cellulose, silica and talcum powder, parts by weight recipe ratio are：50-60 parts of sodium chondroitin sulfate, cornstarch 30-40
Part, 3-8 parts of low-substituted hydroxypropyl cellulose, -5 parts of silica 1 and 1-5 parts of talcum powder.
It is advanced optimized as the present invention, parts by weight recipe ratio is：53-56 parts of sodium chondroitin sulfate, cornstarch 34-
1-3 parts of 38 parts, 4-6 parts of low-substituted hydroxypropyl cellulose, -3 parts of silica 1 and talcum powder.
It is advanced optimized as the present invention, the low-substituted hydroxypropyl cellulose is LH-11.
It is advanced optimized as the present invention, the grain size of the chondroitin sulfate sodium raw materials is 40-80 mesh.
The present invention also provides a kind of preparation methods of chondroitin sulfate natrium capsule, include the following steps：
(1) chondroitin sulfate sodium raw materials are dried with baking oven, 65~75 DEG C of temperature；
(2) take dried sodium chondroitin sulfate 50-60 parts, 30-40 parts of cornstarch, low-substituted hydroxypropyl cellulose 3-8
1-5 parts of part, -5 parts of silica 1 and talcum powder are mixed together uniformly；
(3) more than medicinal powder is filled with filling machine；
(4) capsule after filling is subjected to bubble-cap with bubble-cap machine, by bubble cap tray be packed into moisture barrier bag to get.
It is advanced optimized as this preparation method, baking oven is by sodium chondroitin sulfate raw material drying to moisture in step (1)
5.0%.
It is advanced optimized as this preparation method, control humidity is no more than 55% in step (3).
The beneficial effects of the invention are as follows：
1st, the present invention solves the hygroscopicity problems of chondroitin sulfate natrium capsule, makes product quality stability more preferable, makes it
It can guarantee before the deadline up-to-standard.
2nd, inventive formulation uses low-substituted hydroxypropyl cellulose ether, is that a kind of multiduty nonionic cellulose derives
Object.Low-substituted hydroxypropyl cellulose ether is mainly used as solid pharmaceutical preparation disintegration and adhesive, since its powder has larger surface
Product and porosity, therefore the quick water swelling of energy, make preparation fater disintegration, while have between its coarse structure and drug and particle
Larger inlays, and can significantly improve hardness, while does not influence to be disintegrated, and so as to accelerate the dissolution rate of drug, improves bioavilability.
3rd, limit low-substituted hydroxypropyl cellulose ether as LH-11, be due to LH-11 be medium degree of substitution, select LH-11 for
During low-substituted hydroxypropyl cellulose, grain size is maximum, and LH-11 is mainly used for preventing the disintegration of tablet capping and direct tablet compressing；Grain size is big,
Good fluidity, content uniformity is best during filling.
Specific embodiment
Embodiment 1
A kind of chondroitin sulfate natrium capsule, raw material include sodium chondroitin sulfate, cornstarch, low-substituted hydroxypropyl cellulose,
Silica and talcum powder, parts by weight recipe ratio are：50 parts of sodium chondroitin sulfate, 40 parts of cornstarch, low-substituted hydroxypropyl are fine
3 parts of 3 parts of dimension element, 4 parts of silica and talcum powder.
Embodiment 2
A kind of chondroitin sulfate natrium capsule, raw material include sodium chondroitin sulfate, cornstarch, low-substituted hydroxypropyl cellulose,
Silica and talcum powder, parts by weight recipe ratio are：60 parts of sodium chondroitin sulfate, 30 parts of cornstarch, low-substituted hydroxypropyl are fine
1 part of 8 parts of dimension element, silica 1 part and talcum powder.
The grain size of the chondroitin sulfate sodium raw materials is 80 mesh.
Embodiment 3
A kind of chondroitin sulfate natrium capsule, raw material include sodium chondroitin sulfate, cornstarch, low-substituted hydroxypropyl cellulose,
Silica and talcum powder, parts by weight recipe ratio are：52 parts of sodium chondroitin sulfate, 32 parts of cornstarch, low-substituted hydroxypropyl are fine
5 parts of 6 parts of dimension element, 5 parts of silica and talcum powder.
The grain size of the chondroitin sulfate sodium raw materials is 50 mesh.
Embodiment 4
A kind of chondroitin sulfate natrium capsule, raw material include sodium chondroitin sulfate, cornstarch, low-substituted hydroxypropyl cellulose,
Silica and talcum powder, parts by weight recipe ratio are：53 parts of sodium chondroitin sulfate, 38 parts of cornstarch, low-substituted hydroxypropyl are fine
2 parts of 6 parts of dimension element, silica 1 part and talcum powder.
The grain size of the chondroitin sulfate sodium raw materials is 40 mesh.
The low-substituted hydroxypropyl cellulose is LH-11.
Embodiment 5
A kind of chondroitin sulfate natrium capsule, raw material include sodium chondroitin sulfate, cornstarch, low-substituted hydroxypropyl cellulose,
Silica and talcum powder, parts by weight recipe ratio are：56 parts of sodium chondroitin sulfate, 34 parts of cornstarch, low-substituted hydroxypropyl are fine
2 parts of 5 parts of dimension element, 3 parts of silica and talcum powder.
The grain size of the chondroitin sulfate sodium raw materials is 70 mesh.
The low-substituted hydroxypropyl cellulose is LH-11.
Embodiment 6
A kind of chondroitin sulfate natrium capsule, raw material include sodium chondroitin sulfate, cornstarch, low-substituted hydroxypropyl cellulose,
Silica and talcum powder, parts by weight recipe ratio are：55 parts of sodium chondroitin sulfate, 36 parts of cornstarch, low-substituted hydroxypropyl are fine
3 parts of 4 parts of dimension element, 2 parts of silica and talcum powder.
The grain size of the chondroitin sulfate sodium raw materials is 45 mesh.
The low-substituted hydroxypropyl cellulose is LH-11.
Embodiment 7
A kind of chondroitin sulfate natrium capsule, raw material include sodium chondroitin sulfate, cornstarch, low-substituted hydroxypropyl cellulose,
Silica and talcum powder, parts by weight recipe ratio are：54 parts of sodium chondroitin sulfate, 37 parts of cornstarch, low-substituted hydroxypropyl are fine
1 part of 5 parts of dimension element, 3 parts of silica and talcum powder.
The grain size of the chondroitin sulfate sodium raw materials is 55 mesh.
The low-substituted hydroxypropyl cellulose is LH-11.
Embodiment 10
The present embodiment proposes a kind of preparation method of chondroitin sulfate natrium capsule, including following on the basis of embodiment 1
Step：
(1) chondroitin sulfate sodium raw materials are dried with baking oven, temperature is 65 DEG C；
(2) dried sodium chondroitin sulfate, cornstarch, low-substituted hydroxypropyl cellulose, silica and talcum powder are taken
It is mixed together uniformly；
(3) more than medicinal powder is filled with filling machine；
(4) capsule after filling is subjected to bubble-cap with bubble-cap machine, by bubble cap tray be packed into moisture barrier bag to get.
Wherein, baking oven is by sodium chondroitin sulfate raw material drying to moisture 5.0% in step (1), control humidity in step (3)
No more than 55%.
Embodiment 11
The present embodiment proposes a kind of preparation method of chondroitin sulfate natrium capsule, including following on the basis of embodiment 2
Step：
(1) chondroitin sulfate sodium raw materials are dried with baking oven, temperature is 75 DEG C；
(2) dried sodium chondroitin sulfate, cornstarch, low-substituted hydroxypropyl cellulose, silica and talcum powder are taken
It is mixed together uniformly；
(3) more than medicinal powder is filled with filling machine；
(4) capsule after filling is subjected to bubble-cap with bubble-cap machine, by bubble cap tray be packed into moisture barrier bag to get.
Wherein, baking oven is by sodium chondroitin sulfate raw material drying to moisture 5.0% in step (1), control humidity in step (3)
No more than 55%.
Embodiment 12
The present embodiment proposes a kind of preparation method of chondroitin sulfate natrium capsule, including following on the basis of embodiment 3
Step：
(1) chondroitin sulfate sodium raw materials are dried with baking oven, temperature is 70 DEG C；
(2) dried sodium chondroitin sulfate, cornstarch, low-substituted hydroxypropyl cellulose, silica and talcum powder are taken
It is mixed together uniformly；
(3) more than medicinal powder is filled with filling machine；
(4) capsule after filling is subjected to bubble-cap with bubble-cap machine, by bubble cap tray be packed into moisture barrier bag to get.
Wherein, baking oven is by sodium chondroitin sulfate raw material drying to moisture 5.0% in step (1), control humidity in step (3)
No more than 55%.
Embodiment 13
Traditional method of granulating of chondroitin sulfate natrium capsule, includes the following steps：
(1) preparation of adhesive：46.7% low-substituted hydroxypropyl cellulose of total amount is taken to add in purified water, makes its swelling, is made
20% low-substituted hydroxypropyl cellulose solution, stirring are placed, and make adhesive；
(2) it pelletizes：By the low-substituted hydroxypropyl cellulose mistake of sodium chondroitin sulfate, cornstarch and remaining total amount 53.3%
Sieve adds in more than adhesive after mixing, pelletized, be put into heated-air circulation oven with 16 mesh, and control drying temperature is 70-80 DEG C,
Terminate drying when measuring moisture to 5.0%-6.5% with fast tester for water content；Whole grain is sieved with 16 mesh, adds in magnesium stearate mixing
Uniformly；
(3) it fills：More than medicinal powder is filled with filling machine, control humidity is no more than 55%；
(4) it packs：Capsule after filling is subjected to bubble-cap, and bubble cap tray is packed into moisture barrier bag with bubble-cap machine.
The experimental data of traditional method of granulating of the chondroitin sulfate natrium capsule refers to table 1, a kind of sulphur of the present invention
The experimental data of the preparation method of aching and limp ossein natrium capsule refers to table 2.As shown in Table 1, prepared by time longer traditional preparation methods
Most of chondroitin sulfate natrium capsule weight it is heavier, it was demonstrated that traditional preparation methods prepare the chondroitin sulfate natrium capsule moisture absorption
Property is than more serious.As shown in Table 2, the weight of chondroitin sulfate natrium capsule that prepared by time longer preparation method of the present invention is lighter,
Prove that chondroitin sulfate natrium capsule prepared by preparation method of the present invention solves the problems, such as moisture absorption well.
The experimental data of traditional method of granulating of 1 chondroitin sulfate natrium capsule of table
A kind of experimental data of sodium chondroitin sulfate capsule preparation method thereof of the present invention of table 2
Embodiment described above only expresses the specific embodiment of the present invention, and description is more specific and detailed, but simultaneously
Cannot the limitation to the scope of the claims of the present invention therefore be interpreted as.It should be pointed out that for those of ordinary skill in the art
For, without departing from the inventive concept of the premise, various modifications and improvements can be made, these belong to the guarantor of the present invention
Protect range.
Claims (7)
1. a kind of chondroitin sulfate natrium capsule, which is characterized in that raw material includes sodium chondroitin sulfate, cornstarch, low substitution hydroxyl
Third cellulose, silica and talcum powder, parts by weight recipe ratio are：50-60 parts of sodium chondroitin sulfate, cornstarch 30-40
Part, 3-8 parts of low-substituted hydroxypropyl cellulose, -5 parts of silica 1 and 1-5 parts of talcum powder.
2. a kind of chondroitin sulfate natrium capsule according to claim 1, which is characterized in that its parts by weight recipe ratio is：Sulphur
Aching and limp 53-56 parts of ossein sodium, 34-38 parts of cornstarch, 4-6 parts of low-substituted hydroxypropyl cellulose, -3 parts of silica 1 and talcum powder
1-3 parts.
A kind of 3. chondroitin sulfate natrium capsule according to claim 1, which is characterized in that the low-substituted hydroxypropyl cellulose
For LH-11.
A kind of 4. chondroitin sulfate natrium capsule according to claim 1, which is characterized in that the grain of the sodium chondroitin sulfate
Diameter is 40-80 mesh.
5. the preparation method of a kind of chondroitin sulfate natrium capsule according to claim 1, which is characterized in that including following step
Suddenly：
(1) chondroitin sulfate sodium raw materials are dried with baking oven, 65~75 DEG C of temperature；
(2) take dried sodium chondroitin sulfate 50-60 parts, 30-40 parts of cornstarch, 3-8 parts of low-substituted hydroxypropyl cellulose, two
1-5 parts of 1-5 parts of silica and talcum powder are mixed together uniformly；
(3) more than medicinal powder is filled with filling machine；
(4) capsule after filling is subjected to bubble-cap with bubble-cap machine, by bubble cap tray be packed into moisture barrier bag to get.
6. the preparation method of a kind of chondroitin sulfate natrium capsule according to claim 5, which is characterized in that in step (1)
Baking oven is by sodium chondroitin sulfate raw material drying to moisture 5.0%.
7. the preparation method of a kind of chondroitin sulfate natrium capsule according to claim 5, which is characterized in that in step (3)
Humidity is controlled to be no more than 55%.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810018404.1A CN108159015B (en) | 2018-01-09 | 2018-01-09 | Sodium chondroitin sulfate capsule and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810018404.1A CN108159015B (en) | 2018-01-09 | 2018-01-09 | Sodium chondroitin sulfate capsule and preparation method thereof |
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| Publication Number | Publication Date |
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| CN108159015A true CN108159015A (en) | 2018-06-15 |
| CN108159015B CN108159015B (en) | 2020-09-29 |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1899300A (en) * | 2006-06-30 | 2007-01-24 | 北京润德康医药技术有限公司 | Medicinal composition using amino glucose hydrochloride and chondroitin sulfate as active components and its preparing method and use |
| JP2007051077A (en) * | 2005-08-17 | 2007-03-01 | Nippon Barrier Free:Kk | Composition for prevention and treatment of osteoarthritis |
| US20070122473A1 (en) * | 2005-11-12 | 2007-05-31 | Felton Linda A | Aminosugar and/or glycosaminoglycan composition having therapeutic use |
| CN104606165A (en) * | 2015-02-04 | 2015-05-13 | 上海华源安徽仁济制药有限公司 | Norfloxacin capsules and preparation method thereof |
-
2018
- 2018-01-09 CN CN201810018404.1A patent/CN108159015B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2007051077A (en) * | 2005-08-17 | 2007-03-01 | Nippon Barrier Free:Kk | Composition for prevention and treatment of osteoarthritis |
| US20070122473A1 (en) * | 2005-11-12 | 2007-05-31 | Felton Linda A | Aminosugar and/or glycosaminoglycan composition having therapeutic use |
| CN1899300A (en) * | 2006-06-30 | 2007-01-24 | 北京润德康医药技术有限公司 | Medicinal composition using amino glucose hydrochloride and chondroitin sulfate as active components and its preparing method and use |
| CN104606165A (en) * | 2015-02-04 | 2015-05-13 | 上海华源安徽仁济制药有限公司 | Norfloxacin capsules and preparation method thereof |
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| CN108159015B (en) | 2020-09-29 |
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