CN105496982A - Chitosan tablets and preparation method thereof - Google Patents
Chitosan tablets and preparation method thereof Download PDFInfo
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- CN105496982A CN105496982A CN201510980321.7A CN201510980321A CN105496982A CN 105496982 A CN105496982 A CN 105496982A CN 201510980321 A CN201510980321 A CN 201510980321A CN 105496982 A CN105496982 A CN 105496982A
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- chitosan
- tablet
- hydrogen phosphate
- label
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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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/2873—Proteins, e.g. gelatin
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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
- A61K31/716—Glucans
- A61K31/722—Chitin, chitosan
-
- 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
Abstract
The invention belongs to the technical field of pharmaceutical preparations and particularly relates to chitosan tablets and a preparation method thereof. The chitosan tablets comprise tablet cores and coating layers, wherein the tablet cores comprise components in parts by weight as follows: 70-76 parts of chitosan, 3-6 parts of crospovidone, 7-12 parts of calcium hydrogen phosphate, 8-12 parts of microcrystalline cellulose, 1-3 parts of aerosil and 4-6 parts of sodium carboxymethyl cellulose; the coating layers are prepared from raw materials in parts by weight as follows: 4-6 parts of zein, 7-9 parts of hydroxypropyl methoxyl cellulose, 3-5 parts of polyethylene glycol and 80-84 parts of ethyl alcohol with the volume fraction of 30%-40%. The chitosan tablets have bright and clean appearance and are stable in physical and chemical properties and long in shelf life, and the disintegration time, hardness, friability and the like agree with related regulations of the Chinese pharmacopoeia.
Description
Technical field
The invention belongs to pharmaceutical preparations technology field, be specifically related to a kind of chitosan tablet and preparation method thereof.
Background technology
Chitosan (chitosan) is also known as chitosan, that the chitin (chitin) extensively existed by nature obtains through deacetylation, it is one of natural polymer that the earth enriches the most, content is only second to cellulose, and its chemical name is Chitosan (1-4)-2-amino-B-D glucose.From 1859, after first Frenchman Rouget obtains chitosan, the premium properties such as the biological functionality of this natural polymer and the compatibility, blood compatibility, film property, safety, microbic resolvability, by all trades and professions extensive concern, achieve major progress at the applied research of the numerous areas such as medicine, food, chemical industry, cosmetics, water treatment, METAL EXTRACTION and recovery, biochemistry and biomedical engineering.
Current, chitosan is widely used in pharmaceutical dosage form by as pharmaceutical adjunct.Experimental studies have found that, chitosan as pharmaceutical carrier can Drug controlled release, reduce adverse effect, prolong drug curative effect, not only can improve the permeability of hydrophobic drug cell membrane and the stability of medicine and change route of administration, greatly can also strengthen the target administration ability of preparation.But chitosan self also possesses good physiologically active: (1) controls cholesterol: the Cholesterol Excretion in blood of human body, by stoping the absorption of fat, is fallen two mechanism and reduces cholesterol by chitosan simultaneously; (2) prevention and corntrol hypertension: chitosan passes through the adsorption between the chloride ion of self and ammonia radical ion, excretion chloride ion, reduces angiotensin II, reaches and prevent and control hypertensive object; (3) absorption and excretion heavy metal: chitosan has the absorbability of remarkable characteristic, adsorbable metal ion, cholesterol, triglyceride, cholic acid and organic mercury etc.; (4) immunoregulatory activity: chitosan has the series of biologic effect of activating machine system, mediation airframe systems, improve cytophagous systemic-function, realize the adjustment of body to T cell, NK cell and B cell, the cellullar immunologic response of mediation body and humoral immunoresponse(HI).So chitosan is also a kind of medicine and prevention and health care medicine of possessing good physiologically active, but rarely has the research of oral formulations for chitosan and technique at present.But because chitosan belongs to Chinese medicine fecula class, cellulose is more, poor compressibility, easily rebound after tabletting, therefore, be necessary to research and develop a kind of tablet formulation to solve the problem of the difficult tabletting of chitosan, also provide the chitosan tablet of this good stability to ensure the stable performance of its drug effect simultaneously.
Summary of the invention
In order to overcome the deficiencies in the prior art, the object of the present invention is to provide a kind of chitosan tablet, its smooth appearance, disintegration time, hardness and friability etc. all meet the relevant regulations of Chinese Pharmacopoeia, stable in physicochemical property, long shelf-life.
To achieve these goals, technical scheme of the present invention is as follows:
A kind of chitosan tablet, be made up of label and coatings, described label is made up of the component of following parts by weight: chitosan 70 ~ 76 parts, polyvinylpolypyrrolidone 3 ~ 6 parts, calcium hydrogen phosphate 7 ~ 12 parts, microcrystalline Cellulose 8 ~ 12 parts, micropowder silica gel 1 ~ 3 part and sodium carboxymethyl cellulose 4 ~ 6 parts; Described coatings is prepared from by the raw material of following weight portion: zein 4 ~ 6 parts, hydroxypropyl methoxycellulose 7 ~ 9 parts, Polyethylene Glycol 3 ~ 5 parts and volume fraction are the ethanol 80 ~ 84 parts of 30 ~ 40%.
As the preferred embodiment of the present invention, described label is made up of the component of following parts by weight: chitosan 70 parts, polyvinylpolypyrrolidone 5 parts, calcium hydrogen phosphate 8 parts, microcrystalline Cellulose 10 parts, micropowder silica gel 2 parts and sodium carboxymethyl cellulose 5 parts.
Described coatings is prepared from by following raw material: zein 5 parts, hydroxypropyl methoxycellulose 8 parts, Polyethylene Glycol 4 parts and volume fraction are the ethanol 83 parts of 30 ~ 40%.
Present invention also offers the preparation method of above-mentioned chitosan tablet, comprise the following steps:
S1, getting zein, hydroxypropyl methoxycellulose and Polyethylene Glycol, to join volume fraction be in the ethanol of 30 ~ 40%, stirs, obtain coating solution;
S2, respectively by chitosan, polyvinylpolypyrrolidone, calcium hydrogen phosphate, microcrystalline Cellulose and micropowder silica gel drying, porphyrize, cross 100 mesh sieves, for subsequent use;
S3, get sodium carboxymethyl cellulose, use water to be mixed with the carboxymethylcellulose sodium solution that weight concentration is 5%, for subsequent use;
S4, by equivalent, chitosan is mixed homogeneously with calcium hydrogen phosphate, polyvinylpolypyrrolidone and microcrystalline Cellulose by method of progressively increasing, and adds carboxymethylcellulose sodium solution soft material under stirring, granulates, cross 18 mesh sieves, 40 DEG C of dryings, sieve, granulate, add micropowder silica gel, mix homogeneously, tabletting obtains label;
S5, described label removing fine powder is placed on preheating in coating pan, control inlet temperature 35 ~ 45 DEG C, preheating 6 ~ 8min, then coating pan rotating speed is slowly increased to 25rpm, described wicking surface of rotation is slowly sprayed at described coating solution, control intake air temperature 40 ~ 45 DEG C, coating pan rotating speed 25rpm, in coating process, sheet bed tempertaure keeps constant, spraying operation is until weightening finish 3 ~ 5% forms coatings, after having sprayed, continue to put coating pan inner drying 8 ~ 10min, then room temperature is cooled to, the tablet wrapping clothing is placed on dry 3h in the baking oven of 40 DEG C, obtain chitosan tablet.
Therefore, compared with prior art, advantage of the present invention is:
(1) the invention provides a kind of chitosan tablet, be made up of label and coatings, label is made up of chitosan and polyvinylpolypyrrolidone, calcium hydrogen phosphate, microcrystalline Cellulose, micropowder silica gel and sodium carboxymethyl cellulose, and the indexs such as label smooth appearance, disintegration time, hardness and friability all meet the relevant regulations of Chinese Pharmacopoeia; Coatings is formed by zein, hydroxypropyl methoxycellulose, Polyethylene Glycol and alcoholic solution, evenly, sheet wicking surface is wrapped in continuously, densely, further increase the outward appearance of tablet, disintegration time, hardness and friability, and make chitosan tablet physicochemical property more stable, extend the tablet shelf-life;
(2) simple, the raw material of the formula of chitosan tablet of the present invention is easy to get, and preparation method is simple and easy simultaneously, and process stabilizing, can be applicable.
Detailed description of the invention
Further describe the present invention below by way of detailed description of the invention, but the present invention is not limited only to following examples.Within the scope of the invention or not departing from content of the present invention, spirit and scope, chitosan tablet of the present invention is suitably improved, replaces the identical component of effect, will become apparent to those skilled in the art that they are all deemed to be included within scope of the present invention.
The embodiment of the present invention 1 ~ 4 chitosan tablet is made up of the component of following table parts by weight:
The preparation method of the embodiment of the present invention 1 ~ 4 chitosan tablet:
S1, getting zein, hydroxypropyl methoxycellulose and Polyethylene Glycol, to join volume fraction be in the ethanol of 30 ~ 40%, stirs, obtain coating solution;
S2, respectively by chitosan, polyvinylpolypyrrolidone, calcium hydrogen phosphate, microcrystalline Cellulose and micropowder silica gel drying, porphyrize, cross 100 mesh sieves, for subsequent use;
S3, get sodium carboxymethyl cellulose, use water to be mixed with the carboxymethylcellulose sodium solution that weight concentration is 5%, for subsequent use;
S4, by equivalent, chitosan is mixed homogeneously with calcium hydrogen phosphate, polyvinylpolypyrrolidone and microcrystalline Cellulose by method of progressively increasing, and adds carboxymethylcellulose sodium solution soft material under stirring, granulates, cross 18 mesh sieves, 40 DEG C of dryings, sieve, granulate, add micropowder silica gel, mix homogeneously, tabletting obtains label;
S5, described label removing fine powder is placed on preheating in coating pan, control inlet temperature 35 ~ 45 DEG C, preheating 6 ~ 8min, then coating pan rotating speed is slowly increased to 25rpm, described wicking surface of rotation is slowly sprayed at described coating solution, control intake air temperature 40 ~ 45 DEG C, coating pan rotating speed 25rpm, in coating process, sheet bed tempertaure keeps constant, spraying operation is until weightening finish 3 ~ 5% forms coatings, after having sprayed, continue to put coating pan inner drying 8 ~ 10min, then room temperature is cooled to, the tablet wrapping clothing is placed on dry 3h in the baking oven of 40 DEG C, obtain chitosan tablet.
Comparative example one
This comparative example formula is as different from Example 1: label is made up of the component of following parts by weight: chitosan 70 parts, calcium hydrogen phosphate 8 parts, microcrystalline Cellulose 10 parts, micropowder silica gel 2 parts and sodium carboxymethyl cellulose 5 parts.
This comparative example preparation method is with reference to the preparation method of the embodiment of the present invention.
Comparative example two
This comparative example formula is as different from Example 1: label is made up of the component of following parts by weight: chitosan 70 parts, carboxymethyl starch sodium 5 parts, calcium hydrogen phosphate 8 parts, microcrystalline Cellulose 10 parts, Pulvis Talci 2 parts and sodium carboxymethyl cellulose 5 parts.
This comparative example preparation method is with reference to the preparation method of the embodiment of the present invention.
Comparative example three
This comparative example formula is as different from Example 1: coatings is prepared from by the raw material of following weight portion: hydroxypropyl methoxycellulose 13 weight portion, Polyethylene Glycol 4 weight portion and volume fraction are ethanol 83 weight portion of 30 ~ 40%.
This comparative example preparation method is with reference to the preparation method of the embodiment of the present invention.
test example
Investigate according to Chinese Pharmacopoeia version in 2010 outward appearance of obtained label, embodiment 1 ~ 4 and the comparative example one ~ tri-of embodiment 1, hardness, friability, disintegration time, and carry out accelerated test and long term test, result is as following table 1 ~ 3.
Table 1
Table 2
Table 3
Known by this test example:
(1) smooth appearance of the embodiment of the present invention 1 ~ 4 chitosan tablet, hardness is suitable for, and disintegration time and friability etc. all meet the relevant regulations of Chinese Pharmacopoeia, stable in physicochemical property, long shelf-life;
(2) contrasted by the label of embodiment 1 and the tablet of embodiment 1, the character, shelf-life etc. of tablet are obviously better than label, illustrate that coatings of the present invention effectively can improve the stability of tablet;
(3) compared with embodiment 1, comparative example one lacks some component, and comparative example two is containing different components, and comparative example three coating material is slightly different, and the hardness of three comparative example tablets, friability, shelf-life equistability decline all to some extent.
Above-described embodiment is the present invention's preferably embodiment; but embodiments of the present invention are not restricted to the described embodiments; change, the modification done under other any does not deviate from spirit of the present invention and principle, substitute, combine, simplify; all should be the substitute mode of equivalence, be included within protection scope of the present invention.
Claims (4)
1. a chitosan tablet, it is characterized in that, be made up of label and coatings, described label is made up of the component of following parts by weight: chitosan 70 ~ 76 parts, polyvinylpolypyrrolidone 3 ~ 6 parts, calcium hydrogen phosphate 7 ~ 12 parts, microcrystalline Cellulose 8 ~ 12 parts, micropowder silica gel 1 ~ 3 part and sodium carboxymethyl cellulose 4 ~ 6 parts; Described coatings is prepared from by the raw material of following weight portion: zein 4 ~ 6 parts, hydroxypropyl methoxycellulose 7 ~ 9 parts, Polyethylene Glycol 3 ~ 5 parts and volume fraction are the ethanol 80 ~ 84 parts of 30 ~ 40 parts.
2. chitosan tablet as claimed in claim 1, it is characterized in that, described label is made up of the component of following parts by weight: chitosan 70 parts, polyvinylpolypyrrolidone 5 parts, calcium hydrogen phosphate 8 parts, microcrystalline Cellulose 10 parts, micropowder silica gel 2 parts and sodium carboxymethyl cellulose 5 parts.
3. chitosan tablet as claimed in claim 1, it is characterized in that, described coatings is prepared from by following raw material: zein 5 parts, hydroxypropyl methoxycellulose 8 parts, Polyethylene Glycol 4 parts and volume fraction are the ethanol 83 parts of 30 ~ 40%.
4. prepare as arbitrary in claim 1 ~ 3 as described in the method for chitosan tablet, it is characterized in that, comprise the following steps:
S1, getting zein, hydroxypropyl methoxycellulose and Polyethylene Glycol, to join volume fraction be in the ethanol of 30 ~ 40%, stirs, obtain coating solution;
S2, respectively by chitosan, polyvinylpolypyrrolidone, calcium hydrogen phosphate, microcrystalline Cellulose and micropowder silica gel drying, porphyrize, cross 100 mesh sieves, for subsequent use;
S3, get sodium carboxymethyl cellulose, use water to be mixed with the carboxymethylcellulose sodium solution that weight concentration is 5%, for subsequent use;
S4, by equivalent, chitosan is mixed homogeneously with calcium hydrogen phosphate, polyvinylpolypyrrolidone and microcrystalline Cellulose by method of progressively increasing, and adds carboxymethylcellulose sodium solution soft material under stirring, granulates, cross 18 mesh sieves, 40 DEG C of dryings, sieve, granulate, add micropowder silica gel, mix homogeneously, tabletting obtains label;
S5, described label removing fine powder is placed on preheating in coating pan, control inlet temperature 35 ~ 45 DEG C, preheating 6 ~ 8min, then coating pan rotating speed is slowly increased to 25rpm, described wicking surface of rotation is slowly sprayed at described coating solution, control intake air temperature 40 ~ 45 DEG C, coating pan rotating speed 25rpm, in coating process, sheet bed tempertaure keeps constant, spraying operation is until weightening finish 3 ~ 5% forms coatings, after having sprayed, continue to put coating pan inner drying 8 ~ 10min, then room temperature is cooled to, the tablet wrapping clothing is placed on dry 3h in the baking oven of 40 DEG C, obtain chitosan tablet.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510980321.7A CN105496982B (en) | 2015-12-24 | 2015-12-24 | A kind of chitosan tablet and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510980321.7A CN105496982B (en) | 2015-12-24 | 2015-12-24 | A kind of chitosan tablet and preparation method thereof |
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| CN105496982A true CN105496982A (en) | 2016-04-20 |
| CN105496982B CN105496982B (en) | 2018-10-19 |
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| CN201510980321.7A Active CN105496982B (en) | 2015-12-24 | 2015-12-24 | A kind of chitosan tablet and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108553426A (en) * | 2018-06-01 | 2018-09-21 | 广东药科大学 | A kind of chitosan dripping pill and preparation method thereof |
| CN109330987A (en) * | 2018-11-16 | 2019-02-15 | 深圳市阳光之路生物材料科技有限公司 | A kind of chitosan piece of fater disintegration and dissolution |
Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN101103995A (en) * | 2007-07-10 | 2008-01-16 | 贵州博康生物工程有限公司 | Application of fly maggot chitosan in preparing regulating blood sugar product |
| WO2010041279A2 (en) * | 2008-10-08 | 2010-04-15 | V.B. Medicare Pvt. Ltd. | Sustained release drug delivery system |
| CN104940946A (en) * | 2014-03-28 | 2015-09-30 | 香港理工大学 | Coating composition, coated drug preparation prepared from same and preparation method of coated drug preparation |
| CN104971354A (en) * | 2015-05-15 | 2015-10-14 | 广东一力罗定制药有限公司 | Film coating and preparation method thereof |
-
2015
- 2015-12-24 CN CN201510980321.7A patent/CN105496982B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101103995A (en) * | 2007-07-10 | 2008-01-16 | 贵州博康生物工程有限公司 | Application of fly maggot chitosan in preparing regulating blood sugar product |
| WO2010041279A2 (en) * | 2008-10-08 | 2010-04-15 | V.B. Medicare Pvt. Ltd. | Sustained release drug delivery system |
| CN104940946A (en) * | 2014-03-28 | 2015-09-30 | 香港理工大学 | Coating composition, coated drug preparation prepared from same and preparation method of coated drug preparation |
| CN104971354A (en) * | 2015-05-15 | 2015-10-14 | 广东一力罗定制药有限公司 | Film coating and preparation method thereof |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN108553426A (en) * | 2018-06-01 | 2018-09-21 | 广东药科大学 | A kind of chitosan dripping pill and preparation method thereof |
| CN108553426B (en) * | 2018-06-01 | 2020-04-03 | 广东药科大学 | Chitosan dropping pill and preparation method thereof |
| CN109330987A (en) * | 2018-11-16 | 2019-02-15 | 深圳市阳光之路生物材料科技有限公司 | A kind of chitosan piece of fater disintegration and dissolution |
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| Publication number | Publication date |
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| CN105496982B (en) | 2018-10-19 |
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Address after: 510224 Haizhuqu District City, Guangzhou Province Po Po Kong Han straight street, No. 40 Applicant after: Guangdong Pharmaceutical University Address before: 510224 Haizhuqu District City, Guangzhou Province Po Po Kong Han straight street, No. 40 Applicant before: Guangdong Pharmaceutical University |
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