CN108553425A - A kind of chitosan oligosaccharide dripping pill and preparation method thereof - Google Patents
A kind of chitosan oligosaccharide dripping pill and preparation method thereof Download PDFInfo
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- CN108553425A CN108553425A CN201810554013.1A CN201810554013A CN108553425A CN 108553425 A CN108553425 A CN 108553425A CN 201810554013 A CN201810554013 A CN 201810554013A CN 108553425 A CN108553425 A CN 108553425A
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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
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- 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
- A61K31/7016—Disaccharides, e.g. lactose, lactulose
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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
- A61K31/702—Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
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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
- A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/06—Antihyperlipidemics
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P39/00—General protective or antinoxious agents
- A61P39/06—Free radical scavengers or antioxidants
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Abstract
The present invention relates to technical field of pharmaceuticals, and in particular to a kind of chitosan oligosaccharide dripping pill and preparation method thereof.The chitosan oligosaccharide dripping pill of the present invention is formed by chitosan oligosaccharide and dripping pill substrate preparation, and the weight proportion of each ingredient is：Chitosan oligosaccharide: dripping pill matrix=1: 11: 5.Dropping pill formulation prescription of the present invention is determined by the screening test of science.It can significantly improve the dissolution rate of chitosan oligosaccharide and stability, have significant technical advantage.The chitosan oligosaccharide dripping pill preparation process of the present invention is simple, and at low cost, application prospect is good.
Description
Technical field
The present invention relates to technical field of pharmaceuticals, and in particular to a kind of chitosan oligosaccharide dripping pill and preparation method thereof.
Background technology
Chitosan oligosaccharide is that chitosan (is also had the report using chemical degradation, microwave degradation technology through special biological enzyme technology
Road) obtained a kind of degree of polymerization of degrading oligosaccharide product, molecular weight≤3200Da between 2~20 are that water-soluble preferable, function is made
With the high low molecular weight product of big, bioactivity.It has the unexistent higher solubility of chitosan, is dissolved in water entirely, is easy quilt
Organism such as is absorbed and utilized at many unique functions, and it acts as 14 times of chitosan.Chitosan oligosaccharide is that unique band is being just in nature
Charge cation basic amine group oligosaccharide is animal fiber element.
Numerous studies show that COS has adjusting blood pressure and blood lipoid, anti-oxidant, anti-infective, strengthen immunity and antitumor equal work(
Can, it is a kind of ideal bioactive substance, there is wide medical applications foreground.
Chinese patent CN107223752A discloses a kind of pressed candy of chitosan oligosaccharide rush gastrointestinal disturbances absorption function.
Chinese patent CN103316031B discloses the Weight-reducing and lipid-lowering application of chitosan oligosaccharide, the chitosan oligosaccharide control body weight,
Reducing body fat and when reduce in serum, there is significant application to imitate in terms of the content of total cholesterol and low density lipoprotein cholesterol
Fruit shows that chitosan oligosaccharide has significant weight-reducing, fat-reducing effect, while also having and alleviating fatty liver, reduces the blood fat in serum
Function.
Chen Jian has delivered entitled " chitosan oligosaccharide, Glucosamine anti-obesity activity and a load capsaicine chitosan microball intestines
The paper of molten research ", which shows that chitosan oligosaccharide has preferable fat-reducing effect, but also has and have no toxic side effect, inhale
Advantage good with raw compatibility soon is received, is a kind of ideal slimming medicine.
Chitosan oligosaccharide molecular weight is low, easy to absorb moisture, and solution has strong reducing property, and it is anti-that oxidation easily occurs in air for exposure
It answers, greatly limits its application in health products or medicine field.It is relatively low that chitosan oligosaccharide is made tablet its stability, is guaranteed the quality
Phase is shorter.Chinese patent CN105496981A discloses a kind of chitosan oligosaccharide tablet, and Chinese patent CN105380924A discloses one
Kind chitosan oligosaccharide capsule agent, but chitosan tablet or capsule dissolution are slow, bioavilability is low.
Therefore, it is necessary to study with develop a kind of stability is good, dissolution rate is high chitosan oligosaccharide dosage form to promote chitosan oligosaccharide
Application in health products or medicine field.
Invention content
In order to solve the problems, such as that stability is poor existing for chitosan oligosaccharide in the prior art, dissolution rate is low, the purpose of the present invention exists
In a kind of chitosan oligosaccharide dripping pill of offer and preparation method thereof.
The object of the present invention is to provide a kind of chitosan oligosaccharide dripping pill and preparation method thereof, chitosan oligosaccharide dripping pill of the invention can be significantly
Improve the stability and solution rate of chitosan oligosaccharide.Chitosan oligosaccharide dripping pill surface made from the method for the present invention is smooth, and roundness is good, greatly
Small, uniform color, no adhesion phenomenon；Surface frozen-free medium adherency.Pill weight variation, to leach time limit, dissolution rate and content etc. each
Item index meets pharmacopoeial requirements.
Dripping pill of the present invention containing active constituent chitosan oligosaccharide is made using active constituent chitosan oligosaccharide with matrix, base
Matter is mainly water soluble adjuvant.Chitosan oligosaccharide and the matrix melting mixing of the present invention, the stability of chitosan oligosaccharide dripping pill obtained and molten
Out-degree is improved largely compared with chitosan oligosaccharide bulk pharmaceutical chemicals and its tablet or capsule.
The weight ratio of the chitosan oligosaccharide dripping pill of the present invention, chitosan oligosaccharide and matrix is 1: 1-1: 5.The weight of usual chitosan oligosaccharide and matrix
Amount is than being the key factor for influencing chitosan oligosaccharide solubility and solution rate.Inventor the study found that chitosan oligosaccharide and matrix weight
When than being less than 1/1, the dispersion and solubilization of matrix are weaker, living in pill when the weight ratio of chitosan oligosaccharide and matrix is more than 1/5
Property component content is low, and practicability is poor.
The chitosan oligosaccharide dripping pill of the present invention, contained water soluble adjuvant can be selected from polyethylene glycol (PEG) class, as PEG2000,
PEG4000、PEG6000、PEG12000；Polyoxyethylene poly-oxygen propylene aether class, as poloxamer (Poloxamer 188 or
Pluronic F-68), urea, organic acid, carbohydrate, polyvinylpyrrolidone and its mixture.Polyethylene glycols make matrix, system
The dripping pill obtained has good hardness and mouldability.
The chitosan oligosaccharide dripping pill of the present invention, it includes preservative, colorant, corrigent, fragrance that other additives, which can also be added,
Agent, to improve the performance of the stability of dripping pill, dissolubility, appearance, color and luster, mouthfeel etc..
The chitosan oligosaccharide dripping pill of the present invention, forms by gravity dripping, its condensed rear shape is round or similar round ball
Agent.
The chitosan oligosaccharide dripping pill of the present invention is prepared using melting-dropping preparation method.Another object of the present invention is to disclose a kind of shell
The preparation method of oligosaccharides dripping pill, which is characterized in that chitosan oligosaccharide instills with after the heating melting of dripping pill matrix and forms drop in condensate liquid
Ball, the specific steps are：
(1) matrix is heated and is melted；
(2) it heats while stirring and chitosan oligosaccharide is added to melting, matrix and chitosan oligosaccharide are mixed well；
(3) fusant of step (2) is poured into pill dripping machine, spice instills in cooling medium, condenses, and solidification forms dripping pill
Afterwards, it takes out, is dry to get chitosan oligosaccharide dripping pill.
Further, the step (3) Chinese medicine material temperature degree is 85 DEG C, and condensation temperature is 15 DEG C, and cooling medium is liquid stone
Wax, for drop away from for 15cm, drop speed is 30-35 drops/min.
Chitosan oligosaccharide dripping pill of the present invention overcomes chitosan oligosaccharide conventional dosage forms such as tablet or capsule stability is poor, and dissolution is slow, treats
Imitate low disadvantage.The stability and solution rate of chitosan oligosaccharide can be increased substantially, promotes to absorb the effect for improving curative effect, is suitable for work
Industry metaplasia is produced, and clinical administration preparation is can be developed into.
Specific implementation mode
It is further illustrated the present invention below in conjunction with specific implementation case, the scope of protection of present invention is not limited to
Following implementation.
Embodiment 1-6 chitosan oligosaccharide dripping pills of the present invention
Chitosan oligosaccharide dripping pill is prepared by 1 component proportion of table
1 chitosan oligosaccharide pill prescription example of table
| Prescription number | 1 | 2 | 3 | 4 | 5 | 6 |
| Chitosan oligosaccharide | 5g | 5g | 5g | 5g | 5g | 5g |
| Macrogol 4000 | 0g | 15g | 0g | 0g | 0g | 0g |
| Macrogol 6000 | 15g | 10g | 10g | 6g | 0g | 0g |
| Polyethylene glycol 12000 | 0g | 0g | 2g | 3g | 10g | 10g |
| PLURONICS F87 | 0g | 0g | 5g | 0g | 0g | 0g |
| Urea | 0g | 0g | 0g | 5g | 0g | 3g |
| Polyvinylpyrrolidone | 0g | 0g | 0g | 0g | 10g | 5g |
Chitosan oligosaccharide dripping pill is prepared according to the following steps.
Step：Matrix is heated by the way of water-bath and is melted；It heats while stirring and chitosan oligosaccharide is added to melting, by matrix
It is mixed well with chitosan oligosaccharide；Above-mentioned fusant is poured into pill dripping machine, spice temperature is 85 DEG C, spice to drip away from 15cm, by 30 drops/
The drop speed of min instills in atoleine, 15 DEG C of condensations, solidification, after forming dripping pill, takes out, is dry to get chitosan oligosaccharide dripping pill.
Any of the above-described prescription, dripping pill hardness is big, and color and luster is uniform, no adhesion, no hangover.Pill weight variation is less than ± 10%.
7 chitosan oligosaccharide dripping pill dissolution rate of the present invention of embodiment and leach the time limit research
It presses《Pharmacopoeia of People's Republic of China》Disintegration time limited inspection method (annex XA) specified in versions two in 2000 into
The inspection of row disintegration time.It presses《Pharmacopoeia of People's Republic of China》The first method of dissolution method in the two annex XC of version in 2000
Carry out dissolution determination.
Meanwhile using chitosan oligosaccharide tablet disclosed in Chinese patent CN105496981A as comparative example, measuring the dissolution of comparative example
Spend and leach the time limit.
The formula of comparative example 1 is chitosan oligosaccharide 85.5%, crospovidone 4%, calcium monohydrogen phosphate 4%, microcrystalline cellulose 4%, hard
Fatty acid magnesium 0.5% and PVP K30 solution (a concentration of 3%) 2%；The coating solution that coating membrane uses by following parts by weight raw material
It is prepared：1 part of 10 parts of pulullan polysaccharide, 6 parts of sodium alginate, 2 parts of polyethylene glycol and titanium dioxide.
The formula of comparative example 2 is chitosan oligosaccharide 85%, crospovidone 5%, calcium monohydrogen phosphate 3.5%, microcrystalline cellulose 5%, hard
Fatty acid magnesium 0.5% and PVP K30 solution (a concentration of 3%) 1%；The coating solution that coating membrane uses by following parts by weight raw material
It is prepared：0.5 part of 8 parts of pulullan polysaccharide, 7 parts of sodium alginate, 2 parts of polyethylene glycol and titanium dioxide.
It leaches the time limit and dissolution results is shown in Table 2.
2 chitosan oligosaccharide dripping pill of table leaches time limit and dissolution rate
The accumulation dissolution rate of chitosan oligosaccharide dripping pill of the present invention has been more than 90% in 20min, meets pharmacopoeial requirements；In 20min
When, the dissolution of comparative example 1 and comparative example 2 is respectively 90.3% and 87.2%, compare under, chitosan oligosaccharide dripping pill of the invention
Dissolution rate is more preferable when 20min.
Chitosan oligosaccharide dripping pill of the present invention leaches the time limit and is respectively less than 10 minutes, and comparative example 1 and comparative example 2 leach time limit relatively this hair
Bright chitosan oligosaccharide to leach the time limit longer.
8 chitosan oligosaccharide dripping pill stability test of the present invention of embodiment
With reference to《Chinese Pharmacopoeia》(version in 2010) two annex XIXC bulk pharmaceutical chemicals and pharmaceutical preparation stability test guidance are former
Then, accelerated test and stability test are carried out to chitosan oligosaccharide dripping pill of the present invention.Investigation project includes that appearance character, chitosan oligosaccharide contain
It measures, in relation to substance and hardness, all investigation projects meet States Pharmacopoeia specifications and are then considered as qualifying, have one or more project not meet
Pharmacopoeial requirements, which are then considered as, fails.It the results are shown in Table 3 and table 4.
3 chitosan oligosaccharide dripping pill accelerated test result of table
Note："+" indicates qualified；"-" indicates unqualified.
4 chitosan oligosaccharide dripping pill long-term test results of table
Note："+" indicates qualified；"-" indicates unqualified.
By this test example：The stable in physicochemical property of chitosan oligosaccharide dripping pill of the present invention, long shelf-life.
Claims (7)
1. a kind of dripping pill containing chitosan oligosaccharide, it is characterised in that be made of with matrix active constituent chitosan oligosaccharide, the chitosan oligosaccharide
Weight ratio with matrix is 1: 1-1: 5.
2. the dripping pill according to claim 1 containing chitosan oligosaccharide, it is characterised in that the matrix is selected from polyethylene glycols
Or polyoxyethylene poly-oxygen propylene aether class.
3. the dripping pill according to claim 1 containing chitosan oligosaccharide, it is characterised in that the matrix is selected from polyethylene glycols
Selected from one or more of PEG2000, PEG4000, PEG6000 or PEG12000.
4. the dripping pill according to claim 1 containing chitosan oligosaccharide, it is characterised in that the polyoxyethylene poly-oxygen propylene aether
Class is selected from the one or more of poloxamer, urea, organic acid, carbohydrate, polyvinylpyrrolidone.
5. the dripping pill according to claim 1 containing chitosan oligosaccharide, it is characterised in that the additive includes preservative, coloring
Agent, corrigent and aromatic.
6. a kind of preparation method of chitosan oligosaccharide dripping pill, which is characterized in that chitosan oligosaccharide instills condensation with after the heating melting of dripping pill matrix
Dripping pill is formed in liquid, the specific steps are：
(1) matrix is heated and is melted；
(2) it heats while stirring and chitosan oligosaccharide is added to melting, matrix and chitosan oligosaccharide are mixed well；
(3) fusant of step (2) is poured into pill dripping machine, spice instills in cooling medium, condenses, and solidification takes after forming dripping pill
Go out, dry to get chitosan oligosaccharide dripping pill.
7. preparation method as claimed in claim 6, which is characterized in that described step (3) the Chinese medicine material temperature degree is 85 DEG C, condensation
Temperature is 15 DEG C, and cooling medium is atoleine, and for drop away from for 15cm, drop speed is 30-35 drops/min.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810554013.1A CN108553425A (en) | 2018-06-01 | 2018-06-01 | A kind of chitosan oligosaccharide dripping pill and preparation method thereof |
| PCT/CN2018/103510 WO2019227743A1 (en) | 2018-06-01 | 2018-08-31 | Chitosan oligosaccharide dropping pill and preparation method therefor |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810554013.1A CN108553425A (en) | 2018-06-01 | 2018-06-01 | A kind of chitosan oligosaccharide dripping pill and preparation method thereof |
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| Publication Number | Publication Date |
|---|---|
| CN108553425A true CN108553425A (en) | 2018-09-21 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201810554013.1A Pending CN108553425A (en) | 2018-06-01 | 2018-06-01 | A kind of chitosan oligosaccharide dripping pill and preparation method thereof |
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| Country | Link |
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| WO (1) | WO2019227743A1 (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2023138173A1 (en) * | 2022-01-18 | 2023-07-27 | 广东药科大学 | Chitosan oligosaccharide enteric dripping pill and application thereof in preparing non-alcoholic fatty liver disease drug |
| WO2023138172A1 (en) * | 2022-01-18 | 2023-07-27 | 广东药科大学 | Chitosan oligosaccharide enteric capsule, and preparation method therefor and use thereof |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1506067A (en) * | 2002-12-06 | 2004-06-23 | 中国科学院大连化学物理研究所 | Application of chitin oligose in anticancer drug |
| CN104586877A (en) * | 2015-02-10 | 2015-05-06 | 河北工业大学 | Chitosan oligosaccharide-containing pharmaceutical composition and applications thereof |
-
2018
- 2018-06-01 CN CN201810554013.1A patent/CN108553425A/en active Pending
- 2018-08-31 WO PCT/CN2018/103510 patent/WO2019227743A1/en active Application Filing
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1506067A (en) * | 2002-12-06 | 2004-06-23 | 中国科学院大连化学物理研究所 | Application of chitin oligose in anticancer drug |
| CN104586877A (en) * | 2015-02-10 | 2015-05-06 | 河北工业大学 | Chitosan oligosaccharide-containing pharmaceutical composition and applications thereof |
Non-Patent Citations (1)
| Title |
|---|
| 徐榕青等: "水溶性壳聚糖固体分散体的制备及质量研究.", 《福建医药杂志》 * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2023138173A1 (en) * | 2022-01-18 | 2023-07-27 | 广东药科大学 | Chitosan oligosaccharide enteric dripping pill and application thereof in preparing non-alcoholic fatty liver disease drug |
| WO2023138172A1 (en) * | 2022-01-18 | 2023-07-27 | 广东药科大学 | Chitosan oligosaccharide enteric capsule, and preparation method therefor and use thereof |
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| Publication number | Publication date |
|---|---|
| WO2019227743A1 (en) | 2019-12-05 |
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