CN108498531A - A kind of chitosan oral solution and preparation method thereof - Google Patents

A kind of chitosan oral solution and preparation method thereof Download PDF

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Publication number
CN108498531A
CN108498531A CN201810554042.8A CN201810554042A CN108498531A CN 108498531 A CN108498531 A CN 108498531A CN 201810554042 A CN201810554042 A CN 201810554042A CN 108498531 A CN108498531 A CN 108498531A
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chitosan
oral solution
weight
solubilizer
parts
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苏政权
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Guangdong Pharmaceutical University
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Guangdong Pharmaceutical University
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Priority to CN201810554042.8A priority Critical patent/CN108498531A/en
Priority to PCT/CN2018/103513 priority patent/WO2019227746A1/en
Publication of CN108498531A publication Critical patent/CN108498531A/en
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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
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K9/0087—Galenical forms not covered by A61K9/02 - A61K9/7023
    • A61K9/0095—Drinks; Beverages; Syrups; Compositions for reconstitution thereof, e.g. powders or tablets to be dispersed in a glass of water; Veterinary drenches
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • 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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04—Antibacterial agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Obesity (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Molecular Biology (AREA)
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  • Heart & Thoracic Surgery (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
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  • Endocrinology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
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Abstract

The present invention provides a kind of chitosan oral solutions and preparation method thereof.The chitosan oral solution includes 6~12 parts by weight of chitosan；0.5~3.5 parts by weight of solubilizer；0.1~0.5 parts by weight of preservative.The oral solution of the present invention has stability good, the advantage that Clinical practice is safe, validity is good, has significant technical advantage.

Description

A kind of chitosan oral solution and preparation method thereof
Technical field
The present invention relates to field of medicaments, more particularly to a kind of oral solution of chitosan and preparation method thereof.
Background technology
Chitosan (chitosan, CTSH) is a kind of natural macromolecule alkaline polysaccharide next in number only to cellulose, by Glucose (β copolymers (1-4) and 2-amino-2-deoxy-D-Glucose) and N-acetyl-glucosamine (2-acetamido-2- Deoxy-d-glucose it) forms.
Chitosan has a variety of pharmacological activity, and such as bacteriostasis, antitumor action reduce blood glucose, reduce lipid-loweringing sterol, anti- Hypertension, strengthen liver function, Acidinhibitor, the healthcare function for gastrointestinal system, anticoagulant active, anti thrombotic action, Immunologic enhancement.But chitosan is insoluble in water, and bioavilability is poor in body, it is difficult to give full play to its bioactivity work( Energy.
Chinese patent CN101298502 discloses a kind of chitosan solid dispersion, specifically by chitosan and poly- second two Alcohol 4000- Macrogol 6000s are mixed with to obtain, to increase the water solubility of chitosan.Still there are chitosan microball, nanoparticle system The report of agent, as Chinese patent CN101978954A discloses a kind of preparation method and its usage of chitosan microball.
Dispersion degree of the oral liquid with drug is big, it is fast to absorb, and drug effect can be played rapidly by comparing with solid dosage forms；Easily It is convenient to take in divided dose, therefore be clinically widely used.Currently, not finding the oral solution of chitosan in the market.
Invention content
The purpose of the present invention is being directed to problems of the prior art, a kind of chitosan oral solution, the oral solution are provided Middle chitosan dissolubility is high, and better stability of preparation can ensure clinical application safety and validity, and convenient to take.
In view of chitosan poorly water-soluble, inventor is added to solubilizer, to carry during studying chitosan oral solution Rise its solute effect.The increase of solubilizer can make solubilizing effect have certain increase, but excessive solubilizer can make biological utilisation The raising of degree reaches saturation.Type and dosage of the present invention also to solubilizer in chitosan oral solution have carried out preferably.The present invention Chitosan oral solution solubilizer and chitosan are interacted so that chitosan is completely dissolved in the solution.
Since the dispersion degree of drug in liquid preparation is big, there is larger boundary and interface energy, accordingly, there exist certain journeys The unstability of degree, and aqueous liquid preparation is easy to go mouldy.For different drugs, it should be selected according to its own feature Suitable auxiliary material and its amount ranges ensure safety and the validity of clinical application to obtain preferable stability.
The present inventor finally determines technical scheme of the present invention by a large amount of experimental study.
The present invention is achieved by the following technical solutions.
The present invention provides a kind of chitosan oral solution, which includes the supplementary material of following weight proportion：
6~12 parts by weight of chitosan；
0.5~3.5 parts by weight of solubilizer；
0.1~0.5 parts by weight of preservative.
Preferably, the chitosan oral solution includes the supplementary material of following weight proportion：
8~10 parts by weight of chitosan；
1.2~2.0 parts by weight of solubilizer；
0.2~0.3 parts by weight of preservative.
In the chitosan oral solution of the present invention, the one kind of the solubilizer in propylene glycol, polyethylene glycol, tween Or it is a variety of；Preservative is one or more in ethylparaben, propylben, Potassium Benzoate.
The polyethylene glycol is cetomacrogol 1000, Macrogol 4000, Macrogol 6000 or PEG 8000 In one kind.
The tween is one kind in polysorbas20, polysorbate40 or polysorbate60.
As more preferred embodiment, the solubilizer is that weight ratio is 1：0.2 propylene glycol and polysorbate40；On The dissolubility of chitosan can be significantly improved by stating the solubilizer, and chitosan oral solution obtained is clarified, no muddiness.
Further, it is 1 that the preservative, which is weight ratio,:1 ethylparaben and propylben.
The present invention also provides the preparation methods of the chitosan oral solution.
The preparation method of oral solution comprises the steps of：Solubilizer is added in 1/3~2/3 purified water, is stirred evenly, so After be added chitosan, 35~40 DEG C of stirrings are to being completely dissolved；Preservative is added, after mixing plus purified water is to 1000ml, fills Dress, 115 DEG C sterilizing 15~20 minutes to get.
The present invention chitosan oral solution accelerated test investigate the result shows that, character, microbial limit, pH value and drug Content has no significant change compared with 0 month, and stability is good.The present invention chitosan oral solution long term test investigate the result shows that, Its character, microbial limit, pH value and medicament contg have no significant change compared with 0 month, and stability is good.With comparative example 1, comparison Example 2 is compared, and chitosan stability of Oral of the invention is more preferable, shows that the chitosan oral solution component of the present invention and proportioning are closed Reason.
The chitosan oral solution of the present invention compared with prior art, has the following advantages that：
1, by the present invention in that with specific auxiliary material and its dosage so that the stability of oral solution is good, ensure that clinical use The safety of medicine and validity.
2, chitosan oral medicine liquid dispersion degree of the present invention is big, it is fast to absorb, and convenient to take, drug effect plays rapid.
3, chitosan oral solution of the invention is simple for process, at low cost, is suitble to industrialized production.
Specific implementation mode
The composition and experiment effect of oral solution of the present invention are described in detail below by specific embodiment.
Embodiment 1
Chitosan 6g
Propylene glycol 0.5g
Potassium Benzoate 0.5g
Purified water Add to 1000ml
Preparation method comprises the steps of：Solubilizer is added in 1/3~2/3 purified water, stirs evenly, shell is then added Glycan, 35~40 DEG C of stirrings are to being completely dissolved；Preservative is added, after mixing plus purified water is to 1000ml, filling, 115 DEG C Sterilizing 15~20 minutes to get.
Embodiment 2
Chitosan 10g
Propylene glycol 1g
Polysorbate40 0.2g
Ethylparaben 0.1g
Propylben 0.1g
Purified water Add to 1000ml
Preparation method comprises the steps of：Solubilizer is added in 1/3~2/3 purified water, stirs evenly, shell is then added Glycan, 35~40 DEG C of stirrings are to being completely dissolved；Preservative is added, after mixing plus purified water is to 1000ml, filling, 115 DEG C Sterilizing 15~20 minutes to get.
Embodiment 3
Chitosan 8g
Propylene glycol 1.2g
Polysorbate60 0.24g
Propylben 0.3g
Purified water Add to 1000ml
Preparation method comprises the steps of：Solubilizer is added in 1/3~2/3 purified water, stirs evenly, shell is then added Glycan, 35~40 DEG C of stirrings are to being completely dissolved；Preservative is added, after mixing plus purified water is to 1000ml, filling, 115 DEG C Sterilizing 15~20 minutes to get.
Embodiment 4
Chitosan 12g
Polysorbas20 2.0g
Potassium Benzoate 0.1g
Purified water Add to 1000ml
Preparation method comprises the steps of：Solubilizer is added in 1/3~2/3 purified water, stirs evenly, shell is then added Glycan, 35~40 DEG C of stirrings are to being completely dissolved；Preservative is added, after mixing plus purified water is to 1000ml, filling, 115 DEG C Sterilizing 15~20 minutes to get.
Embodiment 5
Chitosan 10g
Cetomacrogol 1000 3.5g
Ethylparaben 0.3g
Purified water Add to 1000ml
Preparation method comprises the steps of：Solubilizer is added in 1/3~2/3 purified water, stirs evenly, shell is then added Glycan, 35~40 DEG C of stirrings are to being completely dissolved；Preservative is added, after mixing plus purified water is to 1000ml, filling, 115 DEG C Sterilizing 15~20 minutes to get.
Embodiment 6
Chitosan 8g
Propylene glycol 0.1g
Ethylparaben 0.15g
Propylben 0.15g
Purified water Add to 1000ml
Preparation method comprises the steps of：Solubilizer is added in 1/3~2/3 purified water, stirs evenly, shell is then added Glycan, 35~40 DEG C of stirrings are to being completely dissolved；Preservative is added, after mixing plus purified water is to 1000ml, filling, 115 DEG C Sterilizing 15~20 minutes to get.
Comparative example 1
Chitosan 10g
Propylene glycol 0.8g
Polysorbate40 0.4g
Ethylparaben 0.1g
Propylben 0.1g
Purified water Add to 1000ml
Preparation method is the same as embodiment 2.
Comparative example 2
Chitosan 10g
Propylene glycol 1g
Polysorbate40 0.2g
Ethylparaben 0.05g
Propylben 0.15g
Purified water Add to 1000ml
Preparation method is the same as embodiment 2.
The accelerated test of 1 chitosan oral solution of the present invention of test example
1, sample is investigated
The chitosan oral solution obtained with reference to the prescription and preparation method of 1-6.
2, test method
Accelerated test：Take the present invention totally 20 parts of chitosan oral solution, 40 DEG C ± 2 DEG C of temperature, relative humidity 75% ± It is placed 6 months under conditions of 5%, the 0th during experiment, respectively samples once within 1,3,6 month, investigate character, the pH value of oral solution And content.
Test result is shown in Table 1.
3, test result
It is investigated 6 months the result shows that the chitosan oral solution of 1-6 of the embodiment of the present invention is accelerated, character, microorganism limit Degree, pH value and medicament contg have no significant change compared with 0 month, illustrate that the chitosan stability of Oral of the present invention is good.
1 chitosan oral solution accelerated test result of the present invention of table
The long term test of 2 chitosan oral solution of the present invention of test example
1, sample is investigated
The chitosan oral solution obtained with reference to embodiment 2, comparative example 1, the prescription of comparative example 2 and preparation method.
2, test method
Long term test：Take the present invention totally 30 parts of chitosan oral solution, 25 DEG C ± 2 DEG C of temperature, relative humidity 60% ± It is placed 24 months under conditions of 10%, respectively at 0,3,6,12,24 month, each sampling was primary, investigated character, the pH value of oral solution And content.
Test result is shown in Table 2.
3, test result
The result shows that the chitosan oral solution of the embodiment of the present invention 2 is through long term test 24 months, character, microorganism limit Degree, pH value and medicament contg have no significant change compared with 0 month, illustrate that the chitosan stability of Oral of the present invention is good.Comparison When the chitosan oral solution long term test of example 1, there is turbid phenomenon, microbial limit detection is also against regulation；Comparative example 2 When chitosan oral solution long term test, there is turbid phenomenon, microbial limit detection is also against regulation.The above results show this The chitosan oral solution prescription and proportioning of invention are reasonable.
2 chitosan oral solution long-term test results of the present invention of table

Claims (7)

1. a kind of chitosan oral solution, which is characterized in that the oral solution includes the supplementary material of following weight proportion：
6~12 parts by weight of chitosan；
0.5~3.5 parts by weight of solubilizer；
0.1~0.5 parts by weight of preservative.
2. chitosan oral solution as described in claim 1, which is characterized in that the oral solution includes the original of following weight proportion Auxiliary material：
8~10 parts by weight of chitosan；
1.2~2.0 parts by weight of solubilizer；
0.2~0.3 parts by weight of preservative.
3. chitosan oral solution as claimed in claim 1 or 2, which is characterized in that the solubilizer is selected from propylene glycol, poly- second It is one or more in glycol, tween；The one kind or more of preservative in ethylparaben, propylben, Potassium Benzoate Kind.
4. chitosan oral solution as claimed in claim 3, which is characterized in that the polyethylene glycol be cetomacrogol 1000, One kind in Macrogol 4000, Macrogol 6000 or PEG 8000.
5. chitosan oral solution as claimed in claim 3, which is characterized in that the tween is polysorbas20, tween 40 or polysorbate60 in one kind.
6. chitosan oral solution as claimed in claim 3, which is characterized in that the solubilizer is that weight ratio is 1：0.2 Propylene glycol and polysorbate40；Preservative is that weight ratio is 1:1 ethylparaben and propylben.
7. the preparation method of the chitosan oral solution as described in claim 1~6 is any, which is characterized in that comprise the steps of： Solubilizer is added in 1/3~2/3 purified water, is stirred evenly, is then added chitosan, 35~40 DEG C of stirrings are to being completely dissolved； Preservative is added, after mixing plus purified water is to 1000ml, filling, 115 DEG C of sterilizings 15~20 minutes to get.
CN201810554042.8A 2018-06-01 2018-06-01 A kind of chitosan oral solution and preparation method thereof Pending CN108498531A (en)

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PCT/CN2018/103513 WO2019227746A1 (en) 2018-06-01 2018-08-31 Chitosan oral solution and preparation method therefor

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019227746A1 (en) * 2018-06-01 2019-12-05 广东药科大学 Chitosan oral solution and preparation method therefor

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1985845A (en) * 2006-12-30 2007-06-27 哈尔滨华雨制药集团有限公司 Oral antilipemic liquid and its preparing method
CN101298502A (en) * 2007-04-30 2008-11-05 福建省医学科学研究所 Method for increasing chitose water-solubility
CN102441158A (en) * 2010-10-15 2012-05-09 天津瑞普生物技术股份有限公司 Eye drop having Cecropins for pet and preparation method thereof
CN104856978A (en) * 2015-05-18 2015-08-26 福建中医药大学 Chitosan spraying film agent and preparation method thereof

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108498531A (en) * 2018-06-01 2018-09-07 广东药科大学 A kind of chitosan oral solution and preparation method thereof

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1985845A (en) * 2006-12-30 2007-06-27 哈尔滨华雨制药集团有限公司 Oral antilipemic liquid and its preparing method
CN101298502A (en) * 2007-04-30 2008-11-05 福建省医学科学研究所 Method for increasing chitose water-solubility
CN102441158A (en) * 2010-10-15 2012-05-09 天津瑞普生物技术股份有限公司 Eye drop having Cecropins for pet and preparation method thereof
CN104856978A (en) * 2015-05-18 2015-08-26 福建中医药大学 Chitosan spraying film agent and preparation method thereof

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019227746A1 (en) * 2018-06-01 2019-12-05 广东药科大学 Chitosan oral solution and preparation method therefor

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Application publication date: 20180907