CN111450048B - Gel for antipyretic patch and preparation method thereof - Google Patents

Gel for antipyretic patch and preparation method thereof Download PDF

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Publication number
CN111450048B
CN111450048B CN202010309020.2A CN202010309020A CN111450048B CN 111450048 B CN111450048 B CN 111450048B CN 202010309020 A CN202010309020 A CN 202010309020A CN 111450048 B CN111450048 B CN 111450048B
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gel
urea
dispersion medium
liquid dispersion
antipyretic
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CN111450048A (en
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田文超
刘贤贤
刘莹艳
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Guangzhou Yuchun Biotechnology Co ltd
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Guangzhou Yuchun Biotechnology Co ltd
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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
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18—Magnoliophyta (angiosperms)
    • A61K36/185—Magnoliopsida (dicotyledons)
    • A61K36/53—Lamiaceae or Labiatae (Mint family), e.g. thyme, rosemary or lavender
    • 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
    • A61K47/02—Inorganic compounds
    • 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
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • 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
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/42—Proteins; Polypeptides; Degradation products thereof; Derivatives thereof, e.g. albumin, gelatin or zein
    • 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
    • A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • 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]
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

Abstract

The invention relates to a gel for antipyretic plaster and a preparation method thereof, wherein the gel contains macromolecule and liquid dispersion medium, and is characterized in that the gel layer contains urea, and the urea content is more than the solubility of the urea at 37.5 ℃; the colloidal particles or macromolecules can be dispersed or dissolved in a liquid dispersion medium to form a gel. The gel prepared by the application has stable quality, is convenient for continuous production, and can not cause the problems of aggravation, cough, throat inflammation and the like after being applied to defervescence paste.

Description

Gel for antipyretic patch and preparation method thereof
Technical Field
The invention relates to an antipyretic patch gel and a preparation method thereof.
Background
The gel for the existing defervescing patch is mainly composed of water and polymers, heat is taken away by utilizing evaporation of the water, so that the purpose of cooling is achieved, and in order to achieve a better cooling effect, the method for preparing the intelligent child defervescing patch by adding the endothermic agent into the gel is explored, for example, the method comprises the following steps of: 2016102500843 the solubility of urea in the endothermic agent is large and the amount of absorbed heat is large, so that the addition is the first choice, however, due to the large solubility of urea, the amount of urea precipitated and dissolved is relatively large along with the change of temperature, so that in actual production, the problem of urea precipitation in the process of cooling the gel exists, the prepared gel has the problem of inconsistent urea content in the upper, middle and lower layers, the quality of the prepared defervescing patch is also inconsistent, and the batch production is troublesome.
Meanwhile, the object-oriented sales of the prepared defervescence patch is a drugstore rather than a direct user, so that the problem of storage exists, the fact that the defervescence patch added with urea also has quality change in the storage process, even the drugstore reacts, the defervescence patch added with urea with good cooling effect is most complaint, because the problem that the user even aggravates illness state after using the defervescence patch added with urea is slight fever without cough and throat inflammation, and the problem of cough and throat inflammation after using the product is difficult to popularize the functional defervescence patch with better cooling effect is found.
The stability of the gel quality determines the stability of the antipyretic patch quality and also determines whether the product can be popularized in the market and takes a place, so the market needs a gel with stable quality in production, mass production can be realized, and meanwhile, the gel can maintain better stability when being applied to the antipyretic patch, and the problems of illness state and throat inflammation cannot be aggravated.
Disclosure of Invention
The technical problem to be solved in the application is to provide a gel for an antipyretic patch and a preparation method thereof, and the technical problem to be solved in the application 1) is to provide a preparation method of the gel, wherein the gel prepared by the method has stable quality and can be produced in batches, and meanwhile, the antipyretic patch prepared by the gel prepared by the method has stable quality, does not aggravate illness state and does not cause cough and throat inflammation.
In order to solve the technical problems, the invention adopts the following technical scheme:
an antipyretic patch gel comprises polymer and liquid dispersion medium, and urea, wherein the urea content is greater than its solubility at 37.5 ℃; the polymer is capable of dispersing or dissolving in a liquid dispersion medium to form a gel.
The pH of the gel is 6.5-8.5.
The liquid dispersion medium is one of water or an aqueous solution.
The liquid dispersion medium is a buffer solution, and the pH of the buffer solution is 6.5-8.5.
The polymer is one or more of gelatin, carbomer and polyvinyl alcohol.
The macromolecule is carbomer.
The preparation method of the antipyretic paste gel comprises the following steps: heating the liquid dispersion medium;
adding urea to dissolve the urea;
adding macromolecule, dissolving or mixing to obtain mixture;
and (5) gel.
The heating temperature is 37.5-42 ℃,
the gel was allowed to cool and the mixture was allowed to lose fluidity within 1 minute.
The heating temperature is 37.5-42 ℃; the gel is kept at a constant temperature and alkali is added to make the mixture lose fluidity.
The invention has the following beneficial technical effects:
1. since the gel is allowed to lose fluidity in one minute, the quality of the gel can be ensured to be stable.
2. The buffer solution used in the present application can make the gel product more stable.
3. The carbomer is preferably selected as the polymer, the temperature is kept unchanged, and the mixture is gelled by adding alkali, so that no crystal is precipitated in the gelling process, the quality of a gelled product can be better stabilized, and the polymer is superior to other polymers needing cooling gel.
4. The solubility of urea content when this application adds urea content and be greater than its 37.5 ℃, this is by the human fever temperature is more than 37.2 and sets for, and even when using this article, because the influence of human temperature makes the urea in the gel dissolve to the heat absorption cooling better can also carry out intelligent cooling according to the difference of fever temperature.
Detailed Description
The invention will be further illustrated with reference to specific examples.
Example 1
An antipyretic paste gel comprises polymer and liquid dispersion medium, and urea, wherein the urea content is the solubility at 40 ℃; the solubility of urea at 40 ℃ was 129g of urea dissolved in 100g of water.
The gel pH was 8.2.
The liquid dispersion medium is a buffer solution which is a barbituric sodium-hydrochloric acid buffer solution with a pH of 8.2.
The macromolecule is carbomer.
The gel is prepared according to the following steps: heating the buffer solution to 40 ℃ and maintaining;
adding urea to dissolve the urea;
adding carbomer in an amount of 1/20 of that of water, maintaining the temperature unchanged, adding 10% sodium hydroxide solution to pH 8.2, stirring, and gelling.
Example 2
An antipyretic paste gel comprises polymer and liquid dispersion medium, and urea, wherein the urea content is the solubility at 40 ℃; the solubility of urea at 40 ℃ was 129g of urea dissolved in 100g of water.
The gel pH was 8.2.
The liquid dispersion medium is water.
The macromolecule is carbomer.
The gel is prepared according to the following steps: heating water to 40 ℃ and maintaining;
adding urea to dissolve the urea;
adding carbomer in an amount of 1/20 of that of water, maintaining the temperature unchanged, adding 10% sodium hydroxide solution to pH 8.2, stirring, and gelling.
Example 3
An antipyretic paste gel comprises polymer and liquid dispersion medium, and urea, wherein the urea content is the solubility at 40 ℃; the solubility of urea at 40 ℃ was 129g of urea dissolved in 100g of water.
The liquid dispersion medium is water; the polymer is gelatin.
The gel is prepared according to the following steps: heating water to 40 ℃ and maintaining;
adding urea to dissolve the urea;
adding gelatin with the addition amount of 2/1000 of that of water, and stirring to obtain a mixture;
the mixture was allowed to gel in one minute after cooling.
Example 4
An antipyretic gel comprises polymer and liquid dispersion medium, and urea, wherein the urea content is its solubility at 39deg.C.
The gel pH was 7.8.
The liquid dispersion medium was barbituric sodium-hydrochloric acid buffer at pH 7.8.
The gel also contains an auxiliary therapeutic drug, wherein the auxiliary therapeutic drug is lavender essential oil.
The gel in the gel layer is carried out according to the following steps: heating the buffer solution to 40 ℃ and maintaining;
adding urea to dissolve the urea;
adding lavender essential oil, and uniformly dispersing;
adding 6% aqueous solution of polyvinyl alcohol, and mixing to obtain a mixture;
cooling and gelling.
The gel lost fluidity of the mixture within 1 minute.
Example 5
An antipyretic paste gel comprises polymer and liquid dispersion medium, and urea, wherein the urea content is the solubility at 40 ℃; the solubility of urea at 40 ℃ was 129g of urea dissolved in 100g of water.
The gel pH was 8.0.
The liquid dispersion medium is a buffer solution which is a disodium hydrogen phosphate-sodium dihydrogen phosphate buffer having a pH of 8.0.
The macromolecule is carbomer.
The gel is prepared according to the following steps: heating the buffer solution to 40 ℃ and maintaining;
adding urea to dissolve the urea;
adding carbomer in an amount of 1/20 of that of water, maintaining the temperature unchanged, adding triethanolamine to pH 8.0, stirring, and gelling.
The beneficial effects of the invention are further illustrated below in conjunction with experimental data:
experiment one
1. Experimental test Material
1 materials and methods:
1.1 test sites: coastal state medical college.
1.2 test materials: the procedure was as in example 3 for the gel prepared in example 1, the gel prepared in example 2, the gel prepared in example 3 and comparative 1 (the procedure for the preparation of the gel was identical to that of example 3 except for the 5 min gel).
1.3 observation and detection: the phenomenon after gelation was observed and the urea content was examined.
1.4 experimental design: observing the gel phenomenon, and detecting the N content after the gel preparation is completed.
Urea content detection: the detection is carried out according to the detection method of GB/T2440-2017 urea.
The experiment was consistent with other operations except for the experimental treatment.
2 results and analysis
The initial and final urea contents and experimental phenomena are shown in Table 1
TABLE 1
As can be seen from the experimental data in Table 1, the temperature is kept unchanged, and the quality of the middle layer and the lower layer on the gel can be kept stable by adding alkali into the mixture to form the gel; by allowing the mixture to lose fluidity within 1 minute, the upper, middle and lower layers of the product were not very different, but were separated, whereas comparative 1 (gel preparation method, except for 5 minutes, was identical to example 3) was a relatively large upper, middle and lower layer separation, and the quality was unstable.
Experiment two
1 materials and methods:
1.1 test sites: coastal state medical college.
1.2 test materials: the antipyretic patch prepared in example 1 and the antipyretic patch prepared in example 2 were used.
1.3 experimental design: the prepared heat-relieving patches prepared in example 1, the heat-relieving patches prepared in example 2 and comparative 2 (except that the amount of sodium hydroxide added was as much as in example 1, the other preparation methods were the same as in example 2, the pH was measured to be 9.2), 10 pieces were taken for each set of experiments, placed in a cooling and heating box to be tempered to 40℃for 20 minutes, the temperature of the heat-relieving patches was measured and recorded using an infrared thermometer, and recorded as M1, tempered to 15℃and stored in a cooling and heating box for 2 months, the cooling and heating box was tempered to 40℃for 20 minutes, and the temperature of the heat-relieving patches was measured and recorded using an infrared thermometer, and recorded as M2.
The experiment was consistent with other operations except for the experimental treatment.
2 results and analysis
The temperature of the antipyretic patches in each group is shown in Table 2
TABLE 2
Example 1M1 (. Degree. C.) Example 2M1 (. Degree. C.) Comparative 2M2 (. Degree.C) Example 1M2 (. Degree. C.) Example 2M2 (. Degree. C.) Comparative 2M2 (. Degree.C)
Sample 1 38.6 38.7 38.6 38.6 38.9 39.4
Sample 2 38.6 38.6 38.6 38.6 38.9 39.5
Sample 3 38.6 38.6 38.6 38.7 39.0 39.6
Sample 4 38.6 38.7 38.6 38.6 38.9 39.5
Sample 5 38.7 38.6 38.7 38.7 38.9 39.4
Sample 6 38.6 38.6 38.7 38.6 39.0 39.5
Sample 7 38.7 38.6 38.7 38.7 38.9 39.4
Sample 8 38.6 38.6 38.6 38.6 39.0 39.5
Sample 9 38.6 38.6 38.6 38.6 38.9 39.4
Sample 10 38.6 38.7 38.6 38.7 38.9 39.5
As can be seen from table 2, the effect of example 1 of the present application is basically unchanged along with the extension of the storage time, while the effect of example 2 is obviously changed along with the extension of the storage time, and the change of comparative example 2 is more obvious, which indicates that both the liquid dispersion medium and the pH affect the use effect of the present application.

Claims (4)

1. The preparation method of the antipyretic paste gel is characterized by comprising the following steps of: heating the liquid dispersion medium;
adding urea to dissolve the urea;
adding macromolecule, dissolving or mixing to obtain mixture;
gel;
the heating is carried out at a temperature of 37.5-42 ℃;
the gel was cooled, allowing the mixture to lose fluidity within 1 minute;
and urea, said urea having a content greater than its solubility at 37.5 ℃;
the pH of the gel is 6.5-8.5;
the liquid dispersion medium is a buffer solution, and the pH of the buffer solution is 6.5-8.5.
2. The preparation method of the antipyretic paste gel is characterized by comprising the following steps of: heating the liquid dispersion medium;
adding urea to dissolve the urea;
adding macromolecule, dissolving or mixing to obtain mixture;
gel;
the heating is carried out at a temperature of 37.5-42 ℃;
the gel is prepared by adding alkali to ensure that the mixture loses fluidity while keeping the temperature unchanged;
and urea, said urea having a content greater than its solubility at 37.5 ℃;
the pH of the gel is 6.5-8.5;
the liquid dispersion medium is a buffer solution, and the pH of the buffer solution is 6.5-8.5.
3. The gel for antipyretic patch according to claim 1 or 2,
the polymer is one or more of gelatin, carbomer and polyvinyl alcohol.
4. The gel for antipyretic according to claim 3, wherein the polymer is carbomer.
CN202010309020.2A 2020-04-19 2020-04-19 Gel for antipyretic patch and preparation method thereof Active CN111450048B (en)

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Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104337796A (en) * 2014-10-12 2015-02-11 浙江欧洁科技股份有限公司 Polymeric hydrogel fever cooling patch for children and preparation method thereof
CN105687446A (en) * 2016-04-21 2016-06-22 吴美燕 Preparation method of intelligent traditional Chinese medicine fever abatement paste
CN105878218A (en) * 2016-04-21 2016-08-24 吴美燕 Preparation method of intelligent children's fever cooling patch
WO2016141755A1 (en) * 2015-03-12 2016-09-15 施敬东 Medical defervescence patch and preparation method therefor
CN105998251A (en) * 2016-06-17 2016-10-12 刘泰 Preparation method of antipyretic patch
WO2020051914A1 (en) * 2018-09-14 2020-03-19 湖南新金辐医疗科技有限公司 Antipyretic patch and preparation method therefor

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104337796A (en) * 2014-10-12 2015-02-11 浙江欧洁科技股份有限公司 Polymeric hydrogel fever cooling patch for children and preparation method thereof
WO2016141755A1 (en) * 2015-03-12 2016-09-15 施敬东 Medical defervescence patch and preparation method therefor
CN105687446A (en) * 2016-04-21 2016-06-22 吴美燕 Preparation method of intelligent traditional Chinese medicine fever abatement paste
CN105878218A (en) * 2016-04-21 2016-08-24 吴美燕 Preparation method of intelligent children's fever cooling patch
CN105998251A (en) * 2016-06-17 2016-10-12 刘泰 Preparation method of antipyretic patch
WO2020051914A1 (en) * 2018-09-14 2020-03-19 湖南新金辐医疗科技有限公司 Antipyretic patch and preparation method therefor

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
中药经皮给药凝胶剂的研究进展;汪亚飞等;今日药学(第03期);186-188 *

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