CN116966224B - Preparation method of silver Hu Ganmao antipyretic external preparation - Google Patents

Preparation method of silver Hu Ganmao antipyretic external preparation Download PDF

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CN116966224B
CN116966224B CN202310471961.XA CN202310471961A CN116966224B CN 116966224 B CN116966224 B CN 116966224B CN 202310471961 A CN202310471961 A CN 202310471961A CN 116966224 B CN116966224 B CN 116966224B
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hydrogel
hydrogel layer
temperature
ganmao
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CN116966224A (en
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韩五旗
王一喆
韩卓远
徐吉银
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Guangdong Shizhen Materia Medica Research Institute
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Guangdong Shizhen Materia Medica Research Institute
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/61Myrtaceae (Myrtle family), e.g. teatree or eucalyptus
    • AHUMAN NECESSITIES
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Abstract

The invention belongs to the field of traditional Chinese medicine preparations, and in particular relates to a preparation method of a silver Hu Ganmao antipyretic external preparation. The hydrogel layer, the reverse osmosis layer, the temperature-sensitive color-changing layer and the transparent film layer are sequentially arranged from inside to outside; the hydrogel layer is adhered to the edge of the transparent film layer to wrap the temperature-sensitive color-changing layer inside. The invention uses inclusion technology to replace the separated package of ampoule bottle and medicine bag, which is convenient for consumer to use and transport; the silver Hu Ganmao radiator is changed into a one-piece structure, so that the original functions of the silver Hu Ganmao radiator are reserved, and the heat dissipation and defervescence effects are improved; the application range of the silver Hu Ganmao powder is enlarged. The invention utilizes inclusion of water-soluble superfine powder; when the antipyretic patch is used, the bound water in the hydrogel layer is converted into free water due to the body temperature of the user; the medicine oil of the water-soluble superfine powder is released to act with the medicine powder part in the hydrogel layer.

Description

Preparation method of silver Hu Ganmao antipyretic external preparation
Technical Field
The invention belongs to the field of traditional Chinese medicine preparations, and in particular relates to a preparation method of a silver Hu Ganmao antipyretic external preparation.
Background
Silver Hu Ganmao powder (national drug standard Z20026714) is a long-history external medicine; wherein the components comprise folium Ilicis Asprellae, folium Isatidis, flos Lonicerae, fructus forsythiae, herba Artemisiae Annuae, herba Schizonepetae, bupleuri radix, herba Agastaches, folium Artemisiae Argyi, radix Platycodi, and pericarpium Citri Tangerinae. The functions are mainly used for dispelling wind and relieving exterior syndrome, and clearing heat and detoxicating. Can be used for treating aversion to cold, fever, nasal obstruction, sneeze, cough, headache, and general discomfort caused by wind-heat type common cold.
The package is divided into a medicine oil part packaged by ampoule bottles and a medicine powder part packaged by medicine bags; when in use, the ampoule bottle is opened, the medicine oil is poured on the medicine bag, and then the medicine bag is stuck on the navel or the greater vertebral point of a human body.
Due to the particularity of the ampoule, the difficulty of opening is high for ordinary consumers who are not familiar with the operation; meanwhile, when the medicine bag is poured into the medicine bag, the concentration of the medicine oil in the part in direct contact is highest, and the other parts are inconvenient to use due to slower diffusion, so that the medicine bag has concentration difference; may affect the medicinal effect.
Disclosure of Invention
The invention aims at providing a medicine which does not change the original medicinal components; the improvement on auxiliary materials and the process is convenient for patients to use, and ampoule bottles are not needed any more.
An external preparation for relieving fever of silver Hu Ganmao comprises a hydrogel layer, a reverse osmosis layer, a temperature-sensitive color-changing layer and a transparent film layer from inside to outside; the hydrogel layer is adhered to the edge of the transparent film layer to wrap the temperature-sensitive color-changing layer inside;
the hydrogel layer is divided into an upper hydrogel layer and a lower hydrogel layer, wherein superfine powder is dispersed in the lower hydrogel layer;
the hydrogel layer upper layer consists of the following components in parts by mass:
the water consumption is 8-10 times of the total mass of other raw materials on the upper layer of the hydrogel layer;
the hydrogel layer lower layer consists of the following components in parts by mass:
the water consumption is 8-10 times of the total mass of other raw materials;
the molecular weight of the crosslinked sodium hyaluronate is 1.06-1.25 million;
the adding amount of the superfine powder is 0.8-1.5 times of the adding amount of the medicinal powder;
the superfine powder is water-soluble superfine powder with nanometer size;
the content of the superfine powder consists of the following components in parts by mass:
medicinal oil 1
0.5 to 0.8 percent of volatile silicone oil
The volatile silicone oil is methyl trimethyl silicone;
the reverse osmosis layer is a waterproof film.
In particular, the pharmaceutical oil comprises the components: baeckea frutescens, eucalyptus robusta, sweet wormwood, schizonepeta, peppermint, weeping forsythia, patchouli, mugwort leaf and dried orange peel.
In particular, the powder comprises the components: herba Artemisiae Annuae, herba Schizonepetae, herba Menthae, fructus forsythiae, herba Agastaches, folium Artemisiae Argyi, pericarpium Citri Tangerinae, flos Lonicerae, bupleuri radix, radix Platycodi and fructus forsythiae.
In particular, the temperature-sensitive color-changing layer is a transparent hydrogel-wrapped temperature-sensitive color-changing ink; the temperature-sensitive color-changing ink changes color at a second order or more, wherein the first-order color-changing temperature is 33-35 ℃, and the second-order color-changing temperature is more than or equal to 38.3 ℃.
In particular, a release film is adhered to one side of the hydrogel layer.
The release film is PP, PET, PE or silicon-coated glassine paper.
In particular, the reverse osmosis layer is a polyethylene film.
In particular, the volume ratio of the upper layer to the lower layer of the hydrogel layer is 3-4:1.
The medicine powder and the medicine oil are prepared from the original formula of silver Hu Ganmao for abating fever, and specifically comprise the following components:
prescription: baeckea frutescens 6818g, eucalyptus robusta 6818g, lonicera japonica 159g, fructus forsythiae 136g, sweet wormwood 159g, herba schizonepetae 159g, peppermint 136g, radix bupleuri 136g, pogostemon cablin 114g, folium artemisiae argyi 91g, platycodon grandiflorum 114g and dried orange peel 68g.
The preparation method comprises the following steps: the twelve raw materials are taken, crushed and distilled by water vapor for 2.5 hours, and volatile oil is collected and stored in a container; 45g of sweet wormwood herb, fineleaf schizonepeta herb, peppermint, weeping forsythia and patchouli respectively, 23g of mugwort leaf and dried orange peel respectively, crushing, distilling with water vapor for 3 hours, collecting volatile oil, uniformly mixing the collected volatile oil, bottling and preparing 454 bottles. The preparation method comprises the steps of washing, sun-drying, crushing, sieving, uniformly mixing, drying the medicinal powder at 60 ℃ for 2 hours, bagging and preparing 1000g of the medicinal powder. And (5) respectively filling the medicinal oil and the medicinal powder into aluminum foil bags to obtain the Chinese medicinal composition.
Compared with the prior art, the invention has the advantages that:
(1) The invention uses inclusion technology to replace the separated package of ampoule bottle and medicine bag, which is convenient for consumer to use and transport; the silver Hu Ganmao radiator is changed into a one-piece structure, so that the original functions of the silver Hu Ganmao radiator are reserved, and the heat dissipation and defervescence effects are improved; the application range of the silver Hu Ganmao powder is enlarged; meanwhile, the using part is not limited on the umbilical eye or the big vertebral acupoint of the human body.
(2) The invention utilizes inclusion of water-soluble superfine powder; when the antipyretic patch is used, the bound water in the hydrogel layer is converted into free water due to the body temperature of the user; the medicine oil of the water-soluble superfine powder is released to act with the medicine powder part in the hydrogel layer. Meanwhile, the volatile silicone oil in the superfine powder can further accelerate the diffusion speed of the medicine oil.
(3) According to the invention, the precipitation temperature of water and the vaporization point of the silicone oil are controlled through the component adjustment of the hydrogel layer and the volatile silicone oil; the medicine oil in the medicine oil can be released when the medicine oil is used; meanwhile, in order to control the release directions of water and medicine oil, the hydrogel layer is divided into an upper area and a lower area, wherein the medicine oil is positioned on the lower layer; and a waterproof reverse osmosis layer is arranged above the hydrogel layer to force the separated water and medicine oil to flow towards the human body.
(4) The invention has a thermochromic layer, which can approximately reflect the body temperature of a user; so as to prevent hyperthermia and delay the time of medical delivery; and the state of the product before being used can be monitored, and when the color change occurs, the product is released or used.
Drawings
The invention will be further described with reference to the drawings and examples.
FIG. 1 is a cross-sectional view of the present invention;
in the figure: a transparent film layer 1; a temperature-sensitive color-changing layer 2; an anti-seepage layer 3; an upper hydrogel layer 41; a hydrogel layer lower layer 42; superfine powder 5; and a release film 6.
Detailed Description
The present invention will be described in further detail with reference to the following examples, which are not intended to limit the present invention, but are merely illustrative of the present invention. The experimental methods used in the following examples are not specifically described, but the experimental methods in which specific conditions are not specified in the examples are generally carried out under conventional conditions, and the materials, reagents, etc. used in the following examples are commercially available unless otherwise specified.
In specific embodiments, steps, material selections, numerical parameters that are not described in detail are all routine selections in the art, or any prior art that is presently disclosed.
In the following examples, the molecular weight of the crosslinked sodium hyaluronate is within 1.06-1.25 million;
the superfine powder is water-soluble superfine powder with nanometer size, and the average size is less than or equal to 1000nm;
as shown in FIG. 1, the invention is divided into 5 layers, and a release film 6, a hydrogel layer, a reverse osmosis layer 3, a temperature-sensitive color-changing layer 2 and a transparent film layer 1 are respectively arranged from inside to outside from the side close to the skin.
Wherein the release film 6 is used for protecting the internal structure before use and preventing external pollution such as dust; the release film 6 is removed prior to use. The release film 6 may be PP (polypropylene), PET (polyethylene terephthalate), PE (polyethylene) or silicon coated glassine paper; as long as the protection function can be achieved.
The hydrogel layer is divided into an upper hydrogel layer 41 and a lower hydrogel layer 42; the hydrogel layer lower layer 42 is a part contacting the skin of the human body, and contains a large amount of superfine powder 5 and medicinal powder, wherein the superfine powder 5 is water-soluble chitosan, and when water in the hydrogel is separated out, the chitosan is dissolved, and the medicinal oil is quickly brought out by volatile silicone oil and mixed with the medicinal powder to act on the skin of the human body. The hydrogel layer upper layer 41 is a main water storage area for continuously releasing moisture to maintain a heat dissipation effect.
The reverse osmosis layer 3 is made of a waterproof film material, and a polyethylene film is selected to be better in consideration of transparency and fusion performance with other layers; the main purpose is to control the water outlet direction of the hydrogel layer.
The temperature-sensitive color-changing layer 2 contains color-changing ink which is colorless and color-changing; can approximately reflect the body temperature of the user; so as to prevent erroneous delivery of medical information.
The transparent film layer 1 is used to maintain the shape of the entire product, and at the same time, to ensure the visual effect of the temperature-sensitive color-changing layer 2, it is required to maintain transparency.
Example 1 preparation of samples
1. Preparation of medicinal oil and medicinal powder:
prescription: the traditional Chinese medicine comprises, by weight, 6818 parts of roughhaired holly, 6818 parts of eucalyptus robusta, 159 parts of lonicera japonica, 136 parts of fructus forsythiae, 159 parts of sweet wormwood herb, 159 parts of herba schizonepetae, 136 parts of peppermint, 136 parts of radix bupleuri, 114 parts of patchouli, 91 parts of mugwort leaf, 114 parts of platycodon grandiflorum and 68 parts of dried orange peel.
The preparation method comprises the following steps: taking the above twelve raw materials, pulverizing, steam distilling for 2.5 hr, collecting volatile oil, and storing in another container; 45 parts of sweet wormwood herb, fineleaf schizonepeta herb, peppermint, weeping forsythia and patchouli respectively, 23 parts of mugwort leaf and dried orange peel respectively, crushing, distilling with water vapor for 3 hours, collecting volatile oil, uniformly mixing the collected volatile oil, bottling, and preparing 454 bottles of medicinal oil.
The preparation method comprises the steps of washing, sun-drying, crushing, sieving, uniformly mixing, drying the medicinal powder at 60 ℃ for 2 hours, bagging and preparing 1000 parts of medicinal powder.
Sealing and storing the medicinal oil and the medicinal powder respectively for standby.
2. Preparation of superfine powder 5:
mixing the prepared medicinal oil with the volatile methyl-poly (trimethylsiloxane); dissolving in organic solvent to obtain essential oil solution, dispersing in emulsifier water solution, mixing with chitosan water solution, re-coagulating, and spraying to obtain superfine powder 5.
Wherein the mass ratio of the medicine oil in the superfine powder 5 to the methyl trimethyl silicone is as follows:
number 1 is 1:0.5
Number 2 is 1:0.6
Number 3 is 1:0.8
3. Preparation of the hydrogel layer:
(1) Weighing the raw materials according to the mass parts in the following table 1;
(2) PEG400 and PEG1000 are heated to 115 ℃ and vacuumized for pretreatment;
(3) Cooling PEG400 and PEG1000 to 60-70deg.C, adding crosslinked sodium hyaluronate, glycerol, diethylene glycol, sorbitol and water, and stirring;
(4) Heating to 80-90 ℃, and adding diphenylmethane diisocyanate and citric acid while stirring;
(5) After cooling to less than or equal to 30 ℃, the part serving as the hydrogel layer upper layer 41 is coated and rolled; adding the medicinal powder and the superfine powder 5 as the hydrogel layer lower layer 42, and coating and rolling; the hydrogel layer upper layer 41 and the hydrogel layer lower layer 42 are closely adhered.
TABLE 1
4. Preparation of silver Hu Ganmao antipyretic external preparation:
(1) Sequentially placing and compacting the reverse osmosis layer 3, the temperature-sensitive color-changing layer 2 and the transparent film layer 1; wherein the size of the temperature-sensitive color-changing layer 2 is smaller than that of the reverse osmosis layer 3 and the transparent film layer 1; so that the temperature-sensitive color-changing layer 2 is sandwiched between the reverse osmosis layer 3 and the transparent film layer 1;
(2) Attaching the compacted portion of step (1) to one side of the hydrogel; the other side is stuck with upper release paper 6; as shown in table 2.
TABLE 2
Sequence number 1 2 3 4 5 6
Transparent film layer 1 Polyvinyl alcohol Polyvinyl alcohol Polyvinyl alcohol Polyurethane Polyurethane Polyurethane
Reverse osmosis layer 3 Polyethylene Polyethylene Polyethylene Polyethylene Polyethylene Polyethylene
Hydrogel layer numbering 1 2 3 4 5 6
Release film 6 material PP PP PET PE PE Tu Guige Laxin paper
In Table 2, the temperature-sensitive color-changing layer 2 contains at least 10% of color-changing ink, and the material of the temperature-sensitive color-changing layer 2 is the same as that of polyvinyl alcohol; the adopted color-changing ink is Templ in the United states which accords with the medical and health regulations; wherein the colorless-blue ink has a color change range of 33-35 ℃; colorless-red ink with a discoloration temperature of 38.3 ℃ in a mixing ratio of 1:1.
Example 2 Performance test
1. Viscosity test
The hydrogel layers of the above products were subjected to viscosity test, and the results are shown in Table 3.
2. Irritation test
Skin irritation test and skin allergy test were performed according to sanitary wet towel in GB 15979-2002; the results are shown in Table 3.
3. Peel strength test
The purpose of this item is to measure the firmness after attachment; and (3) fixing the edge of the finished product by using the dynamometer, tearing off the release film 6 of the finished product, attaching the finished product on a smooth peeling surface for 5 seconds, and pulling the dynamometer, and reading the dynamometer when the finished product is torn off.
4. Antipyretic effect test
Applying the antipyretic patch on the forehead of a healthy subject meeting the conditions, respectively measuring the skin surface temperature at the application position and the skin surface temperature at other places by using an infrared thermometer at the 0 th, 1h, 3h, 6h, 9h and 12h, and observing the cooling effect. The samples were also weighed at the above time points and the change in weight during use was observed as shown in table 3.
TABLE 3 Table 3
The sequence numbers in table 3 follow the sequence numbers in table 2.
The foregoing detailed description is directed to one of the possible embodiments of the present invention, which is not intended to limit the scope of the invention, but is to be accorded the full scope of all such equivalents and modifications so as not to depart from the scope of the invention.

Claims (3)

1. An external preparation for relieving fever of silver Hu Ganmao is characterized in that a hydrogel layer, a reverse osmosis layer, a temperature-sensitive color-changing layer and a transparent film layer are sequentially arranged from inside to outside; the hydrogel layer is adhered to the edge of the transparent film layer to wrap the temperature-sensitive color-changing layer inside;
the hydrogel layer is divided into an upper hydrogel layer and a lower hydrogel layer, wherein superfine powder is dispersed in the lower hydrogel layer;
the hydrogel layer upper layer consists of the following components in parts by mass:
PEG400 6.5-14
PEG1000 3.5-7
crosslinked sodium hyaluronate 5-10
Glycerol 5-10
Diethylene glycol 3-5
Sorbitol 12-20
Diphenylmethane diisocyanate 1.2-2
Citric acid 0.05-0.5
The water consumption is 8-10 times of the total mass of other raw materials on the upper layer of the hydrogel layer;
the hydrogel layer lower layer consists of the following components in parts by mass:
PEG400 6.5-14
PEG1000 3.5-7
crosslinked sodium hyaluronate 5-10
Glycerol 5-10
Diethylene glycol 3-5
Sorbitol 12-20
Diphenylmethane diisocyanate 1.2-2
Citric acid 0.05-0.5
Powder 11-22
The water consumption is 8-10 times of the total mass of other raw materials;
the molecular weight of the crosslinked sodium hyaluronate is 1.06-1.25 million;
the adding amount of the superfine powder is 0.8-1.5 times of the adding amount of the medicinal powder;
the superfine powder is water-soluble superfine powder with nanometer size;
the content of the superfine powder consists of the following components in parts by mass:
medicinal oil 1
0.5 to 0.8 percent of volatile silicone oil
The volatile silicone oil is methyl trimethyl silicone;
the reverse osmosis layer is a waterproof film;
the medicinal oil is prepared from the following raw materials: baeckea frutescens, eucalyptus robusta, sweet wormwood, schizonepeta, peppermint, weeping forsythia, patchouli, mugwort leaf and dried orange peel;
the medicinal powder is prepared from the following raw materials: herba Artemisiae Annuae, herba Schizonepetae, herba Menthae, fructus forsythiae, herba Agastaches, folium Artemisiae Argyi, pericarpium Citri Tangerinae, flos Lonicerae, bupleuri radix, and radix Platycodi;
the temperature-sensitive color-changing layer is made of transparent hydrogel-coated temperature-sensitive color-changing ink; the temperature-sensitive color-changing ink changes color at a second order or more, wherein the first-order color-changing temperature is 33-35 ℃, and the second-order color-changing temperature is more than or equal to 38.3 ℃;
the volume ratio of the upper layer to the lower layer of the hydrogel layer is 3-4:1.
2. The external preparation for silver Hu Ganmao fever reducing according to claim 1, wherein a release film is further adhered to one surface of the hydrogel layer.
3. The external preparation for silver Hu Ganmao fever according to claim 1, wherein the reverse osmosis layer is a polyethylene film.
CN202310471961.XA 2023-04-27 2023-04-27 Preparation method of silver Hu Ganmao antipyretic external preparation Active CN116966224B (en)

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Citations (3)

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Publication number Priority date Publication date Assignee Title
CN1293970A (en) * 2000-11-04 2001-05-09 广西源安堂制药厂 Chinese medicine for curing cold by omphalotherapy and its preparing process
CN205181584U (en) * 2015-11-17 2016-04-27 上海卫生材料厂有限公司 Thalposis subsides of bringing down a fever of discolouing
CN109124862A (en) * 2018-07-12 2019-01-04 广州馥邦科技应用有限公司 A kind of control-release long-acting is defervescence plaster used and preparation method thereof

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1293970A (en) * 2000-11-04 2001-05-09 广西源安堂制药厂 Chinese medicine for curing cold by omphalotherapy and its preparing process
CN205181584U (en) * 2015-11-17 2016-04-27 上海卫生材料厂有限公司 Thalposis subsides of bringing down a fever of discolouing
CN109124862A (en) * 2018-07-12 2019-01-04 广州馥邦科技应用有限公司 A kind of control-release long-acting is defervescence plaster used and preparation method thereof

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