CN111905090A - Traditional Chinese medicine composition, traditional Chinese medicine extract, paste and medicinal patch - Google Patents

Traditional Chinese medicine composition, traditional Chinese medicine extract, paste and medicinal patch Download PDF

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CN111905090A
CN111905090A CN202010907937.2A CN202010907937A CN111905090A CN 111905090 A CN111905090 A CN 111905090A CN 202010907937 A CN202010907937 A CN 202010907937A CN 111905090 A CN111905090 A CN 111905090A
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parts
paste
traditional chinese
chinese medicine
phase
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林慧红
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Hangzhou Red Cross Hospital
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Hangzhou Red Cross Hospital
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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)
    • A61K36/75Rutaceae (Rue family)
    • A61K36/754Evodia
    • 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)
    • A61K36/34Campanulaceae (Bellflower family)
    • A61K36/344Codonopsis
    • 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)
    • A61K36/88Liliopsida (monocotyledons)
    • A61K36/906Zingiberaceae (Ginger family)
    • A61K36/9068Zingiber, e.g. garden ginger
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0014Skin, i.e. galenical aspects of topical compositions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/06Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/70Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
    • A61K9/7023Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system

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  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
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  • Bioinformatics & Cheminformatics (AREA)
  • Alternative & Traditional Medicine (AREA)
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Abstract

The invention provides a traditional Chinese medicine composition, a traditional Chinese medicine extract, an ointment and a medicinal patch, wherein the traditional Chinese medicine composition comprises the following raw materials in parts by weight: 1-2 parts of fructus evodiae, 2-4 parts of ginger and 1-2 parts of codonopsis pilosula. The medicinal patch has the advantages that the evodia rutaecarpa, the ginger and the codonopsis pilosula are reasonably compounded and synergized, the medicinal patch has the effects of warming the middle-jiao and harmonizing the stomach, promoting the circulation of qi and relieving pain, tonifying the spleen and benefiting the lung, can effectively improve gastrointestinal tract reaction caused by antituberculosis drugs, has fewer impurities in extracts obtained by solvent extraction, can directly act on a target position to exert curative effect when being applied to the medicinal patch, can avoid the first pass effect of the liver and the gastrointestinal tract and the stimulation of the drugs to the gastrointestinal tract in the treatment process of the antituberculosis drugs, maintains constant blood concentration for a long time, reduces the adverse reaction of the antituberculosis drugs.

Description

Traditional Chinese medicine composition, traditional Chinese medicine extract, paste and medicinal patch
Technical Field
The invention relates to the field of traditional Chinese medicines, and in particular relates to a traditional Chinese medicine composition, a traditional Chinese medicine extract, an ointment and a medicinal patch.
Background
Many studies and clinical observations indicate that adverse reactions of antituberculosis drugs occur in 1 week to 3 months of treatment, peak periods in 1 to 2 weeks, and the most frequently affected organ is the gastrointestinal system (28.9%), wherein nausea, vomiting and anorexia are the most common gastrointestinal reactions in the antituberculosis treatment process of drugs. The gastrointestinal reaction caused by the antiphthisic drugs in western medicine at home and abroad has no specific medicine, mainly treats the disease, the common western medicines comprise metoclopramide, omeprazole and the like, the common traditional Chinese medicines are mostly decoction, and the curative effects are different because the syndrome differentiation and treatment levels of traditional Chinese medical doctors are different. Traditional Chinese medicine nursing technologies such as acupoint injection, auricular point pressure therapy, moxibustion therapy and the like also have certain effects on relieving gastrointestinal tract reaction caused by antiphthisic drugs, but have higher requirements on knowledge structure, communication mode and technical key and are closely related to age, occupation, economy, disease protection and the like of patients, so that the curative effects are also different, and the traditional Chinese medicine nursing technology is more not favorable for popularization and use in places outside medical institutions such as homes.
Disclosure of Invention
The invention aims to provide a traditional Chinese medicine composition, a traditional Chinese medicine extract, an ointment and a medicinal plaster, wherein the traditional Chinese medicine composition obtained by reasonably compounding fructus evodiae, ginger and codonopsis pilosula and synergizing the effects has the effects of warming middle-jiao and stomach, promoting qi circulation and relieving pain, strengthening spleen and benefiting lung, and the extract obtained by extracting the traditional Chinese medicine composition has fewer impurities, can directly act on a target position to exert curative effect when being applied to the medicinal plaster, can effectively improve the first pass effect of liver and gastrointestinal tract and the stimulation of medicaments to gastrointestinal tract in the treatment process of an anti-tuberculosis medicament, maintains constant blood concentration for a longer time, reduces the adverse reaction of the anti-tuberculosis medicament, can reduce the administration times, and is convenient to use.
In order to achieve the above purpose, the invention provides the following technical scheme:
a traditional Chinese medicine composition comprises the following raw materials in parts by weight: 1-2 parts of fructus evodiae, 2-4 parts of ginger and 1-2 parts of codonopsis pilosula.
A preparation method of a traditional Chinese medicine extract is characterized in that the traditional Chinese medicine extract is obtained by extracting the traditional Chinese medicine composition.
As a further improvement of the above technical scheme, the extraction is carried out by using a solvent;
preferably, the solvent comprises ethanol and/or water; preferably, the solvent is 65-75% of ethanol water solution by mass;
optionally, before the extracting, the method further comprises: pulverizing the Chinese medicinal composition into powder.
As a further improvement of the above technical scheme, the extraction is performed by reflux extraction with a solvent;
preferably, the reflux extraction is performed for 2-4 times; the temperature of each reflux extraction is 68-75 ℃, and the time is 60-80 min;
optionally, filtering is further included after the extracting;
preferably, the filtration is performed by adopting a micro-nano filtration device.
A traditional Chinese medicine extract is prepared by the preparation method of the traditional Chinese medicine extract.
An ointment comprises the traditional Chinese medicine extract.
As a further improvement of the above technical solution, the paste further comprises a base;
preferably, the mass ratio of the traditional Chinese medicine extract to the matrix is (1-2): 1;
preferably, the matrix comprises: adhesives, fillers and humectants;
preferably, in the matrix: the mass ratio of the adhesive to the filler to the humectant is (2-16): (0.5-2): (17-30);
preferably, the adhesive comprises at least one of tragacanth, gelatin, carboxymethylcellulose, sodium carboxymethylcellulose, carbomer, sodium polyacrylate, polyvinyl alcohol, and polyvinylpyrrolidone;
preferably, the filler comprises at least one of silica gel, kaolin, bentonite, and zinc oxide;
preferably, the humectant comprises at least one of glycerin, polyethylene glycol, and propylene glycol.
A preparation method of the paste comprises the following steps: mixing the Chinese medicinal extract with the matrix to obtain the paste;
preferably, the preparation method of the matrix comprises:
mixing an adhesive and water, and swelling the adhesive at the temperature of 30-50 ℃ to obtain a phase A;
mixing part of humectant, filler and water to obtain phase B;
uniformly mixing the phase A, the phase B and the rest of the humectant;
preferably, when the phase A is prepared, the mass ratio of the adhesive to the water is (2-16): (37.5 to 150);
preferably, when the phase B is prepared, the mass ratio of part of the humectant, the filler and the water is as follows: (2-5): (0.5-2): (3.5 to 19).
A medicinal patch comprises a support layer and a paste layer arranged on the support layer; the paste layer comprises the paste;
preferably, the patch further comprises a protective layer arranged on one side of the paste layer far away from the support layer;
preferably, the support layer comprises a nonwoven fabric;
preferably, the protective layer comprises a polyethylene film.
A preparation method of the medicinal patch comprises the following steps: applying the paste to the support layer and drying to obtain the paste layer;
preferably, the drying mode adopts vacuum drying;
preferably, the temperature of the vacuum drying is 70-80 ℃, and the time of the vacuum drying is 1-1.5 h;
preferably, the preparation method further comprises: and arranging a protective layer on one side of the paste layer far away from the support layer.
An application of the traditional Chinese medicine composition in preparing a medicine for treating antituberculosis drug adverse reaction.
An application of the Chinese medicinal extract in preparing medicine for treating antituberculosis drug adverse reaction is provided.
The invention has the beneficial effects that:
the evodia rutaecarpa, the ginger and the codonopsis pilosula are reasonably compounded and synergized, so that the obtained traditional Chinese medicine composition has the effects of warming the middle-jiao and stomach, promoting qi circulation and relieving pain, strengthening the spleen and benefiting the lung, and the extract obtained by extracting the traditional Chinese medicine composition has fewer impurities, can directly act on a target position to exert curative effect when being applied to a medicine patch, can effectively improve the first pass effect of the liver and the gastrointestinal tract and the stimulation of the medicine to the gastrointestinal tract in the treatment process of the anti-tuberculosis medicine, maintains constant blood concentration for a long time, reduces the adverse reaction of the anti-tuberculosis medicine, can reduce the administration frequency, and is convenient to use.
In order to make the aforementioned and other objects, features and advantages of the invention more comprehensible, preferred embodiments accompanied with figures are described in detail below.
Detailed Description
In the following description, numerous specific details are set forth in order to provide a thorough understanding of the present invention.
This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein, but rather should be construed as broadly as the present invention is capable of modification in various respects, all without departing from the spirit and scope of the present invention.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. In case of conflict, the present specification, including definitions, will control.
The terms as used herein:
"prepared from … …" is synonymous with "comprising". The terms "comprises," "comprising," "includes," "including," "has," "having," "contains," "containing," or any other variation thereof, as used herein, are intended to cover a non-exclusive inclusion. For example, a composition, process, method, article, or apparatus that comprises a list of elements is not necessarily limited to only those elements but may include other elements not expressly listed or inherent to such composition, process, method, article, or apparatus.
The conjunction "consisting of … …" excludes any unspecified elements, steps or components. If used in a claim, the phrase is intended to claim as closed, meaning that it does not contain materials other than those described, except for the conventional impurities associated therewith. When the phrase "consisting of … …" appears in a clause of the subject matter of the claims rather than immediately after the subject matter, it defines only the elements described in the clause; other elements are not excluded from the claims as a whole.
When an amount, concentration, or other value or parameter is expressed as a range, preferred range, or as a range of upper preferable values and lower preferable values, this is to be understood as specifically disclosing all ranges formed from any pair of any upper range limit or preferred value and any lower range limit or preferred value, regardless of whether ranges are separately disclosed. For example, when the range "1 ~ 5" is disclosed, the ranges described should be construed to include the ranges "1 ~ 4", "1 ~ 3", "1 ~ 2 and 4 ~ 5", "1 ~ 3 and 5", and the like. When a range of values is described herein, unless otherwise stated, the range is intended to include the endpoints thereof and all integers and fractions within the range.
In these examples, the parts and percentages are by mass unless otherwise indicated.
"part by mass" means a basic unit of measure indicating a mass ratio of a plurality of components, and 1 part may represent any unit mass, for example, 1g or 2.689 g. If we say that the part by mass of the component A is a part by mass and the part by mass of the component B is B part by mass, the ratio of the part by mass of the component A to the part by mass of the component B is a: b. alternatively, the mass of the A component is aK and the mass of the B component is bK (K is an arbitrary number, and represents a multiple factor). It is unmistakable that, unlike the parts by mass, the sum of the parts by mass of all the components is not limited to 100 parts.
"and/or" is used to indicate that one or both of the illustrated conditions may occur, e.g., a and/or B includes (a and B) and (a or B).
The invention provides a traditional Chinese medicine composition which comprises the following raw materials in parts by weight:
1-2 parts of fructus evodiae, such as 1 part, 1.2 parts, 1.5 parts, 1.8 parts or 2 parts and the like;
2-4 parts of ginger, such as 2 parts, 2.5 parts, 3 parts, 3.5 parts or 4 parts and the like;
1-2 parts of codonopsis pilosula, such as 1 part, 1.2 parts, 1.5 parts, 1.8 parts or 2 parts.
The invention also provides a preparation method of the traditional Chinese medicine extract, which is obtained by extracting the traditional Chinese medicine composition.
Preferably, before the above extraction, the method further comprises: pulverizing the above Chinese medicinal composition into powder, preferably with particle size of about 100 mesh.
Further, the extraction is carried out by adopting a solvent; preferably, the solvent comprises ethanol and/or water, i.e. the solvent may be ethanol, water or a mixture of ethanol and water (i.e. aqueous ethanol); wherein, the water is preferably deionized water, distilled water or ultrapure water and the like; preferably, the solvent is 65-75% by mass of ethanol aqueous solution (the mass fraction refers to the mass fraction of ethanol in the ethanol aqueous solution).
Preferably, the extraction is performed by refluxing with a solvent; and the reflux extraction frequency is preferably 2-4 times, the temperature of each reflux extraction is 68-75 ℃, the time is 60-80 min, and then the extracting solutions are combined, so that effective components which have the effects of warming the middle-jiao and harmonizing the stomach, promoting qi circulation and relieving pain, tonifying spleen and benefiting lung and effectively improving gastrointestinal tract reaction caused by the antituberculosis drugs can be extracted to the maximum degree.
Further, the method also comprises the step of filtering after the extraction; preferably, the filtration is performed by using a micro-nano filtration device such as a ceramic membrane filter, a micro-nano filter, etc., to obtain the extract of the Chinese medicinal material.
The invention also provides a traditional Chinese medicine extract which is prepared by adopting the preparation method of the traditional Chinese medicine extract.
The present invention also provides a paste comprising: the above Chinese medicinal extract.
Further, the above paste further comprises a base.
Preferably, the mass ratio of the traditional Chinese medicine extract to the matrix is (1-2): 1.
further, the substrate comprises: adhesives, fillers and humectants.
Preferably, in the above matrix: the mass ratio of the adhesive, the filler and the humectant is preferably (2-16): (0.5-2): (17-30);
preferably, the adhesive comprises at least one of tragacanth, gelatin, carboxymethylcellulose, sodium carboxymethylcellulose, carbomer, sodium polyacrylate, polyvinyl alcohol and polyvinylpyrrolidone; the filler comprises at least one of silica gel, kaolin, bentonite and zinc oxide; the humectant comprises at least one of glycerin, polyethylene glycol and propylene glycol.
The invention also provides a preparation method of the paste, which comprises the following steps: mixing the above Chinese medicinal extract with the above matrix to obtain the unguent.
Further, the preparation method of the matrix comprises the following steps: mixing the raw materials including the adhesive, the filler and the humectant.
Preferably, the preparation method of the matrix comprises the following steps:
mixing an adhesive with water, and fully swelling the adhesive under the water bath condition of 30-50 ℃ to obtain a phase A;
mixing part of humectant, filler and water to obtain phase B;
and uniformly mixing the phase A, the phase B and the rest of the humectant.
Preferably, when the phase A is prepared, the mass ratio of the adhesive to the water is (2-16): (37.5 to 150);
preferably, when the phase B is prepared, the mass ratio of part of the humectant, the filler and the water is as follows: (2-5): (0.5-2): (3.5 to 19).
A medicinal patch comprises a support layer and a paste layer arranged on the support layer; the paste layer comprises the paste.
Preferably, the patch further comprises a protective layer disposed on a side of the paste layer remote from the support layer.
The supporting layer is preferably made of non-woven fabric; the protective layer is preferably a polyethylene film.
The invention also provides a preparation method of the medicinal patch, which comprises the following steps: coating the above paste on a support layer and drying to obtain a paste layer.
Preferably, the drying mode adopts vacuum drying, the temperature of the vacuum drying is 70-80 ℃, and the time of the vacuum drying is 1-1.5 h, so that the long-term stable storage of the patch and the better drug effect can be better exerted.
Preferably, the preparation method of the patch further comprises: and arranging a protective layer on one side of the paste layer far away from the support layer.
The anti-tuberculosis drug is prepared by reasonably compounding fructus evodiae, ginger and codonopsis pilosula, and performing synergistic interaction, so that the obtained traditional Chinese medicine composition has the effects of warming the middle-jiao and stomach, promoting qi circulation and relieving pain, and strengthening spleen and benefiting lung, and the extract obtained by extracting the traditional Chinese medicine composition has fewer impurities, can directly act on a target position to exert curative effect, can effectively improve the first pass effect of liver and gastrointestinal tract and the stimulation of the drug to gastrointestinal tract in the treatment process of the anti-tuberculosis drug, maintains constant blood concentration for a long time, reduces the adverse reaction of the anti-tuberculosis drug, and can reduce the administration times, and is convenient to use.
Embodiments of the present invention will be described in detail below with reference to specific examples, but those skilled in the art will appreciate that the following examples are only illustrative of the present invention and should not be construed as limiting the scope of the present invention. The examples, in which specific conditions are not specified, were conducted under conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products available commercially.
Example 1
(1) Weighing 1 part of fructus evodiae, 2 parts of ginger and 2 parts of radix codonopsis, mixing and crushing to obtain a powdery mixture; and then, carrying out reflux extraction on the powdery mixture for 3 times by adopting an ethanol water solution with the mass fraction of 75%, wherein the reflux extraction temperature is 75 ℃ each time, the time is 80min, combining the extracting solutions obtained for 3 times, filtering by adopting a micro-nano filter, recovering ethanol in the filtrate, and simultaneously obtaining an extractum-shaped traditional Chinese medicine extract.
(2) Adding 50 parts of water into 8 parts of tragacanth, and fully swelling the tragacanth under the condition of a constant-temperature water bath at 40 ℃; adding 50 parts of water into 3 parts of sodium polyacrylate, and fully swelling the sodium polyacrylate under the condition of a constant-temperature water bath at 40 ℃; uniformly mixing the swollen tragacanth and sodium polyacrylate to obtain a phase A; adding 3 parts of polyethylene glycol and 1 part of kaolin into 9 parts of water, and uniformly stirring and mixing to obtain a phase B; and then uniformly mixing the phase A and the phase B, adding 19 parts of glycerol, and uniformly stirring and mixing to obtain the matrix.
(3) Mixing the traditional Chinese medicine extract obtained in the step (1) and the matrix obtained in the step (2) according to a mass ratio of 1: 1, stirring and mixing uniformly to obtain the ointment.
(4) And (3) uniformly coating the paste obtained in the step (3) on a non-woven fabric of 5cm multiplied by 6cm multiplied by 0.3cm, then putting the non-woven fabric into a vacuum drying oven of 70 ℃, drying and activating for 1.5h, taking out and flattening, covering a polyethylene film on the surface of the paste layer formed on the non-woven fabric, and packaging to obtain the medicinal patch.
Example 2
(1) Weighing 1.2 parts of fructus evodiae, 2.5 parts of ginger and 1.8 parts of codonopsis pilosula, mixing and crushing to obtain a powdery mixture; and then, carrying out reflux extraction on the powdery mixture for 3 times by adopting 65% ethanol water solution by mass, wherein the reflux extraction temperature is 70 ℃ each time, the time is 60min, combining the extracting solutions obtained for 3 times, filtering by adopting a micro-nano filter, recovering ethanol in the filtrate, and simultaneously obtaining an extractum-shaped traditional Chinese medicine extract.
(2) Adding 50 parts of water into 9 parts of tragacanth, and fully swelling the tragacanth under the condition of a constant-temperature water bath at 40 ℃; adding 50 parts of water into 4 parts of sodium polyacrylate, and fully swelling the sodium polyacrylate under the condition of a constant-temperature water bath at 40 ℃; uniformly mixing the swollen tragacanth and sodium polyacrylate to obtain a phase A; adding 2.5 parts of polyethylene glycol and 1.5 parts of kaolin into 9 parts of water, and uniformly stirring and mixing to obtain a phase B; and then uniformly mixing the phase A and the phase B, adding 20 parts of glycerol, and uniformly stirring and mixing to obtain the matrix.
(3) Mixing the traditional Chinese medicine extract obtained in the step (1) and the matrix obtained in the step (2) according to a mass ratio of 1: 1, stirring and mixing uniformly to obtain the ointment.
(4) And (3) uniformly coating the paste obtained in the step (3) on a non-woven fabric of 5cm multiplied by 6cm multiplied by 0.3cm, then putting the non-woven fabric into a vacuum drying oven of 80 ℃, drying and activating for 1h, taking out and flattening, covering a polyethylene film on the surface of the paste layer formed on the non-woven fabric, and packaging to obtain the medicinal patch.
Example 3
(1) Weighing 1.5 parts of fructus evodiae, 3 parts of ginger and 1.5 parts of radix codonopsis, mixing and crushing to obtain a powdery mixture; and then, carrying out reflux extraction on the powdery mixture for 3 times by adopting an ethanol water solution with the mass fraction of 75%, wherein the reflux extraction temperature is 70 ℃ for 70min each time, combining the extracting solutions obtained for 3 times, filtering by adopting a micro-nano filter, recovering ethanol in the filtrate, and simultaneously obtaining an extractum-shaped traditional Chinese medicine extract.
(2) Adding 37.5 parts of water into 6 parts of tragacanth, and fully swelling the tragacanth under the condition of a constant-temperature water bath at 40 ℃; adding 2 parts of sodium polyacrylate into 40 parts of water, and fully swelling the sodium polyacrylate under the condition of a constant-temperature water bath at 40 ℃; uniformly mixing the swollen tragacanth and sodium polyacrylate to obtain a phase A; adding 2 parts of polyethylene glycol and 0.5 part of kaolin into 3.5 parts of water, and uniformly stirring and mixing to obtain a phase B; and then uniformly mixing the phase A and the phase B, adding 15 parts of glycerol, and uniformly stirring and mixing to obtain the matrix.
(3) Mixing the traditional Chinese medicine extract obtained in the step (1) and the matrix obtained in the step (2) according to a mass ratio of 1: 1, stirring and mixing uniformly to obtain the ointment.
(4) And (3) uniformly coating the paste obtained in the step (3) on a non-woven fabric of 5cm multiplied by 6cm multiplied by 0.3cm, then putting the non-woven fabric into a vacuum drying oven of 80 ℃, drying and activating for 1h, taking out and flattening, covering a polyethylene film on the surface of the paste layer formed on the non-woven fabric, and packaging to obtain the medicinal patch.
Example 4
(1) Weighing 1.8 parts of fructus evodiae, 3.5 parts of ginger and 1.2 parts of radix codonopsis, mixing and crushing to obtain a powdery mixture; and then, carrying out reflux extraction on the powdery mixture for 3 times by adopting an ethanol water solution with the mass fraction of 75%, wherein the reflux extraction temperature is 70 ℃ each time, the time is 80min, combining the extracting solutions obtained for 3 times, filtering by adopting a micro-nano filter, recovering ethanol in the filtrate, and simultaneously obtaining an extractum-shaped traditional Chinese medicine extract.
(2) Adding 75 parts of water into 10 parts of tragacanth, and fully swelling the tragacanth under the condition of a constant-temperature water bath at 40 ℃; adding 6 parts of sodium polyacrylate into 75 parts of water, and fully swelling the sodium polyacrylate under the condition of a constant-temperature water bath at 40 ℃; uniformly mixing the swollen tragacanth and sodium polyacrylate to obtain a phase A; adding 5 parts of polyethylene glycol and 2 parts of kaolin into 19 parts of water, and uniformly stirring and mixing to obtain a phase B; and then uniformly mixing the phase A and the phase B, adding 25 parts of glycerol, and uniformly stirring and mixing to obtain the matrix.
(3) Mixing the traditional Chinese medicine extract obtained in the step (1) and the matrix obtained in the step (2) according to a mass ratio of 1.5: 1, stirring and mixing uniformly to obtain the ointment.
(4) And (3) uniformly coating the paste obtained in the step (3) on a non-woven fabric of 5cm multiplied by 6cm multiplied by 0.3cm, then putting the non-woven fabric into a vacuum drying oven of 80 ℃, drying and activating for 1h, taking out and flattening, covering a polyethylene film on the surface of the paste layer formed on the non-woven fabric, and packaging to obtain the medicinal patch.
Example 5
(1) Weighing 2 parts of fructus evodiae, 4 parts of ginger and 1 part of radix codonopsis, mixing and crushing to obtain a powdery mixture; and then, carrying out reflux extraction on the powdery mixture for 3 times by adopting an ethanol water solution with the mass fraction of 75%, wherein the reflux extraction temperature is 75 ℃ each time, the time is 80min, combining the extracting solutions obtained for 3 times, filtering by adopting a micro-nano filter, recovering ethanol in the filtrate, and simultaneously obtaining an extractum-shaped traditional Chinese medicine extract.
(2) Adding 50 parts of water into 8 parts of tragacanth, and fully swelling the tragacanth under the condition of a constant-temperature water bath at 40 ℃; adding 50 parts of water into 3 parts of sodium polyacrylate, and fully swelling the sodium polyacrylate under the condition of a constant-temperature water bath at 40 ℃; uniformly mixing the swollen tragacanth and sodium polyacrylate to obtain a phase A; adding 3 parts of polyethylene glycol and 1 part of kaolin into 9 parts of water, and uniformly stirring and mixing to obtain a phase B; and then uniformly mixing the phase A and the phase B, adding 19 parts of glycerol, and uniformly stirring and mixing to obtain the matrix.
(3) Mixing the traditional Chinese medicine extract obtained in the step (1) and the matrix obtained in the step (2) according to a mass ratio of 2: 1, stirring and mixing uniformly to obtain the ointment.
(4) And (3) uniformly coating the paste obtained in the step (3) on a non-woven fabric of 5cm multiplied by 6cm multiplied by 0.3cm, then putting the non-woven fabric into a vacuum drying oven of 80 ℃, drying and activating for 1h, taking out and flattening, covering a polyethylene film on the surface of the paste layer formed on the non-woven fabric, and packaging to obtain the medicinal patch.
Comparative example 1
This comparative example differs from example 1 in that: the procedure of step (1) is the same as that of example 1 except that fructus evodiae is removed.
Comparative example 2
This comparative example differs from example 1 in that: the ginger is removed in the step (1), and the method is otherwise the same as the example 1.
Comparative example 3
This comparative example differs from example 1 in that: the codonopsis pilosula is removed in the step (1), and the steps are the same as those in the embodiment 1.
Comparative example 4
This comparative example differs from example 1 in that: replacing the step (1) with weighing 1 part of fructus evodiae, 2 parts of ginger and 2 parts of radix codonopsis, mixing and crushing to obtain a powdery mixture, and replacing the traditional Chinese medicine extract in the embodiment 1 with the mixture, wherein the rest is the same as the embodiment 1.
Comparative example 5
Weighing 1 part of fructus evodiae, 2 parts of ginger and 2 parts of radix codonopsis, mixing, crushing to obtain a powdery mixture, then uniformly mixing with 5 parts of water to obtain a pasty mixture, uniformly coating the pasty mixture on a non-woven fabric of 5cm multiplied by 6cm multiplied by 0.3cm, then putting the non-woven fabric into a vacuum drying oven at 70 ℃, drying and activating for 1.5h, taking out and flattening, covering an anti-sticking cover liner film polyethylene film on the surface of a paste layer formed on the non-woven fabric, and packaging to obtain the medicinal patch.
It should be noted that the aqueous ethanol solution used in the examples and comparative examples can be replaced by ethanol or water alone, tragacanth and sodium polyacrylate can be replaced by the other adhesives mentioned above, kaolin can be replaced by other fillers, and polyethylene glycol and glycerin can be replaced by other humectants, and the same technical effects can be achieved.
The patches prepared in examples 1 to 5 and comparative examples 1 to 5 were administered to a plurality of patients treated with an anti-tuberculosis drug as subjects, respectively, and the patches prepared in each example and each comparative example were administered to three subjects, respectively. The application method comprises respectively applying the medicinal patches to Shenque point, Zhongwan point and Zusanli point once a day for 6 h; the subjects were observed 4h, 12h, 1 day and 3 days after the start of application. The specific results are as follows:
the nausea and vomiting were alleviated after 4h, the vomiting disappeared after 12h, the nausea disappeared after 1 day, and the appetite was recovered after 3 days in the subjects who used the patches of examples 1-5. Unlike examples 1 to 5, the nausea and vomiting were hardly relieved after 3 days in the subjects using the patches of comparative examples 1 to 3, and were slightly relieved after 3 days in the subjects using the patches of comparative examples 4 to 5, so that the overall effect was significantly inferior to that of examples 1 to 5.
Several specific clinical cases are given below:
case 1: for male, 55 years old, frequent nausea, vomiting, sour and smelly vomit, poor appetite, lassitude, white and greasy tongue coating and soft and slow pulse appear after taking antitubercular drugs for 2 days. The medicinal plaster is applied to the Shenque point, the Zhongwan point and the Zusanli point, nausea and vomiting are relieved after 4 hours of application, and the vomiting disappears after 12 hours; the appetite was restored after 2 days by continuing application of the patch of the present invention.
Case 2: the female is 17 years old in a certain period, after taking the antituberculosis drug for 2 hours, the nausea is obvious, no vomiting is caused, the oily fishy smell and the nausea are obvious, only a small amount of porridge can be eaten, the tongue is light red, the coating is thin and white, and the pulse is thin and thready. The medicinal plaster is applied to the Shenque point, the Zhongwan point and the Zusanli point, the nausea is relieved after the medicinal plaster is applied for 4 hours, the medicinal plaster can be eaten with rice, and the nausea disappears after 12 hours. The application of the patch of the invention is continued, and the appetite is recovered after 3 days.
Finally, it should be noted that: the above embodiments are only used to illustrate the technical solution of the present invention, and not to limit the same; while the invention has been described in detail and with reference to the foregoing embodiments, it will be understood by those skilled in the art that: the technical solutions described in the foregoing embodiments may still be modified, or some or all of the technical features may be equivalently replaced; and the modifications or the substitutions do not make the essence of the corresponding technical solutions depart from the scope of the technical solutions of the embodiments of the present invention.
Furthermore, those skilled in the art will appreciate that while some embodiments herein include some features included in other embodiments, rather than other features, combinations of features of different embodiments are meant to be within the scope of the invention and form different embodiments. For example, in the claims above, any of the claimed embodiments may be used in any combination. The information disclosed in this background section is only for enhancement of understanding of the general background of the invention and should not be taken as an acknowledgement or any form of suggestion that this information forms the prior art already known to a person skilled in the art.

Claims (10)

1. The traditional Chinese medicine composition is characterized by comprising the following raw materials in parts by weight: 1-2 parts of fructus evodiae, 2-4 parts of ginger and 1-2 parts of codonopsis pilosula.
2. A method for preparing a herbal extract, wherein the herbal extract is obtained by extracting the herbal composition of claim 1.
3. The method for preparing a herbal extract of claim 2, wherein the extraction is carried out with a solvent;
preferably, the solvent comprises ethanol and/or water; preferably, the solvent is 65-75% of ethanol water solution by mass;
optionally, before the extracting, the method further comprises: pulverizing the Chinese medicinal composition into powder.
4. The method for preparing a herbal extract of claim 3, wherein the extraction is performed by reflux extraction with a solvent;
preferably, the reflux extraction is performed for 2-4 times; the temperature of each reflux extraction is 68-75 ℃, and the time is 60-80 min;
optionally, filtering is further included after the extracting;
preferably, the filtration is performed by adopting a micro-nano filtration device.
5. A Chinese medicinal extract, which is characterized by being prepared by the preparation method of the Chinese medicinal extract as claimed in any one of claims 2 to 4.
6. A paste is characterized in that: comprises the traditional Chinese medicine extract of claim 5.
7. The paste of claim 6, wherein: also includes a substrate;
preferably, the mass ratio of the traditional Chinese medicine extract to the matrix is (1-2): 1;
preferably, the matrix comprises: adhesives, fillers and humectants;
preferably, in the matrix: the mass ratio of the adhesive to the filler to the humectant is (2-16): (0.5-2): (17-30);
preferably, the adhesive comprises at least one of tragacanth, gelatin, carboxymethylcellulose, sodium carboxymethylcellulose, carbomer, sodium polyacrylate, polyvinyl alcohol, and polyvinylpyrrolidone;
preferably, the filler comprises at least one of silica gel, kaolin, bentonite, and zinc oxide;
preferably, the humectant comprises at least one of glycerin, polyethylene glycol, and propylene glycol.
8. A method for preparing the paste according to claim 7, characterized in that: the method comprises the following steps: mixing the Chinese medicinal extract with the matrix to obtain the paste;
preferably, the preparation method of the matrix comprises:
mixing an adhesive and water, and swelling the adhesive at the temperature of 30-50 ℃ to obtain a phase A;
mixing part of humectant, filler and water to obtain phase B;
uniformly mixing the phase A, the phase B and the rest of the humectant;
preferably, when the phase A is prepared, the mass ratio of the adhesive to the water is (2-16): (37.5 to 150);
preferably, when the phase B is prepared, the mass ratio of part of the humectant, the filler and the water is as follows: (2-5): (0.5-2): (3.5 to 19).
9. A medicinal patch is characterized by comprising a support layer and a paste layer arranged on the support layer; the paste layer comprising the paste of any one of claims 6 to 8;
preferably, the patch further comprises a protective layer arranged on one side of the paste layer far away from the support layer;
preferably, the support layer comprises a nonwoven fabric;
preferably, the protective layer comprises a polyethylene film.
10. A method of making a patch according to claim 9, comprising:
applying the paste to the support layer and drying to obtain the paste layer;
preferably, the drying mode adopts vacuum drying;
preferably, the temperature of the vacuum drying is 70-80 ℃, and the time of the vacuum drying is 1-1.5 h;
preferably, the preparation method further comprises: and arranging a protective layer on one side of the paste layer far away from the support layer.
CN202010907937.2A 2020-09-02 2020-09-02 Traditional Chinese medicine composition, traditional Chinese medicine extract, paste and medicinal patch Pending CN111905090A (en)

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Application publication date: 20201110