CN113384561B - Allergy-free dysmenorrhea patch and preparation method thereof - Google Patents

Allergy-free dysmenorrhea patch and preparation method thereof Download PDF

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Publication number
CN113384561B
CN113384561B CN202110916397.9A CN202110916397A CN113384561B CN 113384561 B CN113384561 B CN 113384561B CN 202110916397 A CN202110916397 A CN 202110916397A CN 113384561 B CN113384561 B CN 113384561B
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parts
mass
dysmenorrhea
water
drying
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CN113384561A (en
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孟伟青
张继广
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Shouguang Traditional Chinese Medicine Hospital
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Shouguang Traditional Chinese Medicine Hospital
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    • 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
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/12Ketones
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    • A61K31/125Camphor; Nuclear substituted derivatives thereof
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    • A61K31/185Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
    • A61K31/19Carboxylic acids, e.g. valproic acid
    • A61K31/195Carboxylic acids, e.g. valproic acid having an amino group
    • A61K31/196Carboxylic acids, e.g. valproic acid having an amino group the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
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Abstract

The invention relates to the technical field of medical supplies, and provides an anti-allergic dysmenorrheal patch and a preparation method thereof. The anti-allergic dysmenorrheal plaster comprises a dressing layer and a base material layer, wherein the dressing layer comprises 1-2 parts by mass of a medicine for treating dysmenorrheal, 10-15 parts by mass of methyl cellulose, 2-5 parts by mass of polyvinylpyrrolidone, 2-5 parts by mass of gelatin, 1-2 parts by mass of carboxymethyl chitosan, 4-6 parts by mass of zinc-containing particles and 30-40 parts by mass of water. The anti-allergic dysmenorrheal plaster is convenient to use, can effectively treat dysmenorrheal symptoms, eliminates or relieves the pain of patients, and has good treatment effect and high cure rate; meanwhile, the coating has good air permeability and can effectively prevent allergic symptoms.

Description

Allergy-free dysmenorrhea patch and preparation method thereof
Technical Field
The invention relates to the technical field of medical supplies, in particular to an anti-allergic dysmenorrheal patch and a preparation method thereof.
Background
Dysmenorrhea is one of the most common gynecological symptoms, and refers to the condition of abdominal pain occurring in women during menstrual period. Dysmenorrhea is classified into primary dysmenorrhea and secondary dysmenorrhea. Primary dysmenorrhea refers to dysmenorrhea in which no organic lesions appear in female reproductive organs, and is mainly related to the increase of endometrial prostaglandin, vasopressin, endogenous oxytocin, beta-endorphin and other substances during menstruation, and is common in puberty, usually attacks within 1-2 years after incipient wetness, accompanied by regular attacks of menstrual cycles, and lower abdominal pain is taken as a main symptom. Secondary dysmenorrhea is dysmenorrhea caused by pelvic organic diseases such as endometriosis, adenomyosis and the like, and has basically the same symptoms as primary dysmenorrhea, wherein secondary dysmenorrhea caused by endometriosis is usually progressively aggravated.
Women with dysmenorrhea symptoms can have lower abdomen or waist pain, even pain and lumbosacral pain during and before menstrual period, severe patients can have symptoms of nausea, vomiting, cold sweat, cold hands and feet and the like, even faint, and great troubles are brought to work and daily life, so that effective means are required to be actively adopted for treatment.
The existing methods for treating dysmenorrhea can solve the focus of dysmenorrhea caused by pelvic organic diseases by means of operations and the like, and can also adopt methods such as oral analgesics, oral traditional Chinese medicine preparations for treating dysmenorrhea, external patches for treating dysmenorrhea and the like. Compared with oral administration, the external patch has the advantages of convenient use, small side effect and the like, and is popular with patients with dysmenorrhea. However, the existing external patch for treating dysmenorrhea has the problems of unsatisfactory effect on treating dysmenorrhea, easy allergy at the application position and the like. Therefore, it is necessary to develop a patch for treating dysmenorrhea, which has good effect of treating dysmenorrhea, good air permeability and is not easy to cause allergy.
Disclosure of Invention
The invention aims to provide an allergy-free dysmenorrhea patch, and aims to solve the technical problems that an external patch for treating dysmenorrhea in the prior art is easy to cause allergy and is not ideal in treatment effect.
In order to achieve the purpose, the invention adopts the technical scheme that:
on one hand, the invention provides an anti-allergic dysmenorrheal patch which comprises a dressing layer and a substrate layer, wherein the dressing layer comprises the following components in parts by weight:
medicine for treating dysmenorrhea 1-2
10-15 parts of methyl cellulose
Polyvinylpyrrolidone 2-5
Gelatin 2-5
Carboxymethyl chitosan 1-2
Zinc containing particles 4-6
30-40 parts of water;
the zinc-containing particles are prepared by the following preparation method:
adding 1-2 parts by mass of chitin short fibers into 2-3 parts by mass of 40-60w% polyethylene glycol aqueous solution, and uniformly stirring; adding 3-4 parts by mass of zinc oxide, and uniformly stirring; oven drying, and pulverizing.
In order to improve the anti-allergic effect, the anti-allergic dysmenorrheal patch provided by the invention has the advantages that firstly, the raw materials of the dressing layer are all components which are not easy to cause skin allergy, and secondly, zinc-containing particles capable of improving the anti-allergic effect are added. On one hand, the zinc oxide in the zinc-containing particles has the effects of protecting and repairing the skin, on the other hand, the zinc oxide in the zinc-containing particles and the chitin short fibers form pores in the zinc-containing particles under the adhesion action of the polyethylene glycol, and the zinc-containing particles with the pores are added into the dressing layer, so that the air permeability of the dysmenorrhea patch is improved. The reason why the patch product is prone to cause skin allergy is that the air permeability of the patch product is poor, so that the air permeability of the patch product is improved, the use comfort of a patient can be improved, and skin allergy symptoms can be prevented and improved.
In the invention, the base material layer can be prepared from gauze, non-woven fabric and other materials with good air permeability. The medicine for treating dysmenorrhea can be selected from analgesic suitable for skin absorption, Chinese medicinal preparation with dysmenorrhea treating effect, etc. The molecular weight of the polyethylene glycol used for preparing the zinc-containing particles is preferably 2000-.
Further, the dressing layer also comprises 0.2-0.5 part by mass of fibroin peptide and 0.1-0.3 part by mass of ceruloplasmin. The combination of the fibroin peptide and the ceruloplasmin can effectively prevent and improve the allergic symptoms of the skin.
Further, the medicine for treating dysmenorrhea comprises the following components in parts by mass: 20-30 parts of diclofenac and traditional Chinese medicine components, wherein the traditional Chinese medicine components are mainly prepared from the following components in parts by mass:
motherwort 50-60
White peony root 25-35
Achyranthes root 15-20
Garden balsam stem 40-50
Rhizoma corydalis 20-30
Oletum Trogopterori 10-18
30-40 parts of eucommia bark
Camphor 1.5-3.
Wherein the content of the first and second substances,
motherwort: is fresh or dried aerial part of Leonurus japonicus Houtt. of Labiatae. Harvesting fresh products from a spring seedling stage to an early summer flower stage; collecting the dried product in summer when stem and leaf flourish, flower do not bloom or bloom, sun-drying, or cutting and sun-drying. Has effects in promoting blood circulation, regulating menstruation, promoting urination, relieving swelling, and clearing away heat and toxic materials. Can be used for treating menoxenia, dysmenorrhea, amenorrhea, lochiorrhea, edema, oliguria, pyocutaneous disease, and toxic swelling.
White peony root: is dried root of Paeonia lactiflora pall of Ranunculaceae. Collected in summer and autumn, cleaned, removed head, tail and fine root, boiled in boiling water, peeled or boiled again, and dried in the sun. Has effects in nourishing blood, regulating menstruation, astringing yin, arresting sweating, softening liver, relieving pain, and suppressing liver yang. Can be used for treating blood deficiency, sallow complexion, menoxenia, spontaneous perspiration, night sweat, hypochondriac pain, abdominal pain, limb spasm pain, headache, and vertigo.
Achyranthes root: is dried root of Achyranthus bidentis Bl. belonging to Amaranthaceae. Digging when stem and leaf wither in winter, removing fibrous root and silt, bundling into small bundle, drying in the sun, cutting the top end, and drying in the sun. Has effects in dispelling blood stasis, dredging channels, nourishing liver and kidney, strengthening tendons and bones, inducing diuresis, treating stranguria, and promoting blood circulation. Can be used for treating amenorrhea, dysmenorrhea, soreness of waist and knees, myasthenia of tendons and bones, stranguria, edema, headache, vertigo, toothache, skin ulcer, hematemesis, and epistaxis.
Garden balsam stem: is whole plant of Speranskia turbinata (Bunge) Baill. Has effects in expelling pathogenic wind, removing dampness, relaxing muscles and tendons, promoting blood circulation, dispelling blood stasis, relieving swelling, removing toxic materials, and relieving pain. Can be used for treating rheumatalgia, contracture of tendons and bones, cold-dampness loempe, waist sprain, paralysis, amenorrhea, eczema of scrotum, skin ulcer, furuncle, and pyogenic infections.
Rhizoma corydalis: is dried tuber of corydalis tuber of Papaveraceae. Collected in early summer when stem and leaf withered, removed fibrous root, cleaned, boiled in boiling water until no white heart appears, taken out and dried in the sun. Has effects in promoting blood circulation, activating qi-flowing, and relieving pain. Can be used for treating chest and hypochondrium, abdominal pain, thoracic obstruction, cardialgia, amenorrhea, dysmenorrhea, puerperal stagnation, and traumatic injury with swelling and pain.
Trogopterus dung: is dry feces of petiolus Citri Junoris and squirrel of the family Pteromyidae. Collected in the whole year, but spring and autumn are more important, and the quality of spring collected is better. After the picking, impurities such as sand stone, soil and the like are removed, and the impurities are respectively a trogopterus dung block and a trogopterus dung rice according to the shapes. Unprocessed with the effect of promoting blood circulation to alleviate pain. It can be used for treating pain due to blood and qi in heart and abdomen, amenorrhea, and puerperal pain due to blood stasis, and for treating snake, scorpion, and Scolopendra bite. Stir-baked for stopping bleeding. It can be used for treating metrorrhagia, menorrhagia, and red leucorrhea.
Eucommia ulmoides: is bark of eucommia ulmoides Oliver belonging to family Eucommiaceae. Selecting plants growing for more than 15-20 years from Qingming to summer, peeling off barks according to the size of the medicinal materials, planing off coarse barks, and drying in the sun. Placing the container in a ventilated and dry place. Has effects in nourishing liver and kidney, strengthening muscle and bone, and preventing miscarriage. Can be used for treating soreness of waist and back, weakness of feet and knees, dribbling urination, pruritus vulvae, vaginal discharge, threatened abortion, and hypertension.
Camphor: is a granular substance prepared from roots, stems, branches and leaves of Cinnamomum camphora (L.) Presl of Lauraceae and Cinnamomum by distilling and refining. Has effects in inducing resuscitation, promoting qi stagnation, removing filth, killing parasites, relieving itching, and relieving swelling and pain. Can be used for treating fever unconsciousness, sudden collapse of central aversion, eruptive distention, vomiting, diarrhea, abdominal pain, tinea pedis due to cold-dampness, scabies, intractable tinea, alopecia, chilblain, ecthyma, scald due to water and fire, traumatic injury, toothache, and acute contagious conjunctivitis due to wind-fire.
Diclofenac is a non-steroidal anti-inflammatory drug, and has anti-inflammatory, analgesic and antipyretic effects. It can be used for treating rheumatic arthritis, adhesive spondylitis, non-inflammatory arthralgia, arthritis, non-articular rheumatism, pain caused by non-articular inflammation, neuralgia, cancer pain, pain after wound, and fever caused by inflammation.
Further, the traditional Chinese medicine components are mainly prepared from the following components in parts by mass:
motherwort 55
White peony root 30
Achyranthes root 17
Caulis et folium Gaultheriae Yunnanensis 45
Rhizoma corydalis 25
Oletum Trogopterori 15
Cortex Eucommiae 35
And (3) camphor 2.
Further, the preparation method of the traditional Chinese medicine component comprises the following steps:
pulverizing herba Leonuri, radix Paeoniae alba, Achyranthis radix, caulis et folium Gaultheriae Yunnanensis, rhizoma corydalis, Oletum Trogopterori and Eucommiae cortex into Chinese medicinal powder, mixing with water, stirring, leaching, filtering leaching solution, concentrating, and drying to obtain mixed extract; pulverizing Camphora into 80-100 mesh Camphora powder; mixing the mixed extract and Camphora powder to obtain the Chinese medicinal composition.
Further, the temperature of the stirring leaching is 40-50 ℃.
Further, the traditional Chinese medicine powder and water are mixed according to the weight ratio of 1: 3-8 by mass ratio.
Further, the drying process is spray drying, the air inlet temperature is 60-75 ℃, the air outlet temperature is 40-50 ℃, and the feeding speed is 800 mL/h.
In another aspect, the present invention further provides a preparation method of the anti-allergic dysmenorrhea patch, including:
dissolving the medicine for treating dysmenorrhea in 20-30% water to obtain medicinal water solution, sequentially adding other components into the rest water, stirring, adding the medicinal water solution, stirring, ultrasonic degassing to remove air bubbles, spreading on the surface of the substrate layer to form a dressing layer, and drying to obtain the final product.
Furthermore, the drying temperature is 20-40 ℃, and the drying time is 8-15 h.
The invention has the beneficial effects that:
the anti-allergic dysmenorrheal plaster provided by the invention is convenient to use, can effectively treat dysmenorrheal symptoms, eliminates or relieves pains of patients, and has good treatment effect and high cure rate. Meanwhile, the coating has good air permeability and can effectively prevent allergic symptoms.
Detailed Description
In order to make the technical problems, technical solutions and advantageous effects to be solved by the present invention more apparent, the present invention is further described in detail below with reference to specific embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the present patent and do not limit the scope of the invention in any way.
Unless defined otherwise, technical terms used in the following examples have the same meanings as commonly understood by one of ordinary skill in the art to which the present invention belongs. The reagents used in the following examples, unless otherwise specified, are all conventional biochemical reagents; the raw materials, instruments, equipment and the like used in the following examples are either commercially available or available by existing methods; the dosage of the reagent is the dosage of the reagent in the conventional test operation if no special instruction exists; the test methods are conventional methods unless otherwise specified.
Example 1
The anti-allergic dysmenorrhea patch comprises a dressing layer and a substrate layer, wherein the substrate layer is non-woven fabric, and the dressing layer is prepared from the following components in parts by mass:
medicine for treating dysmenorrhea 1.5
Methylcellulose 12
Polyvinylpyrrolidone 3
Gelatin 4
Carboxymethyl chitosan 2
Zinc containing particles 5
Water 35;
the zinc-containing particles are prepared by the following preparation method:
adding 2 parts by mass of chitin short fibers into 2 parts by mass of 50w% polyethylene glycol aqueous solution, and uniformly stirring; adding 3 parts by mass of zinc oxide, and uniformly stirring; drying and crushing;
the medicine for treating dysmenorrhea comprises the following components in parts by mass: 25 and traditional Chinese medicine components, wherein the preparation method of the traditional Chinese medicine components comprises the following steps: pulverizing 55 parts by mass of motherwort herb, 30 parts by mass of white paeony root, 17 parts by mass of achyranthes root, 45 parts by mass of garden balsam stem, 25 parts by mass of corydalis tuber, 15 parts by mass of trogopterus dung and 35 parts by mass of eucommia bark into traditional Chinese medicine powder, mixing the traditional Chinese medicine powder with 5 times of water by mass, stirring and leaching at 45 ℃, filtering, concentrating and spray-drying the leaching liquor to obtain a mixed extract, wherein the air inlet temperature of spray-drying is 70 ℃, the air outlet temperature is 45 ℃, and the feeding speed is 750 mL/h; pulverizing 2 parts by mass of camphor into 100-mesh camphor powder; mixing the mixed extract and Camphora powder to obtain Chinese medicinal component;
the preparation method of the dysmenorrheal patch comprises the following steps:
dissolving the medicine for treating dysmenorrhea in 25% water to obtain medicine water solution; adding methylcellulose and polyvinylpyrrolidone into the rest water, stirring to dissolve completely, adding gelatin and carboxymethyl chitosan, stirring to dissolve completely, adding zinc-containing particles, stirring completely, adding medicinal water solution, stirring, ultrasonic degassing to remove air bubbles, spreading on the surface of the base material layer to form a dressing layer, drying at 25 deg.C for 12 hr, and cutting into 13cm × 10cm patch for treating dysmenorrhea.
Example 2
The anti-allergic dysmenorrhea patch comprises a dressing layer and a substrate layer, wherein the substrate layer is non-woven fabric, and the dressing layer is prepared from the following components in parts by mass:
medicine for treating dysmenorrhea 1
Methylcellulose 10
Polyvinylpyrrolidone 2
Gelatin 2
Carboxymethyl chitosan 1
Zinc containing particles 4
30 parts of water;
the zinc-containing particles are prepared by the following preparation method:
adding 1 part by mass of chitin short fibers into 2 parts by mass of 50w% polyethylene glycol aqueous solution, and uniformly stirring; adding 3 parts by mass of zinc oxide, and uniformly stirring; drying and crushing;
the medicine for treating dysmenorrhea comprises the following components in parts by mass: 25 and traditional Chinese medicine components, wherein the preparation method of the traditional Chinese medicine components comprises the following steps: crushing 50 parts by mass of motherwort herb, 25 parts by mass of white paeony root, 15 parts by mass of achyranthes root, 40 parts by mass of garden balsam stem, 20 parts by mass of corydalis tuber, 10 parts by mass of trogopterus dung and 30 parts by mass of eucommia bark into traditional Chinese medicine powder, mixing the traditional Chinese medicine powder with 3 times of water by mass, stirring and leaching at 40 ℃, filtering, concentrating and spray-drying the leaching liquor to obtain a mixed extract, wherein the air inlet temperature of spray-drying is 70 ℃, the air outlet temperature is 45 ℃, and the feeding speed is 750 mL/h; pulverizing 1.5 parts by mass of camphor into 80-mesh camphor powder; mixing the mixed extract and Camphora powder to obtain Chinese medicinal component;
the preparation method of the dysmenorrheal patch comprises the following steps:
dissolving the medicine for treating dysmenorrhea in 20% water to obtain medicine water solution; adding methylcellulose and polyvinylpyrrolidone into the rest water, stirring to dissolve completely, adding gelatin and carboxymethyl chitosan, stirring to dissolve completely, adding zinc-containing particles, stirring completely, adding medicinal water solution, stirring, ultrasonic degassing to remove air bubbles, spreading on the surface of the base material layer to form a dressing layer, drying at 25 deg.C for 12 hr, and cutting into 13cm × 10cm patch for treating dysmenorrhea.
Example 3
The anti-allergic dysmenorrhea patch comprises a dressing layer and a substrate layer, wherein the substrate layer is non-woven fabric, and the dressing layer is prepared from the following components in parts by mass:
medicine for treating dysmenorrhea 2
Methyl cellulose 15
Polyvinylpyrrolidone 5
Gelatin 5
Carboxymethyl chitosan 2
Zinc containing particles 6
Water 40;
the zinc-containing particles are prepared by the following preparation method:
adding 2 parts by mass of chitin short fibers into 3 parts by mass of 50w% polyethylene glycol aqueous solution, and uniformly stirring; adding 4 parts by mass of zinc oxide, and uniformly stirring; drying and crushing;
the medicine for treating dysmenorrhea comprises the following components in parts by mass: 25 and traditional Chinese medicine components, wherein the preparation method of the traditional Chinese medicine components comprises the following steps: pulverizing 60 parts by mass of motherwort herb, 35 parts by mass of white paeony root, 20 parts by mass of achyranthes root, 50 parts by mass of garden balsam stem, 30 parts by mass of corydalis tuber, 18 parts by mass of trogopterus dung and 40 parts by mass of eucommia bark into traditional Chinese medicine powder, mixing the traditional Chinese medicine powder with 8 times of water by mass, stirring and leaching at 50 ℃, filtering, concentrating and spray-drying the leaching liquor to obtain a mixed extract, wherein the air inlet temperature of spray-drying is 70 ℃, the air outlet temperature is 45 ℃, and the feeding speed is 750 mL/h; pulverizing 3 parts by mass of camphor into 100-mesh camphor powder; mixing the mixed extract and Camphora powder to obtain Chinese medicinal component;
the preparation method of the dysmenorrheal patch comprises the following steps:
dissolving the medicine for treating dysmenorrhea in 30% water to obtain medicine water solution; adding methylcellulose and polyvinylpyrrolidone into the rest water, stirring to dissolve completely, adding gelatin and carboxymethyl chitosan, stirring to dissolve completely, adding zinc-containing particles, stirring completely, adding medicinal water solution, stirring, ultrasonic degassing to remove air bubbles, spreading on the surface of the base material layer to form a dressing layer, drying at 25 deg.C for 12 hr, and cutting into 13cm × 10cm patch for treating dysmenorrhea.
Example 4
The anti-allergic dysmenorrhea patch comprises a dressing layer and a substrate layer, wherein the substrate layer is non-woven fabric, and the dressing layer is prepared from the following components in parts by mass:
medicine for treating dysmenorrhea 1.5
Methylcellulose 12
Polyvinylpyrrolidone 3
Gelatin 4
Carboxymethyl chitosan 2
Zinc containing particles 5
Fibroin peptide 0.3
Blue copper peptide 0.2
Water 35;
the zinc-containing particles were prepared in the same manner as in example 1;
the medicine for treating dysmenorrhea was the same as in example 1;
the preparation method of the dysmenorrheal patch comprises the following steps:
dissolving the medicine for treating dysmenorrhea in 25% water to obtain medicine water solution; adding methylcellulose and polyvinylpyrrolidone into the rest water, stirring to dissolve completely, adding gelatin and carboxymethyl chitosan, stirring to dissolve completely, adding zinc-containing particles, stirring completely, adding fibroin peptide, copper-coated peptide and medicinal water solution, stirring, ultrasonic degassing to remove air bubbles, spreading on the surface of the base material layer to form a dressing layer, drying at 25 deg.C for 12 hr, and cutting into 13cm × 10cm patch for treating dysmenorrhea.
Example 5
The anti-allergic dysmenorrhea patch comprises a dressing layer and a substrate layer, wherein the substrate layer is non-woven fabric, and the dressing layer is prepared from the following components in parts by mass:
medicine for treating dysmenorrhea 1.5
Methylcellulose 12
Polyvinylpyrrolidone 3
Gelatin 4
Carboxymethyl chitosan 2
Zinc containing particles 5
Fibroin peptide 0.2
Blue copper peptide 0.1
Water 35;
the zinc-containing particles were prepared in the same manner as in example 1;
the medicine for treating dysmenorrhea was the same as in example 1;
the preparation method of the dysmenorrheal patch comprises the following steps:
dissolving the medicine for treating dysmenorrhea in 25% water to obtain medicine water solution; adding methylcellulose and polyvinylpyrrolidone into the rest water, stirring to dissolve completely, adding gelatin and carboxymethyl chitosan, stirring to dissolve completely, adding zinc-containing particles, stirring completely, adding fibroin peptide, copper-coated peptide and medicinal water solution, stirring, ultrasonic degassing to remove air bubbles, spreading on the surface of the base material layer to form a dressing layer, drying at 25 deg.C for 12 hr, and cutting into 13cm × 10cm patch for treating dysmenorrhea.
Example 6
The anti-allergic dysmenorrhea patch comprises a dressing layer and a substrate layer, wherein the substrate layer is non-woven fabric, and the dressing layer is prepared from the following components in parts by mass:
medicine for treating dysmenorrhea 1.5
Methylcellulose 12
Polyvinylpyrrolidone 3
Gelatin 4
Carboxymethyl chitosan 2
Zinc containing particles 5
Fibroin peptide 0.5
Blue copper peptide 0.3
Water 35;
the zinc-containing particles were prepared in the same manner as in example 1;
the medicine for treating dysmenorrhea was the same as in example 1;
the preparation method of the dysmenorrheal patch comprises the following steps:
dissolving the medicine for treating dysmenorrhea in 25% water to obtain medicine water solution; adding methylcellulose and polyvinylpyrrolidone into the rest water, stirring to dissolve completely, adding gelatin and carboxymethyl chitosan, stirring to dissolve completely, adding zinc-containing particles, stirring completely, adding fibroin peptide, copper-coated peptide and medicinal water solution, stirring, ultrasonic degassing to remove air bubbles, spreading on the surface of the base material layer to form a dressing layer, drying at 25 deg.C for 12 hr, and cutting into 13cm × 10cm patch for treating dysmenorrhea.
Comparative example 1
The dysmenorrheal plaster comprises a dressing layer and a base material layer, wherein the base material layer is non-woven fabric, and the dressing layer is prepared from the following components in parts by mass:
medicine for treating dysmenorrhea 1.5
Methylcellulose 12
Polyvinylpyrrolidone 3
Gelatin 4
Carboxymethyl chitosan 2
Chitin short fiber 1.7
Polyethylene glycol 0.8
Zinc oxide 2.5
Water 35;
the medicine for treating dysmenorrhea was the same as in example 1;
the preparation method of the dysmenorrhea patch is the same as that of example 1.
Comparative example 2
The dysmenorrheal plaster comprises a dressing layer and a base material layer, wherein the base material layer is non-woven fabric, and the dressing layer is prepared from the following components in parts by mass:
medicine for treating dysmenorrhea 1.5
Methylcellulose 12
Polyvinylpyrrolidone 3
Gelatin 4
Carboxymethyl chitosan 2
Zinc containing particles 5
Blue copper peptide 0.2
Water 35;
the zinc containing particles were prepared by the same method as in example 4;
the medicine for treating dysmenorrhea was the same as in example 4;
the preparation method of the dysmenorrheal patch comprises the following steps:
dissolving the medicine for treating dysmenorrhea in 25% water to obtain medicine water solution; adding methylcellulose and polyvinylpyrrolidone into the rest water, stirring to dissolve completely, adding gelatin and carboxymethyl chitosan, stirring to dissolve completely, adding zinc-containing particles, stirring completely, adding copper peptide and medicinal water solution, stirring, ultrasonic degassing to remove air bubbles, spreading on the surface of the base material layer to form a dressing layer, drying at 25 deg.C for 12 hr, and cutting into 13cm × 10cm patch for treating dysmenorrhea.
Comparative example 3
A dysmenorrhea patch, which is different from the patch in example 1: the medicine for treating dysmenorrhea comprises the following components in parts by mass: 25 and traditional Chinese medicine components, wherein the preparation method of the traditional Chinese medicine components comprises the following steps: pulverizing 55 parts by mass of motherwort herb, 30 parts by mass of white paeony root, 17 parts by mass of achyranthes root, 45 parts by mass of garden balsam stem, 25 parts by mass of corydalis tuber, 15 parts by mass of trogopterus dung and 35 parts by mass of eucommia bark into traditional Chinese medicine powder, mixing the traditional Chinese medicine powder with 5 times of water by mass, stirring and leaching at 45 ℃, filtering, concentrating and spray-drying the leaching liquor to obtain traditional Chinese medicine components, wherein the air inlet temperature of spray-drying is 70 ℃, the air outlet temperature is 45 ℃, and the feeding speed is 750 mL/h.
Comparative example 4
A dysmenorrhea patch, which is different from the patch in example 1: the medicament for treating dysmenorrhea is a traditional Chinese medicine component, and the preparation method of the traditional Chinese medicine component comprises the following steps: pulverizing 55 parts by mass of motherwort herb, 30 parts by mass of white paeony root, 17 parts by mass of achyranthes root, 45 parts by mass of garden balsam stem, 25 parts by mass of corydalis tuber, 15 parts by mass of trogopterus dung and 35 parts by mass of eucommia bark into traditional Chinese medicine powder, mixing the traditional Chinese medicine powder with 5 times of water by mass, stirring and leaching at 45 ℃, filtering, concentrating and spray-drying the leaching liquor to obtain a mixed extract, wherein the air inlet temperature of spray-drying is 70 ℃, the air outlet temperature is 45 ℃, and the feeding speed is 750 mL/h; pulverizing 2 parts by mass of camphor into 100-mesh camphor powder; mixing the mixed extract and Camphora powder to obtain the Chinese medicinal composition.
Evaluation of permeability of dysmenorrhea patch
The anti-allergic dysmenorrhea patches of examples 1-6 and the dysmenorrhea patches of comparative examples 1-4 were tested for water vapor transmission rate. The water vapor transmission rate is detected according to a test method in a contact wound dressing test method YY/T0471.2-2004. The test results are shown in Table 1.
TABLE 1 statistical table of water vapor transmission rate test results
Figure 794110DEST_PATH_IMAGE001
As can be seen from the data of table 1, the dysmenorrhea patch provided by comparative example 1 has a significantly lower water vapor transmission rate than the other groups, is relatively less breathable, and is more likely to cause allergic symptoms to the skin.
Evaluation of therapeutic effect and antiallergic property of dysmenorrhea patch
1. Inclusion case criteria:
dysmenorrhea patients of 14-40 years old were diagnosed with the following symptoms: obvious symptoms such as abdominal pain, abdominal tenesmus and the like appear in the first 1-2 days or the menstrual period.
2. Method of treatment
The patch is applied to the lower abdomen of the patient 1 day before menstruation and during menstruation, and is replaced once a day until the menstruation is finished, wherein each menstruation is a course of treatment.
One set of experiments was: the anti-allergic dysmenorrhea patch of example 1 was used.
Two groups of experiments were performed: the anti-allergic dysmenorrhea patch of example 4 was used.
Control group: the dysmenorrhea patch of comparative example 2 was used.
Control two groups: the dysmenorrhea patch of comparative example 3 was used.
Control three groups: the dysmenorrhea patch of comparative example 4 was used.
3. Evaluation criteria
(1) Evaluation criteria for therapeutic effect of dysmenorrhea
And (3) healing: after 3 courses of treatment, the abdominal pain in menstrual period disappears, and no dysmenorrhea appears in half a year of follow-up visit.
The effect is shown: after 3 courses of treatment, the abdominal pain in menstrual period is obviously relieved, or the analgesic tablet is not needed to be taken to relieve pain during menstruation.
The method has the following advantages: after 3 courses of treatment, the abdominal pain in menstrual period is relieved, or the analgesic tablet is taken for a little to relieve pain during menstruation.
And (4) invalidation: after 3 courses of treatment, the abdominal pain in menstrual period is not improved obviously.
(2) Criteria for allergy assessment:
during or within 48h after the application, symptoms such as pruritus, red swelling, erythema, desquamation, and various rashes appear on the skin around the dysmenorrhea patch, and it is judged as allergy.
4. Analysis of efficacy
After 3 courses of treatment, the treatment effect is shown in table 2.
TABLE 2 statistical table of treatment effect
Figure 445671DEST_PATH_IMAGE003
As can be seen from the data in Table 2, the anti-allergic dysmenorrhea patch provided by the invention has a good treatment effect on dysmenorrhea symptoms, and has high cure rate and high effective rate.
In addition, the data of the test group, the test two groups, the control two groups and the control three groups are compared, so that the camphor and the diclofenac which are used as the components in the medicament for treating the dysmenorrhea have a synergistic enhancement effect when the medicament is used for treating the dysmenorrhea, and the effective rate and the cure rate of the test group and the test two groups are obviously improved compared with those of the control two groups and the control three groups.
5. Allergy status analysis
The allergy conditions of the dysmenorrhea patients in each test group and the dysmenorrhea patients in each control group in 3 treatment courses are counted, wherein 1 patient has skin allergy symptoms in 1 treatment course, and 3 patients have skin allergy symptoms in 3 treatment courses. The statistical results are shown in Table 3.
TABLE 3 allergy statistics Table
Figure 225408DEST_PATH_IMAGE005
As can be seen from the data in table 3, the allergic rate of the two groups tested is significantly lower than that of the other groups, which indicates that the anti-allergic dysmenorrhea patch provided in example 4 has better anti-allergic effect by adding fibroin peptide and ceruloplasmin.
The above description is only for the purpose of illustrating the preferred embodiments of the present invention and is not to be construed as limiting the invention, and any modifications, equivalents and improvements made within the spirit and principle of the present invention are intended to be included within the scope of the present invention.

Claims (8)

1. The allergy-free dysmenorrheal patch is characterized by comprising a dressing layer and a substrate layer, wherein the dressing layer comprises the following components in parts by mass:
medicine for treating dysmenorrhea 1-2
10-15 parts of methyl cellulose
Polyvinylpyrrolidone 2-5
Gelatin 2-5
Carboxymethyl chitosan 1-2
Zinc containing particles 4-6
30-40 parts of water;
the zinc-containing particles are prepared by the following preparation method:
adding 1-2 parts by mass of chitin short fibers into 2-3 parts by mass of 40-60w% polyethylene glycol aqueous solution, and uniformly stirring; adding 3-4 parts by mass of zinc oxide, and uniformly stirring; drying and crushing;
the dressing layer also comprises 0.2-0.5 mass part of fibroin peptide and 0.1-0.3 mass part of copper-coated peptide;
the medicine for treating dysmenorrhea comprises the following components in parts by mass: 20-30 parts of diclofenac and traditional Chinese medicine components, wherein the traditional Chinese medicine components are mainly prepared from the following components in parts by mass:
motherwort 50-60
White peony root 25-35
Achyranthes root 15-20
Garden balsam stem 40-50
Rhizoma corydalis 20-30
Oletum Trogopterori 10-18
30-40 parts of eucommia bark
Camphor 1.5-3.
2. The allergy-free dysmenorrhea patch according to claim 1, wherein the traditional Chinese medicine components are mainly prepared from the following components in parts by mass:
motherwort 55
White peony root 30
Achyranthes root 17
Caulis et folium Gaultheriae Yunnanensis 45
Rhizoma corydalis 25
Oletum Trogopterori 15
Cortex Eucommiae 35
And (3) camphor 2.
3. The allergy-free dysmenorrhea patch according to claim 2, wherein the preparation method of the traditional Chinese medicine components comprises the following steps:
pulverizing herba Leonuri, radix Paeoniae alba, Achyranthis radix, caulis et folium Gaultheriae Yunnanensis, rhizoma corydalis, Oletum Trogopterori and Eucommiae cortex into Chinese medicinal powder, mixing with water, stirring, leaching, filtering leaching solution, concentrating, and drying to obtain mixed extract; pulverizing Camphora into 80-100 mesh Camphora powder; mixing the mixed extract and Camphora powder to obtain the Chinese medicinal composition.
4. The anti-allergic dysmenorrhea patch according to claim 3, wherein the temperature of said agitation extraction is 40-50 ℃.
5. The allergy-free dysmenorrhea patch according to claim 3, wherein the ratio of the traditional Chinese medicine powder to water is 1: 3-8 by mass ratio.
6. The allergy-free dysmenorrhea patch as claimed in claim 3, wherein the drying process is spray drying, the air inlet temperature is 60-75 ℃, the air outlet temperature is 40-50 ℃, and the feeding speed is 700-800 mL/h.
7. A method for preparing the anti-allergic dysmenorrhea patch according to any one of claims 1 to 6, comprising:
dissolving the medicine for treating dysmenorrhea in 20-30% water to obtain medicinal water solution, sequentially adding other components into the rest water, stirring, adding the medicinal water solution, stirring, ultrasonic degassing to remove air bubbles, spreading on the surface of the substrate layer to form a dressing layer, and drying to obtain the final product.
8. The method according to claim 7, wherein the drying temperature is 20 to 40 ℃ and the drying time is 8 to 15 hours.
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