阅读说明：本技术 一种防治早泄的中药粘贴膜 (Traditional Chinese medicine adhesive film for preventing and treating premature ejaculation ) 是由 张奎昌 张志年 于 2019-12-21 设计创作，主要内容包括：本发明具体公开了一种防治早泄的中药粘贴膜。本发明是通过多种中药如生晒参、大当归、细辛、公丁香、花椒、蛇床子、蟾酥、麝香酮经组分或单独提取组成的中药提取物成分与天然粘附剂和合成粘附剂配组成,制成一种含有中药成分的具有治疗或预防早泄疗效的粘贴膜,其特征包含中药提取物、粘附剂和溶媒,其质量比的含量为中药提取物2-20%,粘附剂3-30%,溶媒50-95%。本发明粘贴膜无毒、无刺激性,性质稳定,具有所需的粘着力,剥离时无疼痛感,对皮肤无损伤,安全性高,热稳定性良好,作为一种防治早泄的中药粘贴膜,具有广阔的医用前景。(The invention particularly discloses a traditional Chinese medicine adhesive film for preventing and treating premature ejaculation. The invention relates to a sticking film which is prepared by compounding traditional Chinese medicine extract components which are prepared by separately or independently extracting a plurality of traditional Chinese medicines such as sun-dried ginseng, angelica sinensis, asarum, flos caryophyllata, pepper, fructus cnidii, toad venom and muscone with a natural adhesive and a synthetic adhesive, and has the efficacy of treating or preventing premature ejaculation, and is characterized by comprising the traditional Chinese medicine extract, the adhesive and a solvent, wherein the content of the traditional Chinese medicine extract, the adhesive and the solvent in mass ratio is 2-20%, 3-30% and 50-95%. The adhesive film disclosed by the invention is non-toxic, non-irritant, stable in property, free of pain during stripping, free of damage to skin, high in safety and good in thermal stability, has a required adhesive force, is free of pain during stripping, and has a wide medical prospect when being used as a traditional Chinese medicine adhesive film for preventing and treating premature ejaculation.)

1. A traditional Chinese medicine adhesive film for preventing and treating premature ejaculation is characterized by comprising 2-20% of traditional Chinese medicine extract, 3-30% of adhesive and 50-95% of solvent by mass ratio; the traditional Chinese medicine extract is prepared from 200g of sun-dried ginseng, 300g of angelica sinensis, 150g of asarum, 150g of flos caryophyllata, 100g of pepper, 200g of hops, 10g of toad venom and 5g of musk ketone by the following method: (1) firstly, taking a toad cake, placing the toad cake in a steamer for steaming, cutting the toad cake into slices, placing the toad cake in an electric oven for baking, grinding the toad cake into fine powder of 80 meshes, then adding ethanol with the concentration of 75% V/V which is 10 times of the weight of toad cake, respectively leaching for three times, leaching for 36 hours for the first time, leaching for 24 hours for the second time and leaching for 18 hours for the third time, combining leaching solutions of the three times, and filtering to respectively obtain an ethanol leaching solution of the toad cake and toad cake for later use; (2) adding 10 times of 95% V/V ethanol into muscone, and stirring to obtain muscone ethanol solution; (3) respectively pulverizing sun-dried ginseng, angelica sinensis, asarum, flos caryophyllata, pepper and fructus cnidii into 50-60-mesh powder, mixing the powder with the venenum bufonis residue obtained in the step (1), adding 75% V/V ethanol which is 10 times of the weight of the powder, extracting for 24 hours at normal temperature, and performing solid-liquid separation to obtain ethanol extract and residue respectively for later use; (4) adding purified water with the weight 3-5 times of that of the medicinal materials into the separated medicine residue in the step (3), leaching twice at the temperature of 95-100 ℃, leaching for 25-30min by using 4-5 times of water for the first time, leaching for 15-20min by using 3-4 times of water for the second time, filtering the leaching solution, centrifuging the leaching solution by using a centrifugal filter under the condition of 3500 plus 4500r/min to remove insoluble solid matters to obtain a centrifugal liquid, and evaporating and concentrating the centrifugal liquid until the specific gravity is 1.15-1.20 to obtain a concentrated liquid; (5) recovering ethanol from the ethanol leaching liquor obtained in the step (3) to obtain concentrated solution, and then respectively and uniformly mixing the concentrated solution with the toad venom ethanol leaching liquor obtained in the step (1), the muscone ethanol liquor obtained in the step (2) and the concentrated solution obtained in the step (4); (6) and (3) putting the uniformly mixed materials in the step (5) into a vacuum drying oven, and performing vacuum drying at the temperature of 50-55 ℃ and the vacuum degree of 93.5-96.5KPa until the water content is less than 6% to obtain the traditional Chinese medicine extract.

2. A traditional Chinese medicine adhesive film for preventing and treating premature ejaculation is characterized by comprising 3-20% of traditional Chinese medicine extract, 5-30% of adhesive and 50-92% of solvent by mass ratio; the traditional Chinese medicine extract is prepared from 200g of sun-dried ginseng, 300g of angelica sinensis, 150g of asarum, 150g of flos caryophyllata, 100g of pepper, 200g of hops, 10g of toad venom and 5g of musk ketone by the following method: (1) firstly, taking a toad cake, placing the toad cake in a steamer for steaming, cutting the toad cake into slices, placing the toad cake in an electric oven for baking, grinding the toad cake into fine powder of 80 meshes, then adding ethanol with the concentration of 75% V/V which is 10 times of the weight of toad cake, respectively leaching for three times, leaching for 36 hours for the first time, leaching for 24 hours for the second time and leaching for 18 hours for the third time, combining leaching solutions of the three times, and filtering to respectively obtain an ethanol leaching solution of the toad cake and toad cake for later use; (2) adding 10 times of 95% V/V ethanol into muscone, and stirring to obtain muscone ethanol solution; (3) respectively pulverizing sun-dried ginseng, angelica sinensis, asarum, flos caryophyllata, pepper and fructus cnidii into 50-60-mesh powder, mixing the powder with the venenum bufonis residue obtained in the step (1), adding 75% V/V ethanol which is 10 times of the weight of the powder, extracting for 24 hours at normal temperature, and performing solid-liquid separation to obtain ethanol extract and residue respectively for later use; (4) adding purified water with the weight 3-5 times of that of the medicinal materials into the separated medicine residue in the step (3), leaching twice at the temperature of 95-100 ℃, leaching for 25-30min by using 4-5 times of water for the first time, leaching for 15-20min by using 3-4 times of water for the second time, filtering the leaching solution, centrifuging the leaching solution by using a centrifugal filter under the condition of 3500 plus 4500r/min to remove insoluble solid matters to obtain a centrifugal liquid, and evaporating and concentrating the centrifugal liquid until the specific gravity is 1.15-1.20 to obtain a concentrated liquid; (5) recovering ethanol from the ethanol leaching liquor obtained in the step (3) to obtain concentrated solution, and then respectively and uniformly mixing the concentrated solution with the toad venom ethanol leaching liquor obtained in the step (1), the muscone ethanol liquor obtained in the step (2) and the concentrated solution obtained in the step (4); (6) and (3) putting the uniformly mixed materials in the step (5) into a vacuum drying oven, and performing vacuum drying at the temperature of 50-55 ℃ and the vacuum degree of 93.5-96.5KPa until the water content is less than 6% to obtain the traditional Chinese medicine extract.

3. The traditional Chinese medicine adhesive film for preventing and treating premature ejaculation is characterized by comprising 5-10% of traditional Chinese medicine extract, 10-30% of adhesive and 60-85% of solvent by mass ratio; the traditional Chinese medicine extract is prepared from 200g of sun-dried ginseng, 300g of angelica sinensis, 150g of asarum, 150g of flos caryophyllata, 100g of pepper, 200g of hops, 10g of toad venom and 5g of musk ketone by the following method: (1) firstly, taking a toad cake, placing the toad cake in a steamer for steaming, cutting the toad cake into slices, placing the toad cake in an electric oven for baking, grinding the toad cake into fine powder of 80 meshes, then adding ethanol with the concentration of 75% V/V which is 10 times of the weight of toad cake, respectively leaching for three times, leaching for 36 hours for the first time, leaching for 24 hours for the second time and leaching for 18 hours for the third time, combining leaching solutions of the three times, and filtering to respectively obtain an ethanol leaching solution of the toad cake and toad cake for later use; (2) adding 10 times of 95% V/V ethanol into muscone, and stirring to obtain muscone ethanol solution; (3) respectively pulverizing sun-dried ginseng, angelica sinensis, asarum, flos caryophyllata, pepper and fructus cnidii into 50-60-mesh powder, mixing the powder with the venenum bufonis residue obtained in the step (1), adding 75% V/V ethanol which is 10 times of the weight of the powder, extracting for 24 hours at normal temperature, and performing solid-liquid separation to obtain ethanol extract and residue respectively for later use; (4) adding purified water with the weight 3-5 times of that of the medicinal materials into the separated medicine residue in the step (3), leaching twice at the temperature of 95-100 ℃, leaching for 25-30min by using 4-5 times of water for the first time, leaching for 15-20min by using 3-4 times of water for the second time, filtering the leaching solution, centrifuging the leaching solution by using a centrifugal filter under the condition of 3500 plus 4500r/min to remove insoluble solid matters to obtain a centrifugal liquid, and evaporating and concentrating the centrifugal liquid until the specific gravity is 1.15-1.20 to obtain a concentrated liquid; (5) recovering ethanol from the ethanol leaching liquor obtained in the step (3) to obtain concentrated solution, and then respectively and uniformly mixing the concentrated solution with the toad venom ethanol leaching liquor obtained in the step (1), the muscone ethanol liquor obtained in the step (2) and the concentrated solution obtained in the step (4); (6) and (3) putting the uniformly mixed materials in the step (5) into a vacuum drying oven, and performing vacuum drying at the temperature of 50-55 ℃ and the vacuum degree of 93.5-96.5KPa until the water content is less than 6% to obtain the traditional Chinese medicine extract.

4. The Chinese medicinal adhesive film for preventing and treating premature ejaculation according to claim 1, 2 or 3, wherein the adhesive is one or more of natural adhesive and/or chemical synthetic adhesive.

5. The Chinese medicinal adhesive film for preventing and treating premature ejaculation according to claim 4, wherein the natural adhesive is any one or a mixture of two or more of gelatin, pectin, acacia, tragacanth, peach gum, perilla gum, bletilla gum, xanthan gum and sodium alginate.

6. The traditional Chinese medicine adhesive film for preventing and treating premature ejaculation according to claim 4, wherein the chemical synthesis adhesive is any one of sodium carboxymethylcellulose (CMC-Na), polyvinyl 934 (CP for short), polyacrylate, hydroxypropyl methylcellulose (HPMC), hydroxyethyl methylcellulose (HEC), polyvinylpyrrolidone (PVP) and polyvinyl alcohol (PVA).

7. The Chinese medicinal adhesive film for preventing and treating premature ejaculation according to claim 6, wherein the polyvinyl alcohol (PVA) is any one of PVA204C, PVA205C, PVA217C, PVA220C and PVA 224C.

8. The Chinese medicinal adhesive film for preventing and treating premature ejaculation according to claim 1, 2 or 3, wherein the solvent is purified water, ethanol, a single solvent in methanol or a mixed organic solvent prepared from dichloromethane and methanol in a weight ratio of 1: 1; the ethanol is ethanol with the concentration of 95 percent V/V.

9. The Chinese medicinal adhesive film for preventing and treating premature ejaculation according to claim 8, wherein the purified aqueous solution medium further comprises a plasticizer in a proportion of 0-20% by mass; the plasticizer is any one of polyethylene glycol, propylene glycol, butanediol, glycerol, maltitol, mannitol, sorbitol and xylitol; the polyethylene glycol is one or a mixture of two or more of polyethylene glycol 300, polyethylene glycol 400 or polyethylene glycol 600.

10. The Chinese medicinal adhesive film for preventing and treating premature ejaculation according to claim 8, wherein the methanol, ethanol or mixed organic solvent further comprises a plasticizer in a proportion of 0-10% by mass; the plasticizer is any one of castor oil, diethyl phthalate, diethyl citrate, ethyl sebacate, acetyl monoglyceride, ethyl oleate, glycerol diacetate, succinate and ethyl acetate.

Technical Field

The invention belongs to the field of Chinese herbal medicine preparations, and relates to a mucosa patch. The invention relates to a mucosa adhesive agent, in particular to an adhesive film containing Chinese herbal medicine components, which is a preparation prepared by processing a medicament and a proper biological adhesive agent. In particular to a traditional Chinese medicine adhesive film for treating premature ejaculation.

Background

The mucosa adhesive is a novel preparation based on the theory of biological adhesion. According to the requirements of clinical application, the mucosa sticking agent is made into the dosage forms of stick, powder, ointment, tablet, film agent, etc., and has a plurality of varieties in clinical medical application, but relates to a sticking film containing Chinese herbal medicine components. In particular to a traditional Chinese medicine adhesive film for treating or preventing premature ejaculation, which is not reported in literature data at present.

Chinese patent 200410038933.6 specifically discloses a patch for treating premature ejaculation, which is technically characterized by a band body having: a tape zone; a circular drug region; a medicated belt comprises round medicated pad and non-adhesive region, wherein the medicated region is prepared by grinding Gypsum Fibrosum, Mirabilitum crystallina, Galla chinensis, and Borneolum Syntheticum into 100-200 mesh fine powder, mixing with appropriate amount of flour and boiling water, and placing into round medicated region of premature ejaculation patch. There is a great inconvenience in use.

Premature ejaculation is one of the diseases of male sexual disorder. With the acceleration of modern life rhythm and the increase of working pressure, the incidence rate of the disease is on the rising trend year by year, the incidence rate accounts for about 35-50% of adult men, and the disease becomes one of the most common diseases in clinical diagnosis and treatment of urological men all over the world. Premature ejaculation belongs to orgasm disorder and ejaculation disorder, and the main clinical manifestation is that ejaculation is too fast, which is manifested as 'no-crossing and leakage' or 'at first sight crossing and leakage' which is manifested by that the penis is not inserted into the vagina after erection or the penis is inserted into the vagina during intercourse and ejaculation is performed before orgasm arrives, then the penis becomes soft and can not complete normal intercourse, or the penis is erected normally, but the penis is not inserted into the vagina or the ejaculation is performed within less than 2 minutes after the penis enters the vagina. The clinical diagnosis standard of premature ejaculation is divided into severe, moderate and mild according to the standard set by the third Chinese andropathy meeting in China, namely (1) the penis erects normally, but the penis does not enter the vagina, namely the semen excreting person is severe; (2) the penis erects normally, but the penis is moderate when less than 1 point of the penis enters the vagina, namely the penis is discharged; (3) the penis erects normally, but the penis is slightly discharged after less than 2 minutes of entering the vagina. The premature ejaculation is accompanied by mental depression, dizziness, mental fatigue, lassitude, insomnia and other disease states, which affect work, are not beneficial to male fertility and the like, and the long-term treatment failure can not only aggravate the disease condition, but also cause couple relationship rupture. The clinical report data on the treatment of premature ejaculation is less, doctors in all generations have few monographs on the treatment, Chinese patent application is less in the preparation of drugs for treating premature ejaculation, and the Chinese patent application is also the only Chinese herbal medicine oral preparation in few patent application documents, such as powder, pills, wine and the like. Therefore, the search for various clinically effective methods and medicines is also very important for improving the clinical curative effect, and particularly, the method is innovative, so that the medicine is convenient for patients to use, more patients can be treated more beneficially, and the sexual harmony of the patients is satisfied. Although the prior disclosed formulas have various characteristics in the aspect of treating premature ejaculation, the patients take the medicines for a long time for a plurality of times, the burden of taking the medicines is increased for the patients, the toxic and side effects of the medicines after long-term taking are accompanied, and the beneficial effects are not satisfactory. Provides a treatment method with convenient use and reliable efficacy, which is the subject of key research on male functional diseases at present.

Disclosure of Invention

The present invention has been made to solve the above-mentioned problems occurring in the treatment, and it is an object of the present invention to provide a Chinese medicinal adhesive film which has a long retention time of a preparation at the skin site due to its biological adhesiveness, increases the tightness and persistence of the contact of a medicament with the skin, facilitates the absorption of the medicament, has a high therapeutic effect, and causes less irritation to the skin. Has good long-term storage stability and thermal stability, less irritation to skin, and convenient use and carrying.

The present inventors have earnestly studied to achieve the above object and have completed the present invention based on the following findings: the adhesive film containing Chinese medicinal components and having the effect of treating or preventing premature ejaculation is prepared by matching Chinese medicinal extract components, a natural adhesive and a synthetic adhesive, which are prepared by combining or independently extracting a plurality of Chinese medicinal herbs, has no physical irritation such as fine hair or skin traction during stripping, has no skin injury, and can obtain excellent long-term stability.

In order to achieve the purpose, the invention adopts the following technical scheme. The traditional Chinese medicine adhesive film for treating premature ejaculation is characterized by comprising 2-20% of traditional Chinese medicine extract, 3-30% of adhesive and 50-95% of solvent by mass.

The traditional Chinese medicine extract is prepared from 200g of sun-dried ginseng, 300g of angelica sinensis, 150g of asarum, 150g of flos caryophyllata, 100g of pepper, 200g of hops, 10g of toad venom and 5g of musk ketone by the following method: (1) firstly, taking a toad cake, placing the toad cake in a steamer for steaming, cutting the toad cake into slices, placing the toad cake in an electric oven for baking, grinding the toad cake into fine powder of 80 meshes, then adding ethanol with the concentration of 75% V/V which is 10 times of the weight of toad cake, respectively leaching for three times, leaching for 36 hours for the first time, leaching for 24 hours for the second time and leaching for 18 hours for the third time, combining leaching solutions of the three times, and filtering to respectively obtain an ethanol leaching solution of the toad cake and toad cake for later use; (2) adding 10 times of 95% V/V ethanol into muscone, and stirring to obtain muscone ethanol solution; (3) respectively pulverizing sun-dried ginseng, angelica sinensis, asarum, flos caryophyllata, pepper and fructus cnidii into 50-60-mesh powder, mixing the powder with the venenum bufonis residue obtained in the step (1), adding 75% V/V ethanol which is 10 times of the weight of the powder, extracting for 24 hours at normal temperature, and performing solid-liquid separation to obtain ethanol extract and residue respectively for later use; (4) adding purified water with the weight 3-5 times of that of the medicinal materials into the separated medicine residue in the step (3), leaching twice at the temperature of 95-100 ℃, leaching for 25-30min by using 4-5 times of water for the first time, leaching for 15-20min by using 3-4 times of water for the second time, filtering the leaching solution, centrifuging the leaching solution by using a centrifugal filter under the condition of 3500 plus 4500r/min to remove insoluble solid matters to obtain a centrifugal liquid, and evaporating and concentrating the centrifugal liquid until the specific gravity is 1.15-1.20 to obtain a concentrated liquid; (5) recovering ethanol from the ethanol leaching liquor obtained in the step (3) to obtain concentrated solution, and then respectively and uniformly mixing the concentrated solution with the toad venom ethanol leaching liquor obtained in the step (1), the muscone ethanol liquor obtained in the step (2) and the concentrated solution obtained in the step (4); (6) and (3) putting the uniformly mixed materials in the step (5) into a vacuum drying oven, and performing vacuum drying at the temperature of 50-55 ℃ and the vacuum degree of 93.5-96.5KPa until the water content is less than 6% to obtain the traditional Chinese medicine extract.

Wherein the adhesive is one or more of natural adhesive and/or chemical synthetic adhesive.

The natural adhesive is any one or mixture of two or more of gelatin, pectin, acacia, tragacanth, peach gum, perilla gum, bletilla gum, xanthan gum and sodium alginate.

The synthetic adhesive is any one of sodium carboxymethylcellulose (CMC-Na), polyhydroxyethylene 934 (CP for short), polyacrylate, hydroxypropyl methylcellulose (HPMC), hydroxyethyl methylcellulose (HEC), polyvinylpyrrolidone (PVP) and polyvinyl alcohol (PVA).

The traditional Chinese medicine adhesive film is used by directly contacting with a body, and considering the selection and application of PVA, the formed film is harmless and nonirritating to the skin due to the use of high-purity products, and any one of PVA204C, PVA205C, PVA217C, PVA220C and PVA224C is preferably used in the invention.

Whether the bioadhesive is properly selected or not has a great influence on the formulation formation and quality thereof. Of course, the practice or test selection is very important, if the selection is proper, the traditional Chinese medicine extract is uniform in the biological adhesive, the material is easy to form, the prepared dosage form has strong mucosa adhesive force, and the medicine is easy to release. If the material of the drug is not properly selected, the drug is not easy to form, and the prepared mucosa adhesive force is not enough or too strong, and the release of the drug on the mucosa is influenced, which is not desirable in the invention.

The adhesive force of the Chinese medicinal adhesive plaster can be mainly controlled by controlling the composition.

The forming of the traditional Chinese medicine pasting film preparation needs beneficial solvent to promote completion, and specifically, single solvent of purified water, ethanol and methanol can be effectively selected according to actually selected adhesive and different proportion or proportion of the adhesive, or composite organic solvent can be selected, such as mixed solvent prepared from dichloromethane and methanol according to the ratio of 1:1, and the like. Wherein the concentration of ethanol is 95% V/V.

In order to maintain the size of the prepared adhesive film dosage form and make the film dosage form have better flexibility at room temperature, the plasticizer is usually considered to be selected to enhance the effect.

When water is selected as a solvent in the preparation of the adhesive film, any one of polyethylene glycol, propylene glycol, butanediol, glycerol, maltitol, mannitol, sorbitol and xylitol can be selected according to actual needs, and the selected dosage is 0-20% of the total mass of the formula.

The polyethylene glycol is one or a mixture of two or more of polyethylene glycol 300, polyethylene glycol 400 or polyethylene glycol 600.

When organic solvents such as ethanol or methanol are selected as solvents in the preparation of the adhesive film, any one of castor oil, diethyl phthalate, diethyl citrate, ethyl sebacate, acetyl monoglyceride, ethyl oleate, glycerol diacetate, succinate and ethyl acetate can be selected according to actual needs, and the selected dosage is 0-10% of the total mass of the formula.

Of course, depending on the choice of bioadhesive and solvent, the use of a plasticizer may not be chosen.

The traditional Chinese medicine adhesive film is prepared according to the proportion of traditional Chinese medicine extracts and biological adhesives, wherein the extraction quality and proportion content of the traditional Chinese medicine extracts are related to the using effect of the traditional Chinese medicine extracts. The selection and dosage of the adhesive is also a critical component in maintaining the stability and effectiveness of the adhesive film. The preferred mass ratio of the traditional Chinese medicine extract, the adhesive and the solvent is 3-20%, 5-30% and 50-92%. More preferably, the mass ratio of the traditional Chinese medicine extract to the adhesive to the solvent is 5-10%, 10-30% and 60-85%.

Whether the adhesive is properly selected or not has great influence on the formation of the preparation and the quality of the preparation. If the selection is proper, the medicine is dissolved in the biological adhesive uniformly, the material is easy to form, the prepared preparation has strong adhesive force, and the medicine is easy to release. If the materials are improperly selected, the materials of the medicine are not easy to form, and the adhesion of the preparation is not enough or too strong, which influences the percutaneous release of the medicine.

The sodium carboxymethyl cellulose (CMC-Na) selected by the invention is white powder or fine granules, and has no odor and no taste. The mucosa has the strongest adhesive force and hygroscopicity, is hydrophilic colloid, and the aqueous solution is sticky and insoluble in common organic solvents. The 1% aqueous solution has a pH of 6-8, and the adhesion decreases when the pH is below 5 or above 10. Is stable to light and heat, non-toxic and non-irritant, and is a common mucosa adhesive; polyhydroxyethylene 934 (carbopol, CP for short), colorless or white-like fine particles, odorless, tasteless, non-toxic, and non-irritating. The water-swelling property is good, the adhesive force of the mucous membrane is strong, and the stability to light and heat is good; the polyacrylate is a polymer formed by loose crosslinking of diethylene glycol (3, 4-dihydroxy-1, 5-ethylene) and polyacrylic acid, is granular, stable in property, non-toxic, insoluble in water and common organic solvents, but can be expanded into viscous liquid, and has strong adhesive force; hydroxyethyl cellulose (HEC for short) is nonionic cellulose ether, is nontoxic and odorless, is easily dissolved in cold water and hot water, is insoluble in most organic solvents, has thickening, adhering, emulsifying, dispersing, suspending and other effects in the preparation, and can be used for preparing solutions with different viscosity ranges; hydroxypropyl cellulose (HPC for short) has strong hygroscopicity, can be dissolved into viscous liquid in water, methanol and ethanol, and has strong adhesion; hydroxypropyl methylcellulose (HPMC for short) is white fibrous or granular powder, swells into clear or slightly turbid viscous colloidal solution in water, is used as an adhesive and a thickening agent on a preparation, and is a common material for slow-release mucosa adhesive preparations; in order to improve the rapid penetration and absorption of the adhesive film, HPMC is not selected in the formula, and in order to improve the penetration and absorption of the medicinal components in the formula, a transdermal enhancer with the mass ratio of 0-5% can be selected. However, when considering the insufficient transdermal acceleration, it is considered to use one or a mixture of two of laurocapram, dimethyl sulfoxide, menthol, camphor, limonene, citric oil, peppermint oil, eucalyptus oil, dimethylformamide and dimethylacetamide as the transdermal acceleration agent, which can satisfy the needs of patients in a short time, in general, the product can be made without considering the addition of a transdermal enhancer, which is usually 0-5% by mass, when 0% does not exhibit the purpose of enhancing the drug effect, an amount range of less than 5% by mass, particularly one or two of the aforementioned accelerator complexes is sufficient in effect, while more than 5% is not preferable, since their penetration-promoting effects tend not to increase with increasing concentration, the penetration-promoting effect on the drugs is maximized at a concentration of 3% of laurone if a vehicle such as propylene glycol, ethanol, etc. is selected in the formulation.

The Chinese medicinal adhesive film prepared by the invention can be cut into required sizes, and can be stored in a sealed plastic bag and then is pasted when in use.

If the prepared medicament is coated on a backing material, a polyester nonwoven fabric can be selected because it feels good to the touch and use, and it is preferable to coat the medicament on an ethylcellulose film backing material in view of its better therapeutic effect. In addition, the thickness of the coating layer is preferably 0.3-1.5 mm.

Hereinafter, the method for preparing the Chinese medicinal adhesive film according to the present invention will be further described.

Dissolving one or two kinds of natural or synthetic biological adhesive agent in purified water, stirring, optionally adding plasticizer and transdermal penetrating agent, stirring, adding Chinese medicinal extract, stirring, dissolving, standing, removing bubbles, directly spreading the obtained mixture on glass plate, drying at 150 deg.C to obtain film containing Chinese medicinal extract, cutting into suitable size, and sealing in plastic bag for storage. Alternatively, the mixed product may be cast on a peelable cover at a time and then transferred under pressure to cover the support. The releasable cover may suitably be selected from release paper, cellophane or release treated polyethylene, polypropylene, polyester film.

According to the invention, if the organic solvent is selected, the traditional Chinese medicine extract can be dissolved in the organic solvent and stirred uniformly, then the biological adhesive fine powder is added, dissolved, stirred uniformly and kept still for defoaming, the prepared mixed product is directly coated on a glass plate according to a conventional method, so that the solvent is slowly evaporated, finally, the film agent with the solvent volatilized completely is placed at 50 ℃ for drying for 24-30 hours, then is cut into proper size and sealed in a plastic bag for storage, according to the invention, the prepared mixture is coated on a back lining material, so that the application convenience and/or better application effect can be achieved, and a polyester non-woven fabric or an ethyl cellulose film can be selected. Preferably, ethyl cellulose films are used.

The compounding order of the raw materials, the pharmaceutical ingredients and other ingredients in the above preparation method is merely an example, and the present invention is not limited to such a compounding order.

The prepared adhesive film can be selected according to the actual application requirements, such as different specifications of 1.5 × 3cm, 2 × 2cm, 1.5 × 1.5cm, 1.5 × 2cm, 2 × 3cm and the like. The sticking film for preventing and treating premature ejaculation of the invention is mainly used for being externally stuck on acupuncture points such as perineum acupuncture point, Shenque acupuncture point, Guanyuan acupuncture point and Shenshu acupuncture point. The medicine curative effect is exerted by percutaneous absorption, the cutting size is determined according to the range of acupuncture points, the purpose of medicine absorption by the acupuncture points is difficult to achieve if the size is too small, and waste is not desirable if the size is too large. The size specification of 2 x 3cm is used as a special treatment part for sticking, and if the sticking film is vertically stuck to the cavernous part of the penis, the treatment effect is better.

The mass ratios according to the present invention are all "%" ratios unless otherwise specified.

The traditional Chinese medicine adhesive film for preventing and treating premature ejaculation has the advantages of percutaneous absorption, circulation of qi, blood and body fluid, abundant circulation of qi, blood and body fluid, weakened nerve reflection, increased ejaculation threshold value and prolonged ejaculation time, and achieves the harmonious sexual life satisfaction and plays a certain treatment role. In practical application, the sticking film is only used by a patient to be pasted on perineum, Shenque, Guanyuan and Shenshu acupuncture points, the specific usage is that the sticking film is pasted on the perineum acupuncture point, Shenque acupuncture point, Guanyuan acupuncture point and Shenshu acupuncture point 1 time a day, the sticking film can be uncovered after 6 hours, the effective rate of the method for treating premature ejaculation patients is more than 98 percent after one week, and the cure rate is more than 80 percent. The adhesive film with the specification of 2 multiplied by 3cm is adhered to the cavernous body of the penis 3 to 4 hours before sexual life and is torn off when a user walks into a room, so that the effect of eliminating premature ejaculation is achieved.

The adhesive film has the advantages of no toxicity, no irritation, stable property, no adverse effect of drug administration through digestive tracts, good adhesive property, required adhesive force, no pain during stripping, no damage to skin, high safety and good thermal stability, is used as a traditional Chinese medicine adhesive film for preventing and treating premature ejaculation, has simple preparation process, controllable operation and convenient use, is a novel prevention and treatment method, has wide medical prospect, and is extremely useful in industrial manufacturing industry.

Detailed Description

The following further describes the embodiments of the present invention, but the traditional Chinese medicine patch for preventing and treating premature ejaculation according to the present invention is not always limited to the following formulation, i.e., not all of the present invention.