Navel-applied gel plaster and preparation method thereof

Abstract

The invention provides a navel paste gel plaster and a preparation method thereof. The navel paste gel plaster comprises the following components: a traditional Chinese medicine extract, a hydrophilic polymer material, a humectant, a penetration enhancer, a cross-linking agent, a pH regulator and water, the traditional Chinese medicine extract is prepared from the following raw materials: rhizoma zingiberis, alpinia katsumadai, radix aucklandiae, pericarpium citri reticulatae, fructus psoraleae, rhizoma atractylodis, fructus amomi, fructus evodiae, bighead atractylodes rhizome, poria cocos, codonopsis pilosula and schisandra chinensis. The navel gel plaster provided by the invention is transdermally administered through the Shenque acupoint, directly acts on a local part, plays the effects of warming the kidney, strengthening the spleen and strengthening the intestines to stop diarrhea, is high in pertinence, can be used for treating long-term diarrhea caused by insufficiency of kidney yang, solves the problems of sweet and sour belly, abdominal flatulence, diarrhea in the early morning, poor appetite, weak digestion, yellow complexion and cold hands and feet after continuous diarrhea, and can be used for treating the long-term diarrhea caused by insufficiency of kidney yang. The curative effect on spleen-kidney yang deficiency type chronic diarrhea is obvious.

Description

Technical Field

[0001] This invention belongs to the field of medical technology, specifically relating to an umbilical patch gel plaster and its preparation method. Background Technology

[0002] Diarrhea is a common symptom in patients with IgA nephropathy, with a significantly higher incidence rate than in healthy individuals (up to 30%). It is also prone to recurrence and is often chronic, seriously affecting patients' quality of life and prognosis.

[0003] CN105920453A discloses a traditional Chinese medicine composition for treating IgA nephropathy of spleen and kidney qi deficiency type, which is made from the following medicinal materials in the indicated weight ratios: 25 parts of Rosa laevigata root, 15 parts of Psoralea corylifolia, 20 parts of Aralia elata, 9 parts of Smilax china, 15 parts of Achyranthes bidentata, 10 parts of Clematis armandii, 20 parts of Lysimachia christinae, 15 parts of Smilax china, 10 parts of Pistachio scabra, 15 parts of Achyranthes bidentata, 8 parts of Salvia miltiorrhiza, 10 parts of Ziziphus jujuba, 8 parts of Cyperus rotundus, 20 parts of Lysimachia christinae, and 8 parts of Glycyrrhiza uralensis. This traditional Chinese medicine composition is used to treat IgA nephropathy of spleen and kidney qi deficiency type, with high efficacy, reliable curative effect, and no recurrence after recovery.

[0004] CN105816681A discloses a traditional Chinese medicine composition for treating IgA nephropathy of Qi and Yin deficiency type, which is made from the following medicinal materials in the indicated weight ratios: 10 parts of Acanthopanax senticosus, 20 parts of Cyperus rotundus, 15 parts of Caragana korshinskii root, 15 parts of Deer Herb, 15 parts of Herba Sedum, 10 parts of Herba Clematis, 20 parts of Artemisia argyi branch, 10 parts of Herba Australis, 20 parts of Herba Sedum, 15 parts of Herba Sedum, 20 parts of Herba Lysimachiae, 25 parts of Herba Euonymus fortunei, 9 parts of Herba Lysimachiae, 20 parts of Herba Gynostemma pentaphyllum, and 8 parts of Glycyrrhiza uralensis. This traditional Chinese medicine composition is used to treat IgA nephropathy of Qi and Yin deficiency type, with high efficacy, reliable curative effect, and no recurrence after recovery.

[0005] Currently, diarrhea is mostly treated with oral medications. Long-term use can lead to various adverse reactions such as peptic ulcers, liver and kidney damage, and leukopenia, and may even cause drug-induced diseases, resulting in poor treatment efficacy or treatment failure. Traditional Chinese medicine's external therapies have a long history, and "the principles of external treatment are the same as those of internal treatment." Gel patches are a new type of transdermal drug delivery preparation with advantages such as high drug loading capacity (suitable for complex Chinese medicine ingredients), good moisturizing properties, strong skin affinity, breathability and sweat resistance, low allergenicity, reusability, and convenient administration. Transdermal absorption avoids the first-pass effect in the liver, maintaining a relatively stable blood drug concentration and reducing toxic side effects.

[0006] Therefore, there is an urgent need to develop a gel patch-based drug for treating diarrhea. Summary of the Invention

[0007] To address the shortcomings of existing technologies, the present invention aims to provide an umbilical gel patch and its preparation method. The umbilical gel patch provided by the present invention has accurate dosage, is easily absorbed through the skin, has good stability, and is convenient to use. It can be used for chronic diarrhea caused by spleen and kidney yang deficiency.

[0008] To achieve this objective, the present invention adopts the following technical solution:

[0009] In a first aspect, the present invention provides an umbilical patch gel plaster, the components of which include traditional Chinese medicine extracts, hydrophilic polymer materials, moisturizers, penetration enhancers, crosslinking agents, pH adjusters, and water; the raw materials of the traditional Chinese medicine extracts include dried ginger, cardamom, costus root, tangerine peel, psoralea, atractylodes, amomum, evodia, atractylodes macrocephala, poria cocos, codonopsis, and schisandra.

[0010] The umbilical gel patch provided by this invention delivers medication transdermally through the navel (Shenque acupoint), acting directly on the local area to exert the effects of warming the kidneys and strengthening the spleen, astringing the intestines and stopping diarrhea. It is highly targeted and can be used for chronic diarrhea caused by kidney yang deficiency, resolving accompanying symptoms such as gurgling stomach, abdominal bloating, loose stools in the early morning, poor appetite and weak digestion, yellowing of the face after persistent diarrhea, and cold hands and feet. It is particularly effective for chronic diarrhea of ​​the spleen and kidney yang deficiency type (such as IgA nephropathy-related diarrhea). The umbilical gel patch acts directly on the patient's navel through transdermal absorption, thereby maintaining a relatively stable local transdermal absorption rate and blood drug concentration, achieving the effects of tonifying the kidneys, strengthening the spleen, astringing, and stopping diarrhea.

[0011] Dried ginger warms the middle jiao and dispels cold; cardamom warms the spleen and dries dampness; costus root regulates the middle jiao, promotes qi circulation, and relieves pain; poria and tangerine peel strengthen the spleen and promote diuresis; psoralea tonifies kidney fire to warm the spleen; atractylodes dries dampness and strengthens the spleen; amomum villosum transforms dampness and promotes qi circulation; evodia rutaecarpa warms the spleen to dispel cold pathogens; atractylodes macrocephala and codonopsis pilosula tonify qi and strengthen the spleen; and schisandra chinensis enhances astringent and consolidating effects. The combined effects of these herbs warm the middle jiao, strengthen the spleen, and astringe to stop diarrhea, consistent with the pathological mechanism of chronic diarrhea. They possess excellent effects in warming the middle jiao, tonifying the kidneys, strengthening the spleen, drying dampness, and stopping diarrhea, exerting anti-inflammatory, antidiarrheal, intestinal mucosal protective, intestinal flora regulating, and intestinal local immunity-enhancing effects. Among them, dried ginger, cardamom, costus root, and tangerine peel have a synergistic effect, working together to warm the kidneys, strengthen the spleen, and consolidate the intestines to stop diarrhea.

[0012] Preferably, the components of the umbilical patch gel plaster, by weight percentage, include 10-25% of traditional Chinese medicine extract, 3-7% of hydrophilic polymer material, 20-35% of moisturizer, 0.5-6% of penetration enhancer, 0.05-0.25% of crosslinking agent, 0.15-0.5% of pH adjuster, and 40-70% of water.

[0013] The weight percentage of the herbal extract can be 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 23%, or 25%, etc.

[0014] The weight percentage of the hydrophilic polymer material can be 3%, 3.5%, 4%, 4.5%, 5%, 5.5%, 6%, 6.5%, or 7%, etc.

[0015] The weight percentage of the humectant can be 20%, 21%, 22%, 23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 33%, or 35%, etc.

[0016] The weight percentage of the penetration enhancer can be 0.5%, 0.7%, 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, 5%, 5.5%, or 6%, etc.

[0017] The weight percentage of the crosslinking agent can be 0.05%, 0.06%, 0.07%, 0.08%, 0.09%, 0.1%, 0.15%, 0.2%, or 0.25%, etc.

[0018] The weight percentage of the pH adjuster can be 0.15%, 0.17%, 0.2%, 0.23%, 0.25%, 0.28%, 0.3%, 0.35%, 0.4%, 0.45%, or 0.5%, etc.

[0019] The weight percentage of water can be 40%, 43%, 45%, 47%, 50%, 55%, 60%, 65%, or 70%, etc.

[0020] Other specific point values ​​within the range of the above values ​​can be selected, and will not be elaborated on here.

[0021] Preferably, the raw materials of the traditional Chinese medicine extract include, by weight, 8-15 parts dried ginger, 10-20 parts cardamom, 5-12 parts costus root, 5-12 parts dried tangerine peel, 20-40 parts psoralea, 5-12 parts atractylodes, 5-12 parts amomum, 10-20 parts evodia, 5-12 parts atractylodes macrocephala, 5-12 parts poria cocos, 8-15 parts codonopsis, and 10-20 parts schisandra.

[0022] The weight percentage of the dried ginger can be 8, 8.3, 8.5, 8.7, 9, 9.5, 10, 11, 12, 13, 14, or 15 parts, etc.

[0023] The weight parts of the cardamom can be 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 parts, etc.

[0024] The weight percentage of the costus root can be 5, 6, 7, 8, 9, 10, 11, or 12 parts, etc.

[0025] The weight percentage of the dried tangerine peel can be 5, 6, 7, 8, 9, 10, 11, or 12 parts, etc.

[0026] The weight parts of the psoralea can be 20, 22, 25, 27, 30, 33, 35, 38, or 40 parts, etc.

[0027] The weight of Atractylodes lancea can be 5, 6, 7, 8, 9, 10, 11 or 12 parts, etc.

[0028] The weight of the cardamom can be 5, 6, 7, 8, 9, 10, 11 or 12 parts, etc.

[0029] The weight parts of Evodia rutaecarpa can be 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 parts, etc.

[0030] The weight of Atractylodes macrocephala can be 5, 6, 7, 8, 9, 10, 11, or 12 parts, etc.

[0031] The weight parts of the Poria cocos can be 5, 6, 7, 8, 9, 10, 11 or 12 parts, etc.

[0032] The weight parts of the Codonopsis pilosula can be 8, 8.2, 8.5, 8.7, 9, 9.5, 10, 11, 12, 13, 14 or 15 parts, etc.

[0033] The weight of the Schisandra chinensis can be 10, 11, 12, 13, 14, 15, 16, 17, 18, 19 or 20 parts, etc.

[0034] Other specific point values ​​within the range of the above values ​​can be selected, and will not be elaborated on here.

[0035] Preferably, the herbal extract is prepared by a method comprising the following steps:

[0036] Mix all the raw materials and then decoct them with water, or decoct the raw materials separately with water and then mix them; filter and concentrate to obtain the Chinese herbal extract.

[0037] Preferably, the mass ratio of the raw material to water is 1:(6-10).

[0038] The specific point values ​​in (6-10) can be 6, 6.3, 6.5, 6.7, 7, 7.2, 7.5, 7.8, 8, 8.5, 9, 9.5 or 10, etc.

[0039] Other specific point values ​​within the range of the above values ​​can be selected, and will not be elaborated on here.

[0040] Preferably, the decoction is performed 1-3 times, for example, once, twice or three times; the decoction time for each time is 1-2 hours, for example, 1 hour, 1.1 hours, 1.2 hours, 1.3 hours, 1.4 hours, 1.5 hours, 1.6 hours, 1.7 hours, 1.8 hours, 1.9 hours or 2 hours.

[0041] Other specific point values ​​within the range of the above values ​​can be selected, and will not be elaborated on here.

[0042] Preferably, the concentration includes concentrating the filtrate to a relative density of 1-1.5, for example, 1, 1.1, 1.2, 1.3, 1.4 or 1.5.

[0043] Other specific point values ​​within the range of the above values ​​can be selected, and will not be elaborated on here.

[0044] Preferably, the concentration process further includes a drying process.

[0045] Preferably, the drying method is spray drying.

[0046] Preferably, the penetration enhancer comprises any one or a combination of at least two of the following: laurocapram, eucalyptus oil, propylene glycol monolaurate, N-methylpyrrolidone, 1,2-propanediol, peppermint oil, or oleic acid.

[0047] Preferably, the penetration enhancer includes laurocapram, eucalyptus oil, propylene glycol monolaurate, and N-methylpyrrolidone.

[0048] The preferred ingredients are laurocapram, eucalyptus oil, propylene glycol monolaurate, and N-methylpyrrolidone. These four components work synergistically to maintain a relatively stable transdermal absorption rate and blood drug concentration, allowing the drug to exert its optimal effects of tonifying the kidney, strengthening the spleen, astringing, and stopping diarrhea.

[0049] Preferably, the mass ratio of laurocapram, eucalyptus oil, propylene glycol monolaurate and N-methylpyrrolidone is (0.2-2):(0.1-2):(0.1-1):(0.1-1).

[0050] The specific point values ​​in (0.2-2) can be 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.2, 1.5, 1.7 or 2, etc.

[0051] The specific point values ​​in (0.1-2) can be 0.1, 0.2, 0.5, 0.7, 1, 1.3, 1.5, 1.8 or 2, etc.

[0052] The specific point value in the first (0.1-1) can be 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9 or 1, etc.

[0053] The specific point value in the second (0.1-1) can be 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9 or 1, etc.

[0054] Other specific point values ​​within the range of the above values ​​can be selected, and will not be elaborated on here.

[0055] Preferably, the hydrophilic polymeric material includes any one or a combination of at least two of sodium polyacrylate, carbomer, sodium carboxymethyl cellulose, polyvinyl alcohol, povidone, polyacrylic acid-sodium polyacrylate copolymer, sodium alginate, or gelatin.

[0056] Preferably, the moisturizer includes any one or a combination of at least two of glycerin, propylene glycol, polyethylene glycol, or 1,3-butanediol.

[0057] Preferably, the crosslinking agent includes any one or a combination of at least two of aluminum glycinate, aluminum glutamate, aluminum hydroxide, aluminum chloride, or calcium chloride.

[0058] Preferably, the pH adjuster comprises any one or a combination of at least two of citric acid, tartaric acid, malic acid, lactic acid, or phosphoric acid.

[0059] Preferably, the umbilical patch gel plaster further includes a filler.

[0060] Preferably, the umbilical patch gel plaster further comprises 0.1-1% filler by weight percentage, for example, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9% or 1%, etc.

[0061] Other specific point values ​​within the range of the above values ​​can be selected, and will not be elaborated on here.

[0062] Preferably, the filler comprises any one or a combination of at least two of kaolin, titanium dioxide, zinc oxide, or micronized silica gel.

[0063] Preferably, the umbilical patch gel plaster also includes a cooling agent.

[0064] Preferably, the components of the umbilical patch gel plaster further include 0.1-1% cooling agent by weight percentage, for example, 0.1%, 0.2%, 0.3%, 0.4%, 0.5%, 0.6%, 0.7%, 0.8%, 0.9% or 1%, etc.

[0065] Other specific point values ​​within the range of the above values ​​can be selected, and will not be elaborated on here.

[0066] Preferably, the cooling agent includes any one or a combination of at least two of menthol, camphor, or borneol.

[0067] Preferably, the umbilical patch gel plaster also includes preservatives.

[0068] Preferably, the umbilical patch gel plaster further includes 0.1-0.5% preservative by weight percentage, for example, 0.1%, 0.15%, 0.2%, 0.25%, 0.3%, 0.35%, 0.4%, 0.45%, or 0.5%.

[0069] Other specific point values ​​within the range of the above values ​​can be selected, and will not be elaborated on here.

[0070] Preferably, the preservative includes any one or a combination of at least two of sodium benzoate, potassium sorbate, ethylparaben, or methylparaben.

[0071] In a second aspect, the present invention provides a method for preparing the umbilical patch gel plaster as described in the first aspect, the method comprising:

[0072] (1) Mix the humectant and penetration enhancer, add the crosslinking agent and homogenize to prepare phase A;

[0073] A pH crosslinking agent and water were mixed, a hydrophilic polymer was added to swell the mixture, and then a traditional Chinese medicine extract was added for homogenization to prepare phase B.

[0074] (2) Mix phase A and phase B, homogenize them, coat them onto the backing material, dry them, and coat them with a film to obtain the umbilical patch gel plaster.

[0075] Preferably, the homogenization process in preparing phase A further includes the addition of a cooling agent.

[0076] Preferably, the mixing process in preparing phase B also includes the addition of a preservative.

[0077] Preferably, the homogenization process in the preparation of phase B further includes the addition of a filler.

[0078] Preferably, in step (2), the mixing process involves adding phase A into phase B.

[0079] Preferably, in step (2), the homogenization method is stirring.

[0080] Preferably, the stirring is carried out under vacuum conditions.

[0081] Preferably, the stirring process includes stirring at 70-90 rpm (e.g., 70 rpm, 72 rpm, 75 rpm, 77 rpm, 80 rpm, 83 rpm, 85 rpm, 88 rpm, or 90 rpm, etc.) for 10-15 minutes (e.g., 10 minutes, 10.5 minutes, 11 minutes, 11.5 minutes, 12 minutes, 12.5 minutes, 13 minutes, 13.5 minutes, 14 minutes, 14.5 minutes, or 15 minutes, etc.) and then stirring at 30-50 rpm (e.g., 30 rpm, 32 rpm, 35 rpm, 37 rpm, 40 rpm, 42 rpm, 45 rpm, 48 rpm, or 50 rpm, etc.) for 15-25 minutes (e.g., 15 minutes, 16 minutes, 17 minutes, 18 minutes, 19 minutes, 20 minutes, 21 minutes, 22 minutes, 23 minutes, 24 minutes, or 25 minutes, etc.).

[0082] Other specific point values ​​within the range of the above values ​​can be selected, and will not be elaborated on here.

[0083] Compared with the prior art, the present invention has the following beneficial effects:

[0084] The umbilical patch gel plaster provided by this invention delivers medication transdermally through the navel (Shenque acupoint), acting directly on the local area to exert the effects of warming the kidneys and strengthening the spleen, and solidifying the intestines and stopping diarrhea. It is highly targeted and can be used for chronic diarrhea caused by kidney yang deficiency, solving problems such as gurgling stomach, abdominal bloating, diarrhea in the early morning, poor appetite and weak digestion, yellowing of the face and cold hands and feet after persistent diarrhea. It has a significant effect on chronic diarrhea of ​​spleen and kidney yang deficiency type (such as diarrhea related to IgA nephropathy). Detailed Implementation

[0085] To further illustrate the technical means and effects of the present invention, the following describes the technical solution of the present invention in conjunction with preferred embodiments of the present invention. However, the present invention is not limited to the scope of the embodiments.

[0086] Where specific techniques or conditions are not specified in the examples, they shall be performed in accordance with the techniques or conditions described in the literature in this field, or in accordance with the product instructions. Reagents or instruments whose manufacturers are not specified are all conventional products that can be purchased through legitimate channels.

[0087] The sources of materials used in the following specific embodiments are as follows:

[0088] Raw material name Purchase manufacturer model Sodium polyacrylate Aladdin S108368-500ml Carbomer Aladdin C299587-500g Sodium carboxymethyl cellulose Aladdin C104986-500g Polyvinyl alcohol Aladdin P119362-250g

[0089] Preparation Example 1

[0090] This preparation example provides a traditional Chinese medicine extract, which is prepared by a method including the following steps:

[0091] By weight, 12 parts dried ginger, 15 parts cardamom, 8 parts costus root, 8 parts dried tangerine peel, 30 parts psoralea, 8 parts atractylodes, 8 parts amomum, 15 parts evodia, 8 parts atractylodes macrocephala, 8 parts poria cocos, 12 parts codonopsis, and 15 parts schisandra are mixed and decocted twice with 8 times the weight of the above ingredients, each time for 1.5 hours. The decoctions are combined, filtered, and the filtrate is concentrated to a clear extract with a relative density of 1.13 at 60°C. The extract is then spray-dried at an inlet air temperature of 170°C and an outlet air temperature of 85°C to obtain the Chinese herbal extract.

[0092] Preparation Example 2

[0093] This preparation example provides a traditional Chinese medicine extract, which is prepared by a method including the following steps:

[0094] By weight, 14 parts dried ginger, 12 parts cardamom, 7 parts costus root, 7 parts dried tangerine peel, 25 parts psoralea, 7 parts atractylodes, 9 parts amomum, 13 parts evodia, 8 parts atractylodes macrocephala, 9 parts poria cocos, 10 parts codonopsis, and 14 parts schisandra were mixed and decocted twice with 8 times the weight of the above ingredients, each time for 1.5 hours. The decoctions were combined, filtered, and the filtrate was concentrated to a clear extract with a relative density of 1.13 at 60°C. The extract was then spray-dried at an inlet air temperature of 170°C and an outlet air temperature of 85°C to obtain the Chinese herbal extract.

[0095] Comparative Preparation Example 1

[0096] This comparative preparation example provides a traditional Chinese medicine extract, which differs from Preparation Example 1 only in that: dried ginger and cardamom are not added, and their reduced amounts are proportionally allocated to costus root and dried tangerine peel, while the other raw materials and steps remain unchanged.

[0097] Comparative Preparation Example 2

[0098] This comparative preparation example provides a traditional Chinese medicine extract, which differs from Preparation Example 1 only in that: costus root and dried tangerine peel are not added, and their reduced amounts are proportionally allocated to dried ginger and cardamom, while the other raw materials and steps remain unchanged.

[0099] Comparative preparation example 3

[0100] This comparative preparation example provides a traditional Chinese medicine extract, which differs from Preparation Example 1 only in that: dried ginger is replaced with an equal amount of fresh ginger, and cardamom is replaced with an equal amount of nutmeg, while the other raw materials and steps remain unchanged.

[0101] Example 1

[0102] This embodiment provides an umbilical patch gel plaster, which comprises the following components by weight percentage:

[0103]

[0104] Its preparation method is as follows:

[0105] (1) Preparation of phase A: Mix the moisturizer and penetration enhancer, stir evenly, then add the crosslinking agent and stir until there are no visible particles; Preparation of phase B: Mix the pH crosslinking agent and water, add the hydrophilic polymer material to fully swell, then add the traditional Chinese medicine extract and stir evenly.

[0106] (2) Phase A is added to Phase B and transferred to a vacuum stirrer. The vacuum degree is set to -0.08MPa. The mixture is stirred at 80rpm for 12min and then at 40rpm for 20min to obtain a uniform and delicate paste. The paste is coated on a non-woven fabric backing with a thickness of 1.5mm. The paste is allowed to stand and dry for 10h at a temperature of 23℃ and a humidity of 60%. Then, it is covered with a PET anti-stick film, cut into 4cm×4cm sizes, and sealed in an aluminum-plastic bag to obtain the umbilical patch gel plaster.

[0107] Example 2

[0108] This embodiment provides an umbilical patch gel plaster, which comprises the following components by weight percentage:

[0109]

[0110]

[0111] Its preparation method is as follows:

[0112] (1) Preparation of phase A: Mix the moisturizer and penetration enhancer, stir evenly, then add the crosslinking agent and stir until there are no visible particles; Preparation of phase B: Mix the pH crosslinking agent and water, add the hydrophilic polymer material to fully swell, then add the traditional Chinese medicine extract and stir evenly.

[0113] (2) Phase A is added to Phase B and transferred to a vacuum stirrer. The vacuum degree is set to -0.08MPa. The mixture is stirred at 90rpm for 10min and then at 50rpm for 15min to obtain a uniform and delicate paste. The paste is coated on a non-woven fabric backing with a thickness of 1.5mm. The paste is allowed to stand and dry for 10h at a temperature of 23℃ and a humidity of 60%. Then, it is covered with a PET anti-stick film, cut into 4cm×4cm sizes, and sealed in an aluminum-plastic bag to obtain the umbilical patch gel plaster.

[0114] Example 3

[0115] This embodiment provides an umbilical patch gel plaster, which differs from Example 1 only in that: laurocapram and eucalyptus oil are not added to the penetration enhancer, and their reduced amounts are proportionally allocated to propylene glycol monolaurate and N-methylpyrrolidone, while the remaining raw materials and steps remain unchanged.

[0116] Example 4

[0117] This embodiment provides an umbilical patch gel plaster, which differs from Example 1 only in that: propylene glycol monolaurate and N-methylpyrrolidone are not added to the penetration enhancer, and their reduced amounts are proportionally allocated to laurocapram and eucalyptus oil, while the remaining raw materials and steps remain unchanged.

[0118] Comparative Examples 1-3

[0119] This comparative example provides an umbilical patch gel plaster, which differs from Example 1 only in that the "traditional Chinese medicine extract provided in Preparation Example 1" is replaced with the "traditional Chinese medicine extract provided in Comparative Preparation Examples 1-3", while the other raw materials and steps remain unchanged.

[0120] Test Example 1

[0121] (1) Patient condition: IgA nephropathy with chronic diarrhea of ​​spleen and kidney yang deficiency type;

[0122] Inclusion criteria: Renal biopsy pathological diagnosis of IgA nephropathy; history of chronic diarrhea; meeting the TCM diagnosis of spleen and kidney yang deficiency type; stable serum creatinine (fluctuation range less than 30% of baseline); signed informed consent form;

[0123] Exclusion criteria: Acute diarrhea, infectious diarrhea; currently using hormones or immunosuppressive drugs; organic lesions that cause chronic diarrhea; taking medications that easily cause intestinal flora imbalance, such as antibiotics, rhubarb, etc.; unstable renal function due to other factors (non-IgA nephropathy), such as acute kidney injury caused by gross hematuria (previous episodes are not considered as exclusion); pregnant or lactating women; patients with a history of allergy to traditional Chinese medicine, plasters, or patches; participating in other clinical studies (currently participating or participating within the previous month); or the attending physician believes that the subject is unlikely to have good adherence to the treatment plan.

[0124] (2) Treatment method: 32 patients in each group;

[0125] Experimental group: In addition to conventional Western medicine treatment, the Shenque acupoint was treated with the umbilical gel patch provided in Examples 1-4 or Comparative Examples 1-3, 1 patch / day, 8 hours each time, for 1 month, and continued to be observed for 3 months after the treatment ended;

[0126] Control group: In addition to routine Western medicine treatment, patients received oral Bifidobacterium triple live bacteria tablets, 1.5g / time, 3 times / day, for 1 month. After the treatment, patients were observed for another 3 months.

[0127] (3) Evaluation indicators: The efficacy index was calculated using the Traditional Chinese Medicine Syndrome Scoring Scale for Chronic Diarrhea (Spleen and Kidney Yang Deficiency Type) (Table 1). The efficacy index (%) = ((Total symptom score before treatment - Total symptom score after treatment) / Total symptom score before treatment) × 100%. ① Clinically cured: Significant improvement in all symptoms and signs, efficacy index ≥ 90%; ② Markedly effective: Significant improvement in symptoms and signs, 60% ≤ efficacy index < 90%; ③ Effective: Improvement in both symptoms and signs, 30% ≤ efficacy index < 60%; ④ Ineffective: No significant improvement in symptoms and signs, or even worsening, efficacy index < 30%; ⑤ Total effective rate (%) = ((Total number of cases in each group - Number of ineffective cases in each group) / Total number of cases in each group) × 100%.

[0128] Table 1

[0129]

[0130] (4) Test Results: As shown in Table 2, the umbilical patch gel plaster provided by this invention delivers medication transdermally through the umbilicus, exerting the effects of warming the kidneys and strengthening the spleen, and consolidating the intestines and stopping diarrhea. It is significantly effective for chronic diarrhea caused by spleen and kidney yang deficiency due to IgA nephropathy. Among them, dried ginger, cardamom, costus root, and tangerine peel have a synergistic effect on the above-mentioned effects. Laurozone, eucalyptus oil, propylene glycol monolaurate, and N-methylpyrrolidone act as permeation enhancers, synergistically maintaining a relatively stable transdermal absorption rate and blood drug concentration, so as to achieve the best drug efficacy.

[0131] Table 2

[0132] test group Clinically cured (cases) Significant effect (example) Valid (example) Invalid (example) Overall effectiveness (%) Example 1 7 19 4 2 93.75 Example 2 6 21 2 3 90.62 Example 3 5 15 7 5 84.37 Example 4 5 16 6 5 84.37 Comparative Example 1 4 14 8 6 81.25 Comparative Example 2 3 16 7 6 81.25 Comparative Example 3 4 13 8 7 78.12 control group 3 12 8 9 71.87

[0133] This invention illustrates a umbilical patch gel plaster and its preparation method through the above embodiments. However, this invention is not limited to the above embodiments, meaning that this invention does not necessarily rely on the above embodiments for implementation. Those skilled in the art should understand that any improvements to this invention, equivalent substitutions of the raw materials, additions of auxiliary components, and selection of specific methods, etc., all fall within the protection and disclosure scope of this invention.

[0134] The preferred embodiments of the present invention have been described in detail above. However, the present invention is not limited to the specific details in the above embodiments. Within the scope of the technical concept of the present invention, various simple modifications can be made to the technical solution of the present invention, and these simple modifications all fall within the protection scope of the present invention.

[0135] It should also be noted that the various specific technical features described in the above specific embodiments can be combined in any suitable way without contradiction. In order to avoid unnecessary repetition, the present invention will not describe the various possible combinations separately.

Claims

1. A type of umbilical patch gel plaster, characterized in that, The components of the umbilical patch gel plaster include traditional Chinese medicine extracts, hydrophilic polymer materials, moisturizers, penetration enhancers, cross-linking agents, pH adjusters, and water; the raw materials of the traditional Chinese medicine extracts include dried ginger, cardamom, costus root, tangerine peel, psoralea, atractylodes, amomum, evodia, atractylodes macrocephala, poria cocos, codonopsis, and schisandra.

2. The umbilical patch gel plaster according to claim 1, characterized in that, The components of the umbilical patch gel plaster, by weight percentage, include 10-25% of traditional Chinese medicine extract, 3-7% of hydrophilic polymer material, 20-35% of moisturizer, 0.5-6% of penetration enhancer, 0.05-0.25% of crosslinking agent, 0.15-0.5% of pH adjuster, and 40-70% of water. Preferably, the raw materials of the traditional Chinese medicine extract include, by weight, 8-15 parts dried ginger, 10-20 parts cardamom, 5-12 parts costus root, 5-12 parts dried tangerine peel, 20-40 parts psoralea, 5-12 parts atractylodes, 5-12 parts amomum, 10-20 parts evodia, 5-12 parts atractylodes macrocephala, 5-12 parts poria cocos, 8-15 parts codonopsis, and 10-20 parts schisandra.

3. The umbilical patch gel plaster according to claim 1 or 2, characterized in that, The traditional Chinese medicine extract is prepared by a method comprising the following steps: Mix all the raw materials and then decoct them with water, or decoct the raw materials separately with water and then mix them; filter and concentrate to obtain the Chinese herbal extract.

4. The umbilical patch gel plaster according to claim 3, characterized in that, The mass ratio of the raw material to water is 1:(6-10); Preferably, the decoction is performed 1-3 times, and each decoction lasts for 1-2 hours; Preferably, the concentration includes concentrating the filtrate to a relative density of 1-1.5; Preferably, the concentration process further includes a drying process; Preferably, the drying method is spray drying.

5. The umbilical patch gel plaster according to any one of claims 1-4, characterized in that, The penetration enhancer includes any one or a combination of at least two of the following: laurocapram, eucalyptus oil, propylene glycol monolaurate, N-methylpyrrolidone, 1,2-propanediol, peppermint oil, or oleic acid. Preferably, the penetration enhancer includes laurocapram, eucalyptus oil, propylene glycol monolaurate, and N-methylpyrrolidone.

6. The umbilical patch gel plaster according to any one of claims 1-5, characterized in that, The hydrophilic polymer material includes any one or a combination of at least two of the following: sodium polyacrylate, carbomer, sodium carboxymethyl cellulose, polyvinyl alcohol, povidone, polyacrylic acid-sodium polyacrylate copolymer, sodium alginate, or gelatin. Preferably, the moisturizer includes any one or a combination of at least two of glycerin, propylene glycol, polyethylene glycol, or 1,3-butanediol; Preferably, the crosslinking agent comprises any one or a combination of at least two of aluminum glycinate, aluminum glutamate, aluminum hydroxide, aluminum chloride, or calcium chloride; Preferably, the pH adjuster comprises any one or a combination of at least two of citric acid, tartaric acid, malic acid, lactic acid, or phosphoric acid.

7. The umbilical patch gel plaster according to any one of claims 1-6, characterized in that, The components of the umbilical patch gel also include fillers; Preferably, the umbilical patch gel plaster further comprises 0.1-1% filler by weight percentage; Preferably, the filler comprises any one or a combination of at least two of kaolin, titanium dioxide, zinc oxide, or micronized silica gel; Preferably, the components of the umbilical patch gel also include a cooling agent; Preferably, the components of the umbilical patch gel plaster further include 0.1-1% cooling agent by weight percentage; Preferably, the cooling agent includes any one or a combination of at least two of menthol, camphor, or borneol; Preferably, the umbilical patch gel plaster further includes a preservative; Preferably, the components of the umbilical patch gel plaster further include 0.1-0.5% preservative by weight percentage; Preferably, the preservative includes any one or a combination of at least two of sodium benzoate, potassium sorbate, ethylparaben, or methylparaben.

8. The method for preparing the umbilical patch gel plaster according to any one of claims 1-7, characterized in that, The method includes: (1) Mix the humectant and penetration enhancer, add the crosslinking agent and homogenize to prepare phase A; A pH crosslinking agent and water were mixed, a hydrophilic polymer was added to swell the mixture, and then a traditional Chinese medicine extract was added for homogenization to prepare phase B. (2) Mix phase A and phase B, homogenize them, coat them onto the backing material, dry them, and coat them with a film to obtain the umbilical patch gel plaster.

9. The method according to claim 8, characterized in that, In the preparation of phase A, the homogenization process also includes the addition of a cooling agent; Preferably, in the preparation of phase B, the mixing process further includes the addition of a preservative; Preferably, the homogenization process in the preparation of phase B further includes the addition of a filler.

10. The method according to claim 8 or 9, characterized in that, In step (2), the mixing process involves adding phase A into phase B; Preferably, in step (2), the homogenization method is stirring; Preferably, the stirring is carried out under vacuum conditions; Preferably, the stirring process includes stirring at 70-90 rpm for 10-15 minutes, and then stirring at 30-50 rpm for 15-25 minutes.

Images