Mammary patch for preventing and treating mastitis and preparation method thereof

Abstract

The invention discloses a breast patch for preventing and treating mastitis and a preparation method thereof, and relates to the technical field of Chinese herbal medicines. The breast patch for preventing and treating mastitis comprises a base material layer and a traditional Chinese medicine bonding layer, and the traditional Chinese medicine bonding layer is prepared from, by weight, 33-61 parts of traditional Chinese medicine components, 5-10 parts of achyranthes bidentata polysaccharides, 5-10 parts of pullulan, 5-10 parts of locust bean gum, 5-10 parts of xanthan gum and 0.5-1 part of glycerinum. The breast paste for preventing and treating mastitis can contain a plurality of effective components, is tightly adhered to the skin without damaging the skin, and has a positive effect on preventing and treating mastitis.

Description

Technical Field

[0001] The invention relates to the field of Chinese herbal medicines, and in particular to a nipple patch for preventing and treating mastitis and a preparation method thereof. Background Art

[0002] Mastitis is a common breast disease in lactating women, which is mostly caused by milk stasis, bacterial infection, etc., leading to symptoms such as breast pain, redness and swelling. Traditional treatments include drugs and surgery, but there are certain limitations. Drug treatment may only relieve symptoms but cannot cure the disease; surgical treatment will bring pain and financial burden to patients. In recent years, local treatment methods such as topical plasters and nipple patches have gradually attracted attention. These products are applied to the breast area, and the active ingredients in them act directly on the affected area, which can relieve pain, promote blood circulation, and reduce inflammation.

[0003] However, some existing nipple patch products may not be firmly adhered and easily fall off or be too firmly adhered to cause skin damage during use due to the mismatch between the adhesive and the traditional Chinese medicine ingredients. In addition, the drug loading rate is not high, which affects the patient's usage experience and treatment effect. Summary of the invention

[0004] The present invention is made in view of the above problems and provides a nipple patch for preventing and treating mastitis and a preparation method thereof.

[0005] The first aspect of the present invention provides a nipple patch for preventing and treating mastitis and a preparation method thereof. The nipple patch for preventing and treating mastitis comprises a substrate layer and a Chinese medicine adhesive layer. The raw materials of the Chinese medicine adhesive layer comprise, by weight, 33 to 61 parts of Chinese medicine components, 5 to 10 parts of Achyranthes bidentata polysaccharide, 5 to 10 parts of pullulan, 5 to 10 parts of locust bean gum, 5 to 10 parts of xanthan gum, and 0.5 to 1 part of glycerol.

[0006] In some embodiments of the present invention, the Chinese medicine components include 5-9 parts of pangolin, 3-5 parts of zedoaria, 9-15 parts of salvia miltiorrhiza, 6-10 parts of mirabilite, 3-9 parts of safflower, 1-3 parts of frankincense, and 6-10 parts of cloves.

[0007] In some embodiments of the present invention, the substrate layer comprises a non-woven fabric or a polylactic acid fabric, and the air permeability of the substrate layer is ≥500 mL / (cm 2 ·s).

[0008] A second aspect of the present invention provides a method for preparing a nipple patch for preventing and treating mastitis, the method comprising the following steps:

[0009] S1: crushing the Chinese medicine components, sieving, adding to a solvent for dispersion, and obtaining a mixed solution;

[0010] S2: mixing the mixed solution with Achyranthes bidentata polysaccharide, pullulan, locust bean gum, xanthan gum and glycerin to obtain a coating precursor;

[0011] S3: applying the coating precursor on the substrate layer and drying it to obtain a nipple patch for preventing and treating mastitis.

[0012] In some embodiments of the present invention, in step S1, the pulverizing includes pulverizing with an air flow pulverizer, and setting the air flow pressure to be greater than or equal to 0.8 MPa.

[0013] In some embodiments of the present invention, in step S1, the sieved particle size D90 ≤ 15 μm.

[0014] In some embodiments of the present invention, in step S1, the solvent includes propylene glycol and water in a volume ratio of 1:4, and the volume content of the solvent in the mixed solution is 15% to 25%.

[0015] In some embodiments of the present invention, in step S2, the mixing includes stirring at 40° C. to 50° C. for 0.5 h to 1 h.

[0016] In some embodiments of the present invention, in step S2, the shear viscosity of the coating precursor is 0.1 Pa·s to 0.8 Pa·s.

[0017] In some embodiments of the present invention, in step S2, the coating amount is 115-125 g / m 2 , thickness 0.2mm~0.25mm.

[0018] The beneficial effects that can be achieved by the present invention are:

[0019] The present invention provides a nipple patch for preventing and treating mastitis and a preparation method thereof. Through the innovative combination of active ingredients of traditional Chinese medicine and natural polymer materials, multiple therapeutic advantages and improved use experience are achieved: first, multiple Chinese medicinal materials are combined to form a synergistic effect, among which the blood circulation and blood stasis, anti-inflammatory and analgesic, and softening and dispersing components cooperate with each other, which can play a comprehensive conditioning role for the pathological characteristics of mastitis at different stages; secondly, a natural polysaccharide composite system is used as a drug carrier, while ensuring the flexibility and fit of the patch, the continuous and stable release of drug ingredients is achieved, and the effective action time is significantly extended. The formula avoids the use of chemical irritating ingredients throughout the process, and uses biocompatible materials to minimize the risk of skin sensitivity while exerting the therapeutic effect. DETAILED DESCRIPTION

[0020] The following description is provided for those skilled in the art to fully understand the present invention, and is not intended to limit the subject matter described in the claims.

[0021] The "range" disclosed in the present invention is defined in the form of a lower limit and an upper limit, and a given range is defined by selecting a lower limit and an upper limit, and the selected lower limit and upper limit define the boundaries of the particular range. The range defined in this way can be inclusive or exclusive of the end values, and can be arbitrarily combined, that is, any lower limit can be combined with any upper limit to form a range. For example, if a range of 60 to 120 and 80 to 110 is listed for a particular parameter, it is understood that a range of 60 to 110 and 80 to 120 is also expected. In addition, if the minimum range values ​​1 and 2 are listed, and if the maximum range values ​​3, 4 and 5 are listed, the following ranges can all be expected: 1 to 3, 1 to 4, 1 to 5, 2 to 3, 2 to 4 and 2 to 5. In the present invention, unless otherwise specified, the numerical range "a to b" represents an abbreviation of any real number combination between a and b, wherein a and b are both real numbers. For example, the numerical range "0-5" means that all real numbers between "0-5" are listed in this document, and "0-5" is just an abbreviation of these numerical combinations. In addition, when a parameter is expressed as an integer ≥ 2, it is equivalent to disclosing that the parameter is, for example, an integer of 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, etc.

[0022] If not otherwise specified, all embodiments and optional embodiments of the present invention can be combined with each other to form a new technical solution.

[0023] Unless otherwise specified, all technical features and optional technical features of the present invention can be combined with each other to form a new technical solution.

[0024] If not otherwise specified, all steps of the present invention may be performed sequentially or randomly, preferably sequentially. For example, the method includes steps (a) and (b), which means that the method may include steps (a) and (b) performed sequentially, or may include steps (b) and (a) performed sequentially. For example, the method may further include step (c), which means that step (c) may be added to the method in any order, for example, the method may include steps (a), (b) and (c), or may include steps (a), (c) and (b), or may include steps (c), (a) and (b), etc.

[0025] Local treatments such as topical plasters and nipple patches are applied to the breast area, and the active ingredients in them act directly on the affected area to relieve pain, promote blood circulation, and reduce inflammation.

[0026] However, some existing nipple patch products may not be firmly adhered and easily fall off or be too firmly adhered to cause skin damage during use due to the mismatch between the adhesive and the traditional Chinese medicine ingredients. In addition, the drug loading rate is not high, which affects the patient's usage experience and treatment effect.

[0027] In view of this, the present invention provides a nipple patch for preventing and treating mastitis, comprising a base material layer and a Chinese medicine adhesive layer. The raw materials of the Chinese medicine adhesive layer include, by weight: 33-61 parts of Chinese medicine components, 5-10 parts of Achyranthes bidentata polysaccharide, 5-10 parts of pullulan, 5-10 parts of locust bean gum, 5-10 parts of xanthan gum, and 0.5-1 part of glycerol.

[0028] Through the innovative combination of traditional Chinese medicine active ingredients and natural polymer materials, multiple therapeutic advantages and improved user experience are achieved: First, the combination of multiple traditional Chinese medicines forms a synergistic effect, among which the blood circulation and blood stasis, anti-inflammatory and analgesic, and softening and dispersing components cooperate with each other, which can play a comprehensive conditioning role for the pathological characteristics of mastitis at different stages; secondly, the natural polysaccharide complex system is used as a drug carrier, which ensures the flexibility and fit of the patch while achieving the continuous and stable release of drug ingredients, significantly prolonging the effective action time. The formula avoids the use of chemical irritants throughout the process and uses biocompatible materials to minimize the risk of skin sensitivity while exerting the therapeutic effect.

[0029] In particular, the composite colloid formed by Achyranthes bidentata polysaccharide, pullulan, locust bean gum and xanthan gum can stably load more Chinese medicine micropowders through physical adsorption and pore encapsulation mechanism. Adding 0.5-1 parts of glycerol as a colloid interface modifier can preferentially contact the surface of the Chinese medicine particles in the solvent and reduce the solid-liquid interfacial tension.

[0030] In some embodiments, the Chinese medicine components include 5-9 parts of pangolin, 3-5 parts of zedoaria, 9-15 parts of salvia miltiorrhiza, 6-10 parts of mirabilite, 3-9 parts of safflower, 1-3 parts of frankincense, and 6-10 parts of cloves.

[0031] In the treatment of breast diseases, the above-mentioned Chinese medicine formulas play an important role through their unique efficacy and synergistic effects.

[0032] The effects of pangolin in promoting blood circulation, dispersing nodules, unblocking menstruation and promoting lactation, combined with the effects of Curcuma zedoaria in promoting qi, removing blood stasis, eliminating accumulation and relieving pain, can together improve qi stagnation and blood stasis caused by breast nodules and hyperplasia.

[0033] Salvia miltiorrhiza and Chuanxiong further enhance the effect of promoting blood circulation and removing blood stasis. Salvia miltiorrhiza also has the effect of clearing the heart and relieving restlessness, and has a regulating effect on the emotional fluctuations associated with breast diseases.

[0034] The heat-clearing, moistening and hardening effects of Glauber's salt can help relieve breast inflammation and lumps.

[0035] Safflower has the effect of activating blood circulation, enhancing blood circulation and improving the breast microenvironment.

[0036] Frankincense's effects of promoting blood circulation, relieving pain, reducing swelling and promoting tissue regeneration jointly promote the relief of breast inflammation and tissue repair.

[0037] Clove has the effects of warming the middle, relieving adverse reactions, dispelling cold and relieving pain, relieving breast pain and improving the circulation of qi and blood.

[0038] Overall, this formula uses the synergistic effects of various medicinal materials to comprehensively treat breast diseases from multiple angles, including promoting blood circulation and removing blood stasis, softening and dispersing nodules, clearing away heat and purging fire, and promoting qi and relieving pain. It aims to improve blood circulation in breast tissue, eliminate inflammation, relieve pain, dissipate nodules, and promote tissue repair. It embodies the unique advantages of traditional Chinese medicine in treating breast diseases and its holistic conditioning characteristics.

[0039] In some embodiments, the substrate layer comprises a non-woven fabric or a polylactic acid fabric, and the air permeability of the substrate layer is ≥500 mL / (cm 2 ·s). Air permeability ≥500mL / (cm 2 ·s) The base material layer can quickly allow air to circulate on both sides of the material, so that moisture and heat on the skin surface can be dissipated in time, avoiding moisture accumulation, making the user feel drier and more comfortable, and reducing the feeling of stuffiness. Polylactic acid is a biodegradable material that can be decomposed into water and carbon dioxide by microorganisms in the natural environment, and will not cause pollution to the environment.

[0040] In view of this, the present invention also proposes a method for preparing a nipple patch for preventing and treating mastitis, comprising the following steps:

[0041] S1: crushing the Chinese medicine components, sieving, adding to a solvent for dispersion, and obtaining a mixed solution;

[0042] S2: mixing the mixed solution with Achyranthes bidentata polysaccharide, pullulan, locust bean gum, xanthan gum and glycerin to obtain a coating precursor;

[0043] S3: applying the coating precursor on the substrate layer and drying it to obtain a nipple patch for preventing and treating mastitis.

[0044] The preparation method comprises the following steps: crushing, sieving and dispersing the Chinese medicine components in a solvent, and then mixing with Achyranthes bidentata polysaccharide, pullulan, locust bean gum, xanthan gum and glycerol to form a uniform coating precursor, and finally coating the precursor on a substrate layer and drying the precursor to obtain a stable Chinese herbal medicine composition. The method improves the dispersibility and utilization rate of the medicine, enhances the adhesion and stability of the nipple patch, optimizes the fit, comfort and drug release rate of the nipple patch, and simultaneously multiple drug components synergize to enhance the effect, and the nipple patch has good moisturizing, lubricating, anti-inflammatory, detumescent and analgesic effects.

[0045] In some embodiments, in step S1, the pulverizing includes pulverizing with an air flow pulverizer, and setting the air flow pressure to be greater than or equal to 0.8 MPa.

[0046] In some embodiments, in step S1, the sieved particle size D90 is ≤15 μm.

[0047] In some embodiments, in step S1, the solvent includes propylene glycol and water in a volume ratio of 1:4, and the volume content of the solvent in the mixed solution is 15% to 25%. The mixed solvent can improve the solubility of certain poorly soluble drugs, especially when substances of different polarities are involved; and the mixed solvent can improve the stability of the drug in the preparation and reduce the occurrence of reactions such as hydrolysis and oxidation.

[0048] In some embodiments, in step S2, the mixing includes stirring at 40°C to 50°C for 0.5h to 1h.

[0049] In some embodiments, in step S2, the shear viscosity of the coating precursor is 0.1 Pa·s to 0.8 Pa·s.

[0050] In some embodiments, in step S2, the coating amount is 115-125 g / m 2 , thickness 0.2mm~0.25mm.

[0051] The technical solution of the present invention is further described in detail below in conjunction with specific embodiments. It should be understood that the following specific embodiments are only used to explain the present invention, and are not used to limit the present invention.

[0052] Example 1

[0053] In parts by weight, 7 parts of pangolin, 4 parts of zedoaria, 12 parts of salvia miltiorrhiza, 8 parts of mirabilite, 6 parts of safflower, 2 parts of frankincense and 8 parts of cloves are crushed by air flow mill, and the air flow pressure is set to 0.8 MPa, sieved to D90 = 15 μm, added to a solvent (propylene glycol: water = 1:4) for dispersion, and the volume ratio of the solvent is 20% to obtain a mixed solution;

[0054] The mixed solution was mixed with 8 parts of Achyranthes bidentata polysaccharide, 8 parts of pullulan, 8 parts of locust bean gum, 8 parts of xanthan gum, and 0.7 parts of glycerol, and stirred at 50° C. for 40 minutes to obtain a coating precursor, wherein the shear viscosity of the coating precursor was 0.3 Pa·s;

[0055] The coating precursor is applied on the substrate layer with a coating amount of 125 g / m 2 , with a thickness of 0.25 mm, and after drying, a nipple patch for preventing and treating mastitis is obtained.

[0056] Example 2

[0057] Chinese medicinal components: 9 parts of pangolin, 5 parts of zedoaria, 15 parts of salvia miltiorrhiza, 10 parts of mirabilite, 9 parts of safflower, 3 parts of frankincense, 10 parts of cloves, binder: 10 parts of Achyranthes bidentata polysaccharide, 10 parts of pullulan, 10 parts of locust bean gum, 10 parts of xanthan gum, 1 part of glycerol, and other reference examples 1.

[0058] Example 3

[0059] Chinese medicinal components: 5 parts of pangolin, 3 parts of zedoaria, 9 parts of salvia miltiorrhiza, 6 parts of mirabilite, 3 parts of safflower, 1 part of frankincense, 6 parts of cloves, binder: 5 parts of Achyranthes bidentata polysaccharide, 5 parts of pullulan, 5 parts of locust bean gum, 5 parts of xanthan gum, 0.5 parts of glycerol, and other reference examples 1.

[0060] Comparative Example 1

[0061] The binder is 25 parts of sodium carboxymethyl cellulose (CMC-Na) and 0.7 parts of glycerol. For other purposes, refer to Example 1.

[0062] Efficacy test:

[0063] The nipple patch for preventing and treating mastitis obtained in the embodiment and the comparative example and the preparation method thereof were prepared into dressings, and peel strength test, air permeability test, drug release rate test, skin irritation test, clinical efficacy test were carried out, and the results were recorded as Table 1:

[0064] Table 1. Test results

[0065]

[0066]

[0067] From the results in Table 1, it can be seen that the CMC-Na binder is not compatible with the Chinese medicine loading requirements of this scheme, resulting in a permeability of only 320, and a total release rate of as low as 65% in 72 hours (drug retention failure), a high burst release (92% in 24 hours) accompanied by irritating erythema, and a clinical efficacy of only 63%.

[0068] The above examples prove that the present invention's nipple patch for preventing and treating mastitis has achieved multiple therapeutic advantages and improved user experience through the innovative combination of traditional Chinese medicine active ingredients and natural polymer materials: First, the combination of multiple traditional Chinese medicines forms a synergistic effect, among which the blood circulation and blood stasis, anti-inflammatory and analgesic, and softening and dispersing components cooperate with each other, which can play a comprehensive conditioning role for the pathological characteristics of mastitis at different stages; secondly, the natural polysaccharide composite system is used as a drug carrier, which ensures the flexibility and fit of the patch while achieving the continuous and stable release of drug ingredients, significantly prolonging the effective action time. The formula avoids the use of chemical irritants throughout the process and uses biocompatible materials to minimize the risk of skin sensitivity while exerting the therapeutic effect.

[0069] It should be noted that the present invention is not limited to the above-mentioned embodiments. The above-mentioned embodiments are only examples, and the embodiments having the same structure as the technical idea and exerting the same effect within the scope of the technical solution of the present invention are all included in the technical scope of the present invention. In addition, without departing from the scope of the main purpose of the present invention, various modifications that can be thought of by those skilled in the art to the embodiments and other methods of combining some of the constituent elements in the embodiments are also included in the scope of the present invention.

Claims

1. A nipple patch for preventing and treating mastitis, characterized in that: The nipple patch for preventing and treating mastitis comprises a substrate layer and a Chinese medicine adhesive layer. The raw materials of the Chinese medicine adhesive layer comprise, by weight, 33-61 parts of Chinese medicine components, 5-10 parts of Achyranthes bidentata polysaccharide, 5-10 parts of pullulan, 5-10 parts of locust bean gum, 5-10 parts of xanthan gum, and 0.5-1 part of glycerol.

2. The nipple patch for preventing and treating mastitis according to claim 1, characterized in that: The Chinese medicine components include 5-9 parts of pangolin, 3-5 parts of zedoaria, 9-15 parts of salvia miltiorrhiza, 6-10 parts of mirabilite, 3-9 parts of safflower, 1-3 parts of frankincense and 6-10 parts of cloves.

3. The nipple patch for preventing and treating mastitis according to claim 1, characterized in that: The substrate layer includes non-woven fabric or polylactic acid fabric, and the air permeability of the substrate layer is ≥500mL / (cm 2 ·s).

4. A method for preparing a nipple patch for preventing and treating mastitis according to any one of claims 1 to 3, characterized in that: The following steps are involved: S1: crushing the Chinese medicine components, sieving, adding to a solvent for dispersion, and obtaining a mixed solution; S2: mixing the mixed solution with Achyranthes bidentata polysaccharide, pullulan, locust bean gum, xanthan gum and glycerin to obtain a coating precursor; S3: applying the coating precursor on the substrate layer and drying it to obtain a nipple patch for preventing and treating mastitis.

5. The method for preparing the nipple patch for preventing and treating mastitis according to claim 4, characterized in that: In step S1, the pulverizing includes pulverizing with an air flow pulverizer, and setting the air flow pressure to be greater than or equal to 0.8 MPa.

6. The method for preparing the nipple patch for preventing and treating mastitis according to claim 4, characterized in that: In step S1, the sieved particle size D90 is ≤15 μm.

7. The method for preparing the nipple patch for preventing and treating mastitis according to claim 4, characterized in that: In step S1, the solvent includes propylene glycol and water in a volume ratio of 1:4, and the volume content of the solvent in the mixed solution is 15% to 25%.

8. The method for preparing the nipple patch for preventing and treating mastitis according to claim 4, characterized in that: In step S2, the mixing includes stirring at 40°C to 50°C for 0.5h to 1h.

9. The method for preparing the nipple patch for preventing and treating mastitis according to claim 4, characterized in that: In step S2, the shear viscosity of the coating precursor is 0.1 Pa·s to 0.8 Pa·s.

10. The method for preparing the nipple patch for preventing and treating mastitis according to claim 4, characterized in that: In step S2, the coating amount is 115-125 g / m 2 , thickness 0.2mm~0.25mm.

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