Traditional Chinese medicine plaster for warming kidney, dredging collaterals and assisting pregnancy and preparation method thereof

Abstract

The invention discloses a traditional Chinese medicine plaster for warming kidney, dredging collaterals and assisting pregnancy and a preparation method thereof, the traditional Chinese medicine plaster for warming kidney, dredging collaterals and assisting pregnancy is composed of the following traditional Chinese medicine components and plaster matrix in parts by weight: the traditional Chinese medicine components comprise 0.5 part of pilose antler, 3.5 parts of eucommia ulmoides, 2 parts of angelica sinensis, 2 parts of solanum nigrum and 2 parts of ligusticum wallichii; the traditional Chinese medicine components are all raw medicine fine powder, or are mixed with the plaster matrix after being fried, and the plaster matrix is a common matrix of a traditional Chinese medicine patch and can bear the traditional Chinese medicine components and realize skin application; the plaster matrix comprises but is not limited to a rubber matrix, a hot melt adhesive matrix and a cataplasm matrix. The traditional Chinese medicine plaster has the advantage of targeted pregnancy assistance, and the use functionality of the traditional Chinese medicine plaster is remarkably improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine patches, in particular to a traditional Chinese medicine patch for warming kidney, dredging collaterals and assisting pregnancy and a preparation method thereof. BACKGROUND

[0002] The incidence of gynecological infertility and other related diseases is often related to the imbalance of "kidney", "blood and qi" and "meridians", and the causes are mainly "deficiency" and "stasis", which seriously affect the reproductive needs and quality of life of patients; At present, although western medicine has been widely used in promoting pregnancy, it has obvious side effects and can easily affect endocrine balance, which is difficult to meet the needs of patients for safe and effective treatment; Therefore, traditional Chinese medicine has become an important research direction in this field due to its mildness and small side effects, and traditional Chinese medicine patches are more popular in the market as an external administration form because they can avoid the stimulation of oral drugs on the gastrointestinal tract and reduce systemic adverse reactions.

[0003] Traditional Chinese medicine patches often have the problems of complicated component matching and unclear primary and secondary components, and some formulas do not accurately focus on the core causes of gynecological diseases "kidney deficiency" and "blood stasis", but only use general conditioning effects to formulate, resulting in scattered drug effects and poor targeted treatment for infertility; Some patches even blindly stack traditional Chinese medicine components, which not only increases the preparation cost, but also may reduce the overall efficacy due to the antagonistic effect between components. SUMMARY

[0004] The present application provides a traditional Chinese medicine patch for warming kidney, dredging collaterals and assisting pregnancy and a preparation method thereof, which has the advantages of targeted pregnancy assistance and solves the problems in the prior art.

[0005] To achieve the above-mentioned purpose, the present application provides the following technical solutions: The traditional Chinese medicine patch for warming kidney, dredging collaterals and assisting pregnancy is composed of the following weight parts of traditional Chinese medicine components and patch base: the traditional Chinese medicine components include 0.5 parts of deer horn, 3.5 parts of eucommia ulmoides, 2 parts of angelica sinensis, 2 parts of solanum nigrum and 2 parts of ligusticum chuanxiong; the traditional Chinese medicine components are all original medicine fine powder, or are mixed with the patch base after being fried.

[0006] Preferably, the patch base is a commonly used base for traditional Chinese medicine patches, which can carry traditional Chinese medicine components and achieve skin patching; the patch base includes but is not limited to rubber base, hot melt adhesive base and balm base.

[0007] It should be noted that: the patch base covers the types of commonly used bases for traditional Chinese medicine patches, taking into account the advantages of traditional and modern bases, adapting to different production scenes and use requirements, and improving the practicality and flexibility of the technical solution; However, it should be noted that the types of "rubber base, hot melt adhesive base and balm base" listed meet the pharmaceutical standards and have no component conflicts with the traditional Chinese medicine components, and do not affect the efficacy or produce harmful substances.

[0008] A preparation method of the traditional Chinese medicine patch for warming kidney, dredging collaterals and assisting pregnancy as described above, comprising the following steps: S1: Take deer antler, eucommia ulmoides, angelica sinensis, solanum nigrum, chuanxiong by weight, and clean up, remove impurities, and dry in an oven at 60-80°C for 2-4 hours; S2: Put the dried traditional Chinese medicine components into a super micro grinder, crush to 10-50μm fine powder, pass through a 150-200 mesh sieve, and collect the powder under the sieve; S3: Add the traditional Chinese medicine fine powder to the melted plaster base in a ratio of 1:3-1:5 by mass, stir for 30-60 minutes at 50-60°C until evenly mixed, and make a paste; S4: Coat the paste on the backing material with a coating machine, the coating thickness is 0.5-1.5mm, cool to room temperature, and cut into shape according to the preset specifications, then package to get the finished product.

[0009] A preparation method of the warm kidney and dredge collaterals and assist conception traditional Chinese medicine plaster as claimed in the preceding claims, comprising the following steps: S1: Take deer antler, eucommia ulmoides, angelica sinensis, solanum nigrum, chuanxiong by weight, and clean up, remove impurities, and dry in an oven at 60-80°C for 2-4 hours; S2: Put the cut pieces of traditional Chinese medicine components into edible oil, the amount of edible oil is 3-5 times the total mass of traditional Chinese medicine components, heat to 120-150°C and fry for 30-60 minutes, stop heating when the surface of the medicine is dark brown and there is no burnt smell, filter the residue with gauze while hot, and collect the medicine-containing oil agent; S3: Add the medicine-containing oil agent to the melted plaster base in a ratio of 1:2-1:4 by mass, stir for 40-80 minutes at 45-55°C until a uniform paste is formed; S4: Coat the paste on the backing material, cool for 1-2 hours in a 20-25°C environment, cut into shape according to the preset size, and package after quality inspection to get the finished product.

[0010] Preferably, a stabilizer can be added during preparation, including but not limited to hydroxyphenyl ethyl ester and potassium sorbate, the amount of which is 0.1%-0.5% of the total mass of the plaster, and the amount does not affect the warming kidney, sperm production, qi circulation and blood activation, and the efficacy of preventing miscarriage of the traditional Chinese medicine components.

[0011] It is worth noting that: the addition of stabilizers can improve the storage stability of the plaster, prevent paste deterioration, delamination or degradation of active ingredients, prolong the shelf life of the product, and meet the commercial circulation needs; but attention should be paid to verify the compatibility of the selected stabilizer with the traditional Chinese medicine components and the plaster base, to ensure that no chemical reaction occurs, and to meet the safety standards of pharmaceutical excipients, to avoid toxic side effects on the human body.

[0012] Preferably, the use mode of the traditional Chinese medicine patch is to be directly attached to the Shenjue acupoint and the Mingmen acupoint, the attachment time is 8-12 hours each time, and the traditional Chinese medicine patch is used once a day, which is used for warming the kidney, dredging the collaterals, assisting pregnancy and preventing miscarriage, and the traditional Chinese medicine patch is safe, non-toxic, has no adverse reactions, and can be used for a long time.

[0013] It is worth noting that: the precise definition of "Shenjue acupoint and Mingmen acupoint" attachment, the two acupoints are highly consistent with the traditional Chinese medicine theory of "warming the kidney and regulating blood", which can improve the drug targeting, ensure that the drug effect is concentrated on the related meridians of the lesion, and enhance the treatment effect; but it should be noted that the user should clean the skin of the attachment part before use, avoid using the damaged skin, and clearly indicate the specific time range of "long-term use", such as 1-3 months as a cycle, and it is recommended to adjust according to the individual situation under the guidance of a doctor to avoid skin tolerance problems caused by blind long-term use.

[0014] Preferably, the backing material of the traditional Chinese medicine patch is a commonly used backing in traditional Chinese medicine patches, including but not limited to non-woven fabric, elastic cloth and PE film, and the thickness of the backing material is 0.1-0.3mm, which has good air permeability and adhesion.

[0015] It is worth noting that: the thickness range of 0.1-0.3mm ensures that the backing material has enough support to carry the paste, and also does not affect the skin permeability or adhesion due to excessive thickness, balancing practicality and comfort; but it should be noted that the backing material should meet the pharmaceutical grade standard, and there should be no adhesion conflict with the paste, so as to avoid the paste falling off or the backing material contacting the skin and causing allergic reaction.

[0016] Preferably, the traditional Chinese medicine patch further comprises a protective layer, the protective layer is release paper or release film, which covers the surface of the paste, and the protective layer is torn off before use to attach the paste, and the size of the protective layer is consistent with the size of the paste coating area.

[0017] It is worth noting that: the protective layer can effectively isolate the paste from the external environment, prevent the paste from being contaminated, dehydrated or adhered during storage, and protect the product quality; but it should be noted that the protective layer should be completely attached to the surface of the paste without air bubbles or gaps, so as to prevent air from entering and causing oxidation and deterioration of the paste, and it should be ensured that there is no residual paste on the surface of the protective layer after the protective layer is torn off, so as to avoid drug waste.

[0018] Compared with the prior art, the beneficial effects of the present application are as follows: The traditional Chinese medicine components in the present application are matched according to specific weight parts, and the pilose antler can warm the kidney and tonify yang, the eucommia ulmoides can tonify the liver and kidney and prevent miscarriage, the angelica can tonify blood and activate blood, the solanum nigrum can activate blood and resist inflammation, and the chuanxiong can promote blood circulation and relieve pain, so that the five medicinal materials have a synergistic effect, the core pathogenesis of gynecological diseases, such as kidney deficiency and blood stasis, is accurately targeted, the core effects of warming the kidney, generating essence, promoting blood circulation and preventing miscarriage are focused, the related problems of infertility are targetedly improved, and the curative effect is more concentrated; meanwhile, two adaptive schemes of “directly adding fine powder of raw medicine into medicine” or “extracting medicine oil agent by oil frying” are adopted, the release of water-soluble and fat-soluble effective components is considered, the oil frying process can fully extract active ingredients in traditional Chinese medicine by accurately controlling temperature, time and oil amount, and the subsequent standardized stirring, coating and other steps are matched, so that the uniform distribution of effective components is ensured, the skin penetration efficiency is improved, and the problem of insufficient extraction of effective components in the traditional process is avoided. DETAILED DESCRIPTION

[0019] Embodiment 1 In the conventional industrial production scene: The traditional Chinese medicine paste for warming the kidney, dredging collaterals and assisting pregnancy is composed of the following weight parts of traditional Chinese medicine components and paste matrix: the traditional Chinese medicine components include pilose antler 0.5 parts, eucommia ulmoides 3.5 parts, angelica 2 parts, solanum nigrum 2 parts and chuanxiong 2 parts; the paste matrix selects medicinal grade EVA hot melt adhesive; A preparation method of the traditional Chinese medicine paste for warming the kidney, dredging collaterals and assisting pregnancy as described above, characterized in that it comprises the following steps: S1: the pilose antler, eucommia ulmoides, angelica, solanum nigrum and chuanxiong are weighed according to the weight parts, cleaned and selected, and after removing impurities, the pilose antler is cut into a 0.8 cm thick sheet, and the eucommia ulmoides, angelica, solanum nigrum and chuanxiong are cut into 1.5 cm long segments; S2: the cut traditional Chinese medicine components are placed in medicinal grade soybean oil, the amount of medicinal grade soybean oil is 4 times the total mass of the traditional Chinese medicine components, heated to 135 DEG C and fried for 45 minutes, until the medicine surface is dark brown and there is no burnt smell, then stop heating, filter the medicine residue with 80 mesh gauze while hot, and collect the medicine oil agent; S3: according to the ratio of the medicine oil agent to the paste matrix 1:3, the medicine oil agent is added to the molten paste matrix, stirred at 50 DEG C for 60 minutes to form a uniform paste, and 0.3% of hydroxyphenyl ethyl ester is added at the same time; S4: the paste is coated on a 0.2 mm thick non-woven fabric backing, cooled for 1.5 hours in a 23 DEG C environment, cut into 4 cm x 4 cm square patches, and each patch has a mass of 8 g, which is packaged with release paper after quality inspection.

[0020] Embodiment 2 In the low-temperature production environment, such as in the workshop in winter in the north: The Wenshen Tongluo Zhuyang Chinese medicine plaster is composed of the following components by weight: Chinese medicine components including cornu cervi 0.5 parts, eucommia ulmoides 3.5 parts, angelica sinensis 2 parts, herba solani nigri 2 parts, and ligusticum chuanxiong 2 parts, and a plaster base, i.e., a natural rubber + vaseline compound base, which has better stability at low temperature; A preparation method of the Wenshen Tongluo Zhuyang Chinese medicine plaster is characterized by comprising the following steps: S1: The cornu cervi, eucommia ulmoides, angelica sinensis, herba solani nigri, and ligusticum chuanxiong are weighed and cleaned, and the cornu cervi is cut into 0.5 cm thick pieces, and the eucommia ulmoides, angelica sinensis, herba solani nigri, and ligusticum chuanxiong are cut into 1 cm long segments; S2: The cut Chinese medicine components are placed in medicinal sesame oil, the medicinal sesame oil is heated to 125℃ and fried for 55 minutes, until the medicine surface is dark brown and has no burnt smell, then hot filtration is performed using 100 mesh gauze to remove the drug residue, and the drug-containing oil agent is collected; S3: The drug-containing oil agent is added to the molten plaster base at a ratio of 1:4, and stirred at 55℃ for 70 minutes to form a uniform paste, and 0.5% of potassium sorbate is added to the total mass of the plaster to enhance the low-temperature storage stability, and the stirring is synchronized; S4: The paste is coated on a 0.3 mm thick elastic cloth backing, the elastic cloth has better adhesion, and is suitable for winter clothing rubbing scenarios, and is cooled in a 25℃ constant temperature workshop for 2 hours, cut into 4 cm diameter circular patches, and each has a mass of 10 g, and is packaged with a release film.

[0021] Example 3 In a small-scale clinic self-made scene, the equipment is simplified: The Wenshen Tongluo Zhuyang Chinese medicine plaster is composed of the following components by weight: Chinese medicine components including cornu cervi 0.5 parts, eucommia ulmoides 3.5 parts, angelica sinensis 2 parts, herba solani nigri 2 parts, and ligusticum chuanxiong 2 parts, and a plaster base, i.e., a natural rubber + vaseline compound base, which has better stability at low temperature; A preparation method of the Wenshen Tongluo Zhuyang Chinese medicine plaster is characterized by comprising the following steps: S1: The cornu cervi, eucommia ulmoides, angelica sinensis, herba solani nigri, and ligusticum chuanxiong are weighed and cleaned, and the cornu cervi is cut into 0.5 cm thick pieces, and the eucommia ulmoides, angelica sinensis, herba solani nigri, and ligusticum chuanxiong are cut into 1 cm long segments; S2: The cut Chinese medicine components are placed in medicinal sesame oil, the medicinal sesame oil is heated to 125℃ and fried for 55 minutes, until the medicine surface is dark brown and has no burnt smell, then hot filtration is performed using 100 mesh gauze to remove the drug residue, and the drug-containing oil agent is collected; S3: According to the ratio of the drug-containing oil agent to the plaster base matrix mass ratio 1:2, the drug-containing oil agent is added to the molten plaster base matrix, stirred at 45°C for 40 minutes to form a uniform paste, and 0.1% of the total mass of the plaster is added. The hydroxyethylbenzene is added to meet the small-scale short-term storage requirements, and is added synchronously during stirring; S4: The paste is manually coated on a 0.1 mm thick PE film backing, cooled at 20°C for 1 hour, cut into 5 cm x 3 cm oval-shaped plasters, with a single mass of 5 g, and packaged with release paper.

[0022] Experimental Example Select 200 female patients who meet the diagnostic criteria for "kidney deficiency and blood stasis type" infertility, aged 25-35 years, and randomly divide them into 4 groups, 50 cases in each group: Example 1 group, Example 2 group, Example 3 group, and traditional plaster as a control group; The experimental process is as follows: Examples 1-3 are applied to Shenque and Mingmen points, 10 hours each time, once a day, and continuously used for 3 months; Select a commercially available traditional kidney warming and pregnancy promoting traditional Chinese medicine plaster, apply it according to the instructions, apply it to the lower abdomen, apply it for 6 hours, once a day, and continuously use it for 3 months; Detection index: 1. Efficacy index: pregnancy rate and improvement rate of TCM symptoms after 3 months, TCM symptoms include soreness of waist and knees, irregular menstruation, and dysmenorrhea; 2. Safety index: incidence of skin adverse reactions during application; adverse reactions include redness, itching, and stinging; 3. Experience index: patient satisfaction score for application adhesion and air permeability, full score 10 points; 4. Stability index: effective ingredient retention rate after 6 months of plaster storage; effective ingredients include estradiol in deer horn and pinoresinol diglucoside in eucommia ulmoides.

[0023] The experimental results are shown in Table 1 below:

[0024] Table 1 From the above experiments, we can conclude that: In terms of efficacy: the pregnancy rate and improvement rate of TCM symptoms of Examples 1-3 are significantly higher than those of the traditional plaster group, among which Example 1 has the best effect, with a pregnancy rate of 36.0%, which is twice that of the traditional plaster group; This is due to the precise prescription matching and efficient extraction process of the present application, which has higher effective ingredient utilization rate.

[0025] Safety: The incidence of skin adverse reactions of the Example 1-3 groups was only 4.0%-8.0%, which was much lower than that of the traditional plaster group, which embodied the synergistic advantages of the natural Chinese medicine components, the compliant matrix and the stabilizer of the present application, and avoided the irritation problem caused by improper prescription or impurity residues of the traditional plaster group.

[0026] Experience: The satisfaction scores of the adhesion and air permeability of the Example 1-3 groups were all above 8.5, while those of the traditional plaster group were only 5.8-6.5; the optimized backing material and dosage form design of the present application solved the problems of poor adhesion and insufficient air permeability of the traditional plaster.

[0027] Stability: The effective component retention rate of the Example 1-3 groups was above 90.5% after 6 months of storage, while that of the traditional plaster group was only 75.0%; the reasonable addition of the stabilizer and the standardized preparation process ensured the long-term stability of the plaster of the present application, which was better than the natural storage effect of the traditional plaster.

Claims

1. A kidney-warming, meridian-unblocking and pregnancy-aiding traditional Chinese medicine plaster, characterized in that, The traditional Chinese medicine component and the plaster base are composed of the following weight parts: the traditional Chinese medicine component includes 0.5 parts of pilose antler, 3.5 parts of eucommia ulmoides, 2 parts of angelica sinensis, 2 parts of solanum nigrum and 2 parts of ligusticum chuanxiong; the traditional Chinese medicine component is all original medicine fine powder, or is mixed with the plaster base after being fried.

2. The kidney-warming channel-unblocking conception-boosting traditional Chinese medicine patch of claim 1, characterized in that, The plaster base is a commonly used base of traditional Chinese medicine plaster, which can carry the traditional Chinese medicine component and realize skin pasting; the plaster base includes but is not limited to rubber base, hot melt adhesive base and cataplasm base.

3. The preparation method of the kidney-warming and meridian-unblocking Chinese medicine paste for promoting pregnancy according to claim 2, characterized in that, The following steps are included: S1: the pilose antler, eucommia ulmoides, angelica sinensis, solanum nigrum and ligusticum chuanxiong are weighed according to the weight parts, cleaned and selected, dried in a 60-80℃ oven for 2-4 hours after impurities are removed; S2: the dried traditional Chinese medicine component is put into a super micro grinder, ground into extremely fine powder with a particle size of 10-50μm, sieved through a 150-200 mesh sieve, and the powder under the sieve is collected; S3: the traditional Chinese medicine extremely fine powder is added into the plaster base in a molten state according to the mass ratio of 1:3-1:5, stirred at 50-60℃ for 30-60 minutes until mixed uniformly to form a paste; S4: the paste is uniformly coated on the backing material by a coating machine, the coating thickness is 0.5-1.5mm, and after cooling to room temperature, the paste is cut into a preset shape for packaging to obtain the finished product.

4. The preparation method of the kidney-warming and meridian-unblocking Chinese medicine paste for promoting pregnancy according to claim 2, characterized in that, The following steps are included: S1: the pilose antler, eucommia ulmoides, angelica sinensis, solanum nigrum and ligusticum chuanxiong are weighed according to the weight parts, cleaned and selected, and the pilose antler is cut into a 0.5-1cm thick sheet, and the eucommia ulmoides, angelica sinensis, solanum nigrum and ligusticum chuanxiong are cut into 1-2cm long segments; S2: the cut traditional Chinese medicine component is put into edible oil, the amount of edible oil is 3-5 times the total mass of the traditional Chinese medicine component, heated to 120-150℃ for 30-60 minutes, and when the surface of the medicine is dark brown and there is no burnt smell, the heating is stopped, the residue is removed by filtering with gauze while hot, and the oil containing medicine is collected; S3: the oil containing medicine is added into the molten plaster base according to the mass ratio of 1:2-1:4, stirred at 45-55℃ for 40-80 minutes until a uniform paste is formed; S4: the paste is coated on the backing material, cooled at 20-25℃ for 1-2 hours, cut into a preset shape, and after quality inspection, packaged to obtain the finished product.

5. The preparation method of the kidney-warming and meridian-unblocking Chinese medicine paste for promoting pregnancy according to claim 3 or 4, characterized in that, A stabilizer can be added during preparation, the stabilizer includes but is not limited to hydroxyphenyl ethyl ester and potassium sorbate, and the addition amount is 0.1%-0.5% of the total mass of the plaster, and the addition amount does not affect the effects of warming kidney, generating essence, promoting blood circulation and preventing miscarriage of the traditional Chinese medicine component.

6. The kidney-warming channel-unblocking conception-boosting traditional Chinese medicine patch of claim 2, characterized in that, The use mode of the traditional Chinese medicine plaster is to be directly pasted on the human body Shenque point and Mingmen point, the pasting time is 8-12 hours each time, and the plaster is used once a day for warming kidney, promoting blood circulation and preventing miscarriage, and the plaster is safe, non-toxic, has no adverse reactions, and can be used for a long time.

7. The kidney-warming channel-unblocking conception-boosting traditional Chinese medicine patch of claim 2, characterized in that, The backing material of the traditional Chinese medicine plaster is a commonly used backing in traditional Chinese medicine plaster, including but not limited to non-woven fabric, elastic cloth and PE film, the thickness of the backing material is 0.1-0.3mm, and the backing material has good air permeability and adhesion.

8. The kidney-warming channel-unblocking conception-boosting traditional Chinese medicine patch of claim 2, characterized in that, The traditional Chinese medicine plaster also includes a protective layer, the protective layer is release paper or release film, covers the surface of the paste, and the protective layer is torn off before pasting, the size of the protective layer is consistent with the size of the paste coating area.

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