An external analgesic traditional Chinese medicine composition and a plaster preparation method thereof

Abstract

This invention discloses a topical analgesic traditional Chinese medicine composition and its preparation method for a plaster, belonging to the technical field of topical traditional Chinese medicine preparations. The composition comprises prickly pear, gastrodia elata, cinnamon, myrrh, *Lycopodium clavatum*, frankincense, *Angelica pubescens*, cinnamon twig, *Panax notoginseng*, *Eucommia ulmoides*, *Dipsacus asper*, *Taxillus chinensis*, *Drynaria fortunei*, safflower, vanillin, camphor, and borneol. The plaster comprises the above composition and a pharmaceutically acceptable matrix. The preparation method employs a segmented temperature-controlled process: the raw materials are ground and sieved; petrolatum is heated and then added to the raw materials in stages with constant temperature stirring; after cooling, medical hot melt adhesive is added to form a plaster, which is then coated onto a medical carrier, dried, and cured, and covered with an anti-adhesive film. This invention features a rationally formulated composition, high transdermal efficiency, minimal loss of volatile components, rapid onset of action, and long-lasting efficacy. It can quickly relieve discomfort such as neck, shoulder, waist, and leg pain, with no risk of allergies and good formulation stability.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine external preparation technology, specifically relating to an external analgesic traditional Chinese medicine composition and its plaster preparation method. Background Technology

[0002] Neck, shoulder, back, and leg pain are common clinical symptoms, and topical ointments are commonly used to relieve these symptoms. However, existing topical ointments generally suffer from the following drawbacks: low content of effective volatile components and weak transdermal penetration; significant loss of volatile components during storage and use, resulting in a short duration of efficacy; and difficulty in penetrating the skin barrier to reach the affected area, leading to poor pain relief and soothing effects.

[0003] To overcome the above-mentioned technical defects, the present invention provides a topical analgesic traditional Chinese medicine composition and its ointment preparation method. By optimizing the composition ratio and segmented temperature control preparation process, the transdermal efficiency of the drug is improved and the loss of volatile components is reduced, so as to achieve rapid relief and long-lasting analgesia. Summary of the Invention

[0004] I. Technical problems to be solved 1. Improve the transdermal penetration efficiency of topical Chinese medicine preparations and shorten the onset time; 2. Reduce the loss of volatile active ingredients in the plaster and prolong the duration of its effect; 3. Optimize the formulation to achieve synergistic effects of promoting blood circulation, removing blood stasis, dispelling wind and dampness, and relaxing muscles and bones, thereby enhancing the analgesic and soothing effects.

[0005] II. Technical Solution 1. External analgesic Chinese medicine composition A topical analgesic traditional Chinese medicine composition comprising the following active ingredients in parts by weight: 1 part prickly pear, 1 part gastrodia elata, 1 part cinnamon, 1 part myrrh, 1 part lycopodium clavatum, 1 part frankincense, 1 part angelica pubescens, 1 part cinnamon twig, 1 part notoginseng, 1 part eucommia ulmoides, 1 part dipsacus asper, 1 part mulberry mistletoe, 1 part drynaria fortunei, 1 part safflower, and penetration-enhancing ingredients: 1.5 parts vanillyl butyl ether, 2 parts camphor, and 2 parts borneol.

[0006] Preferably, the particle size of the active ingredient in the pharmaceutical raw material is such that it passes through an 80-mesh sieve.

[0007] 2. Topical analgesic plasters A topical analgesic plaster comprises the above-mentioned topical analgesic traditional Chinese medicine composition and a pharmaceutically acceptable matrix. The pharmaceutically acceptable matrix preferably comprises a medical hot melt adhesive and petroleum jelly. Further, the medical hot melt adhesive comprises 20 parts by weight, and the petroleum jelly comprises 20 parts by weight.

[0008] 3. Preparation method of external analgesic plaster A method for preparing a topical analgesic plaster includes the following steps: (1) Grind the following ingredients into powder and pass them through an 80-mesh sieve: prickly pear, gastrodia elata, cinnamon, myrrh, lycopodium clavatum, frankincense, angelica pubescens, cinnamon twig, notoginseng, camphor, borneol, eucommia ulmoides, dipsacus asper, mulberry mistletoe, drynaria fortunei, and safflower. (2) Add petroleum jelly to the container, heat to 60-70°C, add the ground and crushed prickly pear, gastrodia elata, lycopodium clavatum, vanillyl butyl ether and Panax notoginseng, stir evenly, keep warm and stir for 20 minutes. (3) Lower the temperature to 50-60℃, add the ground and crushed cinnamon, myrrh, frankincense, Angelica pubescens, cinnamon twig, camphor, borneol, Eucommia ulmoides, Dipsacus asper, Taxillus chinensis, Drynaria fortunei, and safflower, stir evenly, and keep warm for 10 minutes. (4) When the system temperature drops to 40-50℃, add medical hot melt adhesive, stir and mix evenly to form an ointment; (5) The ointment is uniformly coated onto a medical carrier, with a coating thickness preferably of 3 to 5 mm; (6) Dry at a temperature not exceeding 35°C until the paste hardens; (7) Cover the surface of the cured paste with an anti-sticking film.

[0009] Preferably, the medical carrier is a medical impermeable membrane or non-woven fabric; the anti-adhesion membrane is a polyethylene film backing paper. Beneficial effects 1. Synergistic effect of the formula: With Panax notoginseng and myrrh as the core, it can promote blood circulation, remove blood stasis, and relieve pain; Angelica pubescens, cinnamon twig, cinnamon bark, Lycopodium clavatum, and Gastrodia elata can dispel wind and cold, remove dampness and unblock the meridians; Eucommia ulmoides, Dipsacus asper, Taxillus chinensis, Drynaria fortunei, and Carthamus tinctorius can nourish the liver and kidneys, strengthen tendons and bones, promote blood circulation and reduce swelling; Camphor and borneol can quickly relieve pain and assist transdermal absorption; Prickly pear, frankincense, and vanillyl butyl ether can improve the stability of the ingredients and the efficiency of transdermal absorption, thus comprehensively improving the analgesic effect.

[0010] 2. Process protection for efficacy: The segmented temperature control process avoids the loss of volatile components at high temperatures, thus preserving the effective ingredients to the greatest extent and making the efficacy longer lasting.

[0011] 3. Faster transdermal onset of action: Vanillyl butyl ether works synergistically with natural penetration enhancers, allowing the drug to quickly penetrate the skin barrier and take effect within half an hour. The warming sensation lasts for 3 to 5 hours, and the analgesic effect is significant.

[0012] 4. Excellent formulation stability: The ointment has good formability and stable viscosity, with no risk of allergies, making it suitable for long-term external use for soothing.

[0013] The above description is merely an overview of the technical solution of the present invention. In order to better understand the technical means of the present invention and to implement it in accordance with the contents of the specification, the following describes the preferred embodiments of the present invention in detail with reference to the accompanying drawings. Attached Figure Description

[0014] Figure 1This is a schematic flowchart illustrating a preferred embodiment of the preparation method of a topical analgesic plaster according to the present invention. Detailed Implementation

[0015] The preferred embodiments of the present invention will now be described in detail with reference to the accompanying drawings, so that the advantages and features of the present invention can be more easily understood by those skilled in the art, thereby providing a clearer and more explicit definition of the scope of protection of the present invention.

[0016] Example 1: A topical analgesic traditional Chinese medicine composition comprising the following active ingredients in parts by weight: 1 part prickly pear, 1 part gastrodia elata, 1 part cinnamon, 1 part myrrh, 1 part lycopodium clavatum, 1 part frankincense, 1 part angelica pubescens, 1 part cinnamon twig, 1 part notoginseng, 1 part eucommia ulmoides, 1 part dipsacus asper, 1 part mulberry mistletoe, 1 part drynaria fortunei, 1 part safflower, and penetration-enhancing ingredients: 1.5 parts vanillyl butyl ether, 2 parts camphor, and 2 parts borneol.

[0017] The prickly pear is from Guizhou; the gastrodia elata is from Guizhou; the cinnamon is from Anhui; the myrrh is from Hebei; the lycopodium clavatum is from Guangxi; the angelica pubescens is from Guizhou; the cassia twig is from Guizhou; the notoginseng is from Anhui; the camphor is from Anhui; the borneol is from Anhui; the hot melt adhesive is from Anhui; the rest are not limited.

[0018] Prickly pear is rich in vitamin C and vitamin E, and in traditional Chinese medicine external applications, it often plays an auxiliary role in anti-oxidation and promoting tissue repair. Gastrodia elata can dispel wind and unblock meridians, relieve wind and stop spasms, and is often used to relieve numbness and pain in the limbs. Cinnamon can warm the meridians and dispel cold, invigorate blood and unblock meridians; its warming properties penetrate deeply to dispel cold and dampness. Myrrh can disperse blood stasis, relieve pain, reduce swelling and promote tissue regeneration; it is often used in combination with frankincense and is an essential medicine for invigorating blood, relieving pain, and promoting injury repair. Lycopodium clavatum can dispel wind and dampness, relax muscles and invigorate meridians, and is specifically used to relieve joint stiffness and muscle spasms. Angelica pubescens can dispel wind and dampness, relieve pain, and is particularly good at dispelling wind, cold and dampness in the lower body. Cinnamon twig can induce sweating, relieve muscle tension, warm and unblock meridians, and guide the medicinal power to the extremities. Panax notoginseng can invigorate blood, relieve pain, disperse blood stasis and stop bleeding; it is a powerful external ingredient for dispelling blood stasis and reducing swelling. Vanillyl butyl ether is a modern chemical penetration enhancer that can significantly help other drug components penetrate the skin barrier. Camphor can clear the orifices, dispel foul odors, warm and disperse pain, relieve itching, and promote local blood circulation. Borneol can open the orifices and refresh the mind, clear heat and relieve pain, and promote penetration, making it an excellent natural penetration enhancer. Eucommia ulmoides tonifies the liver and kidneys, strengthens tendons and bones, and improves lower back and knee pain caused by liver and kidney deficiency. Dipsacus asper has the effect of healing fractures and, together with Eucommia ulmoides, enhances the effect of strengthening tendons and bones. Taxillus chinensis has the effect of dispelling wind and dampness, and, when combined with Eucommia ulmoides, enhances the effect of tonifying the liver and kidneys and strengthening tendons and bones. Drynaria fortunei has the effects of healing wounds and relieving pain, tonifying the kidneys and strengthening bones, and promoting bone repair. Safflower has the effects of activating blood circulation, clearing menstruation, dispersing blood stasis and relieving pain, promoting local blood circulation, and dissipating blood stasis.

[0019] Example 2: See appendix Figure 1 As shown, a method for preparing a topical analgesic plaster in this embodiment includes the following steps: (a) Grind the prickly pear, gastrodia elata, cinnamon, myrrh, lycopodium clavatum, frankincense, angelica pubescens, cinnamon twig, notoginseng, camphor, borneol, eucommia ulmoides, dipsacus asper, mulberry mistletoe, drynaria fortunei, and safflower as described in Example 1; and pass them through an 80-mesh sieve.

[0020] (ii) Preparation of medicinal extract: Put petroleum jelly into a pot, control the temperature at 60°C, add the ground prickly pear, gastrodia elata, lycopodium clavatum, vanillyl butyl ether and Panax notoginseng containing volatile components, stir well, and simmer over low heat for 20 minutes. (iii) Keep the temperature at 50℃, add the ground cinnamon, myrrh, frankincense, Angelica pubescens, cinnamon twig, camphor, borneol, eucommia, dipsacus, mulberry mistletoe, drynaria and safflower, stir well, and simmer over low heat for 10 minutes; stir constantly during this time to prevent burning.

[0021] (iv) After the petroleum jelly cools down to 40°C, the extract and the base are mixed and stirred; the base is the hot melt adhesive described in Example 1, forming a uniform paste.

[0022] (v) Apply the prepared ointment evenly to the medical geomembrane, with a thickness of 3-5 mm, ensuring uniform thickness; (vi) Dry at 35°C until the paste hardens, then stop drying; (vii) Cover both sides of the ointment with a backing paper made of polyethylene film; The composition is as follows: 20 parts by weight of petroleum jelly, 1 part by weight of prickly pear, 1 part by weight of gastrodia elata, 1 part by weight of cinnamon, 1 part by weight of myrrh, 1 part by weight of lycopodium clavatum, 1 part by weight of angelica pubescens, 1 part by weight of cinnamon twig, 1 part by weight of notoginseng, 1.5 parts by weight of vanillyl butyl ether, 2 parts by weight of camphor, 2 parts by weight of borneol, 20 parts by weight of hot melt adhesive, 1 part by weight of eucommia ulmoides, 1 part by weight of dipsacus asper, 1 part by weight of mulberry mistletoe, 1 part by weight of drynaria fortunei, and 1 part by weight of safflower.

[0023] For components containing volatile substances, a lower temperature should be used for decoction. If the decoction temperature is too high, the volatile components will disperse and escape into the air. For components without volatile substances, a higher temperature should be used for decoction. If the decoction temperature is too low, only a small amount of the active ingredients will dissolve in the petrolatum, while the rest will remain in the medicinal material. Using different decoction temperatures avoids excessive loss of volatile components while ensuring that more non-volatile components dissolve in the petrolatum, thus enhancing the medicinal efficacy.

[0024] Example 3: See appendix Figure 1 As shown, a method for preparing a topical analgesic plaster in this embodiment includes the following steps: (a) Grind the prickly pear, gastrodia elata, cinnamon, myrrh, lycopodium clavatum, frankincense, angelica pubescens, cinnamon twig, notoginseng, camphor, borneol, eucommia ulmoides, dipsacus asper, mulberry mistletoe, drynaria fortunei, and safflower as described in Example 1; and pass them through an 80-mesh sieve.

[0025] (ii) Preparation of medicinal extract: Put petroleum jelly into a pot, control the temperature at 70°C, add the ground prickly pear, gastrodia elata, lycopodium clavatum, vanillyl butyl ether and Panax notoginseng containing volatile components, stir well, and simmer over low heat for 20 minutes. (iii) Keep the temperature at 60℃, add the ground cinnamon, myrrh, frankincense, Angelica pubescens, cinnamon twig, camphor, borneol, eucommia, dipsacus, mulberry mistletoe, drynaria and safflower, stir well, and simmer over low heat for 10 minutes; stir constantly during this time to prevent burning.

[0026] (iv) After the petroleum jelly cools down to 45°C, the extract and the base are mixed and stirred; the base is the hot melt adhesive described in Example 1, forming a uniform paste.

[0027] (v) Apply the prepared ointment evenly to the medical geomembrane, with a thickness of 3-5 mm, ensuring uniform thickness; (vi) Dry at 30°C until the paste hardens, then stop drying; (vii) Cover both sides of the ointment with a backing paper made of polyethylene film; The composition is as follows: 20 parts by weight of petroleum jelly, 1 part by weight of prickly pear, 1 part by weight of gastrodia elata, 1 part by weight of cinnamon, 1 part by weight of myrrh, 1 part by weight of lycopodium clavatum, 1 part by weight of angelica pubescens, 1 part by weight of cinnamon twig, 1 part by weight of notoginseng, 1.5 parts by weight of vanillyl butyl ether, 2 parts by weight of camphor, 2 parts by weight of borneol, 20 parts by weight of hot melt adhesive, 1 part by weight of eucommia ulmoides, 1 part by weight of dipsacus asper, 1 part by weight of mulberry mistletoe, 1 part by weight of drynaria fortunei, and 1 part by weight of safflower.

[0028] Example 4: Example 4 is basically the same as Example 1, except that it does not contain vanillyl butyl ether.

[0029] Example 5: Example 5 is basically the same as Example 2, except that the geomembrane is replaced with non-woven fabric.

[0030] Example 6: Transdermal testing was conducted on the plaster prepared in Example 1. After the plaster was applied to the skin for half an hour, the skin began to feel slightly warm, and the pain lessened. The warmth intensified after about 40 minutes to an hour, and the pain significantly decreased, with the warmth lasting for 3 to 5 hours. No allergic reactions were observed. The plaster was removed after 6 hours. The adhesiveness of the plaster did not decrease significantly.

[0031] Transdermal testing was conducted on the plaster prepared in Example 2. After the plaster was applied to the skin for half an hour, the skin began to feel slightly warm, and the pain lessened. The warmth intensified after about 40 minutes to an hour, and the pain significantly decreased, with the warmth lasting for 3 to 5 hours. No allergic reactions were observed. The plaster was removed after 6 hours. The adhesiveness of the plaster did not decrease significantly.

[0032] Transdermal testing was conducted on the plaster prepared in Example 3. After the plaster was applied to the skin for half an hour, the skin began to feel slightly warm, and the pain lessened. The warmth intensified after about 40 minutes to an hour, and the pain significantly decreased, with the warmth lasting for 3 to 5 hours. No allergic reactions were observed. The plaster was removed after 6 hours. The adhesiveness of the plaster did not decrease significantly.

[0033] Transdermal test data for the plaster prepared in Example 4: After the plaster was applied to the skin for 2 hours, the skin began to feel slightly warm, which lasted for 1 hour, although the heat sensation was weak. Pain was slightly reduced. The warmth lasted for 2-4 hours. No allergic reactions were observed. The plaster was removed after 6 hours. The adhesiveness of the plaster did not decrease significantly.

[0034] Transdermal test data were performed on the plaster prepared in Example 5. After the plaster was applied to the skin for 2 hours, the skin began to feel slightly warm, which lasted for 1 hour, although the heat sensation was weak. Pain was slightly reduced. The warmth lasted for 2-4 hours. No allergic reactions were observed. The plaster was removed after 6 hours. The adhesiveness of the plaster did not decrease significantly.

[0035] Summary table of efficacy of each embodiment: The efficacy summary table shows that Example 1 exhibits earlier skin warming, while Example 4 shows later skin warming. This indicates that vanillyl butyl ether significantly helps other drug components penetrate the skin barrier, improving overall efficacy. Examples 2 and 3 show longer duration of continuous warming, while Example 4 shows a shorter duration. This demonstrates that using different temperatures for preparation of the plaster, one containing volatile components and the other not, avoids excessive loss of volatile components, retaining more volatile components in the plaster and enhancing efficacy.

[0036] The above embodiments are only for illustrating the technical concept and features of the present invention. Their purpose is to enable those skilled in the art to understand the content of the present invention and implement it. They should not be used to limit the scope of protection of the present invention. Any equivalent structural or procedural transformations made using the content of the present invention specification, or direct or indirect applications in other related technical fields, are similarly included within the scope of protection of the present invention.

Claims

1. A topical analgesic traditional Chinese medicine composition, characterized in that, The active ingredients of the raw material are contained in the following parts by weight: 1 part of prickly pear, 1 part of gastrodia elata, 1 part of cinnamon, 1 part of myrrh, 1 part of lycopodium clavatum, 1 part of frankincense, 1 part of angelica pubescens, 1 part of cinnamon twig, 1 part of notoginseng, 1 part of eucommia ulmoides, 1 part of dipsacus asper, 1 part of mulberry mistletoe, 1 part of drynaria fortunei, and 1 part of safflower, as well as the penetration-enhancing ingredients: 1.5 parts of vanillyl butyl ether, 2 parts of camphor, and 2 parts of borneol.

2. The topical analgesic traditional Chinese medicine composition according to claim 1, characterized in that, The particle size of the active ingredient in the raw material is such that it passes through an 80-mesh sieve.

3. A topical analgesic plaster, characterized in that, It comprises the topical analgesic Chinese medicine composition as described in claim 1 or 2, and a pharmaceutically acceptable matrix.

4. The topical analgesic plaster according to claim 3, characterized in that, The pharmaceutically acceptable matrix comprises medical hot melt adhesive and petroleum jelly.

5. The topical analgesic plaster according to claim 4, characterized in that, The medical hot melt adhesive is in the form of 20 parts by weight, and the petroleum jelly is in the form of 20 parts by weight.

6. A method for preparing a topical analgesic plaster according to any one of claims 3 to 5, characterized in that, Includes the following steps: (1) Grind the following ingredients into powder and pass them through an 80-mesh sieve: prickly pear, gastrodia elata, cinnamon, myrrh, lycopodium clavatum, frankincense, angelica pubescens, cinnamon twig, notoginseng, camphor, borneol, eucommia ulmoides, dipsacus asper, mulberry mistletoe, drynaria fortunei, and safflower. (2) Add petroleum jelly to the container, heat to 60-70°C, add the ground and crushed prickly pear, gastrodia elata, lycopodium clavatum, vanillyl butyl ether and Panax notoginseng, stir evenly, keep warm and stir for 20 minutes. (3) Lower the temperature to 50-60℃, add the ground and crushed cinnamon, myrrh, frankincense, Angelica pubescens, cinnamon twig, camphor, borneol, Eucommia ulmoides, Dipsacus asper, Taxillus chinensis, Drynaria fortunei, and safflower, stir evenly, and keep warm for 10 minutes. (4) When the system temperature drops to 40-50℃, add medical hot melt adhesive, stir and mix evenly to form an ointment; (5) Apply the ointment evenly onto a medical carrier; (6) Dry until the paste hardens; (7) Cover the surface of the cured paste with an anti-sticking film.

7. The preparation method according to claim 6, characterized in that, The coating thickness described in step (5) is 3 to 5 mm.

8. The preparation method according to claim 6, characterized in that, The drying temperature in step (6) shall not exceed 35°C.

9. The preparation method according to claim 6, characterized in that, The medical carrier is a medical geomembrane or non-woven fabric.

10. The preparation method according to claim 6, characterized in that, The anti-sticking film is a polyethylene film backing paper.

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