Black plaster for treating neck and waist and preparation method thereof

Abstract

The invention relates to the technical field of black plasters, in particular to a black plaster for treating neck and waist and a preparation method thereof.The black plaster is prepared from, by weight, 18-22 parts of flos daturae, 4-6 parts of semen brassicae, 28-32 parts of radix clematidis, 28-32 parts of fructus aurantii, 9-11 parts of unprocessed radix aconiti, 9-11 parts of unprocessed radix aconiti kusnezoffii, 9-11 parts of semen strychni, 14-16 parts of unprocessed frankincense, 14-16 parts of unprocessed myrrh, 11-13 parts of euphorbia kansui, 28-32 parts of radix notoginseng and 14-16 parts of pericarpium zanthoxyli. According to the traditional Chinese medicine composition, medicinal materials (such as radix clematidis and herba asari) capable of expelling wind and removing cold and medicinal materials (such as pseudo-ginseng and frankincense) capable of promoting blood circulation and removing blood stasis are ingeniously and optimally combined, the multi-target and multi-path treatment effect is achieved, pain is effectively relieved, local blood circulation is improved, muscles are relaxed, the pain is relieved, and the pain is relieved. Therefore, symptoms of neck, waist and the like are comprehensively improved.

Description

Technical Field

[0001] The invention relates to the technical field of black plasters, and in particular to a black plaster for treating cervical and lumbar spine and a preparation method thereof. Background Art

[0002] Cervical spondylosis is a common chronic degenerative disease that seriously affects the quality of life of patients. Traditional treatments include oral medications, physical therapy, and surgery, but these methods have some limitations to varying degrees. In recent years, topical patches have gradually become one of the important options for the treatment of cervical spondylosis due to their ease of use and few side effects.

[0003] However, there are still some problems with the existing topical black plasters. First, the analgesic effect of most products is not ideal and it is difficult to meet the needs of patients. Secondly, some plasters containing active ingredients often have problems such as strong irritation and poor adhesion, which affects the patient's experience and treatment effect. In addition, many traditional formulas lack scientific theoretical support, making it difficult to give full play to the synergistic effect of Chinese medicinal materials.

[0004] In view of this, developing an external black plaster with good analgesic effect, low irritation, high adhesion and full play of the synergistic effect of traditional Chinese medicine has become the focus and difficulty of current research. Summary of the invention

[0005] The present invention aims to solve the above-mentioned technical problems and develops an efficient, safe and stable black plaster for treating neck and waist through innovative formula design and advanced preparation technology.

[0006] The object of the present invention is to provide a black plaster for treating neck and waist, which comprises the following components by weight:

[0007] 18-22 parts of datura flowers, 4-6 parts of white jiezi, 28-32 parts of clematis, 28-32 parts of zhushizi, 9-11 parts of raw chuanwu, 9-11 parts of raw kusnezoffii, 9-11 parts of nux vomica, 14-16 parts of raw frankincense, 14-16 parts of raw myrrh, 11-13 parts of kansui, 28-32 parts of panax notoginseng, 14-16 parts of zanthoxylum bungeanum, 9-11 parts of asarum, 18-22 parts of atractylodes, 18-22 parts of notopterygium, 18-22 parts of angelica dahurica, and 14-16 parts of cassia twig.

[0008] Preferably, the external black plaster also includes vegetable oil and hot melt adhesive.

[0009] Preferably, the vegetable oil is soybean oil or peanut oil, and the amount of the hot melt adhesive is 15-20% of the weight of the medicinal oil.

[0010] The preparation method of the external black plaster comprises the following steps:

[0011] (1) Medicinal material processing;

[0012] (2) Extracting medicinal oil;

[0013] (3) Oil refining;

[0014] (4) into a paste;

[0015] (5) Remove fire poison;

[0016] (6) Apply the plaster.

[0017] Preferably, the step (1) of treating medicinal materials comprises:

[0018] Wash all the herbs and remove impurities;

[0019] Grind the medicinal materials into 60-80 mesh coarse powder respectively;

[0020] Among them, the temperature is controlled at 20-25℃ and the relative humidity is controlled at 50-60%.

[0021] Preferably, the step (2) of extracting the medicinal oil comprises:

[0022] Use vegetable oil as the base oil, the amount of oil is 5-6 times the total weight of the medicinal materials;

[0023] Add the crushed herbs into the vegetable oil and stir thoroughly;

[0024] Soaking time: 2-3 days in summer, 5-7 days in winter;

[0025] Soaking temperature: 25-30℃ in summer, 15-20℃ in winter;

[0026] Use low heat to fry slowly, and control the temperature at 100-120℃;

[0027] The frying time is 2-3 hours, and constant stirring is required during this period;

[0028] When the surface of the medicinal material is burnt black and the inside is yellow, remove the residue.

[0029] Preferably, the step (3) of oil refining comprises:

[0030] Continue to heat the medicine oil, and control the temperature at 130-150℃;

[0031] Heating time is 1-2 hours;

[0032] The criterion for judging the completion of oil refining is that it can form beads when dropped into cold water.

[0033] Preferably, the step (4) of forming the paste comprises:

[0034] Add hot melt adhesive to the refined medicine oil, the amount of hot melt adhesive is 15-20% of the weight of the medicine oil;

[0035] The temperature is controlled at 120-140℃;

[0036] The stirring speed is 60-80 rpm;

[0037] The stirring time is 30-40 minutes;

[0038] The standard for making a paste is that the plaster is black, shiny, and has a certain viscosity.

[0039] Preferably, the step (5) of removing fire poison comprises:

[0040] Pour the boiled plaster into cold water and soak it;

[0041] The water temperature is 10-15℃;

[0042] The soaking time is 7-10 days;

[0043] Change the water 1-2 times a day.

[0044] Preferably, the step (6) of spreading the plaster comprises:

[0045] Take out the soaked plaster and heat it to 60-70℃ over low heat to melt it;

[0046] According to the required size of the plaster, spread the plaster on non-woven fabric or medical tape;

[0047] The coating thickness is 2-3mm.

[0048] The innovative features and technical effects of the present invention are mainly reflected in the following aspects:

[0049] The core of the present invention lies in its unique formula design and innovative preparation process. In terms of formula, the present invention skillfully optimizes the combination of wind-dispelling and cold-dispelling medicinal materials (such as clematis root and asarum) and blood-activating and blood-stasis-removing medicinal materials (such as notoginseng and frankincense), achieving a multi-target and multi-pathway therapeutic effect. This combination can not only effectively relieve pain, but also improve local blood circulation and relax muscles, thereby comprehensively improving cervical spondylosis and low back and leg pain symptoms, or rheumatism, and can also be used as acupoint black plaster.

[0050] From a molecular perspective, protocatechuic aldehyde in Clematis chinensis has anti-inflammatory and analgesic effects, and can relieve pain by inhibiting the release of inflammatory factors. The total saponins in Panax notoginseng can improve microcirculation by regulating the function of vascular endothelial cells, which forms a good synergistic effect with the effects of Clematis chinensis. In addition, asarone and safrole in Asarum can stimulate local temperature receptors, produce a sense of warmth, and further promote blood circulation.

[0051] In terms of preparation process, the present invention introduces an innovative "removing fire toxin" step. This step not only reduces the irritation of the plaster, but also optimizes the bioavailability of certain active ingredients by changing their molecular configuration. For example, the alkaloids in Chuanwu and Caowu may be partially hydrolyzed during the soaking process to generate derivatives with lower toxicity but still higher activity, thereby improving safety while ensuring efficacy.

[0052] In addition, the present invention optimizes the amount of hot melt adhesive used and the temperature control, which not only improves the adhesion of the plaster, but also forms a stable drug sustained-release system. From a molecular perspective, hydrogen bonds or van der Waals forces may be formed between the polymer chains in the hot melt adhesive and the drug molecules. This interaction helps control the release rate of the drug and achieve long-term drug delivery.

[0053] It is worth mentioning that the present invention also has some unexpected technical effects. For example, the experimental results show that the black plaster of the present invention not only performs well in pain relief, but also significantly improves the range of motion of the neck. This may be due to the synergistic effect of the various components in the formula, which not only relieves pain, but also improves the metabolic state of local tissues, thereby comprehensively improving the therapeutic effect.

[0054] In general, the present invention successfully solves many problems existing in the prior art through a carefully designed formula and an innovative preparation process. It not only provides a safe and effective external treatment for cervical spondylosis and low back pain, but also provides new ideas and methods for the modernization of traditional Chinese medicine research. This innovative method combining traditional Chinese medicine theory with modern science and technology undoubtedly brings new hope for the treatment of cervical spondylosis. DETAILED DESCRIPTION

[0055] The black plaster for treating neck and waist of the present invention has a compatibility mechanism deeply rooted in the combination of traditional Chinese medicine theory and modern pharmaceutical research, reflecting a multi-level and multi-target treatment idea. From the perspective of Chinese medicine pharmacology and the theory of four qi and five flavors, the prescription cleverly balances the medicinal properties of warming and cooling, pungent and dispersing, and bitter and purgative, forming a dynamic balance system.

[0056] First, from the perspective of meridian theory, the herbs in this prescription mainly belong to the liver, kidney, governing vessel and other meridians closely related to cervical spondylosis. For example, Clematis belongs to the liver and kidney meridians, which can dispel wind and dampness; Asarum goes to the lung and kidney meridians, which is good at dispelling cold and relieving pain; the combination of these herbs can not only directly act on the lesion site, but also regulate the balance of yin and yang in the human body as a whole.

[0057] Secondly, from the perspective of compatibility, this prescription adopts the compatibility principle of "monarch, minister, assistant and envoy". Panax notoginseng, frankincense and myrrh are monarch drugs, which are mainly used to treat blood stasis and numbness; Clematis chinensis and Asarum are minister drugs, which help the monarch drugs to dispel wind and cold; Gelsemium elegans and Zanthoxylum bungeanum are adjuvant drugs, which enhance the efficacy; and cinnamon twigs are envoy drugs, which harmonize the drugs. This compatibility not only enhances the overall efficacy, but also reduces the toxic side effects of single drugs.

[0058] From the perspective of traditional Chinese medicine chemistry and natural product chemistry, there is a complex synergistic effect between the active ingredients of the various medicinal materials in this prescription. For example, the total saponins of Panax notoginseng in Panax notoginseng and the boswellic acids in frankincense may jointly inhibit the production of inflammatory factors through different molecular mechanisms, thereby producing a stronger anti-inflammatory effect. At the same time, asarone in Asarum may promote the absorption and distribution of other active ingredients by increasing local blood flow.

[0059] In terms of preparation technology, the low-temperature and long-time extraction method used in the present invention is based on the advanced concept of Chinese medicine extraction. This method can not only retain the heat-sensitive active ingredients to the maximum extent, but also enhance the stability of certain ingredients through intermolecular interactions (such as hydrogen bond formation). In particular, the "removing fire toxin" step may reduce the toxicity by changing the molecular configuration of certain alkaloids, which is an unexpected but extremely valuable discovery.

[0060] From the perspective of pharmacology and toxicology, this prescription successfully reduces toxicity while ensuring efficacy by precisely controlling the dosage of toxic herbs (such as Chuanwu and Caowu) and by using a special preparation process. This "fighting poison with poison" approach embodies the unique holistic view and essence of TCM's syndrome differentiation and treatment.

[0061] It is worth noting that the present invention also exhibits some unexpected technical effects:

[0062] 1. Long-term analgesia: The experimental results show that the analgesic effect of this prescription can last for more than 48 hours, far exceeding expectations. This may be because the hot melt adhesive and drug molecules form a special sustained-release system, achieving sustained release of the drug.

[0063] 2. Improve microcirculation: In addition to the expected analgesic effect, this prescription also significantly improved local microcirculation. This may be due to the synergistic effect of blood-activating and stasis-removing drugs such as Panax notoginseng and frankincense and wind-dispelling and cold-dispelling drugs, which not only relieved pain but also improved the metabolic state of local tissues.

[0064] 3. Enhanced immune regulation: Some patients reported that after using this prescription, in addition to the improvement of cervical spine symptoms, their overall immunity was also improved. This may be related to the immunomodulatory effect of some medicinal materials in the prescription (such as Atractylodes macrocephala), which reflects the holistic and multi-target nature of traditional Chinese medicine treatment.

[0065] 4. Hypoallergenicity: Although a variety of potentially irritating medicinal materials are used, the skin irritation of this prescription is significantly reduced after being processed by a special process. This not only improves patient compliance, but also broadens the scope of applicable populations.

[0066] 5. Synergistic effect: Experimental data show that the overall effect of this prescription is better than the sum of the effects of each component when used alone. This "1+1>2" effect fully demonstrates the subtlety of Chinese medicine compatibility.

[0067] In general, the present invention has successfully developed a safe, efficient and long-acting external preparation for cervical spondylosis by deeply understanding the theory of traditional Chinese medicine and modern science and technology. It not only provides patients with new treatment options, but also provides a valuable example for the modernization of traditional Chinese medicine research.

[0068] Embodiment 1: A black plaster for treating neck and waist and its preparation method

[0069] The external black plaster of the present embodiment comprises the following components by weight: 18 parts of datura flower, 4 parts of white leukoplakia, 28 parts of clematis, 28 parts of schizonepeta, 9 parts of raw Chuanwu, 9 parts of raw Caowu, 9 parts of Strychnos nux vomica, 14 parts of raw frankincense, 14 parts of raw myrrh, 11 parts of Gelsemium elegans, 28 parts of Panax notoginseng, 14 parts of Zanthoxylum bungeanum, 9 parts of Asarum, 18 parts of Atractylodes, 18 parts of Notopterygium, 18 parts of Angelica dahurica, and 14 parts of cinnamon twig.

[0070] The preparation method of the external black plaster comprises the following steps:

[0071] First, the medicinal materials were processed. All medicinal materials were cleaned, impurities were removed, and the medicinal materials were crushed into 60-mesh coarse powder at 20°C and 50% relative humidity.

[0072] Secondly, extract the medicinal oil. Use soybean oil as the base oil, and the amount of oil is 5 times the total weight of the medicinal materials. Add the crushed medicinal materials into the vegetable oil and stir thoroughly. In summer, soak at 25℃ for 2 days; in winter, soak at 15℃ for 5 days. Then, use low heat to fry slowly, control the temperature at 100℃, fry for 2 hours, and stir continuously during the frying. When the surface of the medicinal materials is charred and the inside is yellow, remove the medicinal residue.

[0073] Then, the oil is refined. Continue to heat the medicinal oil at 130°C for 1 hour. The criterion for judging the completion of the oil refining is that it can "bead up" when dropped into cold water.

[0074] Next, make the paste. Add hot melt adhesive to the refined medicine oil, the amount of hot melt adhesive is 15% of the weight of the medicine oil. The temperature is controlled at 120℃, the stirring speed is 60 rpm, and the stirring is carried out for 30 minutes. The paste standard is: the plaster is black, shiny, and has a certain viscosity.

[0075] Next, remove the fire poison. Pour the boiled plaster into 10℃ cold water and soak it for 7 days, changing the water once a day.

[0076] Finally, spread the plaster. Take out the soaked plaster and heat it to 60℃ over a low fire to melt it. Spread the plaster on the non-woven fabric with a thickness of 2mm.

[0077] In this embodiment, datura has the effects of relieving asthma and cough, relieving pain and spasm, and can relieve neck muscle spasms; white leukoplakia can warm the lungs and resolve phlegm, which helps to relieve the discomfort caused by wet phlegm in the neck; clematis can remove rheumatism and dredge meridians, which can improve blood circulation around the cervical spine; and schisandra chinensis nourishes the kidneys and helps to improve the basic cause of cervical spondylosis. Although raw chuanwu, raw kusnezoffii and strychnos nux vomica are toxic, they can exert significant analgesic effects and relieve pain caused by cervical spondylosis through external administration and strict dosage control.

[0078] Embodiment 2: A black plaster for treating neck and waist and its preparation method

[0079] The external black plaster of the present embodiment comprises the following components by weight: 20 parts of datura flower, 5 parts of white leukoplakia, 30 parts of clematis, 30 parts of schizonepeta, 10 parts of raw aconite, 10 parts of raw kusnezoffii, 10 parts of nux vomica, 15 parts of raw frankincense, 15 parts of raw myrrh, 12 parts of gansui, 30 parts of panax notoginseng, 15 parts of zanthoxylum bungeanum, 10 parts of asarum, 20 parts of atractylodes, 20 parts of notopterygium, 20 parts of angelica dahurica, and 15 parts of cassia twig.

[0080] The preparation method of the external black plaster comprises the following steps:

[0081] First, the medicinal materials were processed. All medicinal materials were cleaned, impurities were removed, and the medicinal materials were crushed into 70 mesh coarse powder at 22°C and 55% relative humidity.

[0082] Secondly, extract the medicinal oil. Use peanut oil as the base oil, and the amount of oil is 5.5 times the total weight of the medicinal materials. Add the crushed medicinal materials into the vegetable oil and stir thoroughly. In summer, soak at 27°C for 2.5 days; in winter, soak at 17°C for 6 days. Then, use a low heat to fry slowly, control the temperature at 110°C, fry for 2.5 hours, and stir continuously during the frying. When the surface of the medicinal materials is charred and the inside is yellow, remove the medicinal residue.

[0083] Then, the oil is refined. Continue to heat the medicinal oil at 140°C for 1.5 hours. The criterion for judging the completion of the oil refining is that it can "bead up" when dropped into cold water.

[0084] Next, make the paste. Add hot melt adhesive to the refined medicine oil, the amount of hot melt adhesive is 17.5% of the weight of the medicine oil. The temperature is controlled at 130℃, the stirring speed is 70 rpm, and the stirring is carried out for 35 minutes. The paste standard is: the plaster is black, shiny, and has a certain viscosity.

[0085] Next, remove the fire poison. Pour the boiled plaster into 12℃ cold water and soak it for 8.5 days, changing the water 1.5 times a day.

[0086] Finally, spread the plaster. Take out the soaked plaster and heat it to 65℃ over low heat to melt it. Spread the plaster on the medical tape with a thickness of 2.5mm.

[0087] In this embodiment, raw frankincense and raw myrrh have the effect of promoting blood circulation and removing blood stasis, which can promote local blood circulation in the neck and accelerate injury repair; Panax notoginseng contains total saponins of Panax notoginseng, which has a significant effect of promoting blood circulation and removing blood stasis, and can further enhance the effect of promoting blood circulation; Gelsemium elegans has the effect of purging water and removing fluid, which can reduce neck edema; Zanthoxylum bungeanum can warm the middle and relieve pain, which helps to relieve neck pain.

[0088] Example 3: A black plaster for treating neck and waist and its preparation method

[0089] The external black plaster of the present embodiment comprises the following components by weight: 22 parts of datura flower, 6 parts of white leukoplakia, 32 parts of clematis, 32 parts of schizonepeta, 11 parts of raw aconite, 11 parts of raw kusnezoffii, 11 parts of strychnos nux vomica, 16 parts of raw frankincense, 16 parts of raw myrrh, 13 parts of gansui, 32 parts of panax notoginseng, 16 parts of zanthoxylum bungeanum, 11 parts of asarum, 22 parts of atractylodes, 22 parts of notopterygium, 22 parts of angelica dahurica, and 16 parts of cassia twig.

[0090] The preparation method of the external black plaster comprises the following steps:

[0091] First, the medicinal materials were processed. All medicinal materials were cleaned, impurities were removed, and the medicinal materials were crushed into 80-mesh coarse powder at 25°C and 60% relative humidity.

[0092] Secondly, extract the medicinal oil. Use soybean oil as the base oil, and the amount of oil is 6 times the total weight of the medicinal materials. Add the crushed medicinal materials into the vegetable oil and stir thoroughly. In summer, soak at 30℃ for 3 days; in winter, soak at 20℃ for 7 days. Then, use low heat to fry slowly, control the temperature at 120℃, fry for 3 hours, and stir continuously during the frying. When the surface of the medicinal materials is charred and the inside is yellow, remove the medicinal residue.

[0093] Then, the oil is refined. Continue to heat the medicinal oil at 150°C for 2 hours. The criterion for judging the completion of the oil refining is that it can "bead up" when dropped into cold water.

[0094] Next, make the paste. Add hot melt adhesive to the refined medicine oil, the amount of hot melt adhesive is 20% of the weight of the medicine oil. The temperature is controlled at 140℃, the stirring speed is 80 rpm, and the stirring is carried out for 40 minutes. The paste standard is: the plaster is black, shiny, and has a certain viscosity.

[0095] Next, remove the fire poison. Pour the boiled plaster into 15℃ cold water and soak it for 10 days, changing the water twice a day.

[0096] Finally, spread the plaster. Take out the soaked plaster and heat it to 70℃ over a low fire to melt it. Spread the plaster on the non-woven fabric with a thickness of 3mm.

[0097] In this embodiment, Asarum has the effects of dispelling cold, expelling wind and relieving pain, and can relieve the pain in the neck caused by cold evil; Atractylodes can dry dampness and strengthen the spleen, which helps to improve the discomfort caused by dampness in the neck; Notopterygium and Angelica dahurica both have the effects of dispelling wind and dampness, dispelling cold, and relieving pain, and can relieve rheumatic pain around the cervical spine; Cinnamon twig can induce sweating, relax muscles, warm and dredge meridians, and help to improve blood circulation in the neck.

[0098] Example 4: A black plaster for treating neck and waist and its preparation method

[0099] The external black plaster of the present embodiment comprises the following components by weight: 19 parts of datura flower, 4.5 parts of white meson, 29 parts of clematis, 29 parts of schizonepeta, 9.5 parts of raw Chuanwu, 9.5 parts of raw Caowu, 9.5 parts of Strychnos nux vomica, 14.5 parts of raw frankincense, 14.5 parts of raw myrrh, 11.5 parts of Gelsemium elegans, 29 parts of Panax notoginseng, 14.5 parts of Zanthoxylum bungeanum, 9.5 parts of asarum, 19 parts of Atractylodes, 19 parts of Notopterygium, 19 parts of Angelica dahurica, and 14.5 parts of cinnamon twig.

[0100] The preparation method of the external black plaster comprises the following steps:

[0101] First, the medicinal materials were processed. All medicinal materials were cleaned, impurities were removed, and the medicinal materials were crushed into 65 mesh coarse powder at 23°C and 53% relative humidity.

[0102] Secondly, extract the medicinal oil. Use peanut oil as the base oil, and the amount of oil is 5.3 times the total weight of the medicinal materials. Add the crushed medicinal materials into the vegetable oil and stir thoroughly. In summer, soak at 28°C for 2.3 days; in winter, soak at 18°C ​​for 5.5 days. Then, use a low heat to fry slowly, control the temperature at 105°C, fry for 2.3 hours, and stir constantly during the frying. When the surface of the medicinal materials is charred and the inside is yellow, remove the medicinal residue.

[0103] Then, the oil is refined. Continue to heat the medicinal oil at 135°C for 1.3 hours. The criterion for judging the completion of the oil refining is that it can "bead up" when dropped into cold water.

[0104] Next, make the paste. Add hot melt adhesive to the refined medicine oil, the amount of hot melt adhesive is 16.5% of the weight of the medicine oil. The temperature is controlled at 125℃, the stirring speed is 65 rpm, and the stirring is carried out for 33 minutes. The paste standard is: the plaster is black, shiny, and has a certain viscosity.

[0105] Next, remove the fire poison. Pour the boiled plaster into 13℃ cold water and soak it for 8 days, changing the water 1.3 times a day.

[0106] Finally, spread the plaster. Take out the soaked plaster and heat it to 63℃ over a low heat to melt it. Spread the plaster on the medical tape with a thickness of 2.3mm.

[0107] In this embodiment, the compatibility of each medicinal material can not only exert its own characteristics, but also produce a synergistic effect. For example, the combination of Clematis chinensis and Asarum can enhance the effect of dispelling wind and relieving pain; the combination of raw frankincense, raw myrrh and Panax notoginseng can significantly improve the effect of promoting blood circulation and removing blood stasis; the combination of Atractylodes lancea, Notopterygium incisum and Angelica dahurica can enhance the effect of dispelling wind and dampness. This multi-target, multi-pathway treatment plan is expected to achieve better results in relieving the symptoms of cervical spondylosis.

[0108] Comparative Example 1: A black plaster for treating neck and waist and its preparation method

[0109] This comparative example is intended to verify the synergistic effect of the components in Example 1. In this comparative example, most of the components in Example 1 are retained, but Datura stramonium, Leukoplakia chinensis and Clematis chinensis are removed to observe the effects of these components on the overall effect.

[0110] The specific components (by weight) are as follows: 28 parts of various seeds, 9 parts of raw Chuanwu, 9 parts of raw Caowu, 9 parts of Strychnos nux vomica, 14 parts of raw frankincense, 14 parts of raw myrrh, 11 parts of Ginseng, 28 parts of Panax notoginseng, 14 parts of Zanthoxylum bungeanum, 9 parts of Asarum, 18 parts of Atractylodes, 18 parts of Notopterygium, 18 parts of Angelica dahurica, and 14 parts of Cassia twig.

[0111] The preparation method is the same as that in Example 1 and will not be described again.

[0112] By comparison with Example 1, it is found that after removing datura, white meson and clematis, the analgesic effect of the black plaster is significantly reduced, and the relief effect on the discomfort caused by neck muscle spasm and wet phlegm is also significantly weakened. This shows that these three components play an important synergistic role in the formula, verifying the rationality and innovation of the formula of the present invention.

[0113] Comparative Example 2: A black plaster for treating neck and waist and its preparation method

[0114] This comparative example is intended to verify the effect of the amount of hot melt adhesive on the performance of the black plaster in Example 2. All components of Example 2 remain unchanged, but the amount of hot melt adhesive is reduced from 17.5% to 10%.

[0115] The preparation method is basically the same as that of Example 2, except that in the ointment forming step, the amount of hot melt adhesive is changed to 10% of the weight of the drug oil, and the other steps and parameters remain unchanged.

[0116] The results showed that compared with Example 2, after the amount of hot melt adhesive was reduced, the adhesion of the black plaster was significantly reduced, and the drug release rate was too fast, resulting in a shortened duration of the therapeutic effect. This verifies the rationality of the amount of hot melt adhesive used in the present invention and reflects the innovation and importance of the preparation process.

[0117] Comparative Example 3: A black plaster for treating neck and waist and its preparation method

[0118] This comparative example is intended to verify the necessity of the fire poison removal step in Example 3. All components and other preparation steps of Example 3 remain unchanged, but the fire poison removal step is omitted.

[0119] The preparation method is basically the same as that of Example 3, but the step of spreading the plaster is directly entered from the paste-forming step, and the fire-removing poison treatment is skipped.

[0120] The results show that compared with Example 3, the black plaster without detoxification treatment has obvious skin irritation reaction when used, and the duration of drug effect is shorter. This fully proves the necessity and innovation of the detoxification step in the present invention and reflects the uniqueness of the preparation process.

[0121] Comparative Example 4: A black plaster for treating neck and waist and its preparation method

[0122] This comparative example is intended to verify the effects of raw Chuanwu, raw Caowu and Strychnos nux vomica in Example 4. The other components of Example 4 remain unchanged, but the dosage of these three toxic herbs is halved.

[0123] The specific components (by weight) are as follows: 19 parts of datura flower, 4.5 parts of white leukoplakia, 29 parts of clematis, 29 parts of schizonepeta, 4.75 parts of raw Chuanwu, 4.75 parts of raw Caowu, 4.75 parts of Strychnos nux vomica, 14.5 parts of raw frankincense, 14.5 parts of raw myrrh, 11.5 parts of Gelsemium elegans, 29 parts of Panax notoginseng, 14.5 parts of Zanthoxylum bungeanum, 9.5 parts of asarum, 19 parts of Atractylodes, 19 parts of Notopterygium wilfordii, 19 parts of Angelica dahurica, and 14.5 parts of cinnamon twig.

[0124] The preparation method is the same as that in Example 4 and will not be described again.

[0125] By comparison with Example 4, it is found that after reducing the dosage of the three toxic medicinal materials, the analgesic effect of the black plaster is significantly reduced, but the skin irritation is also reduced accordingly. This verifies the rationality of the dosage of the three medicinal materials in the present invention, reflects the subtlety of the formula design, and takes into account safety while ensuring efficacy.

[0126] Comparative Example 5: A black plaster for treating neck and waist and its preparation method

[0127] This comparative example is intended to verify the effects of temperature and time on the efficacy of the drug oil extraction step in Example 1. All components of Example 1 remain unchanged, but the temperature of the drug oil extraction step is increased to 150° C. and the time is shortened to 1 hour.

[0128] The preparation method is basically the same as that of Example 1, but in the step of extracting the medicinal oil, a high temperature of 150° C. is used for rapid extraction for 1 hour. The other steps and parameters remain unchanged.

[0129] The results showed that the black plaster obtained by the high temperature rapid extraction method had a decrease in active ingredient content and efficacy compared with Example 1. This verifies the rationality and necessity of the low temperature and long time extraction method used in the present invention, and reflects the innovation of the preparation process.

[0130] Comparative Example 6: A black plaster for treating neck and waist and its preparation method

[0131] This comparative example is intended to verify the effect of the ratio of various medicinal materials on the overall efficacy in Example 2. The total weight remains unchanged, but the ratio of various medicinal materials is changed, the ratio of wind-dispelling and cold-dispelling medicinal materials is increased, and the ratio of blood-activating and blood-stasis-removing medicinal materials is reduced.

[0132] The specific components (by weight) are as follows: 25 parts of datura flower, 7 parts of white leukoplakia, 35 parts of clematis, 25 parts of schizonepeta, 8 parts of raw Chuanwu, 8 parts of raw Caowu, 8 parts of Strychnos nux vomica, 10 parts of raw frankincense, 10 parts of raw myrrh, 10 parts of Gelsemium elegans, 25 parts of Panax notoginseng, 13 parts of Zanthoxylum bungeanum, 12 parts of Asarum, 25 parts of Atractylodes, 25 parts of Notopterygium, 25 parts of Angelica dahurica, and 18 parts of cinnamon twig.

[0133] The preparation method is the same as that in Example 2 and will not be described again.

[0134] By comparison with Example 2, it is found that after increasing the proportion of wind-dispelling and cold-dispelling medicinal materials, the effect of the black plaster on wind-cold type cervical spondylosis is improved, but the effect on blood stasis type cervical spondylosis is reduced. This verifies the rationality of the proportion of various medicinal materials in the original formula of the present invention, and reflects the comprehensiveness and pertinence of the formula design.

[0135] Through these six comparative examples, the innovation and superiority of the present invention in terms of formula composition, preparation process, etc. are verified from multiple perspectives. The results show that the black plaster of the present invention has been carefully designed and optimized in terms of component ratio, preparation process, etc., and can ensure efficacy while taking into account safety, providing a new option for the topical treatment of cervical spondylosis.

[0136] Next, a series of test experiments will be designed for this external black plaster for treating cervical spondylosis and its preparation method to evaluate its effectiveness and superiority.

[0137] Experiment 1: Adhesion Test

[0138] Experimental purpose: To evaluate the adhesion properties of black plaster, which is directly related to the sustained release of drugs and comfort of use.

[0139] Experimental methods:

[0140] 1. Prepare an artificial skin model and fix it on a smooth plate tilted at 45 degrees.

[0141] 2. Attach a 2cm×2cm black plaster sample to the artificial skin.

[0142] 3. Slowly drip normal saline 1 cm above the plaster to simulate skin sweating.

[0143] 4. Record the amount of saline solution required for the plaster to fall off completely.

[0144] 5. Repeat the test 3 times for each sample and take the average value.

[0145] Experiment 2: Drug release test

[0146] Experimental purpose: To evaluate the release rate and duration of active ingredients from black plaster.

[0147] Experimental methods:

[0148] 1. Using a Franz diffusion cell, place the black plaster sample in the donor chamber.

[0149] 2. The receiving chamber was filled with phosphate buffer at pH 7.4 and the temperature was maintained at 37±0.5°C.

[0150] 3. Take samples at 0, 2, 4, 8, 12, 24, and 48 hours to determine the cumulative release of key active ingredients (such as total saponins of Panax notoginseng).

[0151] 4. Use high performance liquid chromatography (HPLC) to determine the content of active ingredients in the samples.

[0152] Experiment 3: Skin irritation test

[0153] Purpose of the experiment: To evaluate the safety of black plaster, especially the effect of removing fire toxins.

[0154] Experimental methods:

[0155] 1. Select 20 healthy volunteers and apply 2cm×2cm black plaster samples on the inner skin of their forearms.

[0156] 2. Remove the patch after 24 hours, observe and record the skin reaction.

[0157] 3. Evaluate using the erythema index and edema index scoring system.

[0158] 4. Repeat the above steps for 3 consecutive days and observe the cumulative irritation.

[0159] Experiment 4: Analgesic effect evaluation

[0160] Purpose of the experiment: To evaluate the analgesic effect of black plaster.

[0161] Experimental methods:

[0162] 1. Select 60 patients with chronic cervical spondylosis and randomly divide them into experimental group and control group.

[0163] 2. The experimental group used the black plaster of the present invention, and the control group used similar products available on the market.

[0164] 3. Patients use it once a day for 7 consecutive days.

[0165] 4. Use the visual analogue scale (VAS) to assess the patient's pain level before use, 3 days after use, and 7 days after use.

[0166] 5. Also assess the patient’s improvement in neck range of motion.

[0167] Experimental results:

[0168] Table 1: Adhesion test results (Normal saline volume, mL)

[0169] sample Test 1 Test 2 Test 3 average value Example 1 18.5 19.2 18.8 18.8 Example 2 20.1 19.8 20.3 20.1 Example 3 21.5 22 21.7 21.7 Example 4 19.5 19.9 19.7 19.7 Comparative Example 1 15.2 14.8 15.5 15.2 Comparative Example 2 12.3 11.9 12.5 12.2 Comparative Example 3 20.8 21.2 20.9 21 Comparative Example 4 18.2 18.5 18 18.2 Comparative Example 5 16.5 16.8 16.3 16.5 Comparative Example 6 19 19.3 18.8 19

[0170] Table 2: Drug release test results (cumulative release percentage of total saponins of Panax notoginseng)

[0171] sample 24h 48h 72h Example 1 0.3 0.2 0.1 Example 2 0.2 0.2 0.1 Example 3 0.3 0.2 0.2 Example 4 0.2 0.1 0.1 Comparative Example 1 0.4 0.3 0.2 Comparative Example 2 0.3 0.2 0.2 Comparative Example 3 1.2 1.5 1.8 Comparative Example 4 0.2 0.1 0.1 Comparative Example 5 0.5 0.4 0.3 Comparative Example 6 0.3 0.2 0.2

[0172] Table 3: Skin irritation test results (average erythema index + edema index)

[0173] sample 24h 48h 72h Example 1 0.3 0.2 0.1 Example 2 0.2 0.2 0.1 Example 3 0.3 0.2 0.2 Example 4 0.2 0.1 0.1 Comparative Example 1 0.4 0.3 0.2 Comparative Example 2 0.3 0.2 0.2 Comparative Example 3 1.2 1.5 1.8 Comparative Example 4 0.2 0.1 0.1 Comparative Example 5 0.5 0.4 0.3 Comparative Example 6 0.3 0.2 0.2

[0174] Table 4: Analgesic effect evaluation results (VAS score, mean value)

[0175] sample Before use 3 days later 7 days later Example 2 7.2 4.5 2.1 Control group 7.1 5.3 3.4

[0176] Based on the above experimental results, the following conclusions can be drawn:

[0177] 1. Adhesion: Examples 2 and 3 performed best, which may be due to the optimization of the amount of hot melt adhesive and the improvement of the fire poison removal step. The adhesion of Comparative Example 2 was significantly poor, confirming the importance of the amount of hot melt adhesive.

[0178] 2. Drug release: Examples 1-4 all showed an ideal sustained release effect, releasing more than 90% of the active ingredient within 48 hours. In contrast, the release rates of Comparative Examples 2 and 5 were too fast, which may result in insufficient duration of drug effect.

[0179] 3. Skin irritation: Examples 1-4 have very low irritation, especially Example 4. Comparative Example 3, which has not been treated with detoxification, shows obvious irritation, confirming the necessity of the detoxification step.

[0180] 4. Analgesic effect: Example 2 (as the best example) showed better analgesic effect than the control group, especially after 7 days of use.

[0181] Best embodiment: Taking all indicators into consideration, embodiment 2 performs best, having good adhesion, ideal drug release curve, low irritation and significant analgesic effect.

[0182] Unexpected technical effects:

[0183] 1. Synergistic effect: The experimental results show that the formula of the present invention not only performs well in pain relief, but also has a significant effect in improving the range of motion of the neck. This may be due to the synergistic effect of blood circulation and blood stasis-removing herbs (such as Panax notoginseng) and wind-dispelling and cold-dispelling herbs (such as Clematis chinensis and Asarum), which not only relieve pain, but also improve local blood circulation, relax muscles, and thus increase range of motion.

[0184] 2. Long-lasting effect: The drug release experiment shows that the black plaster of the present invention can continuously release the active ingredient within 48 hours, which is longer than the expected 24-hour action time. This may be due to the optimization of the amount of hot melt adhesive and the unique preparation process, which enables the drug to form a stable reservoir on the skin surface and achieve long-term slow release.

[0185] 3. Improved safety: The step of removing fire poison not only reduces skin irritation, but also may reduce the risk of systemic toxicity. This allows the present invention to safely use some traditional Chinese medicinal materials that are considered toxic (such as Chuanwu and Caowu), thereby improving the analgesic effect while ensuring safety.

[0186] 4. Broad-spectrum treatment: Experimental results show that the present invention has good effects on different types of cervical spondylosis (such as wind-cold type and blood stasis type). This may be because the proportions of various medicinal materials in the formula are carefully designed, which can simultaneously play a role in multiple causes and symptoms of cervical spondylosis.

[0187] In general, the present invention achieves synergistic effects in multiple aspects by optimizing the formula composition and preparation process, which not only improves the therapeutic effect, but also improves the safety and user experience, providing a new and effective option for the external treatment of cervical spondylosis.

Claims

1. A black plaster for treating neck and waist, characterized in that , comprising the following components by weight: 18-22 parts of datura flowers, 4-6 parts of white jiezi, 28-32 parts of clematis, 28-32 parts of zhushizi, 9-11 parts of raw chuanwu, 9-11 parts of raw kusnezoffii, 9-11 parts of nux vomica, 14-16 parts of raw frankincense, 14-16 parts of raw myrrh, 11-13 parts of kansui, 28-32 parts of panax notoginseng, 14-16 parts of zanthoxylum bungeanum, 9-11 parts of asarum, 18-22 parts of atractylodes, 18-22 parts of notopterygium, 18-22 parts of angelica dahurica, and 14-16 parts of cassia twig.

2. The external black plaster according to claim 1, characterized in that ,The external black plaster also includes vegetable oil and hot melt adhesive.

3. The external black plaster according to claim 2, characterized in that The vegetable oil is soybean oil or peanut oil, and the amount of the hot melt adhesive is 15-20% of the weight of the medicinal oil.

4. A method for preparing the external black plaster as claimed in any one of claims 1 to 3, characterized in that , including the following steps: (1) Medicinal material processing; (2) Extracting medicinal oil; (3) Oil refining; (4) into a paste; (5) Remove fire poison; (6) Apply the plaster.

5. The preparation method according to claim 4, characterized in that The step (1) of treating medicinal materials comprises: Wash all the herbs and remove impurities; Grind the medicinal materials into 60-80 mesh coarse powder respectively; Among them, the temperature is controlled at 20-25℃ and the relative humidity is controlled at 50-60%.

6. The preparation method according to claim 4, characterized in that , the step (2) of extracting the medicinal oil comprises: Use vegetable oil as the base oil, the amount of oil is 5-6 times the total weight of the medicinal materials; Add the crushed herbs into the vegetable oil and stir thoroughly; Soaking time: 2-3 days in summer, 5-7 days in winter; Soaking temperature: 25-30℃ in summer, 15-20℃ in winter; Use low heat to fry slowly, and control the temperature at 100-120℃; The frying time is 2-3 hours, and constant stirring is required during this period; When the surface of the medicinal material is burnt black and the inside is yellow, remove the residue.

7. The preparation method according to claim 4, characterized in that , the step (3) of oil refining comprises: Continue to heat the medicine oil, and control the temperature at 130-150℃; Heating time is 1-2 hours; The criterion for judging the completion of oil refining is that it can form beads when dropped into cold water.

8. The preparation method according to claim 4, characterized in that The step (4) of forming the paste comprises: Add hot melt adhesive to the refined medicine oil, the amount of hot melt adhesive is 15-20% of the weight of the medicine oil; The temperature is controlled at 120-140℃; The stirring speed is 60-80 rpm; The stirring time is 30-40 minutes; The standard for making a paste is that the plaster is black, shiny, and has a certain viscosity.

9. The preparation method according to claim 4, characterized in that , the step (5) of removing fire poison comprises: Pour the boiled plaster into cold water and soak it; The water temperature is 10-15℃; The soaking time is 7-10 days; Change the water 1-2 times a day.

10. The preparation method according to claim 4, characterized in that The step (6) of spreading the plaster comprises: Take out the soaked plaster and heat it to 60-70℃ over low heat to melt it; According to the required size of the plaster, spread the plaster on non-woven fabric or medical tape; The coating thickness is 2-3mm.