Swelling and pain relieving ointment and preparation method thereof

Abstract

The invention discloses a swelling and pain relieving ointment and a preparation method thereof. The swelling and pain relieving ointment comprises the following components in percentage by weight: 15%-35% of roots and leaves of ardisia quinquefolia, 15%-25% of herb of emilia sonchifolia, 10%-20% of leaves of ovateleaf holly bark, 5%-15% of leaves of buddleia lindleyana and 25%-40% of a camellia oil matrix. The preparation method comprises the following steps: 1) taking roots and leaves of ardisia quinquefolia, whole herb of emilia sonchifolia, leaves of ovateleaf holly bark and leaves of buddleia, drying at a low temperature of 30-50 DEG C, mixing, and crushing to 150-200 meshes through a traditional Chinese medicine wall breaking technology to obtain a pretreated mixed medicinal material; 2, the pretreated mixed medicinal materials and a camellia oil matrix are mixed and stirred into paint.The swelling and pain relieving ointment has the effects of clearing away heat and toxic materials, relieving swelling and pain, promoting blood circulation to remove blood stasis, removing necrotic tissue and promoting tissue regeneration, and is mild in nature and flavor, small in skin irritation and high in transdermal absorption rate.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a swelling-reducing and pain-relieving ointment and its preparation method. Background Technology

[0002] Traditional Chinese medicine anti-inflammatory and analgesic drugs often contain blood-activating and pain-relieving ingredients such as frankincense, myrrh, blister beetle, and natural copper. These ingredients either have strong volatile odors or are inherently toxic, highly irritating, and prone to causing skin allergies. Prolonged use or improper dosage can actually hinder the reduction of swelling and pain and wound healing. Furthermore, existing topical preparations often suffer from low transdermal absorption rates and damage to active ingredients due to unreasonable formulations or manufacturing processes. Therefore, there is an urgent need to develop new anti-inflammatory and analgesic ointments to solve these technical problems. Summary of the Invention

[0003] The main objective of this invention is to provide a swelling-reducing and analgesic ointment and its preparation method, which has the effects of clearing heat and detoxifying, reducing swelling and relieving pain, promoting blood circulation and removing blood stasis, and removing necrotic tissue and promoting tissue regeneration. Moreover, it is mild in nature and taste, has low skin irritation, and high transdermal absorption rate. To achieve this objective, the present invention adopts the following technical solution:

[0004] In a first aspect, the present invention provides an anti-inflammatory and analgesic ointment, which comprises the following components in the following weight ratios: 15%-35% of the root and leaves of *Symplocos buergeriana*, 15%-25% of the whole herb of *Euphorbia hirta*, 10%-20% of the leaves of *Impatiens balsamina*, 5%-15% of the flowers and leaves of *Buddleja officinalis*, and 25%-40% of the camellia oil matrix.

[0005] In at least one embodiment, the component further includes beeswax, wherein the weight percentage of the beeswax is ≤5%.

[0006] In at least one embodiment, the method for preparing the camellia oil matrix includes the following steps: drying the camellia fruit at a low temperature of 30-50℃, crushing it, steaming it in a steamer for 3-10 minutes, pressing it into cakes and cooling it, pressing it in a press for 30-60 minutes, filtering the camellia oil, and sterilizing it.

[0007] In at least one embodiment, the particle size of the roots and leaves of *Symplocos simonii*, the whole plant of *Euphorbia pekinensis*, the leaves of *Ipomoea quamoclit*, and the flowers and leaves of *Buddleja officinalis* is 150-200 mesh.

[0008] Secondly, the present invention also provides a method for preparing the above-mentioned anti-inflammatory and analgesic ointment, characterized by comprising the following steps: 1) taking the root and leaves of *Symplocos buergeriana*, the whole herb of *Symplocos rubrum*, the leaves of *Impatiens balsamina*, and the flowers and leaves of *Buddleja officinalis*, drying them at a low temperature of 30-50℃, mixing them, and then pulverizing them to 150-200 mesh using traditional Chinese medicine cell wall breaking technology to obtain pretreated mixed medicinal materials; 2) mixing the pretreated mixed medicinal materials with camellia oil matrix to form an ointment.

[0009] In at least one embodiment, the method for preparing the camellia oil matrix includes the following steps: drying the camellia fruit at a low temperature of 30-50℃, crushing it, steaming it in a steamer for 3-10 minutes, pressing it into cakes and cooling it, pressing it in a press for 30-60 minutes, filtering the camellia oil, and sterilizing it.

[0010] In at least one embodiment, the method further includes the following steps: mixing and stirring the paste with molten beeswax, cooling, sterilizing, and bottling. The amount of beeswax added is ≤5wt%.

[0011] This invention provides a topical Chinese medicine preparation for reducing swelling and relieving pain. Its main ingredients are derived from traditional Jing ethnic herbs, possessing the effects of promoting blood circulation, reducing swelling and pain, and promoting tissue regeneration. The product is suitable for common symptoms such as sprains, bruises, wound erosion, and joint redness, swelling, heat, and pain. Target users include children, young and middle-aged adults, and the elderly experiencing skin redness, swelling, and pain after fractures, or soft tissue contusions and lacerations caused by trauma, and slow-healing wounds. This invention utilizes authentic Jing ethnic medicinal herbs—such as *Smilax china*, *Ligusticum striatum*, *Ligusticum chuanxiong*, and *Buddleja officinalis*—which have the effects of clearing heat and detoxifying, reducing swelling and relieving pain, promoting blood circulation, and promoting tissue regeneration. Compared with traditional Chinese medicines such as frankincense, myrrh, blister beetles, and natural copper, these herbs are milder in nature, less irritating to the skin, and less likely to cause skin allergies. Combined with camellia oil, which has the effects of clearing heat, reducing inflammation, relieving pain, and promoting skin healing, this ointment not only eliminates concerns about wound infection but also reduces swelling and pain and promotes skin healing. Detailed Implementation

[0012] The anti-inflammatory and analgesic ointment of the present invention comprises the following components in the following weight ratios: 15%-35% of the root and leaves of *Symplocos buergeriana*, 15%-25% of the whole herb of *Euphorbia hirta*, 10%-20% of the leaves of *Impatiens balsamina*, 5%-15% of the flowers and leaves of *Buddleja officinalis*, and 25%-40% of the camellia oil matrix; in addition, it also contains ≤5% beeswax.

[0013] The ingredients of this anti-inflammatory and analgesic ointment are sourced from the following sources: * **Symplocos buergeriana root and leaves:** The root and / or leaves of *Symplocos buergeriana*, a plant in the Myrsinaceae family, possess the effects of clearing heat and detoxifying, promoting blood circulation and regulating menstruation, and dispelling wind and dampness. It is commonly used for amenorrhea, dysmenorrhea, rheumatic pain, and traumatic injuries. * **Symplocos rubra whole herb:** The whole herb of *Symplocos rubra*, a plant in the Asteraceae family, possesses the effects of clearing heat and detoxifying, cooling blood and removing blood stasis, and promoting diuresis and reducing swelling. It is commonly used to treat sore throat, conjunctivitis, oral ulcers, and carbuncles. * **Ilex chinensis leaf:** The leaves of *Ilex chinensis*, a plant in the Aquifoliaceae family, possess the effects of clearing heat and detoxifying, promoting diuresis and removing dampness, regulating qi and relieving pain, and stopping bleeding. It is commonly used for traumatic injuries, rheumatic pain, eczema, and boils. * **Buddleja officinalis flower and leaves:** The flowers and / or leaves of *Buddleja officinalis*, a plant in the Buddlejaceae family, possess the effects of dispelling wind and detoxifying, promoting blood circulation and relieving pain, and killing parasites. It is commonly used to treat rheumatoid arthritis and traumatic injuries. Camellia oil base—namely, camellia oil—is the oil extracted from the seeds of the Camellia oleifera tree (Camellia oleifera var. oleifera), belonging to the Theaceae family. It has the effects of clearing heat, cooling blood, detoxifying, moisturizing the intestines, and relieving itching. It is mainly used to treat eczema, burns, bruises, and abrasions.

[0014] After a fall or sprain, redness, swelling, heat, pain, and bruising often occur. Among the components of this swelling-reducing and pain-relieving ointment, the root and leaves of *Ulmus pumila* promote blood circulation and remove blood stasis; the whole herb of *Polygonum aviculare* clears heat, removes blood stasis, and reduces swelling; the leaves of *Impatiens balsamina* promote blood circulation and relieve pain; the flowers and leaves of *Buddleja officinalis* dispel wind and relieve pain; and camellia oil base is used to harmonize the powder, moisturize the skin, relieve itching, cool the blood, detoxify, and promote skin repair. Furthermore, many studies have shown that the oleic acid in camellia oil has a high similarity to the fatty acids in human skin structure, exhibiting good affinity with the skin and facilitating absorption. It also has antibacterial effects against several bacteria, including *Escherichia coli*, *Bacillus subtilis*, *Aspergillus oryzae*, *Saccharomyces cerevisiae*, *Staphylococcus aureus*, and *Aspergillus niger*, essentially acting as a good skin "antibiotic."

[0015] The preparation method of the present invention includes the following steps: 1) Take the roots and leaves of *Symplocos simonii*, the whole herb of *Lysimachia christinae*, the leaves of *Impatiens balsamina*, and the flowers and leaves of *Buddleja officinalis*, dry them at a low temperature of 30-50℃, mix them, and then pulverize them to 150-200 mesh using traditional Chinese medicine cell wall breaking technology to obtain pretreated mixed medicinal materials; 2) Mix the pretreated mixed medicinal materials with camellia oil matrix to form a paste; 3) Mix the paste with molten beeswax, cool it, sterilize it, and bottle it.

[0016] The aforementioned Chinese medicine cell wall breaking technology involves using ultra-micro pulverization equipment (such as high-speed airflow pulverizers, vibrating mills, etc.) to pulverize Chinese medicinal herbs (such as plant-based medicinal materials) with cellular structures into powdered medicinal materials. Its core objective is to break down plant cell walls, release the effective components (such as alkaloids, flavonoids, saponins, etc.) encapsulated within the cells, and at the same time retain the full composition of the medicinal materials (without high-temperature extraction or the addition of excipients).

[0017] The preparation method of the camellia oil matrix includes the following steps: drying camellia fruit at a low temperature of 30-50℃, crushing, steaming in a steamer for 3-10 minutes, pressing into cakes and cooling, pressing in a press for 30-60 minutes, filtering the camellia oil, and sterilizing. Studies have shown that camellia oil has an inhibitory effect on molds, bacteria, and yeasts. The results show that camellia oil is significantly different from the control group and has a good inhibitory effect. At the same time, a camellia oil concentration of only 7% can simultaneously achieve antibacterial effects against several bacteria, including Escherichia coli, Bacillus subtilis, Aspergillus oryzae, Saccharomyces cerevisiae, Staphylococcus aureus, and Aspergillus niger. It can achieve an antibacterial effect equivalent to 100 μg·mL⁻¹ ampicillin. The oleic acid in camellia oil has a high similarity to the fatty acids in human skin structure, has good affinity with the skin, is conducive to skin absorption, and can maintain the normal physiological functions and metabolic activities of skin cells.

[0018] The sterilization methods used in the preparation of camellia oil matrix and the preparation of anti-inflammatory and analgesic ointment can be any common sterilization methods in this field; irradiation sterilization technology, such as ultraviolet sterilization and 60Co-γ ray irradiation sterilization, are preferred.

[0019] In actual production and use, the swelling-reducing and pain-relieving ointment of this invention can also be equipped with external breathable patches of different specifications, which patients can purchase as needed according to the local area of ​​injury.

[0020] The present invention will be illustrated and explained below through several embodiments. It should be understood that the following embodiments are not intended to limit the present invention.

[0021] Example 1

[0022] The anti-swelling and analgesic ointment is prepared by the following steps:

[0023] 1) Pretreatment of medicinal materials: Dry the roots and leaves of small-leaved umbellatus, the whole herb of red clover, strychnine, and flowers and leaves of Buddleja officinalis at low temperature (40℃), mix them in a weight ratio of 3:3:2:2 to break the cell wall and obtain a pretreated mixed medicinal material with a mesh size of 150-200.

[0024] 2) Preparation of tea oil matrix: Dry the tea fruit at a low temperature of 40℃, crush it, steam it in a steamer for 5 minutes, press the cake and cool it, press it in a press for 40 minutes, filter the tea oil, sterilize it, and obtain the tea oil matrix;

[0025] 3) Mix the pretreated mixed medicinal materials and tea oil base, and add molten beeswax to adjust the rheological properties of the ointment. The mass ratio of the pretreated mixed medicinal materials, tea oil base and beeswax is 60:35:5. After cooling, sterilize the prepared ointment and put it into cans.

[0026] HPLC analysis showed that the release rate of active ingredients such as unsaturated fatty acids was 40% higher than that of traditional grinding methods; transdermal experiments showed that the cumulative penetration amount reached 68.3 μg / cm² after 8 hours.

[0027] Example 2

[0028] The anti-swelling and analgesic ointment is prepared by the following steps:

[0029] 1) Pretreatment of medicinal materials: Dry the roots and leaves of small-leaved umbellatus, the whole herb of red clover, strychnine, and flowers and leaves of Buddleja officinalis at low temperature (30℃), mix and break the cell walls to obtain pretreated mixed medicinal materials with a mesh size of 150-200.

[0030] 2) Preparation of tea oil matrix: Dry the tea fruit at a low temperature of 40℃, crush it, steam it in a steamer for 10 minutes, press the cake and cool it, press it in a press for 60 minutes, filter the tea oil, sterilize it, and obtain the tea oil matrix;

[0031] 3) Mix the pretreated medicinal materials and tea oil base, add molten beeswax to adjust the rheological properties of the ointment, cool, sterilize the prepared ointment and pack it into cans;

[0032] The mass ratio of each component is as follows: 15% of the root and leaves of *Symplocos buergeriana*, 20% of the whole plant of *Euphorbia hirta*, 20% of the leaves of *Impatiens balsamina*, 14% of the flowers and leaves of *Buddleja officinalis*, 30% of the camellia oil matrix, and 1% of the beeswax.

[0033] Example 3

[0034] The anti-swelling and analgesic ointment is prepared by the following steps:

[0035] 1) Pretreatment of medicinal materials: Dry the roots and leaves of small-leaved umbellatus, the whole herb of red clover, strychnine, and flowers and leaves of Buddleja officinalis at low temperature (40℃), mix and break the cell walls to obtain pretreated mixed medicinal materials with a mesh size of 150-200.

[0036] 2) Preparation of tea oil matrix: Dry the tea fruit at a low temperature of 50℃, crush it, steam it in a steamer for 3 minutes, press the cake and cool it, press it in a press for 40 minutes, filter the tea oil, sterilize it, and obtain the tea oil matrix;

[0037] 3) Mix the pretreated medicinal materials and tea oil base, add molten beeswax to adjust the rheological properties of the ointment, cool, sterilize the prepared ointment and pack it into cans;

[0038] The mass ratio of each component is as follows: 35% for the roots and leaves of *Symplocos buergeriana*, 15% for the whole plant of *Euphorbia hirta*, 10% for the leaves of *Euphorbia hirta*, 10% for the flowers and leaves of *Buddleja officinalis*, 25% for the camellia oil matrix, and 5% for beeswax.

[0039] Example 4

[0040] The anti-swelling and analgesic ointment is prepared by the following steps:

[0041] 1) Pretreatment of medicinal materials: Dry the roots and leaves of small-leaved umbellatus, the whole herb of red clover, strychnine, and flowers and leaves of Buddleja officinalis at low temperature (40℃), mix and break the cell walls to obtain pretreated mixed medicinal materials with a mesh size of 150-200.

[0042] 2) Preparation of tea oil matrix: Dry the tea fruit at a low temperature of 30℃, crush it, steam it in a steamer for 5 minutes, press the cake and cool it, press it in a press for 30 minutes, filter the tea oil, sterilize it, and obtain the tea oil matrix;

[0043] 3) Mix the pretreated medicinal materials and tea oil base, add molten beeswax to adjust the rheological properties of the ointment, cool, sterilize the prepared ointment and pack it into cans;

[0044] The mass ratio of each component is as follows: 20% for the roots and leaves of *Symplocos buergeriana*, 15% for the whole plant of *Euphorbia hirta*, 15% for the leaves of *Impatiens balsamina*, 5% for the flowers and leaves of *Buddleja officinalis*, 40% for the camellia oil matrix, and 5% for beeswax.

[0045] Example 5

[0046] The anti-swelling and analgesic ointment is prepared by the following steps:

[0047] 1) Pretreatment of medicinal materials: Dry the roots and leaves of *Symplocos simonii*, the whole herb of *Euphorbia hirta*, *Euphorbia pekinensis*, and the flowers and leaves of *Buddleja officinalis* at low temperature (45℃), mix and break the cell walls to obtain pretreated mixed medicinal materials with a mesh size of 150-200.

[0048] 2) Preparation of tea oil matrix: Dry the tea fruit at a low temperature of 45℃, crush it, steam it in a steamer for 8 minutes, press the cake and cool it, press it in a press for 40 minutes, filter the tea oil, sterilize it, and obtain the tea oil matrix;

[0049] 3) Mix the pretreated medicinal materials and tea oil base, add molten beeswax to adjust the rheological properties of the ointment, cool, sterilize the prepared ointment and pack it into cans;

[0050] The mass ratio of each component is as follows: 25% for the roots and leaves of *Symplocos buergeriana*, 15% for the whole plant of *Euphorbia hirta*, 10% for the leaves of *Impatiens balsamina*, 10% for the flowers and leaves of *Buddleja officinalis*, 38% for the camellia oil matrix, and 2% for beeswax.

[0051] The anti-inflammatory and analgesic ointment prepared in Example 1 was used in a clinical observation of 150 cases, including 25 cases of frozen shoulder, 35 cases of knee arthritis, 30 cases of soft tissue contusion and laceration, 30 cases of soft tissue pain after fracture surgery, and 30 cases of hematoma from bumps and bruises in children. After using the ointment, 95 cases were cured, with a total effective rate of 63%. 30 cases showed significant improvement, accounting for 20%; 15 cases were effective, accounting for 10%; and 10 cases were ineffective, accounting for 7%. The total effective rate was 90%.

[0052] Typical clinical cases:

[0053] Case 1: Ms. Li, 57 years old, was diagnosed with arthritis at the hospital. Her joints were red, swollen and painful. The pain gradually began to disappear after applying the ointment for 7 days. She continued to use it for 25 days and recovered completely.

[0054] Case 2: Mr. Wang, male, 68 years old, had red, swollen and painful skin 10 days after radial fracture surgery. He was diagnosed with postoperative inflammatory reaction and began to improve after applying ointment for 10 days.

[0055] Case 3: Mr. Li, male, 47 years old, had skin swelling and pain 9 days after tibial fracture surgery. He was diagnosed with postoperative inflammatory reaction and recovered after applying ointment for 20 days.

[0056] Case 4: Ms. Liu, 50 years old, was diagnosed with post-traumatic wound infection at the hospital. The wound was red, swollen, painful, and oozing pus. After cleaning the wound and applying ointment for 7 days, the pain gradually began to disappear. She continued to use the ointment for 15 days and recovered completely.

[0057] Case 5: Ms. Tang, 43 years old, was diagnosed with knee arthritis at the hospital. Her joints were red, swollen and painful. After applying the ointment for 10 days, the pain gradually began to disappear. She continued to use it for 20 days and recovered completely.

[0058] Case 6: Ms. Xie, 28 years old, was diagnosed with radial fracture with soft tissue injury at the hospital. The pain gradually began to disappear after applying the ointment for 5 days, and she recovered after continuing to use it for 30 days.

[0059] Case 7: Ms. Hu, 58 years old, was diagnosed with post-traumatic wound infection at the hospital. The wound was red, swollen, painful, eroded, and oozing pus. After cleaning the wound and applying ointment for 3 days, the pain gradually began to disappear. She continued to use the ointment for 10 days and recovered completely.

Claims

1. A medicated ointment for reducing swelling and relieving pain, characterized in that, It contains the following components in the following weight ratios: 15%-35% of the root and leaves of *Symplocos buergeriana*, 15%-25% of the whole plant of *Euphorbia hirta*, 10%-20% of the leaves of *Impatiens balsamina*, 5%-15% of the flowers and leaves of *Buddleja officinalis*, and 25%-40% of the camellia oil substrate.

2. The anti-inflammatory and analgesic ointment according to claim 1, characterized in that, The components also include beeswax, wherein the weight percentage of beeswax is ≤5%.

3. The anti-inflammatory and analgesic ointment according to claim 1, characterized in that, The preparation method of the camellia oil matrix includes the following steps: drying the camellia fruit at a low temperature of 30-50℃, crushing it, steaming it in a steamer for 3-10 minutes, pressing it into cakes and cooling it, pressing it in a press for 30-60 minutes, filtering the camellia oil, and sterilizing it.

4. The anti-inflammatory and analgesic ointment according to claim 1, characterized in that: The particle size of the roots and leaves of *Symplocos simonii*, the whole plant of *Euphorbia pekinensis*, the leaves of *Impatiens balsamina*, and the flowers and leaves of *Buddleja officinalis* is 150-200 mesh.

5. A method for preparing the anti-inflammatory and analgesic ointment as described in claim 1, characterized in that, The process includes the following steps: 1) Take the roots and leaves of *Symplocos simonii*, the whole herb of *Rhododendron simsii*, the leaves of *Impatiens balsamina*, and the flowers and leaves of *Buddleja officinalis*, dry them at a low temperature of 30-50℃, mix them, and then pulverize them to 150-200 mesh using traditional Chinese medicine cell wall breaking technology to obtain pretreated mixed medicinal materials; 2) Mix the pretreated mixed medicinal materials with camellia oil matrix and stir them into a paste.

6. The preparation method according to claim 5, characterized in that, The preparation method of the camellia oil matrix includes the following steps: drying the camellia fruit at a low temperature of 30-50℃, crushing it, steaming it in a steamer for 3-10 minutes, pressing it into cakes and cooling it, pressing it in a press for 30-60 minutes, filtering the camellia oil, and sterilizing it.

7. The preparation method according to claim 5, characterized in that, It also includes the following steps: mixing and stirring the ointment with molten beeswax, cooling, sterilizing, and bottling.

8. The preparation method according to claim 7, characterized in that: The amount of beeswax added is ≤5wt%.