A traditional Chinese medicine composition and preparation thereof

Abstract

This invention relates to a traditional Chinese medicine composition and its preparation, comprising the following raw materials in parts by weight: rhubarb 18-30 parts, gardenia 18-30 parts, chuanxiong rhizome 9-16 parts, cinnamon twig 9-16 parts, safflower 1-10 parts, and frankincense 1-10 parts. This invention relates to the technical field of external preparations of traditional Chinese medicine. In the traditional Chinese medicine composition of this invention, rhubarb: clears heat and detoxifies, drains heat and promotes bowel movement, cools blood and detoxifies, removes blood stasis and unblocks meridians, has anti-inflammatory effects, and immunomodulatory effects; gardenia: clears heat and promotes diuresis, cools blood and detoxifies; chuanxiong rhizome: invigorates blood and promotes qi circulation, dispels wind and relieves pain; safflower: invigorates blood and unblocks meridians, disperses blood stasis and relieves pain; cinnamon twig: induces sweating and relieves muscle tension, warms and unblocks meridians, promotes qi circulation, calms the bladder and lowers qi, relieves joint pain, has antibacterial effects, anti-inflammatory and anti-allergic effects, dilates blood vessels, and promotes sweating. Frankincense: promotes blood circulation, relieves pain, reduces swelling and promotes tissue regeneration; when used together, these herbs target the core pathogenesis of traumatic swelling and pain (blood stasis), gouty arthritis (damp-heat stagnation), and skin infections (heat toxicity), achieving the treatment of three types of diseases with one ointment, filling a market gap.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine external preparations, specifically to a traditional Chinese medicine composition for treating traumatic swelling and pain, gouty arthritis and skin infections, and a plaster preparation similar to "Babu Gao" with the composition as the active ingredient. Background Technology

[0002] Traumatic swelling and pain (such as soft tissue contusions and post-fracture swelling), acute attacks of gouty arthritis (redness, swelling, heat, and pain), and skin and soft tissue infections (such as boils and cellulitis) are common clinical conditions, falling under the respective jurisdictions of orthopedics, rheumatology, and dermatology. Currently, the medications used to treat these three types of conditions typically differ: topical nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used for traumatic swelling and pain (such as diclofenac diethylamine gel); colchicine or oral or topical NSAIDs are commonly used during acute gout attacks; and antibiotic ointments (such as mupirocin and fusidic acid) are frequently used for skin infections. Currently, no single topical preparation can effectively treat all three types of conditions simultaneously.

[0003] Traditional Chinese medicine (TCM) external therapies offer advantages such as direct targeting of the affected area, minimal side effects, and ease of use. Existing TCM external plasters (such as Musk Bone-Strengthening Plaster and Golden Yellow Powder) mostly target single indications, and some plaster bases have poor adhesion, are prone to falling off, and have limited drug loading capacity. Therefore, developing a TCM external preparation that simultaneously possesses the effects of promoting blood circulation, removing blood stasis, clearing heat and dampness, reducing inflammation and relieving pain, while also having good adhesion and ease of use, has significant clinical demand and market value. Summary of the Invention

[0004] In view of the shortcomings of the existing technology, the purpose of the present invention is to provide a traditional Chinese medicine composition to form a "Babu Gao"-like ointment preparation, thereby solving the technical problems in the background art mentioned above.

[0005] The above-mentioned technical objective of the present invention is achieved through the following technical solution:

[0006] A traditional Chinese medicine composition comprising the following raw materials in parts by weight: 18-30 parts rhubarb, 18-30 parts gardenia, 9-16 parts chuanxiong, 9-16 parts cinnamon twig, 1-10 parts safflower, and 1-10 parts frankincense.

[0007] On the other hand, the present invention also provides a plaster preparation similar to "Babu Gao", specifically a pain-relieving and swelling-reducing plaster made into "Babu Gao", comprising an elastic backing layer and a medicated ointment layer applied on the elastic backing layer, wherein the medicated ointment layer is made by mixing a thick extract of traditional Chinese medicine made from a traditional Chinese medicine composition with an adhesive plaster matrix.

[0008] Furthermore, the ointment layer is made of the following components in parts by weight:

[0009] The adhesive plaster matrix is ​​an aqueous poultice matrix: sodium polypropylene 7.40 parts, carbomer 940 0.60 parts, PVPK90 1.2 parts, aluminum hydroxyl 0.16 parts, tartaric acid 0.25 parts, glycerin 22.00 parts, propylene glycol 5.0 parts, micronized silica gel 2.60 parts, kaolin 4.00 parts, and purified water 48.79 parts;

[0010] 8.00 parts of thick extract of traditional Chinese medicine.

[0011] Based on the above, a method for preparing poultice is also provided, comprising the following steps:

[0012] S1. Weigh out the dried rhubarb, gardenia, chuanxiong, cinnamon twig, safflower, and frankincense according to the weight parts, mix them evenly, pulverize them and pass them through a 120-mesh sieve to obtain fine powder of traditional Chinese medicine.

[0013] S2, Add purified water to the fine powder of Chinese medicine from step S1 and decoct twice, 1.5 hours each time. Combine the decoctions, filter, and concentrate the filtrate to a thick extract of Chinese medicine with a relative density of 1.20-1.25 (60℃).

[0014] S3. Weigh out sodium polypropylene, carbomer 940, PVP K90, aluminum hydroxyl, tartaric acid, glycerin, propylene glycol, micronized silica, kaolin and purified water according to the weight parts, mix them evenly and prepare water-based poultice base.

[0015] S4, Mix the thick extract of traditional Chinese medicine with the water-based poultice base, and stir thoroughly until uniform to obtain the ointment;

[0016] S5. Apply the ointment to the elastic backing layer of the poultice, cover with the non-stick layer, and cut to size.

[0017] In summary, the present invention has at least one of the following beneficial technical effects:

[0018] 1. In this invention, the herbal composition contains: Rhubarb: clears heat and detoxifies, drains heat and promotes bowel movement, cools blood and detoxifies, removes blood stasis and unblocks meridians, and has anti-inflammatory and immunomodulatory effects; Gardenia: clears heat and promotes diuresis, cools blood and detoxifies; Ligusticum: invigorates blood and promotes qi circulation, dispels wind and relieves pain; Safflower: invigorates blood and unblocks meridians, disperses blood stasis and relieves pain; Cinnamon Twig: induces sweating and relieves muscle tension, warms and unblocks meridians, promotes qi circulation, calms the stagnation and lowers qi, and relieves joint pain. It also has antibacterial, anti-inflammatory, anti-allergic, vasodilatory, and sweating-promoting effects. Frankincense: invigorates blood and relieves pain, reduces swelling and promotes tissue regeneration; the combined effects of these herbs target the core pathogenesis of traumatic swelling and pain (blood stasis obstruction), gouty arthritis (damp-heat obstruction), and skin infection (heat toxicity accumulation), achieving the treatment of three types of diseases with one ointment, filling a market gap;

[0019] 2. The poultice matrix used in this invention has the characteristics of strong initial adhesion, good holding power and sufficient cohesion, making it suitable for use on moving joints. Moreover, the production process is mature and suitable for mass production. Attached Figure Description

[0020] Figure 1 This is a flowchart of a method for preparing a poultice in Example 2. Detailed Implementation

[0021] The present invention will be further described in detail below with reference to the accompanying drawings.

[0022] Example 1:

[0023] The present invention discloses a traditional Chinese medicine composition comprising the following raw materials in parts by weight: 18-30 parts of rhubarb, 18-30 parts of gardenia, 9-16 parts of chuanxiong, 9-16 parts of cinnamon twig, 1-10 parts of safflower, and 1-10 parts of frankincense.

[0024] Example 2:

[0025] Using the traditional Chinese medicine composition of Example 1, a plaster was prepared, specifically a pain-relieving and swelling-reducing plaster similar to "paste plaster", including an elastic backing layer and a medicated ointment layer applied on the elastic backing layer. The medicated ointment layer is made by mixing a thick extract of traditional Chinese medicine prepared from the traditional Chinese medicine composition with an adhesive plaster matrix.

[0026] The ointment layer is made of the following components in parts by weight:

[0027] The adhesive plaster matrix is ​​an aqueous poultice matrix: sodium polypropylene 7.40 parts, carbomer 940 0.60 parts, PVPK90 1.2 parts, aluminum hydroxyl 0.16 parts, tartaric acid 0.25 parts, glycerin 22.00 parts, propylene glycol 5.0 parts, micronized silica gel 2.60 parts, kaolin 4.00 parts, and purified water 48.79 parts;

[0028] 8.00 parts of thick extract of traditional Chinese medicine.

[0029] The preparation method is as follows: including the following steps:

[0030] S1. Mix 24g of rhubarb, 24g of gardenia, 13g of chuanxiong, 13g of cinnamon twig, 5g of safflower, and 5g of frankincense evenly, pulverize and pass through a 120-mesh sieve to obtain fine powder of traditional Chinese medicine.

[0031] S2, Add purified water to the fine powder of Chinese medicine from step S1 and decoct twice, 1.5 hours each time. Combine the decoctions, filter, and concentrate the filtrate to a thick extract of Chinese medicine with a relative density of 1.20-1.25 (60℃).

[0032] S3. Weigh out sodium polypropylene, carbomer 940, PVP K90, aluminum hydroxyl, tartaric acid, glycerin, propylene glycol, micronized silica, kaolin and purified water according to the above-mentioned weight parts, mix them evenly and prepare water-based poultice base.

[0033] S4, Mix the thick extract of traditional Chinese medicine with the water-based poultice base, and stir thoroughly until uniform to obtain the ointment;

[0034] S5. Apply the ointment to the elastic backing layer of the poultice, cover it with an anti-stick layer, and cut it to obtain the product. Specifically, apply the ointment to the elastic non-woven fabric backing layer with a thickness of 1.0mm, cover it with a polyethylene anti-stick layer, and cut it into two specifications: 5cm×7cm and 7cm×10cm. Then package it to obtain the product.

[0035] In this embodiment, rhubarb: clears heat and detoxifies, cools blood and detoxifies, purges heat and unblocks the intestines, removes blood stasis and unblocks the meridians; when used externally as a wound-regenerating ointment, it has anti-inflammatory, analgesic, and immunomodulatory effects. Gardenia: clears heat and promotes diuresis, purges fire and relieves irritability, cools blood and detoxifies; when used externally, it reduces swelling and relieves pain, and has strong antibacterial and anti-inflammatory effects. Ligusticum: invigorates blood and promotes qi circulation, dispels wind and relieves pain. Safflower: invigorates blood and unblocks the meridians, disperses blood stasis and relieves pain. Cinnamon twig: warms and unblocks the meridians, induces sweating and relieves muscle tension, promotes the transformation of yang qi, calms the surging qi, relieves joint pain, has antibacterial effects, anti-inflammatory and anti-allergic effects, dilates blood vessels, and promotes sweating. Frankincense: invigorates blood and relieves pain, reduces swelling and promotes tissue regeneration. The combined use of these herbs targets the core pathogenesis of traumatic swelling and pain (blood stasis obstruction), gouty arthritis (damp-heat obstruction), and skin infection (heat toxicity accumulation), achieving the treatment of three types of diseases with one ointment, filling a market gap.

[0036] Clinically proven, when used as a topical application before fracture surgery, it can significantly shorten the time for swelling to subside in the affected limb; when used for acute gout attacks, it can significantly reduce redness, swelling, and pain within 24 to 48 hours; and when used for skin infections, it can quickly control the infection when combined with a small dose of antibiotics.

[0037] The adhesive base of the poultice has good adhesion and is suitable for industrial production: The poultice base used in this invention has the characteristics of strong initial adhesion, good holding power (does not fall off or leave residue after 12 hours), and sufficient cohesion. It is suitable for use on moving joints and the production process is mature and suitable for mass production.

[0038] Example 3:

[0039] Based on Example 2, this example demonstrates clinical performance, and the poultice prepared in Example 2 will be referred to below as the analgesic and swelling-reducing ointment.

[0040] trauma diseases

[0041] (1) Ms. Li, female, around 40 years old, dentist. She accidentally twisted her right lateral ankle while going upstairs, resulting in swelling. DR showed a fracture. Within 24 hours, moxibustion on the affected area aggravated the swelling and pain. She came to my clinic and was treated with analgesic and swelling-reducing ointment. That night, the pain intensified, but the swelling and pain significantly decreased the next day (the patient was instructed to use it once every two days). After four applications, the swelling and pain disappeared.

[0042] (2) Liu, male, 16 years old, a middle school student, suffered an accidental injury while at school, resulting in swelling and pain in his left lateral malleolus, making him unable to walk. Radiography showed an avulsion fracture of the lateral malleolus with slight dislocation. After manual reduction, a resin plaster cast was applied to fix the ankle joint in a neutral position, and analgesic and swelling-reducing ointment was applied externally. The ointment was changed every two days, and the swelling and pain disappeared after four applications. He was also given oral calcium D2 tablets. The plaster cast was removed after 4 weeks. There was no local deformity, and the swelling and tenderness disappeared. The reduced DR fracture healed well.

[0043] (3) Mr. Yang, male, 45 years old, presented with unexplained swelling and pain in his left calf for one week. Upon examination, the left calf was swollen but not red, with slight tenderness. Mild varicose veins were visible in the left calf. He was given analgesic and swelling-reducing ointment applied topically every two days. After six applications, the swelling and pain disappeared, and the varicose veins also disappeared. Then, he was given a fumigation and washing treatment with traditional Chinese medicine for one week, and the symptoms disappeared, and the condition was cured.

[0044] gout-related diseases

[0045] (1) Mr. Wang, male, 56 years old, with a history of gout for more than 30 years and gouty tophi. For the past 5 days, he has experienced swelling and slight redness in his left wrist. He also experienced pain. Examination revealed swelling, slight redness, and tenderness on the dorsal side of his left wrist. He was given analgesic and swelling-reducing ointment for external application every two days. After four applications, the swelling and pain disappeared. At the same time, he was also taking febuxostat tablets to lower uric acid.

[0046] (2) Mr. Li, male, 82 years old, developed redness, swelling and pain in the metatarsophalangeal joint of his right foot on the third day after drinking medicinal wine. His body temperature was normal. The local skin temperature was hot and there was obvious tenderness. Rheumatoid factor and rheumatoid factor tests were normal, and uric acid was 483ug / ml. He applied a pain-relieving and swelling-reducing ointment to the affected area. On the third day, the redness and swelling subsided and the pain was significantly reduced. At the same time, he took colchicine 2mg orally once a day for three days. He stopped taking it when he started having diarrhea. Then he took febuxostat tablets orally once a day. He applied the pain-relieving and swelling-reducing ointment three times. The pain and swelling subsided, and the effect was good.

[0047] (3) Mr. Zhou, male, 20 years old, company employee, frequently eats takeout. Two days ago, he suddenly developed redness, swelling, and pain in his left knee, accompanied by limping and limited mobility. Examination of the left knee revealed no abnormalities in bone tissue. Blood tests showed normal uric acid levels, with uric acid at 598 ug / ml. Gouty arthritis of the left knee joint was suspected. He was first given analgesic and swelling-reducing ointment applied topically every two days, and simultaneously given colchicine 2mg orally three times a day. He was also given febuxostat tablets orally once a day to lower uric acid. After three applications of the analgesic and swelling-reducing ointment, the redness, swelling, and pain disappeared, and knee joint function recovered.

[0048] Skin infection

[0049] (1) Mr. Li, male, 50 years old, presented with unexplained redness, swelling and pain in his right calf, accompanied by a low-grade fever. Physical examination revealed local redness, swelling, tenderness, and no fluctuation. Blood tests showed elevated white blood cell and neutrophil counts. Skin infection (erysipelas) was suspected. Treatment included applying analgesic and swelling-reducing ointment to the affected area every two days, along with oral amoxicillin-clavulanate potassium tablets. After 4 days, the swelling and pain subsided, he could walk without limping, and returned to work.

[0050] (2) Mr. Chen, male, 56 years old, presented with redness, swelling and pain in his left calf for three days without any apparent cause. There was a small, tender mass in his left groin with no fluctuation. It was considered to be a skin infection (without abscess formation). He was given analgesic ointment applied to the entire calf every two days. After five applications, the redness, swelling and pain disappeared. At the same time, he was given amoxicillin clavulanate potassium tablets orally for one week, one tablet each time, three times a day.

[0051] (3) Mr. Cai, male, 26 years old, came to me for treatment due to redness, swelling, heat and pain in the middle of his right calf for one day. Visual examination revealed redness and swelling on the anterior side of the middle of his right calf, with significant tenderness, no local fluctuation, and a clear demarcation of the swollen skin. The diagnosis was cellulitis of the right calf, a skin infection. I prescribed topical analgesic and swelling-reducing ointment twice, once every two days. Simultaneously, I prescribed oral amoxicillin-clavulanate potassium tablets. The redness, swelling and pain in his right calf disappeared, and the infection was cured.

[0052] In summary, the above nine typical cases cover the three main indications of the "Pain-Relieving and Swelling-Reducing Ointment" of this invention: traumatic swelling and pain (including soft tissue contusions, post-fracture swelling and pain, and swelling and pain of unknown cause), acute attacks of gouty arthritis (including wrist joints, metatarsophalangeal joints, and knee joints), and skin and soft tissue infections (including erysipelas, cellulitis, and early-stage boils). Onset of action: most cases showed significant improvement within 24-48 hours after the first application, and all nine cases achieved cure or significant improvement, with a total effective rate of 100%. After continuous use for 2-6 times (4-12 days), no adverse reactions such as skin allergies, ulceration, or pigmentation were observed.

[0053] Combined medication: Some cases also took conventional oral medications (antibiotics, uric acid-lowering drugs, calcium supplements), but the local symptoms improved significantly after applying the analgesic and swelling-reducing ointment, and the duration of oral medication use was reduced.

[0054] The "Pain-Relieving and Swelling-Reducing Ointment" of this invention has a definite, rapid, and safe therapeutic effect on traumatic swelling and pain, acute attacks of gouty arthritis, and skin and soft tissue infections, demonstrating the clinical advantage of "one ointment for multiple uses".

[0055] The embodiments described herein are preferred embodiments of the present invention and are not intended to limit the scope of protection of the present invention. Therefore, all equivalent changes made in accordance with the structure, shape, and principle of the present invention should be covered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition, characterized in that, It is composed of the following raw materials in parts by weight: rhubarb 18-30 parts, gardenia 18-30 parts, chuanxiong 9-16 parts, cinnamon twig 9-16 parts, safflower 1-10 parts, and frankincense 1-10 parts.

2. A plaster preparation called "Babu Gao" is characterized in that, It includes an elastic backing layer and an ointment layer applied to the elastic backing layer, the ointment layer being a mixture of a thick extract of traditional Chinese medicine made from the traditional Chinese medicine composition of claim 1 and an adhesive plaster matrix.

3. The plaster preparation for making a "babu ointment" according to claim 2, characterized in that: The ointment layer is made of the following components in parts by weight: The adhesive plaster matrix is ​​an aqueous poultice matrix: sodium polypropylene 7.40 parts, carbomer 940 0.60 parts, PVP K90 1.2 parts, aluminum hydroxyl 0.16 parts, tartaric acid 0.25 parts, glycerin 22.00 parts, propylene glycol 5.0 parts, micronized silica gel 2.60 parts, kaolin 4.00 parts, and purified water 48.79 parts; 8.00 parts of thick extract of traditional Chinese medicine.

4. A method for preparing the poultice according to claim 3, characterized in that: Includes the following steps: S1, Weigh the dried rhubarb, gardenia, chuanxiong, cinnamon twig, safflower and frankincense according to the weight parts described in claim 1, mix them evenly, pulverize them and pass them through a 120-mesh sieve to obtain fine powder of traditional Chinese medicine; S2, Add purified water to the fine powder of Chinese medicine from step S1 and decoct twice, 1.5 hours each time. Combine the decoctions, filter, and concentrate the filtrate to a thick extract of Chinese medicine with a relative density of 1.20-1.25 (60℃). S3, according to the weight proportions of sodium polypropylene, carbomer 940, PVP K90, aluminum hydroxyl, tartaric acid, glycerin, propylene glycol, micronized silica, kaolin and purified water as described in claim 3, mix them evenly to prepare an aqueous poultice base. S4, Mix the thick extract of traditional Chinese medicine with the water-based poultice base, and stir thoroughly until uniform to obtain the ointment; S5. Apply the ointment to the elastic backing layer of the poultice, cover with the non-stick layer, and cut to size.

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