Traditional Chinese medicine preparation for treating traumatology diseases and preparation method thereof
By combining a complex enzyme system with β-cyclodextrin inclusion complexes through fermentation, the problem of low efficacy of traditional Chinese medicine preparations has been solved, achieving highly effective treatment of traumatic diseases, especially fractures, dislocations, and tendon injuries, with significant cure rates and safety.
Patent Information
- Application Number
- CN202511077355.5
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2025-08-01
- Publication Date
- 2025-11-11
AI Technical Summary
Existing Chinese medicine preparations for treating traumatic diseases have low efficacy. Traditional Chinese medicine external application materials have not undergone biotransformation, making it difficult for large molecular components to be absorbed by the skin and for the effective components of the medicine to exert their full effect. In addition, existing fermentation technology lacks the synergistic effect of multiple enzymes, making it difficult to simultaneously transform multiple types of components.
A complex enzyme system (cellulase, papain, lipase, amylase, and protease) combined with β-cyclodextrin inclusion complexes was used to ferment Chinese medicinal materials to prepare Chinese herbal dressings. Enzymatic hydrolysis and microbial fermentation were used to promote the release and transformation of active ingredients and enhance the efficacy.
Traditional Chinese medicine preparations have the effects of promoting blood circulation, removing blood stasis, clearing heat and purging blood stasis, and relieving pain. The treatment rate reaches more than 93%. They are convenient to use and have no toxic side effects, thus improving bioavailability and safety.
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Abstract
Description
Technical Field
[0001] This invention belongs to the field of traditional Chinese medicine composition technology, specifically relating to a traditional Chinese medicine preparation for treating traumatic diseases and its preparation method. Background Technology
[0002] Traditional Chinese medicine (TCM) external application of herbal medicine is a treatment method with unique advantages in traumatology. It can effectively relieve the symptoms of trauma patients, promote the healing of damaged tissues, reduce side effects, and improve the quality of life of patients. However, traditional external application medicines for traumatology do not undergo biological transformation, and the large molecular components (such as polysaccharides and tannins) are difficult to be absorbed by the skin. In addition, the powder is usually mixed with mediums such as wine and vinegar, which means that the medicine faces the volatilization of the medium before it is fully decomposed, and the powder dries out, making it difficult for the effective ingredients of the medicine to exert their full effect.
[0003] Fermentation of traditional Chinese medicine (TCM) for traumatology is a pharmaceutical technology that transforms traditional Chinese medicine into medicinal substances through microbial fermentation. It is an important approach to the modernization of TCM and the research and development of traumatology drugs. This technology utilizes the biosynthesis, decomposition, and transformation of microbial metabolites to release their effective components, thereby enhancing or improving efficacy. Although microbial fermentation provides a new direction for the improvement of TCM traumatology preparations, significant shortcomings remain. For example, existing fermentation technologies often rely on single strains (such as yeast or lactic acid bacteria) or limited enzymes (such as cellulase), lacking the synergistic effect of multiple enzymes and making it difficult to simultaneously transform multiple components. Summary of the Invention
[0004] In view of the above-mentioned prior art, the present invention discloses a traditional Chinese medicine preparation for treating traumatic diseases, so as to solve the technical problem of low efficacy of existing traditional Chinese medicine preparations for treating traumatic diseases.
[0005] To achieve the above objectives, the technical solution adopted by this invention is as follows: A traditional Chinese medicine preparation for treating traumatic diseases is provided, comprising the following raw materials: Panax notoginseng, safflower, Rehmannia glutinosa, dragon's blood, Aucklandia lappa, rhubarb, Phellodendron chinense, raw Aconitum carmichaelii, raw Aconitum kusnezoffii, Datura stramonium, Lycopus lucidus, Angelica dahurica, Hibiscus mutabilis leaf, borneol-β-cyclodextrin inclusion complex, camphor-β-cyclodextrin inclusion complex, artificial musk-β-cyclodextrin inclusion complex, and a fermenting agent; the fermenting agent includes cellulase, papain, lipase, amylase, and protease; the borneol-β-cyclodextrin inclusion complex, camphor-β-cyclodextrin inclusion complex, and artificial musk-β-cyclodextrin inclusion complex are prepared by the following steps: borneol, camphor, and artificial musk are mixed with β-cyclodextrin respectively, then water is added and ground into a paste, which is then dried to obtain the final product.
[0006] Based on the above technical solution, the present invention can be further improved as follows.
[0007] Furthermore, the traditional Chinese medicine preparation comprises the following raw materials in parts by weight: 400-600 parts of Panax notoginseng, 400-600 parts of Carthamus tinctorius, 400-600 parts of Rehmannia glutinosa, 400-600 parts of Dragon's Blood, 400-600 parts of Aucklandia lappa, 400-600 parts of Rheum palmatum, 1800-2200 parts of Phellodendron chinense, 400-600 parts of Aconitum carmichaelii (raw), 400-600 parts of Aconitum kusnezoffii (raw), 400-600 parts of Datura stramonium, 400-600 parts of Lycopus lucidus, 400-600 parts of Angelica dahurica, 400-600 parts of Hibiscus mutabilis leaf, 900-1100 parts of borneol-β-cyclodextrin inclusion complex, 900-1100 parts of camphor-β-cyclodextrin inclusion complex, 1-3 parts of artificial musk-β-cyclodextrin inclusion complex, and 400-600 parts of fermentation agent.
[0008] Furthermore, the traditional Chinese medicine preparation comprises the following raw materials in parts by weight: 500 parts of Panax notoginseng, 500 parts of Carthamus tinctorius, 500 parts of Rehmannia glutinosa, 500 parts of Dragon's Blood, 500 parts of Aucklandia lappa, 500 parts of Rheum palmatum, 2000 parts of Phellodendron chinense, 500 parts of Aconitum carmichaelii (raw), 500 parts of Aconitum kusnezoffii (raw), 500 parts of Datura stramonium, 500 parts of Lycopus lucidus, 500 parts of Angelica dahurica, 500 parts of Hibiscus mutabilis leaf, 1000 parts of borneol-β-cyclodextrin inclusion complex, 1000 parts of camphor-β-cyclodextrin inclusion complex, 1 part of artificial musk-β-cyclodextrin inclusion complex, and 500 parts of fermentation agent.
[0009] Furthermore, the amylase is α-amylase; the protease is a neutral protease or an acidic protease; the cellulase activity is ≥5000 U / g, the papain activity is ≥2000 U / mg, the lipase activity is ≥1000 U / g, the amylase activity is ≥3000 U / g, and the protease activity is ≥1500 U / g; the mass ratio of cellulase, papain, lipase, amylase and protease is 1:1:1:1:1.
[0010] Furthermore, the dosage form of this traditional Chinese medicine preparation for treating traumatic diseases is a traditional Chinese medicine dressing.
[0011] This invention also discloses a method for preparing this traditional Chinese medicine preparation for treating traumatic diseases, which includes the following steps: pulverizing the traditional Chinese medicine materials, then mixing the powdered traditional Chinese medicine, borneol-β-cyclodextrin inclusion complex, camphor-β-cyclodextrin inclusion complex, artificial musk-β-cyclodextrin inclusion complex and fermentation agent in equal amounts to obtain a mixed powder, adding rice wine fermentation liquid and ethanol to the mixed powder, and fermenting under sealed conditions for 2 weeks to obtain the final product.
[0012] Based on the above technical solution, the present invention can be further improved as follows.
[0013] Furthermore, the rice wine fermentation liquid is obtained by filtering rice after fermenting at 30℃ for 72 hours, with an ethanol concentration of 8~12wt%; the amount of rice wine fermentation liquid and ethanol added is such that it submerges the mixed powder by 1.5~2cm; the volume ratio of rice wine fermentation liquid to ethanol is 1:5.
[0014] Furthermore, the fermentation temperature is 22~27℃, and the fermentation humidity is 60~70%.
[0015] Usage: Apply the herbal compress to the affected area on a leak-proof cotton pad, and then bandage with gauze or adhesive tape.
[0016] Guided by the principles of traditional Chinese medicine (TCM) theory of principal, assistant, adjuvant, and guide herbs, this preparation uses Phellodendron bark as the principal herb, which has the effects of clearing heat and detoxifying, dispersing blood stasis and stopping bleeding, and reducing swelling and relieving pain. Safflower, dragon's blood, raw Aconitum carmichaelii, and raw Aconitum kusnezoffii are the assistant herbs. Safflower has the effects of promoting blood circulation, regulating menstruation, dispersing blood stasis, and relieving pain; when combined with Phellodendron bark, it enhances the effect of promoting blood circulation and removing blood stasis. Dragon's blood promotes blood circulation, relieves pain, promotes tissue regeneration and wound healing; it directly works with Phellodendron bark to strengthen the function of removing blood stasis and stopping bleeding. Raw Aconitum carmichaelii and raw Aconitum kusnezoffii have significant analgesic effects, assisting the principal herb in relieving pain. Rhubarb, Panax notoginseng, Costus root, Lycopus lucidus, Angelica dahurica, Rehmannia glutinosa, Hibiscus mutabilis leaves, and Datura stramonium are used as adjuvant herbs. Rhubarb clears heat and drains blood stasis, while Phellodendron amurense clears heat and dries dampness, used to clear local heat toxins caused by external injuries and prevent infection. Costus root promotes qi circulation and relieves pain, Lycopus lucidus invigorates blood and promotes diuresis, and Angelica dahurica reduces swelling and drains pus. The three herbs work together to improve the circulation of qi and blood and promote the reduction of local swelling. Rehmannia glutinosa cools the blood and nourishes yin, while Hibiscus mutabilis leaves clear heat and detoxify, preventing blood stasis from turning into heat and balancing the warming and drying properties of the herbs in the formula. Datura stramonium is used for anesthesia and analgesia to relieve pain. Borneol, camphor, artificial musk, and fermentation agent are used as guiding agents. Borneol opens the orifices and refreshes the mind, clears heat and relieves pain; camphor invigorates blood and removes blood stasis; and musk invigorates blood and unblocks menstruation. All three have transdermal penetration-enhancing effects, guiding other components directly to the lesion and enhancing local absorption. The three are first encapsulated by β-cyclodextrin, which can effectively prevent volatilization loss during fermentation. The synergistic effect of the complex enzyme system decomposes plant cell walls and proteins, selectively hydrolyzes alkaloids, and improves the dissolution rate and safety of the active ingredients of the medicinal materials.
[0017] The beneficial effects of this invention are: 1. The traditional Chinese medicine preparation prepared in this invention has the effects of promoting blood circulation, removing blood stasis, clearing heat and purging blood stasis, and relieving pain. It has a treatment rate of over 93% for traumatic diseases (fractures, dislocations, muscle injuries, tenosynovitis, lumbar muscle strain, frozen shoulder, rheumatoid arthritis, etc.), is convenient to use and has no toxic side effects.
[0018] 2. In this invention, borneol, camphor, and artificial musk are first encapsulated by β-cyclodextrin to effectively prevent volatilization loss during fermentation and increase the content of effective ingredients in the preparation. This method of preparing traditional Chinese medicine preparation combines a compound enzymatic hydrolysis-fermentation process to promote the release of effective ingredients and promote biotransformation. In addition, the small molecule peptides and organic acids produced after enzymatic hydrolysis and fermentation can synergistically enhance the effect of promoting blood circulation and removing blood stasis. Anthraquinones and alkaloids in traditional Chinese medicine are more easily absorbed, enhancing anti-inflammatory and swelling-reducing effects. The toxicity of aconite alkaloids is reduced, thus improving the overall bioavailability and safety. Detailed Implementation
[0019] The specific embodiments of the present invention will be described in detail below with reference to examples.
[0020] Example 1 A traditional Chinese medicine preparation for treating traumatic injuries, comprising the following ingredients: 100g of Panax notoginseng, 100g of Carthamus tinctorius, 100g of Rehmannia glutinosa, 100g of Dragon's Blood, 100g of Aucklandia lappa, 100g of Rheum palmatum, 400g of Phellodendron chinense, 100g of Aconitum carmichaelii (raw), 100g of Aconitum kusnezoffii (raw), 100g of Datura stramonium, 100g of Lycopus lucidus, 100g of Angelica dahurica, 100g of Hibiscus mutabilis leaf, 200g of Borneol-β-cyclodextrin inclusion complex, 200g of Camphor-β-cyclodextrin inclusion complex, 0.2g of Artificial Musk-β-cyclodextrin inclusion complex, 20g of Cellulase, 20g of Papain, 20g of Lipase, 20g of α-Amylase, and 20g of Neutral Protease; wherein the cellulase activity is ≥5000U / g, the papain activity is ≥2000U / mg, the lipase activity is ≥1000U / g, the α-amylase activity is ≥3000U / g, and the neutral protease activity is ≥1500U / g.
[0021] The preparation methods of borneol-β-cyclodextrin inclusion complex, camphor-β-cyclodextrin inclusion complex and artificial musk-β-cyclodextrin inclusion complex are as follows: borneol, camphor and artificial musk are mixed with β-cyclodextrin respectively, then water is added and ground into a paste, and dried at 40℃ for 12h to obtain the final product.
[0022] The Chinese medicinal materials were pulverized into powder using an ultra-micro pulverizer. The powder had a mesh size of 500. Different Chinese medicinal powders, borneol-β-cyclodextrin inclusion complex, camphor-β-cyclodextrin inclusion complex, artificial musk-β-cyclodextrin inclusion complex, and enzymes were weighed according to the formula ratio and then placed in a three-dimensional motion mixer and mixed for 30 minutes to obtain a mixed powder. The mixed powder was then poured into a ceramic jar, and rice wine fermentation liquid and 8wt% ethanol were added. The rice wine fermentation liquid was obtained by filtering rice after fermentation at 30℃ for 72 hours. The volume ratio of rice wine fermentation liquid to ethanol was 1:5. The amount of rice wine fermentation liquid and ethanol added was such that it submerged the mixed powder by 2 cm. The ceramic jar was then sealed and fermented for 2 weeks under environmental conditions of 25℃ and 65% humidity.
[0023] Example 2 A traditional Chinese medicine preparation for treating traumatic injuries, comprising the following ingredients: The ingredients are: Panax notoginseng 80g, Carthamus tinctorius 80g, Rehmannia glutinosa 80g, Dracaena cochinchinensis 80g, Aucklandia lappa 80g, Rheum palmatum 80g, Phellodendron chinense 360g, Aconitum carmichaelii 80g, Aconitum kusnezoffii 80g, Datura stramonium 80g, Lycopus lucidus 80g, Angelica dahurica 80g, Hibiscus mutabilis leaf 80g, Borneol-β-cyclodextrin inclusion complex 180g, Camphor-β-cyclodextrin inclusion complex 180g, Artificial musk-β-cyclodextrin inclusion complex 0.2g, Cellulase 16g, Papain 16g, Lipase 16g, α-amylase 16g, and Neutral protease 16g; wherein the cellulase activity is ≥5000U / g, the papain activity is ≥2000U / mg, the lipase activity is ≥1000U / g, the α-amylase activity is ≥3000U / g, and the neutral protease activity is ≥1500U / g.
[0024] The preparation methods of borneol-β-cyclodextrin inclusion complex, camphor-β-cyclodextrin inclusion complex and artificial musk-β-cyclodextrin inclusion complex are as follows: borneol, camphor and artificial musk are mixed with β-cyclodextrin respectively, then water is added and ground into a paste, and dried at 45℃ for 18h to obtain the final product.
[0025] The Chinese medicinal materials were pulverized into powder using an ultra-micro pulverizer with a mesh size of 500. Different Chinese medicinal powders, borneol-β-cyclodextrin inclusion complex, camphor-β-cyclodextrin inclusion complex, artificial musk-β-cyclodextrin inclusion complex, and enzymes were weighed according to the formula ratio and then placed in a three-dimensional motion mixer and mixed for 30 minutes to obtain a mixed powder. The mixed powder was then poured into a ceramic jar, and rice wine fermentation liquid and 12wt% ethanol were added. The rice wine fermentation liquid was obtained by fermenting rice at 30℃ for 72 hours and then filtering it. The volume ratio of rice wine fermentation liquid to ethanol was 1:5. The amount of rice wine fermentation liquid and ethanol added was such that it submerged the mixed powder by 2 cm. The ceramic jar was then sealed and fermented for 2 weeks under an environment of 22℃ and 60% humidity to obtain the final product.
[0026] Example 3 A traditional Chinese medicine preparation for treating traumatic injuries, comprising the following ingredients: The ingredients are: Panax notoginseng 120g, Carthamus tinctorius 120g, Rehmannia glutinosa 120g, Dragon's blood 120g, Aucklandia lappa 120g, Rheum palmatum 120g, Phellodendron chinense 440g, Aconitum carmichaelii 120g, Aconitum kusnezoffii 120g, Datura stramonium 120g, Lycopus lucidus 120g, Angelica dahurica 120g, Hibiscus mutabilis leaf 120g, Borneol-β-cyclodextrin inclusion complex 220g, Camphor-β-cyclodextrin inclusion complex 220g, Artificial musk-β-cyclodextrin inclusion complex 0.6g, Cellulase 24g, Papain 24g, Lipase 24g, α-amylase 24g, and Acidic protease 24g; wherein the cellulase activity is ≥5000U / g, the papain activity is ≥2000U / mg, the lipase activity is ≥1000U / g, the α-amylase activity is ≥3000U / g, and the acidic protease activity is ≥1500U / g.
[0027] The preparation methods of borneol-β-cyclodextrin inclusion complex, camphor-β-cyclodextrin inclusion complex and artificial musk-β-cyclodextrin inclusion complex are as follows: borneol, camphor and artificial musk are mixed with β-cyclodextrin respectively, then water is added and ground into a paste, and dried at 40℃ for 16h to obtain the final product.
[0028] The Chinese medicinal materials were pulverized into powder using an ultra-micro pulverizer. The powder had a mesh size of 500. Different Chinese medicinal powders, borneol-β-cyclodextrin inclusion complex, camphor-β-cyclodextrin inclusion complex, artificial musk-β-cyclodextrin inclusion complex, and enzymes were weighed according to the formula ratio and then placed in a three-dimensional motion mixer and mixed for 30 minutes to obtain a mixed powder. The mixed powder was then poured into a ceramic jar, and rice wine fermentation liquid and 10wt% ethanol were added. The rice wine fermentation liquid was obtained by fermenting rice at 30℃ for 72 hours and then filtering it. The volume ratio of rice wine fermentation liquid to ethanol was 1:5. The amount of rice wine fermentation liquid and ethanol added was such that it submerged the mixed powder by 1.5 cm. The ceramic jar was then sealed and fermented for 2 weeks under an environment of 27℃ and 70% humidity to obtain the final product.
[0029] Example 4 A traditional Chinese medicine preparation for treating traumatic injuries, comprising the following ingredients: The ingredients are: 100g Panax notoginseng, 80g Carthamus tinctorius, 90g Rehmannia glutinosa, 100g Dragon's Blood, 100g Aucklandia lappa, 80g Rheum palmatum, 400g Phellodendron chinense, 100g Aconitum carmichaelii (raw), 100g Aconitum kusnezoffii (raw), 90g Datura stramonium, 100g Lycopus lucidus, 100g Angelica dahurica, 100g Hibiscus mutabilis leaf, 220g Borneol-β-cyclodextrin inclusion complex, 200g Camphor-β-cyclodextrin inclusion complex, 0.2g Artificial musk-β-cyclodextrin inclusion complex, 20g Cellulase, 20g Papain, 20g Lipase, 20g α-Amylase, and 20g Neutral protease; wherein the cellulase activity is ≥5000U / g, the papain activity is ≥2000U / mg, the lipase activity is ≥1000U / g, the α-amylase activity is ≥3000U / g, and the neutral protease activity is ≥1500U / g.
[0030] The preparation method is the same as in Example 1.
[0031] Comparative Example 1 A traditional Chinese medicine preparation comprising the following raw materials: 100g Panax notoginseng, 100g Carthamus tinctorius, 100g Rehmannia glutinosa, 100g Dragon's Blood, 100g Aucklandia lappa, 100g Rheum palmatum, 400g Phellodendron chinense, 100g Aconitum carmichaelii (raw), 100g Aconitum kusnezoffii (raw), 100g Datura stramonium, 100g Lycopus lucidus, 100g Angelica dahurica, 100g Hibiscus mutabilis leaf, 200g Borneol-β-cyclodextrin inclusion complex, 200g Camphor-β-cyclodextrin inclusion complex, 0.2g Artificial Musk-β-cyclodextrin inclusion complex.
[0032] The preparation methods of borneol-β-cyclodextrin inclusion complex, camphor-β-cyclodextrin inclusion complex and artificial musk-β-cyclodextrin inclusion complex are as follows: borneol, camphor and artificial musk are mixed with β-cyclodextrin respectively, then water is added and ground into a paste, and dried at 40℃ for 12h to obtain the final product.
[0033] The Chinese medicinal materials were pulverized into powder using an ultra-micro pulverizer with a mesh size of 500. Different Chinese medicinal powders, borneol-β-cyclodextrin inclusion complex, camphor-β-cyclodextrin inclusion complex, and artificial musk-β-cyclodextrin inclusion complex were weighed according to the formula ratio and then placed in a three-dimensional motion mixer and mixed for 30 minutes to obtain a mixed powder. The mixed powder was then blended with 8wt% ethanol to obtain the final product.
[0034] Comparative Example 2 A traditional Chinese medicine preparation comprising the following raw materials: 100g Panax notoginseng, 100g Carthamus tinctorius, 100g Rehmannia glutinosa, 100g Dragon's Blood, 100g Aucklandia lappa, 100g Rheum palmatum, 400g Phellodendron chinense, 100g Aconitum carmichaelii (raw), 100g Aconitum kusnezoffii (raw), 100g Datura stramonium, 100g Lycopus lucidus, 100g Angelica dahurica, 100g Hibiscus mutabilis leaf, 200g Borneol-β-cyclodextrin inclusion complex, 200g Camphor-β-cyclodextrin inclusion complex, 0.2g Artificial musk-β-cyclodextrin inclusion complex, 100g Cellulase; wherein the cellulase activity is ≥5000U / g.
[0035] The preparation method is the same as in Example 1.
[0036] Comparative Example 3 A traditional Chinese medicine preparation comprising the following raw materials: 100g of Panax notoginseng, 100g of Carthamus tinctorius, 100g of Rehmannia glutinosa, 100g of Dragon's Blood, 100g of Aucklandia lappa, 100g of Rheum palmatum, 400g of Phellodendron chinense, 100g of Datura stramonium, 100g of Lycopus lucidus, 100g of Angelica dahurica, 100g of Hibiscus mutabilis leaf, 200g of Borneol-β-cyclodextrin inclusion complex, 200g of Camphor-β-cyclodextrin inclusion complex, 0.2g of Artificial Musk-β-cyclodextrin inclusion complex, 20g of Cellulase, 20g of Papain, 20g of Lipase, 20g of α-Amylase, and 20g of Neutral Protease; wherein the cellulase activity is ≥5000U / g, the papain activity is ≥2000U / mg, the lipase activity is ≥1000U / g, the α-amylase activity is ≥3000U / g, and the neutral protease activity is ≥1500U / g.
[0037] The preparation method is the same as in Example 1.
[0038] Comparative Example 4 A traditional Chinese medicine preparation comprising the following raw materials: 100g safflower, 100g rehmannia root, 100g dragon's blood, 100g costus root, 100g rhubarb, 400g phellodendron bark, 100g raw aconite root, 100g raw aconite root, 100g datura flower, 100g eupatorium, 100g angelica root, 100g hibiscus leaf, 200g borneol-β-cyclodextrin inclusion complex, 200g camphor-β-cyclodextrin inclusion complex, 0.2g artificial musk-β-cyclodextrin inclusion complex, 20g cellulase, 20g papain, 20g lipase, 20g α-amylase, and 20g neutral protease; wherein the cellulase activity is ≥5000U / g, the papain activity is ≥2000U / mg, the lipase activity is ≥1000U / g, the α-amylase activity is ≥3000U / g, and the neutral protease activity is ≥1500U / g.
[0039] The preparation method is the same as in Example 1.
[0040] Comparative Example 5 A traditional Chinese medicine preparation comprising the following raw materials: 100g Panax notoginseng, 100g Carthamus tinctorius, 100g Rehmannia glutinosa, 100g Dragon's Blood, 100g Aucklandia lappa, 100g Rheum palmatum, 400g Phellodendron chinense, 100g Aconitum carmichaelii (raw), 100g Aconitum kusnezoffii (raw), 100g Datura stramonium, 100g Lycopus lucidus, 100g Angelica dahurica, 100g Hibiscus mutabilis leaf, 200g Borneol-β-cyclodextrin inclusion complex, 200g Camphor-β-cyclodextrin inclusion complex, and 0.2g Artificial Musk-β-cyclodextrin inclusion complex.
[0041] The preparation methods of borneol-β-cyclodextrin inclusion complex, camphor-β-cyclodextrin inclusion complex and artificial musk-β-cyclodextrin inclusion complex are as follows: borneol, camphor and artificial musk are mixed with β-cyclodextrin respectively, then water is added and ground into a paste, and dried at 40℃ for 12h to obtain the final product.
[0042] The Chinese medicinal materials were pulverized into powder using an ultra-micro pulverizer. The powder had a mesh size of 500. Different Chinese medicinal powders, borneol-β-cyclodextrin inclusion complex, camphor-β-cyclodextrin inclusion complex, and artificial musk-β-cyclodextrin inclusion complex were weighed according to the formula ratio and then placed in a three-dimensional motion mixer and mixed for 30 minutes to obtain a mixed powder. The mixed powder was then poured into a ceramic jar, and rice wine fermentation liquid and 8wt% ethanol were added. The rice wine fermentation liquid was obtained by filtering rice after fermentation at 30℃ for 72 hours. The volume ratio of rice wine fermentation liquid to ethanol was 1:5. The amount of rice wine fermentation liquid and ethanol added was such that it submerged the mixed powder by 2 cm. The ceramic jar was then sealed and fermented for 2 weeks under environmental conditions of 25℃ and 65% humidity.
[0043] Comparative Example 6 A traditional Chinese medicine preparation comprising the following raw materials: 100g of Panax notoginseng, 100g of Carthamus tinctorius, 100g of Rehmannia glutinosa, 100g of Dragon's Blood, 100g of Aucklandia lappa, 100g of Rheum palmatum, 400g of Phellodendron chinense, 100g of Aconitum carmichaelii (raw), 100g of Aconitum kusnezoffii (raw), 100g of Datura stramonium, 100g of Lycopus lucidus, 100g of Angelica dahurica, 100g of Hibiscus mutabilis leaf, 200g of Borneol, 200g of Camphor, 0.2g of Artificial Musk, 20g of Cellulase, 20g of Papain, 20g of Lipase, 20g of α-Amylase, and 20g of Neutral Protease; wherein the cellulase activity is ≥5000U / g, the papain activity is ≥2000U / mg, the lipase activity is ≥1000U / g, the α-amylase activity is ≥3000U / g, and the neutral protease activity is ≥1500U / g.
[0044] The Chinese medicinal materials were pulverized into powder using an ultra-micro pulverizer with a mesh size of 500. Different Chinese medicinal powders and enzymes were weighed according to the formula ratio and then mixed in a three-dimensional motion mixer for 30 minutes to obtain a mixed powder. The mixed powder was then poured into a ceramic jar, and rice wine fermentation liquid and 8wt% ethanol were added. The rice wine fermentation liquid was obtained by filtering rice after fermentation at 30℃ for 72 hours. The volume ratio of rice wine fermentation liquid to ethanol was 1:5. The amount of rice wine fermentation liquid and ethanol added was such that it submerged the mixed powder by 2cm. The ceramic jar was then sealed and fermented for 2 weeks under an environment of 25℃ and 65% humidity to obtain the final product.
[0045] Test case Clinical research trials 1. Clinical observation subjects 240 patients with common traumatic diseases such as fractures, dislocations, muscle injuries, tenosynovitis, lumbar muscle strain, frozen shoulder, and rheumatoid arthritis who visited Sichuan Provincial Orthopedic Hospital from January 2022 to December 2023 were selected. The 240 patients were divided into 8 groups, and the 8 groups of patients were treated with the traditional Chinese medicine preparations prepared in Examples 1-2 and Comparative Examples 1-6, respectively.
[0046] 2. Efficacy evaluation criteria Cured: The pain has completely subsided and all adverse symptoms have completely disappeared.
[0047] Significant effect: Pain is basically relieved and adverse symptoms are basically eliminated.
[0048] Effective: Pain was somewhat relieved, but adverse symptoms did not improve significantly.
[0049] Ineffective: The pain was not relieved and the adverse symptoms were not improved.
[0050] 3. Treatment Results Based on the above evaluation criteria, the therapeutic effects of using traditional Chinese medicine preparations are shown in Table 1.
[0051] Table 1
[0052] The treatment results show that the traditional Chinese medicine preparation in this invention has an overall effective rate of over 93% for common traumatic diseases, demonstrating good efficacy and a wide range of applications.
[0053] Although specific embodiments of the present invention have been described in detail with reference to examples, they should not be construed as limiting the scope of protection of this patent. Various modifications and variations that can be made by those skilled in the art without inventive effort within the scope described in the claims are still within the scope of protection of this patent.
Claims
1. A traditional Chinese medicine preparation for treating traumatic injuries, characterized in that, The raw materials include: Panax notoginseng, safflower, Rehmannia glutinosa, dragon's blood, costus root, rhubarb, Phellodendron chinense, raw Aconitum carmichaelii, raw Aconitum kusnezoffii, Datura stramonium, Lycopus lucidus, Angelica dahurica, Hibiscus mutabilis leaf, borneol-β-cyclodextrin inclusion complex, camphor-β-cyclodextrin inclusion complex, artificial musk-β-cyclodextrin inclusion complex, and fermentation agent; the fermentation agent includes cellulase, papain, lipase, amylase, and protease; the borneol-β-cyclodextrin inclusion complex, camphor-β-cyclodextrin inclusion complex, and artificial musk-β-cyclodextrin inclusion complex are prepared by the following steps: borneol, camphor, and artificial musk are mixed with β-cyclodextrin respectively, then water is added and ground into a paste, and dried to obtain the final product.
2. The traditional Chinese medicine preparation for treating traumatic diseases according to claim 1, characterized in that, It comprises the following raw materials in parts by weight: 400-600 parts of Panax notoginseng, 400-600 parts of Carthamus tinctorius, 400-600 parts of Rehmannia glutinosa, 400-600 parts of Dragon's Blood, 400-600 parts of Aucklandia lappa, 400-600 parts of Rheum palmatum, 1800-2200 parts of Phellodendron chinense, 400-600 parts of Aconitum carmichaelii, 400-600 parts of Aconitum kusnezoffii, 400-600 parts of Datura stramonium, 400-600 parts of Lycopus lucidus, 400-600 parts of Angelica dahurica, 400-600 parts of Hibiscus mutabilis leaves, 900-1100 parts of borneol-β-cyclodextrin inclusion complex, 900-1100 parts of camphor-β-cyclodextrin inclusion complex, 1-3 parts of artificial musk-β-cyclodextrin inclusion complex, and 400-600 parts of fermenting agent.
3. The traditional Chinese medicine preparation for treating traumatic diseases according to claim 1, characterized in that, It comprises the following raw materials in parts by weight: 500 parts Panax notoginseng, 500 parts Carthamus tinctorius, 500 parts Rehmannia glutinosa, 500 parts Dragon's Blood, 500 parts Aucklandia lappa, 500 parts Rheum palmatum, 2000 parts Phellodendron chinense, 500 parts Aconitum carmichaelii, 500 parts Aconitum kusnezoffii, 500 parts Datura stramonium, 500 parts Lycopus lucidus, 500 parts Angelica dahurica, 500 parts Hibiscus mutabilis leaves, 1000 parts Borneol-β-cyclodextrin inclusion complex, 1000 parts Camphor-β-cyclodextrin inclusion complex, 1 part Artificial Musk-β-cyclodextrin inclusion complex, and 500 parts Fermentation Agent.
4. The traditional Chinese medicine preparation for treating traumatic diseases according to claim 1, characterized in that, The amylase is α-amylase; the protease is a neutral protease or an acidic protease; the cellulase activity is ≥5000 U / g, the papain activity is ≥2000 U / mg, the lipase activity is ≥1000 U / g, the amylase activity is ≥3000 U / g, and the protease activity is ≥1500 U / g; the mass ratio of cellulase, papain, lipase, amylase and protease is 1:1:1:1:
1.
5. The traditional Chinese medicine preparation for treating traumatic diseases according to any one of claims 1 to 4, characterized in that: The dosage form of the traditional Chinese medicine preparation is a traditional Chinese medicine dressing.
6. The method for preparing the traditional Chinese medicine preparation for treating traumatic diseases according to any one of claims 1 to 5, characterized in that, The process includes the following steps: pulverizing the Chinese medicinal materials, then mixing the Chinese medicinal powders, borneol-β-cyclodextrin inclusion complex, camphor-β-cyclodextrin inclusion complex, artificial musk-β-cyclodextrin inclusion complex, and fermentation agent in the specified amounts to obtain a mixed powder. Adding rice wine fermentation liquid and ethanol to the mixed powder and fermenting it under sealed conditions for 2 weeks yields the final product.
7. The method for preparing a traditional Chinese medicine preparation for treating traumatic diseases according to claim 6, characterized in that: The rice wine fermentation liquid is obtained by filtering rice after fermenting it at 30℃ for 72 hours, with an ethanol concentration of 8~12wt%; the amount of rice wine fermentation liquid and ethanol added is such that it submerges the mixed powder by 1.5~2cm; the volume ratio of rice wine fermentation liquid to ethanol is 1:
5.
8. The method for preparing a traditional Chinese medicine preparation for treating traumatic diseases according to claim 6, characterized in that: The fermentation temperature is 22~27℃, and the fermentation humidity is 60~70%.