Traditional Chinese medicine composition for treating muscle and bone diseases, traditional Chinese medicine preparation and preparation method thereof

Abstract

The invention belongs to the technical field of important compositions, and particularly relates to a traditional Chinese medicine composition for treating muscle and bone diseases, a traditional Chinese medicine preparation and a preparation method thereof. The traditional Chinese medicine composition comprises the following raw materials: radix angelicae pubescentis, ligusticum wallichii, rhizoma sparganii, rhizoma atractylodis macrocephalae, peach kernels, radix angelicae sinensis, flos daturae, radix paeoniae rubra, radix angelicae, unprocessed radix aconiti, unprocessed radix aconiti kusnezoffii, unprocessed rhizoma pinelliae, unprocessed rhizoma arisaematis, flos carthami, unprocessed radix rehmanniae, radix et rhizoma rhei, fructus forsythiae, trogopterus dung, unprocessed radix astragali, unprocessed semen strychni, rhizoma et radix notopterygii, unprocessed radix glycyrrhizae, drynaria baronii, frankincense, myrrh and storax. Aiming at the technical problems of single effect and limited curative effect of the existing plaster, the plaster disclosed by the invention combines the functions of eliminating evil and strengthening the body resistance through scientific formula compatibility, and realizes the synergistic effect of multiple effects of clearing heat, tonifying qi, activating blood, dredging collaterals and the like, so that the treatment of the plaster is more comprehensive and deep, and the plaster has a remarkable curative effect on chronic and intractable muscle and bone diseases.

Description

Technical Field

[0001] This invention belongs to the field of important composition technology, specifically relating to a traditional Chinese medicine composition, a traditional Chinese medicine preparation and its preparation method for treating musculoskeletal diseases. Background Technology

[0002] Musculoskeletal disorders (such as joint pain, lower back and leg weakness, bone hyperplasia, synovitis, etc.) are common chronic diseases worldwide, and their pathogenesis is closely related to factors such as liver and kidney deficiency, qi and blood stagnation, and wind-dampness obstruction. Traditional Chinese medicine theory holds that "the liver governs the tendons and the kidneys govern the bones," and the strength of tendons and bones depends on the nourishment of the liver and kidneys and the smooth flow of qi and blood. Modern medicine, on the other hand, emphasizes the influence of pathological mechanisms such as inflammatory responses and local circulatory disorders on tendon and bone damage. Therefore, traditional Chinese medicine treatment for musculoskeletal disorders needs to take into account multiple effects such as "tonifying the liver and kidneys, promoting blood circulation and unblocking the meridians, and dispelling wind and dampness."

[0003] In summary, existing plasters for treating musculoskeletal disorders have the following problems: their efficacy is limited and poor, failing to meet the actual needs of users. Summary of the Invention

[0004] Based on the above technical background, the main objective of this invention is to provide a traditional Chinese medicine composition, a traditional Chinese medicine preparation and its preparation method for treating musculoskeletal diseases, so as to overcome the shortcomings of the prior art.

[0005] To achieve the aforementioned objectives, the technical solution adopted by this invention includes: The first aspect of this invention is to provide a traditional Chinese medicine composition for treating musculoskeletal diseases, the composition comprising the following raw materials in parts by weight: Angelica pubescens 4-8 parts, Ligusticum chuanxiong 4-8 parts, Sparganium stoloniferum 4-8 parts, Curcuma longa 4-8 parts, Prunus persica 4-8 parts, Angelica sinensis (tail) 4-8 parts, Datura stramonium 4-8 parts, Paeonia lactiflora 4-8 parts, Angelica dahurica 4-8 parts, Aconitum carmichaelii (raw) 4-8 parts, Aconitum kusnezoffii (raw) 4-8 parts, Pinellia ternata (raw) 4-8 parts, Arisaema heterophyllum (raw) 4-8 parts, Carthamus tinctorius 4-8 parts, Rehmannia glutinosa (raw) 4-8 parts, Rheum palmatum 8-16 parts, Forsythia suspensa 8-16 parts, Trogopterus xanthipes 8-16 parts, Astragalus membranaceus (raw) 8-16 parts, Strychnos nux-vomica (raw) 8-16 parts, Notopterygium incisum 5-13 parts, Glycyrrhiza uralensis (raw) 2-4 parts, Zingiber officinale 8-16 parts, Boswellia carterii 4-8 parts, Commiphora myrrha 4-8 parts, Styrax benzoin 2-4 parts.

[0006] According to a preferred embodiment of the present invention, the traditional Chinese medicine composition comprises the following raw materials in parts by weight: Duhuo 6 parts, Chuanqiong 6 parts, Sanleng 6 parts, Wentu 6 parts, Taoren 6 parts, Dangguiwei 6 parts, Yangjinhu 6 parts, Chishao 6 parts, Baizhi 6 parts, Shengchuanwu 6 parts, Shengcaowu 6 parts, Shengbanxia 6 parts, Shengnansheng 6 parts, Honghua 6 parts, Shengdi 6 parts, Chuananhuan 12 parts, Lianqiao 12 parts, Wulingzhi 12 parts, Shengqi 12 parts, Shengmachenzi 12 parts, Chuanqiaohuo 9 parts, Shenggancao 3 parts, Shengjiang 12 parts, Ruoxiang 6 parts, Metyang 6 parts, Suhe 3 parts.

[0007] According to a preferred embodiment of the present application, the traditional Chinese medicine composition comprises the following raw materials by weight: Duhuo 4 parts, Chuanqiong 4 parts, Sanleng 4 parts, Wentu 4 parts, Taoren 4 parts, Dangguiwei 4 parts, Yangjinhu 4 parts, Chishao 4 parts, Baizhi 4 parts, Shengchuanwu 4 parts, Shengcaowu 4 parts, Shengbanxia 4 parts, Shengnansheng 4 parts, Honghua 4 parts, Shengdi 4 parts, Chuananhuan 8 parts, Lianqiao 8 parts, Wulingzhi 8 parts, Shengqi 8 parts, Shengmachenzi 8 parts, Chuanqiaohuo 5 parts, Shenggancao 2 parts, Shengjiang 8 parts, Ruoxiang 4 parts, Metyang 4 parts, Suhe 2 parts.

[0008] According to a preferred embodiment of the present application, the traditional Chinese medicine composition comprises the following raw materials by weight: Duhuo 8 parts, Chuanqiong 8 parts, Sanleng 8 parts, Wentu 8 parts, Taoren 8 parts, Dangguiwei 8 parts, Yangjinhu 8 parts, Chishao 8 parts, Baizhi 8 parts, Shengchuanwu 8 parts, Shengcaowu 8 parts, Shengbanxia 8 parts, Shengnansheng 8 parts, Honghua 8 parts, Shengdi 8 parts, Chuananhuan 16 parts, Lianqiao 16 parts, Wulingzhi 16 parts, Shengqi 16 parts, Shengmachenzi 16 parts, Chuanqiaohuo 13 parts, Shenggancao 4 parts, Shengjiang 16 parts, Ruoxiang 8 parts, Metyang 8 parts, Suhe 4 parts.

[0009] The effects of each raw material in the traditional Chinese medicine composition are as follows: Duhuo: pungent, bitter, slightly warm. Belongs to kidney and bladder channels. It has the effects of dispelling wind and dampness, relieving arthralgia. Chuanqiong: pungent, warm. It has the effects of activating blood and qi, dispelling wind and relieving pain, calming.

[0010] Sanleng: pungent, bitter, neutral. It has the effects of breaking blood and qi, relieving pain.

[0011] Wentu: pungent, bitter, warm, belongs to liver and spleen channels. It has the effects of activating blood and qi, resolving accumulation and relieving pain.

[0012] Taoren: bitter, sweet, neutral. It has the effects of moistening intestines and relieving constipation, activating blood and removing stasis.

[0013] Dangguiwei: sweet, pungent, warm. It has the effects of activating blood and removing stasis, protecting cardiovascular.

[0014] Yangjinhu: pungent, warm, toxic, can enter liver and lung channels. It has the effects of relieving asthma and cough, anesthetizing and relieving pain, relieving convulsions and spasms.

[0015] Red peony root: It tastes bitter and is slightly cold in nature. It enters the liver and spleen meridians and has the effects of clearing heat and cooling blood, removing blood stasis and relieving pain.

[0016] Angelica dahurica: pungent and warm in nature; enters the lung, stomach, and large intestine meridians. It has the effects of relieving exterior syndromes and dispelling cold, dispelling wind and relieving pain, clearing nasal passages, drying dampness and stopping leukorrhea, reducing swelling and draining pus, and dispelling wind and relieving itching.

[0017] Raw aconite root: It is hot in nature and has a pungent and bitter taste. It has the effects of dispelling cold and dampness, dispersing wind-evil, warming the meridians and relieving pain, and breaking up accumulations and eliminating phlegm.

[0018] Raw aconite: It has a pungent and bitter taste, and is hot in nature. It has the effects of dispelling wind and dampness, relieving cold and pain, and anesthetic properties.

[0019] Raw Pinellia: It is pungent, warm, and toxic. It enters the spleen, stomach, and lung meridians and has the effects of drying dampness and resolving phlegm, relieving nausea and vomiting, and eliminating masses and nodules.

[0020] Raw Arisaema: Bitter and pungent in taste, warm in nature, and toxic; it enters the lung, liver, and spleen meridians. It has the effects of drying dampness and resolving phlegm, dispelling wind and relieving spasms, and dispersing nodules and reducing swelling.

[0021] Safflower: It has a pungent taste and warm properties, and a special aroma. It enters the heart and liver meridians and has the effects of promoting blood circulation and regulating menstruation, reducing swelling and relieving pain, and assisting in the treatment of cardiovascular and cerebrovascular diseases.

[0022] Rehmannia glutinosa: It is cold in nature and sweet in taste. It enters the heart, liver and kidney meridians and has the effects of clearing heat and cooling blood, nourishing yin and promoting body fluid.

[0023] Rhubarb: It tastes bitter and is cold in nature. It enters the spleen, stomach, large intestine, liver, and pericardium meridians and has the effects of purging stagnation, promoting blood circulation, and removing blood stasis.

[0024] Forsythia: It has a dry and bitter taste, is slightly cold in nature, and enters the lung, heart, and small intestine meridians. It has antibacterial, anti-inflammatory, and wind-heat dispersing effects.

[0025] Wulingzhi: It is sweet and warm in nature, and enters the liver and spleen meridians. It has the effects of promoting blood circulation, relieving pain, removing blood stasis, and stopping bleeding.

[0026] Astragalus membranaceus: It is sweet and slightly warm in nature, and enters the spleen and lung meridians. It has the effects of tonifying qi and raising yang, strengthening wei qi and consolidating the exterior, promoting diuresis and reducing swelling, and promoting tissue regeneration and detoxification.

[0027] Raw nux vomica: It has a faint odor, an extremely bitter taste, and is toxic. It enters the liver and spleen meridians and has the effects of clearing the meridians, dispersing nodules, attacking toxins, and relieving pain.

[0028] Notopterygium incisum: It has a pungent and bitter taste, and is warm in nature. It enters the bladder and kidney meridians. Notopterygium incisum is pungent, warm, and dispersing, with a strong aroma and flavor. It is good at dispersing and releasing exterior pathogens, and has the effects of relieving exterior syndromes, dispelling cold, eliminating wind and dampness, and relieving pain.

[0029] Raw licorice root: sweet in taste and neutral in nature, it enters the spleen, stomach, and lung meridians. It has the effects of relieving cough and expectoration, and protecting the stomach and intestines.

[0030] Ginger: It has a bitter taste and is warm in nature, primarily entering the liver and kidney meridians. It has the effects of tonifying the kidneys and strengthening yang, promoting blood circulation and stopping bleeding.

[0031] Frankincense: It is pungent, bitter and warm in nature, and enters the heart, liver and spleen meridians. It has the effects of promoting blood circulation and relieving pain, reducing swelling and promoting tissue regeneration, and regulating menstruation.

[0032] Myrrh: It is pungent, bitter, and neutral in nature. It enters the heart, liver, and spleen meridians and has the effects of reducing swelling and promoting tissue regeneration, regulating qi and relieving pain, and promoting blood circulation and removing blood stasis.

[0033] Styrax: Properties: Sweet, warm. Enters the heart and spleen meridians. Has the effects of opening the orifices and resolving phlegm.

[0034] A second aspect of the present invention is to provide a traditional Chinese medicine preparation for treating musculoskeletal diseases, wherein the traditional Chinese medicine preparation for treating musculoskeletal diseases is prepared from the traditional Chinese medicine composition described in the first aspect of the present invention.

[0035] Preferably, the traditional Chinese medicine preparation for treating musculoskeletal diseases is a plaster.

[0036] A third aspect of the present invention is to provide a method for preparing the plaster for treating musculoskeletal diseases as described in the second aspect of the present invention, the method comprising the following steps: Step 1: Weigh all the raw materials, wash them with water, and then soak them in pure sesame oil. Step 2: Turn on low heat and heat the soaked raw materials to cook. Then turn on high heat and continue to cook. After cooking, cool to room temperature to obtain a semi-solid ointment. Spread the semi-solid ointment evenly on a cotton cloth.

[0037] The steps described above are described in detail below.

[0038] In step 1, the raw materials are soaked in pure sesame oil at a temperature of 22-27°C for 6-8 days.

[0039] Preferably, the raw material is soaked in pure smelt oil at 25°C for 7 days.

[0040] In step 2, turn on low heat and heat the soaked ingredients for 70-80 hours.

[0041] Preferably, the soaked raw materials are heated over low heat and simmered for 72 hours.

[0042] Turn the heat to high and continue to simmer for 8–12 hours.

[0043] Preferably, turn the heat to high and continue heating and simmering for 10 hours.

[0044] The beneficial effects of this invention are as follows: (1) The traditional Chinese medicine composition of the present invention is strictly formulated. The traditional Chinese medicine composition not only contains drugs that promote blood circulation and remove blood stasis, dispel wind and unblock collaterals, but also creatively adds drugs that clear heat and cool blood, replenish qi and strengthen the exterior, and is combined with drugs that open the orifices and guide the meridians. It takes into account both "eliminating evil" and "supporting the body", so that the traditional Chinese medicine composition achieves the synergistic effect of multiple functions such as clearing heat, replenishing qi, promoting blood circulation and unblocking collaterals. Compared with the single function of promoting blood circulation and unblocking collaterals in the prior art, the traditional Chinese medicine composition of the present invention and the plaster made therefrom have a more comprehensive and in-depth treatment and significant curative effect.

[0045] Compared to a comparative composition lacking any one component, the complete combination of the traditional Chinese medicine composition described in this invention significantly reduces pain scores and swelling rates, while simultaneously downregulating the levels of inflammatory factors (TNF-α, IL-6). This demonstrates the significant synergistic effect of the traditional Chinese medicine composition in promoting blood circulation, relieving pain, and reducing inflammation and swelling. This invention simultaneously improves the core pathological aspects of musculoskeletal diseases, rapidly relieving pain, promoting swelling reduction, and inhibiting the release of inflammatory factors. The natural components of the traditional Chinese medicine compound avoid the side effects risks of single chemical drugs, making it suitable for long-term use. Furthermore, its standardized preparation process ensures the stability of the plaster's efficacy, providing a safe and effective treatment option for musculoskeletal diseases (such as arthritis and sprains).

[0046] (2) The plaster of the present invention is made from the Chinese herbal composition as the main raw material. Through scientific formulation and compatibility, the plaster has strong permeability and its efficacy can reach the lesion directly. It has a more significant therapeutic effect on musculoskeletal diseases caused by various reasons, especially chronic and stubborn diseases.

[0047] (3) The preparation method of the plaster disclosed in this invention ensures the maximum extraction of the effective components of each medicinal material in the Chinese medicine composition through a specific soaking and two-stage boiling process, while ensuring the excellent physical properties and process stability of the plaster, making it easy to achieve large-scale production. Detailed Implementation

[0048] The present invention will now be described in detail, and its features and advantages will become clearer and more apparent from these descriptions.

[0049] Example The present invention is further illustrated below with specific examples. These embodiments are merely illustrative and not intended to limit the scope of the invention. All raw materials used in the embodiments of the present invention are commercially available.

[0050] Example 1 A traditional Chinese medicine composition for treating musculoskeletal disorders, the composition comprising the following raw materials in parts by weight: Angelica pubescens 6 parts, Ligusticum chuanxiong 6 parts, Sparganium stoloniferum 6 parts, Curcuma longa 6 parts, Prunus persica 6 parts, Angelica sinensis (tail) 6 parts, Datura stramonium 6 parts, Paeonia lactiflora 6 parts, Angelica dahurica 6 parts, Aconitum carmichaelii (raw) 6 parts, Aconitum kusnezoffii (raw) 6 parts, Pinellia ternata (raw) 6 parts, Arisaema heterophyllum (raw) 6 parts, Carthamus tinctorius 6 parts, Rehmannia glutinosa (raw) 6 parts, Rheum palmatum 12 parts, Forsythia suspensa 12 parts, Trogopterus xanthipes 12 parts, Astragalus membranaceus (raw) 12 parts, Strychnos nux-vomica (raw) 12 parts, Notopterygium incisum 9 parts, Glycyrrhiza uralensis (raw) 3 parts, Zingiber officinale 12 parts, Boswellia carterii 6 parts, Commiphora myrrha 6 parts, Styrax benzoin 3 parts.

[0051] Example 2 A traditional Chinese medicine composition for treating musculoskeletal disorders, the composition comprising the following raw materials in parts by weight: Angelica pubescens 4 parts, Ligusticum chuanxiong 4 parts, Sparganium stoloniferum 4 parts, Curcuma longa 4 parts, Prunus persica 4 parts, Angelica sinensis (tail) 4 parts, Datura stramonium 4 parts, Paeonia lactiflora 4 parts, Angelica dahurica 4 parts, Aconitum carmichaelii (raw) 4 parts, Aconitum kusnezoffii (raw) 4 parts, Pinellia ternata (raw) 4 parts, Arisaema heterophyllum (raw) 4 parts, Carthamus tinctorius 4 parts, Rehmannia glutinosa (raw) 4 parts, Rheum palmatum 8 parts, Forsythia suspensa 8 parts, Trogopterus xanthipes 8 parts, Astragalus membranaceus (raw) 8 parts, Strychnos nux-vomica (raw) 8 parts, Notopterygium incisum 5 parts, Glycyrrhiza uralensis (raw) 2 parts, Zingiber officinale 8 parts, Boswellia carterii 4 parts, Commiphora myrrha 4 parts, Styrax benzoin 2 parts. Example 3 A traditional Chinese medicine composition for treating musculoskeletal disorders, the composition comprising the following raw materials in parts by weight: Angelica pubescens 8 parts, Ligusticum chuanxiong 8 parts, Sparganium stoloniferum 8 parts, Curcuma longa 8 parts, Prunus persica 8 parts, Angelica sinensis (tail) 8 parts, Datura stramonium 8 parts, Paeonia lactiflora 8 parts, Angelica dahurica 8 parts, Aconitum carmichaelii (raw) 8 parts, Aconitum kusnezoffii (raw) 8 parts, Pinellia ternata (raw) 8 parts, Arisaema heterophyllum (raw) 8 parts, Carthamus tinctorius 8 parts, Rehmannia glutinosa (raw) 8 parts, Rheum palmatum 16 parts, Forsythia suspensa 16 parts, Trogopterus xanthipes 16 parts, Astragalus membranaceus (raw) 16 parts, Strychnos nux-vomica (raw) 16 parts, Notopterygium incisum 13 parts, Glycyrrhiza uralensis (raw) 4 parts, Zingiber officinale 16 parts, Boswellia carterii 8 parts, Commiphora myrrha 8 parts, Styrax benzoin 4 parts. Example 4 A plaster for treating musculoskeletal disorders, said plaster being prepared by the following method: Weigh each raw material according to the weight proportions of the traditional Chinese medicine composition described in Example 1, wash the raw materials with clean water, and then soak the cleaned raw materials in pure sesame oil at a temperature of 25°C for 7 days until the raw materials are completely immersed in the sesame oil.

[0052] Heat the soaked ingredients over low heat for 72 hours, then turn to high heat and continue heating and simmering for 10 hours. After simmering, cool to room temperature to obtain a semi-solid ointment. Spread the semi-solid ointment evenly on a cotton cloth to obtain a plaster for treating musculoskeletal diseases.

[0053] Example 5 A plaster for treating musculoskeletal disorders, said plaster being prepared by the following method: Weigh each raw material according to the weight proportions of the traditional Chinese medicine composition described in Example 2, wash the raw materials with clean water, and then soak the cleaned raw materials in pure sesame oil at a temperature of 22-27°C for 6-8 days until the raw materials are completely immersed in the sesame oil.

[0054] Heat the soaked raw materials over low heat for 70-80 hours, then turn to high heat and continue heating and simmering for 8-12 hours. After simmering, cool to room temperature to obtain a semi-solid ointment. Spread the semi-solid ointment evenly on a cotton cloth to obtain a plaster for treating musculoskeletal diseases.

[0055] Example 6 A plaster for treating musculoskeletal disorders, said plaster being prepared by the following method: Weigh each raw material according to the weight proportions of the traditional Chinese medicine composition described in Example 3, wash the raw materials with clean water, and then soak the cleaned raw materials in pure sesame oil at a temperature of 22-27°C for 6-8 days until the raw materials are completely immersed in the sesame oil.

[0056] Heat the soaked raw materials over low heat for 70-80 hours, then turn to high heat and continue heating and simmering for 8-12 hours. After simmering, cool to room temperature to obtain a semi-solid ointment. Spread the semi-solid ointment evenly on a cotton cloth to obtain a plaster for treating musculoskeletal diseases.

[0057] Comparative Example Comparative Example 1 The ointment was prepared in a manner similar to that in Example 4, except that frankincense was not added. Comparative Example 2 The ointment was prepared in a manner similar to that in Example 4, except that myrrh was not added. Comparative Example 3 The ointment was prepared in a manner similar to that in Example 4, except that no styrax was added.

[0058] Experimental Example Experimental Example 1 Animal selection: SPF-grade male SD rats (to avoid potential interference from estrogen on experimental results), weighing between 180 and 220 g, were purchased from Beijing Vital River Laboratory Animal Technology Co., Ltd., a company with a laboratory animal production license. Animals were housed in a standard environment with a temperature controlled at 22±2℃, relative humidity at 55±5%, and a light / dark cycle of 12 h light / 12 h dark. They were provided with free access to standard rat feed and sterile drinking water. The selection of male SD rats eliminated the interference of sex hormone fluctuations on musculoskeletal diseases; the SPF-grade environment and standardized housing conditions minimized the impact of microbial contamination and environmental factors on experimental results.

[0059] Test drug: The drugs used in this experiment included the ointments of Examples 4-6 and Comparative Examples 1-3. The specific testing procedures are as follows: Modeling and testing reagents The modeling reagents include Freund's complete adjuvant (for inducing an inflammation model) and surgical sutures (for surgical modeling); specific information on the testing reagents is shown in Table 1 below: Table 1

[0060] All reagents were used within their expiration date and were operated strictly in accordance with the provided instructions.

[0061] The specific experimental method is as follows: Model preparation method: This experiment used a rheumatoid arthritis model as the research subject and established an animal model using Freund's complete adjuvant induction method. The specific modeling steps are as follows: Healthy adult rats were selected, and 0.1 mL of Freund's complete adjuvant was injected intradermally into the right hind paw. The blank control group rats were injected with an equal volume of physiological saline at the same site. After modeling, the degree of redness and swelling, range of motion, and gait changes of the rats' right hind paw joint were observed daily for 7–14 days. The model was considered successfully established when the rats in the model group showed significant joint swelling, limited movement, and no spontaneous remission trend.

[0062] Validation of test drug preparation: The test drugs include the ointments of Examples 4-6 and the ointments of Comparative Examples 1-3.

[0063] The testing methods for the indicators are as follows: (1) Pain sensitivity was tested using the modified Von Frey method: rats were placed in a transparent observation box with a metal mesh bottom. After acclimatization for 30 minutes, the skin of the middle part of the right hind foot was vertically stimulated with a series of Von Frey fibers. The threshold (unit: g) that elicited a 50% foot withdrawal response was recorded. Each rat was measured 3 times and the average value was taken.

[0064] (2) The swelling of the foot was measured using an electronic vernier caliper (accuracy 0.01 mm): The thickness of the right hind foot of the rat was measured at the same time every day before and after modeling, and the swelling was calculated (swelling = thickness after modeling - thickness before modeling, unit: mm).

[0065] (3) ELISA method was used to detect inflammatory factor levels: At the end of the experiment, rats were sacrificed, and serum and synovial tissue were collected. The serum sample was centrifuged at 3000 r / min for 15 min (4℃), and the supernatant was collected. The synovial tissue was homogenized with 10% pre-cooled PBS, and the supernatant was collected after centrifugation. The concentration of inflammatory factors in the samples (unit: pg / mL) was measured strictly according to the instructions of the TNF-α and IL-6 ELISA kits. The detection wavelength was set to 450 nm. A standard curve was plotted with the concentration of the standard as the x-axis and the absorbance value as the y-axis, and the sample concentration was calculated.

[0066] Group design: To clarify the mechanism of action of key components in the plaster, this study employed a controlled group design, setting up 7 experimental groups, with 12 SPF-grade rats in each group. Through systematic comparison of the intervention effects of different component combinations, the synergistic effects of the core medicinal materials in the formula were revealed. The group settings are shown in Table 2 below: Table 2

[0067] Administration method and testing cycle: The drug was administered topically once daily at a fixed time (9:00 AM) to ensure stable drug exposure. The specific dosage regimen was the same for both the experimental and control groups, achieving standardized treatment.

[0068] The testing period lasted 28 days, with drug administration starting on day 1 after model establishment (i.e., day 1 of the experiment), forming a complete time-series observation. To dynamically monitor disease progression and the effectiveness of drug intervention, five key detection points were established: Before drug administration (day 0 of the experiment): Baseline measurements were performed only on the blank control group and the model control group to assess the success of model establishment; 7 days (day 7 of the experiment), 14 days (day 14 of the experiment), and 21 days (day 21 of the experiment): The dynamic changes in pain scores and joint swelling were closely monitored. Day 28 of drug administration (experimental day 28): In addition to pain and swelling indicators, serum and joint tissue samples were collected after the animals were euthanized for the detection of inflammatory factor levels.

[0069] To ensure the statistical reliability of the data, eight animals were randomly selected from each group at each testing time point for index measurement. By controlling the sample size and randomizing the design, experimental errors were reduced, ensuring the continuity and scientific validity of the results.

[0070] Test data and results analysis: Test metrics: (1) Pain sensitivity assessment The 50% paw withdrawal threshold is used as the core indicator for quantifying pain sensitivity. This indicator, measured using von Frey fiber stimulation, determines the stimulus intensity at which the probability of a paw withdrawal response to a noxious stimulus reaches 50%, objectively reflecting the degree of improvement in hyperalgesia. A higher value indicates more significant pain relief. The unit of measurement is usually grams (g) or seconds (s), and the normal reference range is based on the baseline threshold of the blank control group (e.g., the normal 50% PWT for SD rats is generally 8-12 g).

[0071] (2) Assessment of joint inflammation and edema Swelling degree directly reflects the degree of inflammation and edema by measuring the difference in joint circumference (before and after treatment, or between the affected and healthy sides). The calculation formula is: Swelling degree difference = circumference before treatment - circumference after treatment (or circumference of the affected side - circumference of the healthy side), in millimeters (mm). The smaller the difference, the better the swelling reduction effect. The difference in joint circumference in the blank control group is usually close to 0 mm, while the difference in the model group is generally greater than 2 mm.

[0072] (3) Detection of inflammatory factor levels Tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6) were selected as key inflammatory markers. These two are core mediators of the inflammatory cascade in musculoskeletal diseases, and their concentrations in serum or synovial fluid can be detected by enzyme-linked immunosorbent assay (ELISA), measured in picograms per milliliter (pg / mL). Decreased levels suggest that the drugs are exerting an anti-inflammatory effect. In the blank control group, the normal reference range for serum TNF-α is generally 5–15 pg / mL, and for IL-6, it is 10–30 pg / mL; the model group typically showed increases of 2–5 times compared to the blank control group.

[0073] (4) Comprehensive evaluation of motor function Supplementing the rat open field test (OFT) with indicators to assess musculoskeletal function recovery, this included movement distance (in centimeters) and number of stands (in times). Movement distance reflects the animal's voluntary movement ability, while the number of stands reflects hind limb support and balance function; the combination of these two metrics provides a comprehensive evaluation of limb motor function improvement. In the blank control group, rats typically moved a distance of 1500–2500 cm and stood 15–25 times within 30 minutes.

[0074] Test Results (1) Pain score results: The pain level of rats in each group was assessed at different time points after drug administration using the 50% withdrawal threshold (g). The results are presented in Table 1, "Pain Scores of Rats in Each Group at Different Time Points After Drug Administration (50% Withdrawal Threshold, g, x±s, n=8)," and the specific test data are shown in Table 3 below. This table contains 5 columns: group, 7 days, 14 days, 21 days, and 28 days after drug administration, clearly showing the trend of pain score changes in each group at different time points.

[0075] Table 3 Pain scores of rats at different time points after drug administration (50% foot withdrawal threshold, g, x±s, n=8)

[0076] Note: Compared with the model control group, # indicates P<0.05, ## indicates P<0.01; compared with Example 1 group, * indicates P<0.05, * indicates P<0.01.

[0077] Table 3 shows that the model control group had the lowest pain scores at all time points, indicating the most severe inflammatory pain. The pain scores of groups 4-6 were significantly higher than those of groups 1 (lacking frankincense), 2 (lacking myrrh), and 3 (lacking styrax) at 7, 14, 21, and 28 days after administration (P<0.05 or P<0.01), and their scores were close to those of the positive control group. These results indicate that the ointment has a significant analgesic effect. Further comparison revealed that the pain scores of groups 1, 2, and 3 decreased sequentially, suggesting that frankincense, myrrh, and styrax all play important roles in pain relief, and that the optimal effect is achieved when all three work together.

[0078] The above results confirm that frankincense, myrrh, and styrax are the important active ingredients in this ointment that exert analgesic effects. The synergistic effect of the three can significantly enhance the pain relief effect, providing important experimental evidence for the clinical treatment of pain related to musculoskeletal diseases.

[0079] (2) Swelling results To evaluate the anti-swelling effect of the ointment, the experiment was conducted by measuring the swelling degree of rat paws (the difference in thickness before modeling) for quantitative analysis. The results are shown in Table 4.

[0080] Table 4. Foot swelling (mm, x±s, n=8) at different time points after drug administration in each group of rats.

[0081] Note: Compared with the model control group, # indicates P<0.05, ## indicates P<0.01; compared with the Example 1 group, P<0.05, * indicates P<0.01; n=8 indicates 8 rats in each group, x±s is the mean ± standard deviation.

[0082] Table 4 shows that the swelling degree in the model control group was the highest at all time points, indicating that its inflammatory edema was the most severe. The swelling degree in groups 4-6 gradually decreased with the extension of drug administration time, and the swelling degree at each time point of 7, 14, 21 and 28 days of drug administration was significantly lower than that in groups 1-3 of the control group (P<0.05 or P<0.01); until 28 days of drug administration, the swelling degree in group 4 was close to that of the blank control group, indicating that its swelling reduction effect was close to that of normal physiological state.

[0083] Further analysis showed that the swelling degree in comparative groups 1-3 increased sequentially, indicating that frankincense, myrrh, and styrax have a synergistic effect in promoting swelling reduction. The absence of any one of these components in the plaster would weaken the swelling-reducing effect. This result demonstrates that frankincense, myrrh, and styrax, when combined in specific dosages, can significantly enhance anti-inflammatory and swelling-reducing activities, providing important experimental evidence for the clinical application of plasters.

[0084] The above results also indicate that the synergistic effect of frankincense, myrrh, and styrax is an important mechanism by which the plaster described in this invention exerts a significant anti-swelling effect. The combination of the three can effectively reduce the degree of inflammatory edema, and the anti-swelling effect is better than that of the control group lacking a single component.

[0085] (3) Results of inflammatory factor levels This invention assesses the anti-inflammatory effect of a topical ointment by detecting the serum levels of tumor necrosis factor-α (TNF-α) and interleukin-6 (IL-6) in rats of each group 28 days after administration. The results are presented in tabular form (Table 5). The table includes three core columns: group, TNF-α, and IL-6. Data are expressed as mean ± standard deviation (pg / mL, x ± s), and the sample size for each group is 8 rats.

[0086] Table 5. Serum inflammatory factor levels in rats of each group after 28 days of drug administration (pg / mL, x±s, n=8)

[0087] Note: Compared with the model control group, # indicates P<0.05, ## indicates P<0.01; compared with Example 1 group, * indicates P<0.05, * indicates P<0.01.

[0088] Table 5 shows that the levels of TNF-α and IL-6 in the model control group were significantly higher than those in the other groups, confirming the successful construction of the model. The levels of both inflammatory factors in Example 4 were significantly lower than those in Comparative Examples 1-3 (P<0.01), and there was no statistically significant difference compared to the positive control group (P>0.05). Notably, the levels of inflammatory factors in Comparative Example 1 (lacking frankincense), Comparative Example 2 (lacking myrrh), and Comparative Example 3 (lacking styrax) showed a sequentially increasing trend. These results indicate that frankincense, myrrh, and styrax have a synergistic effect in inhibiting the release of inflammatory factors, and the absence of any one component can lead to a decrease in anti-inflammatory activity.

[0089] The above results show that, through the synergistic effect of the three components, the inflammatory factor inhibition effect of Examples 4, 5, and 6 is significantly better than that of the control group lacking a single component (P<0.01), and comparable to that of the positive control group, indicating that the traditional Chinese medicine composition described in this invention has a clear advantage in anti-inflammatory effects.

[0090] The present invention has been described in detail above with reference to specific embodiments and exemplary examples; however, these descriptions should not be construed as limiting the present invention. Those skilled in the art will understand that various equivalent substitutions, modifications, or improvements can be made to the technical solutions and embodiments of the present invention without departing from the spirit and scope of the invention, and all such modifications and improvements fall within the scope of the present invention. The scope of protection of the present invention is defined by the appended claims.

Claims

1. A traditional Chinese medicine composition for treating musculoskeletal diseases, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: Angelica pubescens 4-8 parts, Ligusticum chuanxiong 4-8 parts, Sparganium stoloniferum 4-8 parts, Curcuma longa 4-8 parts, Prunus persica 4-8 parts, Angelica sinensis (tail) 4-8 parts, Datura stramonium 4-8 parts, Paeonia lactiflora 4-8 parts, Angelica dahurica 4-8 parts, Aconitum carmichaelii (raw) 4-8 parts, Aconitum kusnezoffii (raw) 4-8 parts, Pinellia ternata (raw) 4-8 parts, Arisaema heterophyllum (raw) 4-8 parts, Carthamus tinctorius 4-8 parts, Rehmannia glutinosa (raw) 4-8 parts, Rheum palmatum 8-16 parts, Forsythia suspensa 8-16 parts, Trogopterus xanthipes 8-16 parts, Astragalus membranaceus (raw) 8-16 parts, Strychnos nux-vomica (raw) 8-16 parts, Notopterygium incisum 5-13 parts, Glycyrrhiza uralensis (raw) 2-4 parts, Zingiber officinale 8-16 parts, Boswellia carterii 4-8 parts, Commiphora myrrha 4-8 parts, Styrax benzoin 2-4 parts.

2. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: Angelica pubescens 6 parts, Ligusticum chuanxiong 6 parts, Sparganium stoloniferum 6 parts, Curcuma longa 6 parts, Prunus persica 6 parts, Angelica sinensis (tail) 6 parts, Datura stramonium 6 parts, Paeonia lactiflora 6 parts, Angelica dahurica 6 parts, Aconitum carmichaelii (raw) 6 parts, Aconitum kusnezoffii (raw) 6 parts, Pinellia ternata (raw) 6 parts, Arisaema heterophyllum (raw) 6 parts, Carthamus tinctorius 6 parts, Rehmannia glutinosa (raw) 6 parts, Rheum palmatum 12 parts, Forsythia suspensa 12 parts, Trogopterus xanthipes 12 parts, Astragalus membranaceus (raw) 12 parts, Strychnos nux-vomica (raw) 12 parts, Notopterygium incisum 9 parts, Glycyrrhiza uralensis (raw) 3 parts, Zingiber officinale 12 parts, Boswellia carterii 6 parts, Commiphora myrrha 6 parts, Styrax benzoin 3 parts.

3. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: Angelica pubescens 4 parts, Ligusticum chuanxiong 4 parts, Sparganium stoloniferum 4 parts, Curcuma longa 4 parts, Prunus persica 4 parts, Angelica sinensis (tail) 4 parts, Datura stramonium 4 parts, Paeonia lactiflora 4 parts, Angelica dahurica 4 parts, Aconitum carmichaelii (raw) 4 parts, Aconitum kusnezoffii (raw) 4 parts, Pinellia ternata (raw) 4 parts, Arisaema heterophyllum (raw) 4 parts, Carthamus tinctorius 4 parts, Rehmannia glutinosa (raw) 4 parts, Rheum palmatum 8 parts, Forsythia suspensa 8 parts, Trogopterus xanthipes 8 parts, Astragalus membranaceus (raw) 8 parts, Strychnos nux-vomica (raw) 8 parts, Notopterygium incisum 5 parts, Glycyrrhiza uralensis (raw) 2 parts, Zingiber officinale 8 parts, Boswellia carterii 4 parts, Commiphora myrrha 4 parts, Styrax benzoin 2 parts.

4. The traditional Chinese medicine composition according to claim 1, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: Angelica pubescens 8 parts, Ligusticum chuanxiong 8 parts, Sparganium stoloniferum 8 parts, Curcuma longa 8 parts, Prunus persica 8 parts, Angelica sinensis (tail) 8 parts, Datura stramonium 8 parts, Paeonia lactiflora 8 parts, Angelica dahurica 8 parts, Aconitum carmichaelii (raw) 8 parts, Aconitum kusnezoffii (raw) 8 parts, Pinellia ternata (raw) 8 parts, Arisaema heterophyllum (raw) 8 parts, Carthamus tinctorius 8 parts, Rehmannia glutinosa (raw) 8 parts, Rheum palmatum 16 parts, Forsythia suspensa 16 parts, Trogopterus xanthipes 16 parts, Astragalus membranaceus (raw) 16 parts, Strychnos nux-vomica (raw) 16 parts, Notopterygium incisum 13 parts, Glycyrrhiza uralensis (raw) 4 parts, Zingiber officinale 16 parts, Boswellia carterii 8 parts, Commiphora myrrha 8 parts, Styrax benzoin 4 parts.

5. A traditional Chinese medicine preparation for treating musculoskeletal diseases, characterized in that, The traditional Chinese medicine preparation for treating musculoskeletal diseases is prepared from the traditional Chinese medicine composition according to any one of claims 1 to 4.

6. The traditional Chinese medicine preparation according to claim 5, characterized in that, The traditional Chinese medicine preparation used to treat musculoskeletal diseases is a plaster.

7. A method for preparing a plaster for treating musculoskeletal diseases as described in claim 6, characterized in that, The preparation method includes the following steps: Step 1: Weigh all the raw materials, wash them with water, and then soak them in pure sesame oil. Step 2: Turn on low heat and heat the soaked raw materials to cook. Then turn on high heat and continue to cook. After cooking, cool to room temperature to obtain a semi-solid ointment. Spread the semi-solid ointment evenly on a cotton cloth.

8. The preparation method according to claim 7, characterized in that, In step 1, Soak the raw materials in pure sesame oil at a temperature of 22-27°C for 6-8 days.

9. The preparation method according to claim 7, characterized in that, In step 2, Heat the soaked ingredients over low heat and simmer for 70-80 hours.

10. The preparation method according to claim 7, characterized in that, In step 2, Turn the heat to high and continue to simmer for 8–12 hours.

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