Traditional Chinese medicine composition and preparation combined with acupuncture for treating scapulohumeral periarthritis and application thereof

Abstract

The application relates to the technical field of traditional Chinese medicines, in particular to a traditional Chinese medicine composition capable of treating periarthritis of shoulder in combination with acupuncture, a preparation and application thereof, which is composed of the following medicinal materials in parts by weight: 15-30 parts of chuanxiong, 20-30 parts of curcuma, 15-30 parts of peach kernel, 15-30 parts of safflower, 10-20 parts of vinegar pericarpium citri reticulatae, 10-20 parts of corydalis, 5-10 parts of prepared aconite, 10-15 parts of cassia, 3-6 parts of asarum, 20-30 parts of pittosporium, 20-30 parts of siegesbeckia, 15-25 parts of red sandalwood, 10-20 parts of white mustard seed, 15-25 parts of mulberry branch, and 10-15 parts of raw licorice. The application provides a brand-new traditional Chinese medicine composition capable of treating periarthritis of shoulder in combination with acupuncture, a preparation and application thereof. The traditional Chinese medicine composition is combined with acupuncture, can improve the pain, stiffness and activity limitation of periarthritis of shoulder in combination through the functions of 'internal regulation of qi and blood and external dredging of meridians', and provides a new traditional Chinese medicine treatment idea for the clinical treatment of periarthritis of shoulder.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine composition technology, specifically relating to a traditional Chinese medicine composition, preparation and application that can be used in combination with acupuncture to treat frozen shoulder. Background Technology

[0002] Frozen shoulder is an aseptic inflammation of the soft tissues around the shoulder caused by various factors. It is characterized by shoulder pain and limited range of motion, which seriously affects the patient's life. Frozen shoulder falls under the category of "shoulder pain" in traditional Chinese medicine. Shoulder movement is coordinated by muscles and tendons and is also related to the internal organs. The "Suwen·Weilun" states: "The spleen governs the muscles of the body, the liver governs the fascia of the body, and the kidney governs the bone marrow of the body." It is believed that when the spleen is healthy, the muscles are full and vigorous; when the liver's qi and blood are sufficient, the fascia are nourished and the tendons are strong; and the kidney is the root of the bones. Therefore, shoulder diseases are connected to the internal organs.

[0003] Currently, the Western medical causes and pathogenesis of frozen shoulder are still unclear. Clinical studies indicate that many diseases, including cervical spondylosis, thyroid disease, diabetes, and cardiovascular disease, are related to frozen shoulder, with an incidence rate generally between 3-5%. Frozen shoulder is a self-limiting disease, and most patients experience prolonged and persistent pain, severely impacting their physical and mental health. In severe cases, it can lead to loss of shoulder joint function, affecting daily work, study, and life. In recent years, the fast pace of life and significantly increased working hours and workloads, coupled with prolonged desk work and lack of exercise, have further increased the incidence of frozen shoulder.

[0004] With the continuous development of medicine, the treatment methods for frozen shoulder have become increasingly diversified. Currently, Western medicine treatments, besides surgical intervention, mainly rely on oral analgesics and injections, as well as physical therapy, joint exercises, and shoulder joint release. However, the treatment effects are often unsatisfactory, and many side effects are associated with these methods. For example, non-steroidal anti-inflammatory drugs (NSAIDs) can easily damage the patient's gastrointestinal tract, cardiovascular system, and kidneys. Manual release under anesthesia can significantly improve shoulder joint mobility in the early stages. Combined with intra-articular steroid injections, it can achieve better long-term efficacy in treating frozen shoulder. However, postoperative complications include the risk of joint hemarthrosis, capsular tear, lip detachment, and fractures of the humerus or glenoid fossa. Furthermore, general anesthesia can affect the patient's respiratory and circulatory systems, as well as cerebral blood flow perfusion, impacting the patient's prognosis and health. Therefore, further exploration of new treatment methods for frozen shoulder is still needed. Summary of the Invention

[0005] To address the shortcomings of existing technologies, this invention provides a novel traditional Chinese medicine composition, preparation, and application for the combined treatment of frozen shoulder with acupuncture. This composition, when combined with acupuncture, works by "regulating qi and blood internally and unblocking meridians externally" to synergistically improve pain, stiffness, and limited range of motion in frozen shoulder, offering a new TCM treatment approach for this condition. This invention provides an in-depth analysis of the causes of frozen shoulder and establishes corresponding treatment principles, ultimately forming a unique synergistic effect between the ingredients. Each herb in the formula plays its specific role, working synergistically and mutually reinforcingly, and none can be omitted, ultimately achieving a comprehensive therapeutic effect for frozen shoulder and similar conditions.

[0006] Common causes of frozen shoulder include trauma and strain (directly leading to blood stasis), wind-cold-dampness (inducing or aggravating stagnation), emotional imbalance (leading to qi stagnation and subsequently blood stasis), and qi and blood deficiency (resulting in stagnation due to weak circulation). Qi stagnation and blood stasis severely obstruct the flow of qi and blood, causing blockages in the meridians, muscles, and joints of the shoulder, resulting in local qi and blood stagnation and meridian obstruction. This leads to typical frozen shoulder pain symptoms such as stabbing pain, fixed pain location, tenderness upon pressure, and worsening at night (blood belongs to yin, and yin is predominant at night, making the pain from blood stasis more severe). Treatment principles for frozen shoulder often focus on promoting blood circulation, removing blood stasis, and relieving pain, but these principles often lack consideration for joint adhesions and tissue hardening. Furthermore, frozen shoulder is often a cold syndrome or a mixture of cold and heat with a predominance of cold; therefore, treatment should also consider stimulating yang qi to promote qi and blood circulation and dispel cold and stagnation.

[0007] Based on the above considerations regarding the etiology and treatment principles of frozen shoulder, this invention proposes a novel traditional Chinese medicine composition that can be used in conjunction with acupuncture to treat frozen shoulder. This traditional Chinese medicine composition is an external application.

[0008] Specifically, the first aspect of the present invention provides a traditional Chinese medicine composition for treating frozen shoulder, the composition comprising the following medicinal materials: Ligusticum chuanxiong, Curcuma longa, Prunus persica, Carthamus tinctorius, Citrus reticulata peel (processed with vinegar), Corydalis yanhusuo, processed Aconitum carmichaelii, Cinnamomum cassia, Asarum heterotropoides, Erythrina variegata bark, Siegesbeckia orientalis, Sappanwood, Sinapis alba, Morus alba twigs, and Glycyrrhiza uralensis.

[0009] The compatibility significance of the traditional Chinese medicine composition provided by this invention is as follows: The principal herbs are Ligusticum chuanxiong and Curcuma longa, which work synergistically to form a powerful effect of activating blood circulation, removing blood stasis, promoting qi circulation, and clearing the meridians, specifically targeting the shoulder and arm, directly addressing the core pathogenesis of blood stasis and qi stagnation in the shoulder and arm; the assistant herbs are Prunus persica, Carthamus tinctorius, Citrus reticulata peel (processed with vinegar), and Corydalis yanhusuo, among which Prunus persica and Carthamus tinctorius work synergistically to assist the principal herbs in enhancing their effects of breaking up blood stasis, removing blood stasis, and dispersing blood stasis; Citrus reticulata peel (processed with vinegar) breaks up liver stagnation and promotes qi circulation, while Corydalis yanhusuo promotes qi circulation, activates blood circulation, clears the meridians, and relieves pain. The combination of the two enhances the liver-soothing, qi-clearing, blood-activating, and pain-relieving effects of the formula; Prepared Aconitum carmichaelii, Cinnamomum cassia, Asarum heterotropoides, Erythrina variegata, and Siegesbeckia orientalis are adjuvant herbs, with Prepared Aconitum carmichaelii being a large... The formula is characterized by its strong heat and tonifying properties, including tonifying fire and assisting yang, dispelling cold and relieving pain. Cinnamon warms the kidneys and assists yang, dispels cold and unblocks the meridians. Asarum is pungent and warm, penetrating the meridians. The combination of these three ingredients has a strong warming and cold-dispelling effect, deeply warming and unblocking yang qi and dispelling cold. Erythrina bark and Siegesbeckia orientalis can dispel wind and dampness, unblock the meridians and relieve pain, while turmeric has the effect of warming and dispelling dampness. The guiding herbs are sappanwood, white mustard seed, mulberry twig and licorice. Sappanwood and white mustard seed together have the effect of breaking up blood stasis, dispersing nodules, unblocking the meridians and relieving pain, thereby enhancing the effect of the formula in loosening soft tissue adhesions and softening stiff tissues. Mulberry twig can guide the meridians and unblock the meridians to the affected area of ​​the shoulder and arm. Raw licorice plays a role in harmonizing the properties of the herbs.

[0010] Chuanxiong (Ligusticum striatum): Nature: Cold; Taste: Bitter, pungent. Meridians: Liver, Kidney. External Use: Dispels wind and dampness, unblocks meridians and relieves pain: Used externally to treat rheumatic pain, muscle and bone pain, joint swelling, and difficulty in flexion and extension. Often combined with other rheumatoid herbs for decoction fumigation or poultice. Clears heat and detoxifies: Used externally to treat carbuncles, boils, eczema, itching, urticaria, scabies, and other skin diseases. Fresh product can be poultice, decocted for washing, or used as a wet compress. Relieves muscle tension and promotes blood circulation: Used externally to relieve discomfort such as sprains, muscle soreness, and muscle spasms.

[0011] Turmeric: Nature: Warm; Flavor: Pungent, Bitter. Meridians: Liver, Spleen. External Use Effects: Promotes blood circulation and qi flow, clears the meridians and relieves pain: External use is one of turmeric's most prominent effects. It is used to treat injuries from falls and blows, swelling and pain due to blood stasis, and rheumatic pain (joint and muscle pain, numbness, and difficulty in flexion and extension). Its pungent and warming properties can promote local blood circulation, dissipate stagnation, and relieve pain. Reduces swelling and dissipates nodules: External use helps to dissipate early-stage carbuncles and boils (redness, swelling, heat, and pain). It is often used in combination with other heat-clearing, detoxifying, and swelling-reducing drugs for external application. Dispels wind and relieves itching: It can be used to relieve rashes, itchy skin, etc. Its pungent and dispersing properties help to dispel wind. Antibacterial and anti-inflammatory (modern understanding): Its active ingredients, such as curcumin, have significant anti-inflammatory and antibacterial effects.

[0012] Peach kernel: Nature: Neutral (slightly warm); Taste: Bitter, sweet. Channels entered: Heart, Liver, Large Intestine. External use of peach kernel primarily utilizes its core function of promoting blood circulation and removing blood stasis, extending to the following effects: Promoting blood circulation, removing blood stasis, reducing swelling and relieving pain: This is the most important external effect. It is used to treat injuries from falls and blows, swelling and pain due to blood stasis, and local bruising. It can promote blood circulation, dissipate blood stasis, and relieve pain and swelling. Moisturizing and unblocking meridians: Because it contains oil (peach kernel oil), it has a lubricating effect. It can be used to relieve dry skin and chapped skin (chapped hands and feet). Promoting tissue regeneration (modern understanding): The effect of promoting blood circulation and removing blood stasis helps improve local microcirculation, which may indirectly promote wound healing and soften scars (often combined with repair drugs).

[0013] Safflower: Nature: Warm; Flavor: Pungent. Meridian Tropism: Heart and Liver Meridians. Safflower is used externally for its core functions of dispersing and warming, promoting blood circulation, clearing the meridians, removing blood stasis, and relieving pain, and extends to the following effects: Promoting blood circulation, removing blood stasis, reducing swelling and relieving pain (core): This is the most important external effect. It is used to treat traumatic injuries, swelling and pain due to blood stasis, sprains and contusions, and local purplish ecchymosis. It can quickly improve local blood circulation, promote the dissipation of blood stasis, and rapidly reduce pain and swelling. Clearing the meridians: Its warming nature can penetrate the meridians, and it is used for wind-cold-dampness arthralgia (cold pain, numbness, and difficulty in flexion and extension of joints and muscles), old injuries, and frostbite (non-ulcerated). It can relieve pain caused by poor blood circulation and cold stagnation. Promoting wound healing (auxiliary): The blood-activating and stasis-removing effect can improve local microcirculation, increase blood oxygen supply, and may indirectly promote the healing of late-stage sores, chronic ulcers, and soften scar tissue.

[0014] Vinegar-processed Green Tangerine Peel: Nature: Warm; Flavor: Bitter, pungent. Meridians: Liver, Gallbladder, Stomach. Green tangerine peel is the peel of young or immature tangerine fruit. It is potent and has a strong effect on regulating qi, especially good at soothing the liver, breaking up qi stagnation, resolving stagnation, and relieving pain. Its effects are as follows: Soothing the liver, breaking up qi stagnation, and relieving pain: Used to treat liver qi stagnation, chest and rib pain, breast pain / lumps (mastopathy, early stage of mastitis), and hernia pain. It can unblock the meridians and relieve distension and pain caused by qi stagnation. Resolving lumps and swelling: Its strong pungent and bitter properties can break up qi stagnation and resolve lumps. Used for local swelling, lumps, and mastitis caused by qi stagnation, blood stasis, or phlegm-qi stagnation. Resolving stagnation: Its strong qi-regulating effect can be used externally to help improve abdominal distension and pain caused by qi stagnation and food stagnation (often combined with digestive herbs such as hawthorn and malt powder).

[0015] Corydalis Rhizome: Nature: Warm; Taste: Pungent, Bitter. Meridians: Liver, Spleen, Heart. Corydalis Rhizome is pungent and warm, entering both the blood level to invigorate blood and remove blood stasis, and the qi level to regulate qi and relieve pain. It is considered a "qi-regulating herb within the blood, and a blood-regulating herb within the qi," exhibiting remarkable analgesic power. Externally, it is used for its effects of invigorating blood, removing blood stasis, regulating qi, and relieving pain. Its effects are as follows: Invigorating blood, regulating qi, and relieving pain (core): Used for various types of pain, whether it is qi stagnation pain (distending pain, migratory pain), blood stasis pain (stabbing pain, fixed pain), or pain caused by both qi stagnation and blood stasis. It is particularly effective in treating traumatic injuries with swelling and pain, blood stasis masses, joint and muscle pain, stomach pain, rib pain, dysmenorrhea, hernia pain, headache, toothache, and neuralgia (such as sciatica and trigeminal neuralgia). Its analgesic effect is significant and its application is widespread. Removing blood stasis and reducing swelling: Through its blood-invigorating and stasis-removing effects, it dissipates blood stasis and reduces swelling. It is suitable for external traumatic bruising and swelling, early stages of carbuncles and boils (must be combined with heat-clearing and detoxifying drugs), and local blood stasis and induration. It also helps to unblock meridians and relieve pain: its pungent and warm properties help to clear the meridians and relieve joint and muscle pain, numbness, and contracture caused by wind-cold-dampness obstructing the meridians.

[0016] Prepared Aconite: Properties: Pungent, sweet, very hot; toxic. Channels Entered: Heart, Kidney, Spleen. External application of prepared aconite primarily functions to dispel cold and relieve pain. It is suitable for localized pain or sores caused by excessive cold, specifically including: Cold-dampness arthralgia: such as joint pain, difficulty in flexion and extension, rheumatoid arthritis, etc., relieving pain by dispelling cold and dampness and warming the meridians. Cold pain in the heart and abdomen, cold hernia: External application can help relieve abdominal pain caused by cold stagnation. Yang deficiency with external pathogenic factors: Some ancient texts record that it can be used externally to assist in the treatment of mild cases of yang deficiency and recurrent wind-cold.

[0017] Cinnamon: Properties: pungent, sweet, very hot. Channels entered: kidney, spleen, heart, liver. Cinnamon is used externally for its effects of "dispersing cold and relieving pain, warming and unblocking the channels," primarily for local ailments caused by cold stagnation and poor blood circulation. Specifically, it includes: dispersing cold and relieving pain: suitable for frostbite, cold-dampness arthralgia (such as joint pain and difficulty in flexion and extension), cold pain in the heart and abdomen, and cold hernia abdominal pain caused by cold stagnation and blood stasis, relieving pain by warming and unblocking local blood circulation. Warming and unblocking the channels: promotes local blood circulation and improves skin cyanosis and numbness caused by cold stagnation and blood stasis, such as in the early stages of frostbite before ulceration.

[0018] Asarum: Properties: Pungent, warm; slightly toxic. Channels entered: Lung, Kidney, Heart. External uses: Dispels wind and cold, relieves pain: Suitable for wind-cold headache, toothache, and rheumatic pain (such as joint pain and muscle soreness). Opens nasal passages: Relieves nasal congestion (such as nasal congestion caused by rhinitis and sinusitis), and runny nose. Warms the channels and unblocks the meridians: Assists in the treatment of local numbness caused by cold and dampness, and early-stage frostbite.

[0019] Erythrina bark: Properties: Bitter, pungent, neutral. Channels entered: Liver and Kidney. Erythrina bark is pungent and bitter, neutral in nature, primarily entering the Liver and Kidney channels. It can dispel wind and dampness, unblock channels and relieve pain, kill parasites and relieve itching. Externally, it is particularly effective in treating local skin and joint ailments. Erythrina bark's pungent and dispersing properties dispel wind, while its bitter and drying properties dispel dampness. Its penetrating nature allows it to unblock channels and reach joints. Externally, it can penetrate the skin and directly act on the affected area, relieving pain and limited mobility caused by rheumatic obstruction and blocked channels. Erythrina bark's bitter and cold properties clear heat and dry dampness, and it can also kill parasites, inhibiting or killing skin fungi and scabies mites, while relieving itching caused by local damp heat or parasite infestation. Modern pharmacology confirms that it works through anti-inflammatory, analgesic, antibacterial, and local circulation-improving effects, making it a commonly used external medicine in Traditional Chinese Medicine for treating rheumatic pain and skin tinea.

[0020] Siegesbeckia orientalis: Taste and nature: bitter, pungent, cold. Meridian tropism: Liver and Kidney meridians. Externally, Siegesbeckia orientalis is mainly used to dispel wind and dampness, unblock meridians, clear heat and detoxify, reduce swelling and relieve pain. Clinically, it is often used for rheumatic pain, numbness of limbs, and stiffness of muscles and bones. External application can relieve joint and muscle pain and limited mobility caused by wind and dampness by dispelling wind and dampness and unblocking meridians. For traumatic injuries and swelling due to blood stasis: Through promoting blood circulation, removing blood stasis, reducing swelling and relieving pain, external application can help relieve local swelling and pain caused by traumatic injuries. Siegesbeckia orientalis mainly contains alkaloids, siegesbeckin, and siegesbeckin lactones, etc. Its external pharmacological effects include: anti-inflammatory and analgesic, antibacterial and antiviral, and improvement of local circulation.

[0021] Sappanwood: Sweet and salty in taste, neutral in nature. Meridian tropism: Enters the heart, liver, and spleen meridians. Externally, sappanwood has the effects of promoting blood circulation, removing blood stasis, reducing swelling, and relieving pain. Its dispersing nature allows it to break up blood stasis and unblock meridians, effectively dispersing old blood stasis and hard lumps / nodules formed by tissue adhesions. For local swelling and pain caused by blood stasis, such as traumatic injuries, muscle injuries, fractures, swelling and pain due to blood stasis, as well as early-stage sores and carbuncles (before ulceration) and skin ecchymosis, its mild nature and gentle effect allow it to promote blood circulation and remove blood stasis without harming the body's vital energy. Through external application, it promotes local blood and qi circulation, dissipates blood stasis, and relieves swelling and pain.

[0022] White mustard seed: Properties: pungent, warm; slightly toxic. Channels entered: Lung and Stomach channels. Externally, white mustard seed has the effects of warming and unblocking the meridians, dispelling cold and relieving pain, and resolving phlegm and nodules. It is mainly used to treat local swelling and pain, phlegm nodules, and other diseases caused by cold phlegm stagnation and cold-dampness obstruction. Specifically, it includes: dispelling cold and unblocking the meridians to relieve pain: used for cold-dampness arthralgia (such as cold pain in the joints, difficulty in flexion and extension), numbness of the limbs, and swelling and pain in the early stages of traumatic injuries (belonging to the category of cold stagnation and blood stasis). Resolving phlegm and nodules to reduce swelling: used for yin carbuncles (subcutaneous swelling and hardening, unchanged skin color), phlegm nodules and scrofula (such as swollen cervical lymph nodes), and mastopathy (breast nodules and lumps) caused by cold phlegm stagnation. Warming the lungs and dispelling cold (indirect effect): through acupoint application (such as Sanfu paste), it can assist in the treatment of chronic cough and asthma (such as cold-phlegm-induced lung-type asthma and chronic bronchitis).

[0023] Mulberry twigs: Taste and nature: slightly bitter, neutral. Meridian tropism: Liver meridian. Externally, mulberry twigs have the effects of dispelling wind and dampness, unblocking meridians, and relieving pain. They are mainly used for the following conditions: Rheumatic pain: suitable for joint pain, numbness, and difficulty in flexion and extension caused by wind-dampness invading the meridians, especially effective for upper limb pain (such as shoulder and arm pain). Skin itching: can be used for skin itching and eczema caused by rheumatism or wind-heat, relieving symptoms by dispelling wind, drying dampness, and relieving itching.

[0024] Raw licorice root: Taste and nature: sweet, neutral. Meridian tropism: Heart, Lung, Spleen, Stomach. The core external effects of raw licorice root are clearing heat and detoxifying, reducing swelling and relieving pain, and promoting wound healing and tissue regeneration. It is mainly used in the following scenarios: Carbuncles and boils: Whether in the initial stage of redness, swelling, heat, and pain (before pus formation) or after ulceration that is slow to heal (pus has drained but the wound is not healing), it can be applied externally for relief. Skin injuries: Such as chapped skin, burns, frostbite, and ulcers, it can promote wound healing. Eczema and dermatitis: Relieves inflammatory reactions such as itching, redness, swelling, and exudation.

[0025] As a further explanation of the present invention, the composition comprises the following medicinal materials in parts by weight: 15-30 parts of Ligusticum chuanxiong, 20-30 parts of Curcuma longa, 15-30 parts of Prunus persica, 15-30 parts of Carthamus tinctorius, 10-20 parts of Citrus reticulata peel (processed with vinegar), 10-20 parts of Corydalis yanhusuo, 5-10 parts of processed Aconitum carmichaelii, 10-15 parts of Cinnamomum cassia, 3-6 parts of Asarum heterotropoides, 20-30 parts of Erythrina variegata bark, 20-30 parts of Siegesbeckia orientalis, 15-25 parts of Sappanwood, 10-20 parts of Sinapis alba, 15-25 parts of Morus alba twigs, and 10-15 parts of raw Glycyrrhiza uralensis.

[0026] As a further explanation of the present invention, the composition comprises the following medicinal materials in parts by weight: 25 parts of Ligusticum chuanxiong, 25 parts of Curcuma longa, 20 parts of Prunus persica, 20 parts of Carthamus tinctorius, 15 parts of Citrus reticulata peel (processed with vinegar), 15 parts of Corydalis yanhusuo, 7 parts of processed Aconitum carmichaelii, 12 parts of Cinnamomum cassia, 5 parts of Asarum heterotropoides, 25 parts of Erythrina variegata bark, 25 parts of Siegesbeckia orientalis, 20 parts of Caesalpinia sappan, 15 parts of Sinapis alba, 20 parts of Morus alba twigs, and 12 parts of Glycyrrhiza uralensis.

[0027] A second aspect of the present invention provides a method for preparing a traditional Chinese medicine composition for treating frozen shoulder, comprising the following steps:

[0028] S1: Grind the following ingredients into 40-60 mesh coarse powder: Ligusticum chuanxiong, turmeric, peach kernel, safflower, vinegar-processed green tangerine peel, corydalis rhizome, prepared aconite root, cinnamon, asarum, erythrina bark, siegesbeckia herb, sappanwood, white mustard seed, mulberry twig, and raw licorice root. Mix them evenly and set aside.

[0029] S2: The coarse powder of Chinese medicine obtained in step S1 is put into a cloth bag to make a Chinese medicine hot compress bag.

[0030] The third aspect of the present invention provides a traditional Chinese medicine external preparation for treating frozen shoulder, wherein the traditional Chinese medicine external preparation is made by conventional preparation method using the traditional Chinese medicine composition described in any one of the above-mentioned methods and clinically acceptable excipients.

[0031] As a further explanation of the present invention, the traditional Chinese medicine external preparation is any one of ointment, powder, lotion, gel, patch, or aerosol.

[0032] The fourth aspect of the present invention provides a traditional Chinese medicine hot compress pack for treating frozen shoulder, wherein the traditional Chinese medicine hot compress pack is made from the traditional Chinese medicine composition described in any one of the above-mentioned methods.

[0033] The fifth aspect of the present invention provides the use of any of the above-mentioned traditional Chinese medicine compositions, or the above-mentioned traditional Chinese medicine external preparations, or the above-mentioned traditional Chinese medicine hot compress packs in the preparation of a medicament for treating frozen shoulder.

[0034] The sixth aspect of the present invention provides the use of any of the above-mentioned traditional Chinese medicine compositions, or the above-mentioned traditional Chinese medicine external preparations, or the above-mentioned traditional Chinese medicine hot compress packs in the preparation of a medicament for combined acupuncture treatment of frozen shoulder.

[0035] Compared with the prior art, the present invention has the following beneficial technical effects:

[0036] This invention provides a novel traditional Chinese medicine composition, preparation, and application for the combined treatment of frozen shoulder (adhesive capsulitis) with acupuncture. This composition, when combined with acupuncture, synergistically improves pain, stiffness, and limited range of motion in frozen shoulder by "internal regulation of Qi and blood and external unblocking of meridians." It offers a new TCM treatment approach for the clinical treatment of frozen shoulder. This invention provides an in-depth analysis of the causes of frozen shoulder and formulates corresponding treatment principles, ultimately forming a unique combination with complementary advantages. Each herb in the formula plays its specific role, working synergistically and mutually reinforcingly, and none can be omitted, achieving the goal of fully treating frozen shoulder and similar conditions. Attached Figure Description

[0037] Figure 1 The results of serum IL-1β and IL-6 content determination in rabbits of each group;

[0038] Figure 2 The histopathological scores of the shoulder joint tissues of rabbits in each group;

[0039] Figure 3 The content of Hyp in the tendon tissue of rabbits in each group. Detailed Implementation

[0040] The technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0041] The Chinese medicinal materials used in the following examples and comparative examples are all commercially available processed products.

[0042] Example 1

[0043] This embodiment provides a method for preparing a traditional Chinese medicine hot compress pack for treating frozen shoulder, including the following steps:

[0044] S1: Grind the following ingredients into 60-mesh coarse powder in sequence: Ligusticum chuanxiong, turmeric, peach kernel, safflower, vinegar-processed green tangerine peel, corydalis rhizome, prepared aconite root, cinnamon, asarum, erythrina bark, siegesbeckia herb, sappanwood, white mustard seed, mulberry twig, and raw licorice root.

[0045] S2: Weigh out the coarse powder of the above Chinese herbs in the following proportions: 25g of Ligusticum chuanxiong, 25g of Curcuma longa, 20g of Prunus persica, 20g of Carthamus tinctorius, 15g of Citrus reticulata peel (processed with vinegar), 15g of Corydalis yanhusuo, 7g of processed Aconitum carmichaelii, 12g of Cinnamomum cassia, 5g of Asarum heterotropoides, 25g of Erythrina variegata bark, 25g of Siegesbeckia orientalis, 20g of Sappanwood, 15g of Sinapis alba, 20g of Morus alba twigs, and 12g of raw Glycyrrhiza uralensis. Mix them evenly and set aside.

[0046] S3: The coarse powder of Chinese medicine obtained in step S2 is put into a pure cotton bag to make a Chinese medicine hot compress bag.

[0047] Example 2

[0048] This embodiment provides a method for preparing a traditional Chinese medicine hot compress pack for treating frozen shoulder. The difference between this method and Embodiment 1 is that the weights of the crude powders of each traditional Chinese medicine are as follows: 15g of Ligusticum chuanxiong, 20g of Curcuma longa, 15g of Prunus persica, 15g of Carthamus tinctorius, 10g of Citrus reticulata peel (processed with vinegar), 10g of Corydalis yanhusuo, 5g of processed Aconitum carmichaelii, 10g of Cinnamomum cassia, 3g of Asarum heterotropoides, 20g of Erythrina variegata bark, 20g of Siegesbeckia orientalis, 15g of Sappanwood, 10g of Sinapis alba, 15g of Morus alba twigs, and 10g of Glycyrrhiza uralensis.

[0049] Example 3

[0050] This embodiment provides a method for preparing a traditional Chinese medicine hot compress pack for treating frozen shoulder. The difference between this method and Embodiment 1 is that the weights of the crude powders of each traditional Chinese medicine are as follows: 30g of Ligusticum chuanxiong, 30g of Curcuma longa, 30g of Prunus persica, 30g of Carthamus tinctorius, 20g of Citrus reticulata peel (processed with vinegar), 20g of Corydalis yanhusuo, 10g of processed Aconitum carmichaelii, 15g of Cinnamomum cassia, 6g of Asarum heterotropoides, 30g of Erythrina variegata bark, 30g of Siegesbeckia orientalis, 25g of Sappanwood, 20g of Sinapis alba, 25g of Morus alba twigs, and 15g of Glycyrrhiza uralensis.

[0051] Comparative Example 1:

[0052] This comparative example provides a method for preparing a traditional Chinese medicine hot compress pack for treating frozen shoulder. The difference between this method and Example 1 is that the traditional Chinese medicine composition contains chuanxiong and turmeric.

[0053] Comparative Example 2:

[0054] This comparative example provides a method for preparing a traditional Chinese medicine hot compress pack for treating frozen shoulder. The difference between this method and Example 1 is that vinegar-processed green tangerine peel and corydalis rhizome are removed from the traditional Chinese medicine composition.

[0055] Comparative Example 3:

[0056] This comparative example provides a method for preparing a traditional Chinese medicine hot compress pack for treating frozen shoulder. The difference between this method and Example 1 is that the processed aconite and cinnamon are removed from the traditional Chinese medicine composition.

[0057] Comparative Example 4:

[0058] This comparative example provides a method for preparing a traditional Chinese medicine hot compress pack for treating frozen shoulder. The difference between this method and Example 1 is that the Erythrina bark and Siegesbeckia orientalis are removed from the traditional Chinese medicine composition.

[0059] Comparative Example 5:

[0060] This comparative example provides a method for preparing a traditional Chinese medicine hot compress pack for treating frozen shoulder. The difference between this method and Example 1 is that the sappanwood and white mustard seed in the traditional Chinese medicine composition are removed.

[0061] I. Animal experiments were conducted to verify the efficacy of the traditional Chinese medicine hot compress packs provided in the embodiments and comparative examples of this invention on periarthritis of the shoulder in rabbits.

[0062] 1. Experimental materials:

[0063] Laboratory animals: Healthy male New Zealand rabbits (weight: 2500±500g) were purchased from the Laboratory Animal Center of Yulin Traditional Chinese Medicine Hospital. The rabbits were required to undergo an acclimatization trial for one week before the experiment was conducted.

[0064] Experimental reagents: The weight of each herb in the herbal hot compress packs provided in Example 1 and Comparative Examples 1-6 was reduced to 1 / 9 of the original weight to prepare a herbal hot compress pack suitable for use on rabbits.

[0065] 2. Experimental methods:

[0066] 2.1 Experimental Grouping:

[0067] Rabbits were randomly divided into four groups: Example 1 hot compress group, Comparative Examples 1-5 hot compress groups, blank control group, and model group, with 8 rabbits in each group.

[0068] 2.2 Establishment of a rabbit model of frozen shoulder:

[0069] A rabbit model of frozen shoulder was established using continuous mechanical strain combined with ice application: The rabbits' shoulders were shaved, and then their hind limbs and left forelimb were fixed to an operating table (ensuring the rabbit was in a prone position). The right forelimb upper arm was fixedly connected to a vibrator, and the shoulder joint was horizontally vibrated at a frequency of 240 times / min and an amplitude of 1.5 cm for 4 hours daily for 3 consecutive days. Then, an ice pack was fixed to the rabbit's shoulder joint (closely monitoring the melting of the ice pack and replacing it promptly when it was almost melted), and ice was applied for 4 hours daily for 3 consecutive days, thus establishing the rabbit model of frozen shoulder. Except for the blank control group, all other groups of rabbits underwent the above-mentioned frozen shoulder modeling treatment.

[0070] 2.3 Drug therapy:

[0071] Starting the day after successful model establishment, rabbits in all groups except the blank control group and the model group were treated with traditional Chinese medicine hot compress: the herbal hot compress bag was heated in water for 30 minutes, then removed and cooled to about 35°C. The preheated herbal hot compress bag was then applied to the area around the rabbit's shoulder joint. During the hot compress, the hot compress bag was fixed to the rabbit's shoulder joint with a strap, and the rabbit's limbs were fixed to a support frame to prevent the hot compress bag from falling off due to running. Each hot compress lasted 20 minutes (the hot compress bag was preheated every 5 minutes to maintain a temperature of 35°C), once a day (each herbal pack was replaced every three days), for 4 consecutive weeks.

[0072] 2.4 Observation indicators detection:

[0073] 2.4.1 Measurement of pro-inflammatory factors in serum:

[0074] After anesthetizing rabbits, blood was collected from the abdominal artery, and the levels of pro-inflammatory factors, interleukin-1β (IL-1β) and interleukin-6 (IL-6), in the serum of each group of rabbits were measured using ELISA (enzyme-linked immunosorbent assay).

[0075] 2.4.2 Shoulder joint histopathological scoring

[0076] Preparation of pathological sections (HE staining): After anesthetizing rabbits, the hair on the shoulders was shaved to expose the shoulder joint capsule, rotator cuff tendon, and subacromial bursa. Key tissues around the shoulder joint (including: joint capsule (including synovium), supraspinatus tendon (and insertion point), and subacromial bursa) were taken. The removed shoulder joint tissues were fixed by immersing them in 4% formaldehyde solution and then dehydrated with anhydrous ethanol. After dehydration, they were cleared by immersing in xylene and then immersed in molten paraffin for paraffin treatment. The paraffin block of the shoulder joint tissue specimen was cut into thin slices with a thickness of 5 μm and stained with hematoxylin and eosin in sequence. Finally, the stained sections were washed with water, dehydrated with anhydrous ethanol, and mounted with neutral resin.

[0077] Pathological section scoring: A double-blind scoring method was used to independently score sections under a light microscope (×200 or ×400 field of view), and the average value and standard error were taken. Three to five typical lesion fields were randomly selected from each section (excluding peripheral areas), and a comprehensive evaluation was conducted before scoring. Specific evaluation indicators and scoring criteria are as follows (total score 0-12 points, higher scores indicate more severe pathological damage).

[0078] 1. Inflammatory cell infiltration: 0 points: No inflammatory cells or occasional mononuclear cells (<5 cells / field). 1 point: A small number of inflammatory cells are scattered (5-20 cells / field), mainly mononuclear cells. 2 points: A moderate amount of inflammatory cells are aggregated, forming small focal infiltrations (20-50 cells / field), with a small number of neutrophils visible. 3 points: A large number of inflammatory cells diffusely infiltrate (>50 cells / field), or form obvious inflammatory foci / lymphoid follicles.

[0079] 2. Fibrosis: 0 points: Small amount of collagen fibers, regularly arranged (normal tissue). 1 point: Mild fibrosis: Slightly increased collagen fibers, locally disordered (fibrosis area <25% of the field of view). 2 points: Moderate fibrosis: Significantly increased collagen fibers, widely disordered (fibrosis area 25%~50% of the field of view), with visible thickening of fiber bundles. 3 points: Severe fibrosis: Dense deposition of collagen fibers, diffusely disordered (fibrosis area >50% of the field of view), accompanied by tissue stiffness and structural damage.

[0080] 3. Synovial hyperplasia and hyperemia: 0 points: Normal synovium (1-2 layers of flat cells), no hyperemia, normal vascular morphology. 1 point: Mild thickening (3-4 layers of cells), a small number of vessels slightly dilated, no erythrocyte exudation. 2 points: Moderate thickening (5-6 layers of cells), accompanied by papillary projections, moderate vascular dilation, local erythrocyte exudation. 3 points: Significant thickening (>6 layers of cells), villous projections fused, numerous vessels congested and tortuous, widespread erythrocyte exudation.

[0081] 4. Joint capsule thickening and structural disorder: 0 points: Normal thickness (no difference from the control group), intact structure, clear layers. 1 point: Mild thickening (1~1.5 times that of the control group), with a small amount of local myofibroblast infiltration. 2 points: Moderate thickening (1.5~2 times that of the control group), diffuse infiltration of myofibroblasts, and partial breakage of elastic fibers. 3 points: Severe thickening (>2 times that of the control group), dense distribution of myofibroblasts, widespread breakage of elastic fibers, and disappearance of tissue layers.

[0082] 2.4.3 Determination of hydroxyproline content:

[0083] The hydroxyproline (Hyp) content in rabbit tendon tissue was determined using an alkaline hydrolysis method. Rabbit tendon tissue was minced, rinsed, and weighed quantitatively. A 6 mol / L NaOH solution was added, and the tissue was hydrolyzed at 110℃ for 20 h (ensuring complete hydrolysis of collagen). After hydrolysis, the tissue was neutralized with acid, decolorized with activated charcoal, and brought to a final volume. 0.5 mL of chloramine-T solution was added for oxidation, followed by Ehrlich's reagent for colorimetric reaction. A separate hydroxyproline standard was diluted to a gradient concentration, and the absorbance was measured for colorimetric reaction. A standard curve was plotted with hydroxyproline concentration (C, μg / mL) on the x-axis and A on the y-axis.

[0084] Measure the absorbance of the sample colorimetric solution (Asample), subtract the absorbance of the blank (Ablank), and obtain Anet = Asample - Ablank. Substitute Anet into the standard curve regression equation to calculate the concentration of hydroxyproline in the sample hydrolysate (C0). 样 (μg / mL).

[0085] Content calculation in tissues: Hydroxyproline content (μg / mg) = ;

[0086] In the formula: V 定容 D: Volume of hydrolysate (mL); D: Dilution factor; m 样品 Tendon tissue mass (mg).

[0087] 3. Experimental Results:

[0088] 3.1 Statistical Methods

[0089] Differences were tested using a two-sample t-test, and all measurement data were analyzed using... It is stated that SPSS version 22.0 was used for data processing.

[0090] 3.2 Experimental Statistical Results

[0091] 3.2.1 Results of serum pro-inflammatory factors in rabbits of each group

[0092] Table 1. Serum IL-1β and IL-6 levels in rabbits from each group.

[0093]

[0094] Note: Compared with the blank control group, #P<0.05, ##P<0.01; compared with the model group, , Compared with the hot compress group in Example 1, , n=8.

[0095] Table 1 and Figure 1The results of serum IL-1β and IL-6 levels in rabbits from each group show that, compared to the blank control group, the serum IL-1β and IL-6 levels in the model group were significantly higher, indicating a strong inflammatory response. Conversely, compared to the model group, the serum IL-1β and IL-6 levels in the hot compress group of Example 1 were significantly lower, and the difference was statistically significant, indicating that the traditional Chinese medicine preparation provided by this invention can effectively improve the inflammatory response in rabbits with frozen shoulder. Compared to the hot compress groups of Comparative Examples 1-5, the serum IL-1β and IL-6 levels in the hot compress group of Example 1 were significantly lower, and the difference was statistically significant, indicating that the absence or substitution of any single traditional Chinese medicine in the pharmaceutical composition of this invention reduces the therapeutic effect of the traditional Chinese medicine preparation.

[0096] 3.2.2 Histopathological scores of shoulder joint tissues in rabbits of each group

[0097] Table 2. Histopathological scores of the shoulder joint tissues in rabbits of each group.

[0098]

[0099] Note: Compared with the blank control group, #P<0.05, ##P<0.01; compared with the model group, , Compared with the hot compress group in Example 1, , n=8.

[0100] Table 2 and Figure 2 The pathological scores of the shoulder joint tissues of rabbits in each group were presented. Statistical results show that, compared to the blank control group, the pathological scores of the shoulder joint tissues of the model group rabbits were significantly higher, indicating a significantly higher degree of shoulder joint lesions. Conversely, compared to the model group rabbits, the pathological scores of the shoulder joint tissues of the rabbits in the hot compress group of Example 1 were significantly lower, and the difference was statistically significant, indicating that the traditional Chinese medicine preparation provided by this invention can effectively improve the degree of shoulder joint lesions in the rabbit model of frozen shoulder. Compared to the hot compress groups of Comparative Examples 1-5, the pathological scores of the shoulder joint tissues of the rabbits in the hot compress group of Example 1 were even lower, and the difference was statistically significant, indicating that the absence or substitution of any single traditional Chinese medicine in the pharmaceutical composition of this invention will reduce the therapeutic effect of the traditional Chinese medicine preparation.

[0101] 3.2.3 Statistical results of hydroxyproline content in tendon tissue of rabbits in each group

[0102] Table 3. Statistical results of Hyp content in tendon tissue of rabbits in each group

[0103]

[0104] Note: Compared with the blank control group, #P<0.05, ##P<0.01; compared with the model group, , Compared with the hot compress group in Example 1, , n=8.

[0105] Hydroxyproline (Hyp) is a characteristic amino acid of collagen (especially type I collagen, the main structural protein of tendons), accounting for approximately 10% of the total amino acids in collagen. Hydroxyproline content reflects the synthesis and repair capacity of tendon collagen. For example, after tendon injury (such as lacerations or degenerative injuries), an increase in hydroxyproline content suggests increased collagen synthesis in the tendon tissue, possibly indicating a repair and regeneration phase (fibroblast proliferation and collagen deposition). Therefore, this invention measured the hydroxyproline content in rabbit tendon tissue to characterize tendon collagen metabolism during the onset and recovery phases of periarthritis of the shoulder. Table 3 and... Figure 3 The Hyp content in the tendon tissue of rabbits in each group was measured. Statistical results show that, compared to the blank control group, the Hyp content in the tendon tissue of the model group rabbits was significantly increased. However, compared to the model group rabbits, the Hyp content in the tendon tissue of the rabbits in the hot compress group of Example 1 was significantly decreased, and the difference was statistically significant. Compared to the hot compress groups of Comparative Examples 1-5, the Hyp content in the tendon tissue of the rabbits in the hot compress group of Example 1 was even lower, and the difference was statistically significant. This indicates that the absence or substitution of any single herb in the pharmaceutical composition of this invention will reduce the therapeutic effect of the herbal medicine.

[0106] In summary, the above animal experiments have verified that the traditional Chinese medicine composition provided by this invention has a significant therapeutic effect on rabbits with frozen shoulder. At the same time, the traditional Chinese medicine composition provided by this invention has a significant synergistic effect. No matter whether some single traditional Chinese medicine materials are removed or replaced, the final therapeutic effect is not ideal, thus demonstrating the unique compatibility advantages of the traditional Chinese medicine preparation provided by this invention.

[0107] II. The clinical efficacy of the traditional Chinese medicine hot compress combined with acupuncture provided in this embodiment of the invention for patients with frozen shoulder was verified through clinical trials.

[0108] 1. Materials and Methods

[0109] 1.1 General Information

[0110] Two hundred patients with frozen shoulder admitted to Yulin Traditional Chinese Medicine Hospital from April 2023 to April 2025 were included in this study and randomly divided into four groups: acupuncture group (mean age 53.67±6.32, mean disease duration 5.73±0.51), hot compress group (mean age 55.34±6.53, mean disease duration 5.45±0.63), hot compress control group (mean age 54.81±5.87, mean disease duration 5.67±0.56), and acupuncture + hot compress group (mean age 55.64±5.26, mean disease duration 5.54±0.48), with 50 patients in each group. There were no statistically significant differences in age and disease duration among the four groups (P>0.05).

[0111] 1.2 Diagnostic criteria

[0112] 1.2.1 Western Medicine Diagnostic Criteria

[0113] According to the diagnosis of frozen shoulder in "New Practical Orthopedics", the criteria are: ① Clinical symptoms include limited shoulder joint movement; ② Physical signs include widespread tenderness and joint stiffness; ③ X-ray examination shows symptoms such as osteoporosis and arthritis.

[0114] 1.2.2 Traditional Chinese Medicine Diagnostic Criteria

[0115] Based on the "Chinese Acupuncture Clinical Diagnosis and Treatment Guidelines", the diagnosis is consistent with the syndrome of Qi and Blood Stasis: ① The onset is caused by shoulder injury, strain or cold; ② Pain in a fixed area of ​​the shoulder, limited joint movement on the affected side, shoulder stiffness, and occasional joint swelling; ③ Dark tongue with ecchymosis, yellow and thin coating, and thready, wiry or hesitant pulse; ④ Atrophy of shoulder muscles due to long-term disuse; ⑤ Widespread tenderness at the attachment points of tendons and ligaments of the shoulder joint.

[0116] 1.3 Inclusion Criteria

[0117] ① After diagnosis, the clinical manifestations meet the diagnostic criteria of Western medicine and traditional Chinese medicine; ② Age 40-70 years old; ③ No recent treatment with related drugs or acupuncture; ④ Can accept the Chinese herbal hot compress formula and acupuncture treatment provided by this invention; ⑤ Know about the research, join the research on a voluntary basis, and sign an informed consent form.

[0118] 1.4 Exclusion Criteria

[0119] ① Those with rotator cuff injury or tear, or subacromial impingement syndrome; ② Those with shoulder pain caused by cervical spondylosis or fracture; ③ Those with shoulder skin damage or disease; ④ Those with shoulder tumors, rheumatoid arthritis or osteoarthritis; ⑤ Those with diseases of the liver, kidneys or other organs that cause referred pain; ⑥ Those with blood diseases or coagulation disorders; ⑦ Those with mental or cognitive impairments who are unable to cooperate.

[0120] 1.5 Treatment Methods

[0121] The acupuncture group adopted the shoulder three-needle + hand three-needle therapy. Wu-style disposable micro sterile musculoskeletal needles were selected. The shoulder three needles were selected from the muscle and tendon areas of the white hand Yangming meridian, the muscle and tendon areas of the hand Shaoyang meridian, and the muscle and tendon areas of the hand Taiyang meridian. The hand three needles were selected from the above muscle and tendon areas, specifically the three points of Sanjian-Hegu, Yimen-Zhongzhu, Qiangu-Houxi. Shoulder Three-Needle Technique: With the patient's arm raised and abducted to the maximum extent, use a 0.3 mm tendon-bone needle to obliquely separate the Hand Yangming meridian tendon area laterally and upwards. Use the fascial plucking and loosening method to separate from top to bottom and from left to right, loosening from superficial to deep for 3 needles. After the patient moves, raise the arm again and loosen until a feeling of looseness is felt before removing the needles. Loosen the Hand Shaoyang meridian tendon area using the same method, employing the fascial fan-shaped loosening method. With the patient's arm pronated and internally rotated to the maximum extent, separate the Hand Taiyang meridian tendon area from bottom to top, using the fascial fan-shaped loosening method to loosen from superficial to deep for 3 needles. After movement, loosen again until a feeling of looseness is felt before removing the needles. Hand Three-Needle Technique: Insert the needle obliquely towards the center to reach the fascia layer, and use a fan-shaped swinging motion with the needle tail to loosen and separate 3-6 needles, then retain the needles for 20 minutes. 3 times / week, for 2 consecutive weeks.

[0122] The hot compress treatment group was treated with hot compress: the hot compress cloth bag obtained in Example 1 was heated in water for 30 minutes, and after heating, it was taken out and placed at about 60°C. Then, the medicine bag was wrapped with a wet towel and applied to the area around the shoulder joint for hot compress treatment. The hot compress time was about 30 minutes, once a day (each medicine bag was used for 3 days), and the treatment was continued for 2 weeks.

[0123] The hot compress control group was treated with hot compress: the hot compress bag obtained in Comparative Example 1 was heated in water for 30 minutes, then removed and placed at about 60°C. The bag was then wrapped with a wet towel and applied to the area around the shoulder joint for about 30 minutes, once a day (each bag was used for 3 days), for 2 consecutive weeks.

[0124] The acupuncture + hot compress group was treated with the hot compress therapy of the above-mentioned muscle and bone acupuncture shoulder three needles + hand three needles therapy, and the treatment was continued for 2 weeks.

[0125] 1.6 Observation Indicators

[0126] Clinical efficacy: According to the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine", it is divided into: cured: pain disappears and shoulder joint movement returns to normal; significantly effective: pain basically disappears and shoulder joint movement basically returns to normal with occasional discomfort; effective: pain is relieved and shoulder joint range of motion is improved; ineffective: there is no significant improvement in either pain or shoulder joint movement.

[0127] 2. Results

[0128] 2.1 Statistical Methods

[0129] The chi-square test was used to test differences for count data, and SPSS version 22.0 was used for data processing.

[0130] 2.2 Comparison of clinical efficacy among the four groups of patients

[0131] Table 4 Comparison of clinical efficacy among the four groups of patients

[0132]

[0133] Note: Compared with the acupuncture + hot compress group, , Compared with the hot compress treatment group, , n=50.

[0134] Table 4 compares the clinical efficacy of the four groups of patients. It shows that the acupuncture + hot compress group had the best clinical efficacy, with a total effective rate of 96% and only two patients showing no effect. The overall efficacy was significantly better than the acupuncture group, the hot compress control group, and the hot compress treatment group, and the difference was statistically significant. This indicates that the herbal hot compress pack provided by this invention combined with acupuncture has a significant clinical therapeutic effect on patients with frozen shoulder, and the effect is superior to hot compress or acupuncture alone. Furthermore, compared with the hot compress control group, the hot compress treatment group had significantly better clinical efficacy, and the difference was statistically significant. This indicates that the various herbal components in the herbal hot compress pack provided by this invention have a synergistic effect, and removing certain herbs would significantly affect the final clinical efficacy.

[0135] It should be noted that, in this document, terms such as “comprising,” “including,” or any other variations thereof are intended to cover non-exclusive inclusion, such that a process, method, article, or apparatus that comprises a list of elements includes not only those elements but also other elements not expressly listed, or elements inherent to such process, method, article, or apparatus.

[0136] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A traditional Chinese medicine composition for treating scapulohumeral periarthritis, characterized in that, The composition is made of the following weight parts of medicinal materials: Chuanxiong 15-30 parts, turmeric 20-30 parts, peach kernel 15-30 parts, safflower 15-30 parts, vinegar green skin 10-20 parts, Corydalis 10-20 parts, prepared aconite 5-10 parts, cassia 10-15 parts, asarum 3-6 parts, Pittosporum 20-30 parts, incisive grass 20-30 parts, red sandalwood 15-25 parts, white mustard seed 10-20 parts, mulberry branch 15-25 parts, raw licorice 10-15 parts.

2. The Chinese medicine composition for treating scapulohumeral periarthritis according to claim 1, wherein, The composition is made of the following weight parts of medicinal materials: Chuanxiong 25 parts, turmeric 25 parts, peach kernel 20 parts, safflower 20 parts, vinegar green skin 15 parts, Corydalis 15 parts, prepared aconite 7 parts, cassia 12 parts, asarum 5 parts, Pittosporum 25 parts, incisive grass 25 parts, red sandalwood 20 parts, white mustard seed 15 parts, mulberry branch 20 parts, raw licorice 12 parts.

3. A preparation method of a traditional Chinese medicine hot compress bag for treating scapulohumeral periarthritis, characterized in that, It comprises the following steps: S1: The Chuanxiong, turmeric, peach kernel, safflower, vinegar green skin, Corydalis, prepared aconite, cassia, asarum, Pittosporum, incisive grass, red sandalwood, white mustard seed, mulberry branch, raw licorice in the traditional Chinese medicine composition of any one of claims 1-2 are crushed into 40-60 mesh coarse powder and then mixed uniformly for standby; S2: The traditional Chinese medicine mixed coarse powder obtained in step S1 is loaded into a cloth bag to prepare a traditional Chinese medicine hot compress bag.

4. A Chinese medicine external preparation for treating scapulohumeral periarthritis, characterized in that, The traditional Chinese medicine external preparation is prepared by using the traditional Chinese medicine composition of any one of claims 1-2 and clinically acceptable adjuvants in a conventional preparation method.

5. The external preparation of traditional Chinese medicine for treating scapulohumeral periarthritis according to claim 4, characterized in that, The traditional Chinese medicine external preparation is any one of ointment, powder, lotion, gel, patch, and aerosol.

6. A traditional Chinese medicine hot compress bag for treating scapulohumeral periarthritis, characterized in that, The traditional Chinese medicine hot compress bag is prepared by using the traditional Chinese medicine composition of any one of claims 1-2.

7. The use of the traditional Chinese medicine composition of any one of claims 1-2 or the traditional Chinese medicine external preparation of any one of claims 4-5 or the traditional Chinese medicine hot compress bag of claim 6 in the preparation of a medicament for treating periarthritis of shoulder.

8. The use of the traditional Chinese medicine composition of any one of claims 1-2 or the traditional Chinese medicine external preparation of any one of claims 4-5 or the traditional Chinese medicine hot compress bag of claim 6 in the preparation of a medicament for treating periarthritis of shoulder in combination with acupuncture.

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