Traditional Chinese medicine composition for treating shoulder pain and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine composition for treating shoulder pain and a preparation method thereof, and belongs to the technical field of traditional Chinese medicine decoction. The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by mass: 15 parts of radix rehmanniae recen, 15 parts of bran radix paeoniae alba, 12-15 parts of radix achyranthis bidentatae, 10-30 parts of vinegar-processed rhizoma corydalis, 10-15 parts of salted eucommia ulmoides, 9 parts of salted fructus psoraleae, 9 parts of angelica sinensis, 9-12 parts of ligusticum wallichii, 9 parts of fried semen raphani and 10 parts of honey-fried licorice root. The traditional Chinese medicine composition disclosed by the invention takes tonifying liver and kidney and nourishing blood and strengthening tendons as a core and is supplemented with mild and collateral activating, so that the traditional Chinese medicine composition has the effects of tonifying but not greasy, activating but not losing healthy energy and better conforms to the physique characteristics of middle-aged and elderly people. The traditional Chinese medicines in the formula are mild in nature and rigorous in compatibility, and can play a continuous and steady role in improving shoulder joint local tissue blood supply, relieving chronic inflammation and promoting rotator cuff and surrounding soft tissue repair.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine decoction technology, and in particular to a traditional Chinese medicine composition for treating shoulder pain and its preparation method. Background Technology

[0002] In primary care, shoulder pain is considered the third most common musculoskeletal disorder after lower back pain and knee pain. Among those complaining of shoulder pain, frozen shoulder, rotator cuff tears, and shoulder impingement syndrome are the most common causes of shoulder pain in adults. Frozen shoulder, rotator cuff tears, and shoulder impingement syndrome are all shoulder pain disorders characterized by shoulder pain and limited shoulder joint movement. They are usually caused by a combination of factors, including age-related degeneration and insufficient blood supply, repetitive mechanical overload or acute trauma, relatively narrow subacromial anatomical space, scapular-rotator cuff motor control imbalance, and inadequate long-term postoperative immobilization and rehabilitation. These factors are often interconnected and can transform into one another.

[0003] Clinically, the conventional treatment for the aforementioned shoulder conditions is mainly conservative, including oral nonsteroidal anti-inflammatory drugs (NSAIDs), intra-articular injections, physical therapy, and rehabilitation training. These treatments can alleviate pain and improve function to some extent, but the overall efficacy is mostly short-term and limited, and it is difficult to reverse structural lesions such as joint capsule fibrosis or tendon lesions. Currently, the most widely used drugs for treating shoulder soft tissue lesions are NSAIDs, with celecoxib being a representative drug. However, long-term or repeated use of NSAIDs can lead to gastrointestinal adverse reactions, increased risk of renal and cardiovascular adverse events. Regarding intra-articular injections, long-term use of steroids can increase tendon fragility and complications such as infection, and in the medium to long term, it is not superior to simple physical therapy. Physical therapies such as ultrasound and extracorporeal shock wave therapy may exacerbate acute inflammatory exudation in acute inflammatory shoulder soft tissue injuries. For moderate to large-area rotator cuff tears or refractory impingement, although arthroscopic release, decompression, or repair can be performed, these procedures are costly, heavily reliant on postoperative rehabilitation, and still present problems such as stiffness, re-tearing, and slow functional recovery. Therefore, it is urgent to find a long-term effective, inexpensive, and low-toxicity treatment, and it is necessary to give full play to the advantages and characteristics of traditional Chinese medicine.

[0004] Existing traditional Chinese medicines for frozen shoulder, rotator cuff injury, and shoulder impingement syndrome include anti-inflammatory and analgesic plasters, Du Huo Ji Sheng Wan (Angelica and Loranthus Pills), Wang Bi capsules, and Shu Jin Huo Xue Pian (Muscle and Tendon Relaxing and Blood Circulation Tablets). These traditional Chinese medicines are mainly composed of herbs that dispel wind and cold, and promote blood circulation and remove blood stasis. They may increase the cardiovascular risk of elderly patients, leading to adverse reactions such as arrhythmia and limb numbness. Summary of the Invention

[0005] In view of this, the purpose of this invention is to provide a traditional Chinese medicine composition for treating shoulder pain and its preparation method. The traditional Chinese medicine composition formulated in this invention has the effect of tonifying the liver and kidneys, and can be used to treat patients with shoulder pain caused by liver and kidney deficiency, especially patients diagnosed with frozen shoulder, rotator cuff injury and shoulder impingement syndrome.

[0006] To achieve the above objectives, the present invention provides the following technical solution: One of the technical solutions of this invention is a traditional Chinese medicine composition for treating shoulder pain, made from the following raw materials in parts by weight: 15 parts of Rehmannia glutinosa, 15 parts of Paeonia lactiflora (bran-processed), 12-15 parts of Achyranthes bidentata, 10-30 parts of Corydalis yanhusuo (vinegar-processed), 10-15 parts of Eucommia ulmoides (salt-processed), 9 parts of Psoralea corylifolia (salt-processed), 9 parts of Angelica sinensis, 9-12 parts of Ligusticum chuanxiong, 9 parts of stir-fried Raphanus sativus seeds, and 10 parts of Glycyrrhiza uralensis (processed).

[0007] The second technical solution of the present invention is a method for preparing the above-mentioned traditional Chinese medicine composition for treating shoulder pain, comprising the following steps: After weighing the raw materials according to the mass fractions, add water and decoct for the first time, filter, and collect filtrate 1 and residue 1; The filter residue 1 is boiled with water a second time, filtered, and the filtrate 2 is collected. Combine filtrate 1 and filtrate 2.

[0008] The present invention discloses the following technical effects: This invention focuses on tonifying the liver and kidneys, nourishing blood and strengthening muscles, supplemented by gentle and invigorating herbs, making it "nourishing without being cloying, and invigorating without depleting vital energy," thus better suited to the physical characteristics of middle-aged and elderly people. Its decoction form allows for rapid absorption and minimal irritation, enabling long-term use without increasing cardiovascular risk. The formula contains mild and carefully formulated herbs, providing sustained and stable efficacy in improving local blood supply to the shoulder joint, alleviating chronic inflammation, and promoting the repair of the rotator cuff and surrounding soft tissues. This enhances the range of motion and daily living abilities of middle-aged and elderly patients with shoulder pain, fully embodying the characteristics of traditional Chinese medicine's syndrome differentiation and treatment, addressing both the root cause and symptoms, and providing a feasible treatment option for adult patients with shoulder pain due to liver and kidney deficiency. Attached Figure Description

[0009] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0010] Figure 1 This is a VAS score chart of the patient after treatment in this invention; Figure 2 This is a SPADI score chart of the patient after treatment in this invention; Figure 3 This is a CMS score chart of patients after treatment in this invention; Figure 4 This is a TCM score chart of patients after total treatment according to the present invention; Figure 5 This refers to CRP data of patients after treatment in this invention; Figure 6 This refers to TNF-α data of patients after treatment in this invention; Figure 7 This refers to IL-6 data of patients after treatment in this invention; Figure 8 This represents the total effective rate of the experimental group and the control group in this invention. Detailed Implementation

[0011] Various exemplary embodiments of the present invention will now be described in detail. This detailed description should not be considered as a limitation of the present invention, but rather as a more detailed description of certain aspects, features, and embodiments of the present invention.

[0012] It should be understood that the terminology used in this invention is merely for describing particular embodiments and is not intended to limit the invention. Furthermore, with respect to numerical ranges in this invention, it should be understood that each intermediate value between the upper and lower limits of the range is also specifically disclosed. Any stated value or intermediate value within a stated range, as well as each smaller range between any other stated value or intermediate value within said range, is also included in this invention. The upper and lower limits of these smaller ranges may be independently included or excluded from the range.

[0013] Unless otherwise stated, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. While only preferred methods and materials have been described herein, any methods and materials similar or equivalent to those described herein may be used in the implementation or testing of this invention. All references to this specification are incorporated by way of citation to disclose and describe methods and / or materials associated with those references. In the event of any conflict with any incorporated reference, the content of this specification shall prevail.

[0014] Various modifications and variations can be made to the specific embodiments described in this specification without departing from the scope or spirit of the invention, as will be apparent to those skilled in the art. Other embodiments derived from this specification will also be apparent to those skilled in the art. This specification and embodiments are merely exemplary.

[0015] The terms “include,” “including,” “have,” “contain,” etc., used in this article are all open-ended terms, meaning that they include but are not limited to.

[0016] The first aspect of the present invention provides a traditional Chinese medicine composition for treating shoulder pain, which is made from the following raw materials in parts by weight: 15 parts of Rehmannia glutinosa, 15 parts of Paeonia lactiflora (bran-processed), 12-15 parts of Achyranthes bidentata, 10-30 parts of Corydalis yanhusuo (vinegar-processed), 10-15 parts of Eucommia ulmoides (salt-processed), 9 parts of Psoralea corylifolia (salt-processed), 9 parts of Angelica sinensis, 9-12 parts of Ligusticum chuanxiong, 9 parts of stir-fried Raphanus sativus seeds, and 10 parts of Glycyrrhiza uralensis (processed).

[0017] In a preferred embodiment of the present invention, the traditional Chinese medicine composition for treating shoulder pain is made from the following raw materials in parts by weight: 15 parts Rehmannia glutinosa, 15 parts Paeonia lactiflora (bran-processed), 12 parts Achyranthes bidentata, 10 parts Corydalis yanhusuo (vinegar-processed), 10 parts Eucommia ulmoides (salt-processed), 9 parts Psoralea corylifolia (salt-processed), 9 parts Angelica sinensis, 9 parts Ligusticum chuanxiong, 9 parts Raphanus sativus (fried), and 10 parts Glycyrrhiza uralensis (processed).

[0018] In a preferred embodiment of the present invention, the traditional Chinese medicine composition for treating shoulder pain is made from the following raw materials in parts by weight: 15 parts Rehmannia glutinosa, 15 parts Paeonia lactiflora (bran-processed), 15 parts Achyranthes bidentata, 30 parts Corydalis yanhusuo (vinegar-processed), 15 parts Eucommia ulmoides (salt-processed), 9 parts Psoralea corylifolia (salt-processed), 9 parts Angelica sinensis, 12 parts Ligusticum chuanxiong, 9 parts Raphanus sativus (fried), and 10 parts Glycyrrhiza uralensis (processed).

[0019] Many middle-aged and elderly patients with shoulder pain fall under the categories of "Bi syndrome," "tendon injury," and "shoulder Bi" in Traditional Chinese Medicine (TCM). The underlying pathogenesis is often liver and kidney deficiency, insufficient Qi and blood, and difficulty in nourishing the tendons and bones. With age, liver blood gradually declines, kidney essence becomes insufficient, and tendons and bones lose nourishment. The shoulder joint cavity and surrounding tendons and ligaments lose their normal lubrication, easily leading to shoulder tissue degeneration, tendon weakness, rotator cuff injury, and shoulder impingement. Furthermore, sluggish Qi and blood circulation obstructs the meridians, further contributing to recurrent shoulder pain, worsening at night, and limited range of motion. Based on the theoretical system of "the liver governs the tendons, the kidneys govern the bones, and Qi and blood are essential for nourishment," this invention selects multiple medicinal herbs with the functions of tonifying the liver and kidneys, strengthening tendons and bones, and nourishing blood and activating the meridians. This allows for synergistic effects of tonification and meridian unblocking, thus providing a fundamental therapeutic effect on chronic shoulder pain in adults, especially the middle-aged and elderly.

[0020] This invention uses Achyranthes bidentata and Eucommia ulmoides (processed with salt) as the principal herbs. These two herbs warm and tonify the liver and kidneys, strengthen tendons and bones, and are essential for treating shoulder pain in middle-aged and elderly people caused by liver and kidney deficiency and malnourishment of tendons and bones. Rehmannia glutinosa and Paeonia lactiflora (processed with wheat bran) are the assistant herbs, nourishing yin and softening tendons, tonifying the liver and nourishing blood, thus moisturizing the tendons and vessels. Psoralea corylifolia (processed with salt) warms and tonifies kidney yang, strengthens bones and tendons, and is also an assistant herb. Angelica sinensis and Ligusticum chuanxiong are also assistant herbs, tonifying blood, promoting blood circulation, regulating collaterals and relieving pain, improving local blood supply to the shoulder, and promoting the repair of damaged tissues. Corydalis yanhusuo (processed with vinegar) is an adjuvant herb, regulating qi and blood, relieving pain and unblocking collaterals, ensuring smooth flow of qi and blood and effectively relieving shoulder pain. Radish seed (processed with roasted radish seed) is also an adjuvant herb, regulating the middle jiao, harmonizing qi and stomach, making the tonifying herbs easier to absorb and avoiding the drawbacks of being too rich and greasy. Glycyrrhiza uralensis (processed with roasted licorice root) is the guiding herb, both tonifying the spleen and replenishing qi to aid in the absorption of the medicine, and harmonizing the other herbs, making the formula more balanced and the overall therapeutic effect more stable.

[0021] In a preferred embodiment of the present invention, the dosage form of the traditional Chinese medicine composition for treating shoulder pain is a decoction.

[0022] A second aspect of the present invention provides a method for preparing the above-mentioned traditional Chinese medicine composition for treating shoulder pain, comprising the following steps: After weighing the raw materials according to the mass fractions, add water and decoct for the first time, filter, and collect filtrate 1 and residue 1; The filter residue 1 is boiled with water a second time, filtered, and the filtrate 2 is collected. Combine filtrate 1 and filtrate 2.

[0023] In a preferred embodiment of the present invention, when adding water for the first decoction, the amount of water added is 8-9 times the mass of the raw material; the first decoction time is 40-60 minutes after the water boils.

[0024] In a preferred embodiment of the present invention, when adding water for the second decoction, the amount of water added is 6-7 times the mass of the filter residue 1; the second decoction time is 20-40 minutes after the water boils.

[0025] Unless otherwise specified, the technical solutions described in this invention are all conventional solutions in the field, and the reagents or raw materials used are all purchased from commercial channels or are publicly available unless otherwise specified.

[0026] To better understand the present invention, the following embodiments further illustrate the content of the present invention, but the content of the present invention is not limited to the following embodiments.

[0027] Example 1 Weigh out 15g of raw Rehmannia glutinosa, 15g of wheat bran-processed white peony root, 12g of Achyranthes bidentata, 10g of vinegar-processed Corydalis yanhusuo, 10g of salt-processed Eucommia ulmoides, 9g of salt-processed Psoralea corylifolia, 9g of Angelica sinensis, 9g of Ligusticum chuanxiong, 9g of stir-fried radish seed, and 10g of prepared licorice root. Add water and decoct twice. For the first decoction, add 8 times the weight of the raw materials in water and boil for 40 minutes. Collect the filtrate and residue. For the second decoction, add 6 times the weight of the residue in water and boil for 20 minutes. Collect the filtrate. Mix the filtrates from the two decoctions.

[0028] Example 2 Weigh out 30g of vinegar-processed Corydalis Rhizome, 15g of raw Rehmannia Root, 15g of wheat bran-processed White Peony Root, 15g of salt-processed Eucommia Bark, 15g of Achyranthes Root, 12g of Ligusticum Rhizome, 9g of Angelica Root, 9g of salt-processed Psoralea Root, 9g of stir-fried Radish Seed, and 10g of prepared Licorice Root. Other steps are the same as in Example 1.

[0029] Example of effect 1 A randomized controlled clinical trial was conducted to test the clinical efficacy and safety of the traditional Chinese medicine decoction prepared in Example 2 (the method of administration for the traditional Chinese medicine decoction prepared in Example 2 is as follows: one dose is taken daily, divided into two doses, morning and evening, for 4 weeks as one course of treatment). Sixty-four patients with shoulder pain were randomly divided into an experimental group and a control group according to the treatment plan. The baseline values ​​of the two groups were comparable. The control group consisted of 32 patients (17 males, 15 females, age (52.7±11.8) years); the experimental group consisted of 32 patients (16 males, 16 females, age (51.3±9.3) years). The treatment plan for the experimental group included the traditional Chinese medicine decoction in addition to the treatment for the control group (the control group received only extracorporeal shock wave therapy, with treatment parameters set as follows: frequency 10 Hz, energy flux density 0.08 mJ / mm²). 2 The total number of shocks was 2000, once a week, for a total of 4 weeks. Patient responses were carefully observed during treatment, and the shock wave energy level was adjusted promptly according to their tolerance. The experimental group received the decoction from Example 2 in addition to the treatment given to the control group. Both groups underwent a one-month treatment course, with a follow-up period of 3 months. After treatment, the clinical efficacy of the two groups was assessed using the Visual Analogue Scale (VAS), the Spadaccum Alpha Index (SPADI), the Chinese version of the Constant-Murley Score (CMS), the Traditional Chinese Medicine Syndrome Assessment (TCM), and inflammatory markers such as serum C-reactive protein (CRP), tumor necrosis factor-α (TNF-α), and interleukin-6 (IL-6).

[0030] A total of 64 patients were followed up (data statistics are shown in Tables 1-3). The VAS scores of patients after treatment were... Figure 1 ), SPADI score ( Figure 2 CMS score Figure 3 Traditional Chinese Medicine syndrome score () Figure 4 ) and inflammatory markers (CRP ( Figure 5 ), TNF-α ( Figure 6 ), IL-6 ( Figure 7 Both groups showed significant improvement compared to pre-treatment levels, with statistically significant differences (P<0.05). Furthermore, the degree of improvement in the experimental group was significantly greater than that in the control group after treatment, with statistically significant differences in VAS scores, SPADI scores, CMS scores, and TCM syndrome scores (P<0.05). The total effective rate in the experimental group was 87.5%, higher than the 62.5% total effective rate in the control group. Figure 8The differences were statistically significant (P<0.05). This indicates that oral administration of the decoction of this invention, while concurrent with conventional shoulder pain treatment, significantly enhances the relief of pain and improves daily functional abilities, demonstrating superior clinical efficacy and safety. Furthermore, no significant adverse reactions were observed during our follow-up. Therefore, the clinical efficacy of the traditional Chinese medicine composition of this invention for treating shoulder pain is confirmed.

[0031] Table 1 Comparison of subjective outcome scores of shoulder joint between the two groups ( - x±s, minutes) Note: Compared with before treatment p <0.001.

[0032] Table 2 Comparison of objective outcome scores of shoulder joint between the two groups ( - x±s, minutes) Note: Compared with before treatment p <0.001.

[0033] Table 3 Overall effective rate of the two intervention groups The above description is only a preferred embodiment of the present invention. It should be noted that for those skilled in the art, several improvements and modifications can be made without departing from the principle of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating shoulder pain, characterized in that, It is made from the following raw materials in parts by weight: 15 parts Rehmannia glutinosa, 15 parts Paeonia lactiflora (bran), 12-15 parts Achyranthes bidentata, 10-30 parts Corydalis yanhusuo (vinegar-processed), 10-15 parts Eucommia ulmoides (salt-processed), 9 parts Psoralea corylifolia (salt-processed), 9 parts Angelica sinensis, 9-12 parts Ligusticum chuanxiong, 9 parts stir-fried Raphanus sativus seeds, and 10 parts Glycyrrhiza uralensis (processed).

2. The traditional Chinese medicine composition for treating shoulder pain according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: 15 parts Rehmannia glutinosa, 15 parts Paeonia lactiflora (bran), 12 parts Achyranthes bidentata, 10 parts Corydalis yanhusuo (vinegar-processed), 10 parts Eucommia ulmoides (salt-processed), 9 parts Psoralea corylifolia (salt-processed), 9 parts Angelica sinensis, 9 parts Ligusticum chuanxiong, 9 parts stir-fried radish seeds, and 10 parts prepared licorice root.

3. The traditional Chinese medicine composition for treating shoulder pain according to claim 1, characterized in that, It is made from the following raw materials in parts by weight: 15 parts Rehmannia glutinosa, 15 parts Paeonia lactiflora (bran), 15 parts Achyranthes bidentata, 30 parts Corydalis yanhusuo (vinegar-processed), 15 parts Eucommia ulmoides (salt-processed), 9 parts Psoralea corylifolia (salt-processed), 9 parts Angelica sinensis, 12 parts Ligusticum chuanxiong, 9 parts stir-fried radish seeds, and 10 parts prepared licorice root.

4. The traditional Chinese medicine composition for treating shoulder pain according to claim 1, characterized in that, The dosage form is a decoction.

5. A method for preparing a traditional Chinese medicine composition for treating shoulder pain as described in any one of claims 1 to 4, characterized in that, Includes the following steps: After weighing the raw materials according to the mass fractions, add water and decoct for the first time, filter, and collect filtrate 1 and residue 1; The filter residue 1 is boiled with water a second time, filtered, and the filtrate 2 is collected. Combine filtrate 1 and filtrate 2.

6. The preparation method according to claim 5, characterized in that, When adding water for the first decoction, the amount of water should be 8-9 times the weight of the raw material; the first decoction time should be 40-60 minutes after the water boils.

7. The preparation method according to claim 5, characterized in that, When adding water for the second time, the amount of water added should be 6-7 times the mass of filter residue 1; the second time, the water should be added and boiled for 20-40 minutes after the water boils.

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