A traditional Chinese medicine massage oil for treating pediatric muscular torticollis, a preparation method and application thereof

Abstract

The application discloses a traditional Chinese medicine massage oil for treating pediatric muscular torticollis and a preparation method and application thereof. The traditional Chinese medicine massage oil is mainly prepared from the following raw materials in parts by weight: Amomum villosum 5-15 parts, Picrorhiza scrophulariiflora 2-8 parts, Syzygium aromaticum 2-8 parts, Pericarpium Citri Reticulatae Viride 2-8 parts and Sedi Herba 2-8 parts. Compared with the prior art, the application provides a brand-new traditional Chinese medicine massage oil, which is scientific in formula, novel in compatibility, simple in preparation method and convenient to use. Animal experiments prove that the traditional Chinese medicine massage oil can significantly improve creatine kinase (CK) activity in neck muscles and superoxide dismutase (SOD) content in serum, reduce malondialdehyde (MDA) content in serum and effectively repair muscle damage. Clinical results prove that the traditional Chinese medicine massage oil can effectively improve clinical symptoms of pediatric muscular torticollis, and is worthy of further promotion.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine massage oil technology, and in particular relates to a traditional Chinese medicine massage oil for treating pediatric muscular torticollis, its preparation method and application. Background Technology

[0002] Congenital muscular torticollis, also known as pediatric muscular torticollis, is a common congenital musculoskeletal disorder in pediatric orthopedics and rehabilitation departments. Its incidence rate is approximately 0.3% to 2.0%, ranking second only to congenital hip dislocation and congenital clubfoot among congenital musculoskeletal deformities. The characteristic pathological change is fibrous contracture of the sternocleidomastoid muscle. Clinically, it manifests as the child's head tilting to the affected side and the jaw turning to the healthy side. In severe cases, complications such as facial asymmetry, compensatory cervical scoliosis, and plagiocephaly may occur.

[0003] Currently, the pathogenesis of muscular torticollis in children is not fully understood. Mainstream theories include the ischemic fibrillation theory caused by abnormal intrauterine posture, the muscle hematoma mechanism theory caused by birth trauma, and the venous return obstruction theory. Regardless of the cause, the common pathway ultimately involves degeneration and necrosis of muscle fibers within the sternocleidomastoid muscle and abnormal proliferation of fibrous connective tissue. Animal studies have shown that a muscular torticollis model can be successfully established by injecting anhydrous ethanol into the lower segment of the rabbit sternocleidomastoid muscle. The pathological changes include disordered muscle cell structure, interstitial fibrosis, extensive activation of α-smooth muscle actin-positive myofibroblasts, and predominant type I collagen deposition. This model provides an important platform for studying the treatment mechanism of this disease.

[0004] In terms of treatment strategies, pediatric muscular torticollis follows the principle of "early detection, early intervention, and early rehabilitation." For infants under one year old, non-surgical treatment is the first choice, including manual traction, passive movement, postural correction, and physical therapy. Clinical practice shows that the cure rate of early non-surgical treatment can reach 80% to 90%. However, for some children with more severe fibrosis or those who receive late intervention, the effect of manual therapy alone is limited, and some children eventually need to undergo sternocleidomastoid muscle resection or partial resection.

[0005] External application of traditional Chinese medicine (TCM) is a characteristic therapy in TCM orthopedics and has been used to some extent in the clinical treatment of pediatric muscular torticollis. Traditional Chinese medicine theory considers this disease to fall under the categories of "muscle contracture" and "muscle knot," with the pathogenesis being qi stagnation and blood stasis, and obstruction of the meridians and tendons. Treatment should focus on promoting blood circulation, removing blood stasis, softening and dispersing nodules, and relaxing muscles and tendons. Currently reported external TCM treatments mainly include herbal fumigation, herbal poultices, and herbal massage mediums, commonly using herbs such as safflower, angelica, frankincense, myrrh, and *Clematis chinensis* (a type of herb) to promote blood circulation and remove blood stasis. However, existing techniques have the following limitations:

[0006] First, most existing external preparations of traditional Chinese medicine are made by decocting coarse powder in water or soaking it in alcohol before direct use. This results in low extraction efficiency of active ingredients, low drug utilization, and a lack of unified preparation process standards, leading to unstable product quality and difficulty in achieving industrialized production.

[0007] Secondly, most existing Chinese herbal massage mediums are prepared on an ad-hoc basis, and their viscosity, lubricity, and permeability are insufficient to meet the actual needs of clinical massage procedures. The core functions of massage oil as a massage medium include reducing friction damage, carrying medicinal components to penetrate the skin, and prolonging the duration of the massage effect. Existing formulations need improvement in their overall performance in these three aspects.

[0008] Third, there is no systematic research on traditional Chinese medicine massage oils for pediatric muscular torticollis in the existing technology, and there is a lack of clear theoretical basis for formulation and scientific extraction process.

[0009] Therefore, developing a traditional Chinese medicine massage oil with a reasonable formulation, stable preparation process, and both lubrication and drug penetration properties, and systematically applying it to the treatment of pediatric muscular torticollis, has significant clinical and industrial value. Summary of the Invention

[0010] Objective of the Invention: To address the problems existing in the prior art, this invention provides a traditional Chinese medicine massage oil for treating pediatric muscular torticollis, its preparation method, and its application. Animal experiments and clinical results have confirmed that the traditional Chinese medicine massage oil provided by this invention can significantly increase the activity of creatine kinase (CK) in the neck muscles and the content of serum superoxide dismutase (SOD), while reducing the content of serum malondialdehyde (MDA), thus significantly improving the clinical symptoms of pediatric muscular torticollis.

[0011] Technical solution: To achieve the above-mentioned objectives, the present invention adopts the following technical solution:

[0012] In a first aspect, the present invention provides a traditional Chinese medicine massage oil for treating pediatric muscular torticollis, the traditional Chinese medicine massage oil being mainly made from the following raw materials in parts by weight:

[0013] 5-15 parts Amomum villosum, 2-8 parts Picrorhiza scrophulariiflora, 2-8 parts Syzygium aromaticum, 2-8 parts Citrus reticulata peel, 2-8 parts Lycopodium clavatum.

[0014] As a specific implementation plan, the herbal massage oil is mainly made from the following raw materials in parts by weight:

[0015] 8-12 parts Amomum villosum, 4-6 parts Picrorhiza scrophulariiflora, 4-6 parts Syzygium aromaticum, 4-6 parts Citrus reticulata peel, and 4-6 parts Lycopodium clavatum.

[0016] As a specific implementation plan, the herbal massage oil is mainly made from the following raw materials in parts by weight:

[0017] 10 parts Amomum villosum, 4-6 parts Picrorhiza scrophulariiflora, 4-6 parts Clove, 4-6 parts Citrus reticulata peel, 4-6 parts Lycopodium clavatum.

[0018] As a specific implementation plan, the herbal massage oil is mainly made from the following raw materials in parts by weight:

[0019] 10 parts Amomum villosum, 5 parts Picrorhiza scrophulariiflora, 5 parts cloves, 5 parts Citrus reticulata peel, and 5 parts Lycopodium clavatum.

[0020] Secondly, the present invention provides a method for preparing the traditional Chinese medicine massage oil for treating pediatric muscular torticollis, comprising the following steps:

[0021] Take the raw materials Amomum villosum, Coptis chinensis, cloves, Citrus reticulata peel and Lycopodium clavatum, crush them, mix them, soak them in medium chain triglycerides for a period of time, then add almond oil and continue soaking for a period of time, filter them, and you will get the Chinese herbal massage oil.

[0022] As a specific implementation scheme, the total mass of the raw materials and the mass ratio of medium-chain triglycerides are (13-47):50, preferably 30:50; the medium-chain triglycerides are soaked at a temperature of 50-70°C for 4-8 hours.

[0023] As a specific implementation scheme, the total mass ratio of the raw materials to the almond oil is (13-47):50, preferably 30:50; the almond oil is soaked at room temperature for 10-14 hours.

[0024] Thirdly, the present invention provides the application of the aforementioned traditional Chinese medicine massage oil in the preparation of a medicine for treating muscular torticollis.

[0025] Preferably, the present invention provides the application of the aforementioned traditional Chinese medicine massage oil in the preparation of a drug for the treatment of pediatric muscular torticollis in combination with massage.

[0026] The formula of this herbal massage oil uses Amomum villosum as the principal ingredient to warm and promote the flow of qi, disperse stagnation, and relieve spasms. Citrus reticulata peel and cloves are the assistant ingredients to enhance the flow of qi and blood, soften hardened masses, and disperse stagnation. Lycopodium clavatum is used as a secondary ingredient to relax muscles and relieve spasms, and Coptis chinensis is used as a secondary ingredient to counteract its warming and drying properties. Together, they warm and unblock the meridians, promote the flow of qi, disperse stagnation, relax muscles, and relieve spasms. For external use in conjunction with massage, it is suitable for children with muscular torticollis due to qi stagnation, muscle spasms, and muscle stiffness. Furthermore, the preparation method of this invention is unique, employing a combined extraction of medium-chain triglycerides and almond oil. Compared to extraction using a single oil, this method results in more complete extraction of the active ingredients and significantly better therapeutic effects. Therefore, its preparation method is novel and its extraction effect is excellent.

[0027] Beneficial Effects: Compared with existing technologies, this invention provides a novel traditional Chinese medicine massage oil with a scientifically formulated composition, novel compatibility, simple preparation method, and convenient use. Animal experiments have confirmed that this traditional Chinese medicine massage oil can significantly increase the activity of creatine kinase (CK) in neck muscles and the content of serum superoxide dismutase (SOD), reduce the content of serum malondialdehyde (MDA), and effectively repair muscle damage. Clinical results have confirmed that this traditional Chinese medicine massage oil can effectively improve the clinical symptoms of pediatric muscular torticollis and is worthy of further promotion. Attached Figure Description

[0028] Figure 1 This is the first ultrasound examination report for clinical patient Luo.

[0029] Figure 2 This is an ultrasound examination report for a clinical patient, Mr. Luo, after treatment with massage oil. Detailed Implementation

[0030] The present invention will be further described below with reference to specific embodiments, but the scope of protection of the present invention is not limited to the following embodiments. All equivalent substitutions, simple modifications, or conventional technical adjustments made based on the concept and principles of the present invention should fall within the scope of protection of the present invention.

[0031] Example 1: Preparation of Traditional Chinese Medicine Massage Oil

[0032] prescription:

[0033] 5g Amomum villosum, 2g Picrorhiza scrophulariiflora, 2g Syzygium aromaticum, 2g Citrus reticulata peel, 2g Lycopodium clavatum.

[0034] Preparation method:

[0035] Weigh the raw materials according to the above prescription, crush and mix them. First, soak 50g of medium-chain triglycerides at 60℃ for 6 hours, then add 50g of almond oil and soak at room temperature for 12 hours. Filter with gauze to obtain the massage oil for the treatment of torticollis.

[0036] Example 2: Preparation of Traditional Chinese Medicine Massage Oil

[0037] prescription:

[0038] 15g Amomum villosum, 8g Picrorhiza scrophulariiflora, 8g cloves, 8g green tangerine peel, 8g Lycopodium clavatum.

[0039] Preparation method:

[0040] Weigh the raw materials according to the above prescription, crush and mix them. First, soak 50g of medium-chain triglycerides at 60℃ for 6 hours, then add 50g of almond oil and soak at room temperature for 12 hours. Filter with gauze to obtain the massage oil for the treatment of torticollis.

[0041] Example 3: Preparation of Traditional Chinese Medicine Massage Oil

[0042] prescription:

[0043] 10g Amomum villosum, 5g Picrorhiza scrophulariiflora, 5g Syzygium aromaticum, 5g Citrus reticulata peel, 5g Lycopodium clavatum.

[0044] Preparation method:

[0045] Weigh the raw materials according to the above prescription, crush and mix them. First, soak 50g of medium-chain triglycerides at 60℃ for 6 hours, then add 50g of almond oil and soak at room temperature for 12 hours. Filter with gauze to obtain the massage oil for the treatment of torticollis.

[0046] Comparative Example 1

[0047] The prescription and preparation method are basically the same as those in Example 3, except that the almond oil is replaced with medium-chain triglycerides.

[0048] Comparative Example 2

[0049] The prescription and preparation method are basically the same as those in Example 3, except that the medium-chain triglycerides are replaced with almond oil.

[0050] Experimental Example 1: Intervention Study of Massage Oil on a Muscular Torticollis Animal Model

[0051] 1. Materials and Methods

[0052] 1.1 Laboratory Animals and Grouping

[0053] Sixty New Zealand rabbits, 6 weeks old and weighing 1.1–1.6 kg, were used as experimental animals. They were kept under constant 12-hour day-night alternating light, relative humidity of 50%–70%, and temperature of 22–26°C, with free access to food and water.

[0054] 1.2 Test Methods

[0055] 1.2.1 Model Establishment

[0056] Rabbits were acclimatized for 7 days, and a muscular torticollis rabbit model was established by injecting anhydrous ethanol into the sternocleidomastoid muscle, following the method described in the literature. Fifty rabbits were injected with 0.5 ml / kg of anhydrous ethanol, while the remaining 10 rabbits served as a control group without any intervention. One week after modeling was completed, the 40 surviving rabbits injected with anhydrous ethanol were selected for subsequent experimental studies.

[0057] 1.2.2 Intervention Methods

[0058] After successful modeling, the rabbits were randomly divided into four groups using a random number table: model group, Example 3 group, Comparative Example 1 group, and Comparative Example 2 group, with 10 rabbits in each group. In Example 3 group, the herbal massage oil obtained in Example 3 of this invention was applied to the neck of the model rabbits, and the mass and sternocleidomastoid muscle were gently tapped with the thumb for 3 minutes, twice daily, morning and evening. Comparative Example 1 and Comparative Example 2 groups used the massage oils obtained in Comparative Example 1 and Comparative Example 2, respectively, with the same application method and dosage as in Example 3 group. No treatment was performed on the control group and model group during the period.

[0059] 1.2.3 Serum SOD and MDA detection

[0060] After completing the intervention on days 15 and 30, fasting blood samples were collected from the ear veins of rabbits in each group the following morning. The samples were centrifuged and stored at -20°C for testing after all samples were collected. Following the final blood collection, serum SOD and MDA levels in each group of rats were measured using an enzyme-linked immunosorbent assay (ELISA) kit, strictly following the kit's instructions.

[0061] 1.2.4 Evaluation of therapeutic effect

[0062] After completing serum testing, the efficacy was evaluated, and the total effective rate of each group was calculated as follows: Total effective rate = (cured + effective) / total number of cases × 100%. The evaluation criteria were as follows: cured (dissipation of head and neck mass, facial symmetry); effective (significant reduction in head and neck mass); ineffective (no significant improvement in symptoms compared to before intervention); worsened (local skin ulceration and other postoperative phenomena).

[0063] 1.2.5 Neck muscle CK activity test

[0064] After evaluating the efficacy of each group of rabbits, the rabbits were euthanized, and their neck muscles were homogenized. The supernatant was used to detect serum CK activity using an ELISA kit, strictly following the kit's instructions.

[0065] 1.3 Statistical Methods

[0066] One-way ANOVA, LSD-t test, and Pearson correlation analysis were performed using SPSS 22.0 software.

[0067] 2 Results

[0068] 2.1 Evaluation of therapeutic effects in each group

[0069] The efficacy evaluation results for each group are shown in Table 1 below.

[0070] Table 1. Evaluation of therapeutic effects in each group (n, n=10)

[0071]

[0072] As can be seen from the results in Table 1 above, the massage oil obtained by this invention can cure up to 9 torticollis rabbits, with a total effective rate of 100%. In contrast, the massage oils obtained by Comparative Examples 1 and 2 have total effective rates of only 70% and 60%, respectively.

[0073] 2.2 Comparison of serum SOD levels among groups

[0074] The results are shown in Table 2. Compared with the blank group, the serum SOD in the model group decreased significantly on days 15 and 30 (P<0.05), indicating successful modeling. Compared with the model group, the serum SOD in Example 3 group, Comparative Example 1 group, and Comparative Example 2 group increased significantly on days 15 and 30, indicating that the intervention in all three groups had a certain effect. Compared with Comparative Example 1 and 2 groups, the serum SOD in Example 3 group increased significantly on day 30 (P<0.05), indicating that the massage oil extracted by combining medium-chain triglycerides and almond oil in this invention has a more complete extraction of effective components and a significantly better therapeutic effect. In contrast, the therapeutic effect is significantly reduced when medium-chain triglycerides or almond oil are used alone.

[0075] 2.3 Comparison of serum MDA among groups

[0076] The results are shown in Table 2. Compared with the blank group, the serum MDA in the model group was significantly increased on days 15 and 30 (P<0.05), indicating successful modeling. Compared with the model group, the serum MDA in Example 3 group, Comparative Example 1 group, and Comparative Example 2 group was significantly decreased on days 15 and 30 (P<0.05), indicating that the intervention in all three groups had a certain effect. Compared with Comparative Example 1 and 2 groups, the serum MDA in Example 3 group was significantly decreased on day 30 (P<0.05), indicating that the massage oil extracted by combining medium-chain triglycerides and almond oil in this invention has a more complete extraction of effective components and a significantly better therapeutic effect. In contrast, the therapeutic effect was significantly reduced when medium-chain triglycerides or almond oil were used alone.

[0077] 2.4 Comparison of CK activity in neck muscles among different groups

[0078] The results are shown in Table 2. Compared with the blank group, the neck muscle CK activity in the model group was significantly reduced (P<0.05), indicating that the model was successfully established. Compared with the model group, the neck muscle CK activity in Example 3, Comparative Example 1, and Comparative Example 2 was significantly increased (P<0.05), indicating that the intervention in all three groups had a certain effect. Compared with Comparative Example 1 and 2, the neck muscle CK activity in Example 3 was significantly increased (P<0.05), indicating that the massage oil extracted by combining medium-chain triglycerides and almond oil in this invention has a more complete extraction of effective components and a significantly better therapeutic effect. In contrast, the therapeutic effect was significantly reduced when medium-chain triglycerides or almond oil were used alone.

[0079] Table 2 Comparison of serum SOD, MDA, and CK levels at different time points in each group (x̄±s, n=10)

[0080]

[0081] Note: *P<0.05 compared to the control group; #P<0.05 compared to the model group; &P<0.05 compared to comparative examples 1 and 2.

[0082] Superoxide dismutase (SOD), an antioxidant enzyme that directly combats and eliminates free radicals in the body's cells, maintains homeostasis by reacting with free radicals. Its level can reflect the body's ability to scavenge free radicals to some extent. When muscles are damaged, SOD levels increase significantly to counteract the accumulation of oxygen free radicals at the site of injury, thus maintaining bodily stability. In contrast to SOD, microalcoholic acid (MDA), a peroxidation product of free radicals, can also be used as an oxidative stress factor to measure the degree of peroxidation in the body. Chromosomal oxidase (CK) is widely present in skeletal muscle cells. When cells are damaged, CK flows from inside the cell to outside, losing its activity and leading to varying degrees of thrombosis and occlusion, which manifests as masses of varying degrees in cerebral thrombosis (CMT).

[0083] In summary, the massage oil obtained by this invention can significantly increase serum SOD and neck muscle CK activity, reduce serum MDA levels, and effectively repair muscle damage. Furthermore, experimental results confirm that the massage oil extracted using a combination of medium-chain triglycerides and almond oil in this invention achieves more complete extraction of active ingredients and significantly better therapeutic effects.

[0084] Test Example 2: Clinical Application of the Massage Oil of the Present Invention

[0085] Patient XX, age 40 days, ultrasound examination report as follows: Figure 1 As shown: Exploration of the right neck muscle layer revealed a heterogeneous hypoechoic area, approximately 2.3cm x 1.3cm in size, with indistinct borders, no obvious blood flow signal, and unclear demarcation from the right sternocleidomastoid muscle. The report indicates that the patient has significant muscular torticollis.

[0086] The patient sought treatment at Jiangsu Provincial Hospital of Integrated Traditional and Western Medicine. The herbal massage oil prepared according to Example 3 of this invention was applied in appropriate amounts to the affected area of ​​the right neck, and massaged for 3-5 minutes, twice daily, morning and evening. After two months of treatment, a color Doppler ultrasound examination was performed at the hospital, and the results were as follows... Figure 2 As shown, the thickness of the right sternocleidomastoid muscle was significantly reduced, indicating a remarkable therapeutic effect.

[0087] The embodiments of the present invention have been described in detail above with reference to specific examples. However, the present invention is not limited to the above embodiments. Within the scope of knowledge possessed by those skilled in the art, various changes can be made without departing from the spirit of the present invention.

Claims

1. A traditional Chinese medicine massage oil for treating pediatric muscular torticollis, characterized in that, The herbal massage oil is mainly made from the following raw materials in parts by weight: 5-15 parts Amomum villosum, 2-8 parts Picrorhiza scrophulariiflora, 2-8 parts Syzygium aromaticum, 2-8 parts Citrus reticulata peel, 2-8 parts Lycopodium clavatum.

2. The herbal massage oil for treating pediatric muscular torticollis according to claim 1, characterized in that, The herbal massage oil is mainly made from the following raw materials in parts by weight: 8-12 parts Amomum villosum, 4-6 parts Picrorhiza scrophulariiflora, 4-6 parts Syzygium aromaticum, 4-6 parts Citrus reticulata peel, and 4-6 parts Lycopodium clavatum.

3. The herbal massage oil for treating pediatric muscular torticollis according to claim 1, characterized in that, The herbal massage oil is mainly made from the following raw materials in parts by weight: 10 parts Amomum villosum, 4-6 parts Picrorhiza scrophulariiflora, 4-6 parts Clove, 4-6 parts Citrus reticulata peel, 4-6 parts Lycopodium clavatum.

4. The herbal massage oil for treating pediatric muscular torticollis according to claim 1, characterized in that, The herbal massage oil is mainly made from the following raw materials in parts by weight: 10 parts Amomum villosum, 5 parts Picrorhiza scrophulariiflora, 5 parts cloves, 5 parts Citrus reticulata peel, and 5 parts Lycopodium clavatum.

5. The method for preparing the herbal massage oil for treating pediatric muscular torticollis according to any one of claims 1-4, characterized in that, Includes the following steps: Take the raw materials Amomum villosum, Coptis chinensis, cloves, Citrus reticulata peel and Lycopodium clavatum, crush them, mix them, soak them in medium chain triglycerides for a period of time, then add almond oil and continue soaking for a period of time, filter them, and you will get the Chinese herbal massage oil.

6. The method for preparing the traditional Chinese medicine massage oil for treating pediatric muscular torticollis according to claim 5, characterized in that, The total mass ratio of the raw materials to the medium-chain triglycerides is (13-47):50; the medium-chain triglycerides are soaked at a temperature of 50-70℃ for 4-8 hours.

7. The method for preparing the traditional Chinese medicine massage oil for treating pediatric muscular torticollis according to claim 5, characterized in that, The total mass ratio of the raw materials to the almond oil is (13-47):50; the almond oil is soaked at room temperature for 10-14 hours.

8. The use of the traditional Chinese medicine massage oil according to any one of claims 1-4 in the preparation of a medicament for treating muscular torticollis.

9. The application according to claim 8, characterized in that, The application of the aforementioned herbal massage oil in the preparation of a drug for the combined treatment of pediatric muscular torticollis with massage.

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