Application of ostalgia tincture in preparation of medicine for treating fascitis

Abstract

The invention belongs to the technical field of new application of ostalgia tincture, and provides application of ostalgia tincture in preparation of a medicine for treating fasciitis. Animal experiments and clinical tests prove that the ostalgia tincture can remarkably improve local blood vessel microcirculation of experimental animals when being externally used; in clinical application, the traditional Chinese medicine composition takes effect quickly and has a remarkable curative effect on treating fasciitis, so that the traditional Chinese medicine composition has an application prospect in preparing medicines for treating fasciitis.

Description

Technical Field

[0001] The invention belongs to the technical field of new applications of Gutongling tincture, and in particular relates to the application of Gutongling tincture in preparing a medicine for treating fasciitis. Background Art

[0002] Fascia, also known as tendons, is attached to bones and gathered at joints. It is a kind of tissue that connects joints and muscles. Fascia is a soft, collagen-rich, dense fibrous connective tissue that connects the whole body. The fascia layer lacks fat, forms nerve and blood vessel sheaths, wraps tissues and organs, and is an independent layer of loose fibrous tissue separated from the epimysium.

[0003] Fasciitis, also known as fibrositis and myofascial pain syndrome, is an aseptic inflammation of the muscle fascia caused by chronic strain or improper treatment or misdiagnosis after trauma, which leads to local edema and adhesion. Over time, the muscles and blood become stagnant, and the capillaries and microcirculation become poor, leading to fibrosis. It can occur in various parts of the body, often causing pain, muscle tension or weakness, muscle spasms, skin numbness, stiffness, movement disorders, etc., including shoulder and back myofasciitis and plantar fasciitis. It is a common and frequently occurring clinical disease.

[0004] As the pace of modern life accelerates and people sit for long periods of time, the incidence of fasciitis continues to increase. When patients touch the painful area, they may touch a harder lump or cord-like nodule, which may cause the pain to worsen when touched or pressed.

[0005] There are many treatments for fasciitis, including drug therapy and related physical therapy. From the perspective of clinical practice, Western medicine can only relieve pain in the short term, and long-term efficacy evaluation cannot achieve satisfactory results, and there are risks of drug side effects and toxicity. Physical therapy includes: massage, cupping, scraping, acupuncture, physical therapy, needle knife, etc. However, the above methods have a long treatment cycle, slow onset, and are difficult to eradicate, which can easily lead to recurrence of the disease.

[0006] Therefore, it is of great significance to find a simple, safe, cheap and effective treatment method.

[0007] Gutongling tincture is a Chinese patent medicine for external use, the main ingredients of which are Artemisia sibiricum, dried ginger, dragon's blood, frankincense, myrrh, and borneol. Among them, Artemisia sibiricum has the effects of dispelling wind, removing dampness, and relieving pain, and has a strong analgesic effect on the pain caused by stagnation of joint meridians. Borneol and dragon's blood have the effects of anti-inflammatory, analgesic, and swelling, and can relieve inflammation and swelling. Frankincense and myrrh have the effects of promoting blood circulation, relieving pain, reducing swelling and promoting tissue regeneration. The combination of the two medicines can enhance the effects of promoting blood circulation, dispersing blood stasis and dredge menstruation. Dried ginger has the effect of warming the meridians and dispersing cold, which can enhance the penetration of drugs through the meridians in the joints.

[0008] The whole formula of GUTONGLING TINCTURE has the efficacy of warming meridians to dispel cold, expelling wind and promoting blood circulation, dredging collaterals and relieving pain. It can be used to treat lumbar and cervical spondylosis, osteoarthritis, scapulohumeral periarthritis, and rheumatoid arthritis. SUMMARY OF THE INVENTION

[0009] Aiming at the above deficiencies in the prior art, the purpose of the present invention is to provide the application of GUTONGLING TINCTURE in the preparation of drugs for treating fasciitis.

[0010] In order to achieve the above purpose, the solution adopted by the present invention is:

[0011] The present invention provides the application of GUTONGLING TINCTURE in the preparation of drugs for treating fasciitis.

[0012] Furthermore, in a preferred embodiment of the present invention, the dosage forms of the drugs include solution, ointment, emulsion, gel, film-forming agent and aerosol.

[0013] Furthermore, in a preferred embodiment of the present invention, fasciitis includes myofasciitis and plantar fasciitis.

[0014] Furthermore, in a preferred embodiment of the present invention, myofasciitis includes lumbodorsal myofasciitis, gluteal myofasciitis, dorsal myofasciitis and posterior cervical myofasciitis.

[0015] The beneficial effect of the application of GUTONGLING TINCTURE provided by the present invention in the preparation of drugs for treating fasciitis is that: it is confirmed by animal experiments and clinical trials that the external use of GUTONGLING TINCTURE can significantly improve the local vascular microcirculation of experimental animals; in clinical application, it has a rapid onset and significant curative effect in the treatment of fasciitis, so it has the application prospect of preparing drugs for treating fasciitis. DETAILED DESCRIPTION OF THE INVENTION

[0016] In order to make the purpose, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below. Those not specified in the embodiments are carried out according to conventional conditions or conditions recommended by the manufacturer. Those reagents or instruments not specified by the manufacturer can be obtained as conventional products through commercial purchase.

[0017] The features and properties of the present invention will be further described in detail below with reference to the embodiments.

[0018] Example 1

[0019] Experimental animals: 30 Balb / c / nu nude mice, 4-5 weeks old, weighing 18-20 g, provided by Chongqing Tengxin Biotechnology Co., Ltd., license number: SCXK(Yu)2022-0005. The disposal of animals during the experiment complied with the requirements of the "Guiding Opinions on the Humane Treatment of Laboratory Animals" issued by the Ministry of Science and Technology.

[0020] Experimental method:

[0021] (1) Experimental groups and medication:

[0022] Thirty nude mice were randomly divided into three groups: a control group, a positive control group, and a Gutongling tincture group, with 10 mice in each group (half male and half female).

[0023] Gutongling tincture group: 1.4 mg / kg of Gutongling tincture was applied to the right ear of each mouse, each treatment lasted for 1 hour, once a day, for 5 consecutive days;

[0024] Control group: 1.4 mg / kg normal saline was applied to the right ear of each mouse, each treatment lasted for 1 hour, twice a day, for 5 consecutive days;

[0025] Positive control group: Diclofenac diethylamine cream was applied to the right ear of each mouse at a dose of 1.4 mg / kg, with each treatment lasting 1 hour, twice a day, for 5 consecutive days.

[0026] After the last treatment on the 5th day, the animals were anesthetized by intraperitoneal injection of 0.1% sodium pentobarbital (0.1 ml / 10 g), followed by tail vein injection of 0.1% adrenaline (0.1 ml / 10 g). The right ear micromotion, vein caliber (μm) and 0.2 mm 2 Number of capillary points.

[0027] (2) Data processing:

[0028] The observation data were statistically analyzed using SPSS 17.0 software. Indicates that t test is used; count data are represented by x 2 The test level was a=0.05, and P<0.05 was considered statistically significant.

[0029] (3) The experimental results are shown in Table 1 (micro-movements, venous calibers and number of open capillaries in each group of mice):

[0030] Table 1

[0031] Group Arteriolar caliber / μm Caliber of microvenules / μm Number of capillaries Control group 18.8±8.1 92.3±13.3 2.8±0.6 Positive control group <![CDATA[30.2±9.0 * ]]> <![CDATA[110.2±15.4 * ]]> <![CDATA[4.8±1.2 * ]]> Gutongling Tincture Group <![CDATA[38.5±7.2 *# ]]> <![CDATA[126.5±12.2 *# ]]> <![CDATA[5.5±0.8 **# ]]>

[0032] Note: Compared with the control group, * P<0.05, ** P<0.01; compared with the positive control group, # P<0.05.

[0033] The data in Table 1 show that compared with the control group, the right ear microartery, venous caliber and number of open capillaries of mice in the positive control group and Gutongling tincture group were significantly increased (P < 0.05 or P < 0.01), indicating that both the positive control group and Gutongling tincture group have the effect of promoting microcirculation.

[0034] Compared with the positive control group, the right ear micro-arteries, venous caliber and number of open capillaries in the Gutongling tincture group were significantly increased (P < 0.05), indicating that the Gutongling tincture group has a significant effect in promoting microcirculation.

[0035] Example 2

[0036] 1. Clinical data

[0037] (1) General data: All 150 cases were qualified patients with myofasciitis recruited from Sichuan Provincial People's Hospital from August 2018 to August 2020, including 62 males and 88 females; aged 18-65 years, with an average of 45.22 years; disease course 5-25 months. There was no significant difference in baseline data among the groups (P>0.05), and they were comparable.

[0038] (2) Diagnostic criteria: Diagnosis is based on the “Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes” issued by the State Administration of Traditional Chinese Medicine in 1994. Patients with back pain, muscle stiffness, and a feeling of heaviness often experience weather changes. Symptoms may be aggravated on rainy days or after fatigue. Patients may have a history of improper treatment of trauma, strain, or exogenous colds. Patients may have fixed tender points or widespread tenderness on the back, stiff back muscles, and cord-like changes can often be felt along the direction of the sacrospinal muscles. Functional activities of the shoulder and back may be impaired. X-ray examinations show no positive signs.

[0039] (3) Inclusion criteria: Meet the diagnostic criteria for dorsal myofasciitis mentioned above; be between 18 and 65 years old, volunteer to participate in the study, have good compliance, and sign the informed consent.

[0040] (4) Exclusion criteria: ① patients with acute soft tissue injury, cervical or lumbar spondylosis, frozen shoulder, or rheumatism; ② patients who had received Chinese or Western medicine treatment related to the disease within 1 week; ③ patients with serious life-threatening primary diseases such as cardiovascular, liver, kidney, and hematopoietic system diseases, as well as mental illness; ④ pregnant or lactating women.

[0041] (5) Efficacy criteria: Refer to the efficacy criteria of new Chinese medicine for the treatment of myofasciitis in accordance with the "Efficacy Criteria for Diagnosis of TCM Diseases" and the "Guidelines for Clinical Research of New Chinese Medicines" formulated and issued in 1997:

[0042] Cured: back pain disappeared, free movement, no tenderness, no recurrence in 3-month follow-up;

[0043] Markedly effective: local pain basically disappeared, there was no obvious tenderness, limb movement was roughly normal, and the condition did not worsen after 3 months of observation;

[0044] Effective: local pain is relieved, tenderness is mild, limb activity is improved, and the patient can participate in light work. There is no aggravation of the condition after 3 months of observation;

[0045] Ineffective: No improvement in any aspect compared with before treatment.

[0046] Total effective rate = (number of cured cases + markedly effective cases + effective cases) / total number of cases × 100%.

[0047] 2. Treatment methods

[0048] Case grouping: The above cases were randomly divided into Gutongling tincture group, control group and blank group, 50 people in each group.

[0049] Gutongling Tincture Group: Pour 10 ml of Gutongling Tincture onto a patch and apply it to the most painful area. Treat for 1 hour each time, once a day, for 5 days.

[0050] Blank group: Pour 10 ml of normal saline onto the patch and apply it to the most painful area. Each treatment lasts 1 hour, once a day, for 5 days.

[0051] Control group: Apply flurbiprofen gel patch to the most painful area, apply for 10 hours each time, twice a day, with an interval of 4 hours in between, for 5 days.

[0052] 3. Treatment results: see Table 2.

[0053] Table 2

[0054] Group Number of cases get well Significant effect efficient invalid Total Effectiveness Gutongling Tincture Group 50 34 13 3 0 100％ Blank group 50 0 0 0 50 0％ Control group 50 18 10 8 14 72％

[0055] Clinical experiments showed that after treatment, the total effective rate of the Gutongling tincture group reached 100.00%, and the total effective rate of the control group was 72%. The difference between the two groups was statistically significant (P<0.05). The clinical cure rate of the Gutongling tincture group was significantly higher than that of the control group, indicating that Gutongling tincture can significantly enhance the therapeutic effect of myofasciitis.

[0056] Example 3

[0057] 1. Clinical data

[0058] (1) General information: All 100 cases were eligible patients with plantar fasciitis recruited from Sichuan Provincial People's Hospital from March 2019 to March 2021, including 48 males and 52 females; aged 18-65 years, with an average of 50.46 years; disease course 4-22 months. There was no significant difference in baseline information among the groups (P>0.05), and the groups were comparable.

[0059] (2) Diagnostic criteria: According to the diagnostic criteria for plantar fasciitis in the Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes issued by the State Administration of Traditional Chinese Medicine in 1994: ① Slow onset, with a history of several days or even years, mostly occurring in middle-aged and obese people, and is somewhat related to degenerative changes in the elderly; ② The main complaint is pain in the sole of the foot, which worsens when walking or standing, especially when walking on uneven surfaces; ③ There is generally no redness or swelling in the affected area, but localized tenderness at the inner edge of the sole of the foot. Ultrasound and magnetic resonance imaging (MRI) examinations can show thickening and edema of the plantar fascia.

[0060] (3) Inclusion criteria: Meet the diagnostic criteria for plantar fasciitis mentioned above; age between 18 and 65 years old; patients volunteer to participate in the study, have good compliance, and sign the informed consent form.

[0061] (4) Exclusion criteria: ① Women who are pregnant, have blood system diseases, serious medical diseases, or have poorly controlled blood sugar in diabetes; ② Those with fractures, foot contusions, lower limb neuropathy, or lumbar spine disease; ③ Those who have taken analgesics for more than 1 week; those with foot skin ulcers or inflammatory exudates; ④ Those who do not cooperate during the trial, withdraw from the trial, or are lost to follow-up, or have incomplete clinical data.

[0062] (5) Efficacy evaluation criteria: ① Clinical cure: The patient's local swelling, pain and other symptoms disappeared, the pain point on the plantar disappeared, and normal function was restored; ② Marked effect: The local swelling and pain were significantly reduced, the pain point on the plantar was improved, and there was no difficulty in walking; ③ Effective: The local swelling and pain were reduced, the pain point on the plantar was improved, the pain was slightly reduced, and walking was still difficult; ④ Ineffective: There was no improvement before and after treatment.

[0063] Total effective rate = (number of clinically cured + markedly effective + effective) cases / total number of cases × 100%.

[0064] 2. Treatment methods:

[0065] Case grouping: The above cases were randomly divided into a Gutongling tincture group and a control group, 50 people per group. Patients in the Gutongling tincture group received a 7-day treatment with Gutongling tincture; the control group received a 7-day oral administration of Erectile Dysfunction Tablets. If the patient's pain did not significantly improve or even worsened after 7 days of treatment, the trial would be terminated and the patient would be transferred to the pain department for treatment. There was no difference in the statistical analysis of the two groups.

[0066] Gutongling tincture group: Pour 10ml of Gutongling tincture on the patch and stick it on the heel, apply for 1 hour every day for 7 consecutive days;

[0067] Control group: Oral administration of Erelcoxib tablets, 0.1 g each time, twice a day, for 7 consecutive days.

[0068] 3. Treatment results: See Table 3 (Comparison of therapeutic effects on plantar fasciitis between the Gutongling tincture group and the control group).

[0069] Table 3

[0070] Group Number of cases get well Significant effect efficient invalid Total Effectiveness Gutongling Tincture Group 50 40 7 3 0 100％ Control group 50 18 9 5 18 64％

[0071] Clinical experiments showed that after treatment, the total effective rate of the Gutongling tincture group reached 100.00%, and the total effective rate of the control group was 64%. The difference between the two groups was statistically significant (P<0.05). The clinical cure rate of the Gutongling tincture group was significantly higher than that of the control group, indicating that Gutongling tincture can significantly enhance the therapeutic effect of plantar fasciitis. Specific embodiment 1

[0073] The patient, Wang, female, 46 years old, has suffered from lumbar myofasciitis for more than 6 years. At first, she could take aceclofenac tablets to relieve the pain, but in recent years, the pain has gradually worsened. Oral aceclofenac tablets have no effect. She has received traction, massage and acupoint injection blockade treatment. The pain was relieved during the treatment, but relapsed the next day. At the same time, she also suffered from sore waist and knees, fatigue, dizziness and other symptoms.

[0074] Since August 15, 2022, after massaging the affected area for 8-10 minutes every day, 10 ml of Gutongling tincture was applied to the affected area for 1 hour, and the treatment lasted for 5 consecutive days. After 1 day, the pain was significantly relieved, and it was cured after 5 days. There was no recurrence after 1 year of follow-up. Specific embodiment 2

[0076] The patient, Mr. Li, male, 52 years old, had suffered from myofasciitis in his left shoulder for more than three years. He often felt pain in his left shoulder and was unable to raise his hand, which was worse at night. In recent years, he had tried massage, acupuncture, moxibustion and other treatments, but the pain was only relieved during treatment and recurred the next day. He was not cured and was deeply troubled by it.

[0077] Since March 10, 2022, after massaging the affected area for 8-10 minutes every day, 10 ml of Gutongling tincture was applied to the affected area for 1 hour, and the treatment lasted for 5 consecutive days. After 1 day, the pain was significantly relieved and the hand could be raised; after 3 days, there was no pain, the hand could be raised strongly and stretched freely, and the treatment was continued for 5 days to recover. There was no recurrence after 1 year of follow-up. Specific embodiment 3

[0079] The patient, Mr. Huang, male, 38 years old, had suffered from plantar fasciitis on the right side of his foot for more than 6 months. He had obvious tingling pain in the morning and after walking for a long time, and the pain occurred intermittently; if he engaged in more strenuous activities, the tingling pain intensified and increased in frequency, and he still felt pain when standing, which was slightly relieved after rest.

[0080] Since January 2, 2021, after massaging the affected area for 8-10 minutes every day, 10 ml of Gutongling tincture was applied to the affected area for 1 hour, and the treatment lasted for 7 consecutive days. After 1 day, the pain was significantly relieved; after 4 days, there was no pain, and the tingling sensation completely disappeared. After 7 days of treatment, the patient was completely cured, and there was no recurrence in the 1-year follow-up.

[0081] The above experimental results show that, as confirmed by animal experiments and clinical trials, external application of Gutongling tincture can significantly improve the local vascular microcirculation of experimental animals; in clinical applications, it has a rapid and significant effect in the treatment of myofasciitis and plantar fasciitis, and therefore has application prospects in the preparation of drugs for the treatment of fasciitis.

[0082] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. For those skilled in the art, the present invention may have various modifications and variations. Any modification, equivalent replacement, improvement, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. Application of Gutongling tincture in the preparation of medicines for the treatment of fasciitis.

2. The use of Gutongling tincture according to claim 1 in preparing a drug for treating fasciitis, characterized in that: The dosage forms of the drug include solutions, ointments, emulsions, gels, film coatings and aerosols.

3. The use of Gutongling tincture according to claim 1 in preparing a drug for treating fasciitis, characterized in that: The fasciitis includes myofasciitis and plantar fasciitis.

4. The use of Gutongling tincture according to claim 3 in preparing a drug for treating fasciitis, characterized in that: The myofasciitis includes lumbar myofasciitis, gluteal myofasciitis, back myofasciitis and posterior cervical myofasciitis.