External pharmaceutical composition for waist training injury pain and patch thereof

Abstract

The invention belongs to the technical field of medicine, and provides an external pharmaceutical composition for waist training injury pain and a patch thereof, the external pharmaceutical composition is prepared from scutellaria baicalensis, angelica sinensis, poria cocos, salvia miltiorrhiza, radix angelicae pubescentis, golden cypress, ligusticum wallichii, frankincense, garden balsam stem, safflower, galangal, liquorice and diclofenac sodium. According to the external medicine composition, the medicines generate a mutual synergistic effect in a manner of combined application of traditional Chinese medicines and western medicines, so that the purpose of enhancing the medicine effect is achieved, and the analgesic effect is remarkable. The combined action of Chinese and western medicines alleviates the side effect of pure western medicines and improves the problem of unstable curative effect of pure traditional Chinese medicines. The external medicine composition is high in safety, free of stimulation, exact in curative effect, free of pain in treatment, high in clinical cure rate and easy to accept by patients after being used for a long time.

Description

Technical Field

[0001] The invention belongs to the technical field of medicines and relates to an external medicine composition and a patch thereof for waist training pain. Background Art

[0002] Pain is an unpleasant feeling and emotional experience associated with actual or potential tissue damage, or similar experiences. Long-term pain not only affects patients' sleep, work and living abilities, but also increases the incidence of emotional disorders such as depression and anxiety, seriously affecting human health and quality of life.

[0003] In clinical pain treatment, Western analgesics and partial anesthetics (local anesthesia, general anesthesia) play a major role, but the existing different types of analgesics have various side effects to varying degrees, such as inducing ulcers, coagulation disorders, allergic reactions, liver necrosis, hemolytic anemia, kidney damage, thyroid enlargement, toxic amblyopia, etc. Although analgesics have a strong analgesic effect, their obvious dependence greatly limits their scope of use and increases the difficulty of decision-making. Local administration has low systemic exposure and high safety, so topical dosage forms (such as gels, ointments, patches, etc.) that can be used for local administration are increasingly valued by clinical physicians. Summary of the invention

[0004] In order to make up for the deficiencies of the prior art, the present invention provides a new external medicine composition and patch for treating waist training pain, which has a reasonable formula, good efficacy and safe medication.

[0005] The present invention also provides a method for preparing the external-use pharmaceutical composition.

[0006] The present invention also provides medical use of the external medicine composition.

[0007] Specifically, the technical problem to be solved by the present invention is achieved through the following technical solutions.

[0008] The invention provides an external medicinal composition for treating pain. The external medicinal composition is prepared from scutellaria baicalensis, angelica sinensis, tuckahoe, salvia miltiorrhiza, angelica pubescens, phellodendron amurense, ligusticum chuanxiong, frankincense, radix scutellariae, safflower, galangal, liquorice and diclofenac sodium.

[0009] Specifically, the topical pharmaceutical composition is made of the following raw materials in parts by weight: 15-25 parts of scutellaria baicalensis, 15-25 parts of angelica sinensis, 10-20 parts of poria cocos, 10-20 parts of salvia miltiorrhiza, 10-20 parts of angelica pubescens, 10-20 parts of phellodendron chinense, 10-15 parts of ligusticum chuanxiong, 12-18 parts of frankincense, 12-18 parts of radix striatae, 10-15 parts of safflower, 12-18 parts of galangal, 8-10 parts of licorice and 6-8 parts of diclofenac sodium.

[0010] In one embodiment of the present invention, the topical pharmaceutical composition is made of the following raw materials in parts by weight:

[0011] 20 parts of Scutellaria baicalensis, 20 parts of Angelica sinensis, 15 parts of Poria cocos, 15 parts of Salvia miltiorrhiza, 15 parts of Angelica dahurica, 15 parts of Angelica pubescens, 15 parts of Phellodendron chinense, 12 parts of Ligusticum chuanxiong, 15 parts of Olibanum, 15 parts of Herba Polygoni Multiflori, 12 parts of Carthamus tinctorius, 15 parts of Alpinia officinalis, 9 parts of Licorice and 7 parts of Diclofenac Sodium.

[0012] The preparation method of the external medicinal composition for treating pain of the present invention is as follows: weigh Chinese medicinal raw materials, add 6-8 times the weight of water, soak for 1-2 hours, decoct twice, each time for 1-2 hours, and prepare an external preparation according to a conventional method.

[0013] The preparation method of the external medicinal composition for treating pain of the present invention is as follows: weigh Chinese medicinal raw materials, add 6 times the weight of water, soak for 1.5 hours, decoct twice, each time for 1.5 hours, and prepare an external preparation according to a conventional method.

[0014] Furthermore, the dosage form of the external preparation is a lotion, a patch, a paste, an ointment, a gel, a film coating or a papule.

[0015] Furthermore, the dosage form of the external preparation is a patch.

[0016] The invention provides use of an external medicinal composition for treating pain in preparing a drug for treating swelling and relieving pain.

[0017] The invention provides use of an external medicinal composition for treating pain in preparing an analgesic drug for treating scapulohumeral periarthritis.

[0018] “Pain occurs when there is obstruction and pain occurs when there is no nourishment” is the theoretical basis of pain in Traditional Chinese Medicine. Clinically, pain is treated with methods of promoting blood circulation and removing blood stasis, unblocking meridians and relieving pain, and warming the middle and dispersing cold.

[0019] According to the theory of TCM surgery, swelling and pain are symptoms of the body caused by the blockage of meridians and stagnation of qi and blood due to various pathogenic factors such as heat, cold, wind, dampness, phlegm, qi, and blood stasis. Bitter and cold herbs can clear away heat, dry dampness, and detoxify, and also have the effects of descending and strengthening yin. Pungent and warm herbs can disperse and move, dredge the meridians and activate blood circulation, remove blood stasis, and disperse heat in the blood. In addition to using cold herbs to reduce fire, the treatment of pain also requires pungent and warm herbs to dispel cold, dispel wind, dry dampness, resolve phlegm, promote qi movement, and activate blood circulation.

[0020] The external medicinal composition for treating pain is composed of scutellaria baicalensis, angelica sinensis, tuckahoe, salvia miltiorrhiza, angelica pubescens, phellodendron amurense, ligusticum chuanxiong, frankincense, radix scutellariae, safflower, galangal, liquorice and diclofenac sodium.

[0021] Scutellaria baicalensis: It is cold in nature and enters the lung, gallbladder, stomach and large intestine meridians. It clears away heat and dampness, purges fire and detoxifies. Its effects are mainly on the upper lung and large intestine. It is good at clearing fire from the lungs and large intestine, especially clearing heat from the lungs. It can also remove dampness and heat from the stomach, intestines, liver and gallbladder. It also enters the blood, and can clear heat, cool blood and stop bleeding.

[0022] Angelica: sweet in taste, warm in nature, enters the heart, liver, and spleen meridians, nourishes and regulates blood, regulates menstruation and relieves pain, moisturizes and lubricates the intestines. Treats irregular menstruation, amenorrhea and abdominal pain, accumulation of masses, metrorrhagia; headache due to blood deficiency, dizziness, paralysis; constipation due to dry intestines, heaviness after dysentery; carbuncle, ulcer, and injuries from falls.

[0023] Poria: sweet in taste, neutral in nature, enters the heart, spleen, and lung meridians, dissipates dampness and promotes diuresis, benefits the spleen and stomach, and calms the mind. It is used to treat urinary problems, edema, phlegm and cough, vomiting, diarrhea, spermatorrhea, stranguria, palpitations, and forgetfulness.

[0024] Danshen: bitter in taste, cold in nature, enters the heart and spleen meridians, activates blood circulation and removes blood stasis, cools blood and eliminates carbuncle, clears the heart and relieves restlessness. It is used for irregular menstruation, blood stasis and amenorrhea, abdominal pain due to postpartum stasis, pain in the heart and abdomen, accumulation of masses, and limb pain.

[0025] Duhuo: spicy, warm in nature, enters the kidney and bladder meridians, dispels wind, overcomes dampness, dispels cold, and relieves pain. Treats wind-cold-damp arthralgia, sore waist and knees, cramps in hands and feet, chronic tracheitis, headaches, and toothaches.

[0026] Huangbai: bitter in taste, cold in nature, used for diarrhea caused by damp-heat, jaundice, dark urine, leucorrhea, itchy vaginal discharge, painful stranguria caused by heat, beriberi, paralysis, bone steaming, fatigue fever, night sweats, spermatorrhea, sores, swelling and infection, eczema and wet sores.

[0027] Chuanxiong: Spicy in taste, warm in nature, enters the hand and foot Jueyin meridians, specializes in blood supplementation, effectively treats headaches, circulates blood, clears the liver meridian, breaks up blood stasis, removes old blood and regenerates new blood after childbirth, and can treat vomiting blood, nosebleeds, hematuria, blood in stool, and metrorrhagia. It can clear blood stasis, disperse external infection, and effectively treat headaches and stop the pain of wounds.

[0028] Frankincense: spicy and bitter in taste, warm in nature, enters the heart, liver and spleen meridians, promotes blood circulation, relieves qi and relieves pain, reduces swelling and promotes tissue regeneration.

[0029] Radix Phellodendri: sweet and spicy in taste, warm in nature, enters the liver and lung meridians, dispels wind and dampness, relaxes muscles and tendons, promotes blood circulation and relieves pain, detoxifies and reduces rashes.

[0030] Safflower: spicy in taste, warm in nature, enters the heart and liver meridians, promotes blood circulation and menstruation, dissipates blood stasis and relieves pain, used for amenorrhea, dysmenorrhea, lochia retention, lumps and masses, chest pain, abdominal pain due to blood stasis, stabbing pain in the chest and flanks, injuries from falls, and sores and swelling.

[0031] Alpinia galanga: spicy in taste, hot in nature, enters the spleen and stomach meridians, warms the stomach and stops vomiting, dispels cold and relieves pain, used for cold pain in the abdomen, vomiting due to stomach cold, belching and acid regurgitation.

[0032] Licorice: It is mild in nature and enters the heart, spleen, lung and stomach meridians. It nourishes the spleen and replenishes qi, moistens the lungs and relieves cough, clears away heat and detoxifies, relieves pain, and moderates the properties of the medicine.

[0033] Diclofenac sodium: It is a non-steroidal anti-inflammatory drug with a fast onset of action. It mainly produces analgesic, anti-inflammatory and antipyretic effects by inhibiting the synthesis of prostaglandins. It is used to relieve the symptoms of joint swelling and pain in various arthritis such as rheumatoid arthritis, osteoarthritis, spondyloarthropathies, gouty arthritis, rheumatic arthritis, etc.; it is used to treat various non-articular soft tissue rheumatic pains, such as shoulder pain, tenosynovitis, bursitis, myalgia and pain caused by sports injuries, etc.; it is used for acute mild and moderate pain such as post-surgery, post-traumatic, post-strain, dysmenorrhea, toothache, headache, etc.; it has a certain antipyretic effect on fever.

[0034] In the compatibility of the external medicine composition for treating pain of the present invention, angelica and radix scutellariae are combined as monarch drugs; scutellariae baicalensis, salvia miltiorrhizae, phellodendron chinense and safflower are collectively ministerial drugs; tuckahoe, angelica pubescens, frankincense, ligusticum chuanxiong and galangal are collectively adjuvant drugs; liquorice is a guiding drug, which harmonizes various drugs and relieves pain. The whole prescription has the functions of promoting blood circulation and unblocking collaterals, reducing swelling and relieving pain. The traditional Chinese medicine formula theory and clinical application attach great importance to the mutual coordination of various drugs of "monarch, minister, adjuvant and guiding" in the formula. The present invention not only exerts the efficacy of each single medicine through the mutual coordination of the above drugs of "monarch, minister, adjuvant and guiding", but also improves the synergistic effect of Chinese and Western medicines in the formula.

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

[0036] (1) External treatment with Chinese medicine is an important part of traditional Chinese medicine. Through external administration, the medicine can directly reach the diseased area, thereby achieving the purpose of eliminating pathogens and curing diseases. The external medicine composition of the present invention is not a simple combination of several medicines, nor is it a simple accumulation of drug effects. The present invention uses a combination of Chinese and Western medicines to produce a synergistic effect between the drugs, thereby achieving the purpose of enhancing drug efficacy and having a significant analgesic effect.

[0037] (2) The external-use pharmaceutical composition for treating pain of the present invention has a synergistic effect of Chinese and Western medicines, which reduces the side effects of Western medicine alone and improves the problem of unstable efficacy of Chinese medicine alone.

[0038] (3) The topical pharmaceutical composition of the present invention is highly safe and non-irritating. Long-term use not only has a definite therapeutic effect, but also is painless, has a high clinical cure rate, and is easily accepted by patients. BRIEF DESCRIPTION OF THE DRAWINGS

[0039] Figure 1 The effect of the patch of the present invention on ear swelling in mice, compared with group A, * P<0.05, ** P<0.01; compared with group B, # P<0.05.

[0040] Figure 2 The effect of the patch of the present invention on hot plate analgesia in mice, compared with group A, * P<0.05, ** P<0.01; compared with group B, # P<0.05. Specific embodiments

[0041] The content of the present invention is further described in detail below through specific implementation methods, but this should not be understood as the scope of the above subject matter of the present invention is limited to the following examples. The following examples are used to illustrate the technical solution of the present invention rather than to limit the scope of protection of the present invention. If a person of ordinary skill in the art modifies or replaces the technical solution of the present invention with an equivalent without departing from the essence and scope of the technical solution of the present invention, it still belongs to the scope of protection of the present invention.

[0042] Example 1: Pharmaceutical composition patch of the present invention

[0043] 20 parts of Scutellaria baicalensis, 20 parts of Angelica sinensis, 15 parts of Poria cocos, 15 parts of Salvia miltiorrhiza, 15 parts of Angelica dahurica, 15 parts of Angelica pubescens, 15 parts of Phellodendron chinense, 12 parts of Ligusticum chuanxiong, 15 parts of Olibanum, 15 parts of Herba Polygoni Multiflori, 12 parts of Carthamus tinctorius, 15 parts of Alpinia officinalis, 9 parts of Licorice and 7 parts of Diclofenac Sodium.

[0044] The preparation method is as follows: weigh the above Chinese medicinal raw materials, add 6 times the weight of water, soak for 1.5 hours, decoct twice, each time for 1.5 hours, combine the decoctions, concentrate under vacuum pressure, remove the aqueous solution, and vacuum dry the obtained extract; add diclofenac sodium and medicinal glycerin to the obtained extract, mix into a paste, and evenly spread it on a square medical tape of a fixed size, leaving a certain size on the edges to fix the tape, so as to obtain a patch for treating pain.

[0045] Example 2 Pharmaceutical composition patch of the present invention

[0046] 15 parts of Scutellaria baicalensis, 25 parts of Angelica sinensis, 10 parts of Poria, 20 parts of Salvia miltiorrhiza, 10 parts of Angelica dahurica, 20 parts of Phellodendron chinense, 10 parts of Ligusticum chuanxiong, 18 parts of Olibanum, 12 parts of Herba Polygoni Multiflori, 15 parts of Carthamus tinctorius, 18 parts of Alpinia officinalis, 8 parts of Licorice and 6 parts of Diclofenac Sodium.

[0047] The preparation method is similar to that of Example 1.

[0048] Example 3 Pharmaceutical composition ointment of the present invention

[0049] 25 parts of Scutellaria baicalensis, 15 parts of Angelica sinensis, 20 parts of Poria cocos, 20 parts of Salvia miltiorrhiza, 20 parts of Angelica dahurica, 10 parts of Phellodendron chinense, 15 parts of Ligusticum chuanxiong, 12 parts of Olibanum, 18 parts of Herba Polygoni Multiflori, 10 parts of Carthamus tinctorius, 12 parts of Alpinia officinalis, 10 parts of Licorice and 8 parts of Diclofenac Sodium.

[0050] The preparation method is as follows: weigh the above Chinese medicinal raw materials, add 8 times the weight of water, soak for 1 hour, decoct twice, each time for 1.5 hours, combine the decoctions, and concentrate under vacuum to obtain a medicinal liquid concentrate; add beeswax and yellow vaseline to the concentrate, decoct and stir over a low heat, and cool into a paste to obtain an ointment for treating pain.

[0051] Example 4 Pharmaceutical composition gel of the present invention

[0052] 20 parts of Scutellaria baicalensis, 15 parts of Angelica sinensis, 15 parts of Poria cocos, 20 parts of Salvia miltiorrhiza, 15 parts of Angelica dahurica, 15 parts of Phellodendron chinense, 15 parts of Ligusticum chuanxiong, 12 parts of Olibanum, 18 parts of Herba Polygoni Multiflori, 10 parts of Carthamus tinctorius, 18 parts of Alpinia officinalis, 8 parts of Licorice and 8 parts of Diclofenac Sodium.

[0053] The preparation method is as follows: weigh the above Chinese medicinal raw materials, add 6 times the weight of water, soak for 1.5 hours, decoct twice, decoct for 1 hour each time, combine the decoctions, and concentrate under vacuum to obtain a concentrated medicinal liquid; add carbomer to glycerin and grind it to moisten it, then add a small amount of distilled water to grind it, move it to a measuring cup, take appropriate amounts of triethanolamine, ethylparaben, and distilled water to dissolve them, stir into a gel, and then add appropriate amount of distilled water to stir evenly; add the above concentrate, grind evenly to obtain a gel for treating pain.

[0054] Example 5 Pharmaceutical composition gel of the present invention

[0055] 25 parts of Scutellaria baicalensis, 15 parts of Angelica sinensis, 15 parts of Poria cocos, 20 parts of Salvia miltiorrhiza, 10 parts of Angelica dahurica, 16 parts of Phellodendron chinense, 11 parts of Ligusticum chuanxiong, 16 parts of Olibanum, 12 parts of Herba Polygoni Multiflori, 15 parts of Carthamus tinctorius, 12 parts of Alpinia officinalis, 10 parts of Licorice and 7 parts of Diclofenac Sodium.

[0056] The preparation method is as follows: weigh the above Chinese medicinal raw materials, add 8 times the weight of water, soak for 2 hours, decoct twice, decoct for 2 hours each time, combine the decoctions, and concentrate under vacuum to obtain a concentrated medicinal liquid; add carbomer to glycerin and grind it to moisten it, then add a small amount of distilled water to grind it, move it to a measuring cup, take appropriate amounts of triethanolamine, ethylparaben, and distilled water to dissolve them, stir them into a gel, and then add appropriate amount of distilled water to stir evenly; add the above concentrate, grind evenly to obtain a gel for treating pain.

[0057] Example 6: Cataplasm of the pharmaceutical composition of the present invention

[0058] 15 parts of Scutellaria baicalensis, 20 parts of Angelica sinensis, 15 parts of Poria cocos, 20 parts of Salvia miltiorrhiza, 10 parts of Angelica dahurica, 10 parts of Phellodendron chinense, 15 parts of Ligusticum chuanxiong, 18 parts of Olibanum, 16 parts of Herba Polygoni Multiflori, 12 parts of Carthamus tinctorius, 16 parts of Alpinia officinalis, 9 parts of Licorice and 7 parts of Diclofenac Sodium.

[0059] The preparation method is as follows: weigh the above Chinese medicinal materials, add 7 times the weight of water, soak for 1 hour, decoct twice, each time for 2 hours, combine the decoctions, and concentrate under vacuum to obtain a medicinal liquid concentrate; add sorbitol, glycerin and other conventional cataplasm bases to the concentrate, stir well, apply it to the support layer, and add a protective layer to obtain a cataplasm for treating pain.

[0060] Comparative Example 1

[0061] 20 parts of Sophora flavescens, 20 parts of Astragalus, 15 parts of Poria, 15 parts of Campsis creeper, 15 parts of Notopterygium wilfordii, 15 parts of Phellodendron chinense, 12 parts of Ligusticum chuanxiong, 15 parts of Olibanum, 15 parts of Herba speranskiae spermatae, 12 parts of Carthamus tinctorius, 15 parts of Alpinia officinalis, 9 parts of Licorice and 7 parts of Diclofenac sodium.

[0062] The preparation method is similar to that of Example 1.

[0063] Comparative Example 2

[0064] 15 parts of Poria cocos, 15 parts of Angelica dahurica, 12 parts of Ligusticum chuanxiong, 15 parts of frankincense, 15 parts of Alpinia officinalis, 9 parts of Licorice and 7 parts of Diclofenac Sodium.

[0065] The preparation method is similar to that of Example 1.

[0066] Comparative Example 3

[0067] 21 parts of Scutellaria baicalensis, 21 parts of Angelica sinensis, 16 parts of Poria cocos, 16 parts of Salvia miltiorrhiza, 16 parts of Angelica pubescens, 16 parts of Phellodendron chinense, 13 parts of Ligusticum chuanxiong, 15 parts of Olibanum serrata, 15 parts of Herba Polygoni Multiflori, 12 parts of Carthamus tinctorius, 15 parts of Alpinia officinalis and 9 parts of Licorice.

[0068] The preparation method is similar to that of Example 1.

[0069] Efficacy Example 1 Effect of the patch of the present invention on ear swelling in mice

[0070] 1. Experimental Methods

[0071] 56 SPF-grade ICR male mice, weighing 18-20 g, were provided with free access to water and food, and the room temperature was maintained at 20-25°C.

[0072] The mice were randomly divided into model control group (Group A): blank matrix; Example 1 group (Group B): 1.2g / kg; Example 2 group (Group C): 1.2g / kg; Comparative Example 1 group (Group D): 1.2g / kg; Comparative Example 2 group (Group E): 1.2g / kg; Comparative Example 3 group (Group F): 1.2g / kg, 8 mice in each group. The abdomen of each group of mice was shaved, and after drug administration, they were fixed with tape. Apply for 2 hours every day for 2 consecutive days. On the 3rd day, 0.03mL of xylene was applied to both sides of the right ears of each group of animals to cause inflammation. After 30 minutes, the mice were dislocated to death, and the circular ear pieces were removed from the symmetrical parts of the left and right ears with a 7mm diameter puncher, weighed, and the weight difference between the left and right ears was used as the degree of swelling, and the swelling inhibition rate was calculated.

[0073] Inhibition rate (%) = (right ear weight - left ear weight) / left ear weight × 100%.

[0074] 2. Statistical methods

[0075] Graphpad Prism 9.0 software was used for data processing, and the measured data were expressed as mean ± standard deviation. One-way analysis of variance was used for comparison among multiple groups, and SNK-q was used for pairwise comparison among groups. The difference was considered statistically significant when P < 0.05.

[0076] 3. Experimental results

[0077] Effects on ear swelling in mice

[0078] Compared with the model group, Example 1 and Example 2 groups significantly inhibited the ear swelling of mice caused by xylene, and their effect of inhibiting the ear swelling of mice caused by xylene was significantly better than that of the control group. Figure 1 .

[0079] Efficacy Example 2 Analgesic effect of the patch of the present invention on hot plate-induced pain in mice

[0080] 1. Experimental Methods

[0081] 56 SPF-grade ICR female mice, weighing 18-20 g, were provided with free access to water and food, and the room temperature was maintained at 20-25°C.

[0082] The temperature of the thermostatic water bath was set to 55°C. When the water temperature rose to (55±0.5)°C, a 500mL beaker was placed in the water bath and preheated for 10 minutes. One mouse was taken each time and placed in the beaker. The time required for the two feet to touch the bottom of the beaker to lick the hind feet was recorded as the pain threshold of the mouse. Those who did not lick the hind feet within 30 seconds were discarded. After the mice were marked, the basic pain threshold was measured, and the measurement was repeated twice, and the average was taken as the basic pain threshold. The mice were randomly divided into the model control group (Group A): blank matrix; Example 1 group (Group B): 1.2g / kg; Example 2 group (Group C): 1.2g / kg; Comparative Example 1 group (Group D): 1.2g / kg; Comparative Example 2 group (Group E): 1.2g / kg; Comparative Example 3 group (Group F): 1.2g / kg, 8 mice in each group, the abdomen of each group of mice was shaved, and after the drug was administered, they were fixed with tape. Apply the patch for 2 hours every day for 3 consecutive days, once a day, and measure the pain threshold 90 minutes after the last dose.

[0083] 2. Statistical methods

[0084] Graphpad Prism 9.0 software was used for data processing, and the measured data were expressed as mean ± standard deviation. One-way analysis of variance was used for comparison among multiple groups, and SNK-q was used for pairwise comparison among groups. The difference was considered statistically significant when P < 0.05.

[0085] 3. Experimental results

[0086] Effects on hot plate-induced pain in mice

[0087] Compared with the model group, the Example 1 group and the Example 2 group significantly increased the pain threshold of the hot plate-induced pain mice, and their effect of increasing the pain threshold of the hot plate-induced pain mice was significantly better than that of the control group. Figure 2 .

[0088] Clinical Example Observation on the therapeutic effect of the external medicinal composition of the present invention on pain of shoulder arthritis

[0089] 1. Materials and Methods

[0090] 1. Clinical data

[0091] Forty-five patients with shoulder arthritis who visited the outpatient clinic were selected.

[0092] 2. Diagnostic criteria

[0093] Diagnosis is made in accordance with the "Guidelines for Clinical Research of New Chinese Medicines" of the National Health Commission of the People's Republic of China and the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases" of the State Administration of Traditional Chinese Medicine.

[0094] Patients with local joint, muscle pain and joint dysfunction caused by frozen shoulder. Pain evaluation method: Visual analog scale (VAS) was used to evaluate the pain of the affected part. Method: Patients were asked to indicate the degree of their pain on a pain scale with a scale of 0-10 cm, 0 for no pain and 10 for extreme pain. Tenderness and functional observation were observed based on the requirements, with tenderness and joint dysfunction as the observation contents. The degree of the observation contents was scored as 0, 1, 2, and 3, as shown in Table 1 below.

[0095] Table 1 Tenderness and joint function scoring criteria

[0096]

[0097] 3. Inclusion criteria

[0098] Patients with the above typical symptoms, VAS score ≥ 4 points and willing to receive treatment can be included as trial cases.

[0099] 4. Exclusion criteria

[0100] ① Patients over 65 years old, pregnant or lactating women, and those who are allergic to this drug; ② Patients with serious diseases such as heart, liver, kidney and hematopoietic system and mental illness; ③ Patients who do not meet the inclusion criteria, do not use the medicine as prescribed, cannot judge the efficacy or have incomplete data that affect the efficacy and safety judgment; ④ Patients with a VAS score of less than 4 points.

[0101] 5. Treatment Methods

[0102] The patients were given the patch of Example 1 of the present invention. Each patch was applied for 24 hours, 1 patch per day, and 12 patches in total.

[0103] 6. Statistical methods

[0104] SPSS 19.0 software was used for data processing, and the data were expressed as mean ± standard deviation. The data of each group were subjected to normal distribution test and variance homogeneity test, and the inter-group comparison was performed with one-way analysis of variance, with P < 0.05 as the difference being statistically significant.

[0105] 2. Results

[0106] Comparison of pain-related indicators

[0107] After treatment, the VAS, tenderness, and joint dysfunction scores were significantly reduced, with statistically significant differences (see Table 2).

[0108] Table 2 Comparison of symptoms of patients with shoulder arthritis before and after treatment

[0109]

[0110] Note: Compared with before treatment, ## p<0.01.

[0111] The external medicinal composition of the present invention can significantly improve the pain symptoms of shoulder arthritis and has a significant analgesic effect.

[0112] The above description of the disclosed embodiments enables one skilled in the art to implement or use the present invention. Various modifications to these embodiments will be apparent to one skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the present invention. Therefore, the present invention will not be limited to the embodiments shown herein, but rather to the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A topical medicinal composition for treating pain caused by waist training, characterized in that: The external medicine composition is prepared from the following raw materials: 15-25 parts of scutellaria baicalensis, 15-25 parts of angelica sinensis, 10-20 parts of tuckahoe, 10-20 parts of salvia miltiorrhiza, 10-20 parts of angelica pubescens, 10-20 parts of phellodendron amurense, 10-15 parts of ligusticum chuanxiong, 12-18 parts of frankincense, 12-18 parts of radix striatae, 10-15 parts of safflower, 12-18 parts of galangal, 8-10 parts of liquorice and 6-8 parts of diclofenac sodium.

2. The external pharmaceutical composition according to claim 1, characterized in that The external medicine composition is prepared from the following raw materials in parts by weight: 20 parts of scutellaria baicalensis, 20 parts of angelica sinensis, 15 parts of tuckahoe, 15 parts of salvia miltiorrhiza, 15 parts of angelica pubescens, 15 parts of phellodendron amurense, 12 parts of ligusticum chuanxiong, 15 parts of frankincense, 15 parts of radix schizonepetae, 12 parts of safflower, 15 parts of galangal, 9 parts of liquorice and 7 parts of diclofenac sodium.

3. The external pharmaceutical composition according to any one of claims 1 or 2, characterized in that The preparation method of the external medicine composition is as follows: weigh the Chinese medicine raw materials, add 6-8 times the weight of water, soak for 1-2 hours, decoct twice, decoct for 1-2 hours each time, and prepare the external preparation according to the conventional method.

4. The external pharmaceutical composition according to claim 3, characterized in that The preparation method of the external medicine composition is as follows: weigh the Chinese medicine raw materials, add 6 times the weight of water, soak for 1.5 hours, decoct twice, decoct for 1.5 hours each time, and prepare the external preparation according to the conventional method.

5. The external pharmaceutical composition according to any one of claims 1 or 2, characterized in that The dosage form of the external pharmaceutical composition is lotion, patch, paste, ointment, gel, film coating or papule.

6. The external pharmaceutical composition according to claim 5, characterized in that The dosage form of the external pharmaceutical composition is a patch.

7. The external pharmaceutical composition according to claim 6, characterized in that The preparation method of the topical drug composition patch is as follows: weigh scutellaria baicalensis, angelica, tuckahoe, salvia miltiorrhiza, angelica pubescens, phellodendron, ligusticum chuanxiong, frankincense, radix polygoni lobatae, safflower, galangal and liquorice, add 6 times the weight of water, soak for 1.5 hours, decoct twice, decoct for 1.5 hours each time, combine the decoctions, concentrate under vacuum pressure, remove the aqueous solution, and vacuum dry the obtained extract; add diclofenac sodium and medicinal glycerin to the obtained extract, mix into a paste, and evenly spread it on a square medical adhesive tape to obtain a patch for treating pain.

8. Use of the external medicinal composition according to any one of claims 1 or 2 in the preparation of an external medicinal composition for treating swelling and relieving pain.

9. Use of the external medicinal composition according to any one of claims 1 or 2 in the preparation of an external medicament for treating scapulohumeral periarthritis and relieving pain.

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