A pain-relieving and cooling gel patch suitable for subacute thyroiditis

Abstract

The invention relates to the field of medical plasters, and in particular to a pain-relieving and cooling gel patch suitable for subacute thyroiditis, and a preparation method and application thereof. The local pain-relieving and cooling patch suitable for thyroid pain in the acute phase of subacute thyroiditis has the effects of local cooling, clearing away heat and detoxifying, and reducing swelling and relieving pain, and is used to relieve local swelling, pain and fever of the thyroid gland, and has the advantages of safety and few adverse reactions.

Description

Technical Field

[0001] The invention relates to the field of medical plasters, in particular to a pain-relieving and cooling gel plaster suitable for subacute thyroiditis and a preparation method and application thereof. Background Art

[0002] Subacute thyroiditis (subacute thyroiditis), also known as granulomatous thyroiditis, is the most common painful thyroid disease. This disease is related to viral infection and mostly occurs in women aged 30-50. It is a self-limiting disease with a course of 6-8 weeks and a good prognosis. The main symptoms in the acute phase are fever and local pain and swelling of the thyroid gland. Severe pain in the thyroid gland is the main complaint of many patients in the outpatient clinic and is also the most typical symptom of subacute thyroiditis. The main treatment methods at present are non-steroidal anti-inflammatory drugs and hormone therapy, but there are side effects such as recurrence of the disease, adverse gastric reactions and osteoporosis.

[0003] It is now generally recognized that traditional Chinese medicine is effective in treating subacute thyroiditis. According to traditional Chinese medicine theory, the main pathogenesis of subacute thyroiditis is the raging liver fire, which causes the thyroid region, where the liver meridian passes, to become toxic. The treatment method mainly focuses on clearing away heat and detoxifying, cooling blood and dispersing nodules. In addition to taking decoctions orally, applying local patches to the thyroid gland can allow the drug to act directly on the local area, thereby better playing the role of pain relief, detoxification and swelling reduction.

[0004] Chinese patent document CN110179917A discloses a Chinese medicine composition for acupuncture application for the treatment of Hashimoto's thyroiditis goiter, and its active ingredients, measured by weight, include the following components: 1-5 parts of dandelion; 1-4 parts of Trillium; 1-4 parts of Dioscorea bulbifera; 1-5 parts of Angelica sinensis. The invention further provides the use of a Chinese medicine composition or a pharmaceutical preparation in the preparation of a drug for the treatment of Hashimoto's thyroiditis goiter. The invention provides a Chinese medicine composition for acupuncture application for the treatment of Hashimoto's thyroiditis goiter, which reduces adverse drug reactions by changing the action pathway of Chinese medicine, enhances the efficacy of the drug, reduces the pain of patients taking Chinese medicine orally for a long time, and improves patient compliance.

[0005] However, there has been no report on an analgesic and cooling gel patch suitable for subacute thyroiditis. Summary of the invention

[0006] The purpose of the present invention is to provide a pain-relieving and cooling gel patch suitable for subacute thyroiditis, and a preparation method and application thereof.

[0007] The first aspect of the present invention provides a Chinese medicine composition for external use suitable for subacute thyroiditis, which is composed of the following raw materials in parts by weight: 20-30 parts of Corydalis yanhusuo, 10-20 parts of rhubarb, 10-20 parts of scutellaria baicalensis, 10-20 parts of trifoliate orange, 3-5 parts of borneol, and 5-10 parts of mint.

[0008] Furthermore, the external Chinese medicine composition is composed of the following raw materials in parts by weight: 25-30 parts of Corydalis yanhusuo, 15-20 parts of rhubarb, 15-20 parts of scutellaria baicalensis, 15-20 parts of trifoliate orange, 3-4 parts of borneol, and 8-10 parts of mint.

[0009] Furthermore, the external Chinese medicine composition is composed of the following raw materials in parts by weight: 25 parts of Corydalis yanhusuo, 15 parts of rhubarb, 15 parts of scutellaria baicalensis, 15 parts of trifoliate orange, 3 parts of borneol, and 8 parts of mint.

[0010] The second aspect of the present invention provides a pain-relieving and temperature-reducing gel patch having the above-mentioned external Chinese medicine composition as an active ingredient.

[0011] Furthermore, the preparation method of the analgesic and cooling gel patch comprises the following steps:

[0012] (A) After the dosage of the Chinese medicine is prepared according to the composition and ratio, the medicinal materials are washed, dried at 40° C., crushed into fine particles and then mixed; the effective components of the mixture are extracted by supercritical carbon dioxide extraction to obtain a mixed extract;

[0013] (B) dispersing sodium acrylate copolymer and lecithin in glycerol to obtain a glycerol dispersion paste, dispersing xanthan gum in 1,2-pentanediol to obtain a 1,2-pentanediol dispersion, and sequentially adding ultrapure water, glycerol dispersion, 1,2-pentanediol dispersion, and erythritol into a main pot, heating to 80°C-85°C, and stirring for 30 minutes to obtain an aqueous phase material; adding polydimethylsiloxane into the main pot, and when the temperature of the main pot rises to 80°C-85°C, After keeping warm and homogenizing for 10 minutes, keep warm and stir for 3-5 minutes, and then cool down; when the temperature in the main pot drops to 60°C-65°C, add p-hydroxyacetophenone into the main pot; when the temperature in the main pot drops to 45°C, add sodium hyaluronate, butanediol, and the mixed extract obtained in step (A) in sequence, shake on a homogenizer for 3-5 minutes to mix, stir for 30 minutes, and then discharge to obtain the analgesic and cooling gel patch (reference patent document CN114377053A).

[0014] Furthermore, the method for extracting the effective components of the mixture by supercritical carbon dioxide extraction as described in step (A) is as follows: setting the pressure of separation kettle I to 6Mpa and the temperature to 40°C, the pressure of separation kettle II to 4Mpa and the temperature to 30°C, the CO2 flow rate is basically stable at about 25kg / h, and the pressure of the extraction kettle is set to 25Mpa; injecting 95% ethanol from the entrainer pump, after stable extraction for 2.5 hours, closing the device valves in turn to stop the extraction; collecting the extracts at separation kettle I and separation kettle II with a clean large beaker at intervals; mixing the extracts, sterilizing and filtering, and then sealing and storing in a cool place.

[0015] The third aspect of the present invention provides a use of the above-mentioned external Chinese medicine composition in the preparation of a medicament for treating subacute thyroiditis.

[0016] A fourth aspect of the present invention provides a use of the analgesic and cooling gel patch as described above in the preparation of a medicament for treating subacute thyroiditis.

[0017] Furthermore, the analgesic and cooling gel patch is used for local application on the thyroid gland, 1-2 times a day, each time for 1 hour.

[0018] The main effects of the Chinese medicine components of the present invention are clearing away heat and relieving pain, detoxifying and dispersing nodules. Among them, Corydalis yanhusuo is the main medicine, which can promote qi and relieve pain, and regulate the liver meridian, while rhubarb and scutellaria baicalensis are the assistant medicines, which can clear away heat, purge fire and detoxify, and Psoralea corylifolia is the assistant medicine, which can clear away heat and detoxify. Dispersing nodules and relieving swelling, borneol and mint are the assistant medicines, which can not only clear away heat and detoxify, but also use their cooling and penetrating properties to enhance the local cooling feeling and increase the transdermal efficiency of the externally applied Chinese medicine.

[0019] The medicinal properties of each raw material drug in the present invention are as follows:

[0020] Corydalis yanhusuo: It is the dried tuber of Corydalis yanhusuo WTWW, a plant of the Poppy family. It is collected in early summer when the stems and leaves wither, the fibrous roots are removed, washed, boiled in boiling water until there is just no white core, taken out, and dried. It enters the liver and spleen meridians. It is pungent, bitter, and warm in nature. It promotes blood circulation, promotes qi, and relieves pain. It is used for chest, flank, abdominal pain, amenorrhea, dysmenorrhea, postpartum blood stasis, and swelling and pain caused by falls. Its analgesic effect is particularly prominent, and it has obvious analgesic effects when taken orally or applied externally.

[0021] Rhubarb: This product is the dried root and rhizome of Rheum palmatum L, Rheumtanguticum Maxim ex Balf. or medicinal rhubarb Rheum officinale Baill. It is dug up in late autumn when the stems and leaves wither or before budding in the next spring, and the fine roots are removed, the outer skin is scraped off, and the petals or segments are cut and strung into strings for drying or directly dried. It enters the spleen, stomach, large intestine, liver, and pericardium meridians. It is bitter and cold in nature. It can clear away heat and clear the intestines, cool blood and detoxify, and remove blood stasis and dredge the menstruation. It is used for constipation due to excess heat, abdominal pain due to accumulation, diarrhea, jaundice due to damp heat, vomiting and bleeding due to blood heat, red eyes, swollen throat, abdominal pain due to intestinal carbuncle, carbuncle furuncle, amenorrhea due to blood stasis, traumatic injury, external treatment of water and fire burns; it is used for fire poison sores.

[0022] Scutellaria baicalensis: This product is conical, twisted, 8-25cm long, 1-3cm in diameter. The surface is brown or dark yellow, with sparse warty fine root marks, the upper part is rough, with twisted longitudinal wrinkles or irregular reticulation, and the lower part has parallel lines and fine wrinkles. It is hard and brittle, easy to break, with yellow cross section and reddish brown in the middle; the center of the old root is rotten or hollow, dark brown or brown-black. It has a slight smell and bitter taste. It enters the lung, gallbladder, spleen, large intestine, and small intestine meridians. It is bitter and cold in nature. It clears heat and dries dampness, purges fire and detoxifies, stops bleeding, and stabilizes the fetus. It is used for damp-heat, summer heat chest tightness and nausea, damp-heat fullness, diarrhea, jaundice, lung heat cough, high fever and thirst, blood heat vomiting and bleeding, carbuncle, sore, and restless fetus.

[0023] Cigu: It is the pseudobulb of orchids such as azalea and garlic orchid. Dig the pseudobulbs in May and June; remove the stems, leaves and fibrous roots, wash and dry them in the sun. It enters the liver and spleen meridians. It is sweet and slightly spicy in nature and cold. It can reduce swelling, disperse nodules, resolve phlegm and detoxify. It can treat carbuncle, furuncle, scrofula, sore throat, snake, insect and rabies bites.

[0024] Borneol: It is divided into two categories: machine-made borneol and moxa flakes. Machine-made borneol is borneol synthesized by chemical methods using turpentine, camphor and other raw materials; moxa flakes are crystals obtained by steam distillation and cooling of fresh leaves of Artemisia argyi, a plant of the genus Artemisia argyi in the Asteraceae family, also known as "moxa powder" or "flakes". The former is used in this component. It can invigorate the mind, clear away heat and relieve pain. It is used for coma and convulsions caused by fever, syncope caused by phlegm, sudden syncope caused by qi stagnation, coma caused by poisoning, red eyes, mouth sores, sore throat, and pus in the ear canal.

[0025] Mint: This product is the dried aerial part of Mentha haplocalyx Briq., a plant of the Lamiaceae family. It is harvested in batches on sunny days in summer and autumn when the stems and leaves are lush or the flowers are in their third round, and then dried in the sun or in the shade. It enters the lung and liver meridians. It is pungent and cool in nature. It dispels wind-heat. It clears the head and eyes and clears rashes. It is used for wind-heat colds, the initial onset of wind-heat, headaches, red eyes, throat paralysis, mouth sores, rubella, measles, and chest and flank distension.

[0026] The present invention has the advantages that:

[0027] 1. The local analgesic and cooling patch suitable for thyroid pain in the acute phase of subacute thyroiditis of the present invention has the effects of local cooling, clearing away heat and detoxifying, reducing swelling and relieving pain. It is used to relieve local swelling, pain and fever of the thyroid gland and has the advantages of safety and few adverse reactions.

[0028] 2. Compared with the cooling gel patch and dressing currently on the market, the present invention is characterized by being specifically used for thyroid patch in the acute stage of subacute thyroiditis. It contains more Chinese medicine ingredients than the cooling gel patch and has a stronger effect in relieving thyroid pain and swelling. Compared with the dressing, the gel component itself produces a cool feeling by evaporating water, which makes the body feel more comfortable, and the gel is sticky and can be fixed on the thyroid area, reducing the discomfort caused by the fixing method itself. DETAILED DESCRIPTION

[0029] The specific implementation methods provided by the present invention are described in detail below in conjunction with examples.

[0030] The experimental methods in the following examples without specifying specific conditions are usually carried out under conventional conditions or under conditions recommended by the manufacturer. The medicinal materials used in the examples of the present invention can be obtained from Chinese medicinal materials sales companies unless otherwise specified.

[0031] Embodiment 1: Chinese medicine composition of the present invention

[0032] 20 parts of Corydalis yanhusuo, 10 parts of rhubarb, 10 parts of scutellaria, 10 parts of scutellaria baicalensis, 3 parts of borneol, and 5 parts of mint.

[0033] Embodiment 2: Chinese medicine composition of the present invention

[0034] 22 parts of Corydalis yanhusuo, 12 parts of rhubarb, 12 parts of scutellaria, 12 parts of scutellaria baicalensis, 4 parts of borneol, and 6 parts of mint.

[0035] Embodiment 3: Chinese medicine composition of the present invention

[0036] 24 parts of Corydalis yanhusuo, 14 parts of rhubarb, 14 parts of scutellaria, 14 parts of scutellaria baicalensis, 5 parts of borneol, and 7 parts of mint.

[0037] Embodiment 4: Chinese medicine composition of the present invention

[0038] 25 parts of Corydalis yanhusuo, 15 parts of rhubarb, 15 parts of baicalin, 15 parts of scutellaria ... baicalensis, 3 parts of borneol, 8 parts of mint.

[0039] Embodiment 5: Chinese medicine composition of the present invention

[0040] 28 parts of Corydalis yanhusuo, 18 parts of rhubarb, 18 parts of scutellaria, 18 parts of scutellaria baicalensis, 4 parts of borneol, and 9 parts of mint.

[0041] Embodiment 6: Chinese medicine composition of the present invention

[0042] 30 parts of Corydalis yanhusuo, 20 parts of rhubarb, 20 parts of scutellaria, 20 parts of scutellaria baicalensis, 5 parts of borneol, and 10 parts of mint.

[0043] Example 7: Preparation and use of the analgesic and cooling gel patch of the present invention

[0044] After the dosage of Chinese medicine is configured according to the composition and ratio, the medicinal materials are washed, dried at 40°C, crushed into fine particles and mixed. The effective components of the mixture are extracted by supercritical carbon dioxide extraction. Set the pressure of separation kettle I to 6Mpa and the temperature to 40°C, the pressure of separation kettle II to 4Mpa and the temperature to 30°C, the CO2 flow rate is basically stable at about 25kg / h, and the pressure of the extraction kettle is set to 25Mpa. Inject 95% ethanol from the entrainer pump, and after stable extraction for 2.5h, close the device valves in turn to stop the extraction. During this period, use a clean large beaker to collect the extracts at separation kettle I and separation kettle II at intervals. Mix the extracts, sterilize and filter, and seal them in a cool place.

[0045] Disperse sodium acrylic acid (ester) copolymer and lecithin in glycerol to obtain glycerol dispersion paste, disperse xanthan gum in 1,2-pentanediol to obtain 1,2-pentanediol dispersion, put ultrapure water, glycerol dispersion, 1,2-pentanediol dispersion and erythritol into the main pot in turn, heat to 80-85°C, keep warm and stir for 30 minutes to obtain aqueous phase material; add polydimethylsiloxane into the main pot, keep warm and homogenize for 10 minutes when the temperature of the main pot rises to 80-85°C, keep warm and stir for 3-5 minutes, and then cool down. When the temperature in the main pot drops to 60-65°C, add parahydroxyacetophenone into the main pot; when the temperature in the main pot drops to 45°C, add sodium hyaluronate, butanediol and the above mixed extract in turn, shake on the homogenizer for 3-5 minutes to mix, stir for 30 minutes to discharge, and obtain the analgesic and cooling gel patch.

[0046] Example 8: Clinical Trial of the Present Invention

[0047] A clinical observation study included 48 people, who were divided into a control group (not used) and an intervention group (used) according to whether they used cooling gel patches. The thyroid pain and relief were evaluated by scoring, and adverse reactions such as allergies and pain visual analog scale (VAS) scores were recorded: a straight line with a length of 10 cm was used, with 0 and 10 points at both ends. The lower the score, the lighter the pain. 0 means no pain, and 10 means completely unbearable severe pain. The patient was asked to mark the point closest to his or her pain. The doctor calculated the score based on the comments marked by the patient. Each group recorded the VAS score on the 1st, 3rd, 5th, 7th, 14th, and 28th day after treatment, and the mean difference between the groups was calculated and compared.

[0048] The basic situation and research results are as follows:

[0049] Table 1 Comparison of basic conditions of each group before treatment

[0050]

[0051] Table 2 Comparison of VAS scores in each group before and after treatment (points, )

[0052]

[0053] Local thyroid pain is the main symptom of subacute thyroiditis. General fatigue, poor appetite and sleep caused by pain further prolong the course of the disease and cause trouble to patients. For this reason, although subacute thyroiditis is a self-limiting disease, pain relief is still an urgent clinical need. This thyroid patch relieves pain and reduces fever. The results show that both the control group and the treatment group of subacute thyroiditis patients visited the doctor on the third day after the onset of the disease. The intervention group significantly reduced the VAS score from the third day, and the advantage compared with the control group lasted until the 28th day of observation. The VAS score was significantly reduced throughout the whole process, indicating that this gel patch has a significant advantage in relieving pain and has a high clinical use value.

[0054] The preferred embodiments of the present invention have been specifically described above, but the present invention is not limited to the embodiments. Those skilled in the art may make various equivalent modifications or substitutions without violating the spirit of the present invention. These equivalent modifications or substitutions are all included in the scope defined by the claims of this application.

Claims

1. A pain-relieving and cooling gel patch for treating subacute thyroiditis, characterized in that: The invention comprises the following raw materials as active ingredients in parts by weight: 20-30 parts of Corydalis yanhusuo, 10-20 parts of rhubarb, 10-20 parts of scutellaria baicalensis, 10-20 parts of sanchigu, 3-5 parts of borneol and 5-10 parts of mint; the preparation method of the pain-relieving and cooling gel patch comprises the following steps: (A) after preparing the dosage of Chinese medicine according to the composition and proportion, washing the medicinal materials, drying at 40°C, crushing them into fine particles and mixing them; extracting the effective ingredients of the mixture by supercritical carbon dioxide extraction to obtain a mixed extract; (B) dispersing sodium acrylate (ester) copolymer and lecithin in glycerol to obtain a glycerol dispersion paste, dispersing xanthan gum in 1,2-pentanediol to obtain a 1,2-pentanediol dispersion liquid, and sequentially adding ultrapure water, glycerol dispersion paste, 1,2-pentanediol dispersion liquid and erythritol into a main pot and heating them to 80°C. 85°C, keep warm and stir for 30 minutes to obtain an aqueous phase material; add polydimethylsiloxane to the main pot, keep warm and homogenize for 10 minutes when the temperature of the main pot rises to 80°C-85°C, keep warm and stir for 3-5 minutes, and then cool down; when the temperature in the main pot drops to 60°C-65°C, add p-hydroxyacetophenone to the main pot; when the temperature in the main pot drops to 45°C, add sodium hyaluronate, butanediol, and the mixed extract obtained in step (A) in sequence, shake on a homogenizer for 3-5 minutes to mix, stir for 30 minutes to discharge, and obtain the analgesic and cooling gel patch.

2. The analgesic and cooling gel patch according to claim 1, characterized in that: The active ingredients are composed of the following raw materials in parts by weight: 25-30 parts of Corydalis yanhusuo, 15-20 parts of rhubarb, 15-20 parts of scutellaria baicalensis, 15-20 parts of scutellaria baicalensis, 3-4 parts of borneol and 8-10 parts of mint.

3. The analgesic and cooling gel patch according to claim 1, characterized in that: The active ingredients are composed of the following raw materials in parts by weight: 25 parts of Corydalis yanhusuo, 15 parts of rhubarb, 15 parts of scutellaria baicalensis, 15 parts of scutellaria baicalensis, 3 parts of borneol and 8 parts of mint.

4. The analgesic and cooling gel patch according to claim 1, characterized in that: The method for extracting the effective components of the mixture by supercritical carbon dioxide extraction method described in step (A) is as follows: setting the pressure of separation kettle I to 6Mpa and the temperature to 40°C, the pressure of separation kettle II to 4Mpa and the temperature to 30°C, the CO2 flow rate is basically stable at about 25kg / h, and the pressure of the extraction kettle is set to 25Mpa; injecting 95% ethanol from the entrainer pump, after stable extraction for 2.5h, closing the device valves in turn to stop extraction; collecting the extracts at separation kettle I and separation kettle II with a clean large beaker at intervals; mixing the extracts, sterilizing and filtering, and then sealing and storing in a cool place.

5. Use of the analgesic and cooling gel patch according to any one of claims 1 to 4 in the preparation of a medicament for treating subacute thyroiditis.

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