Heat-clearing and goiter-eliminating ointment for treating subacute thyroiditis as well as preparation method and application of heat-clearing and goiter-eliminating ointment

Abstract

The invention relates to the technical field of Chinese patent medicines for treating subacute thyroiditis, and discloses a heat-clearing and goiter-eliminating ointment for treating subacute thyroiditis and a preparation method and application thereof.The heat-clearing and goiter-eliminating ointment is prepared from, by weight, 40 parts of raw rhubarb, 40 parts of wine-processed scutellaria baicalensis, 30 parts of wine-processed coptis chinensis, 40 parts of radix ranunculi ternati and 30 parts of perfoliote knotweed herb. , 20 parts of vinegar frankincense, 20 parts of raw radix astragali, and 9 parts of borneol. The traditional Chinese medicine composition has the beneficial effects of effectively and quickly relieving pain symptoms of SAT patients, relieving inflammatory response, relieving goiter enlargement degree and recovering thyroid functions, and the curative effect of the traditional Chinese medicine composition is superior to that of pure non-steroidal anti-inflammatory medicine treatment. The external preparation is exact in curative effect, few in adverse reaction, capable of achieving the effect of treating both symptoms and root causes, convenient to use and beneficial to development and application.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicines for treating subacute thyroiditis, and in particular to a heat-clearing and goiter-eliminating ointment for treating subacute thyroiditis, and a preparation method and application thereof. Background Art

[0002] Subacute thyroiditis (SAT) is a thyroid disease characterized by thyroid pain. It accounts for approximately 5% of clinical thyroid diseases and most commonly occurs in women aged 20 to 50. Its pathogenesis remains unclear, but most studies suggest a link between viral infection, genetic factors, and decreased autoimmunity. The acute phase of SAT is characterized by characteristic pain in the thyroid region, often accompanied by fever, fatigue, and other symptoms of hyperthyroidism, such as heat intolerance, excessive sweating, and irritability.

[0003] Western medicine often uses non-steroidal anti-inflammatory drugs to treat SAT, and some patients with severe pain use glucocorticoids, which can quickly relieve the patient's clinical symptoms, but the risk of recurrence after stopping the drug is high.

[0004] Traditional Chinese Medicine (TCM) treats SAT based on the principles of holistic treatment and syndrome differentiation. It offers significant symptom improvement without adverse reactions, making it a valuable treatment option in recent years. SAT falls under the TCM categories of "goiter" and "goiter pain." The "Clinical Guide to Medical Cases" states: "Irritability and anger can lead to the formation of goiter due to Qi and fire, which can cause pain in the tendons." This condition is believed to be related to the pathogenic factors of heat and fire. We believe that the initial stage of this disease is in the Shaoyang meridian, where the vital organs are not functioning properly. This pathogenic factor can then transform into heat, leading to toxic heat congestion in the front of the neck, causing swelling and pain. Treatment should focus on clearing heat, purging fire, and detoxifying, while reducing swelling and alleviating pain.

[0005] The thyroid gland is the largest endocrine gland in the human body and the organ with the richest blood supply. Thyroid tissue is close to the skin, making it suitable for topical treatments in Traditional Chinese Medicine (TCM). Topical application of Chinese herbal medicine can directly affect the thyroid gland through transdermal absorption, dilating local blood vessels and clearing away heat and toxins, relieving goiter and pain, and dispersing nodules. However, no existing Chinese patent medicines for topical application in the treatment of subacute thyroiditis have been identified. The official website of the State Food and Drug Administration does not contain any currently marketed similar products, nor are there any reports of similar products domestically or internationally.

[0006] In the patent literature, for example, the invention patent with authorization publication number CN112807362B, entitled "A Chinese medicine composition for treating the acute phase of subacute thyroiditis, its preparation method, and use thereof," discloses a Chinese medicine composition for treating subacute thyroiditis. The composition comprises the following raw materials in parts by weight: 15-20 parts of honeysuckle, 10-15 parts of forsythia, 5-9 parts of burdock fruit, 5-9 parts of platycodon, 5-12 parts of schizonepeta, 5-12 parts of selfheal, 5-12 parts of lithospermum, 5-12 parts of schizonepeta, 5-12 parts of schizonepeta, 5-12 parts of white peony root, 5-12 parts of white peony root, and 5-12 parts of corydalis. However, this Chinese medicine composition is for oral administration and enters the blood circulation system through oral administration. It cannot be directly absorbed through the skin to act on the thyroid gland. This Chinese medicine composition may not be suitable for patients who are unconscious, vomiting, or fasting.

[0007] In summary, there is no Chinese patent medicine for external application to treat subacute thyroiditis in the prior art. Summary of the Invention

[0008] In order to overcome the problem that there is no Chinese patent medicine for external application to treat subacute thyroiditis in the prior art, the present invention proposes a heat-clearing and goiter-eliminating ointment for treating subacute thyroiditis, as well as a preparation method and application thereof, which specifically includes the following technical solutions.

[0009] In a first aspect, the present invention proposes a heat-clearing and goiter-eliminating ointment for treating subacute thyroiditis, which is made from the following raw materials in parts by weight: 40 parts of raw rhubarb, 40 parts of wine-soaked scutellaria, 30 parts of wine-soaked coptis, 40 parts of cat's claw, 30 parts of angelica sinensis, 20 parts of vinegar-soaked frankincense, 20 parts of raw astragalus, and 9 parts of borneol.

[0010] Furthermore, the invention further comprises 21 parts of auxiliary materials; the auxiliary materials are composed of vaseline and / or rapeseed oil and / or beeswax.

[0011] Furthermore, the heat-clearing and goiter-eliminating paste is an ointment.

[0012] In a second aspect, the present invention proposes a preparation method of a heat-clearing and goiter-eliminating paste, which is used for the above-mentioned heat-clearing and goiter-eliminating paste, comprising the following steps: S1, taking 40 parts of raw rhubarb, 40 parts of wine-soaked scutellaria, 30 parts of wine-soaked coptis, 40 parts of cat's claw, 30 parts of angelica sinensis, 20 parts of vinegar-soaked frankincense, and 20 parts of raw astragalus, and grinding them into a first fine powder after mixing; taking 9 parts of borneol and grinding them into a second fine powder; S2, grinding the second fine powder with the first fine powder to obtain a third fine powder; S3, taking 21 parts of vaseline, rapeseed oil, and beeswax in total, heating them to 120 degrees Celsius, filtering them, cooling them to 60 degrees Celsius, adding the third fine powder, and stirring them until they are semi-solidified to obtain the heat-clearing and goiter-eliminating paste.

[0013] In a third aspect, the present invention proposes the use of the above-mentioned heat-clearing and anti-ulcer ointment in the preparation of a medicine for treating subacute thyroiditis.

[0014] According to any of the above embodiments, the present invention has at least the following beneficial effects: the heat-clearing and goiter-eliminating ointment proposed by the present invention is an external ointment, which is applied to the surface skin of the neck to reach the pores, dredge the meridians, and regulate qi and blood, thereby playing a therapeutic role on the thyroid gland. Subacute thyroiditis is mostly caused by liver depression and heat toxins. When the liver is out of balance, liver depression and qi stagnation occur, the body fluids and blood do not flow smoothly, phlegm and blood stasis form, and goiter and pain form in the front of the neck. The depression turns into fire for a long time, and the fire toxins accumulate in the front of the neck, causing goiter and pain. The prescription is targeted at the main pathogenesis of subacute thyroiditis and prescribes the right medicine for the right condition. Borneol skin penetration enhancer is specially added to play its role in leading a group of drugs to penetrate the meridians.

[0015] Clinical data also indicate that the Qingre Xiaoying ointment of the present invention can effectively and rapidly relieve pain symptoms in SAT patients, reduce inflammatory reactions, reduce goiter, and restore thyroid function, with efficacy superior to treatment with nonsteroidal anti-inflammatory drugs alone. This topical preparation has a proven efficacy, few adverse reactions, and can address both the underlying cause and the underlying symptoms. It is easy to use and therefore suitable for development and application. DETAILED DESCRIPTION

[0016] To make the objectives, technical solutions, and advantages of the present invention more clear, the following will be combined with the tables in the present invention to clearly and completely describe the technical solutions in the present invention. Obviously, the embodiments described are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0017] The earliest record of external application of medicinal herbs for goiter can be found in the Yellow Emperor's Classic of Internal Medicine. Ge Hong's "Emergency Prescriptions for the Elbow" first mentioned the use of seaweed wine for external application to treat goiters. Ancient texts document the use of Prunella vulgaris combined with potatoes applied to the neck for goiter treatment. The Ming and Qing dynasties further enriched the application methods for goiter. Chen Shiduo of the Qing Dynasty believed that goiter was caused by damp heat. In his "Shuizhifa Lun" (Stone Chamber Secret Records), he describes grinding mercury, catechu, borneol, borax, musk, phellodendron, and dragon's blood into a fine powder and rubbing it onto the base of the goiter, causing it to fall off as it was rubbed.

[0018] The TCM theory behind the topical application of Chinese medicine to treat goiter encompasses both local and systemic effects. First, local effects: Based on the specific etiology, herbs with varying efficacy are selected and formulated into pastes or ointments, which are applied externally to the skin on the neck to reach the pores and skin, unblock the meridians, and regulate qi and blood, thereby therapeutically targeting the thyroid gland. To enhance penetration through the skin, skin penetration enhancers such as borneol, azone, peppermint oil, and cinnamon bark are added to the formula to promote drug penetration through the meridians. This dosage form accelerates drug absorption across the skin barrier and into the bloodstream, enhancing its efficacy. Second, systemic effects: Topical application of Chinese medicine has a bidirectional regulatory effect on the body's meridian system, blood system, immune system, and neuroendocrine system. There are two mechanisms of action: 1. Qi-carrying medicine: Wei Qi not only circulates on the body's surface but also disperses through the chest and abdomen, entering the internal organs. When applied externally, medicine penetrates the skin and reaches the pores, distributing itself externally to the skin and internally to the internal organs. Once the medicine enters the skin, it travels through the sun vessels and collateral vessels to the meridians, where it then circulates through Qi and blood to the internal organs and spreads throughout the body. 2. Acupoint-organ connection: When Chinese medicine is applied externally to the corresponding meridians and acupoints on the neck, not only is the medicine's scent distributed throughout the body through the meridians, but it also achieves a systemic therapeutic effect through the connection between the meridians and acupoints and the internal organs.

[0019] The Qingre Xiaoying Paste formula is based on the principle of "clearing heat and expelling toxins." It is adapted from the Sanhuang Xiexin Decoction in the "Golden Chamber Synopsis." Targeting the pathogenesis of goiter pain caused by intense heat and toxicity, the paste uses raw rhubarb, wine-infused scutellaria, and wine-infused coptis as the main ingredients, clearing heat, purging fire, and detoxifying. It is supplemented with cat's claw and angelica root as the auxiliary ingredients. Cat's claw detoxifies, dissipates nodules, and resolves phlegm and swelling. It is primarily used for conditions such as carbuncles, scrofula, and snake and insect bites. Angelica root clears heat, detoxifies, and promotes diuresis and swelling. Raw astragalus root nourishes and expells toxins, while vinegar-infused frankincense promotes qi circulation, activates blood circulation, and relieves pain. Borneol is the guiding ingredient. Borneol, with a bitter and slightly cold nature, clears heat and reduces swelling when applied topically, and also promotes transdermal absorption.

[0020] The present invention provides a heat-clearing and goiter-eliminating ointment for treating subacute thyroiditis. The ointment is prepared from the following raw materials in parts by weight: 40 parts of raw rhubarb, 40 parts of wine-soaked scutellaria, 30 parts of wine-soaked coptis root, 40 parts of cat's claw, 30 parts of radix scutellariae, 20 parts of vinegar-soaked frankincense, 20 parts of raw astragalus, and 9 parts of borneol. The heat-clearing and goiter-eliminating ointment also contains appropriate amounts of vaseline, rapeseed oil, and beeswax as auxiliary ingredients.

[0021] A method for preparing a heat-clearing and goiter-eliminating paste for treating subacute thyroiditis comprises: taking 40g of raw rhubarb, 40g of wine-soaked scutellaria, 30g of wine-soaked coptis root, 40g of cat's claw, 30g of scutellaria root, 20g of vinegar-soaked frankincense, and 20g of raw astragalus, and grinding the above seven herbs into a first fine powder; grinding 9g of borneol into a second fine powder, and mixing the powder with the first fine powder; heating 21g of vaseline, sesame oil, and beeswax to 120°C, filtering, and cooling to about 60°C, adding the fine powder, and mixing until semi-solidified to prepare about 250g of the heat-clearing and goiter-eliminating paste.

[0022] The heat-clearing and goiter-eliminating paste of the present invention is used to clear away heat, purge fire, detoxify, reduce swelling and relieve pain. It is suitable for external application treatment of goiter (subacute thyroiditis), a syndrome characterized by intense heat and toxicity. Symptoms include pain in the front of the neck radiating to the submandibular area and ears, irritability, sore throat, and even fever; a red tongue with a thick yellow coating and a wiry pulse.

[0023] The clinical use of the heat-clearing and goiter-eliminating paste of the present invention is as follows:

[0024] Sixty patients with SAT of the toxic heat type who visited our hospital's endocrinology department were randomly divided into a control group (dexamethasone group) and a treatment group (Qingre Xiaoying ointment) with 30 patients in each group. The control group included 3 males and 27 females with a mean age of (45.67±9.59) years. The treatment group included 4 males and 26 females with a mean age of (47.1±10.67) years. No statistically significant differences in general information were found between the two groups (P>0.05), indicating comparability.

[0025] The Western medical diagnostic criteria for subacute thyroiditis refer to the 10th edition of the textbook "Internal Medicine" for higher medical schools, published by the People's Medical Publishing House. The diagnosis is based on: ① Systemic symptoms of acute inflammation; ② Mild to moderate thyroid enlargement, moderate firmness, and significant tenderness; ③ Typical laboratory findings include thyrotoxicosis, hypothyroidism, and recovery.

[0026] The Traditional Chinese Medicine (TCM) diagnostic criteria for subacute thyroiditis are based on the criteria for goiter pain due to excessive heat and toxicity in the "Guiding Principles for Clinical Research of New Traditional Chinese Medicines." Primary symptoms include swelling and tenderness in the anterior neck, with a sense of pressure and radiating pain, accompanied by fever. Secondary symptoms include dry mouth, fatigue, hoarseness, palpitations, sweating, irritability, sore throat, headache, and palpitations. Tongue and pulse: Red tongue with a thin yellow coating and a rapid and floating pulse.

[0027] Inclusion criteria included: (1) meeting the Western medical diagnostic criteria for subacute thyroiditis; (2) meeting the Traditional Chinese Medicine diagnostic criteria for goiter, and at the same time being diagnosed as having a syndrome of heat and toxicity; (3) aged 18 to 60 years, regardless of gender; (4) abiding by the treatment plan of this study and agreeing to undergo relevant laboratory tests; (5) volunteering to be a subject and providing informed consent.

[0028] Exclusion criteria included: (1) patients who did not meet the diagnostic criteria of Western medicine and the criteria of traditional Chinese medicine; (2) patients who could not tolerate nonsteroidal anti-inflammatory drugs or traditional Chinese medicine; (3) patients with a recent history of major surgery or severe infection; (4) patients with serious underlying diseases such as cardiovascular and cerebrovascular diseases, digestive system diseases, and severe liver and kidney dysfunction; and (5) patients who could not cooperate with the treatment plan (refusing traditional Chinese medicine treatment or refusing to complete relevant examinations).

[0029] Exclusion criteria include: (1) patients who did not meet the inclusion criteria but met the exclusion criteria; (2) patients who did not use the medication according to the treatment plan and whose efficacy could not be judged; (3) patients who were participating in clinical studies of other drugs; (4) patients who developed severe cardiovascular and cerebrovascular diseases during treatment; (5) patients who refused to continue the trial, automatically withdrew, or were lost to follow-up.

[0030] Treatment plan: (1) Control group: Diclofenac sodium double-release enteric-coated capsules (trade name: Difen, manufacturer: Temmler Werke GmbH, approval number: Import Drug Registration Certificate No. H20100590, specification: 75mg*10 capsules / box): 75mg / time, once a day, oral, 2 weeks of treatment. (2) Qingre Xiaoying Ointment group: Qingre Xiaoying Ointment 20g was added to the control group and applied externally once a day for 4-6 hours each time, 2 weeks of treatment.

[0031] The clinical efficacy evaluation is as follows:

[0032] (1) Evaluation criteria

[0033] (1) Clinical recovery: Symptoms and signs disappear, serum FT3, FT4, TSH, and erythrocyte sedimentation rate return to normal.

[0034] (2) Significantly effective: Symptoms and signs are significantly relieved, goiter and pain basically disappear, and serum FT3, FT4, TSH and erythrocyte sedimentation rate basically return to normal.

[0035] (3) Effective: Symptoms and signs were significantly relieved, goiter and pain were alleviated, and serum FT3, FT4, TSH and erythrocyte sedimentation rate improved.

[0036] (4) Ineffective: Symptoms and signs did not improve, goiter and pain did not ease, serum FT3 and FT4 remained elevated or fluctuated, TSH remained decreased, and erythrocyte sedimentation rate remained elevated.

[0037] (2) Main clinical symptoms (see the attached table) Efficacy evaluation: After the treatment course, the efficacy is judged by the reduction rate.

[0038] Score reduction rate = [(score before treatment - score after treatment) ÷ score before treatment] × 100%.

[0039] (3) Evaluation method

[0040] 1. Clinically cured: TCM clinical symptoms and signs disappear or almost disappear, and syndrome score decreases by ≥90%;

[0041] 2. Markedly effective: Clinical symptoms and signs of TCM are significantly improved, and the syndrome reduction rate is ≥70%.

[0042] 3. Effective: Clinical symptoms and signs of TCM are improved, and the syndrome reduction rate is ≥30%;

[0043] 4. Ineffective: No improvement in TCM clinical symptoms and signs, and a symptom reduction rate of less than 30% is considered ineffective.

[0044] (IV) Follow-up (8 weeks later) efficacy

[0045] 1. Good control: symptoms and signs disappear, serum FT3, FT4, TSH are normal, and erythrocyte sedimentation rate is basically normal (lower than or equal to the end of treatment).

[0046] 2. Relapse: Symptoms and signs reappear, and serum FT3, FT4, TSH, and erythrocyte sedimentation rate return to pre-treatment levels.

[0047]

[0048] Table 1

[0049] Group Clinical recovery Significantly effective efficient invalid Total effective rate / % Treatment group 2 14 12 2 93.3％* control group 0 12 10 8 73.33％

[0050] Table 2

[0051] Group time Total points Neck swelling Neck pain palpation fever fatigue Treatment group Before treatment 19.53±2.91 4.20±1.32 3.80±1.21 4.00±1.49 3.33±1.21 4.20±1.10 After treatment <![CDATA[8.87±4.35 *# ]]> <![CDATA[2.20±1.52 *# ]]> <![CDATA[1.80±1.52 *# ]]> <![CDATA[1.27±1.23 *# ]]> <![CDATA[1.67±1.58 *# ]]> <![CDATA[1.93±1.34 *# ]]> control group Before treatment 19.47±2.92 4.27±1.26 4.00±1.49 3.87±1.28 3.27±1.11 4.07±1.34 After treatment 16.13±4.71 3.93±1.24 <![CDATA[1.87±1.49 * ]]> 3.65±1.23 <![CDATA[1.80±1.55 * ]]> 3.93±1.53

[0052] Table 3

[0053]

[0054]

[0055] Table 4

[0056] Table 1 is the quantitative scoring table of the main clinical symptoms; Table 2 is the comparison of clinical efficacy of subacute thyroiditis in the two groups (n=60) Table 3 is the comparison of TCM syndrome scores before and after treatment in the two groups of patients ( n=60); Table 4 is the comparison of thyroid-related indicators before and after treatment in the two groups of patients ( n=60). Note: Intra-group comparison, *P<0.05; inter-group comparison, △P<0.05.

[0057] As shown in the table above, Qingre Xiaoying Paste effectively and rapidly relieves pain symptoms, reduces inflammation, reduces goiter, and restores thyroid function in SAT patients, with efficacy superior to treatment with nonsteroidal anti-inflammatory drugs alone. This topical preparation offers proven efficacy, few adverse reactions, and addresses both the underlying cause and symptoms of SAT. It is also convenient to use and is well-suited for development and application.

[0058] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the various embodiments of the present invention.

Claims

1. A heat-clearing and goiter-eliminating ointment for treating subacute thyroiditis, characterized in that: The invention is prepared from the following raw materials in parts by weight: 40 parts of raw rhubarb, 40 parts of wine-soaked scutellaria, 30 parts of wine-soaked coptis, 40 parts of cat's claw, 30 parts of angelica sinensis, 20 parts of vinegar-soaked frankincense, 20 parts of raw astragalus and 9 parts of borneol.

2. The heat-clearing and anti-ulcer ointment for treating subacute thyroiditis according to claim 1, characterized in that: The invention also comprises 21 parts of auxiliary materials; the auxiliary materials are composed of vaseline and / or rapeseed oil and / or beeswax.

3. The heat-clearing and anti-ulcer ointment for treating subacute thyroiditis according to claim 1, characterized in that: The heat-clearing and goiter-eliminating paste is an ointment.

4. A method for preparing a heat-clearing and heat-eliminating goiter paste, characterized in that: The preparation of the heat-clearing and goiter-eliminating ointment according to any one of claims 1 to 3 comprises the following steps: S1, take 40 parts of raw rhubarb, 40 parts of wine-soaked scutellaria, 30 parts of wine-soaked coptis, 40 parts of cat's claw, 30 parts of scutellaria baicalensis, 20 parts of vinegar-soaked frankincense, and 20 parts of raw astragalus, mix and grind into a first fine powder; take 9 parts of borneol and grind into a second fine powder; S2, grinding the second fine powder with the first fine powder to obtain a third fine powder; S3. Take 21 parts of vaseline, vegetable oil and beeswax in total, heat to 120 degrees Celsius, filter, cool to 60 degrees Celsius, add the third fine powder, and stir until semi-solidified to obtain the heat-clearing and goiter-eliminating ointment.

5. Use of the Qingre Xiaoying ointment according to any one of claims 1 to 3 in preparing a medicament for treating subacute thyroiditis.

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