A Chinese medicine composition for external use for treating breast ulcers caused by negative and semi-negative and semi-positive syndromes, and its preparation method and application

Abstract

The invention discloses an external Chinese medicine composition for treating breast Yin syndrome and semi-Yin and semi-Yang syndrome swelling and ulcer, and a preparation method and application thereof. The Chinese medicine composition provided by the invention comprises 9 warming drugs and 3 cold drugs, taking both cold and warm into consideration with warming as the main effect. The whole prescription does not contain pure tonic drugs or pure purgative drugs, and the effects of warming, dispersing cold stagnation, and activating blood circulation are achieved. The external Chinese medicine ointment prepared by the Chinese medicine composition of the invention has clear clinical efficacy in treating breast Yin syndrome and semi-Yin and semi-Yang syndrome swelling and ulcer, has no obvious toxic and side effects, no traumatic damage, low recurrence rate, and good patient compliance, and is worthy of vigorous promotion and application in clinical practice.

Description

Technical Field

[0001] The invention relates to the technical field of ointments, and in particular to an external Chinese medicine composition for treating breast ulcers caused by negative and semi-negative and semi-positive syndromes, and a preparation method and application thereof. Background Art

[0002] Breast Yin syndrome and semi-yin and semi-yang syndrome swelling and ulcer are one of the lumps. They are difficult to disappear, difficult to decay, difficult to ulcerate, and difficult to form pus. The course of the disease is slow. It is a benign and difficult to treat breast disease. The cause of the disease is complex, and conventional antibiotic treatment is ineffective. Although hormone treatment is effective, there are side effects related to long-term use of glucocorticoids. The recurrence rate of simple surgical treatment is high, and the inflammatory mass is prone to form abscesses and repeatedly rupture to form sinuses, fistulas or ulcers, which can cause serious complications such as breast damage to patients, affect the quality of life of patients, and cause harm to the physical and mental health of women.

[0003] In contrast, TCM has certain therapeutic advantages. In TCM, the pathogenesis of this disease is mostly stagnation of liver qi, which causes phlegm to condense into lumps. On this basis, as the course of the disease prolongs, the body qi is insufficient, or cold medicines are taken excessively, which causes yang deficiency and cold blood stasis, and eventually forms breast Yin syndrome and half Yin and half Yang syndrome swelling and ulcers. The treatment principle of TCM for non-Yang syndrome swelling and ulcers is mainly to warm the Yang, disperse the knots and activate the blood circulation. At present, most of the clinical treatments for this type of swelling and ulcers are TCM internal treatments. However, similarly, some of the warming Yang drugs involved in oral Chinese medicine, such as Aconitum kusnezoffii and Aconite, are toxic drugs, and blood circulation drugs such as frankincense and myrrh are irritating to the gastrointestinal tract, and they should not be taken for a long time; while TCM external treatments such as plaster therapy and acupuncture are highly safe, have strong local targeting, and are easier to operate for patients.

[0004] Yanghe Jie Ning Gao was first seen in Wang Weide's "Surgical Symptoms and Treatments Complete Collection", which says: "This prescription treats all kinds of Yin carbuncle, ulcers, and frostbite. Those who have not ulcerated will be completely healed overnight; those who have ulcerated will be cured in three patches. Malaria can be cured immediately by applying it on the back." This ointment contains a variety of medicinal materials such as burdock, radix sutchuenensis, aconite, and cinnamon twigs. It has the functions of warming and unblocking meridians, reducing lumps, and dredging qi and blood. It is suitable for Yin carbuncle that has not yet broken out, scrofula that has not broken out, and joint pain caused by cold and dampness due to insufficient yang qi and stagnation of cold and dampness. However, Yanghe Jie Ning Gao contains 27 herbs such as Chuanfu, cinnamon twigs, angelica, and cinnamon. It has a complex composition and contains many poisonous medicinal materials such as Chuanwu, aconite, aconite, and yellow ochre, as well as national protected medicinal materials such as musk. In addition, Yanghe Jie Ning Gao is an ancient prescription hard ointment. When using it, the ointment needs to be spread on the plaster and then heated for external application, which is a cumbersome step. Summary of the invention

[0005] The invention aims to provide an external Chinese medicine composition for treating breast Yin syndrome and semi-Yin and semi-Yang syndrome swelling and ulcer, and a preparation method and application thereof. The invention provides a Chinese medicine ointment prepared from the Chinese medicine composition for treating breast Yin syndrome and semi-Yin and semi-Yang syndrome swelling and ulcer, which has the effects of warming yang and dispersing nodules, relieving stagnation and unblocking meridians, high cure rate, no recurrence, and no toxic side effects. At the same time, it has low cost, high safety, and is easy to use, thus solving the problems of high cost, complicated use steps, and side effects of existing external plasters.

[0006] The technical solution adopted by the present invention is:

[0007] The invention provides an external Chinese medicinal composition for treating breast ulcers caused by negative syndrome and semi-negative and semi-positive syndrome. The external Chinese medicinal composition is prepared from the following raw materials in parts by weight: 30-60 parts of cinnamon bark, 30-60 parts of processed aconite, 30-60 parts of cassia twig, 30-60 parts of red peony root, 30-60 parts of angelica dahurica, 30-60 parts of frankincense, 30-60 parts of myrrh, 30-60 parts of corydalis, 15-30 parts of white mustard seeds, 15-30 parts of dried ginger, 5-10 parts of borneol and 30-400 parts of raw rhubarb powder.

[0008] Furthermore, the external Chinese medicine composition is preferably made of the following raw materials in parts by weight: 30 parts of cinnamon, 30 parts of processed aconite, 30 parts of cassia twig, 30 parts of red peony root, 30 parts of angelica dahurica, 30 parts of frankincense, 30 parts of myrrh, 30 parts of Corydalis yanhusuo, 15 parts of white mustard seeds, 15 parts of dried ginger, 5 parts of borneol, and 60 parts of raw rhubarb powder.

[0009] Furthermore, the external Chinese medicine composition is preferably made of the following raw materials in parts by weight: 30 parts of cinnamon, 30 parts of processed aconite, 30 parts of cassia twig, 30 parts of red peony root, 30 parts of angelica dahurica, 30 parts of frankincense, 30 parts of myrrh, 30 parts of Corydalis yanhusuo, 15 parts of white mustard seeds, 15 parts of dried ginger, 5 parts of borneol, and 400 parts of raw rhubarb powder.

[0010] Furthermore, the external Chinese medicine composition is preferably made of the following raw materials in parts by weight: 30 parts of cinnamon, 30 parts of processed aconite, 30 parts of cassia twig, 30 parts of red peony root, 30 parts of angelica dahurica, 30 parts of frankincense, 30 parts of myrrh, 30 parts of Corydalis yanhusuo, 15 parts of white mustard seeds, 15 parts of dried ginger, 5 parts of borneol, and 30 parts of raw rhubarb powder.

[0011] The present invention also provides a method for preparing the external Chinese medicine composition, which is carried out according to the following steps:

[0012] (1) Soaking the raw materials except borneol and raw rhubarb powder in sesame oil at room temperature for 3-7 days according to the formula amount to obtain a drug-oil mixture;

[0013] (2) frying the drug-oil mixture in step (1) until it turns dark brown, filtering, and collecting the filtrate;

[0014] (3) adding beeswax to the filtrate of step (2), heating to melt, filtering, and collecting the filtrate;

[0015] (4) When the filtrate of step (3) is cooled to 100°C, add the formulated amount of borneol, stir and cool to 50°C, then add the formulated amount of raw rhubarb powder, stir evenly, let stand in a cool place, and cool into a paste.

[0016] Furthermore, the mass ratio of the total amount of the raw material drug in the step (1) to the sesame oil is 1:(3-12), preferably 1:(3-6). The soaking time is preferably 5 days.

[0017] Furthermore, the temperatures of step (2) frying and step (3) melting are both 220-240° C., and a stainless steel pot or a copper pot is used.

[0018] Furthermore, the filtration in step (1) and step (2) is performed using a 100-mesh sieve.

[0019] Furthermore, in step (3), the mass ratio of the total amount of the raw material drug to the beeswax is 1:(1-6), preferably 1:(1-2).

[0020] The present invention also provides an application of the external Chinese medicine composition in preparing an external Chinese medicine ointment for treating breast ulcers caused by negative breast syndrome and semi-negative and semi-positive breast syndrome.

[0021] The external Chinese medicine composition of the present invention complies with the compatibility principle of "monarch, minister, assistant and envoy". The monarch medicine of the formula is cinnamon bark and processed aconite, cassia twig, dried ginger and white mustard seed are ministers and auxiliary monarch medicines, and red peony root, corydalis yanhusuo and raw rhubarb are adjuvant medicines.

[0022] Cinnamon bark is pungent, dispersing, warming and unblocking. It is good at warming and unblocking blood vessels, promoting blood circulation and dispersing stasis. The "Compendium of Materia Medica" calls it "a medicine for treating chronic cold and coldness". The processed Radix Aconiti Kusnezoffii is pungent, dispersing, warming and unblocking. It is good at dissolving cold poison of yin sores. External use can warm the meridians and activate blood circulation, assist yang and retreat yin, and reduce swelling and ulceration, remove rot and astringe sores. It is used to treat cold and damp yin sores. It is suitable for those with hard swelling but not ulceration or stubborn rot after ulceration. The two are combined as the main medicine to warm and dispel cold stagnation. Cinnamon twig and dried ginger warm the meridians, dispel cold and relieve pain, while white mustard is pungent, dispersing and moving, warming and dispersing cold stagnation, and is also a good medicine for treating yin sores with diffuse swelling. In addition, Zhu Danxi of the Yuan Dynasty said: "Phlegm under the ribs and outside the skin and membrane cannot be reached without white mustard", which also shows that the strong permeability of white mustard can promote the absorption of drugs in the skin. Among the adjuvants, red peony root, corydalis yanhusuo, and raw rhubarb can invigorate blood circulation and relieve stagnation, remove blood stasis and promote menstruation. Frankincense and myrrh can invigorate blood circulation, while frankincense and myrrh can disperse blood. They are often used together to relieve pain, reduce swelling and promote tissue regeneration. In addition, some studies have mentioned that the combination of white mustard with pungent and warm drugs such as asarum and corydalis yanhusuo, combined with toxic Chinese medicines such as gansui and arisaema, can further enhance epidermal absorption, and the ratio is often 1:1. The addition of a small amount of borneol, in addition to transdermal absorption and relieving drug irritation, also has the meaning of counter-assistance with the pungent, cool, bitter and cold nature of red peony root and rhubarb, preventing the other drugs from being too warm and affecting the prognosis of the disease. Finally, Angelica dahurica is used as the adjuvant. Later doctors believed that women's nipples belong to the liver and breasts belong to the stomach. Angelica dahurica, as a meridian-guiding drug for the Yangming stomach meridian, can lead all drugs directly to the diseased area. Modern pharmacology shows that the main component of cinnamon bark is cinnamaldehyde, which has multiple pharmacological effects such as anti-tumor, anti-bacterial, anti-inflammatory, antioxidant, and anti-tyrosinase; many drugs such as cinnamon twig, dried ginger, angelica dahurica, and red peony root also have analgesic, antibacterial, and anti-inflammatory effects; white mustard can play a benign regulatory role in immunity and inflammation by regulating neurotransmitters and signal pathways; studies have shown that rhubarb also has a significant effect in inhibiting inflammation, that is, the catechin in rhubarb inhibits the activity of hyaluronidase in the body, thereby protecting the body's hyaluronidase and achieving anti-inflammatory and analgesic effects; frankincense and myrrh as The classic Chinese medicine pair for promoting blood circulation, removing blood stasis and relieving pain in clinical practice has the key anti-inflammatory active sites being the total triterpene acid site of frankincense and the sesquiterpene site of myrrh. Related studies have shown that the active molecules of frankincense and myrrh, 3-carbonyl-gansui-8,24-diene-21-carboxylic acid (KTDA) and 2-methoxy-5-acetyl-furangemarane-1(10)-ene-6-one (FSA), may participate in biological processes and signal pathways such as immune regulation, defense response, inflammatory response, and interleukin signal transduction, participate in the regulation of inflammation in the body, and exert anti-inflammatory and analgesic effects.

[0023] Compared with the prior art, the beneficial effects of the present invention are mainly reflected in:

[0024] 1. The Chinese medicine composition provided by the present invention comprises 9 warming medicines and 3 cold medicines, taking both cold and warm properties into consideration with warming being the main property. The whole formula does not contain any purely tonic medicine or any purely laxative medicine, and the two medicines can achieve the effects of warming, dispersing cold stagnation, and activating blood circulation.

[0025] 2. The external Chinese medicine ointment prepared by the Chinese medicine composition of the present invention has a clear clinical efficacy in treating breast Yin syndrome and semi-Yin and semi-Yang syndrome swelling and ulcers, has no obvious toxic and side effects, no traumatic damage, low recurrence rate, and good patient compliance, and is worthy of vigorous promotion and application in clinical practice. BRIEF DESCRIPTION OF THE DRAWINGS

[0026] Figure 1 , Comparative Example 1: Lump area change curve between Plaster A and the control group.

[0027] Figure 2 , Example 6 B-ultrasound of the inflamed area at 9-10 o'clock of the left breast before treatment.

[0028] Figure 3 Example 6: B-ultrasound of the inflamed area at 9-10 o'clock on the patient's left breast before pus drainage 2 weeks after treatment.

[0029] Figure 4 Example 6: After 2 weeks of treatment, 20 ml of pus was aspirated and an ultrasound was performed on the inflamed area at 9-10 o'clock on the patient's left breast.

[0030] Figure 5 Example 6: B-ultrasound of the inflammation area deep in the left nipple of the patient after more than 2 months of treatment.

[0031] Figure 6 Example 6: B-ultrasound of the severe area at 12 o'clock of the patient's left breast after more than 2 months of treatment. DETAILED DESCRIPTION

[0032] The present invention is further described below in conjunction with specific examples, but the protection scope of the present invention is not limited thereto: The clinical trial subjects of the present invention meet the requirements of informed consent and ethics. The room temperature of the present invention is 25-30°C.

[0033] The present invention first obtains the basic drug composition of the ointment with reference to Yanghe Jie Ning ointment, and adopts a conventional vaseline method to prepare ointment A in order to save costs, which has a certain therapeutic effect compared with the control. In order to improve the therapeutic effect, the components of ointment A are further adjusted and the preparation method is adjusted with reference to Yanghe Jie Ning ointment, and ointment B, ointment C, and ointment D are obtained, and clinical trials are carried out to verify, and finally ointment C with the best therapeutic effect is obtained, followed by ointment B and ointment D with the second best therapeutic effect.

[0034] Comparative Example 1, Clinical Trial 1

[0035] 1. External use Chinese medicine ointment A

[0036] 1. Formulation

[0037] The invention discloses an external Chinese medicine ointment for treating breast ulcer caused by negative syndrome and semi-negative and semi-positive syndrome, which is prepared from the following raw materials in parts by weight: 30 parts of cinnamon bark, 30 parts of processed aconite, 30 parts of cassia twig, 30 parts of red peony root, 30 parts of angelica dahurica, 30 parts of frankincense, 30 parts of myrrh, 30 parts of corydalis, 15 parts of white mustard seeds, 15 parts of dried ginger, 5 parts of borneol and 25 parts of raw rhubarb powder.

[0038] 2. Preparation method of Chinese medicine ointment:

[0039] (1) According to the formula, grind 30g of cinnamon bark, 30g of processed aconite root, 30g of cassia twig, 30g of red peony root, 30g of angelica root, 30g of frankincense, 30g of myrrh, 30g of corydalis, 15g of white mustard seed, 15g of dried ginger, and 5g of borneol into powder, filter through a 120-mesh sieve; mix with 25g of raw rhubarb powder and place in a medicine jar for later use;

[0040] (2) Take 1000g of yellow vaseline and heat it in a pot until it is half boiling at 110℃ for 5 minutes;

[0041] (3) Pour the melted vaseline in step (2) into the medicine jar containing the mixed medicine powder in step (1) and stir to make a paste; place in a cool place and let it stand to cool into a paste, which is recorded as external Chinese medicine ointment A.

[0042] 2. Clinical Trials 1

[0043] 1. General information: From February to May 2024, 24 patients diagnosed with chronic mastitis who visited our outpatient clinic were randomly divided into an experimental group and a control group, with 12 patients in each group.

[0044] 2. Diagnosis: Referring to the key points of Yin-Yang syndrome differentiation in Traditional Chinese Medicine Surgery, the TCM differentiation of the affected area lump is Yin syndrome or half Yin and half Yang syndrome.

[0045] (1) Yin syndrome: The disease develops slowly, the skin is dark purple or pale, the skin temperature is cool, the swelling is flat and sunken, the swelling is not limited, the heels and feet are scattered, there is no pain, or there is numbness, the disease course is long, and the prognosis is poor.

[0046] (2) Half Yin and Half Yang: The skin color is slightly red or unchanged, the skin temperature is slightly hot or not hot, the swelling is slightly swollen or not swollen, the swelling range is between Yin syndrome and Yang syndrome, and the patient feels slight pain. The prognosis is related to whether the disease is treated properly.

[0047] 3. Treatment content:

[0048] Chinese medicine ointment A, usage: prepare a piece of clean and breathable gauze, first apply the external Chinese medicine ointment A prepared by the above method evenly on the gauze, the thickness is about the thickness of a coin, the size depends on the size of the lump, then apply the gauze upside down on the lump in the affected breast, pay attention to avoid the nipple and ulcerated area, remove it after 6-8 hours of external application, clean the skin, and use once a day.

[0049] Basic formula of Chinese herbal decoction: 12g of Rehmannia root, 12g of ginger charcoal, 30g of Gleditsia sinensis, 12g of stir-fried mustard seeds, 15g of antler slices, 6g of honey ephedra, and 6g of roasted licorice. Add or subtract according to symptoms.

[0050] Usage: Decoction in water, one dose per day, divided into morning and evening.

[0051] 4. Grouping:

[0052] Experimental group: oral administration of Chinese medicine + external application of ointment A

[0053] Control group: oral administration of Chinese medicine

[0054] The observation was conducted for 4 cycles (i.e. 2 months), with one cycle being 2 weeks.

[0055] 5. Efficacy evaluation:

[0056] According to the "Standards for Diagnosis and Efficacy of TCM Diseases" issued by the State Administration of Traditional Chinese Medicine, a comprehensive efficacy evaluation will be conducted after the observation period (after 2 months) and divided into cured, markedly effective, effective, and ineffective. The criteria are as follows:

[0057] a. Cured: The efficacy index is ≥90%, the breast lump disappears, the low echo area basically disappears, and there is no residual lesion.

[0058] b. Significantly effective: 70% ≤ efficacy index < 90%, breast lumps are significantly reduced, but the local texture is still tough, and the low-echo area is significantly reduced.

[0059] c. Effective: 30%≤efficacy index<70%, breast lumps or hypoechoic areas are slightly reduced.

[0060] d. Ineffective: The efficacy index is less than 30%, there is no significant change in the size of the breast lump or the hypoechoic area, and the scope of the lesion may even expand.

[0061] Efficacy index = (the longest diameter of the tumor before treatment × the widest diameter - the longest diameter × the widest diameter after treatment) / the initial longest diameter × the widest diameter × 100%.

[0062] Total effective rate = (cured + markedly effective + effective) / total number of cases × 100%.

[0063] Table 1 Comparison of efficacy between the two groups

[0064]

[0065] Table 2 Evaluation of tumor size between the two groups (manual measurement) (cm 2 )

[0066]

[0067] 6. Results

[0068] According to 2 months of observation, the experimental group used ointment A combined with traditional Chinese medicine to treat local lumps in patients with non-lactational mastitis, which could reduce the lumps, with a total effective rate of 83.3% (see Table 1). Although there was no statistical difference compared with the control group (oral Chinese medicine), from the overall treatment situation, the size of the lumps after treatment with ointment A showed a continuous downward trend, while the size of the lumps in the control group rebounded significantly in the 4th week (see Table 2). Similarly, the results also showed that 4 out of 12 people in the experimental group (oral Chinese medicine + external application of ointment A) had obvious changes from Yin syndrome to Yang syndrome, and corresponding measures such as breast aspiration were taken. The average conversion time was about 21 days, while only 1 person in the control group (oral Chinese medicine) had suppuration, and it took as long as 49 days. It can be seen that the experimental group has a good effect on the conversion of the stiff mass stage of non-lactational mastitis and shortening the course of the disease. The change curve of the size of the lumps of Ointment A and the control group is shown in Figure 1 .

[0069] Example 1: External Chinese medicine ointment C and its preparation

[0070] 1. Formulation

[0071] The external Chinese medicine ointment for treating breast negative syndrome and semi-negative and semi-positive syndrome swelling and ulcer is prepared from the following raw materials in parts by weight: 30 parts of cinnamon bark, 30 parts of processed aconite, 30 parts of cassia twig, 30 parts of red peony root, 30 parts of angelica dahurica, 30 parts of frankincense, 30 parts of myrrh, 30 parts of Corydalis yanhusuo, 15 parts of white mustard seeds, 15 parts of dried ginger, 5 parts of borneol, and 60 parts of raw rhubarb powder.

[0072] 2. Preparation method of Chinese medicine ointment:

[0073] (1) According to the formula, 30g of cinnamon bark, 30g of processed aconite root, 30g of cassia twig, 30g of red peony root, 30g of angelica root, 30g of frankincense, 30g of myrrh, 30g of Corydalis yanhusuo, 15g of white mustard seed, and 15g of dried ginger were placed in 1.25kg of sesame oil and soaked at room temperature for 5 days;

[0074] (2) pouring the medicinal oil mixture soaked in step (1) into a copper pot and frying over medium heat at 220° C. for 60 min. After the medicinal materials are fried to dark brown, turn off the heat and filter out the medicinal residue using a 100-mesh sieve;

[0075] (3) Pour the medicinal oil obtained after filtering in step (2) into the pot again, add 0.5 kg of beeswax to melt it over medium heat (temperature 220°C); after the beeswax is completely melted, turn off the heat and filter it for the second time using a 100-mesh sieve. After filtering, place it in a cool place to cool naturally;

[0076] (4) When the temperature of the medicinal oil obtained in step (3) is cooled to 100°C, add 5 g of borneol and stir evenly. Continue to cool to 50°C, add 60 g of raw rhubarb powder and stir. Let it stand in a cool place and cool into a paste, which is recorded as external Chinese medicine ointment C.

[0077] Example 2, external Chinese medicine ointment B

[0078] 1. Formulation

[0079] The invention discloses an external Chinese medicine ointment for treating breast ulcer caused by negative syndrome and semi-negative and semi-positive syndrome, which is prepared from the following raw materials in parts by weight: 30 parts of cinnamon bark, 30 parts of processed aconite, 30 parts of cassia twig, 30 parts of red peony root, 30 parts of angelica dahurica, 30 parts of frankincense, 30 parts of myrrh, 30 parts of corydalis, 15 parts of white mustard seeds, 15 parts of dried ginger, 5 parts of borneol and 400 parts of raw rhubarb powder.

[0080] 2. Preparation method of Chinese medicine ointment:

[0081] (1) According to the formula, 60g of cinnamon bark, 60g of processed aconite root, 60g of cassia twig, 60g of red peony root, 60g of angelica root, 60g of frankincense, 60g of myrrh, 60g of Corydalis yanhusuo, 30g of white mustard seed, and 30g of dried ginger were placed in 7.5kg of sesame oil and soaked at room temperature for 5 days;

[0082] (2) pouring the medicinal oil mixture soaked in step (1) into a copper pot and frying over medium heat (temperature 240° C.); frying time 45 min. After the medicinal materials are fried to dark brown, turn off the heat and filter out the medicinal residue using a 100-mesh sieve;

[0083] (3) Pour the medicinal oil obtained after filtering in step (2) into the pot again, add 2 kg of beeswax to melt it over medium heat (temperature 240°C); after the beeswax is completely melted, turn off the heat and filter it for the second time using a 100-mesh sieve. After filtering, place it in a cool place to cool naturally;

[0084] (4) When the temperature of the medicinal oil obtained in step (3) is cooled to 100°C, add 10 g of borneol and stir evenly. Continue to cool to 50°C, add 800 g of raw rhubarb powder and stir. Let it stand in a cool place and cool into a paste, which is recorded as external Chinese medicine ointment B.

[0085] Example 3, external Chinese medicine ointment D

[0086] 1. Formulation

[0087] The invention discloses an external Chinese medicine ointment for treating breast ulcer caused by negative syndrome and semi-negative and semi-positive syndrome, which is prepared from the following raw materials in parts by weight: 30 parts of cinnamon bark, 30 parts of processed aconite, 30 parts of cassia twig, 30 parts of red peony root, 30 parts of angelica dahurica, 30 parts of frankincense, 30 parts of myrrh, 30 parts of corydalis, 15 parts of white mustard seeds, 15 parts of dried ginger, 5 parts of borneol and 30 parts of raw rhubarb.

[0088] 2. Preparation method of Chinese medicine ointment:

[0089] (1) According to the formula, 30g of cinnamon bark, 30g of processed aconite root, 30g of cassia twig, 30g of red peony root, 30g of angelica root, 30g of frankincense, 30g of myrrh, 30g of Corydalis yanhusuo, 15g of white mustard seed, and 15g of dried ginger were placed in 1.25kg of sesame oil and soaked at room temperature for 5 days;

[0090] (2) pouring the medicinal oil mixture soaked in step (1) into a copper pot and frying over medium heat (temperature 220° C.); frying time 60 min. After the medicinal materials are fried to dark brown, turn off the heat and filter out the medicinal residue using a 100-mesh sieve;

[0091] (3) Pour the medicinal oil obtained after filtering in step (2) into the pot again, add 0.5 kg of beeswax to melt it over medium heat (temperature 220-240°C); after the beeswax is completely melted, turn off the heat and filter it for the second time using a 100-mesh sieve. After filtering, place it in a cool place to cool naturally;

[0092] (4) When the temperature of the medicinal oil obtained in step (3) is cooled to 100°C, add 5 g of borneol and stir evenly. Continue to cool to 50°C, add 30 g of raw rhubarb powder and stir. Let it stand in a cool place and cool into a paste, which is recorded as Chinese medicine ointment D.

[0093] Example 4, Clinical Trial 2

[0094] 1. General information: From May to July 2024, 30 patients diagnosed with chronic mastitis who visited our outpatient clinic were randomly divided into ointment A, ointment B and a control group, with 10 patients in each group.

[0095] 2. Diagnosis: Same as Comparative Example 1.

[0096] 3. Treatment content:

[0097] Ointment A and Ointment B were prepared by the methods of Comparative Example 1 and Example 2, and the method of use was the same as that of Comparative Example 1. Meanwhile, the Chinese medicine decoction was taken by the method of Comparative Example 1.

[0098] The control group and the method of use are the same as those of Comparative Example 1.

[0099] 4. Efficacy evaluation: Same as Comparative Example 1.

[0100] 5. Results: Using the previous efficacy indicators for evaluation, this experiment showed that in terms of the change in mass size, the mass size reduction rate of ointment B was 59.0% under manual measurement, while the reduction rates of ointment A and the control group were 53.0% and 14.0% respectively (P=0.048) (see Table 3); the mass data measured by B-ultrasound showed that the mass reduction rate of ointment B was as high as 51.0% (P=0.021) (see Table 4); the experimental efficacy evaluation showed that the total effective rate of ointment B reached 100% (see Table 5), while 2 people in the other two groups were ineffective. The above results all show that the clinical effect of ointment B is very significant.

[0101] Table 3. Manually measured tumor area (n=30 Unit: cm 2 )

[0102]

[0103] Table 4. Ultrasound measurement of tumor area (n=30 Unit: cm 2 )

[0104]

[0105] Table 5. Efficacy evaluation (n=30)

[0106]

[0107] Example 5, Clinical Trial 3

[0108] 1. General information: From May to November 2024, 43 patients diagnosed with chronic mastitis visited our outpatient clinic and were divided into ointment B (14 patients), ointment C (5 patients), ointment D (7 patients) and a control group (17 patients) according to the clinical intervention method.

[0109] 2. Diagnosis: Same as Comparative Example 1 above.

[0110] 3. Treatment content:

[0111] Ointment B, Ointment C, and Ointment D were prepared by the methods of Example 2, Example 1, and Example 3, and used in the same manner as Comparative Example 1. Meanwhile, the Chinese herbal decoction was taken in the same manner as Comparative Example 1.

[0112] The control group and the method of use are the same as those of Comparative Example 1.

[0113] 4. Efficacy evaluation: Same as Comparative Example 1.

[0114] 5. Results: The previous efficacy indicators were used for evaluation. This experiment showed that in terms of the change in lump size, the lump size reduction rate of ointment C was 60.0% under manual measurement, while the reduction rates of ointment B and ointment D were 42.0% and 20.0%, respectively, and the lump reduction rate of the control group was only 3.0% (P=0.105) (see Table 6); the lump data measured by B-ultrasound showed that the lump reduction rate of ointment C was as high as 26.0%, while that of the control group was only 15.0% (P=0.932) (see Table 7); the efficacy evaluation showed that the total effective rate of ointment C group was 80%, the total effective rate of ointment B was 78.6%, and the control group was only 35.5% (see Table 8). The above results all show that no matter which type of ointment, its efficacy is much higher than that of the control group, especially the clinical effect of ointment C is very significant.

[0115] Table 6. Manually measured tumor area (unit: cm 2 )

[0116]

[0117] Table 7. Ultrasound-measured tumor area (unit: cm 2 )

[0118]

[0119] Table 8. Efficacy evaluation (n=43)

[0120]

[0121] Example 6, typical case:

[0122] Patient Chen, female, 32 years old, was diagnosed with non-lactation mastitis on October 1, 2023. On February 4, 2024, a lump appeared in the left breast. She came to our outpatient clinic on February 26. At that time, the left breast lump was about 8.5*9cm by hand measurement. B-ultrasound showed that the low echo area at 9-10 o'clock was too large and exceeded the measurement range (see Figure 2 ), the patient was given the Chinese medicine ointment C prepared by the method of Example 1 for external application in the outpatient clinic, and the Chinese medicine described in Comparative Example 1 was taken orally at the same time. On March 11, the patient returned for a follow-up visit. The size of the stiff mass was about 8*4cm by hand measurement, and the size of the low echo area at 9-10 o'clock was 5.7*2.2cm by B-ultrasound. On the same day, 20mL of yellow-green pus was extracted by B-ultrasound (see Figure 3 , Figure 4 ). The patient continued to apply ointment externally and had regular follow-up examinations. On May 13, the patient returned for a follow-up visit. The left breast stiffness had softened and dispersed into multiple lumps, which were approximately 3*1.5cm and 3*2.5cm in size by hand measurement. The scattered low-echo areas under B-ultrasound were 2.5*1.0cm (deep in the nipple) and 2.5*0.9cm (12 o'clock direction) in size (see Figure 5 , Figure 6The results showed that the patient's tumor was significantly smaller than before, and her breast began to fester after only 2 weeks of using the ointment, which fully demonstrated the therapeutic advantages of the ointment.

[0123] It should be understood by those skilled in the art that the embodiments of the present invention described above are only examples and do not limit the present invention. The purpose of the present invention has been fully and effectively achieved. The functional and structural principles of the present invention have been demonstrated and explained in the embodiments, and the embodiments of the present invention may be deformed or modified in any way without departing from the principles.

Claims

1. A Chinese medicine ointment for external use for treating chronic mastitis Yin syndrome and semi-Yang syndrome swelling and ulcer, characterized in that: The external Chinese medicine ointment is prepared from the following raw materials in parts by weight: 30 parts of cinnamon bark, 30 parts of processed aconite, 30 parts of cassia twig, 30 parts of red peony root, 30 parts of angelica dahurica, 30 parts of frankincense, 30 parts of myrrh, 30 parts of corydalis, 15 parts of white mustard seeds, 15 parts of dried ginger, 5 parts of borneol, and 60 parts of raw rhubarb powder; The external Chinese medicine ointment is prepared according to the following steps: (1) Soaking the raw materials except borneol and raw rhubarb powder in sesame oil at room temperature for 3-7 days according to the formula amount to obtain a drug-oil mixture; (2) frying the drug-oil mixture in step (1) until it turns dark brown, filtering, and collecting the filtrate; (3) adding beeswax to the filtrate of step (2), heating to melt, filtering, and collecting the filtrate; (4) When the filtrate of step (3) is cooled to 100°C, add the formulated amount of borneol, stir and cool to 50°C, then add the formulated amount of raw rhubarb powder, stir evenly, let stand in a cool place, and cool into a paste.

2. A Chinese medicine ointment for external use for treating chronic mastitis Yin syndrome and semi-Yang syndrome swelling and ulcer, characterized in that: The external Chinese medicine ointment is prepared from the following raw materials in parts by weight: 30 parts of cinnamon bark, 30 parts of processed aconite, 30 parts of cassia twig, 30 parts of red peony root, 30 parts of angelica dahurica, 30 parts of frankincense, 30 parts of myrrh, 30 parts of corydalis, 15 parts of white mustard seeds, 15 parts of dried ginger, 5 parts of borneol, and 400 parts of raw rhubarb powder; The external Chinese medicine ointment is prepared according to the following steps: (1) Soaking the raw materials except borneol and raw rhubarb powder in sesame oil at room temperature for 3-7 days according to the formula amount to obtain a drug-oil mixture; (2) frying the drug-oil mixture in step (1) until it turns dark brown, filtering, and collecting the filtrate; (3) adding beeswax to the filtrate of step (2), heating to melt, filtering, and collecting the filtrate; (4) When the filtrate of step (3) is cooled to 100°C, add the formulated amount of borneol, stir and cool to 50°C, then add the formulated amount of raw rhubarb powder, stir evenly, let stand in a cool place, and cool into a paste.

3. The external Chinese medicine ointment according to claim 1 or 2, characterized in that: The mass ratio of the total amount of raw materials in the formula of step (1) to sesame oil is 1:3-12.

4. The external Chinese medicine ointment according to claim 1 or 2, characterized in that: The temperatures for frying in step (2) and melting in step (3) are both 220-240° C., and a stainless steel pot or a copper pot is used.

5. The external Chinese medicine ointment according to claim 1 or 2, characterized in that: The filtration in step (1) and step (2) was performed using a 100-mesh sieve.

6. The external Chinese medicine ointment according to claim 1 or 2, characterized in that: The mass ratio of the total amount of the raw material drug to the beeswax in the step (3) formula is 1:1-6.

7. Use of the external Chinese medicine ointment according to claim 1 or 2 in the preparation of a medicine for treating chronic mastitis with Yin syndrome and semi-Yang syndrome swelling and ulcer.

Images