A traditional Chinese medicine cream and its application in treating breast diseases

Abstract

The invention provides a traditional Chinese medicine cream. The cream comprises raw materials consisting of the following components: lithospermum officinale, cimicifuga heracleifolia, cyperus rotundus, bark of bauhinia chinensis, pollen of cattail, angelica sinensis, siler, angelica dahurica, schizonepeta tenuifolia, red peony root, radix notopterygii, schizonepeta tenuifolia, radix notopterygii, safflower, dragon's blood, frankincense, myrrh, aconiti lobata and centipede. A matrix is ​​further added to prepare the cream into a cream with uniform texture, fine texture and good stability. The cream can improve the relevant symptoms of breast diseases and has small toxic and side effects.

Description

Technical Field

[0001] The invention belongs to the technical field of medicine, and specifically relates to a traditional Chinese medicine ointment and application thereof in treating breast diseases. Background Art

[0002] In recent years, due to work pressure and other reasons, breast diseases such as breast hyperplasia and mastitis have become common breast diseases in women. This disease is more common in middle-aged women, adolescents and postmenopausal women, and the pain it causes seriously affects the quality of life of patients. The main symptoms of breast hyperplasia and mastitis are breast tenderness, tingling, pulling pain, breast lumps, nodules, cords, nipple discharge, etc., which are mostly caused by emotional changes before and after menstruation.

[0003] At present, for breast hyperplasia, hormone drugs, iodine preparations and surgical treatment are mostly used clinically. Although hormone drug treatment has good efficacy, it has large side effects and cannot be used for long-term treatment, and it is easy to relapse after stopping the drug. Traditional Chinese medicine has its unique efficacy in treating breast hyperplasia, mastitis and other diseases. Traditional Chinese medicine believes that breast hyperplasia and mastitis are related to mental factors, and are closely related to internal organs such as the liver, kidneys, and spleen. The liver is responsible for dredging and discharging, and the liver meridian is stagnant, the circulation of qi and blood is lost, and qi and blood are stagnant; the spleen is out of order, and phlegm and turbidity are endogenous; phlegm and turbidity, blood stasis are mutually blocked in the milk network and form milk lumps. This application adopts Chinese medicine cream to treat breast-related diseases, and has achieved certain efficacy with small side effects. Summary of the invention

[0004] The invention provides a traditional Chinese medicine cream, which can improve the relevant symptoms of mastitis and has little toxic and side effects.

[0005] Specifically, the present invention provides a traditional Chinese medicine ointment, which comprises medicinal materials composed of the following components: by weight, 200 parts of lithospermum, 200 parts of cimicifuga, 40 parts of cyperus, 100 parts of bauhinia bark, 100 parts of pollen, 100 parts of angelica, 100 parts of siler, 400 parts of angelica, 100 parts of schizonepeta, 200 parts of red peony root, 100 parts of Shenqu, 100 parts of notopterygium, 100 parts of safflower, 20 parts of blood clotting, 40 parts of frankincense, 40 parts of myrrh, 100 parts of aconite, and 100 parts of centipede.

[0006] The main medicinal ingredients in the prescription are lithospermum officinale, cimicifuga heracleifolia, cyperus rotundus, and angelica sinensis. Studies have shown that lithospermum officinale has the effects of clearing heat and cooling blood, promoting blood circulation and detoxifying. Cimicifuga heracleifolia has the effects of dispelling heat and detoxifying, and raising Yang Qi. Cyperus rotundus has the effects of clearing heat and detoxifying, stopping bleeding, and killing insects. Bauhinia bark has the effects of promoting blood circulation and dredging menstruation, reducing swelling and detoxifying. Pollen pollen has the effects of stopping bleeding, removing blood stasis, and relieving stranguria. Angelica sinensis has the effects of nourishing blood and promoting blood circulation, regulating menstruation and relieving pain, and moistening the intestines and relieving constipation. Saposhnikovia divaricata has the effects of dispelling wind and relieving exterior symptoms, relieving dampness and relieving pain, and stopping spasms. Angelica dahurica has the effects of dispelling cold, dispelling wind and relieving pain, clearing the nasal passages, drying dampness and stopping leukorrhea, and reducing swelling and discharging pus. Nepeta tenuifolia has the effects of dispelling wind and relieving exterior symptoms, promoting rash and eliminating sores. Paeonia lactiflora has the effects of clearing heat and cooling blood, removing blood stasis and relieving pain. Shenqu has the effects of digestion and harmonizing the stomach. Notopterygium incisum has the effects of dispelling cold, dispelling wind and removing dampness, and relieving pain. Safflower has the effects of promoting blood circulation and dredging menstruation, removing blood stasis and relieving pain. Xuejie has the effects of promoting blood circulation and relieving pain, removing blood stasis and stopping bleeding, and promoting tissue regeneration and healing sores. Frankincense has the effects of promoting blood circulation, activating qi and relieving pain, reducing swelling and promoting tissue regeneration. Myrrh has the effects of dispersing blood stasis and relieving pain, reducing swelling and promoting tissue regeneration. Ophiopogon japonicus has the effects of promoting blood circulation and relieving pain, removing blood stasis and stopping bleeding. Centipede has the effects of calming wind and relieving spasm, unblocking meridians and relieving pain, and attacking toxins and dispersing nodules.

[0007] The invention is based on the theory of traditional Chinese medicine and adopts the above-mentioned effective drugs to cooperate with each other to achieve the effects of soothing the liver and clearing the stomach, promoting lactation and dispersing stagnation, and clearing away heat and detoxifying. Studies have found that the compatibility between the components is very important. When the weight ratio of pollen typhae, myrrh, cyperus rotundus and frankincense is 5:2:2:2, the effects of dispersing stagnation and relieving pain are better. If the dosage of myrrh, cyperus rotundus and frankincense is too much, endocrine disorders are easily affected.

[0008] In some embodiments, the cream also includes the following matrix components by weight: 20-40 parts of vaseline, 20-40 parts of liquid paraffin, 15-30 parts of monostearate glyceryl, 3-5 parts of Tween 80, and 0.5-1 parts of ethyl paraben. Studies have found that the cream prepared by the application using a mixture of high melting point and low melting point oils has the best performance. In the screening of high melting point oils, it was found that if behenic acid glyceryl with a melting point that is too high is used, the prepared cream is rough and hard, and the granularity is obvious, while the cream prepared by using mono- and di-stearate glyceryl has a delicate and uniform appearance and no obvious odor. In the stability evaluation experiment, the cream prepared by mono- and di-stearate glyceryl is not stratified. Further studies have found that the low melting point oil phase uses a mixture of liquid paraffin and white vaseline, and its cold resistance effect is better.

[0009] In some embodiments, the cream further comprises the following base ingredients in parts by weight: 20-30 parts of vaseline, 20-30 parts of liquid paraffin, 20-30 parts of glyceryl monostearate, 3-4 parts of Tween 80, and 0.5 parts of ethylparaben.

[0010] On the other hand, the present invention also provides a preparation process of a traditional Chinese medicine ointment comprising: (1) After the above medicinal materials are crushed, distilled water in an amount of 8 to 12 times the weight of the medicinal materials is added for decoction, filtered, and 80% ethanol in an amount of 5 to 8 times the weight of the medicinal residue is added for immersion extraction for 24 to 48 hours to obtain a Chinese medicine extract; (2) Concentrating the Chinese medicine extract to a relative density of 1.13 to 1.14 to obtain a Chinese medicine concentrate; (3) Grind the Chinese medicine concentrate and glycerol into a paste as the water phase; mix vaseline, liquid paraffin, and glyceryl monostearate as the oil phase; set the emulsification temperature to 80°C and the stirring speed to 250 rpm, centrifuge the oil phase and the water phase, and heat to the emulsification temperature; first add the oil phase to the stirring container, then add Tween 80 and ethyl paraben, and then immediately add the water phase to the container and stir and emulsify for 20 minutes, then cool it to 40°C with cold water at 2-3°C / min and stir for 10 minutes, then cool it to 20°C with ice water and stir for 10 minutes.

[0011] In the present invention, the effective ingredients of Chinese medicine are extracted by water extraction and alcohol precipitation. Considering that the cream needs to be absorbed through the skin to work, alcohol precipitation is selected at a concentration of 80%. In the preparation process of the cream, the present application first premixes the Chinese medicine concentrate with glycerol to increase the emulsification effect of the water phase, and the prepared cream has a uniform and fine texture. After the emulsification is completed, a slow cooling method is adopted, which not only effectively improves the uniform and fine texture of the cream, but also further improves the stability of the cream.

[0012] In some embodiments, in step (1), decocting is performed twice, each time for 2-3 hours.

[0013] In some embodiments, in step (1), the amount of distilled water used is 8 to 10 times the weight of the medicinal material.

[0014] In some embodiments, in step (1), the amount of 80% ethanol used is 5 to 6 times the weight of the medicinal residue.

[0015] In some embodiments, in step (1), the 80% ethanol immersion extraction time is 24 hours.

[0016] In some embodiments, in step (3), the mass ratio of the traditional Chinese medicine concentrate to glycerol is 5:1.

[0017] In some embodiments, the preparation process of the traditional Chinese medicine cream comprises: (1) After the above medicinal materials are crushed, distilled water in an amount of 8 to 12 times the weight of the medicinal materials is added and boiled twice, each time for 2 to 3 hours, filtered, and 80% ethanol in an amount of 5 to 8 times the weight of the medicinal residue is added and immersed and extracted for 24 hours to obtain a Chinese medicine extract; (2) Concentrating the Chinese medicine extract to a relative density of 1.13 to 1.14 to obtain a Chinese medicine concentrate; (3) Grind the Chinese medicine concentrate and glycerol into a paste, with the mass ratio of Chinese medicine concentrate to glycerol being 5:1, as the water phase; mix vaseline, liquid paraffin, and glyceryl monostearate as the oil phase; set the emulsification temperature to 80°C and the stirring speed to 250rpm, centrifuge the oil phase and the water phase and heat to the emulsification temperature; first add the oil phase to the stirring container, then add Tween 80 and ethyl paraben, and then immediately add the water phase to the container and stir and emulsify for 20 minutes, then cool it to 40°C with cold water at 2-3°C / min and stir for 10 minutes, then cool it to 20°C with ice water and stir for 10 minutes.

[0018] In some embodiments, the relative density of the traditional Chinese medicine concentrated solution is 1.13-1.14, and the weight ratio of the matrix to the traditional Chinese medicine concentrated solution is 4:1.

[0019] The present invention also provides an application of a traditional Chinese medicine cream in preparing a medicine for treating breast diseases.

[0020] In some embodiments, the breast disease includes breast hyperplasia, mastitis, breast cysts, and breast nodules. Preferably, the breast disease includes mastitis. DETAILED DESCRIPTION

[0021] The following examples are used to illustrate the present invention, but are not intended to limit the scope of the present invention.

[0022] Unless otherwise specified, the reagents or consumables used in the present invention are commercially available.

[0023] Experimental Example 1 Study on the Extraction Process of API Components Chinese medicine prescription: 200g of Lithospermum officinale, 200g of Cimicifuga heracleifolia, 40g of Cynomorium wilfordii, 100g of Bauhinia bark, 100g of Pollen Typhae, 100g of Angelica sinensis, 100g of Saposhnikovia divaricata, 400g of Angelica dahurica, 100g of Schizonepeta tenuifolia, 200g of Red Peony Root, 100g of Shenqu, 100g of Notopterygium wilfordii, 100g of Carthamus tinctorius, 20g of Sanguisorba officinalis, 40g of Frankincense, 40g of Myrrh, 100g of Notopterygium wilfordii, and 100g of Centipede.

[0024] Extraction preparation process: (1) After the above ingredients are crushed, add 10 times distilled water, decoct twice, each time for 2 hours, and combine the two extracts to obtain a Chinese medicine extract; (2) The Chinese medicine extract obtained in the previous step was filtered until it was clear and an alcohol precipitation test was performed. The alcohol precipitation concentration was set as the investigation factor, and the three levels were set at 60%, 70%, and 80%. Ethanol was added in a low-to-high ethanol concentration until the alcohol concentration in the water extract reached the preset value, and then allowed to stand overnight at 4°C. The water extract after alcohol precipitation was filtered. The study found that the precipitate was less at 60% and 70% concentrations than at 80%. Considering that the cream needs to be absorbed through the skin to work, an 80% concentration was selected for alcohol precipitation. The alcohol precipitate was concentrated to no alcohol taste by vacuum distillation.

[0025] Experimental Example 2 Study on the formulation of cream Cream refers to a uniform, semi-solid preparation formed by dissolving or dispersing drugs in an emulsion-type matrix. Creams can overcome the shortcomings of fat-soluble matrices that are not easy to absorb water, have poor drug release, and are difficult to clean, and can also improve the protective and lubricating effects of water-soluble matrices on the skin. Therefore, it is not appropriate to use a single oily matrix with poor permeability, nor is it appropriate to use a single water-soluble matrix. It is appropriate to use an emulsion-type matrix to make a cream.

[0026] 1. Evaluation of creams 1.1 Appearance and ductility Appearance: Observe with the naked eye whether there are bubbles or foreign matter in the cream, and whether oil-water stratification occurs after standing still; apply a proper amount of cream on the skin surface to observe whether it is fine and even, and whether there is any obvious granularity.

[0027] 1.2 Extensibility: Weigh 1.0g of cream and place it on a 12cm*12cm glass sheet. Place a glass sheet of the same size on top of the cream. Apply a 100g weight to the upper glass sheet. After standing for 20 minutes, measure the maximum and minimum diameters of the cream interface and take the average value. An average value within the range of 4.0-5.0cm indicates that the cream has good extensibility and is suitable for application.

[0028] 1.3 Physical stability evaluation Centrifugation test: Weigh an appropriate amount of cream and place it in a centrifuge tube. Set the high-speed centrifuge parameters to 3000rpm for 30min. After centrifugation, observe whether there is oil-water stratification in the cream.

[0029] Heat resistance test: Weigh an appropriate amount of cream and place it in a centrifuge tube. Set the parameters of the constant temperature drying oven to 55℃ for 6h, and observe whether there is oil-water stratification in the cream.

[0030] Cold resistance test: Weigh an appropriate amount of cream and place it in a centrifuge tube. Place the centrifuge tube with the cream in a freezer at -15°C. After repeated freezing and thawing three times, observe whether there is any obvious change in the appearance of the cream.

[0031] 2. Screening of cream prescriptions 2.1 Ratio of matrix to main drug The main drug of this product is a Chinese herbal extract. If the Chinese herbal extract is directly added to the matrix, stratification is likely to occur. Preliminary experiments have shown that when the main drug extract is concentrated to a relative density of 1.13 1.14 (20°C), it is easier to mix with the matrix.

[0032] Since creams usually contain a large amount of matrix, in order to improve the efficacy of the drug, the drug loading of the cream should be increased as much as possible. This application uses the same process to prepare three creams of different concentrations, containing 10%, 20%, and 30% of Chinese medicine concentrate respectively. The results show that when the content of Chinese medicine concentrate is 20%, the properties of the cream are the best. When the content is 30%, the drug loading is too large, and the prepared cream is prone to oil-water stratification. Therefore, the relative density of the Chinese medicine concentrate is determined to be 1.13 1.14 (20°C), and the weight ratio of the matrix to the Chinese medicine concentrate is 4:1.

[0033] 2.2 Selection of cream ingredients The oil phase is one of the important components of creams, and the type of oil phase will affect the ductility, fineness, physical stability, etc. of the cream. To ensure the physical stability of the cream, the cream made with a single high-melting-point oil phase has obvious granularity, rough texture, and poor patient experience, so a low-melting-point oil phase must be used when screening the oil phase of the cream.

[0034] In this application, liquid paraffin and vaseline are used as low melting point components in the oil phase, and behenyl glyceryl and mono- and distearic glyceryl are used as high melting point components in the oil phase for prescription screening. The prescription is shown in Table 1. The physical stability of the cream is used as an evaluation index to determine the type of oil phase for subsequent experiments.

[0035] Table 1 Screening prescription and dosage ratio Table 2 Evaluation results of screening prescriptions As shown in Table 2, the melting point of behenic acid glyceryl is too high, the prepared cream is rough and hard, and the granularity is obvious; the cream prepared by mono- and distearic acid glyceryl has a delicate and uniform appearance and no obvious odor. In the stability evaluation experiment, the cream prepared by mono- and distearic acid glyceryl is not stratified. In addition, a mixture of low melting point liquid paraffin and vaseline is selected, and its cold resistance effect is good. Therefore, subsequent experiments select mono- and distearic acid glyceryl, liquid paraffin and vaseline as mixed oil phases for further screening.

[0036] 2.3 Investigation of preparation method Preparation process 1 (premixing of traditional Chinese medicine concentrate and glycerol - slow cooling): The Chinese medicine extract was concentrated under reduced pressure to a relative density of 1.13 1.14 (20°C), and the Chinese medicine concentrate was ground with glycerol (mass ratio of 5:1) into a paste as the water phase; liquid paraffin, vaseline, and glyceryl monostearate were used as the oil phase; Tween 80 was used as an emulsifier; and ethyl paraben was used as a preservative.

[0037] The emulsification temperature was set at 80°C and the stirring speed was set at 250 rpm. The oil phase and the water phase were centrifuged and then heated to the emulsification temperature. The oil phase was added to a stirring container, and an emulsifier and a preservative were added. Then, the water phase was immediately added dropwise to the container and stirred for emulsification for 20 minutes. The mixture was first cooled to 40°C with cold water and stirred for 10 minutes, and then cooled to 20°C with ice water and stirred for 10 minutes at a rate of 2-3°C / minute to obtain cream 1.

[0038] Preparation process 2 (TCM concentrate not premixed with glycerol - slow cooling): The Chinese medicine extract was concentrated under reduced pressure to a relative density of 1.13 1.14 (20°C) as the water phase; liquid paraffin, vaseline, and glyceryl monostearate were used as the oil phase; Tween 80 was used as an emulsifier; and ethylparaben was used as a preservative.

[0039] Set the emulsification temperature to 80°C and the stirring speed to 250rpm, centrifuge the oil phase and the water phase, and then heat them to the emulsification temperature; add the oil phase to the stirring container, add the emulsifier and the preservative, and then immediately add the water phase to the container and stir and emulsify for 20 minutes; first cool down to 40°C with cold water at 2-3°C / min and stir for 10 minutes, then cool down to 20°C with ice water and stir for 10 minutes to obtain cream 2.

[0040] Preparation process 3 (premixing of traditional Chinese medicine concentrate and glycerol - rapid cooling): The Chinese medicine extract was concentrated under reduced pressure to a relative density of 1.13 1.14 (20°C), and the Chinese medicine concentrate was ground with glycerol (mass ratio of 5:1) into a paste as the water phase; liquid paraffin, vaseline, and glyceryl monostearate were used as the oil phase; Tween 80 was used as an emulsifier; and ethyl paraben was used as a preservative.

[0041] The emulsification temperature was set at 80°C and the stirring speed was set at 250 rpm. The oil phase and the water phase were centrifuged and then heated to the emulsification temperature. The oil phase was added to the stirring container, and the emulsifier and the preservative were added. Then, the water phase was immediately added dropwise to the container and stirred for emulsification for 20 minutes. The temperature was lowered to 20°C at 6-8°C / min and stirred for 10 minutes to obtain cream 3.

[0042] The cream 1 3 prepared by the above method was analyzed, and it was found that the obtained cream had a delicate and uniform appearance and no obvious odor; the obtained cream 1 3 was subjected to centrifugation test, heat resistance test, and cold resistance test, as shown in Table 3.

[0043] Table 3 Evaluation results of cream process The results showed that cream 1 obtained by preparation process 1 had no stratification in the centrifugation test, no stratification in the heat resistance test, and no precipitation in the cold resistance test, indicating that the prepared cream had good appearance and physical stability; while creams 2 and 3 obtained showed stratification or precipitation in the centrifugation test, heat resistance test, and cold resistance test.

[0044] Example 1 Preparation of the composition cream of the present invention Prescription: 200g of Lithospermum officinale, 200g of Cimicifuga heracleifolia, 40g of Cynomorium fortunei, 100g of Bauhinia bark, 100g of Pollen Typhae, 100g of Angelica sinensis, 100g of Saposhnikovia divaricata, 400g of Angelica dahurica, 100g of Nepeta tenuifolia, 200g of Red Peony Root, 100g of Shenqu, 100g of Notopterygium incisum, 100g of Safflower, 20g of Sanguisorba officinalis, 40g of Frankincense, 40g of Myrrh, 100g of Penis Enlargement Oil, and 100g of Centipede; Base: Vaseline 20g, liquid paraffin 30g, glyceryl monostearate 26.5g, Tween 80 3g, ethylparaben 0.5g; Preparation process: (1) After the above raw material drug is crushed, 10 times the weight of distilled water is added, and the drug is decocted twice, each time for 2 hours, the two extracts are combined, filtered, and the drug residue is soaked and extracted with 6 times the weight of 80% ethanol for 24 hours to obtain a Chinese medicine extract; (2) Concentrating the Chinese medicine extract to a relative density of 1.13 1.14 (20°C) to obtain a Chinese medicine concentrate; (3) Grind the Chinese medicine concentrate and glycerol (mass ratio of 5:1) into a paste as the water phase; mix vaseline, liquid paraffin, and glyceryl monostearate as the oil phase; set the emulsification temperature to 80°C and the stirring speed to 250 rpm, centrifuge the oil phase and the water phase and heat them to the emulsification temperature; add the oil phase to a stirring container, add Tween and ethyl paraben, and then immediately add the water phase to the container and stir and emulsify for 20 minutes. At 2-3°C / min, first cool it down to 40°C with cold water and stir for 10 minutes, then cool it down to 20°C with ice water and stir for 10 minutes.

[0045] Example 2 Preparation of the composition cream of the present invention Prescription: 200g of Lithospermum officinale, 200g of Cimicifuga heracleifolia, 40g of Cynomorium fortunei, 100g of Bauhinia bark, 100g of Pollen Typhae, 100g of Angelica sinensis, 100g of Saposhnikovia divaricata, 400g of Angelica dahurica, 100g of Nepeta tenuifolia, 200g of Red Peony Root, 100g of Shenqu, 100g of Notopterygium incisum, 100g of Safflower, 20g of Sanguisorba officinalis, 40g of Frankincense, 40g of Myrrh, 100g of Penis Enlargement Oil, and 100g of Centipede; Base: Vaseline 25g, liquid paraffin 25g, glyceryl monostearate 24.5g, Tween 80 4g, ethylparaben 0.5g; Preparation process: (1) After the above raw material drug is crushed, 8 times the weight of distilled water is added, and the drug is decocted twice, each time for 2 hours, the two extracts are combined, filtered, and the drug residue is soaked and extracted with 5 times the weight of 80% ethanol for 24 hours to obtain a Chinese medicine extract; (2) Concentrating the Chinese medicine extract to a relative density of 1.13 1.14 (20°C) to obtain a Chinese medicine concentrate; (3) Grind the Chinese medicine concentrate and glycerol (mass ratio of 5:1) into a paste as the water phase; mix vaseline, liquid paraffin, and glyceryl monostearate as the oil phase; set the emulsification temperature to 80°C and the stirring speed to 250 rpm, centrifuge the oil phase and the water phase and heat them to the emulsification temperature; add the oil phase to a stirring container, add Tween and ethyl paraben, and then immediately add the water phase to the container and stir and emulsify for 20 minutes. At 2-3°C / min, first cool it down to 40°C with cold water and stir for 10 minutes, then cool it down to 20°C with ice water and stir for 10 minutes.

[0046] Test Example 1 Cream Performance Test 1.1 Properties The cream prepared in the example of the present application is a brown semi-fluid ointment, which is shiny, uniform and fine in texture, and has no coarse grain feeling when applied on the skin.

[0047] 1.2 Consistency At room temperature, take an appropriate amount of the cream prepared in the example of the present application and add it to the sample cup. Scrape the surface flat before measuring. Place the sample cup on the base of the cone penetration meter and adjust the position so that its tip just touches the surface of the sample. Quickly release the cone and hold it for 5 seconds, then read the cone penetration depth. One cone penetration unit is equal to 0.1 mm, and the consistency is expressed in cone penetration. Three different batches of cream prepared in the example of the present application were measured in the same way, and the average consistency was 248.

[0048] 1.3 pH The method described in the examples of the present application was used to prepare 3 batches of 3 different batches of cream, 2.0 g of each was put into a beaker, 10 mL of distilled water was added, and ultrasonication was performed for 10 min. After oscillation to make it evenly dispersed, the pH was measured with a pH meter, and the average pH was measured to be 7.25.

[0049] Test Example 2 Physical Stability Investigation The method described in the examples of the present application was used to prepare three different batches of creams, and centrifugation experiments, heat resistance experiments, and cold resistance experiments were performed according to the method under 1.3. In the centrifugation experiment, the oil-water phase of the ointment was not stratified, and the cream did not change. In the heat resistance and cold resistance experiments, the cream had no stratification phenomenon, and the paste did not change. The results show that the cream described in the present application has good stability.

[0050] Test Example 3: Efficacy Test (1) Case details: A total of 209 patients who met the diagnostic criteria for early-stage mastitis were collected. Among them, the oldest was 60 years old and the youngest was 20 years old. None of them had received any other treatment. A total of 132 female patients voluntarily joined this trial.

[0051] (2) Treatment method: Apply an appropriate amount of the cream prepared in the embodiment of the present invention twice a day, and one month is a course of treatment.

[0052] (3) Criteria for evaluating efficacy: Cured: symptoms and signs disappear or almost disappear, pain and discomfort completely disappear, normal life resumes, and syndrome score decreases by ≥95%; Markedly effective: All or major symptoms are significantly eliminated, pain and discomfort are significantly gone, but mild symptoms still occur, most of the normal life is restored, and the symptom score is reduced by ≥70%; Effective: symptoms and signs are improved, pain and discomfort are alleviated, but mild symptoms still occur, normal life is partially restored, and the syndrome score is reduced by ≥30%; Ineffective: There is no significant improvement in symptoms and signs, or they may even worsen, and the syndrome score decreases by less than 30%.

[0053] The nimodipine method was used to calculate the degree of reduction in the disease efficacy score: score reduction rate = (score before treatment - score after treatment) ÷ score before treatment × 100%.

[0054] TCM symptoms: congestion and lumps, nipple discharge, swelling and pain, aversion to cold and fever, headache or body pain, thirst, constipation, etc. Observe the changes every day. Observe the changes in tongue coating, tongue quality, pulse, pulse, body temperature, skin color and temperature, finger pressure pain, etc.

[0055] (4) Treatment results: Table 4 Treatment results Clinical treatment showed that after treatment, the patients in the treatment group had significant improvement in nipple discharge, pain relief, and lump disappearance. During the entire treatment cycle, no adverse events occurred in any patient. The treatment results are shown in Table 4, indicating that the Chinese medicine cream prepared by the present application can effectively treat breast-related diseases.

[0056] Typical cases: Ms. Li, 42 years old, often works overtime and stays up late, has irregular diet, has suffered from mastitis for more than one year, often feels breast pain, milk leakage, and physical examination can touch breast lumps, which are slightly tender. Apply the cream prepared by the embodiment of the present invention, apply an appropriate amount twice a day, and after one month, breast pain is significantly reduced, nipple discharge is alleviated, and breast lumps are significantly reduced.

[0057] Ms. Sun, 34 years old, was found to have breast nodules during physical examination in 2020. Nodules can be touched on one side of the breast, repeated breast pain or pulling pain, aggravated pain before and after menstruation, insomnia, constipation, dry mouth, irregular menstruation, pale purple tongue, thin fur, and slippery pulse. After three courses of treatment with the cream prepared in the embodiment of the present application, the breast pain and discomfort were significantly alleviated, and the nodules were significantly reduced.

[0058] The above is only a preferred embodiment of the present invention. It should be pointed out that for ordinary technicians in this technical field, several improvements and substitutions can be made without departing from the technical principles of the present invention. These improvements and substitutions should also be regarded as the scope of protection of the present invention.

Claims

1. A Chinese medicine ointment, characterized in that: The cream comprises raw materials consisting of the following components: by weight, 200 parts of lithospermum, 200 parts of cimicifuga, 40 parts of cyperus, 100 parts of bauhinia bark, 100 parts of pollen, 100 parts of angelica, 100 parts of siler, 400 parts of angelica, 100 parts of siler, 200 parts of red peony root, 100 parts of radix schizonepetae, 100 parts of herba ...phenantherae, 100 parts of herba notopterae, 100 parts of safflower, 20 parts of blood clotting, 40 parts of frankincense, 40 parts of myrrh, 100 parts of truncatum, and 100 parts of centipede.

2. A Chinese medicine ointment according to claim 1, characterized in that: The cream further comprises the following matrix components in parts by weight: 20-40 parts of vaseline, 20-40 parts of liquid paraffin, 15-30 parts of glyceryl monostearate, 3-5 parts of Tween 80, and 0.5-1 part of ethyl paraben.

3. A Chinese medicine ointment according to claim 2, characterized in that: The cream further comprises the following matrix components in parts by weight: 20-30 parts of vaseline, 20-30 parts of liquid paraffin, 20-30 parts of glyceryl monostearate, 3-4 parts of Tween 80, and 0.5 parts of ethyl paraben.

4. A Chinese medicine cream according to any one of claims 1-3, characterized in that: The preparation process of the Chinese medicine ointment comprises: (1) After the raw materials are crushed, 8 to 12 times the weight of the medicinal materials are added with distilled water for decoction, filtered, and 5 to 8 times the weight of the medicinal residues are added with 80% ethanol for immersion extraction for 24 to 48 hours to obtain a Chinese medicine extract; (2) Concentrating the Chinese medicine extract to a relative density of 1.13 to 1.14 to obtain a Chinese medicine concentrate; (3) Grind the Chinese medicine concentrate and glycerol into a paste as the water phase; mix vaseline, liquid paraffin, and glyceryl monostearate as the oil phase; set the emulsification temperature to 80°C and the stirring speed to 250 rpm, centrifuge the oil phase and the water phase, and heat to the emulsification temperature; first add the oil phase to the stirring container, then add Tween 80 and ethyl paraben, and then immediately add the water phase to the container and stir and emulsify for 20 minutes, then cool it to 40°C with cold water at 2-3°C / min and stir for 10 minutes, then cool it to 20°C with ice water and stir for 10 minutes.

5. A Chinese medicine ointment according to claim 4, characterized in that: In step (1), decoct twice, each time for 2-3 hours.

6. A Chinese medicine cream according to claim 4, characterized in that: In step (1), the amount of distilled water used is 8 to 10 times the weight of the medicinal materials.

7. A Chinese medicine cream according to claim 4, characterized in that: In step (1), the amount of 80% ethanol used is 5 to 6 times the weight of the medicinal residue.

8. A Chinese medicine cream according to claim 4, characterized in that: In step (3), the mass ratio of the Chinese medicine concentrate to glycerol is 5:

1.

9. Use of a Chinese medicine cream in preparing a medicine for treating breast diseases, characterized in that: Including the Chinese medicine ointment as claimed in claim 4.

10. The use according to claim 9, characterized in that: The breast diseases include breast hyperplasia, mastitis, breast cysts and breast nodules.

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