External traditional Chinese medicine preparation for lymphedema

Abstract

The invention provides an external traditional Chinese medicine preparation for lymphedema, and relates to the technical field of traditional Chinese medicine preparation. The traditional Chinese medicine preparation is prepared from astragalus membranaceus, cassia twig, poria cocos, akebiaquinata, ligusticum wallichii, salvia miltiorrhiza, radix bupleuri, scutellaria baicalensis, lalang grass rhizome and herba lycopi, and all the medicines are combined to jointly achieve the effects of tonifying qi, activating blood, inducing diuresis, soothing liver-qi stagnation and clearing away heat and toxic materials. The traditional Chinese medicine preparation has obvious edema eliminating and anti-inflammatory effects on lymphedema model mice, and the treatment effect is remarkable. Meanwhile, the traditional Chinese medicine preparation for external treatment of lymphedema in traditional Chinese medicine provided by the invention can remarkably improve clinical symptoms of a patient, relieve pain of the patient, help the patient recover a functional state, reduce the level of inflammatory factors, promote edema absorption of the patient and remarkably relieve the lymphedema condition of an affected limb, and the curative effect is remarkable.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicine pharmaceutical preparations, and in particular to an external traditional Chinese medicine preparation for lymphedema. Background Art

[0002] Limb lymphedema is caused by anatomical variation or dysfunction of lymphatic vessels. Lymph fluid accumulates in the subcutaneous tissue, which then causes fibrosis, tissue swelling, fat sclerosis, fascia thickening, and rough and hard skin like elephant skin, hence the name "elephanthiosis". Lymphedema is divided into primary lymphedema and secondary lymphedema. Clinically, secondary lymphedema caused by radiotherapy and chemotherapy of tumors, surgical trauma, infection, etc. is the most common. Lymphedema, as a chronic progressive disease that is extremely difficult to cure, has a serious impact on the patient's physiology and psychology. Therefore, relieving symptoms and improving quality of life have become the main goals of treating lymphedema.

[0003] Western medicine mainly treats lymphedema with conservative treatment and surgical treatment. Conservative treatment methods include physical therapy and drug therapy, which are mostly used for early mild lymphedema. Among them, physical therapy is the basis and runs through the beginning and end of the disease. Surgical treatment is mostly used to treat late severe lymphedema. The surgery to reconstruct the lymphatic duct is more difficult, and traditional surgery is more prone to recurrence.

[0004] Limb lymphedema belongs to the category of "big foot wind", "little disease" and "athlete's foot" in traditional Chinese medicine. It is mostly caused by damp-heat evil invading the skin surface and flowing into the limbs, or spleen deficiency and water retention, which blocks the qi mechanism, causing qi and blood stagnation and water overflow. If the disease is long-lasting and difficult to treat, the positive qi will be damaged, the qi deficiency will be unable to move the blood, the blood stagnation will become stasis, and the blood vessels will be blocked, so the symptoms such as rough and hard skin will appear. In short, the early stage of the disease is mostly a positive syndrome of damp-heat obstruction, and the later stage is a mixed syndrome of qi stagnation and blood stasis or qi deficiency and blood stasis. Its pathological nature is always a deficiency in the root and excess in the superficial. In clinical practice, conventional conservative treatment combined with traditional Chinese medicine external treatment is increasingly used in the treatment of lymphedema. Traditional Chinese medicine external treatment refers to a treatment method that uses drugs, surgery, physical methods or certain instruments under the guidance of traditional Chinese medicine theory to directly act on the patient's body surface or lesion site to achieve the purpose of treatment. External treatment methods in traditional Chinese medicine can promote blood circulation and invigorate qi, disperse blood stasis and reduce swelling through percutaneous absorption of medicinal power or stimulation of meridian acupoints. External treatment methods can avoid the adverse reactions caused by absorption of oral drugs through the gastrointestinal tract, and have multi-faceted, multi-level and multi-pathway regulatory effects on the functions of various systems and organs of the human body. They have the advantages of being simple, safe and inexpensive. Summary of the invention

[0005] 1. Technical issues to be solved

[0006] In view of the deficiencies of the prior art, the present invention provides an external Chinese medicine preparation for treating or relieving lymphedema.

[0007] (II) Technical solution

[0008] To achieve the above objectives, the present invention is implemented through the following technical solutions:

[0009] The invention provides an external Chinese medicine preparation for lymphedema. The Chinese medicine preparation is prepared from the following raw materials in parts by weight: 20-40 parts of astragalus, 5-25 parts of cassia twig, 10-30 parts of tuckahoe, 10-30 parts of akebia, 15-35 parts of chuanxiong, 15-35 parts of salvia miltiorrhiza, 5-25 parts of bupleurum, 5-25 parts of scutellaria, 5-25 parts of imperata rhizome and 5-25 parts of zedoaria.

[0010] Furthermore, the Chinese medicine preparation is made of the following raw materials in parts by weight: 25-35 parts of Astragalus, 10-20 parts of Cassia Twig, 15-25 parts of Poria, 15-25 parts of Akebia, 20-30 parts of Chuanxiong, 20-30 parts of Salvia miltiorrhiza, 10-20 parts of Bupleurum, 10-20 parts of Scutellaria, 10-20 parts of Imperata Rhizoma, and 10-20 parts of Zedoariae.

[0011] Furthermore, the Chinese medicine preparation is made of the following raw materials in parts by weight: 30 parts of astragalus, 15 parts of cinnamon twig, 20 parts of poria, 20 parts of akebia, 25 parts of chuanxiong, 25 parts of salvia miltiorrhiza, 15 parts of bupleurum, 15 parts of scutellaria, 10 parts of imperata rhizome, and 10 parts of zedoaria.

[0012] The Chinese medicine preparation provided by the invention is used for preparing medicines used in Chinese medicine external treatment of lymphedema, and the medicines are medicines used in Chinese medicine fumigation therapy, medicines used in Chinese medicine hot ironing therapy, and medicines used in Chinese medicine external application therapy.

[0013] Furthermore, the medicine for Chinese medicine fumigation therapy is prepared according to the following steps: weigh each raw material according to the above weight parts, then soak it in pure water of 5 times the weight parts for more than 30 minutes, and then boil it over high heat for more than 30 minutes. When using, place the affected part in the warm decoction or above the steam.

[0014] Furthermore, the medicine used in the Chinese medicine hot ironing method is prepared according to the following steps: weighing each raw material according to the above weight parts, crushing or slicing each raw material, and putting it into a Chinese medicine bag. When using, the Chinese medicine bag containing the medicine is heated, and then the Chinese medicine bag is placed on the affected part for external application.

[0015] Furthermore, the medicine used for the external application of traditional Chinese medicine is prepared according to the following steps: weigh each raw material according to the above weight proportions, crush each raw material and pass it through a 150-200 mesh sieve, then mix them evenly, add appropriate amounts of water and honey and boil until it becomes a non-flowing viscous paste. Before use, heat the paste to a temperature acceptable to the human body and apply it thickly to the affected area; the thickness of the thick application is 0.3-0.5 cm.

[0016] The pharmacological effects of each medicinal flavor in the external Chinese medicine preparation of the present invention are:

[0017] Astragalus: sweet and slightly warm in nature, it enters the spleen and lung meridians and is an important medicine for replenishing qi. In clinical application, it is usually divided into three types: raw, honey-roasted, and bran-fried. Their medicinal effects are different. Raw Astragalus is mostly used to consolidate the surface, relieve sores, and promote diuresis. Astragalus contains active substances such as polysaccharides, coumarins, flavonoids, saponins, trace folic acid, and several vitamins. Modern pharmacological studies have shown that Astragalus has multiple pharmacological effects such as enhancing immunity and antiviral ability, promoting body metabolism, regulating blood pressure and blood sugar, anti-oxidation, anti-aging, and strengthening the heart.

[0018] Cinnamon twig: It tastes spicy and sweet, is warm in nature, and enters the heart, lung, and bladder meridians; it has the effects of inducing sweat and relieving exterior symptoms, dispelling cold and relieving pain, promoting yang and transforming qi; it is used for colds, various pain symptoms caused by cold and blood stasis, phlegm and fluid, water retention, palpitations, etc.; Cinnamon twig mainly contains volatile oil, the main component of which is cinnamaldehyde. Modern pharmacological studies have shown that cinnamon twig has antiviral, antibacterial, anti-inflammatory, anti-allergic, antipyretic, analgesic, and diuretic effects.

[0019] Poria: sweet, light in taste, neutral in nature, enters the heart, lung, spleen, and kidney meridians; has the effects of promoting diuresis and eliminating dampness, strengthening the spleen, and calming the mind; used to treat edema, oliguria, phlegm and fluid, palpitations, spleen deficiency, poor appetite, and restlessness; Poria mainly contains triterpenes and polysaccharide compounds, which have pharmacological effects such as diuresis, anti-inflammatory, and liver protection.

[0020] Akebia: Cool in nature, bitter in taste; has the effects of diuresis, relieving stranguria, clearing the heart and purging fire, promoting menstruation and promoting lactation; mainly treats short and dark urine, stranguria, edema, cramps and pains all over the body, chest heat, throat numbness and sore throat, body pain, amenorrhea and milk blockage in women. It is not suitable for people with internal dampness and heat, lack of body fluid, weak qi, slippery sperm, frequent urination and pregnant women; it has diuretic and antibacterial pharmacological effects.

[0021] Ligusticum chuanxiong: pungent, warm; enters the liver and gallbladder meridians; promotes qi and relieves depression, dispels wind, dryness and dampness, promotes blood circulation and relieves pain; used for wind-cold headache and dizziness, flank pain and abdominal pain, cold arthralgia and muscle spasms, amenorrhea, dystocia, postpartum blood stasis and pain, carbuncle, ulcer, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain due to lumps, stabbing pain in the chest and flanks, swelling and pain due to falls, headache, and rheumatic pain.

[0022] Salvia miltiorrhiza: bitter in taste, slightly cold in nature, enters the heart and liver meridians; has the effects of promoting blood circulation and removing blood stasis, relieving dysmenorrhea, clearing the heart and relieving restlessness, cooling blood and eliminating carbuncle; used for chest pain, heart pain, heat pain, irregular menstruation, dysmenorrhea and amenorrhea; it mainly includes chemical components such as tanshinone, phenolic acid, volatile oils, polysaccharides, nitrogen-containing compounds; has anticoagulant, anti-inflammatory, antioxidant and anti-tumor effects.

[0023] Bupleurum: pungent, bitter, slightly cold. Enters the liver, gallbladder, and lung meridians. Reconciles the exterior and interior, relieves liver depression, raises yang and lifts depression, reduces fever and stops malaria. Used for colds and fever, alternating cold and heat, chest and flank pain, irregular menstruation, uterine prolapse, and rectal prolapse.

[0024] Scutellaria baicalensis: bitter in taste, cold in nature, enters the spleen and lung meridians; it contains baicalin, baicalein, wogonin, baicalein I and II, norwogonin, volatile oil, phenylethanol glycosides, etc., which can clear away heat and dampness, purge fire and detoxify, stop bleeding, stabilize pregnancy, lower blood pressure, kill bacteria, kill viruses, kill fungi, etc. Baicalin and baicalein contained in Scutellaria baicalensis have good antioxidant function.

[0025] Imperata root: sweet in taste, cold in nature, enters the lung, stomach and bladder meridians; has the effects of cooling blood and stopping bleeding, clearing away heat and promoting diuresis; used for blood heat and vomiting blood, hematuria, thirst due to fever, edema, and painful stranguria due to heat; it contains triterpenes, phenylpropanoids, organic acids, sugars, sterols, flavonoids and other active ingredients, mainly with multiple pharmacological effects such as hemostasis, immunomodulation, diuresis and blood pressure reduction, antibacterial, anti-inflammatory and analgesic, anti-tumor, hypoglycemic and hypolipidemic.

[0026] Ze Lan: bitter and pungent in taste, slightly warm in nature; it enters the liver and spleen meridians; it has the effects of promoting blood circulation and regulating menstruation, removing blood stasis and eliminating carbuncles, promoting diuresis and reducing swelling. It is used to treat irregular menstruation, amenorrhea, dysmenorrhea, abdominal pain due to blood stasis after childbirth, sores, carbuncles, swelling and toxins, edema and ascites, etc.

[0027] (III) Beneficial effects

[0028] The etiology and pathogenesis of lymphedema in traditional Chinese medicine mainly involve invasion of exogenous pathogens, dysfunction of viscera, and multiple aspects such as surgery and chemotherapy. The early stage of its pathogenesis is mostly spleen deficiency, cold and dampness blocking the collaterals, and damp-heat stagnation; the course of the disease is long, and it is mostly phlegm and dampness blocking the collaterals, qi stagnation and blood stasis. Therefore, in treatment, according to the specific condition of the patient, the method of syndrome differentiation and treatment should be adopted to achieve the purpose of detumescence, diuresis, reconciliation of qi and blood, and dredge the collaterals to relieve pain. At the same time, for patients after surgery and chemotherapy, attention should also be paid to replenishing the qi of viscera function, so that it can work normally, and qi and water should be circulated to reduce or prevent the occurrence of lymphedema. Based on the above-mentioned treatment principle, and following the principle of syndrome differentiation and treatment in traditional Chinese medicine, the present invention provides a Chinese medicine preparation for external treatment of lymphedema in traditional Chinese medicine made of astragalus, cinnamon twig, Poria, Akebia, Chuanxiong, Salvia miltiorrhiza, Bupleurum, Scutellaria, Imperata root, and Zedoaria. In the formula, Astragalus membranaceus greatly replenishes the body's Qi. When Qi is strong, blood circulates. When Qi is sufficient, water and moisture can be transported and transformed. Therefore, it can remove blood stasis without hurting the body, and promote diuresis and reduce swelling. Poria cocos tastes sweet and light. The sweet taste can replenish, and the light taste can penetrate. It also enters the spleen meridian. While promoting diuresis and reducing swelling, it can strengthen the spleen and replenish the middle, so that the clear Yang of the middle burner can rise and the turbid Yin of edema can be lowered. Imperata root, Akebia trifoliata, and Zedoariae odorata work together to warm and dredge the meridians, enhance the body's overall function, and improve symptoms such as Qi deficiency, blood stasis, and edema. Akebia trifoliata, Zedoariae odorata and Poria cocos work synergistically to enhance the effect of promoting diuresis and relieving stranguria, which helps to eliminate excess water and toxins in the body. Blood-activating and blood-stasis-removing, analgesic and analgesic drugs such as Chuanxiong, Salvia miltiorrhiza, and Cinnamon twig help improve blood circulation and relieve various discomforts caused by blood stasis. Drugs such as Bupleurum chinense and Scutellaria baicalensis can regulate emotions and clear away heat and detoxify. All the drugs are used together to achieve the effects of replenishing Qi, promoting blood circulation, promoting diuresis, soothing the liver and relieving depression, and clearing away heat and detoxifying.

[0029] The Chinese medicine preparation of the present invention can significantly reduce the increase in the circumference of the hind limbs of lymphedema model mice, and has a significant anti-edema effect. At the same time, the Chinese medicine preparation of the present invention can also effectively reduce the content of inflammatory factors in the serum of lymphedema model mice, and has obvious anti-inflammatory and anti-inflammatory effects; the Chinese medicine preparation of the present invention has a significant therapeutic effect on lymphedema model mice.

[0030] At the same time, the Chinese medicine preparation for external treatment of lymphedema provided by the present invention can significantly improve the clinical symptoms of patients, relieve the pain of patients, help patients restore their functional status, reduce the level of inflammatory factors, promote the absorption of edema in patients, and significantly alleviate the lymphedema of the affected limbs; the total effective rate of the Chinese medicine preparation for the treatment of lymphedema can reach 95.45%, and the therapeutic effect is significant. DETAILED DESCRIPTION

[0031] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in combination with the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0032] Example 1

[0033] A traditional Chinese medicine preparation for external use for lymphedema is prepared from the following raw materials in parts by weight: 20-40 parts of astragalus, 5-25 parts of cassia twig, 10-30 parts of tuckahoe, 10-30 parts of akebia, 15-35 parts of chuanxiong, 15-35 parts of salvia miltiorrhiza, 5-25 parts of bupleurum, 5-25 parts of scutellaria, 5-25 parts of imperata rhizome, and 5-25 parts of zedoaria.

[0034] The Chinese medicine preparation is used for preparing medicines used in Chinese medicine external treatment of lymphedema, and the medicines are medicines used in Chinese medicine fumigation therapy, medicines used in Chinese medicine hot ironing therapy, and medicines used in Chinese medicine external application therapy.

[0035] The medicine for Chinese medicine fumigation therapy is prepared according to the following steps: weigh the raw materials according to the above weight parts, then soak them in pure water 5 times the weight parts for more than 30 minutes, and then boil them over high heat for more than 30 minutes. When using, place the affected part in the warm decoction or above the steam.

[0036] The medicine used in the Chinese medicine hot ironing method is prepared according to the following steps: weigh each raw material according to the above weight parts, crush or slice each raw material, and put it into a Chinese medicine bag. When using, heat the Chinese medicine bag containing the medicine, and then place the Chinese medicine bag on the affected part for external application.

[0037] The medicine used for external application of traditional Chinese medicine is prepared according to the following steps: weigh each raw material according to the above weight proportions, crush each raw material and pass it through a 150-200 mesh sieve, then mix them evenly, add appropriate amount of water and honey and boil until it becomes a non-flowing viscous paste. Before use, heat the paste to a temperature acceptable to the human body and apply it thickly to the affected area; the thickness of the thick application is 0.3-0.5 cm.

[0038] Example 2

[0039] The difference between this embodiment and embodiment 1 is that:

[0040] The Chinese medicine preparation is prepared from the following raw materials in parts by weight: 20-40 parts of astragalus, 5-25 parts of cassia twig, 10-30 parts of tuckahoe, 10-30 parts of akebia, 15-35 parts of chuanxiong, 15-35 parts of salvia miltiorrhiza, 5-25 parts of bupleurum, 5-25 parts of scutellaria, 5-25 parts of imperata rhizome and 5-25 parts of zedoaria.

[0041] Example 3

[0042] The difference between this embodiment and embodiment 1 is that:

[0043] The Chinese medicine preparation is prepared from the following raw materials in parts by weight: 20-40 parts of astragalus, 5-25 parts of cassia twig, 10-30 parts of tuckahoe, 10-30 parts of akebia, 15-35 parts of chuanxiong, 15-35 parts of salvia miltiorrhiza, 5-25 parts of bupleurum, 5-25 parts of scutellaria, 5-25 parts of imperata rhizome and 5-25 parts of zedoaria.

[0044] Example 4

[0045] The difference between this embodiment and embodiment 1 is that:

[0046] The Chinese medicine preparation is prepared from the following raw materials in parts by weight: 25-35 parts of astragalus, 10-20 parts of cassia twig, 15-25 parts of tuckahoe, 15-25 parts of akebia, 20-30 parts of chuanxiong, 20-30 parts of salvia miltiorrhiza, 10-20 parts of bupleurum, 10-20 parts of scutellaria, 10-20 parts of imperata rhizome and 10-20 parts of zedoaria.

[0047] Example 5

[0048] The difference between this embodiment and embodiment 1 is that:

[0049] The Chinese medicine preparation is prepared from the following raw materials in parts by weight: 25-35 parts of astragalus, 10-20 parts of cassia twig, 15-25 parts of tuckahoe, 15-25 parts of akebia, 20-30 parts of chuanxiong, 20-30 parts of salvia miltiorrhiza, 10-20 parts of bupleurum, 10-20 parts of scutellaria, 10-20 parts of imperata rhizome and 10-20 parts of zedoaria.

[0050] Example 6

[0051] The difference between this embodiment and embodiment 1 is that:

[0052] The Chinese medicine preparation is prepared from the following raw materials in parts by weight: 25-35 parts of astragalus, 10-20 parts of cassia twig, 15-25 parts of tuckahoe, 15-25 parts of akebia, 20-30 parts of chuanxiong, 20-30 parts of salvia miltiorrhiza, 10-20 parts of bupleurum, 10-20 parts of scutellaria, 10-20 parts of imperata rhizome and 10-20 parts of zedoaria.

[0053] Example 7

[0054] The difference between this embodiment and embodiment 1 is that:

[0055] The Chinese medicine preparation is prepared from the following raw materials in parts by weight: 25-35 parts of astragalus, 10-20 parts of cassia twig, 15-25 parts of tuckahoe, 15-25 parts of akebia, 20-30 parts of chuanxiong, 20-30 parts of salvia miltiorrhiza, 10-20 parts of bupleurum, 10-20 parts of scutellaria, 10-20 parts of imperata rhizome and 10-20 parts of zedoaria.

[0056] Example 8

[0057] The difference between this embodiment and embodiment 1 is that:

[0058] The Chinese medicine preparation is prepared from the following raw materials in parts by weight: 30 parts of astragalus, 15 parts of cassia twig, 20 parts of tuckahoe, 20 parts of akebia, 25 parts of chuanxiong, 25 parts of salvia miltiorrhiza, 15 parts of bupleurum, 15 parts of scutellaria, 10 parts of imperata rhizome and 10 parts of zedoaria.

[0059] Test Example 1

[0060] Effect of the external Chinese medicine preparation provided by the present invention on lymphedema model mice

[0061] 1 Materials and methods

[0062] 1.1 Experimental animals

[0063] SPF male C57BL / 6J mice, weighing 20-22 g, aged 7-8 weeks, were adaptively raised for 1 week with free access to food and water, at a temperature of 25°C and a humidity of 50%-60%.

[0064] 1.2 Experimental drugs

[0065] Drug 1: 30 parts of Astragalus, 15 parts of Cinnamon Twig, 20 parts of Poria, 20 parts of Akebia, 25 parts of Chuanxiong, 25 parts of Salvia Miltiorrhiza, 15 parts of Bupleurum, 15 parts of Scutellaria, 10 parts of Imperata Root, 10 parts of Zedoaria;

[0066] Drug 2: 15 parts of cinnamon twig, 20 parts of Poria cocos, 20 parts of Akebia, 25 parts of Chuanxiong, 25 parts of Salvia miltiorrhiza, 10 parts of Imperata root, 10 parts of Zedoariae;

[0067] Drug 3: 30 parts of Astragalus, 15 parts of Cinnamon Twig, 25 parts of Chuanxiong, 25 parts of Salvia Miltiorrhiza, 15 parts of Bupleurum, 15 parts of Scutellaria;

[0068] Drug 4: 30 parts of Astragalus, 20 parts of Poria, 20 parts of Akebia, 15 parts of Bupleurum, 15 parts of Scutellaria, 10 parts of Imperata Root, 10 parts of Zedoaria

[0069] Weigh each raw material according to the above weight proportions, crush each raw material and pass it through a 150-200 mesh sieve, then mix them evenly, add appropriate amounts of water and honey and boil until it becomes a non-flowing viscous paste, thereby obtaining medicines 1-4.

[0070] 1.2 Construction of mouse hindlimb lymphedema model

[0071] After 1 week of adaptive feeding, healthy C57BL / 6J male mice were anesthetized by intraperitoneal injection of sodium pentobarbital and routine skin preparation and disinfection. 0.1% evans blue 0.1ml was injected subcutaneously into the left paw of the mouse to identify the lymph nodes and lymphatic vessels. After 5-10 minutes, the left inguinal skin was cut circumferentially, the inguinal and popliteal lymph nodes were removed, and the deep lymphatic vessels were destroyed. A silicone ring about 2-3mm wide was fixed to the edge of the incision skin with 6-0 sutures, leaving a gap to prevent skin contraction and healing and block the formation of superficial lymphatic vessels. After 5-7 days, obvious edema appeared in the hind limbs of the mouse, indicating that the model was successful.

[0072] 1.3 Establishment of sham surgery model in mice

[0073] Five healthy C57BL / 6J male mice were fed adaptively for one week, anesthetized by intraperitoneal injection of sodium pentobarbital, and routine skin preparation and disinfection were performed. Only the left inguinal skin was incised circumferentially without damaging the lymph nodes and lymphatic vessels. A silicone ring with a width of about 2-3 mm was directly fixed to the skin edge using 6-0 sutures. No edema appeared in the hind limbs of the mice.

[0074] 1.4 Group Processing

[0075] The successfully constructed mouse models were divided into sham operation group, model group, and experimental groups 1-4, with 5 mice in each group. The mice in each group were depilated at the modeling site, while the sham operation group and model group did not receive any treatment at the modeling site. The experimental groups 1-4 were respectively applied with drugs 1-4 at the modeling site, and the drugs were evenly and thickly applied to the affected area and kept for 1 hour. The drugs were continuously administered for 14 days, and the changes in edema in the hind limbs of the mice were observed and recorded.

[0076] 1.5 Observation indicators

[0077] 1.5.1 Measurement of hind limb circumference

[0078] The mice were fixed on a dissecting board under anesthesia. After the hair was prepared, the circumference of the mouse 2 mm above the knee was measured with a non-elastic micro tape measure. The measurement was repeated 3 times and the average value was taken.

[0079] All animals were measured before modeling, immediately after modeling, on the 7th day and on the 14th day of drug administration. Each measurement was repeated 3 times and the average value was taken.

[0080] 1.5.2 Determination of inflammatory factors in serum

[0081] Blood was collected from the eyeballs of mice in each group, and serum was collected. The levels of IL-6 and TNF-α in serum were detected by ELISA.

[0082] 1.6 Statistical analysis

[0083] Statistical analysis was performed using Prism 8.0.2, and one-way analysis of variance was used for comparison among groups. The results are expressed as mean ± standard deviation The data were analyzed using t-test. P < 0.05 was considered statistically significant.

[0084] 2 Results

[0085] 2.1 Effect of the external Chinese medicine preparation of the present invention on hind limb edema in lymphedema model mice

[0086] The results are shown in Table 1. The hind limb circumference of mice in the sham operation group did not change significantly during the experiment (P>0.05); compared with the sham operation group, the increase in the hind limb circumference of mice in the model group increased significantly (P<0.05), indicating that the lymphedema model was successfully established. Compared with the model group, the increase in the hind limb circumference of mice in experimental groups 1-4 was significantly reduced on the 7th and 14th days of administration (P<0.05); in experimental groups 1-4, compared with the first day of administration, the increase in the hind limb circumference of mice in each group on the 7th and 14th days of administration was significantly reduced (P<0.05); on the 7th and 14th days of administration, the increase in the hind limb circumference of mice in experimental group 1 was significantly lower than that in experimental groups 2-3 (P<0.05).

[0087] Table 1 Increase in hind limb circumference of mice in each group during the experiment

[0088]

[0089]

[0090] Note: In the same row of data, with lowercase letters or no letters on the shoulders, P>0.05, different lowercase letters mean P<0.05; in the same column of data, with the same capital letters or no letters on the shoulders, P>0.05, different capital letters mean P<0.05.

[0091] 2.2 Effect of the topical Chinese medicine preparation of the present invention on inflammatory factors in the serum of lymphedema model mice

[0092] The results are shown in Table 2. Compared with the sham operation group, the relative levels of IL-6 and TNF-α in the serum of mice in the model group were significantly increased (P<0.05); compared with the model group, the relative levels of IL-6 and TNF-α in the serum of mice in experimental groups 1-4 were significantly decreased (P<0.05); among them, the relative levels of IL-6 and TNF-α in the serum of mice in experimental group 1 were significantly lower than those in experimental groups 2-4 (P<0.05), and there was no significant difference compared with the sham operation group (P>0.05).

[0093] Table 2 Relative levels of inflammatory factors IL-6 and TNF-α in the serum of mice in each group

[0094] Grouping Relative expression of IL-6 Relative expression of TNF-α Sham operation group <![CDATA[1.041±0.014 a ]]> <![CDATA[1.039±0.027 a ]]> Model Group <![CDATA[1.182±0.008 b ]]> <![CDATA[1.176±0.047 b ]]> Experimental Group 1 <![CDATA[1.038±0.013 a ]]> <![CDATA[1.040±0.031 a ]]> Experimental Group 2 <![CDATA[1.067±0.011 c ]]> <![CDATA[1.082±0.036 c ]]> Experimental Group 3 <![CDATA[1.107±0.021 d ]]> <![CDATA[1.113±0.041 d ]]> Experimental Group 4 <![CDATA[1.084±0.018 e ]]> <![CDATA[1.076±0.029 c ]]>

[0095] Note: In the same column of data, the same lowercase letters or no letters on the shoulders indicate P>0.05, and different lowercase letters indicate P<0.05.

[0096] 3 Conclusion

[0097] The above results show that the Chinese medicine preparation of the present invention can significantly reduce the increase in the circumference of the hind limbs of the lymphedema model mice, and has a significant effect of eliminating edema. At the same time, the Chinese medicine preparation of the present invention can also effectively reduce the content of inflammatory factors in the serum of the lymphedema model mice, and has obvious anti-inflammatory and anti-inflammatory effects. It is important that the various components in the Chinese medicine preparation of the present invention complement each other and synergize, and the therapeutic effect on the lymphedema model mice is significantly higher than that of other Chinese medicine preparations (preparations used in experimental groups 2-4).

[0098] Test Example 2

[0099] 1 Materials and methods

[0100] 1.1 General Information

[0101] 88 patients with upper limb lymphedema after breast cancer surgery who were treated in a certain hospital from January 2022 to June 2024 were selected as the research subjects and were divided into two groups according to random sampling, namely the observation group and the control group, with 44 cases in each group. Observation group: age 35-65 years old, average (48.17±9.11) years old; course of disease: 6-18 months, average (12.59±3.66) months. Control group: age 35-65 years old, average (46.09±8.26) years old; course of disease: 6-18 months, average (10.97±5.01) months. There was no significant difference in the general information of the two groups of patients (P>0.05), and they were comparable.

[0102] Diagnostic criteria: meet the grading criteria for upper limb lymphedema after breast cancer surgery in the "Research on the Mechanism and Treatment of Upper Limb Edema after Breast Cancer Surgery".

[0103] Inclusion criteria: (1) upper limb lymphedema within 3 months after breast cancer surgery; (2) voluntary participation in this study, approved by the hospital ethics committee; (3) no other malignant tumor diseases; (4) no history of major trauma to the upper limbs; (5) no allergy to the drugs used in this study.

[0104] Exclusion criteria: (1) patients with severe lymphangitis malformation; (2) patients with severe renal failure; (3) patients with other blood system diseases.

[0105] 1.2 Methods

[0106] Control group: given conventional comprehensive treatment, including limb function training, elastic sleeve, air wave pressure circulation and centripetal massage before bedtime; limb function training was performed once a day in the morning and afternoon, 30 min / time; air wave pressure circulation was performed once a day, 30 min / time; centripetal massage before bedtime was performed from the wrist of the affected limb to the center of the affected limb using kneading, pinching, holding and other techniques, 20 min / time.

[0107] Observation group: On the basis of the above treatment, the external Chinese medicine preparation of the present invention was given for treatment; the specific composition is: 30 parts of Astragalus, 15 parts of Cinnamon Twig, 20 parts of Poria, 20 parts of Akebia, 25 parts of Chuanxiong, 25 parts of Salvia Miltiorrhiza, 15 parts of Bupleurum, 15 parts of Scutellaria, 10 parts of Imperata Root, 10 parts of Ze Lan; weigh each raw material according to the above weight parts, crush each raw material and pass through a 150-200 mesh sieve, then mix evenly, add appropriate amount of water and honey to boil until it becomes a non-flowing viscous paste. Before use, heat the ointment to an acceptable temperature for the human body and apply it thickly to the affected part; the thickness of the thick application is 0.3-0.5cm, covered with gauze, wrapped with non-woven fabric on the outside, fixed with adhesive tape to prevent drug extravasation, once a day, each external application for 4-6h, finally wash the skin with warm water, and apply neutral moisturizing lotion to protect the skin.

[0108] Both groups were treated for 2 weeks.

[0109] 1.3 Evaluation indicators

[0110] (1) TCM symptom score: This score was formulated based on the Guiding Principles for Clinical Research of New Chinese Medicines. The evaluation content includes six items: upper limb edema, pain, limb numbness, fatigue, poor appetite, and irritability. The scores are divided into none, mild, moderate, and severe according to the severity, with 0 points, 1 point, 2 points, and 3 points respectively. Abnormal tongue and pulse are each recorded with 1 point, and the total score is calculated.

[0111] (2) Upper arm circumference: Before and after treatment, use a tape measure to measure the circumference of the wrist crease 5 cm above the elbow crease, 10 cm below the elbow crease, and 10 cm above the elbow crease to the armpit. The difference in upper arm circumference = the sum of the upper arm circumferences of the three points on the affected side - the sum of the upper arm circumferences of the three points on the healthy side. To reduce the error of the manipulation, a fixed nurse was arranged to measure the patient's arm circumference, and the patient's arm circumference was measured and recorded within a fixed time range.

[0112] (3) Inflammatory factors: Fasting venous blood was collected from the two groups before and after treatment, and the levels of C-reactive protein (CRP) and interleukin-6 (IL-6) were detected by enzyme-linked immunosorbent assay.

[0113] (4) Pain score: The visual analogue scale (VAS) was used to assess the patient's pain level, with a total score of 0-10 points. A higher score indicates more severe pain.

[0114] (5) Functional status score: The Karnofsky functional status score (KPS) was used to assess the functional status of patients. The total score ranged from 0 to 100, with a total of 11 levels; 0 indicates death, 10 indicates severe or critical illness, 20 indicates both severe and serious illness, 30 indicates severe inability to take care of oneself, 40 indicates inability to take care of oneself, 50 indicates need for other assistance, 60 indicates occasional need for other assistance, 70 indicates ability to take care of oneself, 80 indicates some symptoms and signs, 90 indicates mild clinical symptoms, and 100 indicates no symptoms and signs.

[0115] (6) Efficacy assessment:

[0116] Markedly effective: clinical symptoms were significantly improved after treatment, and edema was basically eliminated;

[0117] Improvement: Edema is eliminated by >50% compared with the healthy upper limb;

[0118] Effective: Edema is eliminated by 30-50% compared with the healthy upper limb;

[0119] Ineffective: Edema did not change or worsened.

[0120] Total effective rate = (number of markedly effective cases + number of improved cases + number of effective cases) / total number × 100%

[0121] 1.4 Statistical methods

[0122] SPSS 21.0 statistical software was used to express measurement data as mean ± standard deviation, non-independent sample t test was used between groups, paired sample t test was used within groups, count data were expressed as percentages, and inter-group comparisons were performed using the χ 2 Test, P < 0.05 was considered statistically significant.

[0123] 2 Results

[0124] 2.1 Comparison of TCM symptom scores between the two groups of patients before and after treatment

[0125] The results are shown in Table 3. There was no significant difference in the TCM symptom scores between the two groups before treatment (P>0.05). Compared with before treatment, the TCM symptom scores of the two groups of patients decreased significantly after treatment (P<0.05). Among them, the TCM symptom scores of the observation group after treatment were significantly lower than those of the control group (P<0.05).

[0126] Table 3 TCM symptom scores of the two groups of patients before and after treatment (points)

[0127] Grouping n Before treatment After treatment Observation Group 44 13.94±3.11 <![CDATA[4.17±1.81 # *]]> Control group 44 13.79±2.78 7.57±2.03*

[0128] Note: Compared with the control group, # P<0.05; compared with before treatment, *P<0.05.

[0129] 2.2 Comparison of the difference in bilateral upper limb circumference between the two groups of patients before and after treatment

[0130] The results are shown in Table 4. There was no significant difference in the difference in bilateral upper limb circumference between the two groups before treatment (P>0.05). Compared with before treatment, the difference in bilateral upper limb circumference of the two groups of patients decreased significantly after treatment (P<0.05). Among them, the difference in bilateral upper limb circumference of the observation group after treatment was significantly lower than that of the control group (P<0.05).

[0131] Table 4 Difference in bilateral upper limb circumference between the two groups of patients before and after treatment (cm)

[0132] Grouping n Before treatment After treatment Observation Group 44 9.52±4.77 <![CDATA[8.09±3.01 # *]]> Control group 44 9.84±3.56 9.11±4.13*

[0133] Note: Compared with the control group, # P<0.05; compared with before treatment, *P<0.05.

[0134] 2.3 Comparison of inflammatory factors CRP and IL-6 levels between the two groups before and after treatment

[0135] The results are shown in Table 5. Compared with before treatment, the levels of inflammatory factors CRP and IL-6 in the two groups of patients decreased significantly after treatment (P < 0.05); among them, the levels of inflammatory factors CRP and IL-6 in the observation group after treatment were significantly lower than those in the control group (P < 0.05).

[0136] Table 5 Levels of inflammatory factors CRP and IL-6 in the two groups of patients before and after treatment

[0137]

[0138] Note: Compared with the control group, # P<0.05; compared with before treatment, *P<0.05.

[0139] 2.4 Comparison of VAS and KPS scores between the two groups before and after treatment

[0140] The results are shown in Table 6. Compared with before treatment, the VAS scores of the two groups of patients decreased significantly after treatment (P < 0.05), and the KPS scores increased significantly (P < 0.05); among them, the VAS score of the observation group after treatment was significantly lower than that of the control group (P < 0.05), and the KPS score was significantly higher than that of the control group (P < 0.05).

[0141] Table 6 VAS scores and KPS scores of the two groups of patients before and after treatment (points)

[0142]

[0143] Note: Compared with the control group, # P<0.05; compared with before treatment, *P<0.05.

[0144] 2.5 Comparison of clinical efficacy between the two groups

[0145] The results are shown in Table 7. The significant effective rate of the observation group was 56.81%, and the total effective rate was 95.45%; the significant effective rate of the control group was 11.36%, and the total effective rate was 68.18%; the total effective rate of the observation group was significantly higher than that of the control group.

[0146] Table 7 Clinical efficacy of the two groups of patients [n, (%)]

[0147] Grouping n Significant effect Improvement efficient invalid Total effective Observation Group 44 25(56.81) 12(27.27) 5(11.36) 2(4.55) 42(95.45) Control group 44 5(11.36) 9(20.45) 16(36.36) 14(31.81) 30(68.18)

[0148] 3 Conclusion

[0149] The above results show that the Chinese medicine preparation for external treatment of lymphedema provided by the present invention can significantly improve the clinical symptoms of patients, relieve the pain of patients, and help patients recover their functional status. The Chinese medicine preparation of the present invention significantly alleviates the lymphedema of the affected limb, which may be because the Chinese medicine preparation of the present invention can reduce the level of inflammatory factors and promote the absorption of edema in patients; the total effective rate of the Chinese medicine preparation of the present invention for the treatment of lymphedema can reach 95.45%, and the therapeutic effect is significant.

[0150] 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 the technical solutions described in the aforementioned embodiments may still be modified, or some of the technical features may be replaced by equivalents. 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 embodiments of the present invention.

Claims

1. A Chinese medicine preparation for external use for lymphedema, characterized in that: The Chinese medicine preparation is prepared from the following raw materials in parts by weight: 20-40 parts of astragalus, 5-25 parts of cassia twig, 10-30 parts of tuckahoe, 10-30 parts of akebia, 15-35 parts of chuanxiong, 15-35 parts of salvia miltiorrhiza, 5-25 parts of bupleurum, 5-25 parts of scutellaria, 5-25 parts of imperata rhizome and 5-25 parts of zedoaria.

2. The external Chinese medicine preparation for lymphedema according to claim 1, characterized in that: The Chinese medicine preparation is prepared from the following raw materials in parts by weight: 25-35 parts of astragalus, 10-20 parts of cassia twig, 15-25 parts of tuckahoe, 15-25 parts of akebia, 20-30 parts of chuanxiong, 20-30 parts of salvia miltiorrhiza, 10-20 parts of bupleurum, 10-20 parts of scutellaria, 10-20 parts of imperata rhizome and 10-20 parts of zedoaria.

3. The external Chinese medicine preparation for lymphedema according to claim 1, characterized in that: The Chinese medicine preparation is prepared from the following raw materials in parts by weight: 30 parts of astragalus, 15 parts of cassia twig, 20 parts of tuckahoe, 20 parts of akebia, 25 parts of chuanxiong, 25 parts of salvia miltiorrhiza, 15 parts of bupleurum, 15 parts of scutellaria, 10 parts of imperata rhizome and 10 parts of zedoaria.

4. Use of the Chinese medicine preparation according to any one of claims 1 to 3 in the preparation of a Chinese medicine for external treatment of lymphedema, characterized in that: The medicines described are medicines used in traditional Chinese medicine fumigation therapy, medicines used in traditional Chinese medicine hot ironing therapy, and medicines used in traditional Chinese medicine external application therapy.

5. The use of the Chinese medicine preparation according to claim 4 in preparing a Chinese medicine for external treatment of lymphedema, characterized in that: The medicine used for Chinese medicine fumigation therapy is prepared according to the following steps: weigh each raw material according to the above-mentioned weight portions, then soak it in pure water of 5 times or more by weight for more than 30 minutes, and then boil it over high heat for more than 30 minutes to obtain the medicine.

6. Use of the Chinese medicine preparation according to claim 4 in preparing a Chinese medicine for external treatment of lymphedema, characterized in that: The medicine used in the Chinese medicine hot ironing method is prepared according to the following steps: weigh each raw material according to the above weight portions, crush or slice each raw material, and put it into a Chinese medicine packaging bag to obtain the medicine.

7. Use of the Chinese medicine preparation according to claim 4 in preparing a Chinese medicine for external treatment of lymphedema, characterized in that: The medicine used for external application of traditional Chinese medicine is prepared according to the following steps: weigh each raw material according to the above weight proportions, crush each raw material and pass it through a 150-200 mesh sieve, then mix them evenly, add appropriate amount of water and honey and boil until it becomes a non-flowing viscous paste.

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