An external traditional Chinese medicine preparation for lymphedema

Abstract

The application provides a kind of external use traditional Chinese medicine preparation for lymphedema, it relates to the technical field of traditional Chinese medicine pharmacy.The traditional Chinese medicine preparation for treating lymphedema in traditional Chinese medicine of the application is prepared from Huangqi, Guizhi, Fuling, Mutong, Chuanxiong, Danshen, Chaihu, Huangqi, Baomao Gen and Zelan, the combined use of various drugs achieves the effects of tonifying qi, promoting blood circulation, promoting water, soothing liver and relieving depression, clearing heat and resolving toxicity.The traditional Chinese medicine preparation has obvious effects of dehydrating edema and resisting inflammation on lymphedema model mice, and the treatment effect is remarkable.Meanwhile, the traditional Chinese medicine preparation for treating lymphedema in traditional Chinese medicine can significantly improve the clinical symptom of patients, reduce the pain of patients, help patients recover functional state, reduce the level of inflammatory factors, promote the absorption of edema of patients, obviously relieve the lymphedema of affected limbs, and the curative effect is remarkable.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine, in particular to a kind of external use traditional Chinese medicine preparation for lymphedema. BACKGROUND

[0002] Lymphedema is caused by lymphatic vessel anatomical variation or dysfunction, and lymphatic fluid accumulates in subcutaneous tissue, which causes fibrosis, tissue swelling, and fat sclerosis in later stage, fascia thickening, rough and hard skin, and is called " elephant foot disease". Lymphedema is divided into primary lymphedema and secondary lymphedema, and secondary lymphedema caused by tumor radiotherapy and chemotherapy, surgical trauma, infection and other factors is most common in clinic. Lymphedema is a chronic progressive disease with extremely high cure difficulty, which has a serious impact on the physiology and psychology of patients. Therefore, relieving symptoms and improving the quality of life become the main purpose of treating lymphedema.

[0003] Western medicine treatment of lymphedema mainly adopts conservative treatment and surgical treatment. The conservative treatment method includes physical therapy and drug therapy, which is mostly applied to early mild lymphedema. Physical therapy is the basis and runs through the whole disease. Surgical treatment is mostly used for treating advanced severe lymphedema, and the operation of reconstructing lymphatic duct is difficult, and traditional operation is easy to relapse.

[0004] Lymphedema belongs to the category of "big foot wind", "foot disease" and "foot disease" in traditional Chinese medicine. It is mostly caused by invasion of damp-heat evil on the skin, flowing into the limbs, or water retention due to spleen deficiency, blocking the qi mechanism, causing blood stasis, and water overflow. If the disease is prolonged and delayed, the healthy qi is damaged, the blood flow is blocked, the blood stasis is blocked, and the rough and hard skin is seen. In short, the disease is mostly real syndrome of damp-heat obstruction in early stage, and virtual and real mixed syndrome of blood stasis or blood stasis in later stage, and the pathological nature is mostly virtual and real. In clinic, the conventional conservative treatment method is more and more used in the treatment of lymphedema. The external treatment method of traditional Chinese medicine is a treatment method which directly acts on the surface or lesion of the patient under the guidance of traditional Chinese medicine theory, and uses drugs, surgery, physical methods or cooperates with certain instruments to achieve the treatment purpose. The external treatment method of traditional Chinese medicine can play the effect of promoting blood circulation and tonifying qi, removing blood stasis and reducing swelling through skin absorption of drug or stimulation of meridian acupoint, and can avoid the adverse reactions of oral drug absorption through gastrointestinal tract, and has the advantages of simple operation, safety and low cost. SUMMARY

[0005] (1) The technical problem solved

[0006] In view of the shortcomings of the prior art, the present application provides an external use traditional Chinese medicine preparation for treating or relieving lymphedema.

[0007] (II) Technical Solution

[0008] To achieve the above object, the present application is implemented by the following technical solution:

[0009] The present application provides a kind of external use traditional Chinese medicine preparation for lymphedema, the traditional Chinese medicine preparation is made of the following weight fraction raw materials: 20-40 parts of Huangqi, 5-25 parts of Guizhi, 10-30 parts of Fuling, 10-30 parts of Mutong, 15-35 parts of Chuanxiong, 15-35 parts of Danshen, 5-25 parts of Chaihu, 5-25 parts of Huangqin, 5-25 parts of Baomao, 5-25 parts of Zelan.

[0010] Further, the traditional Chinese medicine preparation is made of the following weight fraction raw materials: 25-35 parts of Huangqi, 10-20 parts of Guizhi, 15-25 parts of Fuling, 15-25 parts of Mutong, 20-30 parts of Chuanxiong, 20-30 parts of Danshen, 10-20 parts of Chaihu, 10-20 parts of Huangqin, 10-20 parts of Baomao, 10-20 parts of Zelan.

[0011] Further, the traditional Chinese medicine preparation is made of the following weight fraction raw materials: 30 parts of Huangqi, 15 parts of Guizhi, 20 parts of Fuling, 20 parts of Mutong, 25 parts of Chuanxiong, 25 parts of Danshen, 15 parts of Chaihu, 15 parts of Huangqin, 10 parts of Baomao, 10 parts of Zelan.

[0012] The traditional Chinese medicine preparation provided by the present application is used for preparing medicine for traditional Chinese medicine external treatment of lymphedema, and the medicine is medicine for traditional Chinese medicine fumigation therapy, medicine for traditional Chinese medicine hot compress method, and medicine for traditional Chinese medicine external application method.

[0013] Further, the medicine for traditional Chinese medicine fumigation therapy is prepared according to the following steps: the above-mentioned weight fraction of each raw material is weighed, then soaked in 5 times or more by weight of pure water for 30 minutes or more, and then boiled for 30 minutes or more on high heat, to obtain the medicine. When used, the affected part is placed in the warm boiled liquid or above the steam.

[0014] Further, the medicine for traditional Chinese medicine hot compress method is prepared according to the following steps: the above-mentioned weight fraction of each raw material is weighed, and each raw material is crushed or sliced, and then put into a traditional Chinese medicine sealing bag, to obtain the medicine. When used, the traditional Chinese medicine sealing bag containing the medicine is heated, and then placed on the affected part for external application.

[0015] Further, the medicine for traditional Chinese medicine external application method is prepared according to the following steps: the above-mentioned weight fraction of each raw material is weighed, each raw material is crushed and passed through a 150-200 mesh sieve, and then mixed uniformly, and then boiled with an appropriate amount of water and honey until a thick paste is obtained. Before use, the paste is heated to a temperature acceptable to the human body, and then thickly applied to the affected part; the thick application thickness is 0.3-0.5 cm.

[0016] The pharmacological effects of each medicinal flavor in the external use traditional Chinese medicine preparation of the present application are as follows:

[0017] Astragalus: Sweet and slightly warm in nature, it enters the spleen and lung meridians and is an essential herb for tonifying qi. Clinically, it is typically used in three forms: raw, honey-processed, and stir-fried with wheat bran. Each has different medicinal effects. Raw astragalus is often used to strengthen the exterior, promote wound healing, and promote diuresis. Astragalus contains polysaccharides, coumarins, flavonoids, saponins, trace amounts of folic acid, and several vitamins, among other active substances. Modern pharmacological studies have shown that astragalus has various pharmacological effects, including enhancing immunity and antiviral capabilities, promoting metabolism, regulating blood pressure and blood sugar, anti-oxidation, anti-aging, and cardiotonic effects.

[0018] Cinnamon twig: It has a pungent and sweet taste, and is warm in nature. It enters the heart, lung, and bladder meridians. It has the effects of inducing sweating and relieving exterior syndromes, dispelling cold and relieving pain, and promoting yang and qi circulation. It is used for colds due to wind and cold, pain due to cold stagnation and blood stasis, phlegm retention, water retention syndrome, 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 cocos: It is sweet and bland in taste, neutral in nature, and enters the heart, lung, spleen, and kidney meridians. It has the effects of promoting diuresis and removing dampness, strengthening the spleen, and calming the mind. It is used to treat edema with scanty urine, phlegm retention with dizziness and palpitations, spleen deficiency with poor appetite, and restlessness. Poria cocos mainly contains triterpenoids and polysaccharide compounds, which have pharmacological effects such as diuresis, anti-inflammation, and liver protection.

[0020] Akebia stem: Cool in nature and bitter in taste; it has the effects of promoting urination and relieving strangury, clearing heat from the heart and purging fire, and promoting menstruation and lactation; it is mainly used to treat scanty dark urine, urinary tract infections, edema, general body cramps and pain, chest discomfort and heat, sore throat, general body pain, amenorrhea, and insufficient lactation. It is contraindicated in cases of internal damp-heat, fluid deficiency, weakness of qi, spermatorrhea, frequent urination, and in pregnant women; it has pharmacological effects such as diuresis and antibacterial activity.

[0021] Chuanxiong (Ligusticum striatum): pungent, warm; enters the liver and gallbladder meridians; promotes qi circulation and relieves stagnation, dispels wind and dampness, invigorates blood and relieves pain; used for wind-cold headache and dizziness, hypochondriac pain and abdominal pain, cold-induced muscle spasms, amenorrhea, dystocia, postpartum blood stasis and pain, carbuncles and sores, irregular menstruation, amenorrhea and dysmenorrhea, abdominal pain, chest and hypochondriac pain, traumatic swelling and pain, headache, and rheumatic pain.

[0022] Salvia miltiorrhiza: bitter in taste, slightly cold in nature, and enters the heart and liver meridians; it has the effects of promoting blood circulation and removing blood stasis, relieving dysmenorrhea, clearing the heart and relieving irritability, cooling blood and reducing swelling; it is used for symptoms such as chest pain, pain due to heat, irregular menstruation, dysmenorrhea and amenorrhea; its main chemical components include tanshinone, salvianolic acid, volatile oil, polysaccharides, nitrogen-containing compounds, etc.; it has anticoagulant, anti-inflammatory, antioxidant and anti-tumor effects.

[0023] Bupleurum: pungent and bitter in taste, slightly cold in nature. It enters the liver, gallbladder, and lung meridians. It harmonizes the exterior and interior, soothes the liver and relieves stagnation, raises yang and lifts prolapse, reduces fever and stops malaria. It is used for colds with fever, alternating chills and fever, chest and rib pain, irregular menstruation, uterine prolapse, and rectal prolapse.

[0024] Scutellaria: bitter, cold, spleen, lung; it contains baicalin, baicalein, wogonoside, wogonin, new baicalin I, II, norwogonin, volatile oil, phenethyl alcohol glycosides, etc., can clear heat and dryness, detoxification, hemostasis, anti- pyretic, anti- viral, anti- fungal, etc. Scutellaria baicalin, baicalein have good antioxidant function.

[0025] Imperata: sweet, cold, lungs, stomach, bladder; blood cooling hemostasis, heat diuretic effect; for blood heat hemoptysis, hematuria, hot and thirsty, edema, hot and painful pain, etc.; it contains triterpenoids, phenylpropanoids, organic acids, sugars, sterols, flavonoids and other active ingredients, mainly hemostatic, immunomodulatory, diuretic, antibacterial, anti-inflammatory analgesic, antitumor, hypoglycemic, hypolipidemic and other pharmacological effects.

[0026] Lycopene: bitter, pungent, slightly warm; liver and spleen; has the effect of promoting blood circulation, removing blood stasis, removing water and swelling, etc., used for the treatment of irregular menstruation, amenorrhea, dysmenorrhea, postpartum blood stasis abdominal pain, sore abscess, edema, ascites and other diseases.

[0027] (Three) beneficial effects

[0028] The TCM etiology and pathogenesis of lymphedema mainly involves invasion of external pathogens, dysfunction of viscera, and damage from surgery and radiotherapy. In the early stage of the disease, it is mostly due to spleen deficiency, cold dampness blocking the collaterals, and dampness and heat stagnation. If the disease lasts for a long time, it is mostly due to phlegm-dampness blocking the collaterals and qi stagnation and blood stasis. Therefore, in the treatment, the method of syndrome differentiation should be used according to the specific condition of the patient, in order to achieve the purpose of reducing swelling, promoting water excretion, regulating qi and blood, and dredging collaterals. At the same time, for patients after surgery and radiotherapy, attention should also be paid to tonifying the functional qi of viscera, so that it can work normally and transport water, in order to reduce or prevent the occurrence of lymphedema. Based on the above treatment methods and principles, and in accordance with the principle of TCM syndrome differentiation, the present application provides a traditional Chinese medicine preparation for treating lymphedema by external treatment, which is prepared from Astragalus, Ramulus Cinnamomi, Poria, Akebia, Chuanxiong, Salvia, Bupleurum, Scutellaria, Imperata, and Lycopene. In the formula, Astragalus can tonify the body's qi, and when the qi is strong, the blood will flow, and when the qi is sufficient, the water and dampness will be transported and transformed, so it can remove blood stasis without damaging the normal, promote water excretion and reduce swelling; Poria has a sweet and mild taste, which can tonify and penetrate the spleen, and it also enters the spleen meridian, so it can reduce swelling and tonify the spleen while promoting water excretion, so that the clear yang in the middle can ascend and the turbid yin can descend; Imperata, Akebia, and Lycopene can warm and unblock the meridians, enhance the overall function of the body, and improve symptoms such as qi deficiency, blood stasis, and edema; Akebia and Lycopene can enhance the effect of promoting water excretion and unblocking the urinary bladder, which is helpful for removing excess water and toxins in the body; Chuanxiong, Salvia, and Ramulus Cinnamomi can promote blood circulation and relieve pain, which is helpful for improving blood circulation and relieving various discomforts caused by blood stasis; Bupleurum and Scutellaria can regulate mood and clear heat and detoxify; the combination of all the drugs can achieve the effects of tonifying qi, promoting blood circulation, promoting water excretion, soothing liver and relieving depression, and clearing heat and detoxifying.

[0029] The traditional Chinese medicine preparation of the present application can significantly reduce the increase of the circumference of the hind limbs of the lymphedema model mice, has a significant effect of eliminating edema, and can effectively reduce the content of inflammatory factors in the serum of the lymphedema model mice, has a significant effect of eliminating inflammation and resisting inflammation; the traditional Chinese medicine preparation of the present application has a significant treatment effect on the lymphedema model mice.

[0030] Meanwhile, the traditional Chinese medicine preparation for treating lymphedema in TCM external treatment provided by the present application can significantly improve the clinical symptoms of the patients, reduce the pain of the patients, help the patients to recover the functional state, reduce the level of inflammatory factors, promote the absorption of edema of the patients, and significantly relieve the lymphedema of the affected limbs; the total effective rate of the traditional Chinese medicine preparation of the present application for treating lymphedema can reach 95.45%, and the curative effect is significant. DETAILED DESCRIPTION

[0031] To make the objectives, technical solutions, and advantages of the embodiments of the present application clearer, the technical solutions in the embodiments of the present application will be described clearly and completely below in conjunction with the embodiments of the present application. Obviously, the described embodiments are some embodiments but not all embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative work fall within the protection scope of the present application.

[0032] Embodiment 1

[0033] An external traditional Chinese medicine preparation for lymphedema is prepared from the following raw materials in parts by weight: 20-40 parts of Huangqi, 5-25 parts of Guizhi, 10-30 parts of Fuling, 10-30 parts of Mutong, 15-35 parts of Chuanqiong, 15-35 parts of Danshen, 5-25 parts of Chaihu, 5-25 parts of Huangqin, 5-25 parts of Baomao, and 5-25 parts of Zelan.

[0034] The traditional Chinese medicine preparation is used for preparing a drug for a traditional Chinese medicine external treatment method for lymphedema, and the drug is a drug for a traditional Chinese medicine fumigation and washing therapy, a drug for a traditional Chinese medicine hot compress method, and a drug for a traditional Chinese medicine external application method.

[0035] The drug for the traditional Chinese medicine fumigation and washing therapy is prepared according to the following steps: the raw materials are weighed according to the above weight parts, then soaked in 5 times by weight or more of pure water for 30 min or more, and then boiled for 30 min or more, to obtain the drug. When used, the affected part is placed in the warm boiled liquid or above the steam.

[0036] The drug for the traditional Chinese medicine hot compress method is prepared according to the following steps: the raw materials are weighed according to the above weight parts, and then ground or sliced, and then put into a traditional Chinese medicine sealing bag, to obtain the drug. When used, the traditional Chinese medicine sealing bag containing the drug is heated, and then placed on the affected part for external application.

[0037] The medicine for external application of traditional Chinese medicine is prepared according to the following steps: the raw materials are weighed according to the above weight proportions, the raw materials are crushed and passed through a 150-200 mesh sieve, and then mixed uniformly, and then boiled with appropriate amount of water and honey until it becomes a thick paste that does not flow, and then obtained. Before use, heat the paste to a temperature acceptable to the human body, and apply it thickly on the affected part; the thick application thickness is 0.3-0.5 cm.

[0038] Example 2

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

[0040] The traditional Chinese medicine preparation is made from the following raw materials by weight: 20-40 parts of Huangqi, 5-25 parts of Guizhi, 10-30 parts of Fuling, 10-30 parts of Mutong, 15-35 parts of Chuanxiong, 15-35 parts of Danshen, 5-25 parts of Chaihu, 5-25 parts of Huangqi, 5-25 parts of Baomao, and 5-25 parts of Zelan.

[0041] Example 3

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

[0043] The traditional Chinese medicine preparation is made from the following raw materials by weight: 20-40 parts of Huangqi, 5-25 parts of Guizhi, 10-30 parts of Fuling, 10-30 parts of Mutong, 15-35 parts of Chuanxiong, 15-35 parts of Danshen, 5-25 parts of Chaihu, 5-25 parts of Huangqi, 5-25 parts of Baomao, and 5-25 parts of Zelan.

[0044] Example 4

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

[0046] The traditional Chinese medicine preparation is made from the following raw materials by weight: 25-35 parts of Huangqi, 10-20 parts of Guizhi, 15-25 parts of Fuling, 15-25 parts of Mutong, 20-30 parts of Chuanxiong, 20-30 parts of Danshen, 10-20 parts of Chaihu, 10-20 parts of Huangqi, 10-20 parts of Baomao, and 10-20 parts of Zelan.

[0047] Example 5

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

[0049] The traditional Chinese medicine preparation is made from the following raw materials by weight: 25-35 parts of Huangqi, 10-20 parts of Guizhi, 15-25 parts of Fuling, 15-25 parts of Mutong, 20-30 parts of Chuanxiong, 20-30 parts of Danshen, 10-20 parts of Chaihu, 10-20 parts of Huangqi, 10-20 parts of Baomao, and 10-20 parts of Zelan.

[0050] Example 6

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

[0052] The traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 25-35 parts of Huangqi, 10-20 parts of Guizhi, 15-25 parts of Fuling, 15-25 parts of Mutong, 20-30 parts of Chuanqiong, 20-30 parts of Danshen, 10-20 parts of Chaihu, 10-20 parts of Huangqin, 10-20 parts of Baomao, and 10-20 parts of Zelan.

[0053] Example 7

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

[0055] The traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 25-35 parts of Huangqi, 10-20 parts of Guizhi, 15-25 parts of Fuling, 15-25 parts of Mutong, 20-30 parts of Chuanqiong, 20-30 parts of Danshen, 10-20 parts of Chaihu, 10-20 parts of Huangqin, 10-20 parts of Baomao, and 10-20 parts of Zelan.

[0056] Example 8

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

[0058] The traditional Chinese medicine preparation is made from the following raw materials in parts by weight: 30 parts of Huangqi, 15 parts of Guizhi, 20 parts of Fuling, 20 parts of Mutong, 25 parts of Chuanqiong, 25 parts of Danshen, 15 parts of Chaihu, 15 parts of Huangqin, 10 parts of Baomao, and 10 parts of Zelan.

[0059] Test Example 1

[0060] Effects of the external use traditional Chinese medicine preparation provided by the present application on a lymphedema model mouse

[0061] 1. Materials and methods

[0062] 1.1 Experimental animals

[0063] SPF grade male C57BL / 6J mice, 20-22 g in weight, 7-8 weeks old, adaptive feeding for 1 week, free feeding and drinking water, temperature 25℃, humidity 50%-60%.

[0064] 1.2 Experimental drugs

[0065] Drug 1: 30 parts of Huangqi, 15 parts of Guizhi, 20 parts of Fuling, 20 parts of Mutong, 25 parts of Chuanqiong, 25 parts of Danshen, 15 parts of Chaihu, 15 parts of Huangqin, 10 parts of Baomao, and 10 parts of Zelan;

[0066] Drug 2: 15 parts of Guizhi, 20 parts of Fuling, 20 parts of Mutong, 25 parts of Chuanqiong, 25 parts of Danshen, 10 parts of Baomao, and 10 parts of Zelan;

[0067] Medicine 3: Radix Astragali 30 parts, Ramulus Cinnamomi 15 parts, Rhizoma Chuanxiong 25 parts, Radix Salviae Miltiorrhizae 25 parts, Radix Bupleuri 15 parts, Radix Scrophulariae 15 parts;

[0068] Medicine 4: Radix Astragali 30 parts, Poria 20 parts, Caulis Lonicerae 20 parts, Radix Bupleuri 15 parts, Radix Scrophulariae 15 parts, Imperata Cylindra 10 parts, Lonicera 10 parts

[0069] According to the above weight parts, each raw material is taken, each raw material is crushed and passed through a 150-200 mesh sieve, then mixed uniformly, and a proper amount of water and honey is added to cook until it becomes a thick paste that does not flow, and the medicine 1-4 is obtained.

[0070] 1.2 Construction of mouse hindlimb lymphedema model

[0071] After 1 week of adaptive feeding of healthy C57BL / 6J male mice, pentobarbital sodium was injected intraperitoneally for anesthesia, and the skin was prepared and disinfected routinely. 0.1% evans blue 0.1ml was injected subcutaneously into the left paw of the mouse to identify the lymph nodes and lymphatic vessels, and after 5-10 minutes, the left inguinal skin was circumferentially incised, the inguinal and popliteal lymph nodes were removed, and the deep lymphatic vessels were destroyed. A silicone ring with a width of about 2-3mm was fixed on the incision skin margin using 6-0 suture, leaving a gap to prevent skin contraction and healing, and blocking the superficial lymphatic vessels. After 5-7 days, the mouse hindlimb appeared obvious edema, indicating successful modeling.

[0072] 1.3 Establishment of mouse hindlimb sham operation model

[0073] After 1 week of adaptive feeding of 5 healthy C57BL / 6J male mice, pentobarbital sodium was injected intraperitoneally for anesthesia, and the skin was prepared and disinfected routinely. Only the left inguinal skin was circumferentially incised, without damaging the lymph nodes and lymphatic vessels, and a silicone ring with a width of about 2-3mm was directly fixed on the skin margin using 6-0 suture, and the mouse hindlimb did not appear edema.

[0074] 1.4 Grouping treatment

[0075] The successfully constructed mouse model was divided into sham operation group, model group, experiment 1-4 group, 5 mice in each group. The mice in each group were treated with depilation at the modeling site, and the sham operation group and the model group were not treated at the modeling site, and the experiment 1-4 group was externally applied with medicine 1-4 at the modeling site, and the medicine was evenly thickly applied to the affected part, and was kept for 1h, and the drug was continuously given for 14 days, and the edema changes of the mouse hindlimb were observed and recorded.

[0076] 1.5 Observation index

[0077] 1.5.1 Measurement of hindlimb circumference

[0078] The mouse was fixed on the dissection plate under anesthesia, and after depilation, the circumference at 2mm above the knee of the mouse was measured with an inelastic micro tape, repeated 3 times, and the average value was taken.

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

[0080] 1.5.2 Determination of inflammatory factors in serum

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

[0082] 1.6 Statistical analysis

[0083] Statistical processing was performed using Prism 8.0.2, one-way ANOVA was used for comparison between groups, and the results were expressed as mean ± standard deviation , t-test was used. P<0.05 was statistically significant.

[0084] 2 Results

[0085] 2.1 Effect of the external use of traditional Chinese medicine preparation of the application on the hind limb edema of lymphedema model mice

[0086] The results are shown in Table 1. The hind limb circumference of the 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 the mice in the model group was significantly increased, and the difference was significant (P<0.05), indicating that the lymphedema model was successfully constructed. Compared with the model group, the increase in the hind limb circumference of the mice in experimental groups 1-4 was significantly reduced on the 7th day and the 14th day of administration (P<0.05); within experimental groups 1-4, the increase in the hind limb circumference of the mice in each group was significantly reduced on the 7th day and the 14th day of administration compared with the 1st day of administration (P<0.05); on the 7th day and the 14th day of administration, the increase in the hind limb circumference of the 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, the shoulder mark lowercase letter or no letter P>0.05, different lowercase letters represent P<0.05; in the same column of data, the shoulder mark same capital letter or no letter P>0.05, different capital letters represent P<0.05.

[0091] 2.2 Effect of the external use of traditional Chinese medicine preparation of the application on inflammatory factors in serum of lymphedema model mice

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

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

[0094] grouping IL-6 relative expression TNF-α relative expression sham operation group 1.041 ± 0.014 a ]] 1.039 ± 0.027 a ]] model group 1.182 ± 0.008 b ]] 1.176 ± 0.047 b ]] experiment 1 group 1.038 ± 0.013 a ]] 1.040 ± 0.031 a ]] experiment 2 group 1.067 ± 0.011 c ]] 1.082 ± 0.036 c ]] experiment 3 group 1.107 ± 0.021 d ]] 1.113 ± 0.041 d ]] experiment 4 group 1.084 ± 0.018 e ]] 1.076 ± 0.029 c ]]

[0095] Note: In the same column, the same lowercase letter or no letter P>0.05, different lowercase letters represent P<0.05.

[0096] 3 Conclusion

[0097] The above results show that the traditional Chinese medicine preparation of the present application can significantly reduce the increase in the circumference of the hind limbs of the lymphedema model mice, has a significant dehydrating effect, and the traditional Chinese medicine preparation of the present application can also effectively reduce the content of inflammatory factors in the serum of the lymphedema model mice, has obvious anti-inflammatory effect. Importantly, the components in the traditional Chinese medicine preparation of the present application complement each other and have synergistic effect, and the therapeutic effect on the lymphedema model mice is significantly higher than that of other traditional Chinese medicine preparations (the preparations used in experimental groups 2-4).

[0098] Test Example 2

[0099] 1 Data and Methods

[0100] 1.1 General data

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

[0102] Diagnosis standard: meet the grading standard of postoperative upper limb lymphedema of breast cancer in the research of mechanism and treatment of postoperative upper limb edema of breast cancer.

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

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

[0105] 1.2 Method

[0106] Control group: give conventional comprehensive treatment, including limb function exercise, elastic sleeve, air wave pressure circulation and before sleep centripetal massage treatment; wherein the limb function training is 1 time each morning and afternoon, 30 min / time; air wave pressure circulation 1 time / d, 30 min / time; before sleep centripetal massage is massaged from the wrist of the affected limb to the heart of the affected limb by rubbing, pinching, holding and other methods, 20 min / time.

[0107] Observation group: on the basis of the above treatment, give the external use of traditional Chinese medicine preparation of the application for treatment; the specific composition is: 30 parts of Huangqi, 15 parts of Guizhi, 20 parts of Fuling, 20 parts of Mutong, 25 parts of Chuanqiong, 25 parts of Danshen, 15 parts of Chaihu, 15 parts of Huangqin, 10 parts of Baomao, 10 parts of Zelan; according to the above weight fraction, the raw materials are crushed and passed through a 150-200 mesh sieve, then mixed uniformly, and then boiled with appropriate amount of water and honey until it becomes a thick paste that does not flow. Before use, heat the paste to a temperature acceptable to the human body, and apply it thickly to the affected area; the thick coating thickness is 0.3-0.5 cm, covered with gauze, and then wrapped with non-woven fabric outside, fixed with adhesive tape, to prevent drug extravasation, 1 time daily, each time for 4-6 h of external application, finally wash the skin with warm water, and apply neutral moisturizing cream to protect the skin.

[0108] Both groups were treated for 2 weeks.

[0109] 1.3 Evaluation index

[0110] (1) TCM symptom score: according to the "Guidelines for Clinical Research of New Drugs of Traditional Chinese Medicine", the evaluation content includes 6 items such as upper limb edema, pain, limb numbness, weakness, loss of appetite, restlessness, etc., which are divided into no, mild, moderate and severe according to the severity, respectively 0 points, 1 point, 2 points and 3 points, 1 point for tongue and pulse abnormalities, and the total score is calculated.

[0111] (2) Upper arm circumference: before and after treatment, the circumference of 5 cm above the wrist transverse line, 10 cm below the elbow transverse line, and 10 cm above the elbow transverse line to the axillary fossa of both sides was measured by tape, and the difference in upper arm circumference was calculated as the sum of the upper arm circumference of the affected side minus the sum of the upper arm circumference of the healthy side. To reduce the error of manual measurement, a fixed nurse was arranged to measure the patient's arm circumference within a fixed time range and record it.

[0112] (3) Inflammatory factors: Take fasting venous blood before and after treatment in two groups, and detect C-reactive protein (CRP) and interleukin-6 (IL-6) levels by enzyme-linked immunoassay.

[0113] (4) Pain score: The visual analogue scale (VAS) was used to assess the degree of pain in patients, with a total score of 0-10 points. The higher the score, the more severe the pain.

[0114] (5) Functional status score: The Karnofsky Performance Status Score (KPS) was used to assess the functional status of patients, with a total score of 0-100 points, and a total of 11 grades. 0 points indicate death, 10 points indicate critical, 20 points indicate life, 30 points indicate life, 40 points indicate life, 50 points indicate life, 60 points indicate occasional assistance, 70 points indicate life, 80 points indicate some symptoms and signs, 90 points indicate mild clinical symptoms, and 100 points indicate no symptoms and signs.

[0115] (6) Efficacy determination:

[0116] Marked effect: After treatment, the clinical symptoms improved significantly, and the edema was basically eliminated.

[0117] Improvement: Compared with the healthy upper extremity, the edema was >50% eliminated.

[0118] Effective: Compared with the healthy upper extremity, the edema was 30-50% eliminated.

[0119] Ineffective: The edema did not change or worsened.

[0120] Total effective rate = (marked effect + improvement + effective) / total number x 100%

[0121] 1.4 Statistical methods

[0122] SPSS21.0 statistical software was used to represent the measurement data as mean ± standard deviation, non-independent sample t-test was used between groups, paired sample t-test was used within groups, percentage was used for count data, χ 2 test was used for comparison between groups, P<0.05 was considered statistically significant.

[0123] 2 Results

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

[0125] The results are shown in Table 3. There was no significant difference in TCM symptom scores between the two groups before treatment (P>0.05). Compared with before treatment, the TCM symptom scores of the two groups after treatment were significantly decreased (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 syndrome scores of two groups of patients before and after treatment

[0127] grouping n before treatment after treatment observation group 44 13.94±3.11 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 between the circumferences of bilateral upper limbs of two groups of patients before and after treatment

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

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

[0132] grouping n before treatment after treatment observation group 44 9.52±4.77 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 of two groups of patients before and after treatment

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

[0136] Table 5 Inflammatory factors CRP and IL-6 levels of 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 score and KPS score of two groups of patients before and after treatment

[0140] Results are shown in Table 6. Compared with before treatment, the VAS scores of the two groups of patients were significantly decreased (P<0.05), and the KPS scores were significantly increased (P<0.05); among them, the VAS score of the observation group 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 effects of the two groups of patients

[0145] Results are shown in Table 7. The significant efficiency of the observation group was 56.81%, and the total effective rate was 95.45%; the significant efficiency 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 effects of the two groups of patients [n, (%)]

[0147] grouping n markedly effective improved effective ineffective 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 traditional Chinese medicine preparation for treating lymphedema in TCM external treatment provided by the present application can significantly improve the clinical symptoms of patients, reduce the pain of patients, and help patients recover the functional state. The traditional Chinese medicine preparation of the present application significantly relieves the lymphedema of the affected limb, which may be because the traditional Chinese medicine preparation of the present application can reduce the level of inflammatory factors and promote the absorption of edema of patients. The total effective rate of the traditional Chinese medicine preparation of the present application for treating lymphedema can reach 95.45%, and the curative effect is significant.

[0150] The above examples are only used to illustrate the technical solutions of the present application, but not to limit them; although the present application has been described in detail with reference to the foregoing examples, those skilled in the art should understand that they can still modify the technical solutions recorded in the foregoing examples, or make equivalent replacement for part of the technical features; and these modifications or replacements do not make the essence of the corresponding technical solutions deviate from the spirit and scope of the technical solutions of the embodiments of the present application.

Claims

1. A topical traditional Chinese medicine preparation for lymphedema, characterized in that, The traditional Chinese medicine preparation is made from the following raw materials in parts by weight: Astragalus membranaceus 20-40 parts, Cinnamomum cassia 5-25 parts, Poria cocos 10-30 parts, Akebia trifoliata 10-30 parts, Ligusticum chuanxiong 15-35 parts, Salvia miltiorrhiza 15-35 parts, Bupleurum chinense 5-25 parts, Scutellaria baicalensis 5-25 parts, Imperata cylindrica 5-25 parts, and Lycopus lucidus 5-25 parts.

2. The topical traditional Chinese medicine preparation for lymphedema as described in claim 1, characterized in that, The traditional Chinese medicine preparation is made from the following raw materials in parts by weight: Astragalus membranaceus 25-35 parts, Cinnamomum cassia 10-20 parts, Poria cocos 15-25 parts, Akebia trifoliata 15-25 parts, Ligusticum chuanxiong 20-30 parts, Salvia miltiorrhiza 20-30 parts, Bupleurum chinense 10-20 parts, Scutellaria baicalensis 10-20 parts, Imperata cylindrica 10-20 parts, and Lycopus lucidus 10-20 parts.

3. The topical traditional Chinese medicine preparation for lymphedema as described in claim 1, characterized in that, The traditional Chinese medicine preparation is made from the following raw materials in parts by weight: Astragalus membranaceus 30 parts, Cinnamomum cassia 15 parts, Poria cocos 20 parts, Akebia trifoliata 20 parts, Ligusticum chuanxiong 25 parts, Salvia miltiorrhiza 25 parts, Bupleurum chinense 15 parts, Scutellaria baicalensis 15 parts, Imperata cylindrica 10 parts, and Lycopus lucidus 10 parts.

4. The application of the traditional Chinese medicine preparation as described in any one of claims 1 to 3 in the preparation of a traditional Chinese medicine for external treatment of lymphedema, characterized in that, The drugs mentioned are those used in traditional Chinese medicine fumigation therapy, traditional Chinese medicine hot compress therapy, and traditional Chinese medicine external application therapy.

5. The application of the traditional Chinese medicine preparation according to claim 4 in the preparation of a traditional Chinese medicine for external treatment of lymphedema, characterized in that, The medicine used for traditional Chinese medicine fumigation and washing therapy is prepared according to the following steps: Weigh each raw material according to the above weight proportions, then soak it in pure water with more than 5 times its weight for more than 30 minutes, and then boil it over high heat for more than 30 minutes to obtain the medicine.

6. The application of the traditional Chinese medicine preparation according to claim 4 in the preparation of a traditional Chinese medicine for external treatment of lymphedema, characterized in that, The medicines used in the traditional Chinese medicine hot compress method are prepared according to the following steps: weigh each raw material according to the above weight proportions, crush or slice each raw material, and put them into a traditional Chinese medicine sealing bag to obtain the medicine.

7. The application of the traditional Chinese medicine preparation according to claim 4 in the preparation of a traditional 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 an appropriate amount of water and honey, and boil until it becomes a non-flowing viscous paste.

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