External washing traditional Chinese medicine composition for treating vascular diseases of lower limbs and preparation method of external washing traditional Chinese medicine composition

Abstract

The invention belongs to the technical field of traditional Chinese medicines, and provides an external washing traditional Chinese medicine composition for treating lower limb vascular diseases and a preparation method thereof. The external washing traditional Chinese medicine composition is prepared from the following traditional Chinese medicines: 25 to 35 parts of honeysuckle flower, 25 to 35 parts of herba taraxaci, 25 to 35 parts of cortex dictamni, 12 to 18 parts of radix sophorae flavescentis, 12 to 18 parts of radix angelicae sinensis, 12 to 18 parts of rhizoma chuanxiong, 12 to 18 parts of radix paeoniae rubra, 10 to 15 parts of frankincense, 10 to 15 parts of myrrh, 12 to 18 parts of cortex erythrinae, 25 to 35 parts of herba lycopi and 25 to 35 parts of sappan wood. The external washing traditional Chinese medicine composition disclosed by the invention has the effects of clearing away heat and toxic materials, inducing diuresis to reduce edema and promoting blood circulation to remove blood stasis, is suitable for treating symptoms such as swelling and heat pain, ulceration and purulence caused by lower limb vascular diseases, and has a wide market application prospect.

Description

TECHNICAL FIELD

[0001] The present application belongs to the technical field of traditional Chinese medicine, and relates to a traditional Chinese medicine composition for external washing in treatment of lower limb vascular diseases and a preparation method thereof. BACKGROUND

[0002] Lower limb vascular diseases include arterial diseases, venous diseases and lymphatic system diseases. Arterial diseases are mainly acute limb ischemia caused by arterial obstruction, and the causes may be embolism, thrombosis, dissection or trauma, etc. Venous diseases are mainly chronic venous insufficiency and thrombosis-related diseases.

[0003] There are many types of operations for lower limb vascular diseases, including open surgery, interventional surgery, new minimally invasive surgery (injection of sclerosing agent), etc. Many vascular disease patients need to receive multiple operations repeatedly, and acute and chronic pain caused by the diseases themselves or operations will lead to changes in the pathophysiology of the patients, mainly increased stress response and activation of the autonomic nervous system, which is extremely harmful to the patients with vascular diseases.

[0004] Thromboangiitis obliterans and lower limb venous thrombosis are common vascular diseases. Thromboangiitis obliterans mainly involves the small and medium arteries in the distal part of the limbs, and the accompanying veins and superficial veins are also often involved, which is a non-atherosclerotic, segmental, inflammatory occlusive vascular disease.

[0005] Lower limb venous thrombosis often occurs in postpartum and postoperative patients who have been bedridden for a long time. The three main factors leading to lower limb deep venous thrombosis are blood flow stasis, venous wall injury and high blood coagulation state. After the onset, the blood viscosity and coagulation increase, which provides favorable conditions for thrombosis. After thrombosis, the vascular endothelium is damaged, leading to collagen exposure, easy adhesion of platelets and activation of certain coagulation factors, resulting in further expansion of thrombus and eventually blocking of larger veins, causing blood return disorder.

[0006] Reducing blood viscosity, improving microcirculation and promoting blood circulation to remove blood stasis are the basis for treating vascular diseases, and it is of great significance to explore new drugs for treating lower limb vascular diseases and provide a reference for effective treatment of lower limb vascular diseases. SUMMARY

[0007] Therefore, the present application provides a traditional Chinese medicine composition for external washing in treatment of lower limb vascular diseases and a preparation method thereof.

[0008] The present application also provides a preparation method of the traditional Chinese medicine composition for external washing in treatment of lower limb vascular diseases.

[0009] The present application also provides application of the traditional Chinese medicine composition for external washing in treatment of lower limb vascular diseases in preparation of a drug for treating lower limb vascular diseases.

[0010] The technical scheme adopted by the present application to achieve the above-mentioned purpose is:

[0011] The first aspect of the present application provides an external washing traditional Chinese medicine composition for treating lower extremity vascular diseases, which is composed of the following traditional Chinese medicines: honeysuckle 25-35 parts, dandelion 25-35 parts, bark of Chinese goldthread 25-35 parts, kuh-seng 12-18 parts, angelica 12-18 parts, chuanxiong 12-18 parts, red peony root 12-18 parts, frankincense 10-15 parts, myrrh 10-15 parts, Pittosporium 12-18 parts, lycianthes 25-35 parts, and red sandalwood 25-35 parts.

[0012] As a preferred technical scheme of the present application, the external washing traditional Chinese medicine composition is composed of the following traditional Chinese medicines: honeysuckle 30 parts, dandelion 30 parts, bark of Chinese goldthread 30 parts, kuh-seng 15 parts, angelica 15 parts, chuanxiong 15 parts, red peony root 15 parts, frankincense 12 parts, myrrh 12 parts, Pittosporium 15 parts, lycianthes 30 parts, and red sandalwood 30 parts.

[0013] As a preferred technical scheme of the present application, the external washing traditional Chinese medicine composition is composed of the following traditional Chinese medicines: honeysuckle 35 parts, dandelion 25 parts, bark of Chinese goldthread 35 parts, kuh-seng 12 parts, angelica 18 parts, chuanxiong 12 parts, red peony root 18 parts, frankincense 15 parts, myrrh 10 parts, Pittosporium 18 parts, lycianthes 35 parts, and red sandalwood 25 parts.

[0014] As a preferred technical scheme of the present application, the external washing traditional Chinese medicine composition is composed of the following traditional Chinese medicines: honeysuckle 25 parts, dandelion 35 parts, bark of Chinese goldthread 25 parts, kuh-seng 18 parts, angelica 12 parts, chuanxiong 18 parts, red peony root 12 parts, frankincense 10 parts, myrrh 12 parts, Pittosporium 12 parts, lycianthes 25 parts, and red sandalwood 35 parts.

[0015] The second aspect of the present application provides a preparation method of the external washing traditional Chinese medicine composition for treating lower extremity vascular diseases, which comprises the following steps: mixing the traditional Chinese medicine components, adding water in a total weight of 7-10 times for the first time, decocting for 1.5-2.5 hours, collecting the filtrate, adding water in a total weight of 5-8 times of the filter residue to the filter residue, decocting for 0.5-1.5 hours, collecting the filtrate, and combining the filtrate obtained in the first decocting with the filtrate obtained in the second decocting.

[0016] As a preferred technical scheme of the present application, the preparation method of the external washing traditional Chinese medicine composition for treating lower extremity vascular diseases comprises the following steps: mixing the traditional Chinese medicine components, adding water in a total weight of 8 times for the first time, decocting for 2 hours, collecting the filtrate, adding water in a total weight of 6 times of the filter residue to the filter residue, decocting for 1 hour, collecting the filtrate, and combining the filtrate obtained in the first decocting with the filtrate obtained in the second decocting.

[0017] The third aspect of the present application provides a traditional Chinese medicine preparation of the external washing traditional Chinese medicine composition for treating lower extremity vascular diseases, characterized in that the traditional Chinese medicine preparation is prepared from the external washing traditional Chinese medicine composition for treating lower extremity vascular diseases described above as raw materials.

[0018] Further, the Chinese medicine preparation further comprises a pharmaceutically acceptable excipient. The dosage form of the Chinese medicine preparation is lotion.

[0019] In a fourth aspect of the present application, the use of the external washing Chinese medicine composition for treating lower limb vascular diseases in the preparation of a medicine for preventing or treating lower limb vascular diseases is provided.

[0020] Further, the lower limb vascular disease is lower limb venous thrombosis or thromboangiitis obliterans.

[0021] The pharmacological and beneficial effects of the present application are as follows:

[0022] Honeysuckle: sweet, cold, lungs, heart, stomach, spread of heat, clear blood; for all kinds of hot, such as fever, rash, spots, hot sores, sore throat, etc.

[0023] Dandelion: bitter, sweet, cold, liver, stomach, heat-clearing and detoxifying, diuretic and resolving; for acute mastitis, lymphadenitis, scrofula, abscess, acute conjunctivitis, cold, acute tonsillitis, acute bronchitis, gastritis, hepatitis, cholecystitis, urinary tract infection.

[0024] White bark: bitter, cold, spleen, stomach, bladder, heat-clearing and detoxifying, wind-removing and detoxifying; for wet heat sores, yellow water, eczema, wind rash, scabies, rheumatic arthralgia, red urine, jaundice, etc.

[0025] Sophora: bitter, cold, heart, liver, stomach, large intestine, bladder, heat-clearing and dampness-removing, insecticidal and diuretic; for dysentery, hematochezia, jaundice, leukorrhagia, pruritus, eczema, tinea, leprosy.

[0026] Angelica: bitter, warm, liver, heart, spleen, blood tonic, regulating menstruation and pain, moistening the intestines and relieving constipation; for blood deficiency, dizziness, palpitations, irregular menstruation, amenorrhea, abdominal pain, constipation, rheumatism, sprains, carbuncle and sore.

[0027] Chuanxiong: bitter, warm, liver, gallbladder, qi and depression, wind and dampness, blood circulation and pain relief; for irregular menstruation, amenorrhea, abdominal pain, chest pain, sprains, headache, rheumatism.

[0028] Red peony root: bitter, cold, liver, heat-clearing and blood-cooling, blood circulation and stasis; for heat into the blood, warm toxin rash, hematemesis, epistaxis, liver pain, amenorrhea, abdominal pain, sprains, carbuncle and sore.

[0029] Frankincense: bitter, bitter, warm, heart, liver, spleen, blood circulation, pain, swelling, muscle; for chest pain, stomach pain, dysmenorrhea, postpartum blood stasis, abdominal pain, rheumatism, muscle cramps, sprains, abscesses.

[0030] Myrrh: bitter, bitter, flat, heart, liver, spleen, blood circulation, pain, swelling, muscle; for chest pain, stomach pain, dysmenorrhea, postpartum blood stasis, abdominal pain, rheumatism, sprains, abscesses.

[0031] Pittosporium: bitter, bitter, flat, liver, spleen, kidney, wind, damp, pain, kill insects, itching; for the treatment of rheumatism, limbs, waist and knee pain, pain.

[0032] Herba Lycopi: bitter, bitter, slightly warm, liver, spleen, blood circulation, blood stasis, water retention; for irregular menstruation, amenorrhea, dysmenorrhea, postpartum blood stasis, edema.

[0033] Sappan Wood: sweet, salty, flat, heart, liver, spleen, blood circulation, blood stasis, swelling, pain; for sprains, fractures, blood stasis, abdominal pain, postpartum blood stasis, chest and abdominal pain, abscesses.

[0034] Blood stasis and blood stasis are related to meridian obstruction, so blood stasis and blood stasis are similar, and blood stasis and blood stasis are similar. The main manifestations are blood stasis and blood stasis, and the treatment method is blood stasis and blood stasis. The treatment method is blood stasis and blood stasis. The external use of the present application is combined with honeysuckle, dandelion, white bark, sophora, angelica, chuanxiong, red peony root, frankincense, myrrh, pittosporium, herba lycopi and sappan wood, which can clear heat and detoxify, promote blood circulation and reduce edema.

[0035] The external washing traditional Chinese medicine composition has the effects of clearing heat and detoxifying, reducing edema, promoting blood circulation and reducing blood stasis, and is suitable for treating redness, swelling, heat and pain, ulceration and other symptoms of lower limb vascular diseases.

[0036] PT, INR and FIB are important indicators in the blood coagulation system, which can effectively reflect coagulation dysfunction. The traditional Chinese medicine composition of the present application can significantly reduce FIB, increase PT and INR, and reduce the pathological changes of the affected limb of thrombotic occlusive vasculitis, thereby laying a foundation for the treatment of thrombotic occlusive vasculitis.

[0037] Animal experiments show that the external washing traditional Chinese medicine composition of the present application can significantly inhibit the swelling of rat feet caused by carrageenan, and has a significant swelling effect.

[0038] The external washing traditional Chinese medicine composition of the present application has higher clinical cure rate and total effective rate than the control group in the treatment of lower limb venous ulcers, and has lower recurrence rate than the control group, and has significant curative effect and high safety.

[0039] The traditional Chinese medicine composition has good curative effect, small toxic and side effect, and has wide market application prospect. BRIEF DESCRIPTION OF DRAWINGS

[0040] Figure 1 For each group of FIB comparison, compared with the sham operation group, & P<0.05, && P<0.01; compared with the model group, * P<0.05, **P<0.01; compared with the example 1 group, #P<0.05, ##P<0.01.

[0041] Figure 2 For each group of foot swelling comparison, compared with the blank control group, & P<0.05, && P<0.01; compared with the model control group, * P<0.05, ** P<0.01.

[0042] Figure 3 For each group of curative effect comparison. DETAILED DESCRIPTION

[0043] Now, various exemplary embodiments of the present application will be described in detail with reference to the accompanying drawings. Such detailed description, however, should not be considered to limit the present application, but be understood to be a more detailed description of some aspects, characteristics and embodiments of the present application.

[0044] It should be understood that the terms used in the present application are merely used to describe particular embodiments and are not intended to limit the present application. In addition, for numerical ranges in the present application, it should be understood that each intermediate value between the upper limit and the lower limit of the range is also specifically disclosed. Each smaller range within any stated range or within any stated intermediate value, as well as any other stated value or intermediate value within the stated range, is also encompassed within the present application. The upper and lower limits of these smaller ranges can be independently included or excluded from the range.

[0045] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present application, preferred methods and materials are described. All publications mentioned in this specification are herein incorporated by reference to disclose and describe the methods and / or materials in connection with which the publications are cited. The citation of any reference in this specification is not an admission that it is prior art.

[0046] Many modifications and variations of the specific embodiments of the application can be made without departing from the scope or spirit of the application. Other embodiments of the application will be apparent to those skilled in the art from consideration of the specification and practice of the application. The specification and examples are illustrative only.

[0047] As used herein, the terms "comprises", "comprising", "includes", "including", "has", "having" or variants thereof are open-ended, and specifically mean including, but not limited to.

[0048] Example 1 A Chinese medicine composition for treating lower limb vascular diseases

[0049] Jinyinhua 30 parts, Pugongying 30 parts, Baijianpi 30 parts, Kushen 15 parts, Danggui 15 parts, Chuanqiong 15 parts, Chishao 15 parts, Rushi 12 parts, Muyan 12 parts, Haitongpi 15 parts, Zelan 30 parts, Sumu 30 parts.

[0050] The Chinese medicine components are mixed, 8 times the total weight of water is added for the first time, decocted for 2 hours, the filtrate is collected, 6 times the total weight of water is added to the filter residue, decocted for 1 hour, the filtrate is collected, and combined with the filtrate obtained from the first decoction.

[0051] Example 2 A Chinese medicine composition for treating lower limb vascular diseases

[0052] Jinyinhua 35 parts, Pugongying 25 parts, Baijianpi 35 parts, Kushen 12 parts, Danggui 18 parts, Chuanqiong 12 parts, Chishao 18 parts, Rushi 15 parts, Muyan 10 parts, Haitongpi 18 parts, Zelan 35 parts, Sumu 25 parts.

[0053] The Chinese medicine components are mixed, 7 times the total weight of water is added for the first time, decocted for 1.5 hours, the filtrate is collected, 8 times the total weight of water is added to the filter residue, decocted for 0.5 hours, the filtrate is collected, and combined with the filtrate obtained from the first decoction.

[0054] Example 3 A Chinese medicine composition for treating lower limb vascular diseases

[0055] Jinyinhua 25 parts, Pugongying 35 parts, Baijianpi 25 parts, Kushen 18 parts, Danggui 12 parts, Chuanqiong 18 parts, Chishao 12 parts, Rushi 10 parts, Muyan 12 parts, Haitongpi 12 parts, Zelan 25 parts, Sumu 35 parts.

[0056] The Chinese medicine components are mixed, 10 times the total weight of water is added for the first time, decocted for 2.5 hours, the filtrate is collected, 5 times the total weight of water is added to the filter residue, decocted for 1.5 hours, the filtrate is collected, and combined with the filtrate obtained from the first decoction.

[0057] Example 4 A Chinese medicine composition for treating lower limb vascular diseases

[0058] Honeysuckle 32 parts, dandelion 30 parts, bai xianpi 30 parts, kuh-seng 15 parts, angelica 18 parts, chuan xiong 15 parts, red peony root 12 parts, frankincense 12 parts, myrrh 15 parts, Pittosporium 15 parts, Lonicera 28 parts, Su Mu 35 parts.

[0059] The components of each traditional Chinese medicine are mixed, and 10 times the total weight of water is added for the first time, and decocted for 2 hours. The filtrate is collected, and 5 times the total weight of water is added to the residue for the second time, and decocted for 1.5 hours. The filtrate is collected, and combined with the filtrate obtained in the first decoction.

[0060] Example 5 A traditional Chinese medicine composition for external washing for treating lower extremity vascular diseases

[0061] Honeysuckle 30 parts, dandelion 28 parts, bai xianpi 25 parts, kuh-seng 16 parts, angelica 15 parts, chuan xiong 12 parts, red peony root 18 parts, frankincense 10 parts, myrrh 10 parts, Pittosporium 18 parts, Lonicera 30 parts, Su Mu 30 parts.

[0062] The components of each traditional Chinese medicine are mixed, and 8 times the total weight of water is added for the first time, and decocted for 1.5 hours. The filtrate is collected, and 6 times the total weight of water is added to the residue for the second time, and decocted for 1 hour. The filtrate is collected, and combined with the filtrate obtained in the first decoction.

[0063] Comparative Example 1

[0064] Honeysuckle 30 parts, kuh-seng 15 parts, angelica 15 parts, chuan xiong 15 parts, red peony root 15 parts, frankincense 12 parts, myrrh 12 parts, Pittosporium 15 parts, Lonicera 30 parts, Su Mu 30 parts.

[0065] Compared with Example 1, the difference is that it does not contain dandelion and bai xianpi, and the other components and amounts are unchanged.

[0066] The components of each traditional Chinese medicine are mixed, and 8 times the total weight of water is added for the first time, and decocted for 2 hours. The filtrate is collected, and 6 times the total weight of water is added to the residue for the second time, and decocted for 1 hour. The filtrate is collected, and combined with the filtrate obtained in the first decoction.

[0067] Comparative Example 2

[0068] Dandelion 30 parts, bai xianpi 30 parts, angelica 15 parts, chuan xiong 15 parts, red peony root 15 parts, frankincense 12 parts, myrrh 12 parts, Pittosporium 15 parts, Lonicera 30 parts, Su Mu 30 parts.

[0069] Compared with Example 1, the difference is that it does not contain honeysuckle and kuh-seng, and the other components and amounts are unchanged.

[0070] The components of each traditional Chinese medicine are mixed, and 8 times the total weight of water is added for the first time, and decocted for 2 hours. The filtrate is collected, and 6 times the total weight of water is added to the residue for the second time, and decocted for 1 hour. The filtrate is collected, and combined with the filtrate obtained in the first decoction.

[0071] Comparative Example 3

[0072] Jin Qianhua 30 parts, Pugongying 30 parts, Bai Xianpi 30 parts, Ku Shen 15 parts, Dang Gui 15 parts, Ru Xiang 12 parts, Mo Yao 12 parts, Haitongpi 15 parts, Ze Lan 30 parts, Su Mu 30 parts.

[0073] Compared with Example 1, the difference lies in that it does not contain Chuanqiong and Chishao, and other components and dosages remain unchanged.

[0074] Mix each traditional Chinese medicine component, add 8 times the weight of water for the first time, decoct for 2h, collect the filtrate, add 6 times the weight of water to the filter residue, decoct for 1h, collect the filtrate, and combine the filtrate obtained by the first decoction.

[0075] Comparative Example 4

[0076] Jin Qianhua 30 parts, Pugongying 30 parts, Bai Xianpi 30 parts, Ku Shen 15 parts, Dang Gui 15 parts, Chuanqiong 15 parts, Chishao 15 parts, Ru Xiang 12 parts, Ze Lan 30 parts, Su Mu 30 parts.

[0077] Compared with Example 1, the difference lies in that it does not contain Mo Yao and Haitongpi, and other components and dosages remain unchanged.

[0078] Mix each traditional Chinese medicine component, add 8 times the weight of water for the first time, decoct for 2h, collect the filtrate, add 6 times the weight of water to the filter residue, decoct for 1h, collect the filtrate, and combine the filtrate obtained by the first decoction.

[0079] Study on the effect of external washing traditional Chinese medicine composition on thrombosis obliterans rats

[0080] 1. Experimental method

[0081] 56 SPF male SD rats, weighing (180±20) g, 8 were selected as sham operation group according to random number method, and the rest were as modeling group.

[0082] After the modeling group rats were anesthetized, the left hind limb hair was shaved to expose the femoral artery, a longitudinal incision was made at the midpoint of the left lower limb groin to the medial side of the knee, the femoral artery near the heart was clamped with an artery clamp, 0.1 mL of sodium laurate (10 mg / kg) was injected at the distal end of the automatic artery clamp, and the needle was taken out; 15 min later, the artery clamp was removed, and the blood vessel was sutured when there was no active bleeding; the sham operation group was injected with 0.2 mL of normal saline, and after the operation was completed, penicillin 400kU was injected intraperitoneally to prevent infection.

[0083] The modeling group rats all had color changes in the affected limbs, and even gangrene, indicating that the modeling was successful. The rats after modeling were divided into model group, experimental group 1, control group 1, control group 2, control group 3, control group 4 according to random number method, 8 rats in each group.

[0084] The experimental groups and dosing schedules are shown in Table 1.

[0085] Table 1 Dosage regimen for each group of rats

[0086] Group Administration mode Sham operation group Physiological saline to clean the affected area Model group Physiological saline to clean the affected area Experiment 1 group Example 1 external washing traditional Chinese medicine composition liquid to clean the affected area Control 1 group External washing traditional Chinese medicine composition liquid to clean the affected area of Comparative Example 1 Control 2 group External washing traditional Chinese medicine composition liquid to clean the affected area of Comparative Example 2 Control 3 group External washing traditional Chinese medicine composition liquid to clean the affected area of Comparative Example 3 Control 4 group External washing traditional Chinese medicine composition liquid to clean the affected area of Comparative Example 4

[0087] Starting from the day after modeling, each group was washed twice a day and the drug was administered continuously for 14 days.

[0088] 2. Detection indicators

[0089] 2.1 Rating of morphological changes in the affected limb

[0090] The morphological changes of the affected limbs were graded using a grading standard.

[0091] Grade 0: No change in overall appearance; Grade I: The lesion is limited to the nail; Grade II: The lesion is limited to the toe; Grade III: The lesion is limited to the paw; Grade IV: The lesion extends beyond the ankle joint and below the knee joint; Grade V: The lesion develops above the knee joint.

[0092] 2.2 Coagulation system index detection

[0093] The levels of serum plasma fibrinogen (FIB), prothrombin time (PT) and international normalized ratio (INR) of rats were detected and recorded using a coagulation detector.

[0094] 3. Statistical methods

[0095] GraphPad Prism 8.0 software was used for data processing and the quantitative data were The statistical differences among the groups were compared using one-way analysis of variance, and P < 0.05 indicated that the differences were statistically significant.

[0096] 4. Experimental Results

[0097] 4.1 Effects on the morphological changes of rats' affected limbs

[0098] Rats in the sham-operated group showed no lesions. In the model group, the affected limbs of rats gradually turned dark purple, hardened, dried, and yellowed. The lesions gradually spread from the toes to above the knee joint, accompanied by lameness. Within two weeks, some rats developed gangrene and lost their affected limbs.

[0099] Compared with the model group, the lesions in the affected limbs of rats in experimental group 1 were significantly alleviated.

[0100] Compared with control groups 1-4, experimental group 1 showed significant difference in reducing the pathological changes in the affected limb. The results are shown in Table 2.

[0101] Table 2 Lesion ratings of affected limbs in each group

[0102]

[0103] 4.2 Effect on the indicators of rat blood coagulation system

[0104] The results are shown in Tables 3 and 4.

[0105] Compared with the sham operation group, the PT and INR of the model group rats were significantly reduced.

[0106] Compared with the model group, the PT and INR of the rats in Example 1 were significantly increased.

[0107] The PT and INR indicators of Example 1 were significantly better than those of Control Groups 1-4, with significant differences.

[0108] Table 3 Comparison of PT in each group

[0109]

[0110]

[0111] Note: Compared with the sham operation group, & P<0.05, && P<0.01;

[0112] Compared with the model group, * P<0.05, ** P<0.01;

[0113] Compared with Example 1, # P<0.05, ## P<0.01.

[0114] Table 4 Comparison of INR in each group

[0115]

[0116] Note: Compared with the sham operation group, & P<0.05, && P<0.01;

[0117] Compared with the model group, * P<0.05, ** P<0.01;

[0118] Compared with Example 1, # P<0.05, ## P<0.01.

[0119] The results are shown in Figure 1 .

[0120] Compared with the sham operation group, the FIB of the model group rats was significantly increased.

[0121] Compared with the model group, the FIB of the rats in the experiment 1 group was significantly reduced.

[0122] The FIB index level of the experiment 1 group was significantly better than that of the control 1-4 groups, and there was a significant difference.

[0123] PT, INR and FIB are important indicators in the blood coagulation system, and can effectively reflect coagulation dysfunction. The traditional Chinese medicine composition in the present application significantly reduces FIB, increases PT and INR, and reduces the lesion of the affected limb of thromboangiitis obliterans, thereby laying a foundation for the treatment of lower limb vascular diseases.

[0124] Comparative example 1 does not contain dandelion and white peony bark, comparative example 2 does not contain honeysuckle and sophora, comparative example 3 does not contain chuanxiong and red peony root, and comparative example 4 does not contain myrrh and pittosporum bark. Compared with the control 1-4 groups, the improvement of each index of the experiment 1 group is more significant, which proves that the components of the external washing traditional Chinese medicine composition are indispensable and have a synergistic effect in the treatment of thromboangiitis obliterans.

[0125] Experimental study on the external washing traditional Chinese medicine composition on the plantar swelling caused by carrageenan

[0126] 24 SPF SD rats weighing 160-200g were divided into a blank control group, a model control group, an example 1 group and an example 2 group according to the random number method, with 6 rats in each group.

[0127] The model control group rats were soaked in normal saline for 5 minutes, and the right feet of the rats in the example 1 group and the example 2 group (75mL / kg) were soaked in the corresponding drugs for 15 minutes, 2 times a day, for 5 consecutive days.

[0128] After 1 hour of the end of the administration, the right hind foot volume of the rats in the blank control group was measured by a foot volume measuring instrument, and the mean value was obtained by continuously measuring 3 times. Then, 1% carrageenan suspension solution 0.1mL was subcutaneously injected into the middle of the rat foot to establish a foot swelling model. The right hind foot volume was measured by a foot volume measuring instrument 5 hours after modeling, and the mean value was obtained by continuously measuring 3 times.

[0129] The data were processed by GraphPad Prism 8.0 software, and the measurement data were represented by The statistical differences between groups were compared by one-way analysis of variance, and P<0.05 indicated that the difference had statistical significance.

[0130] Compared with the model control group, the example 1 group and the example 2 group significantly inhibited the rat foot swelling caused by carrageenan. The results are shown in Figure 2 .

[0131] The external washing traditional Chinese medicine composition significantly inhibits the rat foot swelling caused by carrageenan, and has a significant swelling effect.

[0132] Observation on therapeutic effect of external washing traditional Chinese medicine composition on lower limb venous ulcer

[0133] I. Materials and Methods

[0134] 1. General information

[0135] Select 60 patients with lower limb venous ulcer, according to the random number method, divided into control group, treatment group, 30 people each. The basic data of patients in each group showed that there was no statistically significant difference, and they were comparable.

[0136] 2. Diagnostic criteria

[0137] Refer to the diagnosis and treatment standard of TCM syndrome. The lower extremity is ulcerated, with varying sizes, mostly superficial, with grayish white, pale red or purple, surface or attached with yellow pus, with a concave wound, with a rim like a jar, with clear and thin pus, with gray or green, with a fishy smell. The surrounding ulcer can be accompanied by eczema, varicose veins, and pigmentation. The wound is difficult to heal, and the wound is easy to heal, and the recurrence is repeated.

[0138] Meet the above diagnostic criteria; through lower extremity venous color Doppler ultrasound and angiography and other related examinations, diagnosed as lower extremity varicose veins, lower extremity deep venous valve insufficiency, lower extremity deep venous thrombosis and other diseases, leading to lower extremity venous insufficiency, and is a regurgitant reflux disorder; clinical etiology anatomical and physiological classification is clinical manifestation 6 level, skin change plus active ulcer; combined with heart, lung disease cannot tolerate operation, or refuse operation treatment due to psychological factors; willing to accept the treatment strategy in the whole research process, and sign the informed consent form.

[0139] 3. Exclusion criteria

[0140] Allergic to the external use of traditional Chinese medicine composition in this test; receive surgical treatment; have immune system diseases; have mental illness and cannot cooperate with treatment; take oral aspirin or other anticoagulants; have severe heart and lung disease and cannot come to the hospital for dressing change and follow-up; have diabetes; have lower extremity venous obstructive reflux disorder.

[0141] 4. Treatment method

[0142] Control group: given routine treatment. The wound around the trauma is disinfected with iodophor, and the wound is flushed or wiped with 0.9% sodium chloride injection. Vaseline gauze covers the wound, and sterile gauze is bandaged and fixed. Change the dressing once every 3 days, and apply elastic bandage after dressing change. Treatment for 15 weeks.

[0143] Treatment group: external washing of the liquid obtained in Example 1. Pour the liquid obtained in Example 1 into a wooden barrel and dilute it with warm water to 10000-15000 mL. It is appropriate to completely immerse the ulcer above 3-5 cm. Soak both feet for 30 minutes once a day, replace the liquid once every 2-3 days, and continuously treat for 15 weeks.

[0144] 5. Observation index

[0145] 5.1 Therapeutic criteria

[0146] Cure: wound healing, inflammation disappeared;

[0147] Marked effect: wound area reduced by more than 75%, inflammation disappeared, wound had no odor and almost no exudation;

[0148] Effectiveness: wound area reduced by more than 25%, inflammation basically improved, wound odor reduced, and exudation reduced;

[0149] Ineffectiveness: wound area reduced by less than 25%, inflammation basically had no improvement, wound had a strong odor, and had more exudation.

[0150] Total effective rate = (cured cases + effective cases + effective cases) / total cases x 100%.

[0151] 5.2 Adverse reactions

[0152] The clinical effects of the two groups were compared, and the recurrence rate was followed up for 6 months. When there is a local non-traumatic necrotic lesion, it is considered to be recurrence.

[0153] II. Results

[0154] 1. Comparison of therapeutic effects of different groups

[0155] Table 5 Comparison of therapeutic effects of different groups

[0156] Group Number of cases / case Total effective rate / % Treatment group 30 93.33 Control group 30 80.00

[0157] From Figure 3 and Table 5, the total effective rate of the treatment group was 93.33%, and the total effective rate of the control group was 80.00%, and the clinical effect of the treatment group on lower extremity venous ulcer was significantly better than that of the control group.

[0158] 2. Comparison of adverse reactions of different groups

[0159] Table 6 Comparison of adverse reactions of different groups

[0160] Group Number of recurrence cases / case Recurrence rate / % Treatment group 2 6.67 Control group 3 10.00

[0161] The recurrence rate of the treatment group was 6.67%, and the recurrence rate of the control group was 10.00%. The safety of the drug of the treatment group is higher.

[0162] The clinical cure rate and total effective rate of the external washing traditional Chinese medicine composition for treating lower extremity venous ulcer of the application are higher than those of the control group, the recurrence rate is lower than that of the control group, the effect is significant, and the safety of the drug is high.

[0163] The above described embodiments are only to illustrate the preferred modes of the present application, and are not intended to limit the scope of the present application. Any modification and improvement made by those skilled in the art to the technical solutions of the present application without departing from the design spirit of the present application shall fall within the protection scope of the present application.

Claims

1. A Chinese medicinal composition for external washing for treating lower limb vascular diseases, characterized in that: The external wash Chinese medicinal composition for treating lower limb vascular diseases is composed of the following Chinese medicinal herbs by weight: 25-35 parts of honeysuckle, 25-35 parts of dandelion, 25-35 parts of white peony root, 12-18 parts of sophora flavescens, 12-18 parts of angelica, 12-18 parts of ligusticum, 12-18 parts of red peony root, 10-15 parts of frankincense, 10-15 parts of myrrh, 12-18 parts of pittosporum tobira bark, 25-35 parts of zedoaria, and 25-35 parts of sappan wood.

2. The Chinese medicinal composition for treating lower extremity vascular diseases according to claim 1, wherein The external wash Chinese medicine composition for treating lower limb vascular diseases is composed of the following Chinese medicines by weight: 30 parts of honeysuckle, 30 parts of dandelion, 30 parts of white peony root, 15 parts of sophora flavescens, 15 parts of angelica, 15 parts of ligusticum, 15 parts of red peony root, 12 parts of frankincense, 12 parts of myrrh, 15 parts of pittosporum tobira bark, 30 parts of zedoaria, and 30 parts of sappan wood.

3. The Chinese medicinal composition for treating lower extremity vascular diseases according to claim 1, wherein The external wash Chinese medicine composition for treating lower limb vascular diseases is composed of the following Chinese medicines by weight: 35 parts of honeysuckle, 25 parts of dandelion, 35 parts of white peony root, 12 parts of sophora flavescens, 18 parts of angelica, 12 parts of ligusticum, 18 parts of red peony root, 15 parts of frankincense, 10 parts of myrrh, 18 parts of pittosporum tobira bark, 35 parts of zedoaria, and 25 parts of sappan wood.

4. The Chinese medicinal composition for treating lower extremity vascular diseases according to claim 1, wherein The external wash Chinese medicine composition for treating lower limb vascular diseases is composed of the following Chinese medicines by weight: 25 parts of honeysuckle, 35 parts of dandelion, 25 parts of white peony root, 18 parts of sophora flavescens, 12 parts of angelica, 18 parts of ligusticum, 12 parts of red peony root, 10 parts of frankincense, 12 parts of myrrh, 12 parts of pittosporum tobira bark, 25 parts of zedoaria, and 35 parts of sappan wood.

5. The method for preparing the external wash Chinese medicine composition for treating lower extremity vascular diseases according to any one of claims 1 to 4, characterized in that: The preparation method comprises the following steps: mixing the various Chinese medicinal components, adding water in an amount of 7 to 10 times the total weight for the first time, decocting for 1.5 to 2.5 hours, collecting the filtrate, adding water in an amount of 5 to 8 times the total weight of the residue to the residue, decocting for 0.5 to 1.5 hours, collecting the filtrate, and combining the filtrate with the filtrate obtained from the first decoction.

6. The method for preparing the external wash Chinese medicine composition for treating lower extremity vascular diseases according to claim 5, characterized in that: The preparation method comprises the following steps: mixing the various Chinese medicinal components, adding water in an amount of 8 times the total weight for the first time, decocting for 2 hours, collecting the filtrate, adding water in an amount of 6 times the total weight of the residue to the filter residue, decocting for 1 hour, collecting the filtrate, and combining the filtrate with the filtrate obtained from the first decoction.

7. A Chinese medicine preparation for external wash of a Chinese medicine composition for treating lower limb vascular diseases, characterized in that: The Chinese medicine preparation is prepared using the external wash Chinese medicine composition for treating lower limb vascular diseases according to any one of claims 1 to 4 as a raw material.

8. The Chinese medicine preparation of the external wash Chinese medicine composition for treating lower extremity vascular diseases according to claim 7, characterized in that: The traditional Chinese medicine preparation further comprises a pharmaceutically acceptable excipient, and the dosage form of the traditional Chinese medicine preparation is a lotion.

9. Use of the external wash Chinese medicinal composition for treating lower limb vascular diseases according to any one of claims 1 to 4 in preparing a medicament for preventing or treating lower limb vascular diseases.

10. The use of the external wash Chinese medicine composition for treating lower limb vascular diseases according to claim 9, characterized in that: The lower extremity vascular disease is lower extremity venous thrombosis or thromboangiitis obliterans.

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