Meridian Soothing Topical Plaster, its Uses, and Preparation Method

Abstract

This invention belongs to the field of traditional Chinese medicine technology, specifically relating to a topical plaster for relieving pain and irritation, its uses, and preparation method. The traditional Chinese medicine composition is mainly prepared from raw materials such as leeches, scorpions, centipedes, angelica, scrophularia, coix seed, phellodendron bark, honeysuckle, astragalus, and licorice. The plaster of this invention treats deep vein thrombosis of the lower extremities, thrombophlebitis, thromboangiitis obliterans, and arteriosclerosis obliterans of the lower extremities. It is easy to apply, readily penetrates the skin, and is absorbed transdermally for maximum effect. Compared with oral and injectable medications, it has fewer side effects, directly targets the lesion, is absorbed quickly, has immediate effects, a wide range of applications, and no obvious contraindications.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically relating to the use and preparation method of a traditional Chinese medicine composition. More specifically, it relates to a topical plaster for promoting blood circulation and relieving pain, its uses, and its preparation method. Background Technology

[0002] Thrombophlebitis often manifests as superficial thrombophlebitis and deep vein thrombosis, with the latter being more common. This disease typically has a rapid onset, with symptoms including limb swelling, pain, fever, dark red skin, or the presence of cord-like structures. It is caused by dampness retention, blood stasis, obstruction of the blood vessels, or poor blood circulation. Cold and dampness obstruct the blood vessels, and over time, this stagnation transforms into heat, leading to the accumulation of damp-heat that infiltrates the blood vessels, ultimately resulting in the disease due to impaired blood flow.

[0003] Deep vein thrombosis (DVT) of the limbs most commonly occurs in the deep veins of the lower extremities. Clinically, it is relatively common, but treatment outcomes are often unsatisfactory, frequently resulting in deep vein obstruction or venous valve insufficiency. Lower extremity DVT usually originates in the gastrocnemius venous plexus or the segment from the iliac vein to the femoral vein. After thrombosis, except for a few cases that resolve spontaneously or remain localized to the site of origin, most extend to the entire main deep vein trunk of the limb. If not diagnosed and treated promptly, it often develops into post-thrombotic sequelae, significantly impacting the patient's quality of life and work for extended periods. In rare cases, it can lead to pulmonary embolism, causing extremely serious consequences.

[0004] This disease commonly occurs postpartum, after trauma, and after surgery. The incidence of postoperative deep vein thrombosis (DVT) is higher in Europe and the United States, and its incidence in my country has been increasing in recent years. According to literature reports, the incidence of thrombosis above the gastrocnemius venous plexus and pulmonary embolism is as high as 50%, with one-quarter of these cases being fatal. DVT mostly occurs during various surgeries and in the early postoperative period, with 10% of cases occurring 5-9 days postoperatively. How to implement effective preventive measures during the perioperative period, especially for high-risk patients, is a crucial issue that must be addressed.

[0005] Chinese invention patent CN1201787C discloses "a drug for treating thrombophlebitis." Products based on this patented technology possess the functions of clearing heat and detoxifying, resolving blood stasis and unblocking collaterals, and promoting diuresis and reducing swelling. They have certain preventive and therapeutic effects on thrombophlebitis and thromboangiitis obliterans. Preparations based on this invention patent include Mailuoshutong granules and Mailuoshutong pills, which have been widely used clinically to treat thrombophlebitis caused by damp-heat obstructing the collaterals, and lower limb swelling, pain, dark red skin, or cord-like structures caused by non-acute deep vein thrombosis. The clinical treatment has a high efficacy rate and can effectively relieve patients' suffering, receiving unanimous praise from patients and doctors. Summary of the Invention

[0006] This invention is a novel dosage form developed based on Chinese invention patent CN1201787C. The traditional Chinese medicine composition described in this invention can be prepared into a drug, specifically a Mailuoshutong ointment. The Mailuoshutong granules / pills series of products are exclusive products of Lunan Houpu Pharmaceutical Co., Ltd. The usage and dosage of Mailuoshutong ointment have been confirmed in animal experiments and have also been applied in specific medical cases.

[0007] The traditional Chinese medicine composition of the present invention mainly consists of leech, scorpion, centipede, angelica, scrophularia, coix seed, phellodendron bark, honeysuckle, astragalus, licorice, atractylodes, and white peony root.

[0008] The traditional Chinese medicine composition of the present invention is prepared into a topical ointment. Further, the topical ointment is selected from any one of ointment, black ointment, rubber ointment, poultice, paste, film coating, transdermal patch, and liniment. More specifically, the topical ointment is selected from rubber ointment.

[0009] The raw material is composed of the following components:

[0010]

[0011] Preferably, the raw material is composed of the following components:

[0012]

[0013] In a further preferred embodiment, the raw material comprises the following components:

[0014]

[0015] A further preferred embodiment is that the raw material is composed of the following components:

[0016]

[0017]

[0018] The method for preparing the thick paste of the traditional Chinese medicine composition described in this invention is as follows:

[0019] A. Grind leeches, centipedes, and scorpions into ultrafine powder, add 1 / 3 of the amount of medicinal matrix to soak, and obtain a mixture for later use;

[0020] B. Mix honeysuckle, atractylodes, angelica, white peony root, and licorice root evenly, concentrate in a water bath, and obtain concentrated liquid and dregs for later use.

[0021] C. Take Astragalus membranaceus, Phellodendron chinense, Scrophularia ningpoensis, Coix lacryma-jobi and the dregs obtained in step B, mix them evenly, add 1 / 3 of the amount of medicinal matrix to soak, heat, filter, cool, and set the medicinal liquid aside;

[0022] D. Take the concentrated liquid from step B, add ethanol and let it stand. Take the supernatant, filter it, recover the ethanol, concentrate it, vacuum dry it to a dry extract, pulverize the dry extract to obtain a dry extract powder, and set it aside.

[0023] E. Take the dry ointment powder obtained in step D and the mixture in step A, add the remaining pharmaceutical matrix, and prepare a topical ointment.

[0024] The rubber paste of the present invention is prepared by placing the thick paste from step E on rubber, the thickness of the thick paste being 2 mm, and then covering it with a liner to prepare a paste with a length and width of 50 cm.

[0025] This invention utilizes ointments prepared from combinations of traditional Chinese medicine, especially rubber ointments, to treat deep vein thrombosis, thrombophlebitis, thromboangiitis obliterans, and arteriosclerosis obliterans of the lower extremities. These ointments are easy to apply, and the added medicinal base, such as sesame oil, has a protective, moisturizing, and lubricating effect on the skin. The medicinal properties can easily penetrate the skin and be absorbed transdermally to exert their full effect.

[0026] Compared with oral medications and injections, it has very few toxic side effects, directly reaches the lesion, is absorbed quickly, and has an immediate effect. It is especially suitable for patients with digestive tract diseases such as gastric ulcers and chronic gastritis, who are not suitable for oral treatment. It has a wide range of applications and no obvious contraindications. In contrast, oral medications and injections need to be transported to the lesion through blood circulation, which is slower and less absorbed, and causes greater damage to the liver and kidneys. Specific Implementation

[0027] Example 1: A meridian-clearing ointment, the composition and preparation process of which are as follows:

[0028]

[0029] The preparation process is as follows:

[0030] A. Grind leeches, centipedes, and scorpions into ultrafine powder, pass through an 80-mesh sieve, add 1 / 3 of the amount of sesame oil and soak for 10 hours to obtain a mixture for later use;

[0031] B. Mix honeysuckle, atractylodes, angelica, white peony root, and licorice root evenly, reflux extract at 70-95℃ for 2.5h, and concentrate in a water bath at 45-60℃ to a concentrate with a relative density of 1.05-1.10. Set aside the concentrate and the residue.

[0032] C. Take Astragalus membranaceus, Phellodendron chinense, Scrophularia ningpoensis, Coix lacryma-jobi and the dregs obtained in step B, mix them evenly, add 1 / 3 of the amount of sesame oil for 12.5 hours, heat until charred, filter, cool, and set the liquid aside.

[0033] D. Take the concentrated solution from step B, add ethanol with a purity of 90% or higher, let stand for 24 hours, take the supernatant, filter, recover the ethanol, concentrate to a relative density of 1.15-1.18, vacuum dry to dry extract, pulverize the dry extract to obtain dry extract powder, and set aside for later use.

[0034] E. Take the dry powder obtained in step D and the mixture in step A, add the remaining sesame oil, and prepare a thick paste.

[0035] F. Place the slurry from step E onto the rubber, with a thickness of 2 mm, and cover it to prepare a paste with a length and width of 50 cm.

[0036] Example 2: A meridian-clearing ointment, the composition and preparation process of which are as follows:

[0037]

[0038] The preparation process is the same as in Example 1.

[0039] Example 3: A meridian-clearing ointment, the composition and preparation process of which are as follows:

[0040]

[0041] Step E in the preparation process is as follows: Take the dry powder obtained in step D and the mixture in step A, add honey, and prepare an ointment.

[0042] The other processes are the same as in Example 1.

[0043] Example 4: A meridian-clearing ointment, the composition and preparation process of which are as follows:

[0044]

[0045]

[0046] The other processes are the same as in Example 1.

[0047] The preparation process is as follows:

[0048] A. Grind leeches, centipedes, and scorpions into ultrafine powder, pass through an 80-mesh sieve, add 1 / 3 of the amount of sesame oil and soak for 10 hours to obtain a mixture for later use;

[0049] B. Mix honeysuckle, atractylodes, angelica, white peony root, and licorice root evenly, reflux extract at 70-95℃ for 1-4 hours, and concentrate in a water bath at 45-60℃ to a concentrate with a relative density of 1.05-1.10. Set aside the concentrate and the residue.

[0050] C. Take Astragalus membranaceus, Phellodendron chinense, Scrophularia ningpoensis, Coix lacryma-jobi and the dregs obtained in step B, mix them evenly, add 1 / 3 of the amount of sesame oil, heat for 5-20 hours until it turns charred, filter, cool, and keep the liquid for later use.

[0051] D. Take the concentrate from step B, add ethanol with a purity of 90% or higher, let stand for 26 hours, take the supernatant, filter, recover the ethanol, concentrate to a relative density of 1.15-1.18, vacuum dry to dry extract, pulverize the dry extract to obtain dry extract powder, for later use.

[0052] E. Take the dry powder obtained in step D and the mixture in step A, add the remaining sesame oil, and prepare a thick paste.

[0053] F. Place the viscous paste from step E onto the rubber to a thickness of 2 mm, and cover it with a liner to prepare a paste with a length and width of 50 cm.

[0054] Example 5: Commercially available Meridian-Soothing Pills

[0055] Example 6: A meridian-relieving ointment, the composition and preparation process of which are as follows:

[0056]

[0057] The preparation process is as follows:

[0058] The preparation process is as follows:

[0059] A. Grind leeches, centipedes, and scorpions into ultrafine powder, pass through an 80-mesh sieve, add 1 / 3 of the amount of sesame oil and soak for 10 hours to obtain a mixture for later use;

[0060] B. Mix honeysuckle, atractylodes, angelica, white peony root, and licorice root evenly, reflux extract at 70-95℃ for 1 hour, and concentrate in a water bath at 45-60℃ to a concentrate with a relative density of 1.05-1.10. Set aside the concentrate and the residue.

[0061] C. Take Astragalus membranaceus, Phellodendron chinense, Scrophularia ningpoensis, Coix lacryma-jobi and the dregs obtained in step B, mix them evenly, add 1 / 3 of the amount of sesame oil for 5 hours, heat until it turns charred, filter, cool, and keep the liquid for later use.

[0062] D. Take the concentrate from step B, add ethanol with a purity of 90% or higher, let stand for 22 hours, take the supernatant, filter, recover the ethanol, concentrate to a relative density of 1.15-1.18, vacuum dry to dry extract, pulverize the dry extract to obtain dry extract powder, and set aside for later use.

[0063] E. Take the dry powder obtained in step D and the mixture in step A, add the remaining sesame oil, and prepare a thick paste.

[0064] F. Place the thick paste from step E onto the rubber to a thickness of 2 mm, and cover it with a liner to prepare a paste with a length and width of 50 cm.

[0065] Example 7: A meridian-soothing ointment, the composition and preparation process of which are as follows:

[0066]

[0067] The preparation process is as follows:

[0068] A. Grind leeches, centipedes, and scorpions into ultrafine powder, pass through an 80-mesh sieve, add 1 / 3 of the amount of sesame oil and soak for 10 hours to obtain a mixture for later use;

[0069] B. Mix honeysuckle, atractylodes, angelica, white peony root, and licorice root evenly, reflux extract at 70-95℃ for 2.5h, and concentrate in a water bath at 45-60℃ to a concentrate with a relative density of 1.05-1.10. Set aside the concentrate and the residue.

[0070] C. Take Astragalus membranaceus, Phellodendron chinense, Scrophularia ningpoensis, Coix lacryma-jobi and the dregs obtained in step B, mix them evenly, add 1 / 3 of the amount of sesame oil for 12.5 hours, heat until charred, filter, cool, and set the liquid aside.

[0071] D. Take the concentrated solution from step B, add ethanol with a purity of 90% or higher, let stand for 24 hours, take the supernatant, filter, recover the ethanol, concentrate to a relative density of 1.15-1.18, vacuum dry to dry extract, pulverize the dry extract to obtain dry extract powder, and set aside for later use.

[0072] E. Take the dry powder obtained in step D and the mixture in step A, add the remaining sesame oil, and prepare an ointment.

[0073] Comparative Example 1: A meridian-clearing ointment, the composition and preparation process of which are as follows:

[0074]

[0075] The preparation process is the same as in Example 1.

[0076] Comparative Example 2: A meridian-clearing ointment, the composition and preparation process of which are as follows:

[0077]

[0078]

[0079] The preparation process is the same as in Example 1.

[0080] Comparative Example 3: A meridian-clearing ointment, the composition and preparation process of which are as follows:

[0081]

[0082] The preparation process is as follows:

[0083] A. Grind the leeches, centipedes, and scorpions into ultrafine powder, pass through an 80-mesh sieve, and set aside.

[0084] B. Take honeysuckle, atractylodes, angelica, white peony root, licorice, astragalus, phellodendron, scrophularia, and coix seed, mix them evenly, reflux extract at 70-95℃ for 1-4 hours, concentrate in a water bath at 45-60℃ to a concentrated solution with a relative density of 1.05-1.10, and set aside the concentrated solution and the residue.

[0085] C. Take the concentrated liquid from step B, add ethanol with a purity of 90% or higher, let stand for 22-26 hours, take the supernatant, filter, recover the ethanol, concentrate to a relative density of 1.15-1.18, vacuum dry to dry extract, pulverize the dry extract to obtain dry extract powder, for later use.

[0086] D. Take the dry powder obtained in step C and the mixture in step A, add sesame oil, and prepare a thick paste.

[0087] E. Place the thick paste from step D onto a rubber sheet to a thickness of 2 mm, and cover it with a liner to prepare a paste with a length and width of 50 cm.

[0088] Comparative Example 4: A meridian-clearing ointment, the composition and preparation process of which are as follows:

[0089]

[0090] The preparation process is as follows:

[0091] (1) Place the commercially available Mailuoshutong pills in the original bottle, add 20ml of water at 30-40℃, and stir until completely dissolved;

[0092] (2) Add 100-300ml of hot water at 80-100℃ to step (1) and stir well. Place the medicine containing the Meridian Soothing Pill on gauze and soak it completely without seeping through.

[0093] The method of use is as follows: Apply the gauze completely to the affected limb, wrap it with plastic wrap, leave it for about 30 minutes, and repeat 3 times a day.

[0094] Comparative Example 5: A meridian-clearing ointment, the composition and preparation process of which are as follows:

[0095]

[0096] The preparation process is as follows:

[0097] A. Grind the leeches, centipedes, and scorpions into ultrafine powder and pass it through an 80-mesh sieve;

[0098] B. Mix honeysuckle, atractylodes, angelica, white peony root, and licorice root evenly, reflux extract at 70-95℃ for 2.5h, and concentrate in a water bath at 45-60℃ to a concentrate with a relative density of 1.05-1.10. Set aside the concentrate and the residue.

[0099] C. Take Astragalus membranaceus, Phellodendron chinense, Scrophularia ningpoensis, Coix lacryma-jobi and the dregs obtained in step B, mix them evenly, add 1 / 3 of the amount of sesame oil for 12.5 hours, heat until charred, filter, cool, and set the liquid aside.

[0100] D. Take the concentrated solution from step B, add ethanol with a purity of 90% or higher, let stand for 24 hours, take the supernatant, filter, recover the ethanol, concentrate to a relative density of 1.15-1.18, vacuum dry to dry extract, pulverize the dry extract to obtain dry extract powder, and set aside for later use.

[0101] E. Take the dry paste powder obtained in step D and the mixture in step A, add glyceryl monostearate, and prepare a thick paste.

[0102] F. Place the slurry from step E onto the rubber, with a thickness of 2 mm, and cover it to prepare a paste with a length and width of 50 cm.

[0103] Verification of Examples

[0104] I. Pharmacological experiments on venous thrombosis of the ointment of the present invention.

[0105] The modeling method for venous thrombosis was established based on Feng Yaping's "Establishment of a new model of deep vein thrombosis in rabbits and study of accompanying inflammation".

[0106] Thrombus calculation method: Anesthesia was administered via intraperitoneal injection of urethane (25%) (0.5g / Kg). 2ml of 0.225% hypotonic saline was injected through the left femoral vein. The abdominal cavity was opened and the inferior vena cava was separated. The inferior vena cava was ligated with cotton thread below the left renal vein. The abdominal cavity was closed for ten minutes and then reopened. The inferior vena cava was ligated with cotton thread 2cm below the first ligation site. The small veins on both sides of this ligated segment were separated and removed. The vein wall was longitudinally cut open and the intact thrombus was removed and placed on filter paper moistened with physiological saline. The thrombus was then placed in a covered culture dish and allowed to shrink fully. It was removed and weighed after two hours.

[0107] Administration method: On the 15th day after surgery, the ointments of Example 1, Example 2, Comparative Example 3 and Comparative Example 4 of this invention were applied to the thrombus site of the rabbits for 1-3 hours; once a day for 3 consecutive days; the pills of Example 5 were administered orally at a dose of 1.68g / kg once a day for 3 consecutive days.

[0108] Table 1. Effects of Mailuoshutong granules on venous thrombosis in rabbits.

[0109] Group Thrombus weight (mg) Sham surgery group - Model group 38.8±5.02 Example 1 12.8±4.67**@ Example 5 12.7±4.42**@ Comparative Example 3 19.9±5.01** Comparative Example 4 17.6±6.25**

[0110] Note: * indicates P < 0.05 compared to the model group, ** indicates P < 0.01 compared to the model group.

[0111] @ indicates P < 0.05 compared to Comparative Example 3, ** indicates P < 0.01 compared to Comparative Example 3.

[0112] The experimental results in Table 1 show that, compared with the model group, each embodiment showed significant differences (P<0.01). Both Mailuoshutong pills and Mailuoshutong ointment could significantly inhibit the formation of venous thrombosis in rabbits (P<0.05). Although Comparative Example 3 showed significant differences compared with the model group, the thrombus reduction weight of the ointment in Example 1 was significantly lower than that in Comparative Example 3 compared with the embodiments of the present invention.

[0113] II. Typical Cases:

[0114] Mr. Zhang, male, 55 years old, complained of varicose veins for more than 10 years, which had recently become more severe. He also had a severe gastric ulcer. He used the ointment of Example 1 of this invention once a day. After 3 days of continuous application, without taking any painkillers, the pain was significantly reduced. After 7 days of continuous application, the pain disappeared. More than half a year later, there has been no recurrence.

[0115] Ms. Liu, 27 years old, complained of having mild phlebitis in the past, which had improved after taking anti-inflammatory drugs and traditional Chinese medicine. However, her condition worsened after becoming pregnant. In order to protect the healthy growth of the fetus, she did not take any medication. She is currently breastfeeding and has severe varicose veins in her legs. She applied the ointment of Example 1 of this invention once a day for 7 consecutive days, and her severe varicose veins in her legs were completely improved.

[0116] A statistical analysis of 66 patients treated showed an effective rate of 100% and a cure rate of 78%, indicating that the plaster of this invention has significant effects on superficial phlebitis, with a high effective rate and a high cure rate.

[0117] III. Testing the ointment prepared according to this invention on properties such as ointment content and heat resistance.

[0118] The products of Examples 1-4 and Comparative Examples 1-4 were placed in a constant temperature and humidity chamber at 25°C and 25% relative humidity for 6 months for testing.

[0119] Ointment content: Method 1: Take 2 pieces of the test sample (the area of ​​the ointment is 35 cm²). 2 Remove the backing, accurately weigh the contents, and place them in the same covered glass container. Add an appropriate amount of chloroform (a type of organic solvent) to impregnate the contents and shake. After the backing separates from the paste, remove the backing and wash it with the aforementioned solvent until no paste residue remains. Evaporate the solvent and dry at 105°C for 30 minutes. Transfer the dried contents to a desiccator and cool for 30 minutes. Accurately weigh the contents; the weight loss is the paste weight. Convert the weight to 100 cm² based on the indicated area. 2 The content of the extract should comply with the regulations under each product category.

[0120] Heat resistance: Take two pieces of the rubber plaster, remove the backing, heat at 60℃ for 2 hours, and then cool. Check for oil seepage in the backing; check the gloss and stickiness of the plaster surface.

[0121] Excipient properties: Take one sample and place it in a constant temperature and humidity chamber at 37℃ and 64% relative humidity for 30 minutes. Remove it and fix the sample on a flat steel plate with a clamp. The angle between the steel plate and the horizontal plane is 60°. Place it for 24 hours.

[0122] Adhesion: Unless otherwise specified, the adhesion shall be determined according to the Method for Determination of Adhesion of Rubber Plasters (General Rule 0952, Method II) in the 2020 edition of the Chinese Pharmacopoeia, as follows: Before the test, the plaster and patch (together with packaging materials) shall be placed at 18-25℃ and relative humidity of 40%-70% for more than 2 hours. Wipe the test plate and loading plate with a wiping material soaked in anhydrous ethanol, and carefully dry them with a clean, lint-free cloth. Repeat this cleaning process at least 3 times until the surfaces of the test plate and loading plate are visually inspected and found to be clean. The cleaned test plate and loading plate shall not be touched by hands or other objects. Take 3 test samples and adhere them parallel to the longitudinal direction of the plate to the middle of the adjacent test plate and loading plate. Roll the test samples back and forth three times with a pressure roller. After the test samples are adhered to the plates, place them at room temperature for 20 minutes, fix them to the test frame, and record the start time or position of the test.

[0123] Microbial limits: Test according to the microbial limit tests for non-sterile products: microbial count method (General Rule 1105) and control bacteria test method (General Rule 1106) and the microbial limit standard for non-sterile drugs (General Rule 1107). For rubber plaster, per 10cm... 2 Staphylococcus aureus and Pseudomonas aeruginosa must not be detected.

[0124] Table 2 Performance Tests for Each Example

[0125]

[0126] The experimental results in Table 2 show that the performance tests of Examples 1-4 and Comparative Examples 1-5 show that the heat resistance, adhesion, and microbial limit of Examples 1-4 are significantly different from those of Comparative Example 4. Although both are ointments, the technical effects of the comparative examples do not reach the performance of the present invention due to the different medicinal materials and medicinal matrix used.

[0127] The foregoing has shown and described the basic principles, main features, and advantages of the present invention. Those skilled in the art should understand that the present invention is not limited to the above embodiments. The embodiments and descriptions in the specification are merely principles of the invention. Various changes and modifications can be made to the invention without departing from its spirit and scope, and all such changes and modifications fall within the scope of the claimed invention. The scope of protection claimed by the appended claims and their equivalents is defined.

Claims

1. An external ointment prepared from a traditional Chinese medicine composition of leech, scorpion, centipede, angelica, radix scrophulariae, coix seed, phellodendron, honeysuckle, astragalus, licorice, atractylodes, white peony root, wherein, The traditional Chinese medicine composition is composed of: Hirudo 180-280 parts by weight Angelica 100-400 parts by weight Coptis 100-400 parts by weight Honeysuckle 300-700 parts by weight Radix Astragali 300-700 parts by weight Glycyrrhiza 50-100 parts by weight Atractylodes 100-400 parts by weight Radix Paeoniae Alba 100-400 parts by weight The medicinal base is selected from sesame oil, The preparation method of the traditional Chinese medicine composition is: A. grinding Hirudo, centipede and scorpion into superfine powder, soaking the superfine powder in 1 / 3 amount of medicinal base to obtain a mixture for standby; B. mixing Honeysuckle, Atractylodes, Angelica, Radix Paeoniae Alba and Glycyrrhiza uniformly, concentrating in water bath to obtain concentrated liquid and residue for standby; 2. The topical ointment of claim 1, wherein C. mixing Radix Astragali, Coptis, Coptidis, Adlay and the residue obtained in step B uniformly, soaking the mixture in 1 / 3 amount of medicinal base, heating, filtering, cooling and obtaining medicinal liquid for standby; 3. The topical ointment of claim 2, wherein D. taking the concentrated liquid in step B, adding ethanol and standing, taking supernatant, filtering, recovering ethanol, concentrating, vacuum drying to dry extract, grinding the dry extract to obtain dry extract powder for standby; 4. The topical ointment of claim 1, wherein E. taking the dry extract powder in step D, the mixture in step A and the medicinal liquid in step C, adding the remaining medicinal base to prepare an external ointment. The external ointment is selected from any one of ointment, black ointment, rubber ointment and cataplasm. The external ointment is selected from rubber ointment. The traditional Chinese medicine composition is composed of: Hirudo 180-280 parts by weight Angelica 200-300 parts by weight 5. The topical ointment of claim 4, wherein Coptis 200-300 parts by weight Honeysuckle 450-550 parts by weight Radix Astragali 450-550 parts by weight Glycyrrhiza 50-100 parts by weight Atractylodes 200-300 parts by weight Radix Paeoniae Alba 200-280 parts by weight 6. The topical ointment of claim 4, wherein The medicinal base is 200-600 parts by weight. The traditional Chinese medicine composition is composed of: Hirudo 250 parts by weight Angelica 280 parts by weight Coptis 280 parts by weight Honeysuckle 460 parts by weight 7. A plaster patch, characterized in that Radix Astragali 530 parts by weight Glycyrrhiza 83 parts by weight Atractylodes 220 parts by weight Radix Paeoniae Alba 220 parts by weight The medicinal base is 400 parts by weight. The traditional Chinese medicine composition is composed of: Hirudo 250 parts by weight Angelica 250 parts by weight Coptis 250 parts by weight Honeysuckle 500 parts by weight Radix Astragali 500 parts by weight Glycyrrhiza 83 parts by weight Atractylodes 250 parts by weight Radix Paeoniae Alba 250 parts by weight The medicinal base is 400 parts by weight. The plaster includes a mounting material, the traditional Chinese medicine ointment in any one of claims 1-6 coated on the mounting material and a protective layer.

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