Traditional Chinese medicine composition and traditional Chinese medicine preparation for promoting blood circulation and removing swelling

Abstract

The traditional Chinese medicine composition is prepared from the following raw material medicines in parts by mass: 5 to 10 parts of cortex phellodendri, 5 to 10 parts of radix scutellariae, 5 to 10 parts of radix notoginseng, 5 to 10 parts of melastoma dodecandrum lour, 8 to 15 parts of herba lycopi, 8 to 15 parts of rhizoma alismatis, 8 to 15 parts of herba lycopodii, 12 to 18 parts of semen coicis, 1 to 3 parts of borneol, 135 to 150 parts of beewax and 390 to 400 parts of sesame oil. The She nationality characteristic medicinal material melastoma dodecandrum serves as a core component, the Qi and blood theory of traditional Chinese medicine is combined, multiple blood circulation promoting and stasis removing medicinal materials are combined, the comprehensive treatment effects of promoting blood circulation to remove swelling, regulating Qi to dissipate blood stasis and stopping bleeding and relieving pain are jointly achieved, the red, swollen and heat pain symptoms in the acute stage of fracture and sprain can be remarkably relieved, and the curative effect is good. The traditional Chinese medicine composition has the action trend of reducing local exudation and preventing swelling persistence, and has a practical clinical external treatment value for promoting early functional recovery of wounds.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for promoting blood circulation and reducing swelling and a traditional Chinese medicine preparation. BACKGROUND

[0002] Traumatic swelling (including early-stage fracture and sprain) refers to swelling and pain caused by microcirculation disorder of local tissues, increase of capillary permeability, and exudation of blood and tissue fluid due to acute external force injury. If the traumatic swelling cannot be dissipated in time, local tissue adhesion, delayed healing, and even sequelae such as chronic pain may be caused, which seriously affects the recovery of limb function and the quality of life of patients. According to clinical statistics, about 90% of patients with fracture and sprain will have traumatic swelling of different degrees in the early stage of injury, and the recovery period of patients with severe traumatic swelling is prolonged by more than 30% compared with patients with mild traumatic swelling.

[0003] At present, the commonly used drugs for promoting blood circulation and reducing swelling in clinical practice mainly include western medicines such as non-steroidal anti-inflammatory drugs, and traditional Chinese medicine preparations such as Yunnan Baiyao and Huoxue Zhitong Capsules. Western medicines can quickly relieve pain, but have limited effect on dissipation of traumatic swelling, and long-term use may cause adverse reactions of the gastrointestinal tract. Traditional Chinese medicine preparations mostly follow the principle of promoting blood circulation and removing blood stasis, but have the problems of slow effect and poor targeting in the acute stage of injury, and are difficult to achieve the balance of rapid swelling reduction, hemostasis and pain relief. It can be seen that most of the existing drugs only target a certain aspect of the pathology, and lack a multi-pathway coordination mechanism, so the effect is limited when dealing with acute traumatic swelling. SUMMARY

[0004] The application aims to provide a traditional Chinese medicine composition for promoting blood circulation and reducing swelling and a traditional Chinese medicine preparation to solve the problems in the prior art.

[0005] To achieve the above application purpose, the technical scheme of the application is as follows. The application first provides a traditional Chinese medicine composition for promoting blood circulation and reducing swelling, which is composed of the following raw medicinal materials in parts by mass: 5-10 parts of Huangbai, 5-10 parts of Huangqin, 5-10 parts of Sanqi, 5-10 parts of Dieren, 8-15 parts of Zelan, 8-15 parts of Zexie, 8-15 parts of Shenzhigan, 12-18 parts of Yiyiren, 1-3 parts of Bingpian, 135-150 parts of Fengxie, and 390-400 parts of Maoyou.

[0006] The traditional Chinese medicine composition (referred to as "Denglu Shujin recipe" hereinafter) of the present application takes Ge-deng and Shenzhengcao as the monarch drug, and has the effects of activating blood and stopping bleeding, relaxing sinews and activating collaterals (reducing swelling); in the early stage of trauma, the main symptoms are redness, swelling, heat and pain, and Ge-deng and Shenzhengcao are used in large quantities in fresh form, but in the present application, dry products are used, and the medicinal effect is insufficient, so Huangqi and Huangbai are added to clear heat and dry dampness, and Zelan and Zexie are added to promote water and reduce swelling, and Sanqi is added to activate blood and resolve stasis and stop bleeding, and the five ingredients are the minister drugs, and they have the effects of clearing heat and reducing swelling, activating blood and resolving stasis, and they assist Ge-deng and Shenzhengcao to achieve the effects of clearing heat and reducing swelling, activating blood and resolving stasis; Bingpian has the effects of clearing heat and reducing swelling, and is used as the auxiliary drug to disperse local swelling, heat and pain; Yiyiren is sweet, slightly bitter and cool, and is used to harmonize the other ingredients, and is the ministerial drug.

[0007] The Denglu Shujin recipe takes the characteristic medicine Ge-deng of the She nationality as the core ingredient, combines the theory of qi and blood in traditional Chinese medicine, and is combined with various blood-activating and stasis-resolving medicinal materials to jointly play the comprehensive therapeutic effect of activating blood and reducing swelling, and simultaneously having the effects of regulating qi and resolving stasis, stopping bleeding and relieving pain, can significantly relieve the symptoms of redness, swelling, heat and pain in the acute stage of fracture and sprain, has the trend of reducing local exudation and preventing swelling, and has practical clinical external treatment value for promoting early functional recovery of trauma.

[0008] In the present application, Ge-deng is a traditional Chinese medicine for treating trauma in the She nationality area, and has the unique dual-regulation characteristics of stopping bleeding and not leaving stasis, and can effectively stop bleeding and promote the dispersion of blood stasis in the early stage of injury, and fundamentally solves the clinical problem that traditional treatment methods cannot simultaneously achieve the effects of stopping bleeding and activating blood.

[0009] As a preferred embodiment, the traditional Chinese medicine composition comprises the following raw medicinal materials: Huangbai 6 parts, Huangqi 6 parts, Sanqi 6 parts, Ge-deng 9 parts, Zelan 10 parts, Zexie 10 parts, Shenzhengcao 10 parts, Yiyiren 15 parts, Bingpian 1 part, bee wax 141.73 parts, and sesame oil 396.85 parts.

[0010] The present application further provides a traditional Chinese medicine preparation for activating blood and reducing swelling, which is prepared from the traditional Chinese medicine composition described above. The traditional Chinese medicine preparation can be an ointment, a cream, a paste, a spray, an aerosol, a gel, a liniment, a coating, a film coating, a tincture, a patch, a plaster, a lotion, an irrigation agent or a plaster, and is used by being applied or sprayed on the affected area, or by being used for irrigation or washing of the affected area.

[0011] The present application further provides a preparation method of the traditional Chinese medicine preparation, which comprises the following steps: (1) grinding Huangbai, Huangqi, Sanqi, Ge-deng, Zelan, Zexie, Shenzhengcao and Yiyiren into powder; (2) adding Bingpian, bee wax and sesame oil to the powder to make a paste.

[0012] The present invention also provides a traditional Chinese medicine plaster for promoting blood circulation and reducing swelling. The plaster includes a plaster cloth and a medicated paste coated on the plaster cloth. The plaster is made from the above-mentioned traditional Chinese medicine composition.

[0013] Preferably, the thickness of the herbal plaster is 2-4 mm.

[0014] This invention also provides a method for preparing the above-mentioned traditional Chinese medicine plaster, which includes the following steps: (1) Grind the following herbs into powder: Phellodendron bark, Scutellaria baicalensis, Panax notoginseng, Rhodiola rosea, Lycopus lucidus, Alisma plantago-aquatica, Lycopodium clavatum, and Coix lacryma-jobi. (2) Add borneol, beeswax and sesame oil to the powder and mix into a paste; (3) Apply the ointment to the plaster to obtain the Chinese herbal plaster.

[0015] Compared with the prior art, the technical effects of the present invention are reflected in: 1. The Renluo Shujin Formula of this invention uses Renluo, a characteristic medicinal herb of the She ethnic group, as its core ingredient. It combines the theory of Qi and blood in traditional Chinese medicine with a variety of herbs that promote blood circulation and remove blood stasis. Together, they exert a comprehensive therapeutic effect, mainly promoting blood circulation and reducing swelling, while also regulating Qi, dispersing blood stasis, stopping bleeding and relieving pain. It can significantly relieve the symptoms of redness, swelling, heat and pain in the acute phase of fractures and sprains. It has a tendency to reduce local exudation and prevent the swelling from becoming prolonged. It has practical clinical external treatment value in promoting early functional recovery from trauma.

[0016] 2. In this invention, *Rhodiola rosea*, a traditional medicine for trauma treatment passed down through generations in the She ethnic region, has unique bidirectional regulatory properties of "stopping bleeding without leaving blood stasis". It can simultaneously achieve effective hemostasis and promote the dissipation of blood stasis in the early stage of injury, fundamentally solving the clinical problem that it is difficult to achieve both hemostasis and blood circulation in traditional treatment methods. Detailed Implementation

[0017] The following examples and application examples further illustrate the technical solution of the present invention in detail. Example 1

[0018] This embodiment presents a traditional Chinese medicine composition for promoting blood circulation and reducing swelling (Renluo Shujin Fang), which, by weight, consists of the following raw materials: 6 parts of Phellodendron bark, 6 parts of Scutellaria baicalensis, 6 parts of Panax notoginseng, 9 parts of Rhizoma Recens, 10 parts of Lycopus lucidus, 10 parts of Rhizoma Alismatis, 10 parts of Herba Lycopodii, 15 parts of Semen Coicis, 1 part of Borneol, 141.73 parts of Beeswax, and 396.85 parts of Sesame Oil.

[0019] All medicinal materials used (except for Rhodiola rosea) are listed in the 2025 edition of the Chinese Pharmacopoeia, Part I. Rhodiola rosea is listed in the 2015 edition of the Zhejiang Province Processing Standards and was provided by Zhejiang Kangning Pharmaceutical Co., Ltd. Example 2

[0020] The blood circulation promoting and swelling reducing traditional Chinese medicine paste of the embodiment is an external use ointment, and the preparation process thereof comprises the following steps: (1) 7 parts of the traditional Chinese medicine raw materials according to the prescription amount in the formula of the embodiment are taken, and the raw medicine materials except the borneol, the beeswax and the sesame oil are powdered and passed through a No. 6 sieve to obtain medicine powder for standby use; (2) the medicine powder in step (1) is uniformly mixed with 7 parts of borneol, 1000 parts of beeswax and 2800 parts of sesame oil to be adjusted into an ointment, and an ointment is obtained; (3) according to the wound area, the ointment with a thickness of about 3 mm is coated on the plaster cloth to obtain the traditional Chinese medicine paste of the embodiment (hereinafter referred to as: the Linluoshujin ointment).

[0021] The traditional Chinese medicine paste prepared in the embodiment 2 is practically applied, for example as follows: Application Example 1

[0022] A patient, male, 49 years old, was admitted to hospital for treatment due to “right ankle pain and deformity caused by trauma for 2 hours”. CT examination showed right ankle fracture, and the patient was admitted to orthopedics department. The preliminary diagnosis was right ankle fracture. After admission, the patient underwent related examinations and was diagnosed with right distal tibial fracture, right traumatic peroneal tendon dislocation and abnormal liver function test results. Under intraspinal anesthesia, the patient underwent tibial fracture open reduction and internal fixation, peroneal fracture open reduction and internal fixation, and peroneal tendon dislocation repair. After the operation, the patient was given low molecular weight heparin calcium injection to prevent thrombosis, etoricoxib tablets for pain relief, sodium aescinate for swelling relief, traditional Chinese medicine directional drug therapy for inflammation and pain relief (Linluoshujin ointment), and pneumatic therapy to promote venous return. The patient continued to use the Linluoshujin ointment for 5 days, and the wound condition changed from “moderate swelling, skin brightening, possibly with ecchymosis; moderate dysfunction; obvious tenderness” to “slight swelling; slight tenderness”, and the grading and quantitative score decreased from 14 to 8, with a treatment effect standard of 0.43. After re-examination by the doctor, the right ankle pain was significantly relieved, the right ankle dressing was clean, the swelling was significantly reduced, the right foot dorsiflexor muscle strength was reduced, the toe sensation, activity and blood supply were good, and the treatment effect was evaluated as improved, and the patient was discharged. Application Example 2

[0023] A 53-year-old female patient was admitted to the hospital for "multiple pains all over the body for 1 hour due to a car accident". The emergency examination showed suspected right rib fracture and open wound on the medial side of the right ankle. The patient was admitted to the orthopedics department for "multiple contusions". The preliminary diagnosis was open wound of the lower extremity (right ankle), sprain of the right ankle, multiple contusions (right elbow, left knee), mild concussion, scalp hematoma, right 7th rib fracture, and sacral fracture. After admission, the patient underwent skin debridement and suture under local anesthesia in the dressing room. Subsequent systemic examination confirmed the diagnosis, and the treatment included promoting blood circulation to promote fracture healing (Rengluoshujin Plaster), drug anti-inflammatory analgesia, and symptomatic anti-dizziness treatment. After 3 days of continuous use of Rengluoshujin Plaster, the patient's injury changed from "mild dysfunction; mild tenderness; mild secondary symptoms" to "normal activity; no tenderness; no secondary symptoms", the grading and quantitative score decreased from 4 to 2, and the efficacy standard was 0.50. After the doctor's re-examination, the patient's condition was stable, with a little pain in the right ankle (VAS score 1), occasional dizziness, no vomiting, no visual rotation, normal recent body temperature, general appetite, sleep, and bowel movements, and the efficacy evaluation was improved, and the patient was discharged. Application Example 3

[0024] A 61-year-old female patient was admitted to the hospital for "right wrist joint pain and limited activity for 1 hour due to a fall". The right distal radius fracture and fracture end dislocation were found by CT examination of the right wrist joint in the outpatient department, and the patient was admitted to the orthopedics department for "right distal radius comminuted fracture". The patient had a history of "type 2 diabetes" for 1 year, long-term use of hypoglycemic drugs, and self-reported blood sugar control; a history of "hypertension" for 2 years, long-term use of antihypertensive drugs, and self-reported blood pressure control; 15 years ago, the patient underwent surgical treatment for "left breast cancer", and no recurrence was found after the operation every year; and a history of "penicillin" allergy (dizziness, nausea, vomiting, and skin rash all over the body). After admission, the patient underwent blood routine, biochemical, and coagulation function tests, and closed reduction and plaster fixation of the right distal radius fracture under local anesthesia. After the operation, the patient was treated with mannitol injection to reduce swelling, and the diagnosis of osteoporosis and fatty liver was supplemented. After 3 days of continuous use of Rengluoshujin Plaster, the patient's injury changed from "moderate swelling, skin tension, tenderness; mild dysfunction; occasional itching; moderate secondary symptoms" to "no swelling; normal activity; no itching; no secondary symptoms", the grading and quantitative score decreased from 8 to 4, and the efficacy standard was 0.50. After the doctor's re-examination, the patient's pain improved, appetite, sleep, and bowel movements were normal, the right wrist joint was fixed with plaster, and the patient was discharged. Application Example 4

[0025] A 55-year-old female patient was admitted to the hospital for "back pain and limited mobility due to a car accident for 2 hours". CT examination showed L1 vertebral compression fracture, L3 / 4 and L4 / 5 disc herniation, and lumbar degenerative changes. The patient was admitted to the orthopedics department for "L1 vertebral compression fracture and left elbow skin laceration". The preliminary diagnosis was lumbar fracture (L1 A0 / OTA type A1.1), upper limb skin laceration (left elbow), and primary hypertension. The patient had a history of primary hypertension for 5 years and was taking Nifedipine tablets half a tablet once a day. The patient reported that her blood pressure was stable. More than ten years ago, the patient underwent surgery for thyroid cyst and recovered well after surgery. After admission, the patient underwent blood routine, coagulation function, liver and kidney function, electrolytes, electrocardiogram, and MR examinations. The patient was given left elbow wound debridement, anti-inflammatory analgesic (Rengluoshujin Paste), and other symptomatic treatment. The patient was also instructed to exercise the lumbar back extensor function and limb function. After 16 days of continuous use of Rengluoshujin Paste, the patient's injury site changed from "mild pain; minor symptoms" to "no pain; no minor symptoms". The grading and quantification score decreased from 3 to 2, and the efficacy standard was 0.33. After the doctor's re-examination, the patient had no back pain, normal temperature, and no tenderness in the lumbar segment. There was no radiating pain in the lower extremities when tapped, and the muscle strength of the lower extremities was V grade. The limb sensation and blood supply were good. The efficacy evaluation was improved, and the patient was discharged. Application Example 5

[0026] A 71-year-old female patient was admitted to the hospital for "swelling and pain in the right thigh caused by external force for 1 week". She was admitted to the emergency department for "right femoral fracture" and diagnosed with right femoral fracture and rheumatoid arthritis. The patient had a history of rheumatoid arthritis for more than 20 years and was currently treated with "Hanfengjia Jiaosu tablets 20mg po qd, methotrexate tablets 2.5mg po qw". She had been in bed for a long time and had joint deformity and mobility disorder in multiple parts of the body. She had a history of cerebral infarction in 2020 and "type I respiratory failure and left lower lobe community-acquired pneumonia" in the past year. After admission, relevant examinations were performed, and color Doppler ultrasound showed aortic sclerosis, severe aortic valve regurgitation, mild mitral valve regurgitation, and bilateral lower extremity deep vein patency. Pelvis (including both hips) showed a comminuted fracture of the right femoral upper end. CT examination of the chest showed chronic bronchitis, emphysema, left lower pleural changes, and other signs. The patient was diagnosed with chronic bronchitis, unilateral emphysema, severe aortic valve insufficiency, mild mitral valve insufficiency, mild tricuspid valve insufficiency, hypokalemia, hypoproteinemia, severe osteoporosis, and postmenopausal osteoporosis. The patient and her family requested conservative treatment, and during hospitalization, she received symptomatic treatment such as bed rest, pain relief and swelling (Renglu Shujin ointment), and treatment for severe osteoporosis and postmenopausal osteoporosis with Denosumab needle 60mg ih once. After using Renglu Shujin ointment for 10 days, the patient's injury changed from "severe pain, difficult to tolerate, severely affecting daily activities; moderate swelling, skin tension, and tenderness; major symptoms; mild numbness; obvious tenderness" to "mild pain, tolerable, not affecting daily activities; slight swelling, local skin slightly full; moderate symptoms; no numbness; mild tenderness". The grading and quantification score decreased from 13 to 8, and the efficacy standard was 0.38. After the doctor's re-examination, the patient's right thigh swelling and pain improved after 11 days. Her temperature was 36.8℃, respiratory rate was 18 breaths / min, heart rate was 67 beats / min, blood pressure was 136 / 65mmHg, oxygen saturation was 99%, consciousness was clear, spirit was slightly soft, right thigh swelling and deformity, tenderness and longitudinal percussion pain improved, pain activity limitation improved, and the efficacy evaluation was improved. She was discharged.

Claims

1. A traditional Chinese medicine composition for promoting blood circulation and removing blood stasis, characterized in that, By mass parts, consisting of the following raw materials: 5~10 parts of Huangbai, 5~10 parts of Huangqin, 5~10 parts of Sanqi, 5~10 parts of Dieren, 8~15 parts of Zelan, 8~15 parts of Zexie, 8~15 parts of Shenjincao, 12~18 parts of Yiyiren, 1~3 parts of Bingpian, 135~150 parts of Fengla, 390~400 parts of Maoyou.

2. The traditional Chinese medicine composition of claim 1, wherein, Consisting of the following raw materials: 6 parts of Huangbai, 6 parts of Huangqin, 6 parts of Sanqi, 9 parts of Dieren, 10 parts of Zelan, 10 parts of Zexie, 10 parts of Shenjincao, 15 parts of Yiyiren, 1 part of Bingpian, 141.73 parts of Fengla, 396.85 parts of Maoyou.

3. A traditional Chinese medicine preparation for promoting blood circulation and removing blood stasis, characterized in that, The traditional Chinese medicine composition of claim 1 or 2 is used to make.

4. The traditional Chinese medicine preparation of claim 3, characterized in that, It is an ointment, cream, paste, spray, aerosol, gel, liniment, coating, film coating, tincture, patch, plaster, lotion, rinse or plaster.

5. The preparation method of claim 3 or 4, characterized in that, It comprises the following steps: (1) Huangbai, Huangqin, Sanqi, Dieren, Zelan, Zexie, Shenjincao and Yiyiren are ground into powder; (2) Bingpian, Fengla and Maoyou are added to the powder to make a paste.

6. A traditional Chinese medicine paste for promoting blood circulation and removing blood stasis, characterized in that, The plaster comprises a plaster cloth and a medicinal plaster coated on the plaster cloth, wherein the plaster is made of the traditional Chinese medicine composition of claim 1 or 2.

7. The traditional Chinese medicine plaster as described in claim 6, characterized in that, The thickness of the medicinal plaster is 2-4 mm.

8. The preparation method of the traditional Chinese medicine patch according to claim 6 or 7, characterized in that, It comprises the following steps: (1) Huangbai, Huangqin, Sanqi, Dieren, Zelan, Zexie, Shenjincao and Yiyiren are ground into powder; (2) Bingpian, Fengla and Maoyou are added to the powder to make a medicinal plaster; (3) The medicinal plaster is coated on the plaster cloth to obtain the traditional Chinese medicine plaster.