Traditional Chinese medicine composition for preventing and treating lower limb deep venous thrombosis and application thereof

Abstract

The invention discloses a traditional Chinese medicine composition for preventing and treating lower limb deep venous thrombosis and application thereof. The traditional Chinese medicine composition is prepared from rheum officinale, cassia twig, astragalus membranaceus, caulis spatholobi, corydalis tuber, radix paeoniae rubra, fructus kochiae and rhizoma atractylodis macrocephalae. According to the traditional Chinese medicine composition, static lower limb deep venous thrombosis caused by the same disease of ying and wei and concurrence of internal stagnation of blood stasis, vein injury and muscle loss is taken as a pathogenesis, medicines are reasonably combined, and rheum officinale is taken as a monarch medicine and is mainly used for cooling blood, removing blood stasis and stimulating menstrual flow; suberect spatholobus stem, corydalis tuber and red peony root are used as ministerial drugs for promoting blood circulation to remove meridian The cassia twig is used as an adjuvant drug to assist and prevent the rhubarb from being too cold; the radix astragali has the effects of tonifying qi and strengthening superficies, the rhizoma atractylodis macrocephalae has the effects of eliminating dampness and diminishing swelling, and the fructus kochiae has the effects of clearing heat, promoting diuresis, dispelling wind and arresting itching; all the medicines are reasonably combined to achieve the effects of regulating ying and wei so as to restore veins, and removing turbid and generating new energy so as to promote qi circulation, so that the effect of effectively relieving or curing the deep venous thrombosis of the lower limbs is achieved.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicines, and in particular to a traditional Chinese medicine composition for preventing and treating deep vein thrombosis of lower extremities and application thereof. Background Art

[0002] Deep vein thrombosis of the lower extremities (also known as deep vein thrombosis of the lower extremities) is a common clinical disease. Deep vein thrombosis of the lower extremities is an abnormal blood clot formed in the deep vein system of the lower extremities, which leads to obstruction of venous return and causes sudden symptoms such as limb swelling, pain and increased skin temperature in patients. In severe cases, due to severe obstruction of venous return, the pressure of surrounding tissues increases, which can cause arterial compression or spasm. If not treated in time, DVT can cause emergency and life-threatening complications such as shock and venous gangrene. Major surgery, trauma, long-term bed rest, limb immobilization, etc. are all common predisposing factors. At present, anticoagulants are used for treatment in Western medicine, but traditional anticoagulants such as warfarin have a high risk of bleeding in long-term treatment, and coagulation indicators need to be closely monitored; while new anticoagulants, such as NOAC drugs such as rivaroxaban, dabigatran, and apixaban, are expensive and mainly metabolized by the kidneys. Long-term use is difficult to avoid the risk of liver and kidney damage, which is conducive to long-term anticoagulation and thrombolysis. Traditional Chinese medicine usually has few side effects and low cost. Therefore, it is necessary to develop more traditional Chinese medicine suitable for the prevention and treatment of deep vein thrombosis of the lower limbs. Summary of the invention

[0003] Therefore, based on the above background, the present invention provides a Chinese medicine composition for preventing and treating deep vein thrombosis of the lower limbs and its application. The Chinese medicine composition is rationally matched to effectively treat deep vein thrombosis of the lower limbs by harmonizing the Ying and Wei to restore the meridians and removing turbidity to promote the flow of Qi.

[0004] The technical solution provided by the present invention is:

[0005] A Chinese medicine composition for preventing and treating deep vein thrombosis of lower extremities, which is composed of the following raw materials in parts by weight:

[0006] 10-30 parts of rhubarb, 10-20 parts of cinnamon twig, 20-30 parts of astragalus, 10-20 parts of millettia reticulata, 10-20 parts of yanhusuo, 15-30 parts of red peony root, 10-20 parts of kochia scoparia and 20-30 parts of atractylodes.

[0007] Preferably, it is composed of the following raw materials in parts by weight:

[0008] 25 parts of rhubarb, 15 parts of cinnamon twig, 20 parts of astragalus, 15 parts of millettia reticulata, 15 parts of corydalis, 20 parts of red peony root, 10 parts of kochia scoparia and 20 parts of atractylodes.

[0009] Preferably, it is composed of the following raw materials in parts by weight:

[0010] 30 parts of rhubarb, 20 parts of cinnamon twig, 25 parts of astragalus, 20 parts of millettia reticulata, 20 parts of yanhusuo, 20 parts of red peony root, 20 parts of kochia scoparia and 20 parts of atractylodes.

[0011] Preferably, it is composed of the following raw materials in parts by weight:

[0012] 20 parts of rhubarb, 10 parts of cinnamon twig, 20 parts of astragalus, 10 parts of millettia reticulata, 10 parts of corydalis, 15 parts of red peony root, 10 parts of kochia scoparia and 20 parts of atractylodes.

[0013] Preferably, it can be added with medically acceptable adjuvants to prepare an external preparation.

[0014] Preferably, the external preparation is an ointment or a spray.

[0015] Based on the same inventive concept, the present invention applies the above-mentioned Chinese medicine composition to the preparation of drugs for preventing or treating or assisting in preventing and treating deep vein thrombosis of the lower limbs.

[0016] Furthermore, the deep vein thrombosis of the lower limbs is caused by the combination of Ying and Wei diseases with complications of internal blood stasis, vascular damage, and muscle dysfunction.

[0017] Based on the same inventive concept, the present invention also provides a drug prepared by using the above-mentioned Chinese medicine composition for preventing or treating or assisting in preventing and treating deep vein thrombosis of the lower limbs.

[0018] Further, the preparation method thereof is as follows:

[0019] Take each raw material drug according to the amount and crush them into 800-1000 mesh particles respectively;

[0020] After mixing, add Vaseline and stir until evenly mixed.

[0021] Deep vein thrombosis of the lower extremities is caused by abnormal coagulation of blood in the deep veins of the lower extremities, resulting in obstruction of blood return in the blood vessels.

[0022] From the perspective of traditional Chinese medicine, the Yingwei Shenghui states that "the clear part is Ying, the turbid part is Wei, Ying is in the veins, Wei is outside the veins". Under normal physiological conditions, the clear Ying Qi generated by the essence of water and grain in the veins and the strong and smooth turbid Wei Qi outside the veins maintain the normal physiological function of the blood vessels. The Huangdi Neijing Suwen Bilun Pian states that "Ying is the essence of water and grain, which is harmonized in the five internal organs and sprinkled in the six bowels, and can enter the veins. Therefore, it follows the veins up and down, penetrates the five internal organs, and connects the six bowels." Ying Qi returns to the veins to nourish the veins and travels along the veins to the whole body to nourish the internal organs of the whole body. "Wei Qi is used to warm the flesh, fill the skin, nourish the pores, and control the opening and closing... When Wei Qi is harmonious, the flesh is smooth, the skin is soft, and the pores are dense." Wei Qi comes out of the veins and nourishes the muscles, bones, skin, hair, and marrow. "The 33rd Difficulty of the Difficult Classic" states that "When the Ying and Wei are in harmony, the Yin and Yang are in harmony; when the clear and the turbid are not related, then everything is in harmony." If the physiological function is abnormal, it will become a disease. The inventor combined his long-term clinical treatment experience and concluded that the formation of lower extremity venous thrombosis is caused by the Ying and Wei being in harmony, complicated by blood stasis, meridian damage, and muscle dysfunction.

[0023] Aiming at the pathogenesis of upper venous thrombosis, the present invention carries out a reasonable drug combination, wherein rhubarb is used as the main drug, which mainly cools blood, removes blood stasis and promotes menstruation; and modern pharmacological research shows that the chemical components of rhubarb mainly include quinones, anthrone, diphenylethylene, phenylbutyrophenone, polysaccharide, tannin and volatile oil, etc., which have pharmacological effects such as anti-inflammatory, regulating blood lipids and anti-angiogenesis; Millettia reticulata, Corydalis yanhusuo and red peony root are used as assistant drugs, which can promote blood circulation, dredge collaterals and relieve pain; and modern pharmacology believes that Millettia reticulata extract has obvious inhibitory effects on the expression of inflammatory cytokines and pro-inflammatory proteins and has obvious vasodilation effect, and the analgesic effect of corydalis butylene (dl-tetrahydropalmatine (dl-THP)) can even reach 40% of the typical analgesic drug morphine, and the effective chemical components of red peony root can have a good protective effect on cells related to the nervous system; cinnamon twig is used as an adjuvant to prevent rhubarb from being too cold; and modern pharmacology believes that the chemical components in cinnamon twig mainly include volatile components, organic Acids, glycosides, etc., have pharmacological effects such as regulating body temperature, analgesia, antibacterial, anti-inflammatory and anti-allergic, antiviral, promoting vasodilation, diuresis, and sedation; Astragalus, Atractylodes, and Kochia scoparia are used as the guiding drugs, among which Astragalus replenishes qi and consolidates the exterior, Atractylodes lancea dries dampness and reduces swelling, and Kochia scoparia clears heat and dampness, dispels wind and relieves itching; modern pharmacology believes that Astragalus not only regulates blood lipids, anti-fibrosis, antibacterial and antiviral, but also has moisturizing, antioxidant and anti-inflammatory effects; Atractylodes is rich in volatile oils, lactones, polysaccharides, etc., which have anti It has pharmacological effects such as anti-tumor, anti-depression, anti-inflammatory, liver protection, and regulation of the gastrointestinal tract, nervous system, and immune system. Saponin Ic and oleanolic acid glycoside contained in Kochia scoparia can inhibit the release of various inflammatory mediators, exert anti-inflammatory, anti-allergic, and anti-itching effects. Astragalus, Atractylodes macrocephala, and Kochia scoparia help the monarch and minister drugs to eliminate phlegm, promote diuresis, and remove blood stasis. All the medicines are reasonably combined to harmonize the Ying and Wei to restore the meridians, and to eliminate turbidity and promote new qi to promote the flow of qi, so as to effectively relieve or cure deep vein thrombosis of the lower limbs. DETAILED DESCRIPTION

[0024] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in combination with the embodiments of the present invention. Obviously, the described embodiments are part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0025] Example 1: A Chinese medicine composition for preventing and treating deep vein thrombosis of lower extremities, which is composed of the following raw materials in parts by weight:

[0026] 25 parts of rhubarb, 15 parts of cinnamon twig, 20 parts of astragalus, 15 parts of millettia reticulata, 15 parts of yanhusuo, 20 parts of red peony root, 10 parts of kochia scoparia and 20 parts of atractylodes.

[0027] Example 2: A Chinese medicine composition for preventing and treating deep vein thrombosis of lower extremities, which is composed of the following raw materials in parts by weight:

[0028] 30 parts of rhubarb, 20 parts of cinnamon twig, 25 parts of astragalus, 20 parts of millettia reticulata, 20 parts of yanhusuo, 20 parts of red peony root, 20 parts of kochia scoparia and 20 parts of atractylodes.

[0029] Example 3: A Chinese medicine composition for preventing and treating deep vein thrombosis of lower extremities, which is composed of the following raw materials in parts by weight:

[0030] 20 parts of rhubarb, 10 parts of cinnamon twig, 20 parts of astragalus, 10 parts of millettia reticulata, 10 parts of corydalis, 15 parts of red peony root, 10 parts of kochia scoparia and 20 parts of atractylodes.

[0031] Embodiments 1 to 3 can be prepared into external preparations, wherein the preparation method of the external preparation ointment comprises the following steps:

[0032] Take each raw material drug according to the amount and crush them into 800-1000 mesh particles respectively;

[0033] After mixing, add Vaseline and stir until evenly mixed.

[0034] In specific application, mix 5g of mixed powder into 10g of vaseline.

[0035] When using, you only need to apply the ointment to the affected area of ​​venous thrombosis, or apply it to the entire lower limb. The thickness of the external application is 1-2mm, and the external application time is not less than 4 hours.

[0036] When used, the external preparation prepared in the above embodiment can be used alone or in combination with an anticoagulant drug to treat patients with deep vein thrombosis of the lower limbs.

[0037] In specific applications, a suitable amount of a transdermal agent, such as azone, may be added to vaseline.

[0038] Embodiment 4:

[0039] From November 2023 to September 2024, 45 patients with deep vein thrombosis of the lower limbs were admitted, aged 40-70 years old. All patients were diagnosed by Western medicine and traditional Chinese medicine. Western medicine referred to the diagnostic criteria for lower limb DVT in the "Diagnosis and Efficacy Standards for Deep Vein Thrombosis of the Lower Limbs (2015 Revised Draft)".

[0040] ① The skin temperature on the affected side is increased, there is limb pain, and the superficial veins are distended. Physical examination shows a positive Hoffman sign. ② There are risk factors for DVT, such as surgery, tumors, pregnancy, a history of venous thromboembolism, and long-term bed rest. ③ Plasma D-dimer is significantly elevated in the acute phase. ④ The diagnosis is confirmed by intravenous angiography, Doppler ultrasound, and other examinations, excluding diseases such as acute arterial embolism, acute lymphangitis, erysipelas, primary pelvic tumors, calf traumatic hematoma, and calf myofibromyitis.

[0041] According to the relevant standards in the Traditional Chinese Medicine Diagnosis and Therapeutic Effect Evaluation Criteria for Deep Vein Thrombosis and the Diagnosis and Therapeutic Effect Criteria for Deep Vein Thrombosis of Lower Limbs (2015 Revised Draft), Traditional Chinese Medicine diagnoses the disease as both Ying and Wei diseases, phlegm and blood stasis blocking the collaterals, and "blood stasis turns into water", and patients are often accompanied by lower limb edema.

[0042] Exclusion criteria:

[0043] ① Those with severe conditions and a survival period of less than 6 months; ② Those with abnormal immune function and coagulation function; ③ Those with poor compliance and unable to cooperate with treatment; ④ Those who have taken anticoagulant drugs in the past 10 days.

[0044] The above patients were all treated with the ointment prepared in Example 2, which was applied to the affected area or the entire lower limb for no less than 4 hours per day, and the treatment was continued for 15 days.

[0045] Efficacy criteria:

[0046] Recovery: Limb swelling and pain completely disappeared, and color Doppler ultrasound showed that venous thrombus was completely dissolved and blood vessels were reopened;

[0047] Effective: limb swelling and pain were alleviated compared with before medication, and color Doppler ultrasound showed that venous thrombosis was reduced compared with before;

[0048] Ineffective: limb swelling and pain were not relieved, and color Doppler ultrasound showed no change or an increase in venous thrombosis.

[0049] Effective rate = (cured + effective) * 100%.

[0050] The results are as follows: 27 cases were cured, 15 cases were effective, 3 cases were ineffective, and the effective rate was 93.33%.

[0051] None of the patients experienced adverse reactions during the 15-day treatment, such as subcutaneous ecchymosis, swelling, and erythema.

[0052] The hematological indicators D-dimer, plasminogen activity (PLGA), plasma viscosity, and coagulation indexes of the above patients were tested on the first and fifteenth days of treatment. The results are shown in Table 1 below:

[0053] Table 1: Rheological parameters before and after treatment

[0054]

[0055] Example 5: Typical Case

[0056] Case 1: Patient, female, 64 years old, visited the hospital on June 20, 2023.

[0057] Chief complaint: Pain in the right lower limb knee joint and calf for 2 days.

[0058] Current medical history: The patient had pain in the right lower knee joint after fatigue 2 days ago, accompanied by swelling and pain in the calf segment, which was difficult to flex and extend, but no diagnosis or treatment was received.

[0059] The current diagnosis shows: right lower limb knee pain, accompanied by swelling and pain in the calf segment, difficult to flex and extend, occasional chest distress, relieved after eating, good spirits, good appetite, good sleep, dry stool, once every 2-3 days, frequent urination at night. The tongue is pale and dark, with tooth marks, white greasy and slightly yellowish fur, and the pulse is stringy and weak.

[0060] Auxiliary examinations: Anteroposterior and lateral DR of the right knee joint: degenerative osteoarthritis of the right knee joint; Color Doppler ultrasound of both lower limb vessels: widening of the intermuscular veins in the bilateral calf segments with hypoechoic filling.

[0061] Western medicine diagnosis: lower limb venous thrombosis.

[0062] TCM diagnosis: thigh swelling (ying and wei diseases, phlegm and blood stasis blocking the meridians).

[0063] Treatment method: harmonize the Ying and Wei, resolve phlegm, remove blood stasis and dredge the meridians.

[0064] The patient was treated by applying Example 2 to the right lower limb knee joint and calf segment. Apply externally for no less than 4 hours a day

[0065] Second visit on June 26, 2023: No swelling or pain in the right knee joint and calf segment. Re-examination of the vascular ultrasound of both lower limbs: widening of the intermuscular veins in the bilateral calf segments, without hypoechoic filling. The patient recovered well, and the patient was advised to re-examine the vascular ultrasound of both lower limbs regularly.

[0066] Case 2: Patient, female, 70 years old.

[0067] The main cause was "pain and weakness in both lower limbs for more than 6 months". He was admitted to the hospital with "lower limb venous thrombosis" at "15:48 on August 20, 2024".

[0068] Six months ago, the patient had no obvious cause of pain in both lower limbs, accompanied by weakness, no fever, no hemiplegia, speech difficulties, and drooling at the corners of the mouth, and no diagnosis or treatment. Today, in order to seek further treatment of Chinese and Western medicine, he came to our outpatient clinic for treatment. The five-category blood cell classification showed: average hemoglobin 26.70pg, average hemoglobin concentration 312g / L, platelet distribution width 8.80fL; N-terminal B-type natriuretic peptide precursor + electrolyte + liver function showed: calcium ion 1.04mmol / L;

[0069] Color Doppler ultrasound of both lower limb blood vessels showed: multiple intermuscular veins in the right lower calf segment were widened with low echo filling - thrombosis was considered; the intermuscular veins in the left lower calf segment were widened, and the patient was admitted to the hospital with "lower limb venous thrombosis" in the outpatient clinic.

[0070] Symptoms upon admission: pain in both lower limbs, accompanied by weakness, good spirits, good appetite, good sleep, normal bowel movements, and regular urination.

[0071] Auxiliary examination: blood cell five-category classification showed: average hemoglobin 26.70pg average hemoglobin concentration 312g / L platelet distribution width 8.80fL; N-terminal B-type natriuretic peptide precursor + electrolyte + liver function showed: calcium ion 1.04mmol / L;

[0072] Color Doppler ultrasound of both lower limbs showed: multiple intermuscular veins in the right lower limb calf segment were widened with low echo filling - thrombosis was considered, and the intermuscular veins in the left lower limb calf segment were widened. Western medicine diagnosis: lower limb venous thrombosis. Traditional Chinese medicine diagnosis: thigh swelling (yingwei disease, phlegm and blood stasis blocking the collaterals).

[0073] The patient was treated by applying Example 2 to the knee joint and calf of the lower limb.

[0074] Second visit on August 29, 2024: No swelling or pain in both lower limbs. Re-examination of the vascular ultrasound of both lower limbs: widening of the intermuscular veins in the calf segment of the right lower limb, without hypoechoic filling. The patient recovered well, and the patient was advised to re-examine the vascular ultrasound of both lower limbs regularly.

[0075] Comparative Example 1: A Chinese medicine composition for preventing and treating deep vein thrombosis of lower extremities, which is composed of the following raw materials in parts by weight:

[0076] 30 parts of Carthamus tinctorius, 20 parts of Cinnamon twig, 25 parts of Astragalus, 20 parts of Millettia reticulata, 20 parts of Corydalis yanhusuo, 20 parts of Red Peony Root, 20 parts of Kochia scoparia and 20 parts of Atractylodes macrocephala.

[0077] From July 2022 to January 2023, 12 patients diagnosed with deep vein thrombosis of the lower extremities were admitted. The syndromes were diagnosed as Yingwei syndrome and phlegm and blood stasis blocking the collaterals. The ointment made from the Chinese medicine composition of this comparative example 1 was used for treatment. The treatment was carried out in the same way as in Example 2 for 15 consecutive days. During the treatment, 3 patients developed adverse reactions such as subcutaneous ecchymosis or redness and swelling. The efficacy was statistically analyzed, and 4 patients were cured, 6 patients were effective, 2 patients were ineffective, and the effective rate was 83.3%.

[0078] Comparative Example 2: A Chinese medicine composition for preventing and treating deep vein thrombosis of lower extremities, which is composed of the following raw materials in parts by weight:

[0079] 30 parts of Ligusticum chuanxiong, 20 parts of cinnamon twig, 25 parts of astragalus, 20 parts of Millettia reticulata, 20 parts of Corydalis yanhusuo, 20 parts of red peony root, 20 parts of Kochia scoparia and 20 parts of Atractylodes macrocephala.

[0080] From April 2023 to September 2023, 10 patients diagnosed with deep vein thrombosis of the lower extremities were admitted. The syndromes were diagnosed as Yingwei syndrome and phlegm and blood stasis blocking the collaterals. The ointment made from the Chinese medicine composition of this comparative example 2 was used for treatment. The treatment was carried out in the same way as in Example 2 for 15 consecutive days. During the treatment, 6 patients developed adverse reactions such as subcutaneous ecchymosis or redness and swelling. 2 patients were cured, 5 patients were effective, 3 patients were ineffective, and the effective rate was 70%.

[0081] The present invention and its implementation methods are described above, and such description is not restrictive, and the actual methods are not limited thereto. In short, if ordinary technicians in the field are inspired by it, without departing from the purpose of the invention, they can design implementation methods and embodiments similar to the technical solution without creativity, which should all fall within the protection scope of the present invention.

Claims

1. A Chinese medicine composition for preventing and treating deep vein thrombosis of lower extremities, characterized in that: It is composed of the following raw materials in parts by weight: 10-30 parts of rhubarb, 10-20 parts of cinnamon twig, 20-30 parts of astragalus, 10-20 parts of millettia reticulata, 10-20 parts of yanhusuo, 15-30 parts of red peony root, 10-20 parts of kochia scoparia and 20-30 parts of atractylodes.

2. A Chinese medicine composition for preventing and treating deep vein thrombosis of lower extremities according to claim 1, characterized in that: It is composed of the following raw materials in parts by weight: 25 parts of rhubarb, 15 parts of cinnamon twig, 20 parts of astragalus, 15 parts of millettia reticulata, 15 parts of corydalis, 20 parts of red peony root, 10 parts of kochia scoparia and 20 parts of atractylodes.

3. A Chinese medicine composition for preventing and treating deep vein thrombosis of lower extremities according to claim 1, characterized in that: It is composed of the following raw materials in parts by weight: 30 parts of rhubarb, 20 parts of cinnamon twig, 25 parts of astragalus, 20 parts of millettia reticulata, 20 parts of corydalis, 20 parts of red peony root, 20 parts of kochia scoparia and 20 parts of atractylodes.

4. A Chinese medicine composition for preventing and treating deep vein thrombosis of lower extremities according to claim 1, characterized in that: It is composed of the following raw materials in parts by weight: 20 parts of rhubarb, 10 parts of cinnamon twig, 20 parts of astragalus, 10 parts of millettia reticulata, 10 parts of corydalis, 15 parts of red peony root, 10 parts of kochia scoparia and 20 parts of atractylodes.

5. A Chinese medicine composition for preventing and treating deep vein thrombosis of lower extremities according to any one of claims 1 to 4, characterized in that: The compound can be added with medically acceptable adjuvants to prepare an external preparation.

6. A Chinese medicine composition for preventing and treating deep vein thrombosis of lower extremities according to claim 5, characterized in that: The external preparation is ointment, spray, gel, tincture, spirit, powder or oil.

7. Use of the Chinese medicine composition according to any one of claims 1 to 4 in the preparation of a drug for preventing or treating or assisting in the prevention and treatment of deep vein thrombosis of the lower extremities.

8. The use according to claim 7, characterized in that: The deep vein thrombosis of the lower limbs is caused by the combination of Ying and Wei diseases with internal blood stasis, vascular damage, and muscle dysfunction.

9. A drug for preventing or treating or assisting in preventing and treating deep vein thrombosis of lower extremities prepared from the Chinese medicine composition according to any one of claims 1 to 4.

10. The drug for preventing or treating or assisting in preventing and treating deep vein thrombosis of lower extremities according to claim 9, characterized in that: The preparation method is as follows: Take each raw material drug according to the amount and crush them into 800-1000 mesh particles respectively; After mixing, add Vaseline and stir until evenly mixed.

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