Traditional Chinese medicine liquid for treating phlebitis and preparation method thereof

Abstract

The invention provides a traditional Chinese medicine liquid for treating phlebitis and a preparation method thereof, the traditional Chinese medicine liquid comprises the following active components in parts by weight: 10-15 parts of golden cypress, 8-12 parts of coptis chinensis, 10-14 parts of scutellaria baicalensis, 12-18 parts of astragalus membranaceus, 6-10 parts of raw rhubarb, 15-20 parts of honeysuckle, 10-15 parts of fructus forsythiae, 8-12 parts of cortex moutan, 10-14 parts of radix paeoniae rubra and 12-16 parts of angelica sinensis, and the traditional Chinese medicine liquid is compatible with Tibetan capillary artemisia, pterocephalus hookeri, paris polyphylla and rhizoma panacis majoris to enhance the curative effect. During preparation, the raw materials are cleaned and dried, crushed and sieved, then subjected to ethanol reflux extraction, then subjected to vacuum concentration, left to stand and filtered, and finally adjusted in pH value, the traditional Chinese medicine liquid can locally diminish inflammation and integrally regulate qi and blood aiming at the heat toxin stasis pathogenesis of phlebitis, the process is controllable, the advantages of transdermal drug delivery are combined, the curative effect is better than that of magnesium sulfate, and red, swollen and heat pain of phlebitis can be effectively relieved; clinical application is convenient and fast, and the anti-inflammatory and tissue repairing effects are remarkable.

Description

Technical Field

[0001] The present invention relates to the technical field of pharmaceutical preparations and preparation techniques, and particularly relates to a traditional Chinese medicine liquid for treating phlebitis and a preparation method thereof. Background Art

[0002] Phlebitis ( Phlebitis ) is a common vascular disease caused by inflammation of the inner wall of venous blood vessels and is a common complication during clinical infusion. Generally, it is caused by continuous stimulation of blood vessels after infusion of drugs with high osmotic pressure, high toxic side effects, strong irritation, etc., resulting in damage to the endothelial cells of blood vessels. The main manifestations of patients are pain in the venous access, slow blood flow, highly swollen venous puncture sites, increased local temperature, persistent pain, and even cord-like veins can be felt at the puncture site. Severe phlebitis may present local inflammatory secretions and even systemic inflammatory reactions, with symptoms such as fever. Currently, phlebitis is mainly divided into types such as mechanical, chemical, infectious, and thrombotic. If not properly treated, the condition will worsen, and even septicemia may endanger life. Currently, the main clinical treatment methods for phlebitis include external application of drugs such as magnesium sulfate and ethanol, external application of hydrocolloid patches, external application of drugs such as Longzhu Ointment and Hirudoid. Although these treatment methods can relieve the symptoms of phlebitis, they all have some drawbacks, such as strong irritation, high cost, many adverse reactions, long treatment time, and unsatisfactory healing.

[0003] In recent years, traditional Chinese medicine has shown unique advantages in the treatment of phlebitis. Phlebitis can be classified into the categories of "mai bi" and "e mai" in traditional Chinese medicine, and the pathogenesis is the accumulation of damp-heat toxin evil and blood stasis blocking the collaterals. Existing publicly disclosed traditional Chinese medicine prescriptions mostly use heat-clearing and detoxifying medicinal materials such as honeysuckle and forsythia. However, the existing technology still has the following deficiencies: (1) Most of the prescriptions target a single pathogenesis (such as simply clearing heat or promoting blood circulation to remove stasis), and insufficient consideration is given to the complex pathology of the interweaving of damp-heat stasis and toxin, resulting in poor curative effects; (2) There is a lack of targeted action on the vascular endothelial repair mechanism, resulting in a long healing time. However, it is urgent to explore a treatment method for phlebitis that has a rapid onset and significant curative effects. The background technology of the present invention is described as follows: Intravenous infusion is the most commonly used treatment method for inpatients, and more than 80% of inpatients rely on this method. Infusion phlebitis (IP) is one of the most common adverse reactions in infusion therapy, with a clinical incidence rate of 31% - 85%, which seriously affects the treatment and rehabilitation process of patients. Typical symptoms include cord-like red lines along the infusion blood vessels, local heat, sclerosis, and pain, and may even cause systemic symptoms such as shivering and fever. This not only exacerbates the discomfort of patients but also may lead to treatment interruption and increase medical costs. Therefore, it is particularly important to explore and implement scientific and efficient intervention measures to deal with infusion phlebitis. Local treatment is the most commonly used intervention means for infusion phlebitis. The methods commonly used in Western medicine for treating phlebitis have limitations such as high treatment costs, possible skin reactions, and the durability of the curative effect remains to be verified. In contrast, traditional Chinese medicine has certain advantages in preventing and treating phlebitis. Especially through external treatment methods such as traditional Chinese medicine wet compress, it can directly act on the affected area and has achieved remarkable results in treating infusion phlebitis with characteristics such as simple operation, convenient material collection, wide adaptability, significant curative effect, and economy. Summary of the Invention

[0004] In view of this, the present invention proposes a traditional Chinese medicine liquid for treating phlebitis and its preparation method. The technical solution of the present invention is realized as follows: A traditional Chinese medicine liquid for treating phlebitis, comprising the following active ingredients in parts by weight: 10 - 15 parts of Phellodendron amurense Rupr., 8 - 12 parts of Coptis chinensis Franch., 10 - 14 parts of Scutellaria baicalensis Georgi, 12 - 18 parts of Astragalus membranaceus (Fisch.) Bunge, 6 - 10 parts of Rheum officinale Baill., 15 - 20 parts of Lonicera japonica Thunb., 10 - 15 parts of Forsythia suspensa (Thunb.) Vahl, 8 - 12 parts of Paeonia suffruticosa Andr., 10 - 14 parts of Paeonia lactiflora Pall., 12 - 16 parts of Angelica sinensis (Oliv.) Diels.

[0005] Further, a traditional Chinese medicine liquid for treating phlebitis, comprising the following active ingredients in parts by weight: 12 parts of Phellodendron amurense Rupr., 10 parts of Coptis chinensis Franch., 12 parts of Scutellaria baicalensis Georgi, 15 parts of Astragalus membranaceus (Fisch.) Bunge, 8 parts of Rheum officinale Baill., 18 parts of Lonicera japonica Thunb., 13 parts of Forsythia suspensa (Thunb.) Vahl, 10 parts of Paeonia suffruticosa Andr., 12 parts of Paeonia lactiflora Pall., 14 parts of Angelica sinensis (Oliv.) Diels.

[0006] Further, the active ingredients further include 5 - 8 parts of Swertia chirayita (Roxb.) H. Karst., 3 - 6 parts of Pterocephalus hookeri (C. B. Clarke) Hoeck., and 12 - 18 parts of Spatholobus suberectus Dunn.

[0007] Further, the active ingredients further include 2 - 5 parts of Paris vietnamensis (Takht.) H. Li and 2 - 5 parts of Panax japonicus Torr. var. wangianus (Sun) Tsai & Tseng.

[0008] Further, the preparation method of the traditional Chinese medicine liquid for treating phlebitis comprises the following steps: 1) Weigh each raw material according to the parts by weight; 2) Wash the weighed raw materials to remove impurities, and then place them in a cool and ventilated place to dry; 3) Crush the dried raw materials into coarse powder; 4) Put the coarse powder into an extraction tank, add 70%-80% ethanol solution of 8-10 times the total weight of the raw materials, and perform reflux extraction at 60-70°C; 5) Combine the extracts and concentrate under reduced pressure to a relative density of 1.1-1.2 (measured at 60°C); 6) adding 3-5 times the volume of water to the concentrated solution, leaving it to stand for 12-24 hours, filtering, and concentrating the filtrate under reduced pressure to a specified volume to obtain the Chinese medicine solution.

[0009] Furthermore, in step 3), the raw materials are crushed and then passed through a 20-40 mesh sieve.

[0010] Furthermore, the number of reflux extractions in step 4) is 2-4 times, and the time for each extraction is 1-1.5 hours.

[0011] Furthermore, in the step 5), during the reduced pressure concentration process, the vacuum degree is controlled at -0.06 to -0.08 MPa.

[0012] Furthermore, the concentrated Chinese medicine liquid in step 6) needs to be pH-adjusted to a pH value of 6.5-7.5.

[0013] Furthermore, in step 6), the Chinese medicine liquid after adjusting the pH value is filtered through a microporous filter membrane with a pore size of 0.20-0.30 μm, and then filled and sealed.

[0014] Compared with the prior art, the present invention has the following beneficial effects: Drug effects: Astragalus nourishes blood, promotes blood circulation and removes blood stasis, reduces swelling and promotes tissue regeneration, and achieves the effects of removing blood stasis and promoting new tissue; Scutellaria baicalensis has the effects of clearing away heat and detoxifying, and anti-inflammatory and reducing swelling; Honeysuckle clears heat and detoxifies, reduces swelling and disperses nodules; Raw rhubarb clears heat and purges fire, cools blood and detoxifies, and removes blood stasis; Coptis chinensis dries dampness with bitterness and removes heat with coldness, and has the effects of clearing heat and dampness, purging fire and detoxifying; Phellodendron chinense clears heat and dampness, purges fire, detoxifies, and treats sores. It is good for treating heat-toxic sores, redness, swelling, heat and pain when used together with rhubarb, and is often used for a variety of damp-heat diseases. Scutellaria baicalensis, Phellodendron chinense and Coptis chinensis are all heat-clearing and damp-drying drugs. They are bitter and cold in nature and can enter the lung, gallbladder, spleen, large intestine and small intestine meridians. They can assist Phellodendron chinense and Coptis chinensis to jointly clear dampness and heat in the upper, middle and lower three energizers. The bitter and cold nature of raw rhubarb can help Phellodendron chinense and Coptis chinensis to purge heat and detoxify. Forsythia suspensa has similar effects to honeysuckle and can assist Phellodendron chinense, Coptis chinensis and honeysuckle to enhance the effects of clearing heat and detoxifying and dissipating carbuncle. Tibetan Artemisia capillaris clears heat and dampness, detoxifies, Pterocephalus chinensis clears heat and detoxifies, relieves pain, Paris polyphylla clears heat and detoxifies, relieves swelling and relieves pain, Angelica sinensis replenishes blood and activates blood circulation, and Panax pseudoginseng replenishes the lungs and invigorates qi. Cortex moutan clears heat and cools blood, activates blood circulation and removes blood stasis, and Paeonia lactiflora clears heat and cools blood, relieves blood stasis and relieves pain. The two are used together with honeysuckle to enhance the effects of cooling blood and activating blood circulation on the basis of clearing heat and detoxifying. Honeysuckle mainly clears heat and detoxifies, while Cortex moutan and Paeonia lactiflora focus on cooling blood and dispersing blood stasis.

[0015] The above-mentioned drugs together exert the effects of promoting blood circulation to remove blood stasis, purging heat and detoxifying, resolving phlegm and dissipating nodules, detumescence and pain relief, and restoring vitality. External application is a classic route of transdermal drug delivery in traditional Chinese medicine, with advantages such as convenient operation and good safety. Research shows that Coptis chinensis and Phellodendron amurense can detoxify and clear heat, relieve pain and swelling; Rheum palmatum can promote blood circulation to remove blood stasis, detoxify and clear heat, Scutellaria baicalensis can detoxify and clear heat, cool blood and stop bleeding; together with Lonicera japonica and Astragalus membranaceus, it greatly enhances the effects of clearing heat, relieving pain, promoting blood circulation and repair, and the curative effect is significantly better than that of magnesium sulfate. The active component emodin of Rheum palmatum can effectively reduce phlebitis by inhibiting the nuclear factor signaling pathway; Coptis chinensis can inhibit platelet aggregation and improve microcirculation. Baicalin contained in Scutellaria baicalensis has significant anti-inflammatory activity; the effect of emodin in inhibiting the nuclear factor signaling pathway cooperates with the functions of Phellodendron amurense and Coptis chinensis in blocking the release of inflammatory factors to more effectively reduce the inflammatory reaction of phlebitis and relieve symptoms such as redness, swelling, heat and pain; forsythin and chlorogenic acid of Lonicera japonica synergistically further enhance the anti-inflammatory activity and have a good therapeutic effect on local swelling and sores of phlebitis. Swertia chirayita, Pterocephalus hookeri and Paris vietnamensis assist Phellodendron amurense and Coptis chinensis to expand the scope of clearing heat and detoxifying, especially when targeting the complex heat-toxin diseases of phlebitis, they play a unique therapeutic role and further eliminate local inflammation. Angelica sinensis and Astragalus membranaceus synergistically regulate the vital energy of the body, disperse stasis and stop bleeding, detumescence and pain relief, and while assisting Astragalus membranaceus in strengthening the healthy qi, they play a therapeutic role in the symptoms of blood stasis and swelling pain of phlebitis; Lonicera japonica, Paeonia suffruticosa and Paeonia lactiflora jointly target the pathological state of heat in the blood aspect and blood stasis blockage of phlebitis, improve local blood circulation, reduce vascular inflammation, promote the absorption of inflammation and relieve pain. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 is the traditional Chinese medicine liquid for phlebitis of the present invention; Figure 2 is the clinical effect diagram of Case 1 of the present invention; Figure 3 is the clinical effect diagram of Case 2 of the present invention; Figure 4 is the clinical effect diagram of Case 3 of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0017] In order to better understand the technical content of the present invention, specific embodiments are provided below to further illustrate the present invention.

[0018] Unless otherwise specified, the experimental methods used in the embodiments of the present invention are all conventional methods.

[0019] Unless otherwise specified, the materials, reagents, etc. used in the embodiments of the present invention can all be obtained from commercial channels.

[0020] The following introduces the basic situations of the main raw materials according to "Chinese Pharmacopoeia", "Dictionary of Chinese Medicinal Materials" and "Chinese Herbal Medicine". Embodiment

[0021] A traditional Chinese medicine liquid for treating phlebitis, comprising the following active ingredients by weight: 10 grams of Phellodendron amurense, 8 grams of Coptis chinensis, 10 grams of Scutellaria baicalensis, 12 grams of Astragalus membranaceus, 6 grams of Rheum officinale, 15 grams of Lonicera japonica, 10 grams of Forsythia suspensa, 8 grams of Paeonia suffruticosa, 10 grams of Paeonia lactiflora, 12 grams of Angelica sinensis, 5 grams of Hepatitis Saussurea, 3 grams of Pterocephalus hookeri, 2 grams of Paris vietnamensis, 2 grams of Panax japonicus Torr. Example

[0022] A traditional Chinese medicine liquid for treating phlebitis, comprising the following active ingredients by weight: 15 grams of Phellodendron amurense, 12 grams of Coptis chinensis, 14 grams of Scutellaria baicalensis, 18 grams of Astragalus membranaceus, 10 grams of Rheum officinale, 20 grams of Lonicera japonica, 15 grams of Forsythia suspensa, 12 grams of Paeonia suffruticosa, 14 grams of Paeonia lactiflora, 16 grams of Angelica sinensis, 8 grams of Hepatitis Saussurea, 6 grams of Pterocephalus hookeri, 5 grams of Paris vietnamensis, 5 grams of Panax japonicus Torr. Example

[0023] A traditional Chinese medicine liquid for treating phlebitis, comprising the following active ingredients by weight: 12 grams of Phellodendron amurense, 10 grams of Coptis chinensis, 12 grams of Scutellaria baicalensis, 15 grams of Astragalus membranaceus, 8 grams of Rheum officinale, 18 grams of Lonicera japonica, 13 grams of Forsythia suspensa, 10 grams of Paeonia suffruticosa, 12 grams of Paeonia lactiflora, 14 grams of Angelica sinensis, 7 grams of Hepatitis Saussurea, 5 grams of Pterocephalus hookeri, 3 grams of Paris vietnamensis, 3 grams of Panax japonicus Torr.; The above Examples 1-3 adopt the following preparation method: 1) Weigh each raw material according to parts by weight; 2) Wash the weighed raw materials to remove impurities, and then place them in a cool and ventilated place to dry; 3) Crush the dried raw materials into coarse powder and pass through a 30-mesh sieve; 4) Put the coarse powder into an extraction tank, add 9 times the total weight of the raw materials of 75% ethanol solution, and carry out reflux extraction 3 times at 65 °C, with each extraction time being 1.2 hours; 5) Combine the extraction solutions, control the vacuum degree at -0.07 MPa, and concentrate under reduced pressure to a relative density of 1.1 (measured at 60 °C); 6) Add 4 times the volume of water to the concentrated solution, let it stand for 20 hours, filter, concentrate the filtrate under reduced pressure to the specified volume to obtain the traditional Chinese medicine liquid, adjust the pH value to 7.0, filter with a microporous membrane, the pore size of the membrane is 0.22 μm, and then carry out filling and sealing.

[0024] Implementation method: Using the traditional Chinese medicine wet compress technology, soak sterile gauze with the traditional Chinese medicine liquid and apply it to the affected area. Through the transdermal absorption of traditional Chinese medicine, it plays an external treatment method of clearing heat and detoxifying, dissipating swelling and dissipating nodules, promoting blood circulation to remove blood stasis, antibacterial and anti-inflammatory, removing stasis and dredging menstruation, and promoting repair. Each wet compress lasts for 30-60 minutes.

[0025] (I) Case One of the present invention: 1. Medical record introduction: Patient Fu Moujun, male, 50 years old, diagnosis: lung cancer. The patient was admitted to the hospital on February 5, 2025, more than 5 months after being diagnosed with right lung adenocarcinoma and 17 days after the 5th course of targeted therapy. The patient was in poor spirits and had symptoms of headache and vomiting due to high intracranial pressure. On February 10, 22:00, the blood test report of the patient showed that the electrolyte potassium was 3.16 mmol / L. According to the doctor's advice, 0.9% sodium chloride injection + potassium chloride injection were continuously peripherally infused through an infusion pump to supplement potassium. At 06:00 on February 11, when the remaining infusion volume was 10 ml, drug exudation occurred, and the infusion site on the back of the patient's right upper limb hand showed redness and swelling. There was ecchymosis around the puncture site, about 5X5 cm in size, the skin temperature was normal, and there was obvious pain, and phlebitis occurred.

[0026] 2. Measure implementation: Continuously apply the traditional Chinese medicine liquid to the ecchymotic area on the back of the right upper limb hand of the patient, and continue to observe.

[0027] 3. Treatment effect: Phlebitis occurred at 06:00 on February 11, 2025, and the traditional Chinese medicine liquid of this prescription was continuously applied for wet compress; at 18:00 on February 11, 2025, that is, 12 hours after wet compress, the ecchymosis symptoms on the back of the patient's right upper limb hand were significantly improved, and the ecchymosis range was reduced to 3×3 cm. 19 hours after applying the traditional Chinese medicine liquid, at 00:22 on February 12, 2025, 19 hours after wet compress, the ecchymosis symptoms on the back of the patient's hand disappeared, and there was a slight edema symptom at this time. At 06:00 on February 13, 2025, 48 hours after applying the traditional Chinese medicine liquid, the ecchymosis and edema symptoms on the back of the patient's right hand disappeared and healed completely, and the treatment effect was good. Refer to Figure 2 。

[0028] Case two of the present invention: 1. Medical record introduction: Patient Ni Mouren, female, 58 years old, diagnosis: left lung adenocarcinoma. More than 2 months after the operation of left lung adenocarcinoma, the patient was admitted to the hospital due to repeated swelling and pain of both lower extremities for more than 1 month. The patient had taken the self-prepared entrectinib hydrochloride capsules orally for more than one month. When admitted to the hospital, the lower extremities of the patient were edematous and ulcerated, and the palms of both upper extremities were significantly edematous. At 8:30 on January 4, 2025, the patient had a fever symptom, with a body temperature of 38.5°C. According to the doctor's advice, 500 ml of 5% glucose and sodium chloride injection was infused through an intravenous indwelling needle. When 200 ml of the liquid was infused, at 09:30, drug exudation occurred, and there were pain and redness symptoms at the infusion puncture site of the left upper limb. There were flaky blisters of different sizes around the puncture site, and phlebitis occurred.

[0029] 2. Measure implementation: Remove the indwelling needle and externally apply the traditional Chinese medicine liquid of this prescription for wet compress, and continue to observe.

[0030] 3. Treatment effect: 8 hours after wet compress at 17:30 on January 4, 2025, the pain symptoms of the patient disappeared, and the redness, swelling and flaky blisters of different sizes were significantly alleviated, which was highly praised by the patient and his family. Refer to Figure 3 。

[0031] Case Three of the Present Invention: 1. Medical Record Introduction: Patient Wang Mouqiang, male, 58 years old, diagnosis: intestinal cancer. The patient was admitted to the hospital 1 year and more after radical resection of ascending colon cancer due to cessation of defecation from the anus for 1 week. He was conscious, with mental fatigue, weakness and anorexia. A PICC catheter was indwelled in the right upper limb for continuous intravenous nutrition therapy. The skin around the puncture site of the PICC catheter was red, swollen, painful and with small blisters, showing skin breakdown. The venous cord-like change was not obvious, and there was no secretion at the puncture site, belonging to grade IV severe phlebitis.

[0032] 2. Measure Implementation: The affected area of phlebitis in the right upper limb of the patient was wet compress with the Chinese medicine liquid of this prescription, avoiding the puncture site.

[0033] 3. Treatment Effect: After 3 days of wet compress treatment with the Chinese medicine liquid, the symptoms such as redness, swelling, pain, small blisters and breakdown around the puncture site of the patient's PICC catheter were significantly alleviated and improved, with remarkable effect, referring to Figure 4 .

[0034] The above are only the preferred embodiments of the present invention and are not intended to limit the present invention. Any modifications, equivalent replacements, improvements, etc. made within the spirit and principle of the present invention shall be included in the protection scope of the present invention.

Claims

1. A Chinese medicinal liquid for treating phlebitis, characterized in that: The invention comprises the following active ingredients in parts by weight: 10-15 parts of phellodendron, 8-12 parts of coptis root, 10-14 parts of scutellaria root, 12-18 parts of astragalus root, 6-10 parts of raw rhubarb, 15-20 parts of honeysuckle, 10-15 parts of forsythia, 8-12 parts of moutan bark, 10-14 parts of red peony root and 12-16 parts of angelica root.

2. A Chinese medicinal liquid for treating phlebitis as claimed in claim 1, characterized in that: The invention comprises the following active ingredients in parts by weight: 12 parts of phellodendron, 10 parts of coptis root, 12 parts of scutellaria root, 15 parts of astragalus root, 8 parts of raw rhubarb, 18 parts of honeysuckle, 13 parts of forsythia, 10 parts of moutan bark, 12 parts of red peony root and 14 parts of angelica root.

3. A Chinese medicinal liquid for treating phlebitis as claimed in claim 1, characterized in that: The active ingredients also include 5-8 parts of Artemisia capillaris and 3-6 parts of Pterocephalus herba.

4. A Chinese medicinal liquid for treating phlebitis as claimed in claim 1 or 2, characterized in that: The active ingredients also include 2-5 parts of Paris polyphylla and 2-5 parts of Panax notoginseng.

5. A method for preparing a Chinese medicinal liquid for treating phlebitis according to any one of claims 1 to 4, characterized in that: The following steps are involved: 1) Weigh each raw material by weight; 2) Wash the weighed raw materials, remove impurities, and then place them in a cool and ventilated place to dry; 3) Grinding the dried raw materials into coarse powder; 4) Put the coarse powder into an extraction tank, add 70%-80% ethanol solution of 8-10 times the total weight of the raw materials, and perform reflux extraction at 60-70°C; 5) combining the extracts and concentrating under reduced pressure to a relative density of 1.1-1.2; 6) adding 3-5 times the volume of water to the concentrated solution, leaving it to stand for 12-24 hours, filtering, and concentrating the filtrate under reduced pressure to a specified volume to obtain the Chinese medicine solution.

6. The method according to claim 5, characterized in that: In the step 3), the raw materials are crushed and passed through a 20-40 mesh sieve.

7. The manufacturing method according to claim 5, characterized in that: The number of reflux extraction in step 4) is 2-4 times, and the time of each extraction is 1-1.5 hours.

8. The manufacturing method according to claim 5, characterized in that: In the step 5), during the reduced pressure concentration process, the vacuum degree is controlled at -0.06 to -0.08 MPa.

9. The manufacturing method according to claim 5, characterized in that: The concentrated Chinese medicine liquid in step 6) also needs to be pH-adjusted to a pH value of 6.5-7.

5.

10. The manufacturing method according to claim 5, characterized in that: In the step 6), the Chinese medicine liquid after adjusting the pH value is filtered through a microporous filter membrane with a pore size of 0.20-0.30 μm, and then filled and sealed.

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