A blood-activating and pain-stopping traditional Chinese medicine preparation and a preparation method thereof

Abstract

This invention provides a traditional Chinese medicine preparation for promoting blood circulation and relieving pain, and its preparation method, relating to the field of traditional Chinese medicine pharmaceutical technology. The preparation is made from the following parts by weight of traditional Chinese medicine raw materials: 10-30 parts of Polygonatum sibiricum, 10-30 parts of Spatholobus suberectus, 10-30 parts of Curcuma longa, 5-20 parts of Sparganium stoloniferum, 5-20 parts of Areca catechu peel, 5-20 parts of Polygonum hydropiper, 5-20 parts of Rhizoma Scutellariae, 1-5 parts of Artemisia argyi, 5-20 parts of Solanum nigrum, 5-20 parts of Catechu, 10-30 parts of Scutellaria barbata, 5-20 parts of Aristolochia debilis, 10-30 parts of Astragalus membranaceus, and 5-20 parts of Artemisia argyi oil. The traditional Chinese medicine preparations described in this invention differ from those that typically enhance the efficacy of a single herb. Instead, they exhibit a synergistic relationship where one plus one equals more than two. The principal, assistant, adjuvant, and guide herbs complement each other, combining both tonifying and purging effects. This approach effectively promotes the dissipation of blood stasis, unblocks the flow of qi and blood in the meridians, eliminates local inflammation, and reduces swelling and pain. Simultaneously, it nourishes the tendons and bones, supports the body's vital energy, and enhances the body's ability to resist pathogens and repair damage. Thus, it comprehensively alleviates pain caused by various factors, achieving the goals of promoting blood circulation, removing blood stasis, clearing the meridians, reducing inflammation and swelling, and relieving pain.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine pharmaceutical technology, specifically to a traditional Chinese medicine preparation for promoting blood circulation and relieving pain, and its preparation method. Background Technology

[0002] Orthopedic patients often experience soft tissue swelling and pain. If this swelling and pain are not properly managed during treatment, the risk of wound infection, delayed healing, and subsequent complications will significantly increase. Currently, early management methods for orthopedic swelling and pain include limb elevation, medication, and physical therapy, such as compression cryotherapy and intravenous mannitol. These interventions are effective in reducing pain and swelling. However, the effects of relying solely on physical therapy or medication are limited, and over-reliance on medication for pain relief may lead to drug resistance or adverse reactions.

[0003] Traditional Chinese medicine (TCM) believes that early swelling and pain in bone injury patients are mainly related to qi stagnation and blood stasis, and the treatment principle should focus on promoting blood circulation, removing blood stasis, regulating qi, and relieving pain. TCM has a long history of diagnosing and treating bone injuries, with numerous methods and unique techniques, forming a relatively complete theoretical system. External application of Chinese herbal medicine is one of the important methods of TCM treatment. External herbal preparations act directly on the affected ankle, which can unblock local qi flow, dissipate blood stasis, and achieve the effects of promoting blood circulation, reducing swelling, and relieving pain. In addition, the medicinal components in external herbal preparations can effectively inhibit the infiltration and exudation of inflammatory factors and regulate the synthesis and release of pain-causing substances, thereby exerting anti-inflammatory and analgesic effects. This invention aims to provide a Chinese herbal preparation for bone injuries that is fast-acting, has good therapeutic effects, and possesses the effects of promoting blood circulation, removing blood stasis, reducing inflammation, relieving pain, and reducing swelling. Summary of the Invention

[0004] (a) Technical problems to be solved To address the shortcomings of existing technologies, this invention provides a traditional Chinese medicine preparation for promoting blood circulation and relieving pain, and its preparation method.

[0005] (II) Technical Solution To achieve the above objectives, the present invention provides the following technical solution: This invention provides a traditional Chinese medicine preparation for promoting blood circulation and relieving pain, which is made from the following traditional Chinese medicine raw materials in parts by weight: 10-30 parts of Polygonatum sibiricum, 10-30 parts of Spatholobus suberectus, 10-30 parts of Curcuma longa, 5-20 parts of Sparganium stoloniferum, 5-20 parts of Areca catechu, 5-20 parts of Polygonum hydropiper, 5-20 parts of Rhizoma Scrophulariae, 1-5 parts of Artemisia argyi, 5-20 parts of Solanum nigrum, 5-20 parts of Catechu, 10-30 parts of Scutellaria barbata, 5-20 parts of Aristolochia debilis, 10-30 parts of Astragalus membranaceus, and 5-20 parts of Artemisia argyi oil.

[0006] Furthermore, the traditional Chinese medicine preparation is made from the following traditional Chinese medicine raw materials in parts by weight: 15-25 parts of Polygonatum sibiricum, 15-25 parts of Spatholobus suberectus, 10-20 parts of Curcuma longa, 5-15 parts of Sparganium stoloniferum, 5-15 parts of Areca catechu, 5-15 parts of Polygonum hydropiper, 5-15 parts of Rhizoma Scrophulariae, 1-3 parts of Artemisia argyi, 10-20 parts of Solanum nigrum, 5-15 parts of Catechu, 15-25 parts of Scutellaria barbata, 5-15 parts of Aristolochia debilis, 15-25 parts of Astragalus membranaceus, and 5-10 parts of Artemisia argyi oil.

[0007] Furthermore, the traditional Chinese medicine preparation is made from the following parts by weight of traditional Chinese medicine raw materials: 20 parts of Polygonatum sibiricum, 20 parts of Spatholobus suberectus, 15 parts of Curcuma longa, 12 parts of Sparganium stoloniferum, 12 parts of Areca catechu peel, 12 parts of Polygonum hydropiper, 12 parts of Rhizoma Scutellariae, 3 parts of Artemisia argyi, 15 parts of Solanum nigrum, 10 parts of Catechu, 20 parts of Scutellaria barbata, 12 parts of Aristolochia debilis, 18 parts of Astragalus membranaceus, and 9 parts of Artemisia argyi oil.

[0008] The above-mentioned mugwort oil is obtained by distillation of the whole mugwort plant or by purchasing it from the market.

[0009] The traditional Chinese medicine preparation for promoting blood circulation and relieving pain provided by this invention is made from the above-mentioned parts by weight of traditional Chinese medicine raw materials, supplemented with medically acceptable excipients, and prepared into external dosage forms, including oils, black plasters, ointments, tinctures, liniments, sprays, lotions, rubber patches, gels, creams, and films.

[0010] This invention also provides a method for preparing a traditional Chinese medicine preparation for promoting blood circulation and relieving pain, wherein the preparation is a spray, and the preparation is prepared according to the following steps: (1) Weigh each Chinese herbal raw material according to the following weight proportions: 10-30 parts of Polygonatum sibiricum, 10-30 parts of Spatholobus suberectus, 10-30 parts of Curcuma longa, 5-20 parts of Sparganium stoloniferum, 5-20 parts of Areca catechu, 5-20 parts of Polygonum hydropiper, 5-20 parts of Rhizoma Scutellariae, 1-5 parts of Artemisia argyi, 5-20 parts of Solanum nigrum, 5-20 parts of Catechu, 10-30 parts of Scutellaria barbata, 5-20 parts of Aristolochia debilis, and 10-30 parts of Astragalus membranaceus; wash, dry, pulverize to 80-100 mesh, mix well, and obtain Chinese herbal powder for later use; (2) Take 10-15 times the weight of 50% ethanol to soak the Chinese medicine powder, soak it continuously for 3-5 times, each time for 5-7 days, filter, combine the soaking liquid, and keep the soaking liquid and the Chinese medicine filter residue separate for later use. (3) Take 5-10 times the weight of the Chinese medicine filter residue with 60% ethanol, heat and reflux at 55-60℃ for more than 12 hours, and reflux continuously 3-4 times. After the reflux is completed, bring it to room temperature, filter, combine the reflux liquids, and set aside for later use. (4) The extract obtained by combining the soaking solution and the reflux solution is then evaporated and concentrated until the volume of the extract is reduced to one-quarter, and the concentrate is prepared for use. (5) Add 5-20 parts of Artemisia argyi oil to the concentrate and mix evenly. Then add deionized water until the ethanol content is below 40%. Mix well and sterilize to obtain the blood-activating and pain-relieving Chinese medicine spray.

[0011] The traditional Chinese medicine preparation of this invention uses turmeric and polygonatum as the principal ingredients. Turmeric has the functions of promoting blood circulation, regulating qi, and relieving pain. It is a good medicine for clearing the meridians and dispersing blood stasis. Polygonatum tonifies qi and nourishes yin, strengthens the spleen and benefits the kidneys. It can nourish the tendons and bones, protect the body's vital energy and inhibit the pungent and drying properties of turmeric. It can also tonify qi and blood, so that it can promote blood circulation without harming the body's vital energy. Together with turmeric, they complement each other, acting as the principal ingredients. The formula uses four herbs as the principal ingredients: chicken blood vine, water lily seed, stone incisor, and tianxian vine. Chicken blood vine can not only nourish and invigorate blood, but also relax muscles and tendons, assisting the principal ingredients in regulating qi and blood and promoting smooth blood flow. Water lily seed disperses blood stasis, eliminates masses, and relieves pain, enhancing the principal ingredients' ability to resolve blood stasis. Stone incisor is used to invigorate blood, clear the meridians, dispel wind and dampness, and remove stagnation in the meridians, while also clearing damp heat. Tianxian vine promotes qi and blood circulation, promotes diuresis and reduces swelling, assisting qi and blood circulation and relieving pain. The four herbs work together to form a synergistic network of nourishing blood, breaking up blood stasis, penetrating bone, and promoting diuresis, all of which help the principal ingredients break up blood stasis and clear the meridians without depleting blood. Black nightshade clears heat and detoxifies, reduces swelling and dissipates nodules; catechu invigorates blood circulation, heals wounds, stops bleeding and promotes tissue regeneration; *Gnaphalium affine* invigorates blood circulation, relieves pain, dispels wind and unblocks meridians; *Sparganium stoloniferum* breaks up blood stasis, promotes qi circulation, eliminates stagnation and relieves pain; *Areca catechu* peel promotes qi circulation, relieves chest congestion, promotes diuresis and reduces swelling, regulates qi mechanism, promotes water and dampness metabolism, and eliminates swelling; *Astragalus membranaceus* tonifies qi and raises yang, consolidates the exterior and stops sweating, tonifies qi to help blood circulation, strengthens the body's vital energy, and prevents excessive attack from damaging the vital energy; these six herbs work together as adjuvants to achieve the effects of reducing inflammation and swelling, repairing damage, and harmonizing qi and blood, assisting the principal and assistant herbs, while also taking into account both supporting the body's vital energy and eliminating pathogens. *Artemisia argyi* and *Artemisia argyi* oil act as guides, directing the medicine directly to the affected area and enhancing the analgesic effect.

[0012] (III) Beneficial Effects The traditional Chinese medicine preparations described in this invention differ from those that typically enhance the efficacy of a single herb. Instead, they exhibit a synergistic relationship where one plus one equals more than two. The principal, assistant, adjuvant, and guide herbs complement each other, combining both tonifying and purging effects. This approach effectively promotes the dissipation of blood stasis, unblocks the flow of qi and blood in the meridians, eliminates local inflammation, and reduces swelling and pain. Simultaneously, it nourishes the tendons and bones, supports the body's vital energy, and enhances the body's ability to resist pathogens and repair damage. Thus, it comprehensively alleviates pain caused by various factors, achieving the goals of promoting blood circulation, removing blood stasis, clearing the meridians, reducing inflammation and swelling, and relieving pain.

[0013] The traditional Chinese medicine preparation of this invention can significantly prolong the latency period of acetic acid-induced pain in mice and significantly reduce the number of writhing movements in painful mice, thus exhibiting excellent analgesic effects. It also has significant anti-inflammatory and swelling-reducing effects on xylene-induced ear swelling in mice and can rapidly achieve therapeutic effects on soft tissue injury model rats, significantly alleviating swelling and ecchymosis in the soft tissue injury model rats.

[0014] The traditional Chinese medicine preparation of this invention has a total effective rate of 98.57% in treating patients with acute ankle sprains, and can significantly improve clinical symptoms such as pain, tenderness, ecchymosis, swelling and functional impairment at the affected area. Detailed Implementation

[0015] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below in conjunction with the embodiments of the present invention. Obviously, the described embodiments are only some embodiments of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention. Example 1

[0016] A traditional Chinese medicine preparation for promoting blood circulation and relieving pain, wherein the preparation comprises the following raw materials weighed in the following proportions: 20 parts of Polygonatum sibiricum, 20 parts of Spatholobus suberectus, 15 parts of Curcuma longa, 12 parts of Sparganium stoloniferum, 12 parts of Areca catechu peel, 12 parts of Polygonum hydropiper, 12 parts of Rhizoma Scutellariae, 3 parts of Artemisia argyi, 15 parts of Solanum nigrum, 10 parts of Catechu, 20 parts of Scutellaria barbata, 12 parts of Aristolochia debilis, 18 parts of Astragalus membranaceus, and 9 parts of Artemisia argyi oil; supplemented with medically acceptable excipients, and prepared into external dosage forms, including black plaster, ointment, tincture, liniment, spray, lotion, rubber patch, gel plaster, cream, and film coating.

[0017] Specifically, a method for preparing a traditional Chinese medicine preparation for promoting blood circulation and relieving pain, wherein the preparation is a spray, is prepared according to the following steps: (1) Weigh out each Chinese herbal raw material according to the following weight proportions: 20 parts of Polygonatum sibiricum, 20 parts of Spatholobus suberectus, 15 parts of Curcuma longa, 12 parts of Sparganium stoloniferum, 12 parts of Areca catechu, 12 parts of Polygonum hydropiper, 12 parts of Rhizoma Scutellariae, 3 parts of Artemisia argyi, 15 parts of Solanum nigrum, 10 parts of Catechu, 20 parts of Scutellaria barbata, 12 parts of Aristolochia debilis, and 18 parts of Astragalus membranaceus; wash, dry, pulverize to 80-100 mesh, mix well, and obtain Chinese herbal powder for later use; (2) Take 15 times the weight of 50% ethanol to soak the Chinese medicine powder. Soak the Chinese medicine powder continuously for 5 times, 7 days each time. Filter and combine the soaking liquid. Separate the soaking liquid and the Chinese medicine filter residue for later use. (3) Take 10 times the weight of the Chinese medicine filter residue with 60% ethanol, heat and reflux at 55°C for more than 12 hours, reflux continuously 3 times, after the reflux is completed, cool to room temperature, filter, combine the reflux liquids, and set aside for later use; (4) The extract obtained by combining the soaking solution and the reflux solution is then evaporated and concentrated until the volume of the extract is reduced to one-quarter, and the concentrate is prepared for use. (5) Add 9 parts of Artemisia argyi oil to the concentrate and mix well. Then add deionized water until the ethanol content is below 40%. Mix well and sterilize to obtain the blood-activating and pain-relieving Chinese medicine spray. Example 2

[0018] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following parts by weight of traditional Chinese medicine raw materials: 10 parts of Polygonatum sibiricum, 10 parts of Spatholobus suberectus, 10 parts of Curcuma longa, 5 parts of Sparganium stoloniferum, 5 parts of Areca catechu, 5 parts of Polygonum hydropiper, 5 parts of Rhizoma Scutellariae, 1 part of Artemisia argyi, 5 parts of Solanum nigrum, 5 parts of Catechu, 10 parts of Scutellaria barbata, 5 parts of Aristolochia debilis, 10 parts of Astragalus membranaceus, and 1 part of Artemisia argyi oil. Example 3

[0019] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following parts by weight of traditional Chinese medicine raw materials: 30 parts of Polygonatum sibiricum, 30 parts of Spatholobus suberectus, 30 parts of Curcuma longa, 20 parts of Sparganium stoloniferum, 20 parts of Areca catechu peel, 20 parts of Polygonum hydropiper, 20 parts of Rhizoma Scutellariae, 5 parts of Artemisia argyi, 20 parts of Solanum nigrum, 5-20 parts of Catechu, 30 parts of Scutellaria barbata, 20 parts of Aristolochia debilis, 30 parts of Astragalus membranaceus, and 20 parts of Artemisia argyi oil. Example 4

[0020] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following parts by weight of traditional Chinese medicine raw materials: 16 parts of Polygonatum sibiricum, 16 parts of Spatholobus suberectus, 12 parts of Curcuma longa, 8 parts of Sparganium stoloniferum, 8 parts of Areca catechu peel, 8 parts of Polygonum hydropiper, 8 parts of Rhizoma Scutellariae, 2 parts of Artemisia argyi, 10 parts of Solanum nigrum, 6 parts of Catechu, 16 parts of Scutellaria barbata, 8 parts of Aristolochia debilis, 14 parts of Astragalus membranaceus, and 8 parts of Artemisia argyi oil. Example 5

[0021] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following parts by weight of traditional Chinese medicine raw materials: 26 parts of Polygonatum sibiricum, 24 parts of Spatholobus suberectus, 22 parts of Curcuma longa, 16 parts of Sparganium stoloniferum, 16 parts of Areca catechu, 16 parts of Polygonum hydropiper, 16 parts of Rhizoma Scutellariae, 4 parts of Artemisia argyi, 18 parts of Solanum nigrum, 16 parts of Catechu, 26 parts of Scutellaria barbata, 16 parts of Aristolochia debilis, 24 parts of Astragalus membranaceus, and 14 parts of Artemisia argyi oil. Example 6

[0022] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following parts by weight of traditional Chinese medicine raw materials: 15 parts of Polygonatum sibiricum, 15 parts of Spatholobus suberectus, 10 parts of Curcuma longa, 5 parts of Sparganium stoloniferum, 5 parts of Areca catechu peel, 5 parts of Polygonum hydropiper, 5 parts of Rhizoma Scutellariae, 1 part of Artemisia argyi, 10 parts of Solanum nigrum, 5 parts of Catechu, 15 parts of Scutellaria barbata, 5 parts of Aristolochia debilis, 15 parts of Astragalus membranaceus, and 5 parts of Artemisia argyi oil. Example 7

[0023] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following parts by weight of traditional Chinese medicine raw materials: 25 parts of Polygonatum sibiricum, 25 parts of Spatholobus suberectus, 20 parts of Curcuma longa, 15 parts of Sparganium stoloniferum, 15 parts of Areca catechu peel, 15 parts of Polygonum hydropiper, 15 parts of Rhizoma Scutellariae, 3 parts of Artemisia argyi, 20 parts of Solanum nigrum, 15 parts of Catechu, 25 parts of Scutellaria barbata, 15 parts of Aristolochia debilis, 25 parts of Astragalus membranaceus, and 10 parts of Artemisia argyi oil. Example 8

[0024] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following parts by weight of traditional Chinese medicine raw materials: 18 parts of Polygonatum sibiricum, 18 parts of Spatholobus suberectus, 14 parts of Curcuma longa, 7 parts of Sparganium stoloniferum, 8 parts of Areca catechu peel, 6 parts of Polygonum hydropiper, 8 parts of Rhizoma Scutellariae, 1 part of Artemisia argyi, 12 parts of Solanum nigrum, 7 parts of Catechu, 18 parts of Scutellaria barbata, 8 parts of Aristolochia debilis, 16 parts of Astragalus membranaceus, and 8 parts of Artemisia argyi oil. Example 9

[0025] The difference between this embodiment and Embodiment 1 is that the traditional Chinese medicine preparation is made from the following parts by weight of traditional Chinese medicine raw materials: 22 parts of Polygonatum sibiricum, 20 parts of Spatholobus suberectus, 18 parts of Curcuma longa, 14 parts of Sparganium stoloniferum, 10 parts of Areca catechu peel, 14 parts of Polygonum hydropiper, 10 parts of Rhizoma Scutellariae, 2 parts of Artemisia argyi, 18 parts of Solanum nigrum, 12 parts of Catechu, 22 parts of Scutellaria barbata, 14 parts of Aristolochia debilis, 22 parts of Astragalus membranaceus, and 10 parts of Artemisia argyi oil.

[0026] Experimental Example 1

[0027] The analgesic, anti-inflammatory, and anti-soft tissue injury effects of the traditional Chinese medicine preparation of this invention 1. Materials and Methods 1.1 Drugs The traditional Chinese medicine preparation of this invention is as follows: 20 parts of Polygonatum sibiricum, 20 parts of Spatholobus suberectus, 15 parts of Curcuma longa, 12 parts of Sparganium stoloniferum, 12 parts of Areca catechu, 12 parts of Polygonum hydropiper, 12 parts of Rhizoma Scutellariae, 3 parts of Artemisia argyi, 15 parts of Solanum nigrum, 10 parts of Catechu, 20 parts of Scutellaria barbata, 12 parts of Aristolochia debilis, and 18 parts of Astragalus membranaceus. Weigh each raw material according to the above weight proportions, wash them, pulverize them through a 200-mesh sieve, mix them evenly, add 9 parts of Artemisia argyi oil and a small amount of 50% ethanol, mix them into a non-flowing paste-like traditional Chinese medicine ointment, and that is the traditional Chinese medicine preparation of this invention. It can be prepared as needed.

[0028] Diclofenac Sodium Gel (Mayinglong Pharmaceutical Group Co., Ltd.) 1.2 Experimental Methods 1.2.1 Mouse Acetic Acid Writhing Test Thirty male SPF-grade KM mice, weighing 18-22g, were used and acclimatized for one week before the experiment.

[0029] Mice were randomly divided into three groups based on their body weight: a model group (physiological saline), an experimental group (the herbal preparation of this invention was applied evenly to both upper auricles and used as a wet compress for 30 minutes), and a positive control group (diclofenac sodium gel was applied evenly to both upper auricles). Each group consisted of 10 mice. The medication was administered once a day for 7 consecutive days. On the last day after administration, each mouse was injected intraperitoneally with 1% glacial acetic acid (0.1 mL / 10 g) to induce pain. The time when writhing began (writhing latency) and the number of writhing episodes within 15 minutes were recorded. The analgesic effect of the herbal preparation of this invention was evaluated based on the latency, the number of writhing episodes, and the percentage of analgesia.

[0030] Analgesia rate (%) = (Mean number of writhing movements in the model group - Mean number of writhing movements in the treatment group) / Mean number of writhing movements in the model group × 100% 1.2.2 Effect of xylene on mouse ear swelling Thirty male SPF-grade KM mice, weighing 18-22g, were used and acclimatized for one week before the experiment.

[0031] Mice were randomly divided into three groups based on body weight: a model group (physiological saline), an experimental group (the traditional Chinese medicine preparation of this invention was applied evenly to both upper auricles and used as a wet compress for 30 minutes), and a positive control group (diclofenac sodium gel was applied evenly to both upper auricles). Each group consisted of 10 mice. The corresponding drug was applied to the right auricle of each group every 2 hours for 3 consecutive times. Before each administration, the application site was cleaned with physiological saline and allowed to dry before administration. Two hours after the last administration, 0.05 mL of xylene was evenly applied to the front and back of the right auricle of each mouse to induce inflammation. The mice were then placed in a fume hood and allowed to move freely for 30 minutes before being euthanized. An 8 mm ear patch was punched in the left and right auricles of the mice using an 8 mm diameter ear punch and weighed. The degree of swelling and the swelling inhibition rate of each group were calculated.

[0032] Swelling degree (mg) = Right ear mass - Left ear mass Swelling inhibition rate (%) = (Average ear swelling in the model group - Average ear swelling in the treatment group) / Average ear swelling in the model group × 100% 1.2.3 Effects on soft tissue injury in rats Forty male SPF-grade SD rats, weighing 180-220g, were used and acclimatized for one week before the experiment.

[0033] Rats were first dehaired on one side of their lower leg using 10% barium sulfide. Twenty-four hours later, the rats were struck once on the lateral aspect of the middle of the lower leg with a striking device to cause local soft tissue injury. Rats with skin lacerations or fractures were excluded. Thirty successfully modeled rats were randomly divided into three groups: a model group (physiological saline), an experimental group (the herbal preparation of this invention was applied evenly to both upper auricles as a wet compress for 30 minutes), and a positive control group (diclofenac sodium gel was applied evenly to both upper auricles), with ten rats in each group. The medication was administered to the affected area twice daily, with an interval of at least 8 hours between administrations, for seven consecutive days. Swelling and ecchymosis of the injured limb were observed on days 1, 3, and 7, and the injury index was graded and recorded. The scoring criteria are shown in Table 1. Table 1 Damage Index Scoring

[0034] 1.3 Statistical Analysis All data were processed using Graphpad Prism 8.0 software. Data are expressed as mean ± standard deviation. ANOVA was used for analysis of variance when all groups were normally distributed. LSD-test was used for comparisons between groups with homogeneous variances. Dunnett's test was used for comparisons between groups with unequal variances. A p-value < 0.05 was considered statistically significant.

[0035] 1.4 Results 1.4.1 Analgesic effect of the traditional Chinese medicine preparation of this invention Compared with the model group, the pain latency of mice in both the positive control group and the experimental group was significantly increased (P<0.01), and the number of writhing movements was significantly reduced (P<0.05). The analgesic rate in the experimental group was 75.60%, significantly higher than that in the positive control group (66.03%). These results indicate that the traditional Chinese medicine preparation of this invention has a good analgesic effect on acetic acid-induced pain in mice, and is significantly superior to diclofenac sodium gel. The results are shown in Table 2.

[0036] Table 2. Effects of the traditional Chinese medicine preparation of this invention on the analgesic effect of acetic acid writhing test in mice.

[0037] Note: Compared with the model group, *P<0.05, **P<0.01.

[0038] 1.4.2 Anti-inflammatory effect of the traditional Chinese medicine preparation of this invention Compared with the model group, the swelling degree of mice in the positive control group and the experimental group was significantly reduced (P<0.01). The inhibition rate of xylene-induced ear swelling in the experimental group was 66.09%, while the inhibition rate of swelling in the positive control group was 50.73%. These results indicate that the traditional Chinese medicine preparation of this invention has a significant anti-inflammatory effect on xylene-induced ear swelling in mice, and is significantly better than diclofenac sodium gel. The results are shown in Table 3.

[0039] Table 3. Effects of the traditional Chinese medicine preparation of this invention on xylene-induced ear swelling in mice.

[0040] Note: Compared with the model group, *P<0.05, **P<0.01.

[0041] 1.4.3 The therapeutic effect of the traditional Chinese medicine preparation of this invention on soft tissue injury On day 3 of the experiment, compared with the model group, the injury index of the experimental group was significantly lower than that of the model group (P<0.05), and the injury index of the positive control group was lower than that of the model group, but the difference was not statistically significant (P>0.05). On day 7 of the experiment, compared with the model group, the injury index of both the experimental group and the positive control group was significantly lower than that of the model group (P<0.05), with the injury index of the experimental group being significantly lower than that of the positive control group. These results indicate that the traditional Chinese medicine preparation of the present invention can rapidly achieve a therapeutic effect on rats with soft tissue injury, and the final therapeutic effect is significantly better than that of diclofenac sodium gel. The results are shown in Table 4.

[0042] Table 4. Therapeutic effects of the traditional Chinese medicine preparation of this invention on soft tissue injury in rats.

[0043] Note: Compared with the model group, *P<0.05, **P<0.01.

[0044] Experimental Example 2 Evaluation of the therapeutic effect of the traditional Chinese medicine preparation of this invention on acute ankle sprain 1. General Information One hundred and forty patients with acute ankle sprains admitted to Henan Provincial Hospital of Traditional Chinese Medicine (the Second Affiliated Hospital of Henan University of Traditional Chinese Medicine) from January 2024 to March 2025 were selected and randomly divided into a treatment group and a control group, with 70 patients in each group. Treatment group: 38 males and 32 females, mean age (36.41±7.06) years, mean duration of illness (24.86±5.43) hours; 36 cases of inversion sprain and 34 cases of eversion sprain; 37 cases of left ankle and 33 cases of right ankle. Control group: 40 males and 30 females, mean age (34.09±4.22) years, mean duration of illness (26.17±6.39) hours; 32 cases of inversion sprain and 38 cases of eversion sprain; 38 cases of left ankle and 32 cases of right ankle. There were no statistically significant differences in general characteristics between the two groups. P (>0.05), making them comparable.

[0045] Diagnostic criteria: Refer to the Western medicine diagnosis of "acute ankle sprain" in "Practical Orthopedics". (1) History of ankle injury; (2) Swelling, tenderness and ecchymosis of the affected ankle; (3) Positive results of eversion stress, inversion stress or anterior drawer test of the ankle joint; (4) No fracture or dislocation of the ankle joint shown on X-ray, and all patients complain of ankle pain, swelling and limited function at the time of consultation. Refer to the diagnosis of "closed ankle sprain" in "Standards for Diagnosis and Efficacy of Diseases in Traditional Chinese Medicine": The ankle joint is swollen and painful due to trauma, the pain is fixed, there is ecchymosis, it is bluish-purple, the joint movement is restricted, the tongue is dark purple or there is ecchymosis, and the pulse is wiry and hesitant.

[0046] Inclusion criteria: meeting the diagnostic and syndrome differentiation criteria of both traditional Chinese medicine and Western medicine, aged 18-75 years, with a course of illness of less than 60 hours, ankle sprain graded as I or II, no special treatment received before admission, and good compliance.

[0047] Exclusion criteria: complete rupture of soft tissues such as tendons, muscles and ligaments requiring immediate surgical treatment; coexisting conditions such as gout, rheumatoid arthritis and rheumatoid arthritis that affect ankle joint function; coexisting severe skin diseases or local skin damage to the ankle joint; allergic reactions to research drugs or medical tape; pregnancy or lactation; or coexisting severe mental illness.

[0048] 2 Treatment Plan Both groups of patients applied ice for 20 minutes each time within 48 hours of the ankle sprain, with an interval of 4 hours between applications, for a total of at least 2 applications.

[0049] After 48 hours, the control group was given diclofenac diethylamine emulsion topically. The appropriate amount of ointment was applied evenly according to the area of ​​the affected area, and was applied 3 times a day.

[0050] 48 hours later, the treatment group used the herbal spray prepared in Example 1 of this invention for spraying. The spray was applied evenly according to the area of ​​the affected area and gently massaged until the drug was completely absorbed. The medication was administered 3 times a day.

[0051] Both groups of patients received the medication for two consecutive weeks, while the affected ankle was immobilized with an elastic bandage. Under immobilization protection, appropriate functional exercises such as toe flexion and extension, and internal and external rotation of the affected foot were performed.

[0052] 3 Observation Indicators Ankle symptom score: The symptom score standard in the "Standards for Diagnosis and Efficacy of Diseases in Traditional Chinese Medicine" is used to quantify the degree of ankle pain, tenderness, ecchymosis, swelling and functional impairment. Each item is divided into 4 levels, and is scored as 0, 1, 2 and 3 points respectively according to the symptoms of no symptoms, mild, moderate and severe, for a total of 15 points. The higher the score, the more severe the symptoms.

[0053] Pain rating: The visual analog scale (VAS) was used to assess pain at rest, while bearing weight and not walking, and while walking. The score was the average of the three pain scores, with 0 points for no pain and 10 points for the most severe pain.

[0054] Joint function assessment: Ankle joint function is assessed according to the Ankle and Hindfoot Score (AOFAS), which mainly includes pain, support, gait, function and voluntary movement, walking, ankle joint range of motion and stability, etc. The total score is 100 points, and the higher the score, the better the joint function.

[0055] 4. Efficacy criteria Refer to the "Standards for Diagnosis and Treatment of Diseases in Traditional Chinese Medicine".

[0056] Cure: The ankle joint is stable, joint function returns to normal, joint pain and swelling completely disappear, and the joint symptom score is reduced by more than 95%.

[0057] Significant effect: The ankle joint is accompanied by mild pain and subcutaneous ecchymosis. The pain is significantly relieved and the joint symptom score is reduced by 70%-95%.

[0058] Effective: When there is significant pain and subcutaneous ecchymosis in the ankle joint, weakness in walking, pain relief, and a 30%-70% reduction in joint symptom scores.

[0059] Ineffective: No improvement in ankle joint function, swelling, pain, etc., and a reduction in joint symptom score of less than 30%.

[0060] 5. Statistical Analysis Statistical analysis was performed using Graphpad Prism 8.0 software. Quantitative data were expressed as (x ± s) and analyzed using t-tests. Count data were expressed as (%) and analyzed using chi-square tests. 2 test, P <0.05 indicates a statistically significant difference.

[0061] 6 Results 6.1 Clinical efficacy The clinical efficacy results of the two groups are shown in Table 5. The total effective rate of treatment for ankle sprain in the treatment group was 98.57%, while that in the control group was 88.57%. The difference between the two groups was statistically significant.

[0062] Table 5 Comparison of clinical efficacy between the two groups [n (%)]

[0063] Note: *P<0.05 compared with the control group.

[0064] 6.2 Results of joint symptom scores, pain scores, and joint function scores in the two groups Before treatment, there were no statistically significant differences in joint symptom scores, pain scores, and joint function scores between the control group and the treatment group (P>0.05). Compared with before treatment, the joint symptom scores, pain scores, and joint function scores of both the control group and the treatment group were significantly reduced (P<0.05). Compared with the control group after treatment, the joint symptom scores, pain scores, and joint function scores of the treatment group were significantly lower than those of the control group after treatment (P<0.05).

[0065] Table 6. Results of joint symptom scores, pain scores, and joint function scores for the two groups.

[0066] Note: Compared with the pre-treatment values ​​in this group. # P<0.05; *P<0.05 compared with the control group after treatment.

[0067] 3. Conclusion The traditional Chinese medicine preparation of this invention has a total effective rate of 98.57% in treating patients with acute ankle sprains, and can significantly improve clinical symptoms such as pain, tenderness, ecchymosis, swelling and functional impairment at the affected area.

[0068] In this invention, the traditional Chinese medicine preparation uses turmeric and polygonatum as the principal ingredients. Turmeric has the functions of promoting blood circulation, regulating qi, and relieving pain. It is a good medicine for clearing the meridians and dispersing blood stasis. Polygonatum tonifies qi and nourishes yin, strengthens the spleen and benefits the kidneys. It can nourish the tendons and bones, protect the body's vital energy and inhibit the pungent and drying properties of turmeric. It can also tonify qi and blood, so that promoting blood circulation does not harm the body's vital energy. Together with turmeric, they complement each other, acting as the principal ingredients. The formula uses *Spatholobus suberectus*, *Polygonum hydropiper*, *Aristolochia debilis*, and *Gynostemma pentaphyllum* as assistant herbs. *Spatholobus suberectus* can both nourish and invigorate blood, and relax muscles and tendons, assisting the principal herb in harmonizing qi and blood, and ensuring smooth blood flow. *Polygonum hydropiper* disperses blood stasis, eliminates masses, and relieves pain, enhancing the principal herb's ability to resolve blood stasis. *Gynostemma pentaphyllum* invigorates blood, clears the meridians, dispels wind and dampness, and can break up meridian stagnation while clearing damp heat. *Aristolochia debilis* promotes qi and blood circulation, promotes diuresis and reduces swelling, assisting qi and blood circulation and relieving pain. The four herbs work together to form a synergistic network of nourishing blood, breaking up blood stasis, penetrating bone, and promoting diuresis, all helping the principal herb to break up blood stasis and clear the meridians without depleting blood. Black nightshade clears heat and detoxifies, reduces swelling and dissipates nodules; catechu invigorates blood circulation, heals wounds, stops bleeding and promotes tissue regeneration; *Gnaphalium affine* invigorates blood circulation, relieves pain, dispels wind and unblocks meridians; *Sparganium stoloniferum* breaks up blood stasis, promotes qi circulation, eliminates stagnation and relieves pain; *Areca catechu* peel promotes qi circulation, relieves chest congestion, promotes diuresis and reduces swelling, regulates qi mechanism, promotes water and dampness metabolism, and eliminates swelling; *Astragalus membranaceus* tonifies qi and raises yang, consolidates the exterior and stops sweating, tonifies qi to help blood circulation, strengthens the body's vital energy, and prevents excessive attack from damaging the vital energy; these six herbs work together as adjuvants to achieve the effects of reducing inflammation and swelling, repairing damage, and harmonizing qi and blood, assisting the principal and assistant herbs, while also taking into account both supporting the body's vital energy and eliminating pathogens. *Artemisia argyi* and *Artemisia argyi* oil act as guides, directing the medicine directly to the affected area and enhancing the analgesic effect.

[0069] The traditional Chinese medicine preparations described in this invention differ from those that typically enhance the efficacy of a single herb. Instead, they exhibit a synergistic effect where one plus one equals more than two. The principal, assistant, adjuvant, and guide herbs complement each other, combining both tonifying and purging methods to treat both the root cause and the symptoms. This approach effectively promotes the dissipation of blood stasis, unblocks the flow of qi and blood in the meridians, eliminates local inflammation, and reduces swelling and pain. Simultaneously, it nourishes the tendons and bones, strengthens the body's vital energy, and enhances the body's ability to resist pathogens and repair damage. Thus, it comprehensively alleviates pain caused by various factors, achieving the goals of promoting blood circulation, removing blood stasis, clearing the meridians, and reducing inflammation and swelling.

[0070] Even though some Chinese herbs may have similar effects, their meridian tropism, properties, and efficacy are not entirely identical. Furthermore, there are synergistic and antagonistic interactions between herbs in a prescription, such as mutual reinforcement, mutual assistance, and mutual incompatibility. Unless the herbs are difficult to obtain, the prescription should not be modified. Removing one herb from the prescription in rotation or replacing it with a similar herb significantly weakens the overall efficacy. Replacing the principal herb will affect the entire prescription's efficacy. This prescription has a reasonable combination of principal, assistant, adjuvant, and guide herbs, and a clear treatment principle. It is not advisable to add or replace other herbs that differ from the treatment principle or have similar efficacy. Otherwise, not only will the efficacy of this prescription not be increased, but the patient's financial burden will also be added. Moreover, the original balanced compatibility of the herbs in the prescription will be affected, potentially leading to reduced efficacy, increased treatment duration, or even unnecessary toxic side effects.

[0071] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some of the technical features. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the embodiments of the present invention.

Claims

1. A blood-activating analgesic traditional Chinese medicine preparation, characterized in that, The traditional Chinese medicine preparation is made from the following parts by weight of raw materials: 20 parts of Polygonatum sibiricum, 20 parts of Spatholobus suberectus, 15 parts of Curcuma longa, 12 parts of Sparganium stoloniferum, 12 parts of Areca catechu peel, 12 parts of Polygonum hydropiper, 12 parts of Rhizoma Scutellariae, 3 parts of Saussurea involucrata, 15 parts of Solanum nigrum, 10 parts of Catechu, 20 parts of Scutellaria barbata, 12 parts of Aristolochia debilis, 18 parts of Astragalus membranaceus, and 9 parts of Artemisia argyi oil. The blood-activating and pain-relieving traditional Chinese medicine preparation is made by weighing the above-mentioned raw materials according to their respective parts by weight, adding medically acceptable excipients, and preparing a traditional Chinese medicine spray. The traditional Chinese medicine spray is prepared according to the following steps: (1) Weigh out each Chinese herbal raw material according to the following weight proportions: 20 parts of Polygonatum sibiricum, 20 parts of Spatholobus suberectus, 15 parts of Curcuma longa, 12 parts of Sparganium stoloniferum, 12 parts of Areca catechu, 12 parts of Polygonum hydropiper, 12 parts of Rhizoma Scutellariae, 3 parts of Artemisia argyi, 15 parts of Solanum nigrum, 10 parts of Catechu, 20 parts of Scutellaria barbata, 12 parts of Aristolochia debilis, and 18 parts of Astragalus membranaceus; wash, dry, pulverize to 80-100 mesh, mix well, and obtain Chinese herbal powder for later use; (2) Take 10-15 times the weight of 50% ethanol to soak the Chinese medicine powder. Soak the Chinese medicine powder continuously for 3-5 times, each time for 5-7 days. Filter and combine the soaking liquid. Separate the soaking liquid and the Chinese medicine filter residue for later use. (3) Take 5-10 times the weight of 60% ethanol from the Chinese medicine filter residue, heat and reflux at 55-60℃ for more than 12 hours, and reflux continuously 3-4 times. After the reflux is completed, bring it to room temperature, filter, combine the reflux liquids, and set aside. (4) The extract obtained by combining the soaking solution and the reflux solution is then evaporated and concentrated until the volume of the extract is reduced to one-quarter, and the concentrated solution is used for later use. (5) Add 9 parts of Artemisia argyi oil to the concentrate and mix well. Then add deionized water until the ethanol content is below 40%. Mix well and sterilize to obtain the blood-activating and pain-relieving Chinese medicine spray.

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