Traditional Chinese medicine preparation for promoting blood circulation and relieving pain and preparation method thereof

Abstract

The invention provides a blood-activating and pain-relieving traditional Chinese medicine preparation and a preparation method thereof, and relates to the technical field of traditional Chinese medicine preparation. The traditional Chinese medicine preparation is prepared from the following traditional Chinese medicine raw materials in parts by weight: 10-30 parts of rhizoma polygonati, 10-30 parts of caulis spatholobi, 10-30 parts of turmeric, 5-20 parts of rhizoma sparganii, 5-20 parts of pericarpium arecae, 5-20 parts of fructus polygoni orientalis, 5-20 parts of glabrous sarcandra herb, 1-5 parts of short-pedicel aconite root, 5-20 parts of black nightshade herb, 5-20 parts of catechu, 10-30 parts of cudrania cochinchinensis, 5-20 parts of herba aristolochiae, 10-30 parts of radix hedysari and 5-20 parts of artemisia argyl oil. The multiple traditional Chinese medicine preparations are different from a common enhanced single medicine in efficacy, a one-plus-one-greater-than-two synergistic relationship is adopted, monarch, minister, assistant and guide complement each other, purgation and tonification are combined, blood stasis dissipation can be effectively promoted, channels and collaterals are unblocked, local inflammation is eliminated, swelling and pain are relieved, meanwhile, muscles and bones are nourished, healthy qi is supported, and the curative effect is good. Therefore, the pain caused by various factors is comprehensively relieved, and the purposes of promoting blood circulation to remove blood stasis, dredging the channels, diminishing inflammation and swelling, and easing and relieving pain are achieved.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine pharmaceutical preparation, and in particular to a traditional Chinese medicine preparation for promoting blood circulation and relieving pain and a preparation method thereof. Background Art

[0002] Orthopedic patients often experience soft tissue swelling and pain. If the swelling and pain are not properly addressed during diagnosis and treatment, the risk of wound infection, delayed healing, and the probability of later complications will increase significantly. Currently, early treatment methods for orthopedic swelling and pain include limb elevation, medication, and physical therapy, such as pressurized cold therapy and mannitol intravenous drip. These interventions are effective in reducing pain and swelling, but the effects of physical therapy or medication alone are limited. Over-reliance on medication for analgesia may also lead to drug resistance or adverse reactions.

[0003] Traditional Chinese medicine believes that the early swelling and pain in patients with bone injuries are mainly related to qi stagnation and blood stasis, and the treatment principle should be based on promoting blood circulation and removing blood stasis, promoting qi circulation and relieving pain. Traditional Chinese medicine has a long history of diagnosis and treatment of bone injuries, with numerous methods and unique means, and has formed a relatively complete theoretical system. External use of Chinese medicine is one of the important methods of treatment in traditional Chinese medicine. External use of Chinese medicine preparations directly acts on the affected ankle, can unblock the local qi, dissipate blood stasis, and have the effect of promoting blood circulation, reducing swelling and relieving pain. In addition, the medicinal ingredients in external use of Chinese medicine preparations can effectively inhibit the infiltration and exudation of inflammatory factors, regulate the synthesis and release of pain substances, and thus exert anti-inflammatory and analgesic effects. The present invention aims to provide a Chinese medicine preparation for bone injuries that is fast-acting, has good therapeutic effect, and has the effects of promoting blood circulation and removing blood stasis, reducing inflammation, relieving pain, and reducing swelling. Summary of the Invention

[0004] (1) Technical problems solved

[0005] In view of the deficiencies in the prior art, the present invention provides a traditional Chinese medicine preparation for promoting blood circulation and relieving pain and a preparation method thereof.

[0006] (2) Technical solution

[0007] To achieve the above objectives, the present invention is implemented through the following technical solutions:

[0008] The invention provides a traditional Chinese medicine preparation for promoting blood circulation and relieving pain. The traditional Chinese medicine preparation is prepared from the following traditional Chinese medicine raw materials in parts by weight: 10-30 parts of polygonatum, 10-30 parts of millettia spatholobi, 10-30 parts of turmeric, 5-20 parts of trifoliate lanceolate, 5-20 parts of tangerine peel, 5-20 parts of safflower fruit, 5-20 parts of scutellaria baicalensis, 1-5 parts of artemisia snowdrops, 5-20 parts of solanum nigrum, 5-20 parts of catechu, 10-30 parts of radix scutellariae, 5-20 parts of scutellaria baicalensis, 10-30 parts of red astragalus, and 5-20 parts of wormwood oil.

[0009] 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, 15-25 parts of millettia reticulata, 10-20 parts of turmeric, 5-15 parts of trifoliate lanceolate, 5-15 parts of tangerine peel, 5-15 parts of safflower fruit, 5-15 parts of swollen knotweed, 1-3 parts of artemisia annua, 10-20 parts of solanum nigrum, 5-15 parts of catechu, 15-25 parts of scutellaria baicalensis, 5-15 parts of tianxianteng, 15-25 parts of red astragalus, and 5-10 parts of wormwood oil.

[0010] Furthermore, the Chinese medicine preparation is made from the following Chinese medicine raw materials in parts by weight: 20 parts of polygonatum, 20 parts of millettia reticulata, 15 parts of turmeric, 12 parts of trillium, 12 parts of tangerine peel, 12 parts of safflower fruit, 12 parts of swollen knotweed, 3 parts of artemisia selengensis, 15 parts of solanum nigrum, 10 parts of catechu, 20 parts of scutellaria baicalensis, 12 parts of tianxianteng, 18 parts of red astragalus, and 9 parts of wormwood oil.

[0011] The mugwort oil is obtained by distilling and extracting the whole herb of mugwort, or can be purchased commercially.

[0012] The blood-activating and analgesic Chinese medicine preparation provided by the present invention is prepared from the above-mentioned Chinese medicinal raw materials in parts by weight, supplemented with medically acceptable excipients, and prepared into external dosage forms, including oils, black plasters, ointments, unguents, tinctures, liniments, sprays, lotions, rubber patches, gel ointments, creams, and film-coatings.

[0013] The present invention also provides a method for preparing a traditional Chinese medicine preparation for promoting blood circulation and relieving pain, wherein the traditional Chinese medicine preparation is a spray, and the traditional Chinese medicine preparation is prepared according to the following steps:

[0014] (1) Weigh the following Chinese medicinal materials according to the following weight ratios: 10-30 parts of polygonatum, 10-30 parts of millettia repens, 10-30 parts of turmeric, 5-20 parts of trifoliate lanceolate, 5-20 parts of tangerine peel, 5-20 parts of red safflower fruit, 5-20 parts of scutellaria baicalensis, 1-5 parts of artemisia selengensis, 5-20 parts of solanum nigrum, 5-20 parts of catechu, 10-30 parts of radix scutellariae, 5-20 parts of tianxianteng, and 10-30 parts of red astragalus; wash, dry, and crush to 80-100 mesh, mix well, and obtain Chinese medicinal powder for later use;

[0015] (2) taking 50% ethanol (10-15 times by weight of the Chinese herbal medicine powder) and soaking the Chinese herbal medicine powder in it for 3-5 consecutive times, each time for 5-7 days, filtering, combining the soaking liquid, and separating the soaking liquid and the Chinese herbal medicine filter residue for later use;

[0016] (3) Take 5-10 times by weight of the Chinese medicine residue in 60% ethanol, heat and reflux at 55-60°C for more than 12 hours, and reflux continuously for 3-4 times. After the reflux is completed, cool to room temperature, filter, and combine the reflux liquid for later use;

[0017] (4) The extract obtained by combining the impregnation solution and the reflux solution is then evaporated and concentrated to reduce the volume of the extract to one-fourth, and the concentrated solution is prepared for use;

[0018] (5) Add 5-20 parts of wormwood 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 analgesic Chinese medicine spray.

[0019] The Chinese medicine preparation of the present invention uses turmeric and polygonatum as the main medicines. Turmeric has the functions of promoting blood circulation, promoting qi, relieving menstruation and relieving pain, and is a good medicine for dredging meridians and dissipating blood stasis; polygonatum can nourish qi and yin, strengthen the spleen and benefit the kidneys, nourish the muscles and bones, protect the vital energy and inhibit the pungent dryness of turmeric, and nourish qi and blood, so as to promote blood circulation without damaging the vital energy. Together with turmeric, one attacks and the other replenishes, and the hardness and softness complement each other, and the two are the main medicines. The main medicines are Millettia reticulata, Carthamus tinctorius, Cynanchum rotundum and Radix Angelicae Dahuricae. Millettia reticulata can not only replenish blood and promote blood circulation, but also relax muscles and tendons, assist the main medicines in harmonizing qi and blood, and make blood circulation smooth; Carthamus tinctorius disperses blood, eliminates symptoms, eliminates accumulation and relieves pain, and enhances the main medicine's ability to remove blood stasis; Cynanchum tinctorius promotes blood circulation and dredges the meridians, dispels wind and dampness, can break up stagnation in the meridians, and clear away dampness and heat; Radix Angelicae Dahuricae promotes qi and blood circulation, promotes diuresis and reduces swelling, helps qi and blood circulation, and relieves pain; the four medicines are used together to form a synergistic network of replenishing blood, breaking up blood stasis, penetrating bones, and promoting diuresis, which help the main medicine to break up blood stasis and dredge the meridians without the disadvantage of wasting blood. Solanum nigrum clears heat and detoxifies, reduces swelling and resolves stagnation; Catechu invigorates blood circulation, heals wounds, stops bleeding and promotes tissue regeneration; Radix Glehniae invigorates blood circulation and relieves pain, dispels wind and unclogs meridians; Trigonosciadium japonicum invigorates blood circulation and promotes qi, eliminates accumulation and relieves pain; Radix Atractylodes macrocephalae invigorates qi and relieves fullness, promotes diuresis and reduces swelling, regulates qi, promotes water metabolism, and eliminates swelling; Astragalus membranaceus invigorates qi and raises yang, strengthens the exterior and stops sweating, replenishes qi to aid blood circulation, strengthens the body's vital energy, and prevents excessive attack from damaging vital energy. These six herbs collectively serve as adjuvants, achieving the functions of reducing inflammation and swelling, repairing injuries, and harmonizing qi and blood, supporting the power of the monarch and ministerial elements while simultaneously strengthening the body's vital energy and dispelling pathogenic factors. Artemisia selengensis and mugwort oil serve as messengers, guiding the herbs directly to the affected area and enhancing the analgesic effect.

[0020] (3) Beneficial effects

[0021] The multi-ingredient Chinese medicine preparation of the present invention is different from the general method of enhancing the efficacy of a single-ingredient medicine. Instead, it has a synergistic relationship of one plus one being greater than two. The monarch, minister, assistant and envoy complement each other and both attack and supplement the body. It can effectively promote the dissipation of blood stasis, unclog the meridians and qi and blood circulation, eliminate local inflammation, and relieve swelling and pain. At the same time, it nourishes the muscles and bones, supports the positive energy, and enhances the body's ability to resist pathogens and repair damage, thereby comprehensively alleviating pain caused by various factors and achieving the purposes of promoting blood circulation and removing blood stasis, unblocking the meridians, relieving inflammation and swelling, and relieving pain.

[0022] The traditional Chinese medicine preparation of the present invention can significantly prolong the incubation period of acetic acid-induced pain in mice, significantly reduce the number of writhing times in painful mice, and has an excellent analgesic effect; it has a significant anti-edema and anti-inflammatory effect on xylene-induced ear swelling in mice, and can quickly achieve a therapeutic effect on soft tissue injury model rats, significantly alleviating swelling and ecchymosis in soft tissue injury model rats.

[0023] The total effective rate of the Chinese medicinal preparation of the present invention in treating patients with acute ankle sprain can reach 98.57%, and can significantly improve clinical symptoms such as pain, tenderness, ecchymosis, swelling and functional impairment of the affected area of ​​the patients. DETAILED DESCRIPTION

[0024] To make the objectives, technical solutions, and advantages of the embodiments of the present invention more clear, the technical solutions in 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 part of the embodiments of the present invention, not all of the embodiments. All other embodiments obtained by ordinary technicians in this field based on the embodiments of the present invention without making any creative efforts shall fall within the scope of protection of the present invention.

[0025] Example 1

[0026] A traditional Chinese medicine preparation for promoting blood circulation and relieving pain is prepared by weighing the following traditional Chinese medicine raw materials in parts by weight: 20 parts of polygonatum, 20 parts of millettia reticulata, 15 parts of turmeric, 12 parts of trigonosciadium japonicum, 12 parts of tangerine peel, 12 parts of red safflower fruit, 12 parts of swollen knotweed, 3 parts of artemisia selengensis, 15 parts of nightshade, 10 parts of catechu, 20 parts of radix scutellariae, 12 parts of scutellaria baicalensis, 18 parts of red astragalus, and 9 parts of mugwort oil; and supplemented with medically acceptable excipients to prepare external dosage forms, which include black plasters, ointments, tinctures, liniments, sprays, lotions, rubber patches, gel ointments, creams, and film coatings.

[0027] Specifically, a method for preparing a traditional Chinese medicine preparation for promoting blood circulation and relieving pain, wherein the traditional Chinese medicine preparation is a spray, is prepared according to the following steps:

[0028] (1) Weigh the following Chinese medicinal materials according to the following weight ratios: 20 parts of polygonatum, 20 parts of millettia repens, 15 parts of turmeric, 12 parts of trifoliate lanceolate, 12 parts of tangerine peel, 12 parts of red safflower fruit, 12 parts of scutellaria baicalensis, 3 parts of artemisia selengensis, 15 parts of nightshade, 10 parts of catechu, 20 parts of radix scutellariae, 12 parts of scutellaria baicalensis, and 18 parts of red astragalus; wash, dry, and crush to 80-100 mesh, mix well, and obtain Chinese medicinal powder for later use;

[0029] (2) taking 50% ethanol (15 times the weight of the Chinese herbal medicine powder) and soaking the Chinese herbal medicine powder for 5 consecutive times, each time for 7 days, filtering, combining the soaking liquid, and separating the soaking liquid and the Chinese herbal medicine filter residue for later use;

[0030] (3) Take 10 times the weight of the Chinese medicine residue in 60% ethanol, heat and reflux at 55°C for more than 12 hours, and reflux continuously for 3 times. After the reflux is completed, cool to room temperature, filter, and combine the reflux liquid for later use;

[0031] (4) The extract obtained by combining the impregnation solution and the reflux solution is then evaporated and concentrated to reduce the volume of the extract to one-fourth, and the concentrated solution is prepared for use;

[0032] (5) After adding 9 parts of mugwort oil to the concentrate and mixing evenly, deionized water is added until the ethanol content is below 40%, mixed evenly, and sterilized to obtain the blood-activating and analgesic Chinese medicine spray.

[0033] Example 2

[0034] The difference between this embodiment and embodiment 1 is that the Chinese medicine preparation is made of the following Chinese medicine raw materials in parts by weight: 10 parts of polygonatum, 10 parts of millettia reticulata, 10 parts of turmeric, 5 parts of triangularis lanceolata, 5 parts of dried tangerine peel, 5 parts of safflower fruit, 5 parts of swollen knotweed, 1 part of artemisia selengensis, 5 parts of solanum nigrum, 5 parts of catechu, 10 parts of scutellaria baicalensis, 5 parts of tianxianteng, 10 parts of red astragalus, and 1 part of mugwort oil.

[0035] Example 3

[0036] The difference between this embodiment and embodiment 1 is that the Chinese medicine preparation is made of the following Chinese medicinal raw materials in parts by weight: 30 parts of polygonatum, 30 parts of millettia reticulata, 30 parts of turmeric, 20 parts of triangularis lanceolata, 20 parts of dried tangerine peel, 20 parts of safflower fruit, 20 parts of swollen knotweed, 5 parts of artemisia annua, 20 parts of solanum nigrum, 5-20 parts of catechu, 30 parts of scutellaria baicalensis, 20 parts of tianxianteng, 30 parts of red astragalus, and 20 parts of wormwood oil.

[0037] Example 4

[0038] The difference between this embodiment and embodiment 1 is that the traditional Chinese medicine preparation is made of the following traditional Chinese medicine raw materials in parts by weight: 16 parts of polygonatum, 16 parts of millettia reticulata, 12 parts of turmeric, 8 parts of triangularis lanceolata, 8 parts of tangerine peel, 8 parts of safflower fruit, 8 parts of swollen knotweed, 2 parts of artemisia annua, 10 parts of nightshade, 6 parts of catechu, 16 parts of scutellaria baicalensis, 8 parts of tianxianteng, 14 parts of red astragalus, and 8 parts of wormwood oil.

[0039] Example 5

[0040] The difference between this embodiment and embodiment 1 is that the Chinese medicine preparation is made of the following Chinese medicinal raw materials in parts by weight: 26 parts of polygonatum, 24 parts of millettia reticulata, 22 parts of turmeric, 16 parts of triangularis lanceolata, 16 parts of tangerine peel, 16 parts of safflower fruit, 16 parts of swollen knotweed, 4 parts of artemisia annua, 18 parts of nightshade, 16 parts of catechu, 26 parts of scutellaria baicalensis, 16 parts of tianxianteng, 24 parts of red astragalus, and 14 parts of wormwood oil.

[0041] Example 6

[0042] The difference between this embodiment and embodiment 1 is that the Chinese medicine preparation is made of the following Chinese medicinal raw materials in parts by weight: 15 parts of polygonatum, 15 parts of millettia reticulata, 10 parts of turmeric, 5 parts of triangularis lanceolata, 5 parts of dried tangerine peel, 5 parts of safflower fruit, 5 parts of swollen knotweed, 1 part of artemisia selengensis, 10 parts of solanum nigrum, 5 parts of catechu, 15 parts of scutellaria baicalensis, 5 parts of tianxianteng, 15 parts of red astragalus, and 5 parts of wormwood oil.

[0043] Example 7

[0044] The difference between this embodiment and embodiment 1 is that the Chinese medicine preparation is made of the following Chinese medicinal raw materials in parts by weight: 25 parts of polygonatum, 25 parts of millettia reticulata, 20 parts of turmeric, 15 parts of trifoliate lanceolate, 15 parts of tangerine peel, 15 parts of safflower fruit, 15 parts of swollen knotweed, 3 parts of artemisia annua, 20 parts of nightshade, 15 parts of catechu, 25 parts of scutellaria baicalensis, 15 parts of tianxianteng, 25 parts of red astragalus, and 10 parts of wormwood oil.

[0045] Example 8

[0046] The difference between this embodiment and embodiment 1 is that the traditional Chinese medicine preparation is made of the following traditional Chinese medicine raw materials in parts by weight: 18 parts of polygonatum, 18 parts of millettia reticulata, 14 parts of turmeric, 7 parts of trigonosciadium japonicum, 8 parts of tangerine peel, 6 parts of safflower fruit, 8 parts of swollen knotweed, 1 part of artemisia selengensis, 12 parts of solanum nigrum, 7 parts of catechu, 18 parts of scutellaria baicalensis, 8 parts of tianxianteng, 16 parts of red astragalus, and 8 parts of wormwood oil.

[0047] Example 9

[0048] The difference between this embodiment and embodiment 1 is that the Chinese medicine preparation is made of the following Chinese medicinal raw materials in parts by weight: 22 parts of polygonatum, 20 parts of millettia reticulata, 18 parts of turmeric, 14 parts of triangularis lanceolata, 10 parts of tangerine peel, 14 parts of safflower fruit, 10 parts of swollen knotweed, 2 parts of artemisia annua, 18 parts of nightshade, 12 parts of catechu, 22 parts of scutellaria baicalensis, 14 parts of tianxianteng, 22 parts of red astragalus, and 10 parts of wormwood oil.

[0049] Test Example 1

[0050] The analgesic, anti-inflammatory and anti-soft tissue damage effects of the Chinese medicine preparation of the present invention

[0051] 1 Materials and Methods

[0052] 1.1 Drugs

[0053] The Chinese medicine preparation of the present invention comprises the following ingredients: 20 parts of polygonatum, 20 parts of millettia reticulata, 15 parts of turmeric, 12 parts of trifoliate lanceolate, 12 parts of tangerine peel, 12 parts of safflower fruit, 12 parts of swollen knotweed, 3 parts of artemisia selengensis, 15 parts of solanum nigrum, 10 parts of catechu, 20 parts of radix scutellariae, 12 parts of scutellaria baicalensis, and 18 parts of red schizonepeta. The raw materials are weighed according to the above weight parts, washed and crushed, and passed through a 200-mesh sieve. After uniform mixing, 9 parts of wormwood oil and a small amount of 50% ethanol are added, and the mixture is mixed into a non-flowing paste-like Chinese medicine ointment to obtain the Chinese medicine preparation of the present invention, which can be prepared as needed.

[0054] Diclofenac sodium gel (Mayinglong Pharmaceutical Group Co., Ltd.)

[0055] 1.2 Experimental methods

[0056] 1.2.1 Acetic acid writhing test in mice

[0057] Thirty male SPF KM mice with a body weight of 18-22 g were selected and adaptively fed for one week before the experiment.

[0058] The mice were randomly divided into three groups according to body weight: a model group (normal saline), a test group (the Chinese medicine preparation of the present invention was evenly applied to the upper auricles for 30 minutes), and a positive control group (diclofenac sodium gel was evenly applied to the upper auricles for 30 minutes). Each group had 10 mice, and the mice were given the medicine once a day for 7 consecutive days. After the last day of the medicine, each mouse was intraperitoneally injected with 1% glacial acetic acid (0.1 mL / 10 g) to induce pain. The time to the onset of writhing (writhing latency) and the number of writhings within 15 minutes were recorded. The latency, number of writhings, and percentage of analgesia were used to evaluate the analgesic effect of the Chinese medicine preparation of the present invention.

[0059] Analgesia rate (%) = (mean number of writhing times in the model group - mean number of writhing times in the drug-treated group) / mean number of writhing times in the model group × 100%

[0060] 1.2.2 Effect of xylene on ear swelling in mice

[0061] Thirty male SPF KM mice with a body weight of 18-22 g were selected and adaptively fed for one week before the experiment.

[0062] The mice were randomly divided into three groups according to body weight: a model group (normal saline), a test group (the Chinese medicine preparation of the present invention was evenly applied to the upper bilateral auricles for administration and wet compress for 30 minutes), and a positive control group (diclofenac sodium gel was evenly applied to the upper bilateral auricles for administration). There were 10 mice in each group. The corresponding drugs were applied to the right auricle of each group, and the drugs were administered once every 2 hours for 3 consecutive times. The administration site was cleaned with normal saline before each administration and was administered after drying. 2 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. After being placed in a fume hood and moving freely for 30 minutes, the mice were killed by dextromethorphanosis. An 8 mm diameter ear punch was used to punch 8 mm ear pieces at the left and right auricles of the mice and their weights were weighed. The swelling degree and swelling inhibition rate of each group were calculated respectively.

[0063] Swelling degree (mg) = right ear auricle mass - left ear auricle mass

[0064] Swelling inhibition rate (%) = (average ear swelling of the model group - average ear swelling of the drug-treated group) / average ear swelling of the model group × 100%

[0065] 1.2.3 Effects on soft tissue injury in rats

[0066] Forty male SPF SD rats weighing 180-220 g were selected and adaptively fed for one week before the experiment.

[0067] The rats were first depilated on one side of their calf using 10% barium sulfide. 24 hours later, they were struck once on the outside of the middle calf with a wounding device, causing local soft tissue injury. Rats with skin damage or fractures were removed. 30 rats were selected and randomly divided into three groups: a model group (normal saline), a test group (the Chinese medicine preparation of the present invention was evenly applied to the upper auricles for 30 minutes), and a positive control group (diclofenac sodium gel was evenly applied to the upper auricles for administration). Each group had 10 rats. The drug was administered to the affected area twice a day, with an interval of no less than 8 hours between each administration. The drug was administered for 7 consecutive days. The swelling and ecchymosis of the injured limb were observed on the first, third, and seventh days, and the injury index was recorded. The scoring criteria are shown in Table 1.

[0068] Table 1 Injury index score

[0069] Score (points) Judging Criteria 0 The injured part is completely recovered and the soft tissue is normal. 1 There is a slight swelling in the local area, and no bleeding on the surface 2 There is a sense of swelling on the surface, and small bleeding or ecchymosis can be seen, with an area of ​​about 1cm×0.5cm 3 Obvious subcutaneous hemorrhage, ecchymosis, and edema are seen on the surface, with an area of ​​about 1cm×2.5cm 4 Large areas of bleeding, ecchymosis, and edema are seen on the surface, with an area larger than 1 cm × 3.5 cm

[0070] 1.3 Statistical analysis

[0071] All data were processed using Graphpad Prism 8.0 software and expressed as mean ± standard deviation. ANOVA was used for analysis of variance when the data series in each group showed a normal distribution. LSD test was used for comparison between groups when the variances were equal; Dunnett's test was used for comparison between groups when the variances were unequal. Differences were considered statistically significant when P < 0.05.

[0072] 1.4 Results

[0073] 1.4.1 Analgesic effect of the Chinese medicine preparation of the present invention

[0074] Compared with the model group, the pain latency of mice in the positive control and experimental groups was significantly increased (P < 0.01), and the number of writhing episodes was significantly reduced (P < 0.05). The experimental group achieved an analgesic rate of 75.60%, significantly higher than the positive control group (66.03%). These results demonstrate that the traditional Chinese medicine preparation of the present invention has a strong analgesic effect on acetic acid-induced pain in mice, and is significantly superior to diclofenac sodium gel. The results are shown in Table 2.

[0075] Table 2 Effects of the Chinese medicine preparation of the present invention on the analgesic test of acetic acid writhing method in mice

[0076] Group Incubation period / s Number of twists / times Analgesia rate / % Model Group 232.48±16.89 20.9±2.0 — Positive control group 309.48±20.11** 7.1±1.6* 66.03 experimental group 326.39±18.44** 5.1±1.7* 75.60

[0077] Note: Compared with the model group, *P<0.05, **P<0.01.

[0078] 1.4.2 Anti-inflammatory effects of the Chinese medicine preparation of the present invention

[0079] Compared with the model group, the swelling of mice in the positive control and experimental groups 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 in the positive control group was 50.73%. These results indicate that the traditional Chinese medicine preparation of the present invention has a significant anti-inflammatory and anti-edema effect on xylene-induced ear swelling in mice, and is significantly superior to diclofenac sodium gel. The results are shown in Table 3.

[0080] Table 3 Effect of the Chinese medicine preparation of the present invention on xylene-induced ear swelling in mice

[0081] Group Swelling degree / mg Swelling inhibition rate / % Model Group 7.49±0.44 — Positive control group 3.69±0.53** 50.73 experimental group 2.54±0.31** 66.09

[0082] Note: Compared with the model group, *P<0.05, **P<0.01.

[0083] 1.4.3 Therapeutic effects of the Chinese medicinal preparation of the present invention on soft tissue injuries

[0084] On the 3rd day 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 there was no significant difference (P> 0.05). On the 7th day of the experiment, compared with the model group, the injury index of the experimental group and the positive control group was significantly lower than that of the model group (P < 0.05), among which the injury index of the experimental group was significantly lower than that of the positive control group. The above results show that the Chinese medicine preparation of the present invention can quickly achieve a therapeutic effect on rats with soft tissue injury model, and the final therapeutic effect is significantly better than that of diclofenac sodium gel. The results are shown in Table 4.

[0085] Table 4 The therapeutic effect of the Chinese medicine preparation of the present invention on soft tissue injury in rats

[0086]

[0087] Note: Compared with the model group, *P<0.05, **P<0.01.

[0088] Test Example 2

[0089] Evaluation of the therapeutic effect of the Chinese medicine preparation of the present invention on acute ankle sprain

[0090] 1 General Information

[0091] Methods: 140 patients with acute ankle sprains admitted to Henan Provincial Hospital of Traditional Chinese Medicine (Second Affiliated Hospital of Henan University of Traditional Chinese Medicine) between January 2024 and March 2025 were randomly divided into a treatment group and a control group, with 70 patients in each group. The treatment group included 38 males and 32 females with a mean age of (36.41±7.06) years and a mean disease duration of (24.86±5.43) hours. Among these patients, 36 had inversion sprains and 34 had eversion sprains; 37 of these patients were on the left ankle and 33 on the right ankle. The control group included 40 males and 30 females with a mean age of (34.09±4.22) years and a mean disease duration of (26.17±6.39) hours. Among these patients, 32 had inversion sprains and 38 had eversion sprains; 38 of these patients were on the left ankle and 32 on the right ankle. No statistically significant differences in general information were found between the two groups (P>0.05), indicating that the two groups were comparable.

[0092] Diagnostic criteria: Refer to the Western medical diagnosis of "acute ankle sprain" in "Practical Orthopedics". (1) History of ankle injury; (2) Swelling, tenderness and ecchymosis of the affected ankle; (3) Positive ankle valgus stress test, inversion stress test or anterior drawer test; (4) X-ray shows no ankle fracture or dislocation, and the patient complains of ankle pain, swelling and functional limitation at the time of consultation. Refer to the "Standards for Diagnosis and Treatment of Diseases and Syndromes of Traditional Chinese Medicine" for the diagnosis of "closed ankle sprain": Traumatic ankle swelling and pain, fixed pain, ecchymosis, bluish purple color, poor joint movement, dark purple tongue, or ecchymosis, and stringy pulse.

[0093] Inclusion criteria: patients who met the diagnostic and differentiation criteria of traditional Chinese and Western medicine, aged 18 to 75 years, had a disease course of less than 60 hours, had ankle sprains of grade I and II, had not received special treatment before admission, and had good compliance.

[0094] Exclusion criteria: patients with complete rupture of tendons, muscles, ligaments and other soft tissues in urgent need of surgical treatment; patients with gout, rheumatoid arthritis, rheumatoid arthritis and other diseases that affect ankle joint function; patients with severe skin diseases or local skin damage on the ankle joint; patients with allergic reactions to study drugs or medical tapes; patients who are pregnant or breastfeeding; patients with severe mental illness.

[0095] 2 Treatment options

[0096] Both groups of patients applied ice packs within 48 hours of ankle sprain, for 20 minutes each time, with an interval of 4 hours, and at least 2 times.

[0097] After 48 hours, the control group was treated with diclofenac diethylamine emulsion. An appropriate amount of the ointment was applied evenly according to the affected area, 3 times a day.

[0098] After 48 hours, the treatment group was sprayed with the Chinese medicine spray of the present invention prepared in Example 1. The spray was evenly applied according to the area of ​​the affected area, and gently massaged until the drug was completely absorbed. The drug was administered 3 times a day.

[0099] Both groups of patients received medication for 2 consecutive weeks. At the same time, the affected ankle was immobilized with an elastic bandage, and appropriate functional exercises such as toe flexion and extension, and internal and external rotation of the affected foot were performed under the protection of immobilization.

[0100] 3 Observation indicators

[0101] Ankle symptom score: ankle pain, tenderness, ecchymosis, swelling and functional impairment were quantitatively scored according to the symptom score standard in the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases". Each item was divided into 4 levels, with 0, 1, 2 and 3 points respectively for no symptoms, mild symptoms, moderate symptoms and severe symptoms, totaling 15 points. The higher the score, the more severe the symptoms.

[0102] Pain score: The visual analogue scale (VAS) was used to assess pain at rest, while bearing weight but not walking, and while walking. The score was the average of three pain scores, with 0 being no pain and 10 being the most severe pain.

[0103] Joint function assessment: Ankle joint function was assessed with reference to the Ankle and Hindfoot Score (AOFAS) standard, which mainly includes pain, support, gait, function and autonomous activity, walking, ankle joint range of motion and stability, etc. The total score is 100 points. The higher the score, the better the joint function.

[0104] 4 Efficacy standards

[0105] Refer to the "Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases".

[0106] Recovery: The ankle joint is stable, joint function returns to normal, joint pain and swelling completely disappear, and joint symptom score is reduced by more than 95%.

[0107] Markedly effective: The ankle joint was accompanied by mild pain and subcutaneous ecchymosis, and the pain was significantly relieved. The joint symptom score was reduced by 70%-95%.

[0108] Effective: The ankle joint is accompanied by obvious pain and subcutaneous ecchymosis, walking fatigue, pain relief, and joint symptom score reduction of 30%-70%.

[0109] Ineffective: There was no improvement in ankle joint function, swelling, pain, etc., and the joint symptom score decreased by less than 30%.

[0110] 5 Statistical analysis

[0111] Graphpad Prism 8.0 statistical software was used for analysis. t test was used to express the data, and the enumeration data were expressed as (%) and χ test was used to express the data. 2 Test, P < 0.05 indicates that the difference is statistically significant.

[0112] 6 Results

[0113] 6.1 Clinical Efficacy

[0114] The clinical efficacy results of the two groups are shown in Table 5. The total effective rate of the treatment group for ankle sprains was 98.57%, and the total effective rate of the control group for ankle sprains was 88.57%. The difference between the two groups was statistically significant.

[0115] Table 5 Comparison of clinical efficacy between the two groups [n(%)]

[0116] Group example get well Significant effect efficient invalid Total efficiency Treatment group 70 16(22.85) 32(45.71) 21(30.00) 1(1.43) 98.57％* control group 70 10(14.23) 18(25.71) 36(51.43) 8(11.43) 88.57％

[0117] Note: *P<0.05 compared with the control group.

[0118] 6.2 Results of joint symptom scores, pain scores, and joint function scores in the two groups

[0119] Before treatment, there were no statistically significant differences in joint symptom scores, pain scores, and joint function scores between the control and treatment groups (P>0.05). Compared with before treatment, the joint symptom scores, pain scores, and joint function scores in both the control and treatment groups were significantly reduced (P<0.05). After treatment, the joint symptom scores, pain scores, and joint function scores in the treatment group were significantly lower than those in the control group (P<0.05).

[0120] Table 3 Results of joint symptom scores, pain scores and joint function scores in the two groups

[0121]

[0122] Note: Compared with the group before treatment, # P<0.05; compared with the control group after treatment, *P<0.05.

[0123] 3 Conclusion

[0124] The total effective rate of the Chinese medicinal preparation of the present invention for treating patients with acute ankle sprain reaches 98.57%, and can significantly improve clinical symptoms such as pain, tenderness, ecchymosis, swelling and functional impairment of the affected area of ​​the patients.

[0125] In the traditional Chinese medicine preparation of the present invention, turmeric and polygonatum are used as the main drugs. Turmeric has the functions of promoting blood circulation, promoting qi, relieving menstruation and relieving pain, and is a good medicine for dredging meridians and dissipating blood stasis; polygonatum can nourish qi and yin, strengthen the spleen and benefit the kidneys, nourish the muscles and bones, protect the vital energy and inhibit the pungent dryness of turmeric, and nourish qi and blood, so as to promote blood circulation without damaging the vital energy. Together with turmeric, one attacks and the other replenishes, and the hardness and softness complement each other, and they are the main drugs. With Millettia reticulata, Carthamus tinctorius, Cistanche deserticola and Cyperus rotundus as the assistant medicines, Millettia reticulata can not only replenish blood and invigorate blood circulation, but also relax muscles and tendons, assist the main medicine in harmonizing qi and blood, and make blood circulation unobstructed; Carthamus tinctorius can disperse blood, eliminate symptoms, eliminate accumulation and relieve pain, and enhance the main medicine's ability to remove blood stasis; Cyperus rotundus can invigorate blood circulation, dredge meridians, dispel wind and dampness, and can break up meridian stasis, and clear away dampness and heat; Cyperus rotundus can promote qi and blood circulation, promote diuresis and reduce swelling, help qi and blood circulation, and relieve pain; the four medicines are used together to form a synergistic network of replenishing blood, breaking up blood stasis, penetrating bones, and promoting diuresis, and together help the main medicine to break up blood stasis and dredge meridians without the disadvantage of wasting blood. Solanum nigrum clears heat and detoxifies, reduces swelling and resolves stagnation; Catechu invigorates blood circulation, heals wounds, stops bleeding and promotes tissue regeneration; Radix Glehniae invigorates blood circulation and relieves pain, dispels wind and unclogs meridians; Trigonosciadium japonicum invigorates blood circulation and promotes qi, eliminates accumulation and relieves pain; Radix Atractylodes macrocephalae invigorates qi and relieves fullness, promotes diuresis and reduces swelling, regulates qi, promotes water metabolism, and eliminates swelling; Astragalus membranaceus invigorates qi and raises yang, strengthens the exterior and stops sweating, replenishes qi to aid blood circulation, strengthens the body's vital energy, and prevents excessive attack from damaging vital energy. These six herbs collectively serve as adjuvants, achieving the functions of reducing inflammation and swelling, repairing injuries, and harmonizing qi and blood, supporting the power of the monarch and ministerial elements while simultaneously strengthening the body's vital energy and dispelling pathogenic factors. Artemisia selengensis and mugwort oil serve as messengers, guiding the herbs directly to the affected area and enhancing the analgesic effect.

[0126] The multi-ingredient Chinese medicine preparation of the present invention is different from the general method of enhancing the efficacy of a single-ingredient medicine. Instead, it is a synergistic relationship where one plus one is greater than two. The monarch, minister, assistant and envoy complement each other, attack and supplement at the same time, and treat both the symptoms and the root cause. It can effectively promote the dissipation of blood stasis, unclog the meridians and blood circulation, eliminate local inflammation, and relieve swelling and pain. At the same time, it nourishes the muscles and bones, supports the positive energy, and enhances the body's ability to resist pathogens and repair injuries, thereby comprehensively alleviating pain caused by various factors and achieving the purposes of promoting blood circulation, removing blood stasis, dredging the meridians, and relieving inflammation and swelling.

[0127] Even if some Chinese medicines have similar efficacy, they cannot be exactly the same due to their meridians, shapes, and efficacy, and there are synergies and antagonisms between the various medicinal flavors in the prescription, such as mutual dependence, mutual synergy, and mutual hatred. If non-drugs are difficult to obtain, please do not change the prescription. After subtracting one Chinese medicine from the whole prescription or replacing it with a Chinese medicine with similar medicinal properties, the efficacy of the whole prescription will be significantly weakened, and replacing the monarch medicine will affect the efficacy of the entire prescription. The monarch, minister, assistant, and envoy of this prescription are reasonably matched, and the treatment principle is clear. It is not appropriate to add or replace other drugs with different treatment principles or similar efficacy from the present invention. Otherwise, not only will the efficacy of this prescription not be increased, but the economic burden of the patient will be increased, and the originally balanced compatibility relationship in the prescription will be affected, which will reduce the efficacy and increase the treatment cycle at the least, and produce unnecessary toxic and side effects at the worst.

[0128] The above embodiments are only used to illustrate the technical solutions of the present invention, rather than to limit the same. Although the present invention has been described in detail with reference to the aforementioned embodiments, those skilled in the art should understand that they can still modify the technical solutions described in the aforementioned embodiments, or make equivalent replacements for some of the technical features therein. However, these modifications or replacements do not deviate the essence of the corresponding technical solutions from the spirit and scope of the technical solutions of the various embodiments of the present invention.

Claims

1. A Chinese medicine preparation for promoting blood circulation and relieving pain, characterized in that: The traditional Chinese medicine preparation is prepared from the following traditional Chinese medicine raw materials in parts by weight: 10-30 parts of polygonatum, 10-30 parts of millettia repens, 10-30 parts of turmeric, 5-20 parts of trifoliate lanceolate, 5-20 parts of tangerine peel, 5-20 parts of safflower fruit, 5-20 parts of scutellaria baicalensis, 1-5 parts of artemisia selengensis, 5-20 parts of solanum nigrum, 5-20 parts of catechu, 10-30 parts of radix scutellariae, 5-20 parts of scutellaria baicalensis, 10-30 parts of red astragalus, and 5-20 parts of wormwood oil.

2. A Chinese medicinal preparation for promoting blood circulation and relieving pain according to claim 1, characterized in that: The traditional Chinese medicine preparation is prepared from the following traditional Chinese medicine raw materials in parts by weight: 15-25 parts of polygonatum, 15-25 parts of millettia reticulata, 10-20 parts of turmeric, 5-15 parts of trifoliate lanceolate, 5-15 parts of tangerine peel, 5-15 parts of safflower fruit, 5-15 parts of scutellaria baicalensis, 1-3 parts of artemisia annua, 10-20 parts of solanum nigrum, 5-15 parts of catechu, 15-25 parts of scutellaria baicalensis, 5-15 parts of tianxianteng, 15-25 parts of red astragalus, and 5-10 parts of wormwood oil.

3. A Chinese medicinal preparation for promoting blood circulation and relieving pain according to claim 1, characterized in that: The traditional Chinese medicine preparation is prepared from the following traditional Chinese medicine raw materials in parts by weight: 20 parts of polygonatum, 20 parts of millettia reticulata, 15 parts of turmeric, 12 parts of trifoliate lanceolate, 12 parts of tangerine peel, 12 parts of safflower fruit, 12 parts of swollen knotweed, 3 parts of artemisia selengensis, 15 parts of solanum nigrum, 10 parts of catechu, 20 parts of radix scutellariae, 12 parts of scutellaria baicalensis, 18 parts of red astragalus, and 9 parts of mugwort oil.

4. The blood-activating and analgesic Chinese medicine preparation according to any one of claims 1 to 3, characterized in that The Chinese medicine preparation for promoting blood circulation and relieving pain is prepared by weighing the Chinese medicine raw materials according to the above-mentioned weight parts, supplemented with medically acceptable excipients, and made into an external dosage form, which includes oil, black plaster, ointment, ointment, tincture, liniment, spray, lotion, rubber patch, gel ointment, cream, and film coating.

5. The method for preparing a blood-activating and analgesic Chinese medicine preparation according to claim 1, wherein: The Chinese medicine preparation is a spray, and the Chinese medicine preparation is prepared according to the following steps: (1) Weigh the following Chinese medicinal materials according to the following weight ratios: 10-30 parts of polygonatum, 10-30 parts of millettia repens, 10-30 parts of turmeric, 5-20 parts of trifoliate lanceolate, 5-20 parts of tangerine peel, 5-20 parts of red safflower fruit, 5-20 parts of scutellaria baicalensis, 1-5 parts of artemisia selengensis, 5-20 parts of solanum nigrum, 5-20 parts of catechu, 10-30 parts of radix scutellariae, 5-20 parts of tianxianteng, and 10-30 parts of red astragalus; wash, dry, and crush to 80-100 mesh, mix well, and obtain Chinese medicinal powder for later use; (2) taking 50% ethanol (10-15 times by weight of the Chinese herbal medicine powder) and soaking the Chinese herbal medicine powder in it for 3-5 consecutive times, each time for 5-7 days, filtering, combining the soaking liquid, and separating the soaking liquid and the Chinese herbal medicine filter residue for later use; (3) Take 5-10 times by weight of the Chinese medicine residue in 60% ethanol, heat and reflux at 55-60°C for more than 12 hours, and reflux continuously for 3-4 times. After the reflux is completed, cool to room temperature, filter, and combine the reflux liquid for later use; (4) The extract obtained by combining the impregnation solution and the reflux solution is then evaporated and concentrated to reduce the volume of the extract to one-fourth, and the concentrated solution is prepared for use; (5) Add 5-20 parts of wormwood 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 analgesic Chinese medicine spray.

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