Traditional Chinese medicine compound antibacterial gel for promoting blood circulation to remove meridian obstruction and preparation method thereof

Abstract

The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a traditional Chinese medicine compound antibacterial gel for promoting blood circulation to remove meridian obstruction and a preparation method thereof. The traditional Chinese medicine compound antibacterial gel for promoting blood circulation to remove meridian obstruction is prepared from the following components in percentage by mass: 0.01 to 0.03 percent of benzalkonium chloride, 0.02 to 0.05 percent of aromatic phenol acetate, 1 to 2.5 percent of propylene glycol, 0.01 to 0.05 percent of menthol, 0.3 to 0.6 percent of traditional Chinese medicine extracting solution, 0.01 to 0.05 percent of ginger root oil, 0.5 to 1 percent of pandan butyl ether, 0.01 to 0.05 percent of borneol, 0.3 to 5 percent of modified hydroxyethyl cellulose and the balance of water. The gel can relieve tissue edema and improve microcirculation and tissue oxygen supply; meanwhile, by combining with antibacterial components, the anti-infection effect can be synchronously achieved, the effects and advantages of promoting blood circulation and dredging collaterals of the traditional Chinese medicine compound are complementary, the better treatment effect is achieved, and the wound healing quality and speed are improved.

Description

Technical Field

[0001] This invention belongs to the field of pharmaceutical preparation technology, and in particular relates to a traditional Chinese medicine compound antibacterial gel that promotes blood circulation and unblocks collaterals, and its preparation method. Background Technology

[0002] In clinical practice, many local lesions exhibit the pathological characteristics of coexisting microcirculatory disturbances and infection risks. Taking acute soft tissue injury as an example, its pathological process includes both trauma-induced microcirculatory disturbances and the release of inflammatory factors, resulting in "blood stasis," and the risk of secondary infection due to barrier dysfunction. Similarly, the treatment of open wounds requires addressing the dual challenges of pathogenic microbial infection and local blood circulation disturbances. Traditional single-treatment modalities often have limitations: simple antibacterial therapy is insufficient to improve tissue ischemia and hypoxia, while blood-activating drugs alone cannot effectively control wound infection. Therefore, it is necessary to combine blood-activating and meridian-clearing agents with antibacterial components to simultaneously address the two key pathological factors of "stasis" and "toxins," forming a virtuous cycle of "improving the microenvironment - controlling infection - promoting repair," thereby shortening the course of the disease.

[0003] The active ingredients contained in traditional Chinese medicine compound formulas for promoting blood circulation and unblocking collaterals are diverse (such as hydrophilic polysaccharides, moderately polar saponins and fat-soluble volatile oils). Although gels are ideal carriers for local drug delivery due to their unique semi-solid properties and excellent drug loading and sustained-release performance, which can continuously release active drug ingredients and promote transdermal absorption, their weak adhesion properties often lead to premature detachment of the preparation, making it difficult to maintain sufficient drug delivery time, thus seriously affecting the sustained efficacy of the compound formula. Summary of the Invention

[0004] To overcome the shortcomings of existing technologies, one of the objectives of this invention is to provide a traditional Chinese medicine compound antibacterial gel that promotes blood circulation and unblocks meridians. This traditional Chinese medicine compound antibacterial gel can reduce tissue edema, improve microcirculation and tissue oxygenation; at the same time, when used in combination with antibacterial components, it enhances the tissue penetration and retention time of antibacterial components through blood-activating effects, thereby achieving excellent therapeutic effects and improving the quality and speed of wound healing.

[0005] The second objective of this invention is to provide a method for preparing a traditional Chinese medicine compound antibacterial gel that promotes blood circulation and unblocks collaterals. This method is simple to operate and has high production efficiency.

[0006] One of the objectives of this invention is achieved through the following technical solution: A traditional Chinese medicine compound antibacterial gel for promoting blood circulation and unblocking collaterals, comprising, by mass percentage: 0.01-0.03% benzalkonium chloride, 0.02-0.05% inulin acetate, 1-2.5% propylene glycol, 0.01-0.05% menthol, 0.3-0.6% traditional Chinese medicine extract, 0.01-0.05% ginger root oil, 0.5-1% vanillin butyl ether, 0.01-0.05% borneol, 0.3-5% modified hydroxyethyl cellulose, and water as the balance.

[0007] Furthermore, the modified hydroxyethyl cellulose is prepared as follows: (1) Hydroxyethyl cellulose was added to a solvent and heated to dissolve it. Then caffeic acid and p-toluenesulfonic acid were added to react. The reacted material was centrifuged and dried to obtain intermediate 1. (2) Dissolve intermediates 1 and 1,8-octanedithiol in a solvent, add a photoinitiator, and react under nitrogen protection and ultraviolet irradiation. After the reaction is completed, dialyze and freeze dry to obtain modified hydroxyethyl cellulose.

[0008] Further, in step (1), the mass ratio of caffeic acid, hydroxyethyl cellulose, and p-toluenesulfonic acid is 1:(1~5):(0.04~0.2); the amount ratio of hydroxyethyl cellulose to solvent is 1g:20~40mL, and the solvent is N,N-dimethylformamide.

[0009] Further, in step (1), the heating and dissolving temperature is 80~100℃; the reaction temperature is 90~100℃ and the time is 8~10h.

[0010] Further, in step (2), the mass ratio of intermediate 1, 1,8-octanedithiol, and photoinitiator is 1:(0.8~1.5):(0.15~0.3); the amount ratio of intermediate 1 to solvent is 1g:50~150mL; the photoinitiator is benzoin dimethyl ether, and the solvent is a 40~60 vol% ethanol aqueous solution.

[0011] Furthermore, in step (2), the reaction time is 3-8 hours; the wavelength of the ultraviolet irradiation is 350-400 nm.

[0012] Furthermore, the preparation method of the traditional Chinese medicine extract is as follows: a. Mix saffron, black tiger root, chicken blood vine, chuanxiong and water sophora japonica evenly, soak in water, extract after soaking, extract three times, combine the three extracts to obtain crude Chinese herbal extract; b. Concentrate the above crude Chinese herbal extract into a fluid extract, add 95 vol% ethanol, mix well, let stand, filter, and obtain the Chinese herbal extract.

[0013] Further, the mass ratio of saffron, black tiger root, chicken blood vine, chuanxiong, and water sophora in step a is (0.5~1):(0.2~0.5):(0.2~0.5):(0.2~0.5):(0.2~0.5); the mass of the water is 15~25 times the sum of the masses of saffron, black tiger root, chicken blood vine, chuanxiong, and water sophora; the soaking time is 10~12h; the specific extraction steps are: heating to boiling at 0.1~0.4MPa and extracting for 2~5h.

[0014] Further, the concentration conditions in step b are as follows: the crude Chinese herbal extract is concentrated at 0.2~0.4 MPa, vacuum degree -0.03~-0.08 MPa, and 55~65℃; the relative density of the fluid extract is 1.05~1.10; and the amount of 95 vol% ethanol added is 1~3 times the mass of the fluid extract.

[0015] The second objective of this invention is achieved by the following technical solution: The preparation method of the blood-activating and meridian-clearing traditional Chinese medicine compound antibacterial gel of the present invention includes the following steps: S1. Mix ginger root oil, vanillin butyl ether, benzalkonium chloride, inulin acetate, menthol, borneol and propylene glycol evenly to obtain a mixed solution. Add water of equal mass to the mixed solution and stir for 5-10 minutes. Let stand to defoam and obtain material 1 for later use. S2. Add the modified hydroxyethyl cellulose to the remaining water and stir at 60~65℃ for 120~180 min to obtain material 2, which is ready for use. S3. Add material 1 to material 2 and stir for 30-45 minutes. Then add the Chinese herbal extract and stir for 15-30 minutes to obtain the final product.

[0016] Compared with the prior art, the beneficial effects of the present invention are as follows: 1. This invention provides a traditional Chinese medicine compound antibacterial gel that promotes blood circulation and unblocks meridians. It combines an extract of a traditional Chinese medicine compound consisting of saffron, black tiger root, chicken blood vine, chuanxiong rhizome, and water sophora flavescens with antibacterial components (benzalkonium chloride and cinnamyl acetate), forming a unique therapeutic advantage of "promoting blood circulation and unblocking meridians - antibacterial and anti-infective." This compound, through the synergistic dilation of microvessels by saffron and chuanxiong rhizome, the inhibition of platelet aggregation by black tiger root, the promotion of capillary angiogenesis by chicken blood vine, and the enhancement of vascular permeability regulation by water sophora flavescens, significantly improves microcirculation and tissue oxygenation through multiple targets, including these effects. Simultaneously, the antibacterial components work together to exert anti-infective effects, complementing the blood-activating and meridian-unblocking effects of the traditional Chinese medicine compound, resulting in better therapeutic outcomes and improved wound healing quality and speed.

[0017] 2. The gelling agent of this invention uses modified hydroxyethyl cellulose as the gel matrix. Through a click chemical reaction between the double bonds of grafted caffeic acid and octanedithiol, a three-dimensional cross-linked network structure is formed, which can effectively delay the release rate of the traditional Chinese medicine extract, thereby ensuring the sustained retention and release of the drug at the site of action. The aromatic ring structure and long carbon chain (octanedithiol fragment) of caffeic acid introduced during the modification process significantly improve the lipophilicity of the matrix, allowing the lipophilic components (such as volatile oils and flavonoids) in the traditional Chinese medicine extract to be more uniformly dispersed in the gel matrix, avoiding uneven drug distribution caused by phase separation, and further optimizing the effect of the traditional Chinese medicine extract. In addition, the caffeic acid introduced into the modified hydroxyethyl cellulose also helps to improve the antibacterial properties of the gelling agent.

[0018] 3. The gel of the present invention also contains benzalkonium chloride and inermol acetate, which not only reduces the amount of benzalkonium chloride used and improves the safety of the gel, but also significantly improves the antibacterial effect of the gel: inermol acetate enhances the ability of benzalkonium chloride to destroy bacterial cell membranes, significantly reducing the minimum inhibitory concentration of benzalkonium chloride, thereby reducing its dosage while improving the antibacterial effect against Gram-positive and Gram-negative bacteria and reducing the risk of skin irritation. Attached Figure Description

[0019] Figure 1 The infrared contrast spectra of modified hydroxyethyl cellulose, intermediate 1, and hydroxyethyl cellulose in Example 1 of this invention are shown. Detailed Implementation

[0020] The present invention will now be further described with reference to the accompanying drawings and specific embodiments. It should be noted that, without conflict, the various embodiments or technical features described below can be arbitrarily combined to form new embodiments. Specific conditions not specified in the embodiments are performed according to conventional conditions or conditions recommended by the manufacturer. Unless otherwise specified, all reagents or instruments used are conventional products obtained through commercial channels.

[0021] Preparation Example The method for preparing the herbal extract of this invention is as follows: a. Weigh out saffron, black tiger root, chicken blood vine, chuanxiong rhizome, and water sophora root and put them into an extraction tank. The mass ratio of saffron, black tiger root, chicken blood vine, chuanxiong rhizome, and water sophora root is 1:0.5:0.5:0.5:0.5. Add purified water (the amount of purified water is 20 times the sum of the mass of saffron, black tiger root, chicken blood vine, chuanxiong rhizome, and water sophora root) and soak for 12 hours. Then heat to boiling at 0.3 MPa and extract for 2 hours. Collect the filtrate for later use. Perform water extraction three times and combine the three extracts to obtain crude Chinese herbal extract. b. The crude Chinese herbal extract was concentrated at a steam pressure of 0.4 Pa, a vacuum degree of -0.08 MPa, and a temperature of 60 °C until the relative density of the fluid extract was 1.10. Then, 95 vol% ethanol was added to the fluid extract at a mass ratio of 1:1. After mixing evenly, the mixture was allowed to stand for 20 h and then filtered to obtain the Chinese herbal extract.

[0022] Example 1 A traditional Chinese medicine compound antibacterial gel for promoting blood circulation and unblocking collaterals, comprising, by mass percentage: 0.02% benzalkonium chloride, 0.04% inosinate acetate, 2% propylene glycol, 0.03% menthol, 0.4% traditional Chinese medicine extract, 0.03% ginger root oil, 0.75% vanillin butyl ether, 0.03% borneol, 3% modified hydroxyethyl cellulose, and water as the balance.

[0023] The modified hydroxyethyl cellulose is prepared as follows: (1) Hydroxyethyl cellulose was added to N,N-dimethylformamide and heated to 90°C to dissolve. The ratio of hydroxyethyl cellulose to N,N-dimethylformamide was 1 g: 30 mL. Then caffeic acid and p-toluenesulfonic acid were added. The mass ratio of caffeic acid, hydroxyethyl cellulose and p-toluenesulfonic acid was 1:3:0.1. The mixture was then reacted at 95°C for 9 h. The reacted material was centrifuged and dried to obtain intermediate 1. (2) Intermediate 1 and 1,8-octanedithiol were dissolved in an aqueous ethanol solution (50 vol%), with the ratio of intermediate 1 to aqueous ethanol solution being 1 g: 100 mL; benzoin dimethyl ether was added; wherein the mass ratio of intermediate 1, 1,8-octanedithiol and photoinitiator was 1:1.2:0.2; under nitrogen protection and at room temperature, a click chemical reaction was initiated by 365 nm ultraviolet irradiation for 6 h. After the reaction was completed, the mixture was dialyzed and freeze-dried to obtain modified hydroxyethyl cellulose.

[0024] This invention also provides a method for preparing a traditional Chinese medicine compound antibacterial gel with blood-activating and meridian-clearing properties, comprising the following steps: (1) Mix ginger root oil, vanillin butyl ether, benzalkonium chloride, indigo acetate, menthol, borneol and propylene glycol evenly and dissolve them completely to obtain a mixed solution. Add water of the same mass as the mixed solution and stir for 8 minutes. Let stand for 5 minutes to defoam and obtain material 1 for later use. (2) Add the modified hydroxyethyl cellulose to the remaining water, stir at 65°C for 150 min, cool to room temperature to obtain material 2, and set aside; (3) Add material 1 to material 2 and stir for 40 minutes. Then add the Chinese herbal extract and stir for 25 minutes to obtain the final product.

[0025] Example 2 A traditional Chinese medicine compound antibacterial gel for promoting blood circulation and unblocking collaterals, comprising, by mass percentage: 0.01% benzalkonium chloride, 0.02% inosinate acetate, 1% propylene glycol, 0.01% menthol, 0.3% traditional Chinese medicine extract, 0.01% ginger root oil, 0.5% vanillin butyl ether, 0.01% borneol, 1% modified hydroxyethyl cellulose, and water as the balance.

[0026] The modified hydroxyethyl cellulose is prepared as follows: (1) Hydroxyethyl cellulose was added to N,N-dimethylformamide and heated to 80°C to dissolve. The ratio of hydroxyethyl cellulose to N,N-dimethylformamide was 1 g: 20 mL. Then caffeic acid and p-toluenesulfonic acid were added. The mass ratio of caffeic acid, hydroxyethyl cellulose and p-toluenesulfonic acid was 1:1:0.04. The mixture was then reacted at 90°C for 10 h. The reacted material was centrifuged and dried to obtain intermediate 1. (2) Intermediate 1 and 1,8-octanedithiol were dissolved in an aqueous ethanol solution (40 vol%), with the ratio of intermediate 1 to aqueous ethanol solution being 1 g: 50 mL; benzoin dimethyl ether was added; wherein the mass ratio of intermediate 1, 1,8-octanedithiol and photoinitiator was 1:0.8:0.15; under nitrogen protection and at room temperature, a click chemical reaction was initiated by 350 nm ultraviolet irradiation for 8 h. After the reaction was completed, the mixture was dialyzed and freeze-dried to obtain modified hydroxyethyl cellulose.

[0027] This invention also provides a method for preparing a traditional Chinese medicine compound antibacterial gel with blood-activating and meridian-clearing properties, comprising the following steps: (1) Mix ginger root oil, vanillin butyl ether, benzalkonium chloride, indigo acetate, menthol, borneol and propylene glycol evenly and dissolve them completely to obtain a mixed solution. Add water of the same mass as the mixed solution and stir for 5 minutes. Let stand for 5 minutes to defoam and obtain material 1 for later use. (2) Add the modified hydroxyethyl cellulose to the remaining water, stir at 60°C for 180 min, cool to room temperature to obtain material 2, and set aside; (3) Add material 1 to material 2 and stir for 30 minutes. Then add the Chinese herbal extract and stir for 15 minutes to obtain the final product.

[0028] Example 3 A traditional Chinese medicine compound antibacterial gel for promoting blood circulation and unblocking collaterals, by mass percentage, comprises: 0.03% benzalkonium chloride, 0.05% inosinate acetate, 2.5% propylene glycol, 0.05% menthol, 0.6% traditional Chinese medicine extract, 0.05% ginger root oil, 1% vanillin butyl ether, 0.05% borneol, 5% modified hydroxyethyl cellulose, and water as the balance.

[0029] The modified hydroxyethyl cellulose is prepared as follows: (1) Hydroxyethyl cellulose was added to N,N-dimethylformamide and heated to 100°C to dissolve. The ratio of hydroxyethyl cellulose to N,N-dimethylformamide was 1 g: 40 mL. Then caffeic acid and p-toluenesulfonic acid were added. The mass ratio of caffeic acid, hydroxyethyl cellulose and p-toluenesulfonic acid was 1:5:0.2. The mixture was then reacted at 100°C for 8 h. The reacted material was centrifuged and dried to obtain intermediate 1. (2) Intermediate 1 and 1,8-octanedithiol were dissolved in 60 vol% ethanol aqueous solution, and the ratio of intermediate 1 to ethanol aqueous solution was 1 g: 150 mL; benzoin dimethyl ether was added; wherein the mass ratio of intermediate 1, 1,8-octanedithiol and photoinitiator was 1:1.5:0.3; under nitrogen protection and at room temperature, a click chemical reaction was initiated by 400 nm ultraviolet irradiation for 3 h. After the reaction was completed, the mixture was dialyzed and freeze-dried to obtain modified hydroxyethyl cellulose.

[0030] This invention also provides a method for preparing a traditional Chinese medicine compound antibacterial gel with blood-activating and meridian-clearing properties, comprising the following steps: (1) Mix ginger root oil, vanillin butyl ether, benzalkonium chloride, indigo acetate, menthol, borneol and propylene glycol evenly and dissolve them completely to obtain a mixed solution. Add water of the same mass as the mixed solution and stir for 10 min. Let stand for 5 min to defoam and obtain material 1 for later use. (2) Add the modified hydroxyethyl cellulose to the remaining water, stir at 65°C for 120 min, cool to room temperature to obtain material 2, and set aside; (3) Add material 1 to material 2 and stir for 45 minutes. Then add the Chinese herbal extract and stir for 30 minutes to obtain the final product.

[0031] Comparative Example 1 Comparative Example 1 is basically the same as Example 1, except that modified hydroxyethyl cellulose is replaced with hydroxyethyl cellulose.

[0032] Comparative Example 2 Comparative Example 2 is basically the same as Example 1, except that benzalkonium chloride is replaced with inulin acetate.

[0033] Comparative Example 3 Comparative Example 3 is basically the same as Example 1, except that inermol acetate is replaced with benzalkonium chloride.

[0034] Comparative Example 4 Comparative Example 4 is basically the same as Example 1, except that the mass ratio of saffron, black tiger root, chicken blood vine, chuanxiong and water sophora is adjusted to 0.4:0.1:0.1:0.1:0.1 during the preparation of the Chinese herbal extract.

[0035] Experimental Example 1 Infrared spectroscopy was performed on intermediate 1 of Example 1, modified hydroxyethyl cellulose, and hydroxyethyl cellulose. The results are as follows: Figure 1 As shown.

[0036] Depend on Figure 1 It can be seen that, compared to hydroxyethyl cellulose, intermediate 1 is at 1724 cm⁻¹ -1 The presence of a characteristic C=O peak at 684 cm⁻¹ indicates that caffeic acid was successfully grafted onto hydroxyethyl cellulose; compared to intermediate 1, the modified hydroxyethyl cellulose showed a higher peak at 684 cm⁻¹. -1 The presence of infrared characteristic peaks for thioether bonds indicates the successful preparation of octanedithiol crosslinked modified hydroxyethyl cellulose.

[0037] Experimental Example 2 Eighty SD rats (half male and half female), weighing 240-280g, were selected as experimental animals and randomly divided into four groups: Example 1, Example 2, Example 3, Comparative Example 1, Comparative Example 2, Comparative Example 3, Comparative Example 4, and a blank control group, with ten rats in each group. The products from Examples 1-3 and Comparative Examples 1-4 were applied to the skin of the SD rats at a dosage of 0.5g per rat, while the blank control group received no treatment. The skin reactions of the rats were observed and recorded after 7 days.

[0038] Seven days later, no abnormal phenomena such as redness, swelling, itching, stinging, or rashes appeared on the skin surface of rats in any group, which was no different from that of SD rats in the blank control group, indicating that the product of the present invention has low irritation and good safety.

[0039] Experimental Example 3 To investigate the antibacterial properties of the products obtained in Examples 1-3 and Comparative Examples 1-4 of this invention, the following tests were conducted: Escherichia coli bacterial suspensions (1×10⁻⁶) were prepared. 6 (cFU / mL) and Staphylococcus aureus culture (1×10⁻⁶) 6 The test bacterial solution was prepared by adding 0.5 g of the products from Examples 1-3 and Comparative Examples 1-4 to 0.1 mL of the test bacterial solution. After mixing thoroughly and allowing it to incubate for 5 min, 0.5 mL of the treated bacterial solution was added to 5 mL of PBS buffer, mixed thoroughly, and diluted. 50 µL of the diluted bacterial solution was then spread onto a culture medium and incubated upside down at 37 °C for 48 h. The number of viable colonies was counted, and the inhibition rate was calculated. A blank control group was also set up. Inhibition rate (%) = (X1-X2) / X1×100%; Where X1 is the average colony count of the blank control group, and X2 is the average colony count of the test sample. The test results are shown in Table 1.

[0040] Table 1 As shown in Table 1, the gel of the present invention exhibits good antibacterial effects against both *Escherichia coli* and *Staphylococcus aureus*. Compared with Example 1, Comparative Example 1, which replaced modified hydroxyethyl cellulose with hydroxyethyl cellulose, showed a decrease in the antibacterial rate, indicating that the caffeic acid introduced into the modified hydroxyethyl cellulose also enhances the antibacterial activity of the gel. Compared with Example 1, Comparative Examples 2 and 3, which replaced benzalkonium chloride with vinca acetate and vinca acetate with benzalkonium chloride respectively, both showed a decrease in the antibacterial rate. This indicates that the synergistic effect of benzalkonium chloride and vinca acetate in the gel of the present invention significantly improves the antibacterial effect of the gel, and that vinca acetate, by enhancing the ability of benzalkonium chloride to disrupt bacterial cell membranes, can reduce the amount of benzalkonium chloride used, thus improving the safety of the gel.

[0041] Test Example 4 Eighty SD rats (half male and half female), weighing 240-280g, were selected as experimental animals. The right hind limb of the rats was shaved, and they were anesthetized with 2% sodium pentobarbital. The rats were then fixed to a soft tissue impactor, and a 200g hammer was dropped from a height of 50cm to strike the middle and lateral soft tissue of the right hind limb six times consecutively. This resulted in obvious subcutaneous hemorrhage and swelling at the impact site, indicating a successful establishment of a local acute soft tissue injury model in SD rats. The successfully modeled rats were then randomly divided into four groups: Example 1, Example 2, Example 3, Comparative Example 1, Comparative Example 2, Comparative Example 3, Comparative Example 4, and the model group, with ten rats in each group. 0.5g of the corresponding gel (e.g., the gel obtained in Example 1 was applied to the test site) was applied for 5 days. One, three, and five days after drug administration, the circumference of the right hind limb at the injury site was measured using a soft measuring tape in each group of SD rats. Swelling degree = circumference of the right hind limb after injury - circumference of the right hind limb before injury. The test results are shown in Table 2.

[0042] Table 2 As shown in Table 2, the gel of the present invention has a good therapeutic effect on the soft tissue swelling model caused by traumatic injuries in rats, and can reduce the swelling degree of the injured rats. Compared with Example 1, the swelling value of Comparative Example 1 increased, and the effect of reducing swelling was worse, indicating that the modified hydroxyethyl cellulose can enhance the fusion effect of fat-soluble substances in the herbal extract with the matrix, so that the active ingredients in the herbal extract can be effectively released. Furthermore, the herbal extract in the gel can be used in combination with antibacterial components (benzalkonium chloride and inulin acetate) to improve the therapeutic effect. Comparative Example 4 adjusted the proportion of raw materials in the herbal extract, and the swelling-reducing effect of the gel was worse. This shows that the present invention can improve the swelling-reducing effect of the gel by adjusting the proportion of raw materials in the herbal extract and strictly controlling the formulation composition of the herbal extract.

[0043] The above test results show that the gel of the present invention can reduce tissue edema, improve microcirculation and tissue oxygenation, and has the effects of promoting blood circulation, relieving swelling and pain. It has a good therapeutic effect on soft tissue injury caused by blows.

[0044] Experimental Example 5 Seventy SD rats (half male and half female, weighing 240-280g) were selected as experimental animals and randomly divided into seven groups. The rats in each group were first anesthetized, and their backs were shaved. A circular wound with a diameter of 1.5cm was surgically created. On the second day after surgery, 0.5g of the gel from Examples 1-3 and Comparative Examples 1-4 was applied to the test site twice daily. Routine observations of animal behavior and wound appearance were conducted daily, and the time required for complete wound healing was recorded. The results are shown in Table 3.

[0045] Table 3 As shown in Table 3, the gels of Examples 1-3 of this invention have good healing effects on wounds, and their effects are superior to those of Comparative Examples 1-4. Compared with Example 1, Comparative Example 1, which replaced modified hydroxyethyl cellulose with hydroxyethyl cellulose, showed an increase in average healing time. This indicates that modified hydroxyethyl cellulose allows the fat-soluble components in the herbal extract to better integrate into the gel, and the antibacterial components in the gel can effectively exert anti-infection effects, complementing the blood-activating and meridian-clearing effects of the herbal extract, thus improving the quality and speed of wound healing. Compared with Example 1, the wound healing speed of Comparative Example 4 also showed a downward trend. This is because it changed the formulation of the herbal extract, resulting in a poorer blood-activating and meridian-clearing effect.

[0046] The above embodiments are merely preferred embodiments of the present invention and should not be construed as limiting the scope of protection of the present invention. Any non-substantial changes and substitutions made by those skilled in the art based on the present invention shall fall within the scope of protection claimed by the present invention.

Claims

1. A traditional Chinese medicine compound antibacterial gel for promoting blood circulation and unblocking collaterals, characterized in that, The traditional Chinese medicine compound antibacterial gel for promoting blood circulation and unblocking collaterals, by weight percentage, comprises: benzalkonium chloride 0.01~0.03%, inosinic acid acetate 0.02~0.05%, propylene glycol 1~2.5%, menthol 0.01~0.05%, traditional Chinese medicine extract 0.3~0.6%, ginger root oil 0.01~0.05%, vanillin butyl ether 0.5~1%, borneol 0.01~0.05%, modified hydroxyethyl cellulose 0.3~5%, and water as the balance.

2. The traditional Chinese medicine compound antibacterial gel for promoting blood circulation and unblocking collaterals according to claim 1, characterized in that, The modified hydroxyethyl cellulose is prepared as follows: (1) Hydroxyethyl cellulose was added to a solvent and heated to dissolve it. Then caffeic acid and p-toluenesulfonic acid were added to react. The reacted material was centrifuged and dried to obtain intermediate 1. (2) Dissolve intermediates 1 and 1,8-octanedithiol in a solvent, add a photoinitiator, and react under nitrogen protection and ultraviolet irradiation. After the reaction is completed, dialyze and freeze dry to obtain modified hydroxyethyl cellulose.

3. The traditional Chinese medicine compound antibacterial gel for promoting blood circulation and unblocking collaterals according to claim 2, characterized in that, In step (1), the mass ratio of caffeic acid, hydroxyethyl cellulose, and p-toluenesulfonic acid is 1:(1~5):(0.04~0.2); the volume ratio of hydroxyethyl cellulose to solvent is 1g:20~40mL, and the solvent is N,N-dimethylformamide.

4. The traditional Chinese medicine compound antibacterial gel for promoting blood circulation and unblocking collaterals according to claim 2, characterized in that, In step (1), the heating and dissolving temperature is 80~100℃; the reaction temperature is 90~100℃ and the time is 8~10h.

5. The traditional Chinese medicine compound antibacterial gel for promoting blood circulation and unblocking collaterals according to claim 2, characterized in that, In step (2), the mass ratio of intermediate 1, 1,8-octanedithiol and photoinitiator is 1:(0.8~1.5):(0.15~0.3), and the amount ratio of intermediate 1 to solvent is 1g:50~150mL; the photoinitiator is benzoin dimethyl ether, and the solvent is a 40~60 vol% aqueous ethanol solution.

6. The traditional Chinese medicine compound antibacterial gel for promoting blood circulation and unblocking collaterals according to claim 2, characterized in that, In step (2), the reaction time is 3-8 hours; the wavelength of the ultraviolet irradiation is 350-400 nm.

7. The traditional Chinese medicine compound antibacterial gel for promoting blood circulation and unblocking collaterals according to claim 1, characterized in that, The preparation method of the herbal extract is as follows: a. Mix saffron, black tiger root, chicken blood vine, chuanxiong and water sophora japonica evenly, soak in water, extract after soaking, extract three times, combine the three extracts to obtain crude Chinese herbal extract; b. Concentrate the above crude Chinese herbal extract into a fluid extract, add 95 vol% ethanol, mix well, let stand, filter, and obtain the Chinese herbal extract.

8. The traditional Chinese medicine compound antibacterial gel for promoting blood circulation and unblocking collaterals according to claim 7, characterized in that, The mass ratio of saffron, black tiger root, chicken blood vine, chuanxiong, and water sophora in step a is (0.5~1):(0.2~0.5):(0.2~0.5):(0.2~0.5):(0.2~0.5); the mass of the water is 15~25 times the sum of the masses of saffron, black tiger root, chicken blood vine, chuanxiong, and water sophora; the soaking time is 10~12h; the specific extraction steps are: heating to boiling at 0.1~0.4MPa and extracting for 2~5h.

9. The traditional Chinese medicine compound antibacterial gel for promoting blood circulation and unblocking collaterals according to claim 7, characterized in that, The concentration conditions described in step b are as follows: the crude Chinese herbal extract is concentrated at 0.2~0.4 MPa, vacuum degree -0.03~-0.08 MPa, and 55~65℃; the relative density of the fluid extract is 1.05~1.10; and the amount of 95 vol% ethanol added is 1~3 times the mass of the fluid extract.

10. The preparation method of the traditional Chinese medicine compound antibacterial gel for promoting blood circulation and unblocking collaterals according to any one of claims 1 to 9, characterized in that, Includes the following steps: S1. Mix ginger root oil, vanillin butyl ether, benzalkonium chloride, inulin acetate, menthol, borneol and propylene glycol evenly to obtain a mixed solution. Add water of equal mass to the mixed solution and stir for 5-10 minutes. Let stand to defoam and obtain material 1 for later use. S2. Add the modified hydroxyethyl cellulose to the remaining water and stir at 60~65℃ for 120~180 min to obtain material 2, which is ready for use. S3. Add material 1 to material 2 and stir for 30-45 minutes. Then add the Chinese herbal extract and stir for 15-30 minutes to obtain the final product.

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