Formula, preparation method and application of external Tibetan medicine ointment for treating burn

Abstract

The invention discloses an external Tibetan medicine ointment formula for treating burns, a preparation method and application, and belongs to the technical field of burn medicine preparation, the external Tibetan medicine ointment formula comprises the following raw materials by weight: 16.7-20.8 parts of lithospermum, 2.1-2.5 parts of saffron crocus, 5.5-7.6 parts of artificial bear gall powder, 1.5-3.0 parts of artificial musk, and 48-62 parts of a medicine carrier. The external Tibetan medicine ointment prepared by the invention can promote cell regeneration and promote wound healing. After treatment, the VSS score and the VAS score are low, formation of scar tissue can be effectively reduced, and the traditional Chinese medicine composition has good antibacterial and anti-inflammatory effects and can effectively relieve itching. Meanwhile, after treatment, the levels of IL-6 and IL-8 are low, and the level of inflammatory factors can be effectively reduced. The untoward effect occurrence rate of the external Tibetan medicine ointment prepared by the invention is not greatly different from that of commercially available medicines, and the safety risk is low.

Description

Technical Field

[0001] The invention relates to the technical field of burn medicine preparation, and in particular to a prescription, a preparation method and application of an external Tibetan medicine ointment for treating burns. Background Art

[0002] Burn grades are usually divided according to the depth and severity of skin damage. The three-degree four-degree system is most commonly used in clinical practice, including: First-degree burns (minor burns): only the epidermis is damaged.

[0003] Second-degree burns (divided into superficial and deep second-degree burns): Superficial second-degree burns affect the entire epidermis and superficial dermis. Deep second-degree burns affect the deep dermis, leaving some dermal appendages.

[0004] Third-degree burns (severe burns): full-thickness skin necrosis, involving subcutaneous tissue, and even reaching muscles and bones.

[0005] The treatment plans for burns of different degrees are generally different. For first-degree burns, topical ointment can be applied to promote skin repair. For second-degree burns, wound treatment combined with topical ointment treatment is generally required. For third-degree burns, surgery combined with oral antibiotics and topical ointment treatment is generally required.

[0006] Currently, a large number of topical ointments for burn treatment are available on the market. Tibetan medicine, among others, is gaining increasing attention due to its natural ingredients, high safety, and minimal side effects. Due to the unique physiological and pharmacological properties of the high-altitude growing environment (such as strong ultraviolet rays, low oxygen levels, and large diurnal temperature swings), Tibetan medicinal ingredients possess unique physiological and pharmacological activities.

[0007] However, the composition and preparation process of Tibetan medicine still need to be further optimized to better meet clinical needs.

[0008] Based on this, the present invention designs a prescription, preparation method and application of an external Tibetan medicine ointment for treating burns to solve the above problems. Summary of the Invention

[0009] In view of the above-mentioned shortcomings of the prior art, the present invention provides a prescription, preparation method and application of an external Tibetan medicine ointment for treating burns.

[0010] To achieve the above objectives, the present invention is implemented through the following technical solutions: A prescription for an external Tibetan medicine ointment for treating burns comprises the following raw materials in parts by weight: 16.7-20.8 parts of lithospermum erythrorhizon, 2.1-2.5 parts of saffron, 5.5-7.6 parts of artificial bear bile powder, 1.5-3.0 parts of artificial musk, and 48-62 parts of a drug carrier.

[0011] Furthermore, the drug carrier is a composite drug carrier prepared from medical vaseline, chitosan and eggshell membrane collagen.

[0012] Furthermore, the raw materials include the following parts by weight: 18.6 parts of lithospermum erythrorhizon, 2.3 parts of saffron, 6.3 parts of artificial bear bile powder, 2.0 parts of artificial musk, and 58 parts of drug carrier.

[0013] In order to better achieve the purpose of the present invention, the present invention also provides a method for preparing an external Tibetan medicine ointment for treating burns, comprising the following steps: Step (1), preparing a drug carrier: first, using chitosan to modify eggshell membrane collagen to obtain an eggshell membrane collagen-chitosan complex, then using ice bath ultrasound to ultrasonically modify the eggshell membrane collagen-chitosan complex, and finally using medical vaseline to prepare a gel carrier through a high-pressure homogenization process, and then sterilizing it at high temperature for use; Step (2): Put lithospermum officinale, saffron, artificial bear bile powder and artificial musk into a sterile pot and boil over high heat. After boiling, reduce the heat to low heat and simmer while stirring for 22 to 35 minutes. Filter to obtain a filtrate, and concentrate the filtrate to obtain a paste-like substance. Step (3): Under the condition of heating in a water bath at 60-65°C, add the paste into the drug carrier in several portions while stirring. The addition is completed within 15-20 minutes, followed by ultrasonic dispersion. Finally, adjust the pH to 6.5-7.0 with NaOH solution.

[0014] Furthermore, in step (1), the eggshell membrane collagen-chitosan complex is prepared by placing the eggshell membrane collagen in a 1-1.5% (v / v) acetic acid solution of chitosan, stirring the mixture at 35-38°C with magnetic stirring for 2-3 hours, heating the mixture in a water bath at 62-70°C for 1.6-2.3 hours, and cooling the mixture to room temperature in an ice bath; the mass ratio of the eggshell membrane collagen to the chitosan is 1:0.8-1.4; and the concentration of the chitosan acetic acid solution is 32-38 g / L (m / v).

[0015] Furthermore, in step (1), the eggshell membrane collagen-chitosan complex is ultrasonically modified using ice bath ultrasound, and the specific steps are: placing the eggshell membrane collagen-chitosan complex in a dry ice bath and ultrasonically modifying it for 14-20 minutes under ultrasonic conditions of a frequency of 25-30 kHz and a power of 200-230 W; the dry ice bath temperature is -78°C; and then adjusting the pH to 6.5-7.0 using a NaOH solution.

[0016] Furthermore, in step (1), the ultrasonically modified eggshell membrane collagen-chitosan complex and medical vaseline are subjected to a high-pressure homogenization process to prepare a gel carrier, and the specific steps are: heating the medical vaseline to 40-50°C to melt it, and placing it into a high-pressure homogenizer together with the ultrasonically modified eggshell membrane collagen-chitosan complex, the first pressure condition is 15-22 MPa, 2 cycles, and the second pressure condition is 35-40 MPa, 1 cycle.

[0017] Furthermore, in step (3), the ultrasonic dispersion parameters are: frequency of 100-150 kHz, power of 200-220 W, and time of 4-6 min.

[0018] In order to better achieve the purpose of the present invention, the present invention also provides an external Tibetan medicine ointment for treating burns prepared according to the preparation method.

[0019] In order to better achieve the purpose of the present invention, the present invention also provides the use of the external Tibetan medicine ointment formula in preparing an external medicine for treating burns.

[0020] Compared to existing technologies, the present invention offers the following benefits: the topical Tibetan medicine ointment prepared by the present invention promotes cell regeneration and wound healing. After treatment, VSS and VAS scores are reduced, effectively reducing scar tissue formation. The ointment also exhibits significant antibacterial and anti-inflammatory effects, effectively alleviating itching. Furthermore, post-treatment levels of IL-6 and IL-8 are low, effectively reducing inflammatory factors. The incidence of adverse reactions is similar to that of the control group, indicating a low safety risk. DETAILED DESCRIPTION

[0021] To make the purpose, 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. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0022] Example 1: A method for preparing an external Tibetan medicine ointment for treating burns, comprising the following steps: Step (1), preparation of drug carrier: the mass ratio of medical vaseline, eggshell membrane collagen and chitosan is 6:1:1.4. Eggshell membrane collagen is placed in a 1% (v / v) acetic acid solution of chitosan (concentration is 32g / L (m / v)), magnetically stirred at 38°C for 2h, then placed in a 70°C water bath for 1.6h, and cooled to room temperature in an ice bath. The eggshell membrane collagen-chitosan complex is placed in a dry ice bath and ultrasonically modified under ultrasonic conditions of a frequency of 30kHz and a power of 200W for 20min; the dry ice bath temperature is -78°C; and then the pH is adjusted to 6.5 with a NaOH solution. The medical vaseline is heated to 50°C to melt, and placed in a high-pressure homogenizer together with the ultrasonically modified eggshell membrane collagen-chitosan complex. The first pressure condition is 15MPa, 2 cycles, and the second pressure condition is 40MPa, 1 cycle to obtain a gel carrier, which is sterilized at high temperature and set aside.

[0023] Step (2): put 16.7 parts of lithospermum erythrorhizon, 2.1 parts of saffron, 7.6 parts of artificial bear bile powder, and 1.5 parts of artificial musk into a sterile pot and boil over high heat. After boiling, reduce the heat to low and simmer while stirring for 35 minutes. Filter to obtain a filtrate, and concentrate the filtrate to obtain a paste-like substance; Step (3): Add the paste to 48 parts of the drug carrier in several portions under heating at 65°C in a water bath, stirring while adding. The addition is completed over 20 minutes, followed by ultrasonic dispersion at a frequency of 100 kHz, a power of 220 W, and a time of 4 minutes. Finally, adjust the pH to 7.0 with NaOH solution.

[0024] Example 2: A method for preparing an external Tibetan medicine ointment for treating burns, comprising the following steps: Step (1), preparation of drug carrier: the mass ratio of medical vaseline, eggshell membrane collagen and chitosan is 4:1:0.8. Eggshell membrane collagen is placed in a 1.5% (v / v) acetic acid solution of chitosan (concentration is 38g / L (m / v)), magnetically stirred at 35℃ for 3h, then placed in a 62℃ water bath for 2.3h, and cooled to room temperature in an ice bath. The eggshell membrane collagen-chitosan complex is placed in a dry ice bath and ultrasonically modified for 14min under ultrasonic conditions of a frequency of 25kHz and a power of 230W; the dry ice bath temperature is -78℃; and then the pH is adjusted to 7.0 with a NaOH solution. The medical vaseline is heated to 40℃ to melt, and placed in a high-pressure homogenizer together with the ultrasonically modified eggshell membrane collagen-chitosan complex. The first pressure condition is 22MPa, 2 cycles, and the second pressure condition is 35MPa, 1 cycle to obtain a gel carrier, which is sterilized at high temperature and set aside.

[0025] Step (2): put 20.8 parts of lithospermum erythrorhizon, 2.5 parts of saffron, 5.5 parts of artificial bear bile powder, and 3.0 parts of artificial musk into a sterile pot and boil over high heat. After boiling, reduce the heat to low and simmer while stirring for 22 minutes. Filter to obtain a filtrate, and concentrate the filtrate to obtain a paste-like substance; Step (3): Add the paste to 62 parts of the drug carrier in several portions under heating at 60°C in a water bath, stirring while adding. The addition is completed over 15 minutes, followed by ultrasonic dispersion at a frequency of 150 kHz and a power of 200 W for 6 minutes. Finally, adjust the pH to 6.5 with NaOH solution.

[0026] Example 3: A method for preparing an external Tibetan medicine ointment for treating burns, comprising the following steps: Step (1), preparation of drug carrier: the mass ratio of medical vaseline, eggshell membrane collagen and chitosan is 5:1:1.2. Eggshell membrane collagen is placed in a 1.3% (v / v) acetic acid solution of chitosan (concentration is 34g / L (m / v)), magnetically stirred at 36℃ for 2.6h, then placed in a 68℃ water bath for 1.8h, and cooled to room temperature in an ice bath. The eggshell membrane collagen-chitosan complex is placed in a dry ice bath and ultrasonically modified for 16min under ultrasonic conditions of a frequency of 28kHz and a power of 220W; the dry ice bath temperature is -78℃; and then the pH is adjusted to 6.8 with a NaOH solution. The medical vaseline is heated to 45℃ to melt, and placed in a high-pressure homogenizer together with the ultrasonically modified eggshell membrane collagen-chitosan complex. The first pressure condition is 20MPa, 2 cycles, and the second pressure condition is 38MPa, 1 cycle to obtain a gel carrier, which is sterilized at high temperature and set aside.

[0027] Step (2): put 18.6 parts of lithospermum erythrorhizon, 2.3 parts of saffron, 6.3 parts of artificial bear bile powder, and 2.0 parts of artificial musk into a sterile pot and boil over high heat. After boiling, reduce the heat to low and simmer while stirring for 30 minutes. Filter to obtain a filtrate, and concentrate the filtrate to obtain a paste-like substance; Step (3): Add the paste to 58 parts of the drug carrier in several portions under heating at 63°C in a water bath, stirring while adding. The addition is completed over 18 minutes, followed by ultrasonic dispersion at a frequency of 130 kHz and a power of 220 W for 5 minutes. Finally, adjust the pH to 6.8 with NaOH solution.

[0028] The prepared external Tibetan medicine ointment has the following characteristics: Product appearance and smell: This product is a reddish-brown plaster with a slight fragrance.

[0029] Functions and indications: Clears away heat and dampness, reduces swelling and relieves pain, used for burns caused by various reasons.

[0030] Dosage and Administration: For external use 3-5 times a day, apply to the burn area after wound cleaning.

[0031] Comparative Example 1: The difference from Example 3 is that the drug carrier preparation method is: the mass ratio of medical vaseline, eggshell membrane collagen and chitosan is 5:1:1.2, and the drug carrier is obtained by direct blending, and then sterilized at high temperature and set aside.

[0032] Comparative Example 2: The difference from Example 3 is that the raw materials in step (2) are: 10.6 parts of lithospermum erythrorhizon, 10.3 parts of saffron, 6.3 parts of artificial bear bile powder, and 2.0 parts of artificial musk.

[0033] Experimental Example: 60 burn patients admitted between May 2023 and January 2025 were selected as research subjects. Inclusion criteria: deep second- and third-degree burns. Patients were conscious, cooperative, and had not received other wound treatment. Exclusion criteria: patients with coagulation disorders, systemic infections, other complex injuries, and drug allergies.

[0034] Grouping: The 60 patients were divided into Example 1 (10 cases), Example 2 (10 cases), Example 3 (10 cases), Comparative Example 1 (10 cases), Comparative Example 2 (10 cases), and a commercially available medical burn ointment control group (10 cases). The causes of injury in each group included hydrothermal burns, flame burns, and electric current burns.

[0035] Treatment methods for each group: Groups 1-3 were treated with the topical Tibetan medicine ointment prepared in Examples 1-3, applied 3-5 times daily, and rubbed onto the burn site after the wound was cleaned. Groups 1-2 were treated with the topical Tibetan medicine ointment prepared in Comparative Examples 1-2, applied 3-5 times daily, and rubbed onto the burn site after the wound was cleaned. Commercially available medical burn ointment (Wet Burn Ointment, Shantou Meibao Pharmaceutical Co., Ltd.) was used according to the instructions.

[0036] Observation indicators include: (1) Clinical efficacy.

[0037] Markedly effective: The burn scar area is reduced by more than 90%, and there is no itching or pain on the wound surface; Effective: The burn scar area is reduced by 50% to 90%, and the itching and pain on the wound surface are mild; Ineffective: The burn scar area is reduced by <50%, and the wound surface is severely itchy and painful.

[0038] Total effective rate = (number of markedly effective + effective) cases / total number of cases × 100%.

[0039] (2) Scar severity scores before and after treatment.

[0040] The Vancouver Scar Scale (VSS) was used for assessment, including vascularity (0-3 points), scar color (0-3 points), softness (0-5 points), and thickness (0-4 points), with a total score of 0-15 points. A higher score indicates a more severe scar.

[0041] (3) Itching severity scores before and after treatment.

[0042] The visual analogue scale (VAS) was used for evaluation, with a total score of 0 to 10, and a higher score indicated more severe itching.

[0043] (4) Levels of inflammatory factors before and after treatment.

[0044] 5 mL of peripheral venous blood was collected from the patients and centrifuged at 3000 r / min and a radius of 6 cm for 10 min. Serum was collected and the levels of interleukin-6 (IL-6) and interleukin-8 (IL-8) were determined by enzyme-linked immunosorbent assay.

[0045] (5) Incidence of adverse reactions.

[0046] result: Table 1 Clinical efficacy of each group

[0047] It can be seen that the total effective rate of Example 1-3 groups is higher than that of Comparative Example 1-2 groups and the control group. The external Tibetan medicine ointment prepared by the present invention can promote cell regeneration and promote wound healing.

[0048] Table 2 VSS scores of each group before and after treatment

[0049] Note: Before treatment, P >0.05, the difference was not statistically significant.

[0050] It can be seen that after treatment, the VSS scores of Example 1-3 groups were lower than those of Comparative Example 1-2 groups and the control group. The external Tibetan medicine ointment prepared by the present invention can effectively reduce the formation of scar tissue.

[0051] Table 3 VAS scores of each group before and after treatment

[0052] Note: Before treatment, P >0.05, the difference was not statistically significant.

[0053] It can be seen that after treatment, the VAS scores of Example 1-3 groups were lower than those of Comparative Example 2 and the control group. The external Tibetan medicine ointment prepared by the present invention has good antibacterial and anti-inflammatory effects and can effectively relieve itching.

[0054] Table 4 Levels of inflammatory factors in each group before and after treatment

[0055] Note: Before treatment, P >0.05, the difference was not statistically significant.

[0056] It can be seen that after treatment, the IL-6 and IL-8 levels of Example 1-3 groups were lower than those of Comparative Example 1-2 groups and the control group. The external Tibetan medicine ointment prepared by the present invention can effectively reduce the level of inflammatory factors.

[0057] Table 5 Incidence of adverse reactions in each group

[0058] It can be seen that after treatment, the incidence of adverse reactions in the Example 1-3 groups was not much different from that in the control group, and the safety risk was low.

[0059] 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 will not cause the essence of the corresponding technical solutions to deviate from the spirit and scope of the technical solutions of the various embodiments of the present invention.

Claims

1. A prescription for external use Tibetan medicine ointment for treating burns, characterized in that: The invention comprises the following raw materials in parts by weight: 16.7-20.8 parts of lithospermum erythrorhizon, 2.1-2.5 parts of saffron, 5.5-7.6 parts of artificial bear bile powder, 1.5-3.0 parts of artificial musk, and 48-62 parts of drug carrier.

2. The external-use Tibetan medicine ointment prescription for treating burns according to claim 1, wherein The drug carrier is a composite drug carrier prepared from medical vaseline, chitosan and eggshell membrane collagen.

3. The external-use Tibetan medicine ointment prescription for treating burns according to claim 2, wherein The invention comprises the following raw materials in parts by weight: 18.6 parts of lithospermum erythrorhizon, 2.3 parts of saffron, 6.3 parts of artificial bear bile powder, 2.0 parts of artificial musk and 58 parts of drug carrier.

4. A method for preparing the external Tibetan medicine ointment for treating burns according to claim 3, characterized in that: The following steps are involved: Step (1), preparing a drug carrier: first, using chitosan to modify eggshell membrane collagen to obtain an eggshell membrane collagen-chitosan complex, then using ice bath ultrasound to ultrasonically modify the eggshell membrane collagen-chitosan complex, and finally using medical vaseline to prepare a gel carrier through a high-pressure homogenization process, and then sterilizing it at high temperature for use; Step (2): Put lithospermum officinale, saffron, artificial bear bile powder and artificial musk into a sterile pot and boil over high heat. After boiling, reduce the heat to low heat and simmer while stirring for 22 to 35 minutes. Filter to obtain a filtrate, and concentrate the filtrate to obtain a paste-like substance. Step (3): Under the condition of heating in a water bath at 60-65°C, add the paste into the drug carrier in several portions while stirring. The addition is completed within 15-20 minutes, followed by ultrasonic dispersion. Finally, adjust the pH to 6.5-7.0 with NaOH solution.

5. The method for preparing the external Tibetan medicine ointment for treating burns according to claim 4, wherein In step (1), the eggshell membrane collagen-chitosan complex is prepared by placing the eggshell membrane collagen in a 1-1.5% (v / v) acetic acid solution of chitosan, stirring the mixture at 35-38°C with magnetic stirring for 2-3 hours, heating the mixture in a water bath at 62-70°C for 1.6-2.3 hours, and cooling the mixture to room temperature in an ice bath; the mass ratio of the eggshell membrane collagen to the chitosan is 1:0.8-1.4; and the concentration of the chitosan acetic acid solution is 32-38 g / L (m / v).

6. The method for preparing the external Tibetan medicine ointment for treating burns according to claim 4, wherein: In step (1), the eggshell membrane collagen-chitosan complex is ultrasonically modified using ice bath ultrasound, and the specific steps are: placing the eggshell membrane collagen-chitosan complex in a dry ice bath and ultrasonically modifying it for 14 to 20 minutes under ultrasonic conditions of a frequency of 25 to 30 kHz and a power of 200 to 230 W; the dry ice bath temperature is -78°C; and then adjusting the pH to 6.5 to 7.0 using a NaOH solution.

7. The method for preparing the external Tibetan medicine ointment for treating burns according to claim 4, wherein: In step (1), the ultrasonically modified eggshell membrane collagen-chitosan complex and medical vaseline are subjected to a high-pressure homogenization process to prepare a gel carrier. The specific steps are: heating the medical vaseline to 40-50°C to melt it, and placing it into a high-pressure homogenizer together with the ultrasonically modified eggshell membrane collagen-chitosan complex. The first pressure condition is 15-22 MPa, 2 cycles, and the second pressure condition is 35-40 MPa, 1 cycle.

8. The method for preparing the external Tibetan medicine ointment for treating burns according to claim 4, wherein: In step (3), the ultrasonic dispersion parameters are: frequency of 100-150 kHz, power of 200-220 W, and time of 4-6 min.

9. An external Tibetan medicine ointment for treating burns prepared according to the preparation method according to any one of claims 4 to 8.

10. Use of the external Tibetan medicine ointment formulation according to claim 1, 2, 3 or 9 in preparing an external medicine for treating burns.

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