A compound bletilla striata frostbite ointment

Abstract

This invention discloses a compound Bletilla striata frostbite ointment. The ointment is composed of traditional Chinese medicine ingredients and an ointment matrix. The traditional Chinese medicine ingredients include Bletilla striata, raw Angelica sinensis, raw Cinnamomum cassia, Paeonia lactiflora, Asarum sieboldii, Tetrapanax papyriferus, chili pepper twigs, eggplant twigs, Ilex chinensis twigs, fresh watermelon rind, and fresh banana peel. The ointment matrix comprises an oil phase consisting of stearic acid, stearyl alcohol, petrolatum, and liquid paraffin; a Tween 80 emulsifier; and an aqueous phase consisting of glycerin and distilled water. The preparation method includes: decocting some of the medicinal materials into a clear ointment, and pulverizing some of the medicinal materials into a fine powder; melting and heating the ointment matrix and the clear ointment together, then sequentially adding the heat-resistant medicinal powder and the fine powder of Bletilla striata, and stirring to form an ointment. This invention has a reasonable formulation, and through the synergistic effect of the traditional Chinese medicines, it exerts the effects of warming the meridians and promoting blood circulation, removing blood stasis, and promoting wound healing and tissue regeneration. The preparation has good stability, is easy to use, and can effectively promote the healing of frostbite wounds, reduce inflammatory reactions, and lower the risk of recurrence.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine external preparations and dermatological pharmacology, specifically relating to a compound Bletilla striata frostbite ointment for the prevention and treatment of frostbite and its preparation method. Background Technology

[0002] Chilblains are non-freezing inflammatory injuries caused by localized exposure to cold and damp environments, commonly occurring in peripheral circulatory areas such as the hands, feet, ears, and face. Their pathological mechanism is complex. Initially, it is mainly caused by peripheral vasospasm leading to tissue ischemia. Subsequently, after rewarming, abnormal vasodilation and increased permeability lead to plasma exudation, tissue edema, and inflammatory cell infiltration. Clinical manifestations include redness, swelling, itching, and pain; in severe cases, blisters, ulcers, and even tissue necrosis may occur. With the increasing popularity of outdoor sports and cold-region work in winter, the incidence of chilblains continues to rise. Reports indicate that the annual incidence rate among mountaineers and those training in high-altitude areas can reach as high as 36.6% and 10%, respectively, significantly impacting patients' quality of life and work efficiency.

[0003] Current clinical treatment strategies mainly fall into two categories: topical Western medicine and traditional Chinese medicine. Western medicine often uses vasodilators (such as nifedipine), anti-inflammatory drugs (such as ibuprofen), and drugs that improve microcirculation (such as pentoxifylline). Although these can relieve symptoms to some extent, they have risks such as slow onset of action, oral side effects (such as headache and gastrointestinal reactions), and potential skin atrophy and telangiectasia from long-term topical use of hormones. Furthermore, they have limited preventive effect against recurrent chilblains.

[0004] Traditional Chinese medicine (TCM) treatment of chilblains adheres to the principles of "treating cold with heat" and "moving blood stasis," using warming the meridians and dispelling cold, promoting blood circulation and removing blood stasis, and clearing the channels and relieving pain as its basic treatment methods, demonstrating the advantages of multi-target and holistic regulation. Classic oral formulas such as Dang Gui Si Ni Tang, Huang Qi Gui Zhi Wu Wu Tang, and Yang He Tang achieve good results by improving local blood circulation, inhibiting excessive inflammatory responses, and promoting tissue repair. External treatments are more direct, commonly including external washing with decoctions of Chinese herbs (such as chilblain wash formulas) and various ointments, pills, and tinctures (such as Hong Ling Jiu and Qing Liang Gao). However, existing TCM external treatment methods still face three major bottlenecks: First, they lack ease of use, such as external washing methods which require decoction and are subject to environmental restrictions; second, the preparation process is traditional and complex, with most ointments using high-temperature frying or direct powder mixing, which easily leads to the loss of volatile components, uneven distribution of medicinal powder, and rough texture of the ointment, affecting stability and absorption; third, the quality control and efficacy evaluation system is imperfect, lacking quantitative standards for multiple active ingredients and correlation studies with modern pharmacological indicators (such as key inflammatory factors), resulting in poor efficacy reproducibility and difficulties in industrialization and registration applications.

[0005] Existing patented technologies have also failed to systematically solve the above problems. For example, some authorized patents (such as CN115475224B) use alcohol extracts of traditional Chinese medicine combined with Western medicine ingredients. Although they achieve both rapid effects and conditioning, the prescriptions still contain glucocorticoids, raising concerns about regulatory and long-term safety. Furthermore, the stability of the oil-water mixture system presents significant challenges. Another type of technology (such as CN106334176B) focuses on water-extracted gels. While gentle on the skin, they lack sufficient occlusive and physical protection, making it difficult to address the specific needs of chilblains characterized by dryness, scabbing, and hand-foot friction. Therefore, there is an urgent need for a new topical chilblain formulation that integrates traditional efficacy with modern formulation technology, achieving synergistic effects of anti-inflammation, blood circulation promotion, and tissue regeneration while ensuring safety, stability, and convenience.

[0006] The information disclosed in this background section is intended only to enhance the understanding of the overall background of the invention and should not be construed as an admission or in any way implying that the information constitutes prior art known to those skilled in the art. Summary of the Invention

[0007] In view of the shortcomings of the prior art, the present invention provides a frostbite treatment composition.

[0008] To achieve the above objectives, the present invention adopts the following technical solution:

[0009] A compound Bletilla striata frostbite ointment includes raw materials and an ointment base. The raw materials, by weight, include the following components: Bletilla striata 80-100g, raw Angelica sinensis 50-70g, raw Cinnamomum cassia twig 50-70g, Paeonia lactiflora 60g, Asarum heterotropoides 10-30g, Tetrapanax papyriferus 30-50g, Citrus reticulata twig 20-40g, eggplant twig 20-40g, Ilex chinensis twig 20-40g, fresh watermelon rind 20-40g, and fresh banana peel 20-40g.

[0010] The ointment matrix comprises 430-440g of oil phase matrix, 90-100g of emulsifier, and 540-550g of aqueous phase matrix.

[0011] Preferably, a compound Bletilla striata frostbite ointment includes raw materials and an ointment base. By weight, the raw materials include the following components: Bletilla striata 90g, raw Angelica sinensis 60g, raw Cinnamomum cassia 60g, Paeonia lactiflora 60g, Asarum heterotropoides 20g, Tetrapanax papyriferus 40g, chili pepper twigs 30g, eggplant twigs 30g, Ilex chinensis twigs 30g, fresh watermelon rind 30g, and fresh banana peel 30g.

[0012] The ointment matrix comprises 438.67g of oil phase matrix, 94.67g of emulsifier, and 546.67g of aqueous phase matrix.

[0013] Preferably, the aqueous phase matrix includes glycerol and distilled water.

[0014] Preferably, the oil phase matrix comprises 48.0g stearic acid, 144.0g stearyl alcohol, 168.0g petrolatum, and 78.67g liquid paraffin.

[0015] Preferably, the emulsifier is Tween 80 94.67g.

[0016] Preferably, the aqueous phase matrix contains 106.67g of glycerol and 440ml of distilled water.

[0017] Bletilla striata, orchid (Thunb.) Reichb.f., is a dried tuber of this plant. It is bitter, sweet, and astringent in nature, and slightly cold in nature; it enters the lung, stomach, and liver meridians. Its functions include astringing and stopping bleeding, reducing swelling, and promoting tissue regeneration. It is used for hemoptysis, hematemesis, and external bleeding, and is a key herb for astringing and stopping bleeding, especially for bleeding from the lungs and stomach. Bletilla striata can also be used for sores, carbuncles, chapped skin, and burns, and is a commonly used herb for reducing swelling and promoting tissue regeneration in external ulcers. It is potent when used alone, and its efficacy can be further enhanced when combined with other herbs according to the specific symptoms. For example, for chapped hands and feet or burns, it can be ground into powder, mixed with sesame oil, and applied topically to promote wound healing and scab formation. The book "Qianjin Yifang" records the use of "Angelica sinensis, Scutellaria baicalensis, Coptis chinensis, Rheum palmatum, Illicium lanceolatum, Angelica dahurica, Ampelopsis japonica, and Bletilla striata" to be pounded and sifted into a gelatinous form and applied to red, swollen, and ulcerated areas to treat carbuncles and frostbite with punctures that cannot be expelled.

[0018] In Dang Gui Si Ni Tang, Angelica sinensis tonifies Qi and blood, while Cinnamomum cassia and Asarum dispel wind and cold. Tetrapanax papyriferus, Paeonia lactiflora, and Angelica sinensis invigorate blood and unblock the meridians. The formula uses sour and sweet herbs to moderate and tonify, and pungent and sweet herbs to promote and disperse. It harmonizes the Jueyin meridian, warms the meridians and restores the Ying Qi, allowing the Ying Qi to reach the meridians and the pulse to be generated, and the Wei Qi to circulate and warm the extremities. Thus, the cold extremities are restored, the Ying and Wei Qi are unblocked, and the chilblains heal. Studies have shown that both internal and external use of Dang Gui Si Ni Tang and Cinnamomum cassia decoction can significantly improve the clinical symptoms of chilblain patients, and the improvement effect is significant. It is also easy to apply conventional chilblain ointments externally, and the recurrence rate is low.

[0019] In a clinical case, a patient presented with diffuse swelling of the fingertips and palms, purplish skin, and localized black scabs. The prescription was a modified Dang Gui Si Ni Tang: Danshen 15g, Danggui 15g, Baishao 15g, Guizhi 10g, Xixin 3g, Shengjiang 10g, Gancao 3g, Dazao 10 pieces, Mutong 10g. After 6 doses of internal and external treatment, the swelling, pain, and numbness lessened, and the purplish spots on the skin lightened. After another 10 doses, the swelling and pain disappeared, the scabs fell off, and the patient recovered.

[0020] Chili pepper stems are the dried rhizomes of the chili pepper plant (Polygonum hydropiper), a member of the Solanaceae family. They are pungent, sweet, and hot in nature. They have the functions of dispelling cold and dampness, promoting blood circulation, and reducing swelling. The active ingredient, capsaicin, exerts its anti-inflammatory effect by inhibiting the secretion of the pro-inflammatory cytokine IL-1β and increasing the secretion of the anti-inflammatory cytokine IL-10. Capsaicin ointment, commonly used in the clinical treatment of frostbite, uses capsaicin as its main ingredient and has analgesic and antipruritic effects.

[0021] Eggplant branches, in particular, have the effects of dispelling wind and dampness, clearing heat and stopping bleeding. Their active ingredients, lignanamide and aniline, can inhibit LPS-induced release of nitric oxide from RAW264.7 cells to varying degrees, thus exhibiting anti-inflammatory activity.

[0022] Holly branches, in particular, have the effects of clearing heat and detoxifying, promoting blood circulation and unblocking meridians. Their effective components, such as quercetin, oleanolic acid, and eurythrin, exert anti-inflammatory and vascular-protective effects by reducing oxidative stress, lowering lipid peroxidation, reducing platelet aggregation and capillary permeability.

[0023] Fresh watermelon rind is used to relieve summer heat and is traditionally applied externally to treat rheumatoid arthritis and sores. Abroad, it is often used as a traditional herbal medicine for anti-inflammatory, antibacterial, antihypertensive, hypoglycemic, expectorant, anthelmintic, diuretic, and laxative purposes.

[0024] Fresh banana peels have the properties of clearing heat and detoxifying. The polyphenols and flavonoids they contain have strong free radical scavenging and antioxidant activities, which help delay aging, prevent cancer, and fight inflammation.

[0025] The compatibility principle of the traditional Chinese medicine in this invention is as follows:

[0026] The principal herbs are Bletilla striata (for healing sores and promoting tissue regeneration) and raw Cinnamomum cassia (for warming and unblocking the meridians).

[0027] Assistant herbs: raw angelica and red peony root assist in promoting blood circulation and nourishing blood; asarum, tetrapanax papyriferus and various plant branches strengthen the flow of qi and blood and promote diuresis; fresh fruit peel is used to soothe irritation and assist in moisturizing.

[0028] This invention also provides a method for preparing compound Bletilla striata frostbite ointment, characterized by comprising the following steps:

[0029] S1. Boil red peony root, asarum, tetrapanax papyriferus, chili pepper branches, eggplant branches, holly branches, fresh watermelon rind, and fresh banana peel in water three times, press to extract the juice, and make a clear paste.

[0030] S2. After crushing Bletilla striata, raw Angelica sinensis, and raw Cinnamomum cassia into powder, pass them through a 200-mesh sieve for later use;

[0031] S3. Stearic acid, stearyl alcohol, petrolatum, liquid paraffin, Tween, glycerin, and distilled water are used as an emulsion base. They are then mixed with the ointment and heated. After mixing, the non-volatile medicinal powders (raw angelica powder and raw cinnamon twig powder) from S2 are added and the mixture is heated and stirred continuously until the ointment turns brown. Once the consistency is suitable and the temperature drops, fine powder of Bletilla striata is added and stirred quickly to obtain the ointment with the effect of treating frostbite.

[0032] This invention provides a frostbite ointment made from ingredients such as Bletilla striata, raw Angelica sinensis, raw Cinnamomum cassia, Paeonia lactiflora, Asarum sieboldii, Tetrapanax papyriferus, chili pepper twigs, eggplant twigs, Ilex chinensis twigs, fresh watermelon rind, and fresh banana peel. Compared with the prior art, it has the following significant advantages:

[0033] 1. This product has anti-inflammatory, antioxidant, blood circulation promoting, analgesic, wound-healing, and antibacterial effects. It has a reasonable formula, is safe to use, has few side effects, is reasonably priced, easy to prepare, and convenient to use. It can prevent and treat frostbite.

[0034] 2. This formula for frostbite ointment heavily utilizes Bletilla striata to exert its astringent, hemostatic, swelling-reducing, and tissue-regenerating effects. Dang Gui Si Ni Tang harmonizes the Jueyin meridian, warms the meridians, and restores the Ying Qi. When the Ying Qi arrives, the pulse is restored; when the Wei Qi circulates, the extremities are warmed. Thus, the cold extremities are healed, the Ying and Wei Qi are unblocked, and the frostbite heals. Chili pepper branches dispel cold and dampness, invigorate blood, and reduce swelling; eggplant root dispels wind and dampness, clears heat, and stops bleeding, all working together to assist the anti-inflammatory and analgesic effects of Bletilla striata. Holly branches and banana peel clear heat and detoxify; watermelon rind clears summer heat and relieves fever, exerting both anti-inflammatory effects and vascular protection in the formula. This compound Bletilla striata frostbite ointment overcomes the shortcomings of existing frostbite ointment products. Using natural Chinese herbs, its ingredients are highly safe, with few side effects and minimal skin irritation. It can promote frostbite wound healing, condition the skin, and reduce the possibility of recurrent frostbite.

[0035] 3. This frostbite ointment is a traditional Chinese medicine, not a cosmetic. It can not only be used to astringe frostbite wounds and promote skin healing, but also prevent the onset of frostbite by changing the level of inflammatory factors. Attached Figure Description

[0036] Figure 1 Weekly weight changes in rats after modeling;

[0037] Figure 2 Images of frostbite wounds from day 1 to day 7 after frostbite;

[0038] Figure 3 Images of frostbite wounds 8-14 days after frostbite;

[0039] Figure 4 Maximum wound area diagram;

[0040] Figure 5 Line graph of daily wound healing rate;

[0041] Figure 6 The time it takes for the scab to begin to fall off and to fall off completely;

[0042] Figure 7 Product design flowchart;

[0043] Figure 8 Top view of the finished product sample of Compound Bletilla striata Frostbite Ointment (15g);

[0044] Figure 9 Side view of the finished product sample of Compound Bletilla striata Frostbite Ointment (15g). Detailed Implementation

[0045] The present invention will be further described below through specific embodiments. To make the inventive objectives, technical solutions, and beneficial technical effects of the present invention clearer, the present invention will be further described in detail below with reference to the embodiments. It should be understood that the embodiments described in this specification are merely for explaining the present invention and are not intended to limit the present invention.

[0046] Unless otherwise stated, all instruments and reagents used in the examples are commercially available or synthesized using conventional methods and can be used directly without further processing, and all instruments used in the examples are commercially available.

[0047] Example 1:

[0048] Prepare the frostbite ointment according to the following steps:

[0049] The following animal pharmacodynamic experiments were used to verify the healing effect of this compound Bletilla striata frostbite ointment on frostbite wounds.

[0050] I. Materials and Methods

[0051] (a) Experimental materials

[0052] 1. Animals

[0053] SD rats (sex: male, size: 8 weeks old, supplier: Shanghai Silex Co., Ltd., weight: 250-350g) were housed in an SPF environment. Animal experiment ethics approval number: IACUC-20250106-14.

[0054] 2. Drugs

[0055] The frostbite ointment (hereinafter referred to as Compound Bletilla Fever Ointment) is mainly composed of 90g of Bletilla striata, 60g of raw Angelica sinensis, 60g of raw Cinnamomum cassia, 60g of Paeonia lactiflora, 20g of Asarum heterotropoides, 40g of Tetrapanax papyriferus, 30g of chili pepper twigs, 30g of eggplant twigs, 30g of Ilex chinensis twigs, 30g of fresh watermelon rind, and 30g of fresh banana peel. It also contains 48.0g of stearic acid, 144.0g of stearyl alcohol, 168.0g of petrolatum, 78.67g of liquid paraffin, and 80g of Tween. 94.67g, 106.67g of glycerin, and 440ml of distilled water were used as the emulsion base. The preparation room of the School of Pharmacy of Zhejiang University of Traditional Chinese Medicine used (1) repeatedly decoct Paeonia lactiflora, Asarum sieboldii, Tetrapanax papyriferus, chili pepper branches, eggplant branches, holly branches, fresh watermelon rind, and fresh banana peel three times, press to extract the juice, and make a clear paste; (2) crush Bletilla striata, raw Angelica sinensis, and raw Cinnamomum cassia into powder and pass through a 200-mesh sieve for later use; (3) use 48.0g of stearic acid, 144.0g of stearyl alcohol, 168.0g of petrolatum, 78.67g of liquid paraffin, 94.67g of Tween 80, 106.67g of glycerin, and 440ml of distilled water as the emulsion base, mix with the clear paste and heat. After complete mixing, add non-volatile medicinal powder and continue heating. Stir constantly until the paste turns brown. When the texture is suitable and the temperature drops, add fine Bletilla striata and stir quickly to obtain the ointment with the effect of treating frostbite.

[0056] 3. Reagents and Instruments

[0057] Commercially available Qingpeng Ointment (purchased from Tibet Qizheng Tibetan Medicine Co., Ltd.)

[0058] (II) Experimental Methods

[0059] 1. Preparation of a rat frostbite model

[0060] A rat frostbite model was prepared according to the draft guidelines for the preparation of animal models of frostbite. After anesthetizing the rats with 2% isoflurane, a circular area approximately 25 mm in diameter was shaved off on one side of the rat's back. The area was then cleaned with water, leaving the skin exposed. A sterilized one-yuan coin was immersed in liquid nitrogen for 15 minutes to cool it to liquid nitrogen temperature. The coin was then immediately removed and pressed against the shaved area on the rat's back for 20 seconds to create a frostbite wound. This process was repeated to establish the remaining frostbite models.

[0061] 2. Assessment of the degree of frostbite

[0062] Frostbite was classified into two grades by observing changes in color and morphology of the left and right hind limbs of rats: Grade I frostbite (damage is superficial, with purplish-red mottled skin, no blisters, and the skin is warm and dry), and Grade II frostbite (damage reaches the dermis, with obvious local redness and swelling, blisters, and serous or slightly thrombosed fluid). A rat model of frostbite conforming to Grade II frostbite was established based on the frostbite criteria.

[0063] 3. Grouping and administration of rats: Rats were randomly divided into 4 groups of 5 rats each: Compound Bletilla striata frostbite ointment group (frostbite model established and frostbite ointment applied), model group (frostbite model established and no ointment applied), control group (frostbite model not established and no ointment applied), and positive control group (frostbite model established and Qingpeng ointment applied).

[0064] In the compound Bletilla striata frostbite ointment group and the positive control group, 1 ml of the ointment was evenly applied to the frostbite site. The indicators were recorded daily. After 14 days of administration, the administration was stopped. The changes in frostbite on the left and right hind limbs of the rats were photographed daily, and the size of the wounds in each group was measured with calipers. 14 days after administration, the rats were anesthetized with salbutamol and atropine, and skin tissue blocks from the frostbite site were taken and stored in tissue fixation solution and -80℃ respectively according to the detection requirements for subsequent detection.

[0065] (III) Indicator Measurement

[0066] 1. Frostbite healing status: Record the dates when the scabs begin to fall off and when they completely fall off, and show the skin damage and healing status in the form of pictures. Calculate the wound healing rate of frostbitten rats (wound healing rate (%) = [1 - (wound area on day n / wound area on day 1)] × 100%).

[0067] 2. Temperature monitoring: The temperature difference between the skin around the wound and the skin on the wound surface.

[0068] 3. Wound pathological examination: 14 days after the successful establishment of the frostbite model, a 3×3cm section was excised from the frostbite site. 2 Half of the skin tissue was taken, fixed in 10% formaldehyde, dehydrated in ethanol, embedded in paraffin, sectioned, stained with HE and Masson stain, and observed under a light microscope for epidermal necrosis, tissue edema, exudation, lymphocyte infiltration and collagen expression.

[0069] 4. Inflammatory factor detection: 14 days after successful establishment of the frostbite model, a 3×33cm section was excised from the frostbite site. 2 Half of the skin tissue was taken, and the levels of IL-6 and TNF-β in the frostbite tissue were detected by Western blotting.

[0070] (iv) Data statistics

[0071] Image processing software (ImageJ) was used to objectively measure epidermal damage indicators. Healing rate, temperature difference, and TNF-β and IL-6 levels in frostbite tissue were statistically analyzed using SPSS 25.0. Data from each group are expressed as mean ± standard deviation [x ± S]. One-way ANOVA was used for comparisons between groups. P < 0.05 was considered statistically significant, and P < 0.01 was considered highly significant. Graphpad was used to create graphs to visualize the relationship between the inflammatory process of the frostbite and its development, and to explore the mechanism of action of Compound Bletilla striata Frostbite Ointment.

[0072] II. Experimental Results

[0073] In a 3-week rat animal experiment, the rats' body weight, body temperature, and frostbite wound area were measured, and the dates when the scabs began to fall off and completely fell off were recorded. By analyzing the above data, it can be preliminarily determined that Compound Bletilla Rhizome Frostbite Ointment plays a good role in the treatment of frostbite.

[0074] (a) Comparison of body weight of rats in each group

[0075] Analysis of weekly weight changes in rats revealed no statistically significant differences in weekly weight changes compared to the control group (P>0.05), indicating that the formation and development of frostbite wounds and the application of medication did not affect the growth of the rats (see attached reference). Figure 1 ).

[0076] (II) Comparison of frostbite wounds in rats from different groups

[0077] Based on daily images of the wounds of each surviving rat, the area of ​​the frostbite was calculated using ImageJ software. Visual observation revealed similar development patterns in the three groups of frostbite. Initially, the wounds were inconspicuous, pale purple in color, and slightly edematous. Over time, the wound morphology gradually became apparent, turning purplish-red and then dark purple, followed by scab formation and subsequent shedding. Finally, the wound condition significantly improved compared to the initial state. Compared to the positive control group and the model group, the wounds in the compound Bletilla striata frostbite ointment group showed a tendency to heal earlier, and the healed wound area was smaller. Data calculated by ImageJ software also corroborated the above observations (see reference). Figure 2 and Figure 3 ).

[0078] (III) Comparison of frostbite wound healing in rats of different groups

[0079] The area of ​​frostbite was calculated using ImageJ software, and a graph showing the maximum lesion area and the daily wound healing rate was plotted. The daily wound healing rate (%) was calculated as [1 - (wound area on day n / wound area on day 1)] × 100%. In the early stages of frostbite, the wound area expands due to inflammation. As the wound heals spontaneously and / or the medication takes effect, the wound begins to heal. We found that the daily healing rate in the positive control group was more stable than the other two groups, which is speculated to be due to the excessive inflammatory response and fever in this group, which to some extent inhibited wound healing. In contrast, the daily healing rate in the compound Bletilla striata frostbite ointment group showed a rapid upward trend after day 8 of administration, suggesting that the compound Bletilla striata frostbite ointment caused faster healing in the middle and late stages of frostbite wound healing (see details). Figure 4 ).

[0080] The healing rate was calculated using the formula: Healing Rate = (Maximum Wound Area - Area on the Last Day of the Week) / Maximum Wound Area × 100%. The overall healing rates for weeks 1 and 2 were obtained. The Compound Bletilla Rhizome Frostbite Ointment group showed a lower healing rate in the early stage (week 1) and a higher healing rate in the middle and late stages (week 2), consistent with the trend of the line graph of daily wound healing rates mentioned above (see...). Figure 5 ).

[0081] Group Week 1 healing rate Healing rate in week 2 Model group 39.91±2.84% 81.01±7.25% Qingpeng Ointment Set 22.38±11.36% 87.8±4.01% Compound Bletilla striata frostbite ointment group 27.51±14.94% 92.55±7.36%

[0082] III. Comparison of the time when the scabs began to fall off and completely fell off in each group of rats

[0083] Compared with the positive control group, the compound Bletilla striata frostbite ointment group showed significantly earlier and more complete scab removal times (P < 0.01); compared with the model group, there were no significant differences in the scab removal times between the positive control group and the compound Bletilla striata frostbite ointment group (P > 0.05). The distribution of rats in each group showed a relatively concentrated timeframe for scab removal, with the compound Bletilla striata frostbite ointment group exhibiting the earliest scab removal and also the earliest complete scab removal. In conclusion, compound Bletilla striata frostbite ointment can accelerate the healing of frostbite, and its application has a good therapeutic effect on frostbite wound healing (see...). Figure 6 ).

[0084] The above research results indicate that Compound Bletilla striata Ointment effectively reduces the area of ​​skin damage caused by freezing in the treatment of frostbite, and its efficacy is comparable to that of Qingpeng Ointment. During the frostbite healing period, it can significantly shorten the scab formation and shedding time of frostbite sores, promote wound healing, and its efficacy is superior to that of Qingpeng Ointment. In the later stage of frostbite healing, the use of Compound Bletilla striata Ointment can reduce scar tissue formation and help the recovery of the lesion area.

[0085] The above description of the disclosed embodiments enables those skilled in the art to make or use the invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the general principles defined herein may be implemented in other embodiments without departing from the spirit or scope of the invention. Therefore, the invention is not to be limited to the embodiments shown herein, but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims

1. A compound Bletilla striata frostbite ointment, characterized in that, The product includes raw materials and ointment base. By weight, the raw materials include the following components: Bletilla striata 80-100g, raw Angelica sinensis 50-70g, raw Cinnamomum cassia twig 50-70g, Paeonia lactiflora 60g, Asarum heterotropoides 10-30g, Tetrapanax papyriferus 30-50g, chili pepper twig 20-40g, eggplant twig 20-40g, Ilex chinensis twig 20-40g, fresh watermelon rind 20-40g, and fresh banana peel 20-40g. The ointment matrix comprises 430-440g of oil phase matrix, 90-100g of emulsifier, and 540-550g of aqueous phase matrix.

2. The compound Bletilla striata frostbite ointment according to claim 1, characterized in that, By weight, the raw materials include the following components: 90g of Bletilla striata, 60g of raw Angelica sinensis, 60g of raw Cinnamomum cassia, 60g of Paeonia lactiflora, 20g of Asarum heterotropoides, 40g of Tetrapanax papyriferus, 30g of chili pepper twigs, 30g of eggplant twigs, 30g of Ilex chinensis twigs, 30g of fresh watermelon rind, and 30g of fresh banana peel. The ointment matrix comprises 438.67g of oil phase matrix, 94.67g of emulsifier, and 546.67g of aqueous phase matrix.

3. The compound Bletilla striata frostbite ointment according to claim 1, characterized in that, The oil phase matrix includes stearic acid, stearyl alcohol, petrolatum, and liquid paraffin.

4. The compound Bletilla striata frostbite ointment according to claim 1, characterized in that, The emulsifier is Tween 80.

5. The compound Bletilla striata frostbite ointment according to claim 1, characterized in that, The aqueous matrix consists of glycerol and distilled water.

6. The compound Bletilla striata frostbite ointment according to claim 5, characterized in that, The aqueous phase matrix contains 106.67 g of glycerol and 440 ml of distilled water.

7. A method for preparing a compound Bletilla striata frostbite ointment as described in any one of claims 1-6, characterized in that, Includes the following steps: S1. Boil red peony root, asarum, tetrapanax papyriferus, chili pepper branches, eggplant branches, holly branches, fresh watermelon rind, and fresh banana peel in water three times, press to extract the juice, and make a clear paste. S2. After crushing Bletilla striata, raw Angelica sinensis, and raw Cinnamomum cassia into powder, pass them through a 200-mesh sieve for later use; S3. Stearic acid, stearyl alcohol, petrolatum, liquid paraffin, Tween, glycerin, and distilled water are used as an emulsion base. They are then mixed with the ointment and heated. After mixing, the non-volatile medicinal powders (raw angelica powder and raw cinnamon twig powder) from S2 are added and the mixture is heated and stirred continuously until the ointment turns brown. Once the consistency is suitable and the temperature drops, fine powder of Bletilla striata is added and stirred quickly to obtain the ointment with the effect of treating frostbite.

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