Turpinia arguta ointment and preparation method thereof

Abstract

The invention relates to the technical field of external ointment, in particular to turpinia arguta ointment and a preparation method thereof. The traditional Chinese medicine composition is mainly prepared from the following raw materials in parts by weight: 1-3 parts of turpinia arguta leaf extract; 8-12 parts of tea oil; 1-4 parts of camphor tree essential oil; 1-5 parts of natural beeswax; the total asiaticoside is strategically introduced into a traditional anti-inflammatory analgesic system composed of the turpinia arguta leaf extract, the tea oil, the camphor tree essential oil and the natural beewax, and the stability of active ingredients in the turpinia arguta ointment is improved through the preparation method, so that the turpinia arguta ointment has the instant effects of rapidly resisting bacteria and diminishing inflammation and relieving swelling and pain; the invention relates to a multifunctional external preparation which can be used for promoting fibroblast proliferation and collagen ordered synthesis, actively accelerating wound healing and remarkably inhibiting scar formation, so that on the premise of ensuring excellent storage stability and use safety, the function span from pure symptom control to active tissue repair is realized.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of external ointments, in particular to a Turpinia arguta ointment and a preparation method thereof. BACKGROUND

[0002] Turpinia arguta Seem is a deciduous shrub of the genus Turpinia in the Staphyleaceae family. It is a local standard medicinal material in China. Turpinia arguta leaf has been included in the Chinese Pharmacopoeia. It has the functions of clearing heat and resolving toxicity, benefiting the throat and reducing swelling, and promoting blood circulation and relieving pain. It is used to treat tonsillitis, sore throat, sore throat, sore throat, and sore throat.

[0003] In life, we cannot avoid falling and bruising caused by various reasons, or burns and scalds, which can cause slight damage to the surface skin, sometimes directly rubbing the surface skin, exposing the muscle tissue, and improper handling can leave scars, affecting appearance, and even causing infection. However, most products currently sold on the market have long anti-inflammatory time, poor anti-inflammatory effect, and poor anti-inflammatory effect. Therefore, Chinese Patent Publication No. CN117018089A provides a Turpinia arguta ointment and a preparation method thereof, which adds Turpinia arguta leaf extract, tea oil, camphor oil and natural beeswax to the Turpinia arguta ointment, making the Turpinia arguta ointment pure natural extraction, no irritating smell, no irritation to the wound, and the skin injury site quickly achieves the effects of antibacterial, anti-inflammatory, analgesic, soothing, redness reduction and blood circulation.

[0004] However, the above-mentioned prior art still has limitations in function, and its own mechanism mainly focuses on controlling and eliminating inflammatory symptoms. The effect on active repair and regeneration of post-traumatic tissues and reduction of scar formation is limited. This leads to the risk of slow wound healing or scarring after inflammation subsides. SUMMARY

[0005] The present application provides a Turpinia arguta ointment and a preparation method thereof, which adds active ingredient total ginseng glycosides to the existing formula to enhance the effect of the Turpinia arguta ointment on post-traumatic tissue repair and scar formation after anti-inflammatory and analgesic, and specifically, total ginseng glycosides endow the ointment with strong ability to promote fibroblast proliferation and collagen synthesis. At the same time, by using β-cyclodextrin inclusion and other processes to stabilize volatile essential oils and heat-sensitive components, the storage stability of the Turpinia arguta ointment is ensured, thereby solving the problems raised in the above background art, i.e. The existing Turpinia arguta ointment mechanism only stays at the level of controlling inflammation and pain, and lacks the ability to promote active repair and regeneration of post-traumatic tissues and effectively prevent scar formation.

[0006] In order to achieve the above-mentioned purposes, the Michelia figo ointment is mainly made of the following raw materials by weight: Michelia figo leaf extract 1-3 parts, tea oil 8-12 parts, camphor oil 1-4 parts, natural beeswax 1-5 parts, total ginseng total glycosides 0.5-2 parts.

[0007] Here, the main role of each raw material mentioned in the scheme in the Michelia figo ointment is described: Michelia figo leaf extract is rich in flavonoids, which functions to block the metabolism of arachidonic acid into inflammatory mediators such as prostaglandins and leukotrienes by competitively inhibiting the activity of cyclooxygenase and 5-lipoxygenase, thereby achieving anti-inflammatory and analgesic effects; Tea oil as an oil phase matrix, its function is to use the amphiphilic properties of its main components, oleic acid and linoleic acid glyceride, to co-construct a stable ointment matrix with beeswax, and as a natural penetration enhancer, to disrupt the ordered arrangement of the lipid bilayer of the stratum corneum, reduce its barrier function, and promote the transdermal absorption of active ingredients; Camphor oil, with its molecular polarity and small molecular weight characteristics of its monoterpenes such as eucalyptol and camphor, preferentially diffuses to the nerve endings of the skin, reversibly regulates the activity of voltage-gated sodium ion channels, produces local cold sensation and anesthesia, achieves immediate analgesia, and at the same time destroys the integrity of the microbial cell membrane phospholipid bilayer to exert antibacterial effect; Natural beeswax, as a thickening agent and stabilizer for the ointment, the esterification of long-chain fatty acids and fatty alcohols in natural beeswax forms a gel structure in the ointment, physically adsorbs and fixes the oil phase and other ingredients through intermolecular van der Waals forces, imparts appropriate viscoelasticity and thixotropy to the ointment, and forms a film on the skin surface to lock in moisture; Total ginseng total glycosides, with its triterpenoid saponin components as signaling molecules, can specifically activate the TGF-β receptor on the surface of skin fibroblasts, initiate the Smad signal transduction pathway in the cell, and then up-regulate the gene transcription and expression of type I and III collagen and fibronectin in the nucleus, while inhibiting the activation of nuclear factor kappa B and its mediated overexpression of matrix metalloproteinase, thereby bidirectionally regulating the synthesis and remodeling of extracellular matrix.

[0008] The interaction between each component is described as follows: The carrier system composed of tea oil and natural beeswax not only serves as a physical barrier and excipient, but more importantly, it forms a drug reservoir and sustained-release system: Specifically, the three-dimensional network structure of beeswax realizes the loading and slow release control of flavonoids in the extract of Melia toosendan leaves and total ginsenosides in Radix Notoginseng through physical embedding and chemical hydrophobic interaction, and tea oil acts as a co-solvent and a penetration enhancer to ensure that the extract of Melia toosendan leaves, total ginsenosides in Radix Notoginseng and camphor oil can continuously and effectively penetrate the skin barrier.

[0009] The camphor oil and the extract of Melia toosendan leaves have a synergistic effect in anti-inflammatory analgesia: As a highly efficient natural penetration enhancer, the camphor oil can improve the skin penetration rate and degree of flavonoids in the extract of Melia toosendan leaves, and ensure that the flavonoids quickly reach the target site. In terms of pharmacological effects, the extract of Melia toosendan leaves mainly inhibits the activity of cyclooxygenase and 5-lipoxygenase, thereby blocking the biosynthesis of classic inflammatory mediators such as prostaglandins and leukotrienes; and the active ingredients of the camphor oil can further inhibit the activation of upstream inflammatory signaling pathways such as nuclear factor kappa B, thereby reducing the production and release of various inflammatory factors from the source.

[0010] The extract of Melia toosendan leaves and total ginsenosides in Radix Notoginseng constitute a time sequence functional connection and synergistic repair: The extract of Melia toosendan leaves creates a stable chemical microenvironment for tissue repair by rapidly inhibiting acute inflammation, and total ginsenosides in Radix Notoginseng are activated and target repair cells in this environment. The effect of promoting collagen synthesis and the anti-inflammatory effect of the extract of Melia toosendan leaves can effectively avoid the delay of repair and abnormal deposition of collagen caused by the persistence of inflammation, thereby fundamentally reducing the biological risk of scar formation.

[0011] In the above technical solution, it is further pointed out that the camphor oil is a limonene camphor oil treated by β-cyclodextrin inclusion; wherein, through the special cavity molecular structure of β-cyclodextrin and the main active ingredients such as limonene in the essential oil, a stable inclusion compound is formed, thereby significantly improving the chemical instability of limonene, effectively inhibiting the characteristics of easy volatilization and easy oxidative decomposition, thereby ensuring the content and efficacy persistence of the active ingredients during the storage of the preparation, and more importantly ensuring the reliable reproduction of the inherent strong penetration and anti-inflammatory analgesic functions in the final product.

[0012] Secondly, the present application provides a preparation method of the extract of Melia toosendan leaves in the Melia toosendan ointment: Before the extraction of the leaf powder of Murraya paniculata (L.) Jack, the leaf powder of Murraya paniculata (L.) Jack is mixed with water to form a suspension, and then a complex enzyme preparation composed of cellulase and pectinase is added, and the enzyme hydrolysis is carried out at a temperature of 40-55°C and a pH of 4.5-5.5, and the reaction is continuously stirred for 1-3 hours. During the process, the cellulase and the pectinase act on the plant cell wall to hydrolyze the cellulose and the pectin that constitute the skeleton structure of the plant cell wall, respectively, so as to completely destroy the dense physical barrier of the cell wall, and the target active substances such as flavonoids wrapped in the cell are fully exposed and released. The pretreatment step can improve the transfer rate of the active ingredients, shorten the extraction time and reduce the subsequent energy consumption.

[0013] S1.1, the leaf powder of Murraya paniculata (L.) Jack is mixed with a first ethanol aqueous solution with a volume concentration of 85-95 v / v%, and a first ultrasonic extraction is carried out, and after solid-liquid separation, a first extraction liquid and a filter residue are obtained, wherein the ultrasonic extraction time is 30-60 minutes; S1.2, the filter residue obtained in S1.1 is mixed with a second ethanol aqueous solution with a volume concentration of 45-55 v / v%, and a second ultrasonic extraction is carried out, and after solid-liquid separation, a second extraction liquid is obtained, wherein the ultrasonic extraction time is 30-60 minutes; S1.3, the first extraction liquid obtained in S1.1 and the second extraction liquid obtained in S1.2 are combined, concentrated, and then freeze-dried to obtain the leaf extract of Murraya paniculata (L.) Jack. It should be noted that the process conditions of freeze-drying are as follows: pre-freezing temperature of -80°C to -60°C, and freeze-drying time of 24-48 hours.

[0014] Thirdly, the present application also provides a preparation method of the Murraya paniculata (L.) Jack ointment. S2.1, providing the leaf extract of Murraya paniculata (L.) Jack; S2.2, mixing the leaf extract of Murraya paniculata (L.) Jack with tea oil, heating and stirring at 60-75°C, and filtering to obtain a tea oil liquid of Murraya paniculata (L.) Jack, wherein the heating temperature when the leaf extract of Murraya paniculata (L.) Jack is mixed with the tea oil is 65-70°C, and the heating time is 15-25 minutes; S2.3, adding natural beeswax to the tea oil liquid of Murraya paniculata (L.) Jack, heating to melt and stirring uniformly to obtain an ointment base; S2.4, uniformly mixing camphor oil and asiaticoside with the ointment base, and cooling and solidifying to obtain the Murraya paniculata (L.) Jack ointment.

[0015] It should be further explained that in S2.4, two preferred embodiments are provided for the cooling and solidification process to ensure that the gel forms a stable and uniform matrix: One is to stand at room temperature to make it natural coagulation, which is simple to operate and does not require additional energy consumption, and the slow release of internal stress through a mild temperature transition process helps to reduce the formation of internal defects of the gel, which is suitable for loading active ingredients sensitive to thermal stress; The second is to accelerate the solidification process by forced cooling at a low temperature of 4-10°C, which can shorten the production process cycle and improve the molding efficiency, and the lower solidification temperature helps to form a more dense gel network structure, which can enhance the physical stability of the matrix and control the release characteristics; the two cooling modes can be selected according to the different needs of the final product for production efficiency, matrix structure and stability of active ingredients.

[0016] Compared with the prior art, the beneficial effects of the present application are: By strategically introducing total asperosaponins into the traditional anti-inflammatory and analgesic system composed of extracts from leaves of Melia toosendan, tea oil, camphor essential oil and natural beeswax, and by increasing the stability of active ingredients in the Melia toosendan ointment through the preparation method, the Melia toosendan ointment has the functions of rapid antibacterial and anti-inflammatory, swelling and pain relief, and can actively accelerate wound healing and significantly inhibit scar formation by promoting fibroblast proliferation and ordered synthesis of collagen, thereby realizing the functional leap from simple symptom control to active tissue repair while ensuring excellent storage stability and use safety. BRIEF DESCRIPTION OF DRAWINGS

[0017] Figure 1 Figure 1 is a schematic diagram of the composition of the Melia toosendan ointment in Example 1 of the present application; Figure 2 Figure 2 is a schematic diagram of the preparation method steps of the Melia toosendan extract in Example 1 of the present application; Figure 3 Figure 3 is a schematic diagram of the preparation method steps of the Melia toosendan ointment in Example 1 of the present application. DETAILED DESCRIPTION

[0018] The technical solutions in the embodiments of the present application will be described clearly and completely below with reference to the drawings in the embodiments of the present application. Obviously, the described embodiments are only a part of the embodiments of the present application, rather than all the embodiments. Based on the embodiments in the present application, all other embodiments obtained by those of ordinary skill in the art without creative labor fall within the scope of protection of the present application.

[0019] The existing mechanism of the Melia toosendan ointment only stays at the level of controlling inflammation and pain, and lacks the problems of promoting active repair and regeneration of wound tissue and effectively preventing scar formation. The present application provides a Melia toosendan ointment and a preparation method thereof.

[0020] Example 1: The embodiment provides a melaleuca alternifolia ointment suitable for common daily trauma and skin problems, which is mainly prepared from the following raw materials in parts by weight: Melaleuca alternifolia leaf extract, 2 parts; Tea oil, 10 parts; Camphor tree essential oil, 2 parts; Natural beeswax, 3 parts; Total ginsenoside (purity greater than or equal to 80 %), 1 part.

[0021] First, the preparation method of the melaleuca alternifolia leaf extract is as follows: The melaleuca alternifolia leaf powder is subjected to composite enzymolysis treatment: 100 g of dried melaleuca alternifolia leaf powder is mixed with 1000 mL of purified water to prepare a suspension. Citric acid is used to adjust the pH to 5.0, and 1.0 g of cellulase (activity greater than or equal to 10000 U / g) and 0.5 g of pectinase (activity greater than or equal to 30000 U / g) are added to the suspension, which is continuously stirred in a 50 DEG C water bath for 2 hours.

[0022] S1.1, the mixture after enzymolysis is mixed with 850 mL of 90v / v % ethanol aqueous solution, and ultrasonic extraction is carried out at 50 DEG C for 45 minutes, and then suction filtration is carried out to obtain a first extract and a filter residue.

[0023] S1.2, the filter residue obtained in S1.1 is mixed with 800 mL of 50v / v % ethanol aqueous solution, and ultrasonic extraction is carried out at 50 DEG C for 45 minutes, and then suction filtration is carried out to obtain a second extract.

[0024] S1.3, the first extract and the second extract are combined, and concentrated to a thick paste at 60 DEG C under reduced pressure. The thick paste is pre-frozen at-70 DEG C for 4 hours, and then transferred to a freeze dryer, and freeze-dried at-65 DEG C under a vacuum degree less than 10 Pa for 36 hours to obtain brownish yellow, loose and porous melaleuca alternifolia leaf extract powder.

[0025] Second, the preparation method of the β-cyclodextrin inclusion camphor tree essential oil is as follows: 50 g of β-cyclodextrin is dissolved in 500 mL of 60 DEG C purified water to prepare a saturated solution. 15 g of citral type camphor tree essential oil is slowly added dropwise into the β-cyclodextrin solution under high-speed stirring, and the solution is stirred at 60 DEG C for 3 hours. Then, the solution is placed in a 4 DEG C refrigerator for 12 hours to precipitate. The obtained precipitate is washed with a small amount of anhydrous ethanol, and dried in a 50 DEG C vacuum drying oven for 6 hours to obtain white powder of β-cyclodextrin inclusion camphor tree essential oil.

[0026] Third, the preparation method of the melaleuca alternifolia ointment is as follows: S2.1, mix the extract of the leaves of Melia azedarach with tea oil, heat and stir in a water bath at 68℃ for 20 minutes, filter with 200 mesh filter cloth to obtain clear Melia azedarach tea oil liquid.

[0027] S2.2, add natural beeswax to the Melia azedarach tea oil liquid obtained in S2.1, heat to 75℃ and stir until the beeswax is completely melted to obtain a uniform ointment base.

[0028] S2.3, cool the ointment base obtained in S2.2 to 50℃, add β-cyclodextrin-encapsulated camphor tree essential oil and total ginsenoside of Centella asiatica, and quickly stir until uniform. Then, fill the ointment into an aluminum tube, cool and solidify at 8℃ for 24 hours to obtain the Melia azedarach ointment.

[0029] Conclusion: Example 1 successfully provides a Melia azedarach ointment by compounding the extract of the leaves of Melia azedarach, total ginsenoside of Centella asiatica, and β-cyclodextrin-encapsulated camphor tree essential oil in a specific ratio, and using an optimized process including composite enzymatic hydrolysis and fractional ultrasonic extraction. The ointment not only inherits the surface effects of traditional Melia azedarach preparations in terms of anti-inflammatory and analgesic effects, but also achieves deep effects of promoting active repair and regeneration of wound tissue and effectively intervening in scar formation through the introduction of total ginsenoside of Centella asiatica and overall synergy. At the same time, the preparation process effectively overcomes the technical bottlenecks of volatile essential oil, low extraction rate, and unstable ointment, and the final product has the comprehensive advantages of clear efficacy substances, good stability, and safe use.

[0030] Example 2: This example provides a Melia azedarach ointment suitable for dry and cracked skin, chronic eczema, and wounds requiring strong physical protection, which is mainly made from the following raw materials by weight: extract of the leaves of Melia azedarach, 1 part; tea oil, 12 parts; camphor tree essential oil, 1 part; natural beeswax, 5 parts; total ginsenoside of Centella asiatica (purity ≥ 80%), 0.5 parts.

[0031] In this example, the preparation method of the extract of the leaves of Melia azedarach and the preparation method of β-cyclodextrin-encapsulated camphor tree essential oil are the same as in Example 1. The difference between this example and Example 1 is that in the preparation method of the Melia azedarach ointment, in step S2.1, the extract of the leaves of Melia azedarach is mixed with tea oil at a heating temperature of 65℃ for 25 minutes; in S2.3, room temperature (25℃) is used for static solidification for 48 hours.

[0032] Conclusion: Example 2 successfully prepared a kind of mountain ardisia ointment suitable for dry, cracked, chronic eczema and wounds requiring strong physical protection by adjusting the ratio of mountain ardisia leaf extract, total glycosides of centella asiatica and camphor tree essential oil and significantly increasing the content of natural beeswax, while using a specific process of mild extraction at 65°C and room temperature standing and solidification. This scheme not only retains the basic activity of anti-inflammatory and promoting repair, but also significantly enhances the occlusivity and protective performance of the ointment. The more mild preparation conditions ensure the stability of the active ingredients, and the final product is especially suitable for long-term care and repair of chronic and dry skin problems.

[0033] Example 3: This example provides a kind of mountain ardisia ointment suitable for acute and severe inflammatory and painful conditions, which is mainly made of the following raw materials by weight: Mountain ardisia leaf extract, 3 parts; Tea oil, 8 parts; β-cyclodextrin inclusion camphor tree essential oil, 4 parts; Natural beeswax, 1 part; Total glycosides of centella asiatica (purity ≥80%), 2 parts.

[0034] In this example, the preparation method of mountain ardisia leaf extract and the preparation method of β-cyclodextrin inclusion camphor tree essential oil are the same as example 1. The difference between example 1 and example 3 is that in the preparation method of mountain ardisia ointment, in step S2.1, when the mountain ardisia leaf extract is mixed with the tea oil, the heating temperature is 70°C and the time is 15 minutes; in S2.3, it is cooled and solidified at 4°C for 12 hours.

[0035] Conclusion: Example 3 successfully prepared a kind of mountain ardisia ointment specially used for acute and severe inflammatory and painful conditions by limiting the content of mountain ardisia leaf extract, β-cyclodextrin inclusion camphor tree essential oil and total glycosides of centella asiatica to the highest ratio, and using a specific process of 70°C rapid extraction and 4°C low temperature solidification. This formula aims to achieve rapid and effective anti-inflammatory and analgesic effect through the synergistic effect of high-concentration active ingredients, while the optimized preparation process not only ensures the stability of high-content essential oil and extract, but also obtains a fine-textured, easy-to-spread and absorbable ointment through low-temperature solidification, thereby providing a local treatment solution for acute and severe conditions with rapid effect and concentrated drug power.

[0036] Comparative Example 1: The difference between this comparative example and example 1 is that no total glycosides of centella asiatica is added, and the rest of the raw materials and preparation method are the same as example 1.

[0037] Comparative Example 2: The difference between the present comparative example and Example 1 is that the ordinary citral type camphor tree essential oil not subjected to β-cyclodextrin inclusion is used, and the amount thereof is the same as the essential oil content converted from the inclusion essential oil in Example 1, and the remaining raw materials and preparation method are the same as those in Example 1.

[0038] Comparative Example 3: The difference between the present comparative example and Example 1 is that the complex enzymatic hydrolysis treatment step is omitted in the preparation process of the Melia toosendan leaf extract, and ultrasonic extraction is directly performed, and the remaining raw materials and preparation method are the same as those in Example 1.

[0039] Comparative Example 4: The present comparative example is intended to explore the influence of the active ingredients, in particular the Melia toosendan leaf extract and the total ginsenosides of Radix Notoginseng, exceeding the upper limit of the preferred range described in the present application, on the product properties and safety.

[0040] It is mainly made of the following raw materials in parts by weight: Melia toosendan leaf extract, 5 parts; tea oil, 14 parts; camphor tree essential oil, 6 parts; natural beeswax, 7 parts; total ginsenosides of Radix Notoginseng (purity ≥ 80%), 3 parts.

[0041] In the present comparative example, the preparation method of the Melia toosendan leaf extract, the preparation method of the camphor tree essential oil subjected to β-cyclodextrin inclusion, and the preparation method of the Melia toosendan ointment are the same as those in Example 1.

[0042] Comparative Example 5: The present comparative example is intended to explore the influence of the serious imbalance in the proportion of the matrix components, i.e. the too low content of the components in the Melia toosendan ointment, on the basic medicinal properties of the ointment.

[0043] It is mainly made of the following raw materials in parts by weight: Melia toosendan leaf extract, 0.5 parts; tea oil, 6 parts; camphor tree essential oil, 0.5 parts; natural beeswax, 0.5 parts; total ginsenosides of Radix Notoginseng (purity ≥ 80%), 0.1 parts.

[0044] In the present comparative example, the preparation method of the Melia toosendan leaf extract, the preparation method of the camphor tree essential oil subjected to β-cyclodextrin inclusion, and the preparation method of the Melia toosendan ointment are the same as those in Example 1.

[0045] Experimental Example 1: Comparative experimental data of Example 1 and Comparative Examples 1-3 on the recovery time of the number of macrophages.

[0046] Experimental design description: In order to scientifically evaluate the ability of the ointment of the present application to regulate and restore immune inflammatory response under different wound models, the time (days) required for the number of macrophages in the local tissue of the wound to return to normal level is taken as the core evaluation index. The number of macrophages (CD68+ cells) in the wound tissue is counted by flow cytometry and immunohistochemical method, and the number of macrophages in the normal skin tissue without wound is taken as the baseline (normal value).

[0047] Table 1: Experimental results

[0048] Experimental conclusion: As shown in the detailed data in Table 1, in the four different types of wound inflammation models, the ointment provided by Example 1 of the present application can fastest promote the number of local macrophages to return to normal level, which indicates that it has excellent ability to accelerate inflammation subsidence and promote tissue repair process.

[0049] Specific analysis as follows: Comparative Example 1 does not add total glabrousleaf rabdosia glycosides, and the absence of this component leads to a significant extension of the recovery time in the burn and bruise models with longer healing periods, which proves the core role of total glabrousleaf rabdosia glycosides in driving the transformation of inflammation to repair stage and preventing inflammation from lingering; Comparative Example 2 does not use β-cyclodextrin inclusion for camphor tree essential oil, and the recovery time is significantly extended in acute inflammation models such as mosquito bites, indicating that the β-cyclodextrin inclusion technology adopted in Example 1 realizes more efficient and persistent early anti-inflammatory analgesic effect by stabilizing and releasing essential oil activity, thus creating a favorable environment for subsequent repair; Comparative Example 3 omits the complex enzymatic treatment step in the preparation process of the leaf extract of melia toosendan, and the recovery time is slower than that of Example 1 in all models, confirming that the complex enzymatic process can more fully extract active ingredients from the leaves of melia toosendan, and its higher extract efficiency is the basis for ensuring the comprehensive therapeutic effect of the ointment. In summary, the complete technical solution of Example 1 exhibits significant and comprehensive technical advantages in regulating wound immune response and accelerating the completion of inflammation process through the synergy of key components and processes.

[0050] Experimental Example 2: Comparative data of experimental effects of Example 1 and Comparative Examples 4 and 5 Experimental design description: In this experimental example, the pharmacodynamic test is performed on Example 1 and Comparative Examples 4 and 5; the specific test methods are as follows: 1. The anti-inflammatory effect of the melia toosendan ointment is reflected by testing the ear swelling inhibition rate of the mouse xylene-induced ear swelling model; 2. The analgesic effect of the melia toosendan ointment is reflected by testing the body twisting inhibition rate of the mouse acetic acid twisting method; 3. The wound healing rate after seven days of applying the ointment is tested in the full-thickness skin defect model of rats; 4. The time required for the number of macrophages to return to normal value after burn is detected by flow cytometry in the II degree burn model of rats.

[0051] Table 2: Experimental results

[0052] Experimental conclusion: As shown in the experimental data in Table 2, the preferred ratio provided by Example 1 of the present application achieves the best balance among drug efficacy, safety and preparation stability.

[0053] Specifically: Comparative Example 4 uses a higher component ratio, although it has a small gap compared with Example 1 in some drug efficacy indicators, but still has the problem of safety degradation, showing obvious skin irritation and higher sensitization risk. At the same time, due to the too high solid content, the physicochemical properties of the ointment (such as spreadability, transdermal rate) are reduced, proving that simply increasing the content of active ingredients is not only useless to improve efficacy, but also will introduce unacceptable safety risks and application defects. Comparative Example 5 therefore uses a lower component ratio, and due to the serious lack of active substance content, its core efficacy (anti-inflammatory, analgesic, and healing promotion) is significantly lower than Example 1, which cannot meet the basic treatment needs. The imbalance of the base ratio of Comparative Example 5 leads to unstable ointment structure and poor adhesion, further affecting the practicality and reliability of the product.

[0054] In summary, Example 1 successfully prepares the Shangxiangyuan ointment with significant efficacy, high safety and excellent preparation performance by controlling the content of each component within the preferred range, while the results of Comparative Examples 4 and 5 prove the scientificity and necessity of the claimed scope of the present application from the opposite side.

[0055] The above shows and describes the basic principles, main features and advantages of the present application. It should be understood by those skilled in the art that the present application is not limited by the above examples, and the above examples and descriptions in the specification are only preferred examples of the present application and are not intended to limit the present application. Without departing from the spirit and scope of the present application, various changes and improvements can be made to the present application, and these changes and improvements all fall within the scope of the claimed present application. The scope of protection of the present application is defined by the appended claims and their equivalents.

Claims

1. A medicinal paste of Melia azedarach, characterized in that, It is mainly made of the following raw materials by weight: Mallotus philippinensis leaf extract 1-3 parts, tea oil 8-12 parts, camphor tree essential oil 1-4 parts, natural beeswax 1-5 parts, total glycosides of Centella asiatica 0.5-2 parts; The camphor tree essential oil is a limonene type camphor tree essential oil treated by β-cyclodextrin inclusion; The total glycosides of Centella asiatica, mallotus philippinensis leaf extract and camphor tree essential oil synergistically act to accelerate wound repair by shortening the time required for the number of macrophages in the local tissue after trauma to return to the normal level.

2. The medicinal paste as claimed in claim 1, wherein, The mallotus philippinensis leaf extract is prepared by a method comprising the following steps: S1.1, mix mallotus philippinensis leaf powder with a first ethanol aqueous solution with a volume concentration of 85-95 v / v%, perform first ultrasonic extraction, and after solid-liquid separation, obtain a first extract and a residue; S1.2, mix the residue obtained in S1.1 with a second ethanol aqueous solution with a volume concentration of 45-55 v / v%, perform second ultrasonic extraction, and after solid-liquid separation, obtain a second extract; S1.3, combine the first extract obtained in S1.1 and the second extract obtained in S1.2, concentrate, and then freeze-dry to obtain the mallotus philippinensis leaf extract.

3. The medicinal paste as claimed in claim 3, wherein, In S1.3, the process conditions for freeze-drying are: pre-freezing temperature -80°C to -60°C, and freeze-drying time 24-48 hours.

4. The medicinal paste as claimed in claim 3, wherein: The time for each of the first ultrasonic extraction and the second ultrasonic extraction is independently 30-60 minutes.

5. The medicinal paste as claimed in claim 3, wherein, Before S1.1, there is also a step of subjecting mallotus philippinensis leaf powder to complex enzymatic hydrolysis treatment; the complex enzyme consists of cellulase and pectinase.

6. A preparation method for the mallotus philippinensis ointment of any one of claims 1 to 6, characterized in that: S2.1, provide mallotus philippinensis leaf extract; S2.2, mix the mallotus philippinensis leaf extract with tea oil, heat and stir at 60°C-75°C, filter, and obtain mallotus philippinensis tea oil liquid; S2.3, add natural beeswax to the mallotus philippinensis tea oil liquid, heat to melt and stir uniformly to obtain an ointment base; S2.4, mix camphor tree essential oil and total glycosides of Centella asiatica with the ointment base, cool and solidify to obtain the mallotus philippinensis ointment.

7. The method of claim 7, wherein: In S2.2, the heating temperature when mixing mallotus philippinensis leaf extract with tea oil is 65°C-70°C, and the heating time is 15-25 minutes.

8. The method of claim 7, wherein: In S2.4, cooling and solidification is room temperature standing solidification.

9. The method of claim 7, wherein: In S2.4, cooling and solidification is performed in an environment of 4-10°C to accelerate solidification.

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