Musk ointment for treating traumatic injury and preparation method thereof

Abstract

This invention discloses a musk ointment for external treatment of bruises and sprains, and its preparation method. The ointment is prepared through a multi-stage extraction process: fat-soluble components are extracted by frying lard over low heat, while water-soluble and volatile components are extracted by low-temperature extraction using vinegar, wine, and water. High-speed homogenization and emulsification, along with a hydrogel matrix, result in a fine-textured ointment with good spreadability. It shows no layering or odor change under heating, cooling, and centrifugation conditions. Clinical trials show that the ointment exhibits good performance in terms of spreadability, penetration and absorption, pain relief and swelling reduction, and skin comfort. This invention fully retains the advantages of traditional lard frying extraction while overcoming the drawbacks of greasiness, rapid release, and poor stability. It offers advantages such as sustained-release, long-lasting effect, comfortable use, and stable quality, making it suitable for bruises, sprains, fractures, muscle strains, bruises, swelling, and hemiplegia.

Description

Technical Field

[0001] This invention relates to the field of treating sprains and bruises, specifically to a musk ointment for external use in treating sprains and bruises and its preparation method. Background Technology

[0002] Traumatic injuries, fractures, sprains, swelling and pain due to blood stasis, and facial paralysis caused by wind-evil invading the meridians are common and frequently occurring diseases in clinical practice, seriously affecting patients' quality of life. Traditional Chinese medicine external preparations play an important role in the treatment of these diseases due to their convenience, direct targeting of the affected area, and avoidance of the first-pass effect. Traditional Chinese medicine external ointments (such as ointments made by frying medicinal materials in lard, condensing them with beeswax, and then adding finely ground musk) have been clinically verified for hundreds of years, demonstrating definite efficacy and a strong foundation of folk application. The technical advantages of this type of ointment are: lard, as a natural oily matrix, is rich in saturated fatty acids and oleic acid, which can efficiently dissolve the fat-soluble active ingredients (such as momordica saponins, Sichuan pepper oleoresin, cinnamaldehyde, and black snake fatty acids) in medicinal materials such as Momordica cochinchinensis, Sichuan pepper, cinnamon bark, and black snake; beeswax gives the ointment a suitable consistency and skin feel, making it easy to apply; and musk, with its aromatic and penetrating properties, guides the medicine to its destination, opens the orifices and unblocks the meridians, and enhances the efficacy of the medicine. In addition, lard itself has the auxiliary effects of moisturizing the skin and softening muscles and bones, working synergistically with the other ingredients in the formula to achieve a comprehensive effect of "softening muscles and bones, moisturizing skin and flesh, reducing swelling and relieving pain." Therefore, traditional lard and beeswax ointment has long been regarded as a classic dosage form in the treatment of soft tissue injuries and joint pain.

[0003] However, traditional lard and beeswax ointments suffer from several technical defects, severely hindering their modern application and market promotion. First, their greasy texture and poor compliance: the pure oily base results in a greasy feel after application, easily staining clothing and leading to a poor patient experience. This is especially problematic in summer or humid regions, where the ointment easily melts and flows, causing inaccurate dosage and further staining, resulting in low patient compliance. Second, uncontrollable drug release and short duration of action: traditional ointments are homogeneous oily systems, with the drug dissolved or dispersed in the oil phase. After application, the drug rapidly diffuses and is released from the oil phase without any controlled-release design. Release is typically complete within 2-4 hours, requiring frequent dressing changes (3-4 times daily), which is inconvenient and causes large fluctuations in blood drug concentration, affecting the sustainability of efficacy. Third, high-temperature frying destroys heat-sensitive components: traditional processes involve directly frying medicinal materials in hot lard, often at temperatures exceeding 150°C, sometimes even reaching 180-200°C. Heat-sensitive components such as muscone (boiling point approximately 120℃) in musk, asarone (approximately 140℃) in asarum, and ligustilide (approximately 130℃) in angelica and chuanxiong are highly volatile or decomposed at these high temperatures, resulting in a loss of efficacy. Fourth, insufficient extraction of water-soluble components: Lard is a pure oily medium and has almost no extraction capacity for water-soluble components in medicinal materials (such as polysaccharides from atractylodes macrocephala, bletilla striata, dendrobium, achyranthes bidentata saponins, paeoniflorin, alkaloid salts, etc.), resulting in a large amount of water-soluble active ingredients remaining in the residue and being discarded, wasting medicinal resources and reducing efficacy. Fifth, lack of transdermal absorption enhancement design: Traditional ointments rely solely on the occlusive and wetting effects of the oil itself to provide limited penetration enhancement, lacking the systematic application of modern transdermal absorption enhancers, resulting in limited drug penetration under the stratum corneum barrier and low bioavailability. Sixth, the preparation process is crude and the quality is unstable: traditional methods are mostly family or workshop-style production, lacking systematic quality evaluation standards and process control, resulting in large batch-to-batch differences and making it difficult to achieve industrialized and standardized production. Summary of the Invention

[0004] To overcome the shortcomings of existing technologies, the present invention aims to provide a musk ointment for external treatment of bruises and sprains, and its preparation method. This musk ointment is refreshing, non-greasy, and easy to wash off, completely overcoming the drawbacks of traditional ointments that stain clothing. A three-dimensional hydrogel network and nano-emulsion droplets form a dual controlled-release system, enhancing the duration of efficacy.

[0005] One objective of this invention is to provide a method for preparing a musk ointment for external treatment of bruises and sprains, comprising the following steps: (1) Preparation of lard-fried extract: Take cinnamon bark, white silkworm, aconite, inula flower, red peony root, forsythia, momordica cochinchinensis seed, saposhnikovia root, angelica pubescens root, angelica dahurica root, arisaema, Sichuan pepper, and black snake, and fry them in lard at 120~140℃ until angelica dahurica turns yellowish-brown. Filter to obtain medicinal oil, and add beeswax while hot to dissolve it to obtain lard-fried extract. (2) Preparation of vinegar and wine water extract: Take Atractylodes macrocephala, Asarum heterotropoides, Bletilla striata, Chrysanthemum morifolium, Nardostachys jatamansi, Dendrobium nobile, Angelica sinensis, Ligusticum chuanxiong, Rehmannia glutinosa, and Achyranthes bidentata, pulverize them, add rice vinegar, rice wine and pure water, and reflux at 38~42℃ for 2~3 hours. Filter to obtain the residue, add 50% ethanol to the residue and reflux for 1~2 hours. Combine the filtrates, freeze dry and pulverize to obtain vinegar and wine water extract; (3) Musk pretreatment: Grind the musk through a 200-300 mesh sieve and add propylene glycol to disperse it to obtain a musk suspension; (4) Emulsification of lard fried extract: Heat the lard fried extract obtained in step (1) to 70-75°C, add polyoxyethylene hydrogenated castor oil and soybean lecithin, homogenize for 5-15 min, and obtain lard fried extract emulsion. (5) Preparation of musk ointment: Carbomer, glycerin, propylene glycol, ethylparaben, lard fried extract emulsion, vinegar wine extract, musk suspension, azone and menthol are stirred evenly, and the pH is adjusted to 6.5-7.0 with organic base to obtain musk ointment.

[0006] Further, the weight parts of the following ingredients in step (1) are 15-25 parts: cinnamon bark, silkworm pupae, aconite, inula, red peony root, forsythia, momordica cochinchinensis, saposhnikovia divaricata, angelica pubescens, angelica dahurica, arisaema heterophyllum, Sichuan pepper, black snake, lard, beeswax, lard, and beeswax.

[0007] Further, in step (2), the weight parts of Atractylodes macrocephala are 15-25 parts, Asarum heterotropoides 15-25 parts, Bletilla striata 15-25 parts, Chrysanthemum morifolium 15-25 parts, Nardostachys jatamansi 15-25 parts, Dendrobium nobile 15-25 parts, Angelica sinensis 15-25 parts, Ligusticum chuanxiong 15-25 parts, Rehmannia glutinosa 15-25 parts, Achyranthes bidentata 15-25 parts, rice vinegar 720-1200 parts, rice wine 480-800 parts, and pure water 300-500 parts.

[0008] Further, the mass ratio of musk and propylene glycol in step (3) is (2-3):(2-6).

[0009] Further, in step (4), the mass ratio of the lard frying extract, polyoxyethylene hydrogenated castor oil and soybean lecithin is (20-30): (1.5-2.5): (0.5-1).

[0010] Furthermore, the rotational speed for homogenization in step (4) is 10,000 to 15,000 rpm / min.

[0011] Further, the mass ratio of carbomer, glycerin, propylene glycol, ethylparaben, emulsion, vinegar extract, musk suspension, azone and menthol in step (5) is (1-2):(10-20):(2-4):(0.05-0.1):(20-30):(8-12):(4-9):(0.5-1.5):(0.2-0.5).

[0012] Furthermore, in step (5), the organic base is triethylamine.

[0013] The above method produces a musk ointment for external treatment of bruises and sprains.

[0014] The application of the musk ointment for external treatment of sprains and bruises prepared by the above method in drugs that soften tendons and bones, moisturize skin and flesh, reduce swelling and relieve pain, the drugs being used to treat bruises, fractures, and sprains caused by blood stasis and swelling.

[0015] Compared with the prior art, the present invention has the following beneficial effects: This invention fully inherits the advantages of traditional lard frying technology in extracting fat-soluble components, while overcoming the shortcomings of traditional processes through separate extraction and low-temperature technology. The medicinal materials are processed separately into an oil extraction group and a water extraction group: the oil extraction group uses lard for low-heat frying to efficiently extract fat-soluble active components from herbs such as Momordica cochinchinensis, Sichuan pepper, cinnamon bark, and black snake; the water extraction group uses a vinegar-alcohol-water mixed solvent for low-temperature reflux extraction to fully retain polysaccharides and saponins from herbs such as Atractylodes macrocephala, Bletilla striata, and Dendrobium, as well as volatile oils from herbs such as Asarum heterotropoides, Ligusticum chuanxiong, and Angelica sinensis; musk is ground separately and added in suspension form to avoid high-temperature destruction of musk ketones. The three active components are re-fused in the final gel, achieving full retention of the traditional compound formula's components and solving the technical problems of easy loss of heat-sensitive components and insufficient extraction of water-soluble components in traditional frying processes.

[0016] This invention also significantly improves upon the problems of traditional ointments—greasiness, rapid release, and poor absorption—by employing high-speed homogenization emulsification and hydrogel matrix composite technology, thereby enhancing user compliance and the duration of efficacy. The extract from lard is homogenized with an emulsifier at high speed to form an emulsion, which is then uniformly dispersed in a carbomer hydrogel. The resulting ointment is refreshing, non-greasy, and easy to wash off, completely overcoming the shortcomings of traditional ointments that stain clothing. The three-dimensional network of the hydrogel and the nanodroplets form a dual controlled-release system. Simultaneously, chemical penetration enhancers (azone, propylene glycol, menthol) and the terpenoid components of the medicinal materials themselves (limonene, eugenol, and asarone contained in Sichuan pepper, asarum, and cinnamon) synergistically promote transdermal absorption, effectively enhancing bioavailability.

[0017] This invention features a complete formula, controllable process, and stable quality, demonstrating good safety and promising industrialization prospects. The hydrogel is formed by neutralizing carbomer and triethanolamine, requiring no external chemical cross-linking agents. The preparation conditions are mild, and the resulting ointment's pH value closely matches the slightly acidic environment of human skin. The dosage ranges for all 24 medicinal herbs and excipients are clearly defined, and the extraction, emulsification, and gelation steps are complete. The high-speed homogenization equipment used is mature, and excipients such as carbomer are widely available, facilitating large-scale industrial production. The prepared musk ointment possesses the effects of promoting blood circulation, removing blood stasis, reducing swelling and relieving pain, and dispelling wind and unblocking meridians. It is suitable for injuries from falls and blows, fractures, and sprains causing blood stasis and swelling, as well as symptoms such as hemiplegia and facial paralysis caused by external wind-evil. Attached Figure Description

[0018] Figure 1 This is an optical microscope image of the emulsion.

[0019] Figure 2 This is a scanning electron microscope image of musk ointment. Detailed Implementation

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

[0021] Example 1 A musk ointment for external use in treating bruises and sprains, the preparation method of which includes the following steps: (1) Preparation of extract from lard: Take 20 parts of cinnamon bark, 20 parts of silkworm pupae, 20 parts of aconite root, 20 parts of inula flower, 20 parts of red peony root, 20 parts of forsythia fruit, 20 parts of momordica seed, 20 parts of saposhnikovia root, 20 parts of angelica pubescens root, 20 parts of angelica dahurica root, 20 parts of arisaema root, 30 parts of Sichuan pepper, and 30 parts of black snake. Fry them in 1680 parts of lard heated to 130℃ over a low flame until the angelica dahurica root turns a dark yellow color. Filter to obtain the medicinal oil. Then add 100 parts of beeswax to dissolve it, thus obtaining the lard-fried extract (prepared in large batches, 25 parts will be used later).

[0022] (2) Preparation of vinegar wine water extract: Take 20 parts of Atractylodes macrocephala, 20 parts of Asarum heterotropoides, 20 parts of Bletilla striata, 20 parts of Chrysanthemum morifolium, 20 parts of Nardostachys jatamansi, 20 parts of Dendrobium nobile, 20 parts of Angelica sinensis, 20 parts of Ligusticum chuanxiong, 20 parts of Rehmannia glutinosa, and 20 parts of Achyranthes bidentata. After crushing, add 960 parts of rice vinegar, 640 parts of rice wine, and 400 parts of pure water. Reflux at 40°C for 2 hours. Filter. Add 1600 parts of 50% ethanol to the residue and reflux for 1 hour. Combine the filtrates, freeze-dry, and crush to obtain the vinegar-wine water extract.

[0023] (3) Musk pretreatment: Grind 2.5 parts of musk through a 200-mesh sieve and add 4 parts of propylene glycol to disperse it, thus obtaining a musk suspension.

[0024] (4) High-speed homogenization emulsification: The 25 parts of lard-fried extract obtained in step (1) were heated to 72°C, and 2.0 parts of polyoxyethylene hydrogenated castor oil and 0.75 parts of soybean lecithin were added. The mixture was homogenized at 12000 rpm / min for 10 min to obtain the emulsion. The optical microscopic morphology of the emulsion is as follows. Figure 1 As shown.

[0025] (5) Preparation of musk ointment: Add 1.5 parts carbomer to 35 parts pure water, then add 15 parts glycerin, 3 parts propylene glycol, and 0.075 parts ethylparaben, and stir well. While stirring, add 25 parts of the emulsion obtained in step (4), 10 parts of the acetic acid extract obtained in step (2), and the musk suspension obtained in step (3), then add 1.0 part azone and 0.35 parts menthol, and stir well. Adjust the pH to 6.8 using triethanolamine to obtain the musk ointment. The scanning electron microscope image of the musk ointment is shown below. Figure 2 As shown.

[0026] Example 2 A musk ointment for external use in treating bruises and sprains, the preparation method of which includes the following steps: (1) Preparation of extract from lard: Take 15 parts of cinnamon bark, 15 parts of silkworm pupae, 15 parts of aconite root, 15 parts of inula flower, 15 parts of red peony root, 15 parts of forsythia fruit, 15 parts of momordica seed, 15 parts of saposhnikovia root, 15 parts of angelica pubescens root, 15 parts of angelica dahurica root, 15 parts of arisaema root, 23 parts of Sichuan pepper, and 23 parts of black snake. Fry them in 1260 parts of lard heated to 120℃ over a low flame until the angelica dahurica root turns a dark yellow color. Filter to obtain the medicinal oil, then add 75 parts of beeswax to dissolve, thus obtaining the lard-fried extract.

[0027] (2) Preparation of vinegar wine water extract: Take 15 parts of Atractylodes macrocephala, 15 parts of Asarum heterotropoides, 15 parts of Bletilla striata, 15 parts of Chrysanthemum morifolium, 15 parts of Nardostachys jatamansi, 15 parts of Dendrobium nobile, 15 parts of Angelica sinensis, 15 parts of Ligusticum chuanxiong, 15 parts of Rehmannia glutinosa, and 15 parts of Achyranthes bidentata. After crushing, add 720 parts of rice vinegar, 480 parts of rice wine, and 300 parts of pure water. Reflux at 38°C for 2 hours. Filter. Add 1200 parts of 50% ethanol to the residue and reflux for 1.5 hours. Combine the filtrates, freeze-dry, and crush to obtain the vinegar-wine water extract.

[0028] (3) Musk pretreatment: Two parts of musk were ground through a 300-mesh sieve and dispersed with two parts of propylene glycol to obtain a musk suspension.

[0029] (4) High-speed homogenization emulsification: Heat 20 parts of lard-fried extract obtained in step (1) to 70°C, add 1.5 parts of polyoxyethylene hydrogenated castor oil and 0.5 parts of soybean lecithin, and homogenize at 10,000 rpm / min for 5 min to obtain the emulsion.

[0030] (5) Preparation of musk ointment: Add 1 part carbomer to 25 parts pure water, add 10 parts glycerin, 2 parts propylene glycol, and 0.05 parts ethylparaben, and stir well; while stirring, add 20 parts emulsion obtained in step (4), 8 parts vinegar extract obtained in step (2), and musk suspension obtained in step (3), add 0.5 parts azone and 0.2 parts menthol, and stir well; adjust the pH to 6.5 using triethanolamine to obtain musk ointment.

[0031] Example 3 A musk ointment for external use in treating bruises and sprains, the preparation method of which includes the following steps: (1) Preparation of extract from lard: Take 25 parts of cinnamon bark, 25 parts of silkworm pupae, 25 parts of aconite root, 25 parts of inula flower, 25 parts of red peony root, 25 parts of forsythia fruit, 25 parts of momordica seed, 25 parts of saposhnikovia root, 25 parts of angelica pubescens root, 25 parts of angelica dahurica root, 25 parts of arisaema root, 38 parts of Sichuan pepper, and 38 parts of black snake. Fry them in 2100 parts of lard heated to 140℃ over low heat until the angelica dahurica root turns dark yellow. Filter to obtain the medicinal oil. While it is still hot, add 125 parts of beeswax to dissolve it, and you will get the lard-fried extract (30 parts will be used later).

[0032] (2) Preparation of vinegar wine water extract: Take 25 parts of Atractylodes macrocephala, 25 parts of Asarum heterotropoides, 25 parts of Bletilla striata, 25 parts of Chrysanthemum morifolium, 25 parts of Nardostachys jatamansi, 25 parts of Dendrobium nobile, 25 parts of Angelica sinensis, 25 parts of Ligusticum chuanxiong, 25 parts of Rehmannia glutinosa, and 25 parts of Achyranthes bidentata. After crushing, add 1200 parts of rice vinegar, 800 parts of rice wine, and 500 parts of pure water. Reflux at 42℃ for 2 hours. Filter. Add 2000 parts of 50% ethanol to the residue and reflux for 2 hours. Combine the filtrates, freeze-dry, and crush to obtain the vinegar-wine water extract.

[0033] (3) Musk pretreatment: Three parts of musk were ground through a 200-mesh sieve and dispersed with six parts of propylene glycol to obtain a musk suspension.

[0034] (4) High-speed homogenization emulsification: Heat 30 parts of lard fried extract obtained in step (1) to 75°C, add 2.5 parts of polyoxyethylene hydrogenated castor oil and 1 part of soybean lecithin, and homogenize at 15000 rpm / min for 15 min to obtain emulsion.

[0035] (5) Preparation of musk ointment: Add 2 parts carbomer to 45 parts pure water, add 20 parts glycerin, 4 parts propylene glycol, and 0.1 parts ethylparaben, and stir well; while stirring, add 30 parts emulsion obtained in step (4), 12 parts vinegar extract obtained in step (2), and musk suspension obtained in step (3), add 1.5 parts azone and 0.5 parts menthol, and stir well; adjust the pH to 7.0 using triethanolamine to obtain musk ointment.

[0036] Example 4 A musk ointment for external use in treating bruises and sprains, the preparation method of which includes the following steps: (1) Preparation of extract from lard: Take 18 parts of cinnamon bark, 22 parts of silkworm pupae, 19 parts of aconite root, 21 parts of inula flower, 17 parts of red peony root, 23 parts of forsythia fruit, 20 parts of momordica seed, 18 parts of saposhnikovia root, 22 parts of angelica pubescens root, 19 parts of angelica dahurica root, 20 parts of arisaema root, 28 parts of Sichuan pepper, and 32 parts of black snake. Fry these ingredients in 1500 parts of lard heated to 125°C over a low flame until the angelica dahurica root turns a dark yellow color. Filter to obtain the medicinal oil. While still hot, add 90 parts of beeswax to dissolve, thus obtaining the lard-fried extract (28 parts of which will be used later).

[0037] (2) Preparation of vinegar wine water extract: Take 22 parts of Atractylodes macrocephala, 18 parts of Asarum heterotropoides, 20 parts of Bletilla striata, 23 parts of Chrysanthemum morifolium, 17 parts of Nardostachys jatamansi, 19 parts of Dendrobium nobile, 21 parts of Angelica sinensis, 20 parts of Ligusticum chuanxiong, 18 parts of Rehmannia glutinosa, and 22 parts of Achyranthes bidentata. After pulverizing, add 850 parts of rice vinegar, 600 parts of rice wine, and 350 parts of pure water. Reflux at 41°C for 3 hours. Filter. Add 1400 parts of 50% ethanol to the residue and reflux for 1 hour. Combine the filtrates, freeze-dry, and pulverize to obtain the vinegar-wine water extract.

[0038] (3) Musk pretreatment: Grind 2.2 parts of musk through a 200-mesh sieve and add 3.5 parts of propylene glycol to disperse it, thus obtaining a musk suspension.

[0039] (4) High-speed homogenization emulsification: The 28 parts of lard fried extract obtained in step (1) were heated to 73°C, and 2.2 parts of polyoxyethylene hydrogenated castor oil and 0.6 parts of soybean lecithin were added. The mixture was homogenized at 13000 rpm / min for 12 min to obtain the emulsion.

[0040] (5) Preparation of musk ointment: Add 1.8 parts of carbomer to 38 parts of pure water, then add 12 parts of glycerin, 3.5 parts of propylene glycol, and 0.06 parts of ethylparaben, and stir until homogeneous. While stirring, add 28 parts of emulsion obtained in step (4), 9 parts of vinegar extract obtained in step (2), and musk suspension obtained in step (3), then add 0.8 parts of azone and 0.3 parts of menthol, and stir until homogeneous. Adjust the pH to 6.7 using triethanolamine to obtain musk ointment.

[0041] Example 5 A musk ointment for external use in treating bruises and sprains, the preparation method of which includes the following steps: (1) Preparation of extract from lard: Take 21 parts of cinnamon bark, 18 parts of silkworm pupae, 22 parts of aconite root, 19 parts of inula flower, 23 parts of red peony root, 17 parts of forsythia fruit, 21 parts of momordica seed, 22 parts of saposhnikovia root, 18 parts of angelica root, 23 parts of angelica dahurica root, 17 parts of arisaema root, 33 parts of Sichuan pepper, and 28 parts of black snake. Fry these ingredients in 1800 parts of lard heated to 135°C over a low flame until the angelica dahurica root turns a dark yellow color. Filter to obtain the medicinal oil. While still hot, add 105 parts of beeswax to dissolve, thus obtaining the lard-fried extract (22 parts of which will be used later).

[0042] (2) Preparation of vinegar wine water extract: Take 18 parts of Atractylodes macrocephala, 22 parts of Asarum heterotropoides, 19 parts of Bletilla striata, 20 parts of Chrysanthemum morifolium, 21 parts of Nardostachys jatamansi, 17 parts of Dendrobium nobile, 23 parts of Angelica sinensis, 18 parts of Ligusticum chuanxiong, 21 parts of Rehmannia glutinosa, and 19 parts of Achyranthes bidentata. After pulverizing, add 1000 parts of rice vinegar, 700 parts of rice wine, and 450 parts of pure water. Reflux at 39°C for 3 hours. Filter. Add 1550 parts of 50% ethanol to the residue and reflux for 2 hours. Combine the filtrates, freeze-dry, and pulverize to obtain the vinegar-wine water extract.

[0043] (3) Musk pretreatment: Grind 2.8 parts of musk through a 300-mesh sieve and add 5 parts of propylene glycol to disperse it, thus obtaining a musk suspension.

[0044] (4) High-speed homogenization emulsification: The 22 parts of lard fried extract obtained in step (1) were heated to 71°C, and 1.8 parts of polyoxyethylene hydrogenated castor oil and 0.8 parts of soybean lecithin were added. The mixture was homogenized at 11,000 rpm / min for 8 min to obtain the emulsion.

[0045] (5) Preparation of musk ointment: Add 1.2 parts of carbomer to 30 parts of pure water, then add 17 parts of glycerin, 2.5 parts of propylene glycol, and 0.08 parts of ethylparaben, and stir until well mixed. While stirring, add 22 parts of emulsion obtained in step (4), 11 parts of vinegar extract obtained in step (2), and musk suspension obtained in step (3), then add 1.2 parts of azone and 0.4 parts of menthol, and stir until well mixed. Adjust the pH to 6.9 using triethanolamine to obtain musk ointment.

[0046] Comparative Example 1 A medicated ointment, the preparation method of which includes the following steps: (1) Preparation of extract from lard: Take 20 parts of cinnamon bark, 20 parts of silkworm pupae, 20 parts of aconite root, 20 parts of inula flower, 20 parts of red peony root, 20 parts of forsythia fruit, 20 parts of momordica seed, 20 parts of saposhnikovia root, 20 parts of angelica pubescens root, 20 parts of angelica dahurica root, 20 parts of arisaema root, 30 parts of Sichuan pepper, and 30 parts of black snake. Fry them in 1680 parts of lard heated to 130℃ over a low flame until the angelica dahurica root turns a dark yellow color. Filter to obtain the medicinal oil. While still hot, add 100 parts of beeswax to dissolve, thus obtaining the lard-fried extract (prepared in large batches, 25 parts to be used later).

[0047] (2) Preparation of vinegar wine water extract: Take 20 parts of Atractylodes macrocephala, 20 parts of Asarum heterotropoides, 20 parts of Bletilla striata, 20 parts of Chrysanthemum morifolium, 20 parts of Nardostachys jatamansi, 20 parts of Dendrobium nobile, 20 parts of Angelica sinensis, 20 parts of Ligusticum chuanxiong, 20 parts of Rehmannia glutinosa, and 20 parts of Achyranthes bidentata. After crushing, add 960 parts of rice vinegar, 640 parts of rice wine, and 400 parts of pure water. Reflux at 40°C for 2 hours. Filter. Add 1600 parts of 50% ethanol to the residue and reflux for 1 hour. Combine the filtrates, freeze-dry, and crush to obtain the vinegar-wine water extract.

[0048] (3) Musk pretreatment: Grind 2.5 parts of musk through a 200-mesh sieve and add 4 parts of propylene glycol to disperse it, thus obtaining a musk suspension.

[0049] (4) Preparation of the mixture: Heat the 25 parts of lard fried extract obtained in step (1) to 72°C, add 2.0 parts of polyoxyethylene hydrogenated castor oil and 0.75 parts of soybean lecithin, stir for 10 min to mix evenly, and you will get an oil-water mixture.

[0050] (5) Preparation of musk ointment: Add 1.5 parts of carbomer to 35 parts of pure water, then add 15 parts of glycerin, 3 parts of propylene glycol, and 0.075 parts of ethylparaben, and stir until homogeneous. While stirring, add 25 parts of the mixture obtained in step (4), 10 parts of the vinegar extract obtained in step (2), and the musk suspension obtained in step (3). Add 1.0 part of azone and 0.35 parts of menthol, and stir until homogeneous. Adjust the pH to 6.8 using triethanolamine to obtain the musk ointment.

[0051] Comparative Example 2 A medicated ointment, the preparation method of which includes the following steps: (1) Preparation of extract from lard: Take 20 parts of cinnamon bark, 20 parts of silkworm pupae, 20 parts of aconite root, 20 parts of inula flower, 20 parts of red peony root, 20 parts of forsythia fruit, 20 parts of momordica seed, 20 parts of saposhnikovia root, 20 parts of angelica pubescens root, 20 parts of angelica dahurica root, 20 parts of arisaema root, 30 parts of Sichuan pepper, and 30 parts of black snake. Fry them in 1680 parts of lard heated to 130℃ over a low flame until the angelica dahurica root turns a dark yellow color. Filter to obtain the medicinal oil. While still hot, add 100 parts of beeswax to dissolve, thus obtaining the lard-fried extract.

[0052] (2) Preparation of vinegar wine water extract: Take 20 parts of Atractylodes macrocephala, 20 parts of Asarum heterotropoides, 20 parts of Bletilla striata, 20 parts of Chrysanthemum morifolium, 20 parts of Nardostachys jatamansi, 20 parts of Dendrobium nobile, 20 parts of Angelica sinensis, 20 parts of Ligusticum chuanxiong, 20 parts of Rehmannia glutinosa, and 20 parts of Achyranthes bidentata. After crushing, add 960 parts of rice vinegar, 640 parts of rice wine, and 400 parts of pure water. Reflux at 40°C for 2 hours. Filter. Add 1600 parts of 50% ethanol to the residue and reflux for 1 hour. Combine the filtrates, freeze-dry, and crush to obtain the vinegar-wine water extract.

[0053] (3) Musk pretreatment: Grind 2.5 parts of musk through a 200-mesh sieve and add 4 parts of propylene glycol to disperse it, thus obtaining a musk suspension.

[0054] (4) High-speed homogenization emulsification: The 25 parts of lard fried extract obtained in step (1) were heated to 72°C, and 2.0 parts of polyoxyethylene hydrogenated castor oil and 0.75 parts of soybean lecithin were added. The mixture was homogenized at 12000 rpm for 10 min to obtain the emulsion.

[0055] (5) Preparation of the mixture: The 25 parts of emulsion obtained in step (4), the 10 parts of vinegar extract obtained in step (2), and the musk suspension obtained in step (3) were stirred at 500 rpm for 5 min at room temperature until they were mixed evenly to obtain the mixture.

[0056] Test case I. The properties, cold and heat stability and centrifugal stability of the ointments prepared in Examples 1-5 and Comparative Examples 1-2 were tested.

[0057] 1. Appearance: Observe the appearance of the ointment.

[0058] 2. Thermal stability: The cream was sealed in a transparent bottle and refrigerated at 4°C for about a week. No separation was observed. After 24 hours in a constant temperature incubator at 55°C, the cream was observed to see if separation or changes in odor occurred.

[0059] 3. Centrifugal stability: The cream is sealed in a test tube and centrifuged at 3000 r / min for 20 min. Observe whether there is any layering.

[0060] The performance test results are shown in Table 1: Table 1 Performance Tests of the Ointment II. Ointment Efficacy Test: The efficacy of the creams prepared in Examples 1-5 and Comparative Examples 1-2 was evaluated using trial results. Seventy patients aged 15-65 years were selected as trial subjects and randomly divided into 7 groups. The ointments prepared in Examples 1-3 and Comparative Examples 1-2 were applied to the affected areas respectively. The ointments were used twice daily, morning and evening, for two weeks. The total score for each effect was 5 points: 5 points was the highest, indicating very good and highly satisfactory; 4 points was good; 3 points was acceptable; and below 3 points was unacceptable.

[0061] The results of the effectiveness test are shown in Table 2: Table 2. Efficacy Test of the Ointment Based on the stability tests and trial effect scores of Examples 1-5 and Comparative Examples 1-2, the following analytical conclusions can be drawn.

[0062] Examples 1-5 all employed a complete hydrogel matrix and high-speed homogenization emulsification technology. The resulting ointments passed all tests in terms of appearance, thermal stability, and centrifugation—the ointments were fine, spread well, and showed no stratification or odor change during thermal stability testing and centrifugation. This indicates that the process chain consisting of fractional extraction, nano-emulsification, and pH control can form a stable oil-in-water gel network, effectively encapsulating the active ingredients and resisting temperature and mechanical stress. In contrast, Comparative Example 1 lacked high-speed homogenization emulsification, resulting in large droplets and obvious stratification and odor after heat storage and centrifugation; Comparative Example 2 completely lacked a gel matrix and pH adjustment, exhibiting a liquid semi-fluid state with rapid oil-water separation. Both comparative examples failed the stability test, demonstrating the indispensability of high-speed homogenization and the hydrogel framework for the basic quality of the formulation.

[0063] The average overall satisfaction score after two weeks of use in a group of 10 patients showed that Example 1 scored the highest, achieving near-perfect scores in all dimensions, including spreadability, absorption and penetration speed, analgesia and swelling reduction, and skin comfort, demonstrating optimal overall performance. Example 5 scored an average of 4.64, with particularly outstanding skin comfort, suitable for patients seeking a refreshing feel. Example 4 scored 4.44, with relatively fast absorption but slightly oily. Examples 2 and 3 scored 3.94 and 3.88 respectively, indicating acceptable stability, but the slightly thin or thick base resulted in slightly insufficient application feel and drug release, though still within usable limits. This progression clearly demonstrates that within the component range defined by this invention, the ratio near the midpoint yields the most balanced pharmaceutical performance and clinical efficacy.

[0064] Comparative Example 1 scored only 1.90 on average, and Comparative Example 2 scored only 0.86, both far below the acceptable threshold of 3. Comparative Example 1 had a rough texture, poor absorption, and separated after storage; Comparative Example 2 failed to adhere to the affected area at all, with virtually no efficacy. The unique combination of "branch extraction + high-speed homogenization emulsification + hydrogel framework" technology in this invention not only solves the problems of traditional ointments being greasy, unstable, and releasing too quickly, but also significantly improves patient compliance and treatment satisfaction. In summary, Examples 1-5, especially Examples 1, 5, and 4, all possess excellent practical value, with Example 1 being a preferred formulation for large-scale production.

[0065] The above embodiments are merely preferred embodiments of the present invention and should not be construed as limiting the scope of protection of the present invention. Any non-substantial changes and substitutions made by those skilled in the art based on the present invention shall fall within the scope of protection claimed by the present invention.

Claims

1. A method for preparing a musk ointment for external treatment of bruises and sprains, characterized in that, Includes the following steps: (1) Preparation of lard-fried extract: Take cinnamon bark, white silkworm, aconite, inula flower, red peony root, forsythia, momordica cochinchinensis seed, saposhnikovia root, angelica pubescens root, angelica dahurica root, arisaema, Sichuan pepper, and black snake, and fry them in lard at 120~140℃ until angelica dahurica turns yellowish-brown. Filter to obtain medicinal oil, and add beeswax while hot to dissolve it to obtain lard-fried extract. (2) Preparation of vinegar and wine water extract: Take Atractylodes macrocephala, Asarum heterotropoides, Bletilla striata, Chrysanthemum morifolium, Nardostachys jatamansi, Dendrobium nobile, Angelica sinensis, Ligusticum chuanxiong, Rehmannia glutinosa, and Achyranthes bidentata, pulverize them, add rice vinegar, rice wine and pure water, and reflux at 38~42℃ for 2~3 hours. Filter to obtain the residue, add 50% ethanol to the residue and reflux for 1~2 hours. Combine the filtrates, freeze dry and pulverize to obtain vinegar and wine water extract; (3) Musk pretreatment: Grind the musk through a 200-300 mesh sieve and add propylene glycol to disperse it to obtain a musk suspension; (4) Emulsification of lard fried extract: Heat the lard fried extract obtained in step (1) to 70-75°C, add polyoxyethylene hydrogenated castor oil and soybean lecithin, homogenize for 5-15 min, and obtain lard fried extract emulsion. (5) Preparation of musk ointment: Carbomer, glycerin, propylene glycol, ethylparaben, lard fried extract emulsion, vinegar wine extract, musk suspension, azone and menthol are stirred evenly, and the pH is adjusted to 6.5-7.0 with organic base to obtain musk ointment.

2. The method for preparing a musk ointment for external treatment of bruises and sprains according to claim 1, characterized in that, The weight parts of the following ingredients in step (1) are: 15-25 parts of cinnamon bark, 15-25 parts of silkworm pupae, 15-25 parts of aconite, 15-25 parts of inula flower, 15-25 parts of red peony root, 15-25 parts of forsythia, 15-25 parts of momordica cochinchinensis seed, 15-25 parts of saposhnikovia divaricata, 15-25 parts of angelica pubescens, 15-25 parts of angelica dahurica, 15-25 parts of arisaema, 23-38 parts of Sichuan pepper, 23-38 parts of black snake, 1260-2100 parts of lard, and 75-125 parts of beeswax.

3. The method for preparing a musk ointment for external treatment of bruises and sprains according to claim 1, characterized in that, The weight parts of Atractylodes macrocephala mentioned in step (2) are 15-25 parts, Asarum heterotropoides 15-25 parts, Bletilla striata 15-25 parts, Chrysanthemum morifolium 15-25 parts, Nardostachys jatamansi 15-25 parts, Dendrobium nobile 15-25 parts, Angelica sinensis 15-25 parts, Ligusticum chuanxiong 15-25 parts, Rehmannia glutinosa 15-25 parts, Achyranthes bidentata 15-25 parts, rice vinegar 720-1200 parts, rice wine 480-800 parts, pure water 300-500 parts, and ethanol 1200-2000 parts.

4. The method for preparing a musk ointment for external treatment of bruises and sprains according to claim 1, characterized in that, The mass ratio of musk to propylene glycol in step (3) is (2-3):(2-6).

5. The method for preparing a musk ointment for external treatment of bruises and sprains according to claim 1, characterized in that, The mass ratio of lard frying extract, polyoxyethylene hydrogenated castor oil and soybean lecithin in step (4) is (20-30): (1.5-2.5): (0.5-1).

6. The method for preparing a musk ointment for external treatment of bruises and sprains according to claim 1, characterized in that, The rotational speed for homogenization in step (4) is 10,000 to 15,000 rpm / min.

7. The method for preparing a musk ointment for external treatment of bruises and sprains according to claim 1, characterized in that, The mass ratio of carbomer, glycerin, propylene glycol, ethylparaben, emulsion, vinegar extract, musk suspension, azone and menthol in step (5) is (1-2): (10-20): (2-4): (0.05-0.1): (20-30): (8-12): (4-9): (0.5-1.5): (0.2-0.5).

8. The method for preparing a musk ointment for external treatment of bruises and sprains according to claim 1, characterized in that, In step (5), the organic base is triethylamine.

9. A musk ointment for external treatment of bruises and sprains prepared by any one of the preparation methods described in claims 1-8.

10. The application of the musk ointment for external treatment of sprains and bruises prepared by any one of claims 1 to 8 in a drug for softening tendons and bones, moisturizing skin and flesh, reducing swelling and relieving pain, wherein the drug is used to treat sprains, fractures, and contusions caused by blood stasis and swelling.

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