Bamboo paste and preparation method thereof

Abstract

The invention relates to the technical field of traditional Chinese medicine preparations, and discloses a tabasheer paste and a preparation method thereof. The tabasheer paste comprises the following components in parts by weight: 40-50 parts of base oil; heat-clearing and detoxifying medicinal materials: 4-6 parts of chaulmoogra 3-5 parts of fructus cnidii; 3-5 parts of golden cypress; 2-4 parts of rhizoma smilacis glabrae; 2-3 parts of rhizoma arisaematis; wind-expelling and cold-removing medicinal materials: 3-4 parts of Sichuan 2-4 parts of radix angelicae pubescentis; 2-3 parts of divaricate saposhnikovia root; 2-3 parts of dried orange peel; a blood circulation promoting and blood stasis removing medicinal material: 3-4 parts of safflower; 3-4 parts of radix angelicae lateralis preparata; 2 to 3 parts of frankincense; and 2 to 3 parts of myrrh. By optimizing the compatibility of medicinal materials and introducing wet sand fermentation, segmented decoction and curing processes, the extraction efficiency of heat-sensitive and water-soluble components in the tabasheer paste is remarkably improved, and the comprehensive efficacy of clearing away heat and toxic materials, promoting blood circulation to remove blood stasis and expelling wind and removing cold is enhanced.

Description

Technical Field

[0001] The invention relates to the technical field of traditional Chinese medicine preparations, in particular to a Tianzhu ointment and a preparation method thereof. Background Art

[0002] Tianzhu Gao is a traditional Chinese medicine ointment made from a variety of Chinese herbal medicines. It has multiple functions such as clearing away heat and detoxification, dispelling wind and cold, promoting blood circulation and removing blood stasis. It is suitable for a variety of diseases caused by rheumatism, damp-heat toxins, etc., such as joint pain, skin inflammation and blood stasis.

[0003] At present, some existing Tianzhu ointments are prepared by relatively simple compatibility and traditional processes, usually by high-temperature, long-term decoction and direct concentration. Although these preparation methods can retain the effective ingredients in the medicinal materials to a certain extent, and achieve the effects of dispelling dampness and cold and local anti-inflammatory, their effects are mainly concentrated on relieving early rheumatic symptoms and mild skin itching. In addition, the Tianzhu ointment in the prior art can form a relatively stable ointment form during the preparation process, and has good safety in use and certain storage stability.

[0004] However, the existing Tianzhu ointment has some shortcomings. Due to the limitations of the compatibility ratio and process, the extraction efficiency of the effective ingredients in the medicinal materials is low, especially the retention of heat-sensitive or water-soluble components such as volatile oils, flavonoids and polysaccharides is insufficient, resulting in limited efficacy of the ointment. In addition, the traditional high-temperature decoction process easily leads to the degradation of some components, and the comprehensive efficacy of the ointment in clearing away heat and detoxification, promoting blood circulation and removing blood stasis, and dispelling wind and cold is not fully exerted. During storage, the existing Tianzhu ointment is often affected by the stratification of ointment ingredients, viscosity changes or microbial contamination problems, which affects its long-term use effect. Summary of the invention

[0005] In view of the deficiencies in the prior art, the present invention provides a Tianzhu Gao and a preparation method thereof, which solves the problems in the prior art of low extraction efficiency of Tianzhu Gao medicinal materials, failure to fully exert medicinal efficacy, poor storage stability, etc.

[0006] To achieve the above objectives, the present invention is implemented by the following technical scheme: a Tianlan ointment, the Tianlan ointment comprising the following components in parts by weight:

[0007] Base oil: 40-50 parts;

[0008] Heat-clearing and detoxifying herbs: 4-6 portions of magnolia bark; 3-5 portions of cnidium monnieri; 3-5 portions of phellodendron chinense; 2-4 portions of smilax glabra; 2-3 portions of arisaema;

[0009] Herbs for dispelling wind and cold: 3-4 portions of Sichuan Qianghuo; 2-4 portions of Duhuo; 2-3 portions of Fangfeng; 2-3 portions of Chenpi;

[0010] Blood-activating and stasis-removing herbs: 3-4 parts of safflower; 3-4 parts of Radix Angelicae Sinensis; 2-3 parts of frankincense; 2-3 parts of myrrh;

[0011] Aromatic herbs for invigorating the mind: Musk: 0.2-0.5 parts; Borneol: 1-2 parts; Styrax oil: 1-2 parts; Cloves: 0.5-1 parts; Aucklandia: 0.5-1 parts;

[0012] Antibacterial and insecticidal medicinal materials: realgar: 1-2 parts; sapodilla thorn: 1-2 parts; beehive: 1-2 parts; castor bean: 1-2 parts;

[0013] Medicinal materials for warming the meridians and dispelling cold: Aconitum: 1-2 portions; Aconite: 1-2 portions; Ginger juice: 1-2 portions.

[0014] Preferably, the compatibility characteristics of the heat-clearing and detoxifying medicinal materials include:

[0015] The main ingredients are magnolia bark, cnidium monnieri and phellodendron chinense, which provide the ointment’s heat-clearing and detoxifying properties;

[0016] Smilax glabra and Arisaema confusa are auxiliary medicinal materials, used to provide the dehumidifying function and coordinating effect in the ointment.

[0017] Preferably, the compatibility characteristics of the wind-dispelling and cold-dispelling medicinal materials and the blood-activating and blood-stasis-removing medicinal materials include:

[0018] Sichuan Qianghuo and Duhuo are used together as the core herbs for dispelling wind and cold, and are used to provide the paste with the properties of warming the meridians and removing dampness;

[0019] Saposhnikovia divaricata and dried orange peel are used as regulating herbs to balance the rheumatism and cold-dispelling effects in ointment formulas;

[0020] Safflower and Radix Angelicae Sinensis are the main blood-activating herbs, working synergistically with frankincense and myrrh to give the ointment a blood circulation function.

[0021] Preferably, the compatibility characteristics of the aromatic invigorating medicinal materials and the antibacterial and insecticidal medicinal materials include:

[0022] Musk and borneol in the aromatic invigorating herbs are the core herbs, which are used to provide volatile components of the ointment, so that the ointment has the function of invigorating and penetrating; while storax oil, cloves and costusroot are auxiliary herbs, which are used to adjust the aroma components and stability of the ointment;

[0023] Realgar among the antibacterial and insecticidal medicinal materials is the main medicinal material, used to provide the antibacterial component of the ointment; Gleditsia sinensis thorns and honeycomb are auxiliary medicinal materials, used to supplement the physical barrier function and structural adhesion of the ointment;

[0024] Castor seeds are used to provide the oily component in ointments, improving their suppleness and spreadability.

[0025] The present invention also provides a method for preparing Tianzhu Gao, comprising the following steps:

[0026] S1. Soaking in base oil: Add base oil into a container, add heat-clearing and detoxifying herbs according to weight percentage, soak for 48 to 72 hours, and heat in a water bath at 40 to 60°C;

[0027] S2. Pretreatment of medicinal materials: wet fermentation of wind-dispelling and cold-dispelling medicinal materials for 5 to 10 days; crushing of blood-activating and blood-stasis-removing medicinal materials and meridian-warming and cold-dispelling medicinal materials into 1 to 2 mm particles;

[0028] S3, preliminary decoction: mix the base oil with the coarse granular medicinal materials, control the temperature at 70-90°C, decoct for 2-3 hours, and extract the medicinal oil;

[0029] S4, secondary decoction: the extracted medicinal oil is mixed with aromatic invigorating medicinal materials and antibacterial and insecticidal medicinal materials, and decocted at a temperature of 60-80°C for 6-10 hours;

[0030] S5. Ointment concentration: heat the drug oil to 80-90°C and concentrate it until it forms beads when dripped;

[0031] S6. Cooling and maturation: The concentrated ointment is cooled to room temperature and sealed and matured for 20 to 30 days.

[0032] Preferably, the S1 further comprises:

[0033] Place the sealed container in water at 40-60°C and heat it intermittently, with a single heating time of 1-2 hours;

[0034] After each heating cycle, let it cool for 30 to 60 minutes and stir it manually to enhance the solubility of the medicinal materials.

[0035] Preferably, S2 further comprises:

[0036] Fermentation is sealed in wet sand, and the humidity is controlled at 30% to 50%;

[0037] The fermentation environment temperature is maintained at 15-25°C;

[0038] The fermentation time is 5 to 10 days, during which the medicinal materials are turned over every 2 to 3 days to maintain uniformity.

[0039] Preferably, S3 further comprises:

[0040] Mix the base oil with the medicinal materials and fry them at a temperature of 70-90°C;

[0041] Stir every 15 to 20 minutes during the frying process;

[0042] The decocting time is 2 to 3 hours, until the medicinal materials become dry residue and the medicinal oil is light yellow.

[0043] Preferably, the S5 further comprises:

[0044] Heat the medicinal oil evenly at 80-90°C, stirring every 10-15 minutes;

[0045] The completion of ointment concentration is determined by the cold water drop test, i.e., a drop of the ointment is dropped into cold water to form beads that do not disperse;

[0046] Cooling is performed immediately after concentration is completed.

[0047] Preferably, the S6 further comprises:

[0048] The ointment is sealed in a ceramic jar and matured for 20 to 30 days in a curing environment of 15 to 25°C and a humidity of 50% to 70%.

[0049] During the curing period, turn the ointment over every 5 to 7 days to ensure that it is evenly cured.

[0050] The present invention provides a Tianzhu ointment and a preparation method thereof, which has the following beneficial effects:

[0051] 1. The present invention ensures that multiple medicinal effects such as clearing away heat and detoxifying, dispelling wind and cold, promoting blood circulation and removing blood stasis are fully released in the ointment through the scientific compatibility of multiple medicinal materials and step-by-step processing technology. The medicinal ingredients are evenly distributed and have strong permeability, and can quickly act on the lesions to meet the treatment needs of various diseases.

[0052] 2. The preparation method of the present invention adopts precise temperature and humidity control, segmented decoction and maturation process, which effectively improves the physical stability and chemical consistency of the ointment, avoids the inactivation or stratification of the medicinal ingredients, and at the same time gives the ointment good viscosity, ductility and long-term storage performance.

[0053] 3. The preparation process of the ointment of the present invention makes full use of the active ingredients of the medicinal materials, and significantly improves the extraction rate and efficacy utilization rate of the medicinal materials through optimized processes such as soaking, fermentation, decocting and concentration, thereby maximizing the use effect of the ointment and enhancing the comfort of patients when using it. BRIEF DESCRIPTION OF THE DRAWINGS

[0054] Figure 1 The figure is a flow chart of the method of the present invention. DETAILED DESCRIPTION

[0055] The following will be combined with the drawings in the specification of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0056] Please see attached Figure 1The embodiment of the present invention provides a Tianzhu cream, which includes the following components in parts by weight:

[0057] Base oil: 40-50 parts. The use of base oil improves the efficacy, penetration and storage stability of the ointment, and provides an efficient carrier for the fat-soluble components of the medicinal materials;

[0058] Heat-clearing and detoxifying herbs: 4-6 parts of maple seeds; 3-5 parts of cnidium monnieri; 3-5 parts of phellodendron chinense; 2-4 parts of smilax glabra; 2-3 parts of arisaema. The combination of heat-clearing and detoxifying herbs can effectively remove dampness, heat and inflammatory factors, provide targeted solutions for skin problems (such as eczema and itching), and improve the adaptability of ointments for external use.

[0059] Wind-dispelling and cold-dispelling herbs: 3-4 parts of Sichuan Qianghuo; 2-4 parts of Duhuo; 2-3 parts of Fangfeng; 2-3 parts of Chenpi. The synergistic effect of wind-dispelling and cold-dispelling herbs can effectively relieve rheumatic joint pain and muscle stiffness caused by cold and dampness, while balancing the overall medicinal properties of the ointment.

[0060] Blood-activating and stasis-removing herbs: 3-4 parts of safflower; 3-4 parts of Radix Angelicae Sinensis; 2-3 parts of frankincense; 2-3 parts of myrrh. Blood-activating and stasis-removing herbs can improve local circulation, enhance the efficacy of ointments in treating chronic inflammation and blood stasis, and promote the repair of damaged tissues.

[0061] Aromatic herbs for invigorating the mind: Musk: 0.2-0.5 parts; Borneol: 1-2 parts; Styrax oil: 1-2 parts; Clove: 0.5-1 parts; Aucklandia: 0.5-1 parts. The combination of aromatic herbs for invigorating the mind enhances the permeability and diffusion capacity of the ointment, allowing the ointment to act quickly on the lesion site.

[0062] Antibacterial and insecticidal medicinal materials: realgar: 1-2 parts; sapodilla thorn: 1-2 parts; beehive: 1-2 parts; castor bean: 1-2 parts. The combination of antibacterial and insecticidal medicinal materials can effectively prevent skin infections and improve the adaptability of ointments in complex skin disease environments.

[0063] Medicinal materials for warming the meridians and dispersing cold: Aconitum: 1-2 parts; Aconite: 1-2 parts; Ginger juice: 1-2 parts. Medicinal materials for warming the meridians and dispersing cold can significantly relieve joint and muscle pain in patients with cold and damp constitution, and enhance the effect of ointment in treating cold diseases.

[0064] Please refer to the attached Figure 1 In a preferred embodiment of the present invention, the compatibility characteristics of the heat-clearing and detoxifying medicinal materials include:

[0065] Maple, Cnidium monnieri and Phellodendron chinense are the main medicinal materials, providing the ointment with the property of clearing away heat and detoxifying. Using Maple as the main medicinal material can effectively play the function of clearing away heat and detoxifying, provide direct relief for skin diseases caused by damp-heat toxins, and enhance the overall antibacterial effect of the ointment. The introduction of Cnidium monnieri enhances the ointment's ability to dry dampness and kill insects, providing targeted conditioning for skin problems of patients with damp-heat constitution. Finally, Phellodendron chinense strengthens the ointment's effect of clearing away heat and detoxifying, while reducing the redness, swelling and discomfort caused by skin infections.

[0066] Smilax glabra and Arisaema confusa are auxiliary medicinal materials, used to provide the dehumidifying function and compatibility and coordination effect in the ointment. The addition of Smilax glabra regulates the overall moisturizing properties of the ointment and reduces the irritation of excessive dryness and moisture to the skin through the compatibility effect. The introduction of Arisaema confusa improves the compatibility and coordination performance of the ointment, making the ointment more widely applicable in humid and hot environments, while enhancing the dehumidifying properties of the ointment.

[0067] Please see attached Figure 1 In a preferred embodiment of the present invention, the compatibility characteristics of the wind-dispelling and cold-dispelling medicinal materials and the blood-activating and blood-stasis-removing medicinal materials include:

[0068] As core medicinal materials for dispelling wind and cold, Sichuan Qianghuo and Duhuo are used to provide the ointment with the property of warming meridians and removing dampness. The combination of Sichuan Qianghuo and Duhuo is the core of the ointment for dispelling wind and cold, which improves the ointment's effect in relieving joint and muscle pain caused by cold and dampness, while maintaining the ointment's medicinal stability;

[0069] Saposhnikovia divaricata and dried orange peel are used as regulating herbs to balance the rheumatism and cold-dispelling effects in the ointment formula. Saposhnikovia divaricata adjusts the overall performance of the herbs with its wind-dispelling effect; while dried orange peel balances the wind-dispelling and cold-dispelling and meridian-warming effects with its function of promoting qi and removing dampness, and reduces the stimulation of the ointment to cold constitution, thereby enhancing the multifunctional adaptability and overall mildness of the ointment.

[0070] Safflower and Radix Angelicae Sinensis are the main blood-activating herbs, which work synergistically with frankincense and myrrh to give the ointment a blood circulation function. The yellow pigment component in safflower can directly act on capillaries, enhance vascular permeability, promote local blood flow, and reduce blood stasis formation. Radix Angelicae Sinensis can further repair soft tissue injuries through its blood-activating and analgesic functions, and at the same time synergize with safflower to enhance the blood circulation regulation efficiency.

[0071] Please see attached Figure 1 In a preferred embodiment of the present invention, the compatibility characteristics of the aromatic invigorating medicinal materials and the antibacterial and insecticidal medicinal materials include:

[0072] Musk and borneol in the aromatic invigorating herbs are the core herbs, used to provide volatile components of the ointment, so that the ointment has the function of invigorating and penetrating; while storax oil, cloves and costus root are auxiliary herbs, used to adjust the aroma components and stability of the ointment. Musk and borneol, as the core components of aromatic invigorating herbs, contain a variety of volatile aromatic oils and small molecule components, which can penetrate through the skin surface to the lesion site, play the role of invigorating and penetrating the meridians, and borneol also has a cooling property, which can further enhance the permeability of the ointment and the comfort after use. At the same time, the volatility and aroma components of storax oil can adjust the overall smell of the ointment, and enhance the penetration performance of the ointment through trace molecular structures. Cloves and costus root adjust the aroma and medicinal balance of the ointment to make it more suitable for long-term external use. Both also have certain moisturizing properties to prevent the ointment from drying out too quickly;

[0073] Realgar among the antibacterial and insecticidal medicinal materials is the main medicinal material, used to provide the antibacterial component of the ointment; sapodilla thorns and beehives are auxiliary medicinal materials, used to supplement the physical barrier function and structural adhesion of the ointment. Realgar contains antibacterial active ingredients such as arsenic sulfide, which can reduce the number of infectious pathogens by inhibiting the metabolic pathways of microorganisms, and the fine particles of realgar can form a physical barrier covering the skin surface to further prevent the invasion of pathogenic microorganisms. At the same time, the combination of sapodilla thorns and beehives provides the ointment with better adhesion performance and antibacterial function, prolonging the duration of the drug's action.

[0074] Castor seeds are used to provide oily ingredients in ointments to improve their softness and spreadability. Castor oil is rich in unsaturated fatty acids and oily ingredients, which can give the ointment greater softness and make it more spreadable on the skin, thereby improving the ointment's comfort level and enhancing its storage stability.

[0075] The present invention also provides a method for preparing Tianzhu Gao, comprising the following steps:

[0076] S1. Soaking in base oil: Add base oil into a container, add heat-clearing and detoxifying medicinal materials according to weight percentage, soak for 48 to 72 hours, and heat in a water bath at 40 to 60°C. During the soaking process, fat-soluble components (such as volatile oils and fatty acids) are dissolved from the heat-clearing and detoxifying medicinal materials into the base oil. These components are the main active substances for the ointment to exert the heat-clearing and detoxifying and insecticidal effects. At the same time, water bath heating can increase the solubility of the medicinal materials and avoid the decomposition of the effective ingredients of the medicinal materials due to high temperature;

[0077] S2. Pretreatment of medicinal materials: wet fermentation of wind-dispelling and cold-dispelling medicinal materials for 5 to 10 days; crushing of blood-activating and blood-stasis-dispelling medicinal materials and meridian-warming and cold-dispelling medicinal materials into 1 to 2 mm particles. The wet fermentation process activates the active substances in the wind-dispelling and cold-dispelling medicinal materials, while reducing their irritation and improving the dissolution efficiency of the medicinal materials in oils and fats. The crushing of blood-activating and blood-stasis-dispelling medicinal materials and meridian-warming and cold-dispelling medicinal materials increases the surface area of ​​the medicinal materials, so that their active ingredients are released more fully during the decoction process.

[0078] S3, preliminary decoction: the base oil is mixed with the coarse granular medicinal materials, the temperature is controlled at 70-90°C, and the decoction is performed for 2-3 hours to extract the medicinal oil. The preliminary decoction is performed under constant temperature conditions to further release the fat-soluble components of the medicinal materials, and enhance the permeability of the oil to the medicinal materials through thermal diffusion, thereby improving the extraction rate of the heat-clearing and detoxifying medicinal materials and reducing the influence of the impurities of the medicinal materials on the stability of the ointment;

[0079] S4, secondary decoction: the extracted medicinal oil is mixed with aromatic invigorating medicinal materials and antibacterial and insecticidal medicinal materials, and decocted at a temperature of 60-80°C for 6-10 hours. The secondary decoction extracts aromatic volatile components at a lower temperature to avoid their loss at high temperature, and at the same time extracts fat-soluble and water-soluble components in antibacterial and insecticidal medicinal materials to improve the comprehensive performance of the ointment. The uniformity and purity of the medicinal oil are ensured through the stirring and filtering process, thereby ensuring the stability of the ointment in subsequent concentration;

[0080] S5. Ointment concentration: Heat the drug oil to 80-90℃ and concentrate it to the state of water droplets forming beads. Low-temperature concentration reduces the residual water and other volatile impurities, ensuring the stability of the ointment ingredients;

[0081] S6. Cooling and aging: The concentrated ointment is cooled to room temperature and sealed for 20 to 30 days. The cooling process stabilizes the physical structure of the ointment, and the aging process further integrates the ingredients to improve the uniformity and efficacy stability of the ointment. Sealed storage prevents air oxidation or microbial contamination, and appropriate humidity conditions prevent the ointment surface from drying out.

[0082] Please refer to the attached Figure 1 In a preferred embodiment of the present invention, S1 further comprises:

[0083] Place the sealed container in water at 40-60°C and heat it intermittently for 1-2 hours at a time. The intermittent heating method effectively controls the soaking temperature, prevents the degradation of heat-sensitive components (such as volatile oils) in the medicinal materials due to continuous high temperature, and ensures that the active ingredients can be released with maximum efficiency during heating and cooling.

[0084] After each heating cycle, let it stand and cool for 30 to 60 minutes, and stir it manually to enhance the solubility of the medicinal materials. During the heating stage, the kinetic energy of the base oil molecules increases, which accelerates the process of the effective ingredients of the medicinal materials entering the base oil.

[0085] Please refer to the attached Figure 1 In a preferred embodiment of the present invention, S2 further comprises:

[0086] Sealed wet sand fermentation, humidity is controlled at 30% to 50%. The wet sand provides a stable micro-humid environment for the medicinal materials, which helps to trigger the activity of the intrinsic enzymes in the medicinal materials and enhance their pharmacological properties of dispelling wind and cold. At the same time, the sealed state of the wet sand reduces the entry of external oxygen, forming a suitable micro-oxygen environment, which helps to improve the stability of fat-soluble and water-soluble components in the medicinal materials.

[0087] The fermentation environment temperature is maintained at 15-25℃. The temperature controlled at 15-25℃ is the optimal range for microbial activity and medicinal material metabolic enzyme activity. Avoid excessively high temperatures that may cause medicinal materials to deteriorate or excessively low temperatures that may delay fermentation.

[0088] The fermentation time is 5 to 10 days, during which the medicinal materials are turned over every 2 to 3 days to maintain uniformity. The turning operation ensures uniform contact between the medicinal materials and the wet sand, avoids excessive humidity in local areas or uneven fermentation, and thus improves the consistency of the fermentation effect.

[0089] Please refer to the attached Figure 1 In a preferred embodiment of the present invention, S3 further comprises:

[0090] The base oil is mixed with the medicinal materials and then decocted at a temperature of 70-90°C. Within this temperature range, the fat-soluble components in the medicinal materials (such as volatile oils, fatty acids, and flavonoids) can be fully released and dissolved in the base oil. At the same time, this temperature avoids the destruction of heat-sensitive components (such as aromatic components and volatile oils) by high temperature, and prevents the oxidation of oils and fats to produce impurities;

[0091] Stir every 15 to 20 minutes during the decocting process. Stirring can prevent the precipitation of medicinal materials and local overheating, ensure uniform contact between oil and medicinal materials, and promote the dispersion of medicinal materials in oil, so that the effective ingredients of medicinal materials are released more comprehensively, thereby preventing the coking of medicinal materials and the oxidation of oil, ensuring the stability of the quality of the medicinal oil, and avoiding the generation of odor or impurities in the ointment.

[0092] The decocting time is 2 to 3 hours, until the medicinal materials become dry residue and the medicinal oil is light yellow. When the oil is light yellow, it means that the pigments and fat-soluble active ingredients in the medicinal materials have been fully released. At the same time, avoiding too dark color may mean that the oil has been oxidized by heat. By controlling the decocting temperature and time, the fat-soluble components of the medicinal materials can be efficiently released, thereby increasing the concentration of the active ingredients in the medicinal oil.

[0093] Please refer to the attached Figure 1 In a preferred embodiment of the present invention, S5 further comprises:

[0094] The medicinal oil is heated evenly at a temperature of 80 to 90°C and stirred every 10 to 15 minutes. This temperature range can promote the volatilization of water and impurities in the oil, thereby increasing the concentration of the medicinal oil, while ensuring that heat-sensitive components (such as volatile aromatic components) are not destroyed. At the same time, the stirring operation can evenly distribute the fat-soluble and volatile components in the oil, avoiding the problem of sedimentation or uneven concentration during the concentration process. In addition, through the stirring operation, the internal components of the ointment are more evenly distributed, reducing the stratification or crystallization phenomenon, and improving the appearance and application performance of the ointment;

[0095] The cold water drop test method is used to judge the completion state of ointment concentration, that is, take a drop of drug oil and drop it into cold water to form beads without dispersing. The ointment forms beads without dispersing after being dropped into cold water, which is a physical sign that the ointment has reached the appropriate concentration and viscosity. This method is intuitive and fast, and can avoid misjudging the completion time of ointment concentration;

[0096] Cooling is carried out immediately after concentration is completed. The cooling process stabilizes the physical properties of the ointment and avoids the separation or failure of the components caused by high temperature after concentration. Slow cooling can further enhance the uniformity and smoothness of the ointment, laying the foundation for subsequent packaging and maturation steps;

[0097] The combination of uniform heating and cold water drop test method ensures that the ointment is concentrated to the optimal state, which not only increases the concentration of active ingredients but also enhances the physical stability of the ointment.

[0098] Please refer to the attached Figure 1 In a preferred embodiment of the present invention, S6 further comprises:

[0099] The ointment is sealed and matured in a ceramic pot for 20 to 30 days at a temperature of 15 to 25°C and a humidity of 50% to 70%. The ceramic pot material has good air permeability and humidity regulation capabilities, and can provide a stable maturation environment for the ointment in sealed storage, while avoiding chemical reactions or odors that may be caused by plastic or metal containers. At the same time, under the coordination of maturation temperature and humidity control, it can prevent the unpleasant odor caused by the oxidation of fatty acids in the ointment, and avoid excessive loss of volatile components. At the same time, it can also adjust the viscosity and ductility of the ointment by slowly releasing moisture, reducing the negative impact of dryness or excessive moisture on the quality of the ointment.

[0100] During the maturation period, the ointment should be turned over every 5 to 7 days to ensure uniform maturation. During the sealed storage of the ointment, components may settle or stratify. Regular turning can redistribute the components evenly and further promote the fusion of the fat-soluble components in the ointment with other components.

[0101] In order to better understand the present invention, the above contents are described in detail below in conjunction with specific embodiments.

[0102] Embodiment 1

[0103] Material ratio:

[0104] Base oil: 45 parts;

[0105] Heat-clearing and detoxifying herbs: 5 parts of dafengzi, 4 parts of cnidium monnieri, 4 parts of phellodendron, 3 parts of smilax glabra, and 2 parts of arisaema;

[0106] Medicinal materials for dispelling wind and cold: 4 parts of Sichuan Qianghuo, 3 parts of Duhuo, 2 parts of Fangfeng, and 2 parts of Chenpi;

[0107] Blood-activating and stasis-removing herbs: 4 parts of safflower, 3 parts of Radix Angelicae Sinensis, 2 parts of frankincense, and 2 parts of myrrh;

[0108] Aromatic herbs for invigorating the mind: 0.3 parts of musk, 1.5 parts of borneol, 1 part of storax oil, 0.5 parts of cloves, and 0.5 parts of costus root;

[0109] Antibacterial and insecticidal medicinal materials: 1.5 parts of realgar, 1 part of sapodilla thorn, 1.5 parts of beehive, 1.5 parts of castor bean;

[0110] Medicinal materials for warming the meridians and dispelling cold: 1 part of Aconitum carmichaelii, 1 part of Aconitum root, and 1 part of ginger juice.

[0111] Preparation process:

[0112] The base oil immersion time was 48 hours, and the water bath temperature was 40°C;

[0113] The wet sand sealed fermentation time is 5 days, and the humidity is controlled at 30%;

[0114] The initial frying temperature is 70°C and the time is 2 hours;

[0115] The secondary frying temperature is 60°C and the time is 6 hours;

[0116] The ointment concentration temperature is 80°C, and cold water drops form beads;

[0117] The aging time is 20 days, the ambient temperature is 15℃, the humidity is 50%, and the crops are turned over every 7 days;

[0118] In this embodiment, the selection of material ratios and process conditions ensures that the ointment has obvious effects of clearing away heat, detoxifying, dispelling wind and relieving cold, and is suitable for skin diseases caused by damp heat (such as eczema and dermatitis). The lower temperature and shorter decoction time effectively retain the heat-sensitive components of the medicinal materials, making the ointment as a whole highly permeable and mild.

[0119] Embodiment 2

[0120] Material ratio:

[0121] Base oil: 50 parts;

[0122] Heat-clearing and detoxifying herbs: 6 parts of magnolia bark, 5 parts of cnidium monnieri, 3 parts of phellodendron, 2 parts of smilax glabra, and 3 parts of arisaema;

[0123] Herbs for dispelling wind and cold: 3 parts of Sichuan Qianghuo, 4 parts of Duhuo, 3 parts of Fangfeng, and 3 parts of Chenpi;

[0124] Blood-activating and stasis-removing herbs: 3 parts safflower, 4 parts Radix Angelicae Sinensis, 3 parts frankincense, 3 parts myrrh;

[0125] Aromatic herbs for invigorating the mind: 0.2 parts of musk, 2 parts of borneol, 1.5 parts of storax oil, 1 part of cloves, 1 part of costusroot;

[0126] Antibacterial and insecticidal medicinal materials: 2 parts of realgar, 1.5 parts of sapodilla thorn, 2 parts of beehive, and 2 parts of castor beans;

[0127] Medicinal materials for warming the meridians and dispelling cold: 2 parts of Aconitum carmichaelii, 2 parts of Aconitum kusnezoffii, and 2 parts of ginger juice.

[0128] Preparation process:

[0129] The base oil immersion time was 72 hours, and the water bath temperature was 60°C;

[0130] The wet sand sealed fermentation time is 10 days, and the humidity is controlled at 50%;

[0131] The initial frying temperature is 90°C and the time is 3 hours;

[0132] The secondary frying temperature is 80°C and the time is 10 hours;

[0133] The ointment concentration temperature is 90°C, and cold water drops form beads;

[0134] The aging time is 30 days, the ambient temperature is 25℃, the humidity is 70%, and the crops are turned over every 5 days;

[0135] This embodiment, by adjusting the ratio of medicinal materials and process conditions, highlights the effects of promoting blood circulation and removing blood stasis and warming the meridians and dispersing cold, and is suitable for rheumatoid arthritis and muscle soreness caused by cold and dampness. The higher temperature and the extended decoction and maturation time enhance the concentration and durability of the ointment, and at the same time improve the stability of the ointment during long-term storage.

[0136] Comparative experiment 1: drug efficacy test

[0137] Purpose:

[0138] The medicinal effect advantages of the Tianzhu ointment of the present invention are verified, including the comprehensive effects of clearing away heat and detoxifying, dispelling wind and cold, and promoting blood circulation and removing blood stasis.

[0139] Experimental setup

[0140] Experimental Grouping

[0141] Experimental Group:

[0142] The Tianzhu ointment prepared by the invention.

[0143] Control group 1: ointment prepared by traditional technology (no wet sand fermentation, direct high-temperature decocting and concentration).

[0144] Control group 2: The formula and process were simplified, and the ointment was decocted only once (reducing the ratio of medicinal materials and the concentration steps).

[0145] Blank group: Use base oil as a control without any medicinal ingredients.

[0146] Experimental model

[0147] Inflammation inhibition test (clearing heat and detoxifying):

[0148] A mouse auricle inflammation model was used.

[0149] After xylene was applied to the surface of the mouse auricle to induce inflammation, each group of ointments were applied respectively, and the auricle swelling and the expression levels of inflammatory factors (TNF-α, IL-6) were measured 6 hours later.

[0150] Pain relief test (removing wind and cold):

[0151] A rat model of rheumatoid arthritis was used.

[0152] After the rats were injected with inflammatory agents into their knee joints to induce joint inflammation, ointments from each group were applied to the rats and the rats were observed for 5 consecutive days. The range of motion and pain scores were recorded.

[0153] Blood circulation improvement test (promoting blood circulation and removing blood stasis):

[0154] Blood stasis model animals were used.

[0155] After the rabbit ear vein injection formed a blood stasis model, each group of ointments were applied respectively, and the blood flow velocity and coagulation time were measured.

[0156] Experimental procedures

[0157] Heat-clearing and detoxification experimental steps:

[0158] Twenty mice were randomly selected and divided into four groups, with five mice in each group.

[0159] Xylene was applied to the right ear of the mice to induce local inflammation.

[0160] After 30 minutes, ointment was applied to the experimental group and the control group, and base oil was applied to the blank group.

[0161] Six hours later, the thickness of the auricle was measured with a caliper, and the auricle tissues were collected to detect the expression levels of TNF-α and IL-6.

[0162] Experimental steps for dispelling wind and cold:

[0163] Sixteen rats were randomly divided into four groups, with four rats in each group.

[0164] The rheumatoid arthritis model was established by injecting 0.1 ml of complete Freund's adjuvant into the knee joint of each rat.

[0165] The ointment was applied once a day for 5 consecutive days, and the joint range of motion and pain score were observed.

[0166] Experimental steps of promoting blood circulation and removing blood stasis:

[0167] Twelve rabbits were randomly divided into 4 groups, with 3 rabbits in each group.

[0168] The ear vein stasis model was induced by injection of epinephrine.

[0169] After applying the ointment, use a blood flow meter to record blood flow velocity and measure coagulation time

[0170] The comparative experimental data are shown in Table 1-3:

[0171] Table 1 Data of heat-clearing and detoxification experiment - Thickness of ear swelling (mm)

[0172] Group Mouse 1 Mouse 2 Mouse 3 Mouse 4 Mouse 5 average value Experimental Group 0.35 0.37 0.36 0.34 0.38 0.36 Control group 1 0.4 0.42 0.41 0.39 0.43 0.41 Control group 2 0.5 0.48 0.49 0.52 0.51 0.5 Blank Group 0.6 0.62 0.58 0.61 0.59 0.6

[0173] Table 2 Data table of wind-dispelling and cold-dispelling experiment - joint range of motion (score)

[0174] Group Rat 1 Rat 2 Rat 3 Rat 4 average value Experimental Group 8.2 8.5 8.1 8.4 8.3 Control group 1 7.4 7.3 7.6 7.5 7.4 Control group 2 6.8 6.6 6.9 6.7 6.8 Blank Group 5.5 5.6 5.4 5.7 5.6

[0175] Table 3 Blood stasis promoting and blood stasis removing experimental data table - blood coagulation time (seconds)

[0176]

[0177]

[0178] From the data in Table 1-3, we can get:

[0179] Heat-clearing and detoxifying effect: The average auricle swelling of the experimental group was 0.36 mm, which was lower than that of control group 1 (0.41 mm), control group 2 (0.50 mm) and blank group (0.60 mm). Inflammatory factor detection showed that TNF-α and IL-6 levels were significantly reduced, indicating that the ointment in the experimental group had the best effect in inhibiting inflammation and clearing heat and detoxifying.

[0180] Effect of dispelling wind and dispelling cold: The average score of joint mobility in the experimental group was 8.3 points, which was higher than that in control group 1 (7.4 points) and control group 2 (6.8 points). The lowest score in the blank group was 5.6 points. The joint swelling and pain scores in the experimental group were more significantly improved, proving that it has excellent effect of dispelling wind and dispelling cold.

[0181] Blood circulation and stasis-removing effect: The coagulation time of the experimental group was 70 seconds, which was shorter than that of the control group 1 (85.3 seconds), the control group 2 (91 seconds) and the blank group (109 seconds), indicating that the ointment in the experimental group has obvious advantages in promoting blood circulation and improving blood stasis.

[0182] Comparative experiment 2: stability test

[0183] Experimental purpose: To verify the physical and chemical stability of the Tianzhu cream of the present invention under different storage conditions, including the retention rate of active ingredients, changes in physical properties (viscosity, ductility), and anti-microbial contamination ability.

[0184] Experimental setup

[0185] Experimental Grouping

[0186] Experimental group: Tianzhu Gao prepared by the present invention (adopting wet sand fermentation, segmented decocting and maturation process).

[0187] Control group 1 (traditional process group): traditional high-temperature decoction ointment (without the use of maturation and wet sand fermentation process).

[0188] Control group 2 (unripened group): The formula was the same as that of the experimental group, but the cooling and aging steps were omitted, and the product was directly stored after concentration.

[0189] Storage conditions

[0190] The ointment was tested in three different environments:

[0191] High temperature conditions: 40°C, accelerated aging environment.

[0192] Normal temperature conditions: 25°C, simulating normal storage environment.

[0193] Low temperature conditions: 4°C, low temperature storage environment.

[0194] Experimental procedures

[0195] Initial indicator detection:

[0196] The active ingredient content (such as volatile oil, flavonoids), physical properties (viscosity, ductility) and microbial content of the ointments in the experimental group and the control group before storage were determined.

[0197] Storage Test:

[0198] The ointment was stored at high temperature, room temperature and low temperature respectively. Samples were taken from each group at 0 days, 30 days, 90 days and 180 days to test the following indicators:

[0199] Active ingredient content (gas chromatography, ultraviolet spectrophotometry);

[0200] Physical properties (viscosity was tested using a rheometer, ductility was determined by smearing experiments);

[0201] Microbial contamination (total colony count determination).

[0202] Data recording and analysis: Record the changes in the ointments in the experimental and control groups at each time point and compare the differences in stability.

[0203] The comparative experimental data are shown in Table 4-6:

[0204] Table 4 Retention rate of active ingredients under high temperature conditions (%)

[0205]

[0206]

[0207] Table 5 Viscosity changes under normal temperature conditions (mPa·s)

[0208] Time (day) Group Viscosity value 0 Experimental Group 500 Control group 1 480 Control group 2 490 30 Experimental Group 495 Control group 1 460 Control group 2 470 90 Experimental Group 490 Control group 1 420 Control group 2 440 180 Experimental Group 485 Control group 1 380 Control group 2 400

[0209] Table 6 Microbial contamination under low temperature conditions (total colony count, CFU / g)

[0210] Time (day) Group Volatile oil content 0 Experimental Group 100 Control group 1 100 Control group 2 100 30 Experimental Group 92 Control group 1 85 Control group 2 70 90 Experimental Group 85 Control group 1 60 Control group 2 40 180 Experimental Group 75 Control group 1 30 Control group 2 20

[0211] From the data in Table 4-6, we can get:

[0212] Retention rate of active ingredients: Under high temperature conditions, the retention rate of active ingredients in the ointment of the experimental group was higher than those in control group 1 and control group 2. After 180 days, the retention rate of volatile oil in the experimental group was 75%, while that in control group 1 and control group 2 was only 30% and 20%, respectively, indicating that the process of the present invention significantly delayed the degradation of ingredients.

[0213] Viscosity stability: Under room temperature conditions, the viscosity of the ointment in the experimental group only decreased by 3% after 180 days, while the viscosity of the control group 1 and control group 2 decreased by 20% and 18%, respectively. The physical properties of the ointment in the experimental group remained more stable, reflecting the effect of optimizing the process on improving the stability of the ointment structure.

[0214] Anti-microbial contamination performance: Under low temperature conditions, the total colony count of the ointment in the experimental group was 40 CFU / g after 180 days, while that of the control group 1 and the control group 2 reached 200 CFU / g and 300 CFU / g, respectively. The experimental group showed significant anti-contamination ability, indicating that the wet sand fermentation and maturation process has a positive effect on antimicrobial performance.

[0215] Comparative experiment 3: ingredient extraction efficiency test

[0216] Experimental purpose: To verify the advantages of the preparation process of the present invention in the extraction rate of effective ingredients of medicinal materials.

[0217] Experimental setup

[0218] Experimental Grouping

[0219] Experimental group: The complete process of the present invention, including wet sand fermentation, secondary frying and maturation steps.

[0220] Control group 1 (traditional process group): high temperature frying (completed in one frying), without wet sand fermentation and maturation steps.

[0221] Control group 2 (simplified process group): The formula was the same, but wet sand fermentation was omitted, and only single decoction and simple concentration were performed.

[0222] Experimental procedures

[0223] Sample preparation:

[0224] The same batch of medicinal materials (such as big maple seeds, phellodendron, safflower, realgar, etc.) were used to prepare medicinal oil according to the process of each group. Three samples were extracted from each group to ensure repeatability.

[0225] Active ingredient detection:

[0226] Volatile oil: The volatile oil content (mg / g) in the medicinal oil was determined by gas chromatography.

[0227] Flavonoids: The flavonoid content (mg / g) was determined using UV spectrophotometry.

[0228] Polysaccharides: The polysaccharide content (mg / g) was determined by the phenol-sulfuric acid method.

[0229] Calculation of extraction efficiency: Extraction efficiency = (mass of target component in extract / mass of target component in raw medicinal material) × 100%.

[0230] The comparative experimental data are shown in Table 7-9:

[0231] Table 7 Volatile oil extraction efficiency data table (%)

[0232] Sample No. Experimental Group Control group 1 Control group 2 Sample 1 75.2 62.3 50.8 Sample 2 76.1 63.5 49.6 Sample 3 74.8 61.9 51.2 average value 75.4 62.6 50.5

[0233] Table 8 Component analysis comparison data table

[0234] Sample No. Experimental Group Control group 1 Control group 2 Sample 1 68.7 55.1 47.3 Sample 2 69.2 54.6 48 Sample 3 68.4 55.4 46.9 average value 68.8 55 47.4

[0235] Table 9 Component analysis comparison data table

[0236] Sample No. Experimental Group Control group 1 Control group 2 Sample 1 61.3 49.2 41.5 Sample 2 60.8 50.1 42 Sample 3 61.5 48.9 41.8 average value 61.2 49.4 41.8

[0237] From the data in Table 7-9, we can get:

[0238] Volatile oil extraction efficiency: The volatile oil extraction efficiency of the experimental group was 75.4%, which was higher than that of the control group 1 (62.6%) and the control group 2 (50.5%). This indicated that the wet sand fermentation and secondary decocting process of the present invention could effectively retain the heat-sensitive volatile oil components.

[0239] Extraction efficiency of flavonoids: The extraction efficiency of flavonoids in the experimental group was 68.8%, which was better than that in control group 1 (55.0%) and control group 2 (47.4%), indicating that the process of the present invention optimized the release of flavonoid components through precise temperature control and segmented extraction.

[0240] Polysaccharide extraction efficiency: The polysaccharide extraction efficiency of the experimental group was 61.2%, which showed a significant advantage over control group 1 (49.4%) and control group 2 (41.8%), verifying the important role of wet sand fermentation in improving the solubility and release efficiency of polysaccharides.

[0241] Although embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions and variations may be made to the embodiments without departing from the principles and spirit of the present invention, and that the scope of the present invention is defined by the appended claims and their equivalents.

Claims

1. A Tianzhu ointment, characterized in that: The Tianlan cream comprises the following components in parts by weight: Base oil: 40-50 parts; Heat-clearing and detoxifying herbs: 4-6 portions of magnolia bark; 3-5 portions of cnidium monnieri; 3-5 portions of phellodendron chinense; 2-4 portions of smilax glabra; 2-3 portions of arisaema; Herbs for dispelling wind and cold: 3-4 portions of Sichuan Qianghuo; 2-4 portions of Duhuo; 2-3 portions of Fangfeng; 2-3 portions of Chenpi; Blood-activating and stasis-removing herbs: 3-4 parts of safflower; 3-4 parts of Radix Angelicae Sinensis; 2-3 parts of frankincense; 2-3 parts of myrrh; Aromatic herbs for invigorating the mind: Musk: 0.2-0.5 parts; Borneol: 1-2 parts; Styrax oil: 1-2 parts; Cloves: 0.5-1 parts; Aucklandia: 0.5-1 parts; Antibacterial and insecticidal medicinal materials: realgar: 1-2 parts; sapodilla thorn: 1-2 parts; beehive: 1-2 parts; castor bean: 1-2 parts; Medicinal materials for warming the meridians and dispelling cold: Aconitum: 1-2 portions; Aconite: 1-2 portions; Ginger juice: 1-2 portions.

2. The Tianzhu ointment according to claim 1, characterized in that: The compatibility characteristics of the heat-clearing and detoxifying medicinal materials include: The main ingredients are magnolia bark, cnidium monnieri and phellodendron chinense, which provide the ointment’s heat-clearing and detoxifying properties; Smilax glabra and Arisaema confusa are auxiliary medicinal materials, used to provide the dehumidifying function and coordinating effect in the ointment.

3. The Tianzhu ointment according to claim 1, characterized in that: The compatibility characteristics of the wind-dispelling and cold-dispelling medicinal materials and the blood-activating and blood-stasis-removing medicinal materials include: Sichuan Qianghuo and Duhuo are used together as the core herbs for dispelling wind and cold, and are used to provide the paste with the properties of warming the meridians and removing dampness; Saposhnikovia divaricata and dried orange peel are used as regulating herbs to balance the rheumatism and cold-dispelling effects in ointment formulas; Safflower and Radix Angelicae Sinensis are the main blood-activating herbs, working synergistically with frankincense and myrrh to give the ointment a blood circulation function.

4. The Tianzhu ointment according to claim 1, characterized in that: The compatibility characteristics of the aromatic invigorating medicinal materials and the antibacterial and insecticidal medicinal materials include: Musk and borneol in the aromatic invigorating herbs are the core herbs, which are used to provide volatile components of the ointment, so that the ointment has the function of invigorating and penetrating; while storax oil, cloves and costusroot are auxiliary herbs, which are used to adjust the aroma components and stability of the ointment; Realgar among the antibacterial and insecticidal medicinal materials is the main medicinal material, used to provide the antibacterial component of the ointment; Gleditsia sinensis thorns and honeycomb are auxiliary medicinal materials, used to supplement the physical barrier function and structural adhesion of the ointment; Castor seeds are used to provide the oily component in ointments, improving their suppleness and spreadability.

5. A method for preparing Tianzhu Gao, characterized in that: Using the Tianlan ointment according to any one of claims 1 to 5 comprises the following steps: S1. Soaking in base oil: Add base oil into a container, add heat-clearing and detoxifying herbs according to weight percentage, soak for 48 to 72 hours, and heat in a water bath at 40 to 60°C; S2. Pretreatment of medicinal materials: wet fermentation of wind-dispelling and cold-dispelling medicinal materials for 5 to 10 days; crushing of blood-activating and blood-stasis-removing medicinal materials and meridian-warming and cold-dispelling medicinal materials into 1 to 2 mm particles; S3, preliminary decoction: mix the base oil with the coarse granular medicinal materials, control the temperature at 70-90°C, decoct for 2-3 hours, and extract the medicinal oil; S4, secondary decoction: the extracted medicinal oil is mixed with aromatic invigorating medicinal materials and antibacterial and insecticidal medicinal materials, and decocted at a temperature of 60-80°C for 6-10 hours; S5. Ointment concentration: heat the drug oil to 80-90°C and concentrate it until it forms beads when dripped; S6. Cooling and maturation: The concentrated ointment is cooled to room temperature and sealed and matured for 20 to 30 days.

6. The method for preparing Tianzhu Gao according to claim 5, characterized in that: Said S1 further comprises: Place the sealed container in water at 40-60°C and heat it intermittently, with a single heating time of 1-2 hours; After each heating cycle, let it cool for 30 to 60 minutes and stir it manually to enhance the solubility of the medicinal materials.

7. The method for preparing Tianzhu Gao according to claim 5, characterized in that: The S2 further comprises: Fermentation is sealed in wet sand, and the humidity is controlled at 30% to 50%; The fermentation environment temperature is maintained at 15-25°C; The fermentation time is 5 to 10 days, during which the medicinal materials are turned over every 2 to 3 days to maintain uniformity.

8. The method for preparing Tianzhu Gao according to claim 5, characterized in that: The S3 further comprises: Mix the base oil with the medicinal materials and fry them at a temperature of 70-90°C; Stir every 15 to 20 minutes during the frying process; The decocting time is 2 to 3 hours, until the medicinal materials become dry residue and the medicinal oil is light yellow.

9. The method for preparing Tianzhu Gao according to claim 5, characterized in that: The S5 further comprises: Heat the medicinal oil evenly at 80-90°C, stirring every 10-15 minutes; The completion of ointment concentration is determined by the cold water drop test, i.e., a drop of the ointment is dropped into cold water to form beads that do not disperse; Cooling is performed immediately after concentration is completed.

10. The method for preparing Tianzhu Gao according to claim 5, characterized in that: The S6 further comprises: The ointment is sealed in a ceramic jar and matured for 20 to 30 days in a curing environment of 15 to 25°C and a humidity of 50% to 70%. During the curing period, turn the ointment over every 5 to 7 days to ensure that it is evenly cured.

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