A bone-setting plaster and a preparation method thereof

Abstract

The application provides a bone-setting plaster and a preparation method thereof. The method comprises the following steps: grinding and sieving a plurality of medicinal materials to form a composition powder; mixing the composition powder with 95% ethanol to obtain a traditional Chinese medicine mixed solution, and performing several times of heating reflux extraction on the traditional Chinese medicine mixed solution to obtain a traditional Chinese medicine extract, and then obtaining a traditional Chinese medicine extract paste; preparing a base by using lipophilic oil, beeswax, rosin and yellow lead, adding the traditional Chinese medicine extract paste into the base at a first preset temperature to obtain an initial plaster body; preparing the initial plaster body into a stage plaster body, and uniformly coating the stage plaster body on a mounting material to obtain a final bone-setting plaster. The heating reflux extraction replaces the traditional high-temperature frying extraction, avoids the oxidation, polymerization and decomposition of oil in a high-temperature environment, and cuts off the production path of fire toxin. The beeswax and rosin partially replace the yellow lead, significantly reduces the amount of the yellow lead, reduces the heavy metal residue, reduces the possibility of fire toxin production, saves the fire toxin removal process, and improves the preparation efficiency of the bone-setting plaster.

Description

Technical Field

[0001] This invention relates to the field of biomedical technology, and in particular to a bone-setting plaster and its preparation method. Background Technology

[0002] Plasters are a type of external application of traditional Chinese medicine. They were formerly known as thin plasters. They are made by boiling sesame oil or animal oil with medicinal herbs to form a gelatinous substance, which is then applied to one side of cloth, paper, or leather. They can be applied to the affected area for a relatively long time. They follow the principles of syndrome differentiation and treatment in traditional Chinese medicine, as well as the efficacy, indications, and meridian tropism of Chinese herbs. They fully mobilize the synergistic effects of the drugs and form compound prescriptions with multiple herbs.

[0003] Bone-setting plaster, as a type of traditional Chinese medicine plaster, is suitable for the treatment of closed fractures, joint sprains, and soft tissue contusions.

[0004] Traditional bone-setting plasters require high-temperature (250°~320°) oil refining and elixir addition. During the preparation process, the oil and medicinal materials undergo complex chemical reactions at high temperatures, producing a series of irritating substances, namely, fire toxins that have side effects on the skin. Furthermore, a long time is required to remove these fire toxins, which affects the preparation efficiency of the bone-setting plaster. Summary of the Invention

[0005] In view of the shortcomings of the prior art, the purpose of this invention is to provide a bone-setting ointment and its preparation method, which aims to solve the technical problems in the prior art that the preparation of bone-setting ointment by high temperature will produce fire toxicity that has side effects on the skin, and requires a long time to remove the fire toxicity, thus affecting the preparation efficiency of bone-setting ointment.

[0006] To achieve the above objectives, in a first aspect, the present invention provides a method for preparing a bone-setting plaster, comprising the following steps: Angelica sinensis, deer antler powder, chrysanthemum, hemp seed, ground beetle, frankincense, myrrh, Panax notoginseng, Clematis chinensis, Clematis armandii, turmeric, Smilax china, Drynaria fortunei, Strychnos nux-vomica, Lindera strychnifolia, agarwood, dragon's blood, Curcuma zedoaria, and calcined natural copper are pulverized and sieved separately to form a composite powder. The powder of the composition is mixed with 95% ethanol and then soaked to obtain a traditional Chinese medicine mixture. The traditional Chinese medicine mixture is subjected to several heating and reflux extractions to obtain a traditional Chinese medicine extract. The heating and reflux extraction temperature is 76℃~80℃. The traditional Chinese medicine extract is then concentrated under reduced pressure to obtain a traditional Chinese medicine extract. Sesame oil, beeswax, rosin and litharge are prepared as a matrix. The Chinese herbal extract is added to the matrix at a first preset temperature and a first stirring treatment is performed to obtain an initial paste. The first preset temperature is 90℃~100℃. The initial paste is cooled to a second preset temperature, which is 78℃~82℃. Camphor and borneol are added to the cooled initial paste, and a second stirring process is performed to obtain a stage paste. The stage paste is then evenly spread onto the mounting material to obtain the final bone-setting plaster.

[0007] Furthermore, the weight parts of the following ingredients are as follows: Angelica sinensis (8-15 parts), deer antler powder (4-8 parts), Saussurea involucrata (3-6 parts), Hemp seed (4-8 parts), Eupolyphaga sinensis (3-7 parts), frankincense (4-8 parts), myrrh (4-8 parts), Panax notoginseng (6-12 parts), Clematis chinensis (3-6 parts), and Clematis armandii (…). The weight parts are 4 to 8 parts, the weight parts of the turmeric are 3 to 7 parts, the weight parts of the ox-smilax glabra are 4 to 8 parts, the weight parts of the drynaria fortunei are 5 to 10 parts, the weight parts of the strychnos nux-vomica are 2 to 5 parts, the weight parts of the lindera are 3 to 7 parts, the weight parts of the agarwood are 2 to 5 parts, the weight parts of the dragon's blood are 3 to 6 parts, the weight parts of the turmeric are 3 to 7 parts, and the weight parts of the calcined natural copper are 4 to 8 parts.

[0008] Furthermore, the mixing ratio of the composition powder to 95% ethanol is 1:5.

[0009] Furthermore, the soaking treatment time is 22h~25h.

[0010] Furthermore, the heating and reflux extraction is performed 2 to 4 times.

[0011] Furthermore, the step of preparing the matrix from sesame oil, beeswax, rosin, and litharge includes: The sesame oil is heated to a third preset temperature and held for a preset time, then cooled to a fourth preset temperature. Beeswax and rosin were added to cooled sesame oil and stirred to obtain a mixture. The mixture is cooled to a fifth preset temperature, and litharge is added to the mixture at the fifth preset temperature for boiling treatment to obtain a matrix.

[0012] Furthermore, the third preset temperature is 150℃~160℃, the fourth preset temperature is 118℃~122℃, and the preset time is 25min~32min.

[0013] Furthermore, the fifth preset temperature is 100℃~120℃.

[0014] Furthermore, the cooking time is 2 to 3 hours.

[0015] In a second aspect, the present invention provides a bone-setting plaster, which is prepared by the bone-setting plaster preparation method described in the first aspect above.

[0016] Compared with the prior art, the beneficial effects of the present invention are as follows: by mixing the powdered composition with 95% ethanol and then performing the heating reflux extraction at a temperature of 76℃~80℃ to obtain the herbal extract, this replaces the extraction of effective components by high-temperature frying in the traditional bone-setting plaster preparation process, avoiding the oxidation, polymerization, and decomposition of oils under high temperature conditions, and cutting off the generation pathway of irritating small molecule substances (i.e., fire toxicity); furthermore, in the preparation of the matrix, the beeswax partially replaces the thickening and hardening effect of litharge, and the rosin partially replaces the viscosity provided by litharge after forming the plaster network structure, significantly reducing the amount of litharge used, thereby reducing the heavy metal residue caused by litharge in the subsequent preparation process, and further reducing the possibility of fire toxicity generation. Based on this, the fire toxicity removal process in the traditional bone-setting plaster preparation process can be saved, and the preparation efficiency of bone-setting plaster can be improved; the rosin, the beeswax, and the litharge can form a more complex composite matrix network structure at the first preset temperature, ensuring the formation of a sufficiently stable plaster structure. Attached Figure Description

[0017] Figure 1 This is a flowchart of the preparation method of the bone-setting plaster in Example 1 of the present invention; Figure 2 This is a baseline image of Mr. Liang in the preparation method of the bone-setting plaster in Example 1 of the present invention. Figure 3 Image of Liang's treatment in the preparation method of the bone-setting plaster in Embodiment 1 of the present invention; Figure 4 This is a baseline image of Mr. Hu in the preparation method of the bone-setting plaster in Example 1 of the present invention; Figure 5 Image of Mr. Hu's treatment in the preparation method of the bone-setting plaster in Embodiment 1 of the present invention; Figure 6 This is a baseline image of Mr. Chen in the preparation method of the bone-setting plaster in Example 1 of the present invention. Figure 7 Image of Mr. Chen's treatment in the preparation method of the bone-setting plaster in Embodiment 1 of the present invention; The following detailed description, in conjunction with the accompanying drawings, will further illustrate the present invention. Detailed Implementation

[0018] To facilitate understanding of the present invention, a more complete description will be given below with reference to the accompanying drawings. Several embodiments of the invention are illustrated in the drawings. However, the invention can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided so that this disclosure will be thorough and complete.

[0019] It should be noted that when a component is said to be "fixed to" another component, it can be directly on the other component or there may be an intervening component. When a component is said to be "connected to" another component, it can be directly connected to the other component or there may be an intervening component. The terms "vertical," "horizontal," "left," "right," and similar expressions used in this document are for illustrative purposes only.

[0020] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. The terminology used herein in the description of the invention is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. The term "and / or" as used herein includes any and all combinations of one or more of the associated listed items.

[0021] Please see Figure 1 In a first aspect, Embodiment 1 of the present invention provides a method for preparing a bone-setting plaster, comprising the following steps: S10: Angelica sinensis, deer antler powder, chrysanthemum morifolium, hemp seed, ground beetle, frankincense, myrrh, Panax notoginseng, Clematis chinensis, Clematis armandii, turmeric, Smilax china, Drynaria fortunei, Strychnos nux-vomica, Lindera strychnifolia, agarwood, dragon's blood, Curcuma zedoaria and calcined natural copper are pulverized and sieved separately to form a composite powder. The formulation of the powder composition is as follows: The principal drug (chief drug) is the drug that plays the main therapeutic role in treating the fracture, and it has the strongest medicinal effect. It is the core of the prescription. In this embodiment, the principal drug consists of two groups of drugs, which target the core pathological aspects of fracture healing respectively: Blood-activating and bone-healing group: Drynaria fortunei, calcined natural copper (Pyritum), Eupolyphaga seeu Steleophaga. Analysis: Drynaria fortunei tonifies the kidneys and strengthens bones, promoting callus growth; calcined natural copper disperses blood stasis, relieves pain, and heals bones; Eupolyphaga sinensis breaks up blood stasis and promotes tendon and bone healing. These three ingredients work synergistically to directly repair bones, resolving the fundamental problem of nonunion. Blood-activating and stasis-removing group: Notoginseng Radix et Rhizoma, Angelicae Sinensis Radix, and Sanguis Draconis.

[0022] Analysis: In the early stages of a fracture, blood stasis is the main cause of pain and swelling, and a key obstacle to healing. Panax notoginseng invigorates blood, relieves pain, removes blood stasis, and stops bleeding; Angelica sinensis nourishes blood, invigorates blood circulation, and relieves pain; and Dragon's Blood disperses blood stasis, relieves pain, stops bleeding, and promotes tissue regeneration. The combination of these three herbs forms a powerful blood-activating and stasis-removing effect, creating the foundation for bone and tendon healing. Targeting the core pathogenesis of "blood stasis," the herbs are potent and therefore serve as the principal herbs.

[0023] Assistant drugs (or adjuvant drugs) are drugs that assist the principal drug in enhancing its therapeutic effect or treating important concurrent symptoms. In this embodiment, assistant drugs mainly assist the principal drug in two ways: Enhance blood circulation and relieve pain: Frankincense (Boswellia carterii Birdw), Myrrh (Commiphora myrrha), Curcuma zedoaria (Curcumae Rhizoma), Curcuma longa (Curcumae Radix); Frankincense and myrrh are a pair of herbs that promote blood circulation, reduce swelling and promote tissue regeneration. They can enhance the blood circulation, remove blood stasis, reduce swelling and relieve pain of the principal herb. Curcuma zedoaria breaks up blood stasis, promotes blood circulation, eliminates stagnation and relieves pain. Curcuma longa promotes blood circulation, relieves pain, promotes blood circulation and relieves depression. The two herbs can penetrate deep into the blood and qi, assisting the principal herb in breaking up deep stagnation and promoting the smooth flow of qi and blood.

[0024] To clear the meridians, disperse nodules, and relieve pain: Daphne giraldii Nitsche, Strychni Semen, Clematidis Radix et Rhizoma, and Phryma leptostachya. Fractures and injuries often lead to blocked meridians and prolonged pain. Ma Zi (Strychnos nux-vomica) and Gu Zi (Strychnos nux-vomica) have strong effects in clearing the meridians, dispersing nodules, reducing swelling and relieving pain. Wei Ling Xian (Clematis chinensis) and Tou Gu Cao (Clematis armandii) dispel wind and dampness and clear the meridians, assisting the principal medicine in solving the concurrent symptoms of "pain due to obstruction" and helping to relieve possible rheumatic pain.

[0025] Adjuvant drugs (for treating secondary symptoms or enhancing therapeutic effects): Millettia speciosa Champ and Cervi Cornu Degelatinata: Both tonify deficiency and strengthen tendons, warm the kidneys and assist yang. Adding tonifying ingredients to a large amount of blood-activating and stasis-removing drugs can protect the body's vital energy and prevent excessive attack; Saussurea japonica: Its effects are often related to dispelling wind and dampness and strengthening tendons and bones. It can assist Clematis chinensis and other drugs in treating concurrent rheumatic symptoms; Adjuvant drugs (to mitigate toxicity and moderate drug properties): The blood-activating and stasis-removing herbs in this formula (such as ground beetle and turmeric) and the meridian-clearing herbs (such as strychnine) have certain strong properties or slight toxicity. Frankincense and myrrh, while activating blood circulation, also have the effect of promoting tissue regeneration and protecting the stomach. The blood-tonifying and dryness-moistening properties of angelica can also partially alleviate the harshness of the blood-activating herbs. The combination of components, through the compatibility of various herbs, achieves the purpose of mutual restraint, reducing toxicity and increasing efficacy.

[0026] The primary function of the guiding medicine is to direct the medicinal power to the site of the lesion or to harmonize the effects of other medicines. Guiding herbs: Agarwood (Aquilaria sinensis) and Lindera aggregata Kosterm: Both are pungent and warm in nature, and mainly enter the spleen, stomach and kidney meridians. They can promote qi circulation, dispel cold and relieve pain. Their pungent, dispersing and warming properties can guide the power of other medicines in the prescription, especially to help the medicine penetrate deep into the muscles and bones and reach the lower abdomen. They are particularly suitable for fractures and injuries in the waist and legs, and play the role of "guiding other medicines in the prescription to the disease site". Harmonizing medicine: In this embodiment, the harmonization of medicinal properties is mainly achieved through the complex combination of cold and warm, attacking and tonifying, and moving and guarding properties among the drugs. While promoting the flow of qi, the warming and unblocking properties of agarwood and Lindera can also coordinate the qi mechanism of the whole formula, which tends to be pungent and blood-activating, to a certain extent.

[0027] Preferably, the weight parts of the following ingredients are as follows: Angelica sinensis (8-15 parts), deer antler powder (4-8 parts), Saussurea involucrata (3-6 parts), Hemp seed (4-8 parts), Eupolyphaga sinensis (3-7 parts), frankincense (4-8 parts), myrrh (4-8 parts), Panax notoginseng (6-12 parts), Clematis chinensis (3-6 parts), and Clematis armandii (4-8 parts). The weight parts are 4 to 8 parts, the weight parts of the turmeric are 3 to 7 parts, the weight parts of the ox-smilax glabra are 4 to 8 parts, the weight parts of the drynaria fortunei are 5 to 10 parts, the weight parts of the strychnos nux-vomica are 2 to 5 parts, the weight parts of the lindera are 3 to 7 parts, the weight parts of the agarwood are 2 to 5 parts, the weight parts of the dragon's blood are 3 to 6 parts, the weight parts of the turmeric are 3 to 7 parts, and the weight parts of the calcined natural copper are 4 to 8 parts. In this embodiment, the weight parts of Angelica sinensis are 12 parts, the weight parts of deer antler powder are 6 parts, the weight parts of Chrysanthemum morifolium are 5 parts, the weight parts of Ephedra sinica are 7 parts, the weight parts of Eupolyphaga sinensis are 5 parts, the weight parts of frankincense are 6 parts, the weight parts of myrrh are 6 parts, the weight parts of Panax notoginseng are 9 parts, the weight parts of Clematis chinensis are 5 parts, the weight parts of Clematis armandii are 6 parts, the weight parts of Curcuma longa are 4 parts, the weight parts of Achyranthes bidentata are 6 parts, the weight parts of Drynaria fortunei are 8 parts, the weight parts of Strychnos nux-vomica are 3 parts, the weight parts of Lindera strychnifolia are 5 parts, the weight parts of Aquilaria sinensis are 4 parts, the weight parts of Dragon's Blood are 4 parts, the weight parts of Curcuma zedoaria are 5 parts, and the weight parts of calcined natural copper are 6 parts.

[0028] S20: The powder of the composition is mixed with 95% ethanol and then soaked to obtain a traditional Chinese medicine mixture. The traditional Chinese medicine mixture is subjected to several heating and reflux extractions to obtain a traditional Chinese medicine extract. The heating and reflux extraction temperature is 76℃~80℃. The traditional Chinese medicine extract is concentrated under reduced pressure to obtain a traditional Chinese medicine extract. Preferably, the soaking time is 22-25 hours, and the number of reflux extractions is 2-4 times. In this embodiment, the soaking time is 24 hours, the number of reflux extractions is 3 times, and the mixing ratio of the powder composition to 95% ethanol is 1:5. This mixing ratio refers to the ratio between the mass of the powder composition and the volume of 95% ethanol, specifically 1 mg: 5 ml. Through the soaking treatment, 95% ethanol penetrates into the powder composition, re-wetting and swelling the dried medicinal cell tissue, filling the tissue with solvent. During subsequent reflux extraction, heat can be transferred more evenly and quickly to the medicinal tissue, allowing the active ingredients to dissolve more rapidly and thoroughly, thus improving the efficiency of the reflux extraction. It is understood that each reflux extraction yields a sub-extract. After several reflux extractions, the sub-extracts are combined to obtain the herbal extract. Preferably, the herbal extract is concentrated under reduced pressure to a relative density of 1.20-1.25 to form the herbal extract. In this embodiment, the temperature of the heating and reflux extraction is 78°C.

[0029] S30: Sesame oil, beeswax, rosin and litharge are prepared as a matrix, the Chinese herbal extract is added to the matrix at a first preset temperature, and a first stirring treatment is performed to obtain an initial paste, the first preset temperature being 90℃~100℃; Specifically, step S30 includes: S310: Heat the sesame oil to a third preset temperature and maintain it for a preset time, then cool the sesame oil to a fourth preset temperature; S320: Add beeswax and rosin to cooled sesame oil, stir and process to obtain a mixture; Preferably, the third preset temperature is 150℃~160℃, and the preset time is 25min~32min. In this embodiment, the third preset temperature is 150℃, and the preset time is 30min. By heating and maintaining the temperature of the sesame oil, the sesame oil can be deodorized, and the water in the sesame oil can be removed. This avoids unnecessary side reactions between the subsequent addition of litharge and water, which would affect the quality of the finished bone-setting ointment. Preferably, the fourth preset temperature is 118℃~122℃. In this embodiment, the fourth preset temperature is 120℃. By cooling the sesame oil to the fourth preset temperature, it is possible to avoid excessively high temperatures causing hydrolysis or oxidative rancidity of some ester bonds in the beeswax, affecting its thickening effect and matrix stability. At the same time, it is possible to avoid excessively high temperatures causing some components of the rosin to polymerize or decompose, reducing its viscosity, or even producing an irritating odor. This ensures that the beeswax and the rosin are completely and rapidly melted and evenly dispersed, maximizing the protection of their effective components and functional properties from damage by high temperatures. Preferably, the sesame oil (Oleum Sesami) is 40 to 50 parts by weight, the beeswax (Cera Flava) is 5 to 10 parts by weight, and the rosin (Colophonium) is 5 to 10 parts by weight. In this embodiment, the sesame oil is 45 parts by weight, the beeswax is 8 parts by weight, and the rosin is 8 parts by weight.

[0030] S330: Cool the mixture to a fifth preset temperature, and at the fifth preset temperature, add litharge to the mixture for boiling treatment to obtain a matrix; In this embodiment, the fifth preset temperature is 110°C, and the cooking time is 3 hours. By adding beeswax and rosin to the sesame oil, the activation energy required for the mixture to undergo a complete saponification reaction with the litharge is reduced. Therefore, at the fifth preset temperature, the litharge can still react with the mixture to form the matrix. This avoids the complex chemical reactions such as oxidation and cracking of oils at extreme high temperatures in traditional bone-setting plaster preparation processes.

[0031] After obtaining the matrix, controlling the temperature at the first preset temperature ensures that the matrix has a suitable viscosity and good fluidity. This ensures that the viscous herbal extract can be fully and evenly stirred and dispersed into the matrix, preventing the matrix from solidifying due to excessively low temperature, which would prevent effective mixing with the herbal extract, and also preventing excessively high temperature from affecting the medicinal components in the herbal extract, thus ensuring efficacy. In this embodiment, the first preset temperature is 100℃. Preferably, the weight parts of the litharge (Plumbi Oxydum Flavum) are 20 to 30 parts; in this embodiment, the weight parts of the litharge are 25 parts.

[0032] S40: Cool the initial paste to a second preset temperature, which is 78℃~82℃. Add borneol and camphor to the cooled initial paste and perform a second stirring process to obtain a stage paste. Spread the stage paste evenly on the mounting material to obtain the final bone-setting plaster. In this embodiment, the second preset temperature is 80℃. By controlling the temperature at the second preset temperature, excessively high temperatures can prevent the significant loss of borneol and camphor, both of which have low boiling and sublimation points, thus affecting the quality of the finished product. Adding borneol promotes the penetration of other active pharmaceutical ingredients into the skin, deep tissues, and blood circulation, reaching the affected area directly. Adding camphor, in addition to synergistically promoting penetration with borneol, also provides gentle stimulation to the skin, causing local capillary dilation, increasing blood flow, and facilitating drug absorption and the dissipation of local blood stasis. By combining the heating reflux extraction temperature, the first preset temperature, the second preset temperature, the third preset temperature, the fourth preset temperature, and the fifth preset temperature, the temperature during the preparation of the bone-setting plaster is controlled within a small fluctuation range, completing the overall low-temperature process chain for the bone-setting plaster. During the preparation process, the small temperature fluctuation range reduces waiting time caused by temperature changes, improving the preparation efficiency of the bone-setting plaster. Preferably, the borneol is in the form of 1 to 2 parts by weight, and the camphor is in the form of 1 to 2 parts by weight. In this embodiment, the borneol is in the form of 1 part by weight, and the camphor is in the form of 1 part by weight.

[0033] By mixing the powdered composition with 95% ethanol and then subjecting it to reflux extraction at 76°C to 80°C, the herbal extract is obtained. This replaces the traditional bone-setting plaster preparation process that extracts active ingredients through high-temperature frying, avoiding the oxidation, polymerization, and decomposition of oils under high-temperature conditions, thus cutting off the pathway for the generation of irritating small molecules (i.e., fire toxicity). Furthermore, in the preparation of the matrix, beeswax partially replaces the thickening and hardening effect of litharge, and rosin partially replaces the viscosity provided by litharge after forming the plaster network structure, significantly reducing the amount of litharge used. This reduces the heavy metal residue caused by litharge in subsequent preparation processes, further reducing the possibility of fire toxicity generation. Based on this, the fire toxicity removal process in the traditional bone-setting plaster preparation process can be saved, improving the preparation efficiency of the bone-setting plaster. At the first preset temperature, the rosin, beeswax, and litharge can form a more complex composite matrix network structure, ensuring the formation of a sufficiently stable plaster structure.

[0034] Please see Figures 2 to 7 The bone-setting plaster was prepared based on the preparation method of the plaster described in Example 1 of this application, and a clinical trial was conducted. The healing time results obtained through imaging treatment are shown in Table 1. Table 1 , Conservative treatment is a non-surgical intervention for fractures in trauma orthopedic patients. It primarily maintains relative stability at the fracture site through non-surgical methods (such as immobilization and manual reduction), avoiding or delaying open reduction and internal fixation. Its core principle is to promote callus formation and fracture repair through natural healing processes, rather than relying on surgical instruments (such as external fixators, intramedullary nails, and plates) for direct fixation of the fracture ends. The study "The Influence of Conservative Treatment, External Fixation, and Internal Fixation on Callus Formation Time, Fracture Healing Time, and Pain Incidence in Traumatic Orthopedic Patients" verified that conservative treatment resulted in a fracture healing time of 102 days (14 weeks). Compared to conservative treatment, the bone-healing plaster prepared using the method described in this embodiment can shorten the fracture healing time (approximately 6 weeks) and exhibits good therapeutic effects.

[0035] Example 2 of this invention provides a method for preparing a bone-setting plaster, which differs from the method for preparing the bone-setting plaster described in Example 1 in that... The temperature for the heating and reflux extraction was 76°C.

[0036] Example 3 of this invention provides a method for preparing a bone-setting plaster, which differs from the method for preparing the bone-setting plaster described in Example 1 in that... The temperature for the heating and reflux extraction is 80°C.

[0037] Example 4 of this invention provides a method for preparing a bone-setting plaster, which differs from the method for preparing the bone-setting plaster described in Example 1 in that... The fifth preset temperature is 100℃.

[0038] Example 5 of this invention provides a method for preparing a bone-setting plaster, which differs from the method for preparing the bone-setting plaster described in Example 1 in that... The fifth preset temperature is 120℃.

[0039] Comparative Example 1 of this invention provides a method for preparing a bone-setting plaster, which differs from the method for preparing the bone-setting plaster described in Example 1 in that... The temperature for the heating and reflux extraction is 120°C.

[0040] Comparative Example 2 of this invention provides a method for preparing a bone-setting plaster, which differs from the method for preparing the bone-setting plaster described in Example 1 in that... The fifth preset temperature is 150℃.

[0041] Comparative Example 3 of this invention provides a method for preparing a bone-setting plaster, which differs from the method for preparing the bone-setting plaster described in Example 1 in that... After obtaining the herbal extract, sesame oil and litharge were used to prepare a matrix. Specifically, in this comparative example, beeswax and rosin were not used in the preparation of the matrix. Understandably, in this comparative example, the litharge was 41 parts by weight.

[0042] Comparative Example 4 of this invention provides a method for preparing a bone-setting plaster, which differs from the method for preparing the bone-setting plaster described in Example 1 in that... After obtaining the composition powder, the composition powder is soaked in sesame oil and heated to a first temperature, the first temperature being greater than 200°C, to obtain the medicinal oil; The medicinal oil is heated to a second temperature, which is 320°C to 360°C, so that the medicinal oil is transformed into a purified oil. Litharge was added to the purified oil to obtain a bone-setting ointment. In this comparative example, the bone-setting ointment was prepared using the traditional high-temperature oil refining and litharge method. It should be noted that in the traditional preparation process, the bone-setting ointment is subsequently cooled and soaked in cold water to remove any remaining toxicity before being applied to mounting material.

[0043] Bone-setting ointments were prepared based on the preparation methods described in Examples 1-5 and Comparative Examples 1-4 of this invention, and the prepared bone-setting ointments were subjected to index testing. Specifically, the acid value was determined by acid-base titration (according to Method 1 (Acid Value Determination) in General Chapter 0713 of Part IV of the 2020 Pharmacopoeia of the People's Republic of China, "Determination of Fat and Fatty Oils"); the peroxide value was determined by redox titration (according to Method 2 (Peroxide Value Determination) in General Chapter 0713 of Part IV of the 2020 Pharmacopoeia of the People's Republic of China, "Determination of Fat and Fatty Oils"); in animal experiments, the erythema and edema reactions on the animal skin after the sample was applied were scored to obtain the primary skin irritation index (according to Method 8609 of General Chapter IV of the 2020 Pharmacopoeia of the People's Republic of China, "Skin Irritation Test Method for Exogenous Toxicity of Traditional Chinese Medicine"); and heavy metal residues were detected by atomic spectroscopy (according to Method 0406 of General Chapter IV of the 2020 Pharmacopoeia of the People's Republic of China, "Determination of Metal Impurities"). The test results are shown in Table 2 below: Table 2 , Acid value and peroxide value directly reflect the degree of oxidative putrefaction of bone-setting plaster and are key indicators of the generation of fire toxicity. The primary skin irritation index assesses the irritant effect of fire toxicity. As shown in the table above, compared with Comparative Example 4, i.e., compared with the traditional bone-setting plaster preparation method, the bone-setting plaster preparation method in this application embodiment can significantly inhibit the generation of fire toxicity, save the fire toxicity removal process, and improve production efficiency. Compared with Comparative Examples 1 and 2, the temperature control in the preparation process in this application can further inhibit the generation of fire toxicity and maintain the bone-setting plaster at a better viscosity. Compared with Comparative Example 3, the introduction of rosin and beeswax in this application embodiment can significantly reduce the amount of litharge while maintaining a low-temperature preparation process and appropriate viscosity, thereby reducing the heavy metal residue in the bone-setting plaster and synergistically inhibiting the generation of fire toxicity.

[0044] Secondly, Embodiment 6 of the present invention provides a bone-setting plaster, which is prepared by the bone-setting plaster preparation method described in the above embodiments.

[0045] In the description of this specification, references to terms such as "one embodiment," "some embodiments," "example," "specific example," or "some examples," etc., indicate that a specific feature, structure, material, or characteristic described in connection with that embodiment or example is included in at least one embodiment or example of the invention. In this specification, the illustrative expressions of the above terms do not necessarily refer to the same embodiment or example. Furthermore, the specific features, structures, materials, or characteristics described may be combined in any suitable manner in one or more embodiments or examples.

[0046] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are specific and detailed, they should not be construed as limiting the scope of the present invention. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these modifications and improvements all fall within the scope of protection of the present invention. Therefore, the scope of protection of this patent should be determined by the appended claims.

Claims

1. A method for preparing a bone-setting plaster, characterized in that, Includes the following steps: Angelica sinensis, deer antler powder, chrysanthemum, hemp seed, ground beetle, frankincense, myrrh, Panax notoginseng, Clematis chinensis, Clematis armandii, turmeric, Smilax china, Drynaria fortunei, Strychnos nux-vomica, Lindera strychnifolia, agarwood, dragon's blood, Curcuma zedoaria, and calcined natural copper are pulverized and sieved separately to form a composite powder. The powder of the composition is mixed with 95% ethanol and then soaked to obtain a traditional Chinese medicine mixture. The traditional Chinese medicine mixture is subjected to several heating and reflux extractions to obtain a traditional Chinese medicine extract. The heating and reflux extraction temperature is 76℃~80℃. The traditional Chinese medicine extract is then concentrated under reduced pressure to obtain a traditional Chinese medicine extract. Sesame oil, beeswax, rosin and litharge are prepared as a matrix. The Chinese herbal extract is added to the matrix at a first preset temperature and a first stirring treatment is performed to obtain an initial paste. The first preset temperature is 90℃~100℃. The step of preparing the matrix from sesame oil, beeswax, rosin, and litharge includes: The sesame oil is heated to a third preset temperature and held for a preset time, then cooled to a fourth preset temperature. The third preset temperature is 150℃~160℃, the fourth preset temperature is 118℃~122℃, and the preset time is 25min~32min. Beeswax and rosin were added to cooled sesame oil and stirred to obtain a mixture. The mixture is cooled to a fifth preset temperature, which is 100℃~120℃. At the fifth preset temperature, litharge is added to the mixture for boiling treatment to obtain a matrix. The initial paste is cooled to a second preset temperature, which is 78℃~82℃. Camphor and borneol are added to the cooled initial paste, and a second stirring process is performed to obtain a stage paste. The stage paste is then evenly spread onto the mounting material to obtain the final bone-setting plaster.

2. The method for preparing the bone-setting plaster according to claim 1, characterized in that, The weight parts of the following herbs are as follows: Angelica sinensis (8-15 parts), deer antler powder (4-8 parts), Chrysanthemum morifolium (3-6 parts), Ephedra sinica (4-8 parts), Eupolyphaga sinensis (3-7 parts), frankincense (4-8 parts), myrrh (4-8 parts), Panax notoginseng (6-12 parts), Clematis chinensis (3-6 parts), and Clematis armandii (6-15 parts). The weight percentages are as follows: 4-8 parts of turmeric, 3-7 parts of *Smilax glabra*, 4-8 parts of *Drynaria fortunei*, 5-10 parts of *Drynaria fortunei*, 2-5 parts of *Strychnos nux-vomica*, 3-7 parts of *Lindera strychnifolia*, 2-5 parts of *Aquilaria sinensis*, 3-6 parts of *Dracaena cochinchinensis*, 3-7 parts of *Curcuma zedoaria*, and 4-8 parts of calcined natural copper.

3. The method for preparing the bone-setting plaster according to claim 1, characterized in that, The powdered composition is mixed with 95% ethanol at a ratio of 1:

5.

4. The method for preparing the bone-setting plaster according to claim 1, characterized in that, The soaking treatment time is 22h~25h.

5. The method for preparing the bone-setting plaster according to claim 1, characterized in that, The heating and reflux extraction is performed 2 to 4 times.

6. The method for preparing the bone-setting plaster according to claim 1, characterized in that, The cooking time is 2 to 3 hours.

7. A bone-setting plaster, characterized in that, The bone-setting plaster is prepared by the bone-setting plaster preparation method according to any one of claims 1 to 6.

Images