Process for the preparation of a wound healing agent

Abstract

The application discloses a preparation method of traumatic drugs, which comprises the following steps: preparing a lithospermum root extract; water-extracting medicine materials of a, biliardae and gardenia to obtain a a-material extract; water-extracting medicine materials of b, radix scutellariae to obtain a b-material extract; water-extracting medicine materials of c, cortex phellodendri to obtain a c-material extract; pretreating the lithospermum root extract to obtain an emulsified phase containing a lithospermum root fat-soluble filtrate and a lithospermum root water-soluble filtrate; diluting and filtering the a-material extract, the b-material extract and the c-material extract after heating, stirring and homogenizing the filtrate of the a-material extract in the emulsified phase, stirring and homogenizing the filtrate of the b-material extract and the filtrate of the c-material extract, and stirring and homogenizing after cooling to obtain the traumatic drugs. The precipitate generated can be reduced by extracting the radix scutellariae and the cortex phellodendri respectively. The black spots can be removed by pretreating the lithospermum root extract through the heating and filtering steps. The traumatic drugs prepared can still remain stable after being placed for a long time by adding new auxiliary materials, i.e., sodium dodecyl sulfate and polyethylene glycol, in the water phase matrix.

Description

[0001] The present disclosure claims priority to the Chinese patent application No. 202211742991.1, filed on December 30, 2022, and entitled "Preparation method of external injury medicine", the entire content of which is incorporated herein by reference. TECHNICAL FIELD

[0002] The present application relates to the technical field of external injury medicine, in particular to a preparation method of external injury medicine. BACKGROUND

[0003] External injury Ruyi ointment is made of seven medicines including gardenia, rhubarb, lithospermum, willow, scutellaria, cortex phellodendri and borneol, and has the effects of clearing heat and resolving toxins, cooling blood and removing blood stasis, reducing swelling and pain, and stopping bleeding and promoting tissue regeneration, and is widely used in the market.

[0004] At present, the preparation method of external injury Ruyi ointment is as follows: lithospermum is soaked in ethanol as a solvent for 48 hours, then percolation is performed, the percolate is collected, ethanol is recovered under reduced pressure, and the extract is concentrated to have a relative density of 1.20-1.30 (60℃); rhubarb, willow and gardenia are decocted twice, the first time for 2 hours and the second time for 1.5 hours, the decoctions are combined, filtered, the filtrate is concentrated to have a relative density of 1.10-1.20 (80℃), cooled, 3 times the amount of ethanol is added, stirred, and left for 48 hours, filtered, ethanol is recovered, and the extract is concentrated to have a relative density of about 1.25 (80℃); scutellaria and cortex phellodendri are separately prepared into extracts having a relative density of about 1.25 (80℃), and the two extracts are combined for use; borneol is dissolved in an appropriate amount of liquid paraffin. An appropriate amount of glyceryl monostearate, triethanolamine, polysorbate 80, liquid paraffin, octadecanol, lanolin, stearic acid, propylene glycol, hydroxyphenyl ester and potassium sorbate are used to prepare a base, the above extracts and borneol solution are added to the base, mixed, and 1000 g of the mixture is obtained and packed, thereby obtaining the external injury Ruyi ointment.

[0005] In the above preparation steps, scutellaria and cortex phellodendri are usually used together, but a large amount of precipitate is produced in the decoction, which is mainly composed of alkaloids and flavonoids, because the original berberine type alkaloids in cortex phellodendri combine with the acidic compounds such as baicalin in scutellaria to form water-insoluble substances with relatively large molecular weight, and finally produce precipitate; and the lithospermum extract obtained by the above steps has "black spots", and the prepared external injury Ruyi ointment is not stable after long-term storage, which affects the product quality. SUMMARY

[0006] The main purpose of the present application is to provide a preparation method of external injury medicine, which aims to solve the technical problems that the existing external injury Ruyi ointment is easy to produce a large amount of precipitate when scutellaria and cortex phellodendri are extracted at the same time, and is easy to produce "black spots" when lithospermum extract is prepared, and the prepared external injury Ruyi ointment is not stable after long-term storage.

[0007] To achieve the above objectives, this application proposes a method for preparing a trauma medication, comprising the following steps:

[0008] S1. Preparation of Lithospermum erythrorhizon extract;

[0009] S2. A water-extracted extract of medicinal materials is prepared from the medicinal materials of Sanguisorba officinalis, Rheum palmatum, and Gardenia jasminoides.

[0010] S3. Extracting the second-grade medicinal material with water to obtain the second-grade extract, wherein the second-grade medicinal material is Scutellaria baicalensis;

[0011] S4. A resin extract is prepared by water extraction of the resinous medicinal material, wherein the resinous medicinal material is Phellodendron bark.

[0012] S5. The extract of Lithospermum erythrorhizon is pretreated to obtain an emulsion containing both fat-soluble and water-soluble filtrates of Lithospermum erythrorhizon;

[0013] S6. The extracts A, B, and C are heated separately, diluted with purified water, and filtered. The filtrate of extract A is first added to the emulsion containing the lipid-soluble filtrate and water-soluble filtrate of Lithospermum erythrorhizon, and stirred and homogenized. Then, the filtrates of extracts B and C are added, stirred, and homogenized. After cooling, the mixture is stirred and homogenized to obtain the external injury drug.

[0014] In existing preparations of external wound ointments, Scutellaria baicalensis and Phellodendron amurense are often used together, which leads to the formation of a significant amount of precipitation in the decoction. This precipitation mainly consists of alkaloids and flavonoids. The reason is that the protoperberine-type alkaloids in Phellodendron amurense combine with acidic compounds such as baicalin in Scutellaria baicalensis, forming water-insoluble substances with relatively large molecular weights that ultimately precipitate out. Therefore, in this method, Scutellaria baicalensis and Phellodendron amurense are extracted separately to prepare extract B (Scutellaria baicalensis extract) and extract C (Phellodendron amurense extract), resulting in less precipitation, or even no precipitation at all.

[0015] The above preparation steps do not necessarily have to be performed in the order of S1-S2-S3-S4. The order can be changed at will, depending on the actual needs.

[0016] Preferably, step S5 includes the following steps: S51. Add 4.56-5.04 kg of propylene glycol to 1-2 kg of heated Lithospermum erythrorhizon extract, heat at normal pressure for 1.75-2.25 h, stir and filter to obtain water-soluble Lithospermum erythrorhizon filtrate, add 4.56-5.04 kg of liquid paraffin to the filtered residue, stir and filter to obtain fat-soluble Lithospermum erythrorhizon filtrate;

[0017] S52. Add 11.40-12.60 kg of glyceryl monostearate, 8.36-9.24 kg of stearic acid, 1.14-1.26 kg of lanolin, 4.56-5.04 kg of stearyl alcohol, 4.94-5.46 kg of liquid paraffin, and 0.011-0.013 kg of ethylparaben to an oil phase pot, heat and stir until completely melted, then add 4.3-4.7 kg of the lipid-soluble filtrate of the comfrey root and 0.57-0.63 kg of borneol, and stir evenly at a constant temperature to obtain the oil phase matrix;

[0018] S53. Add 2.28-2.52 kg of sodium dodecyl sulfate, 0.340-0.380 kg of polyethylene glycol, 0.340-0.380 kg of polysorbate-80, 0.340-0.380 kg of potassium sorbate, and 57.00-63.00 kg of purified water to an aqueous phase pot, heat and stir, then add 4.0-4.4 kg of the water-soluble filtrate of Lithospermum erythrorhizon and stir evenly. After filtration, collect the filtrate, put the filtrate back into the aqueous phase pot and heat to obtain an aqueous phase matrix;

[0019] S54. The oil phase matrix and the aqueous phase matrix (weight ratio: 1:1.8-2) are mixed, stirred and homogenized to obtain the emulsion phase containing the lipid-soluble filtrate of Lithospermum erythrorhizon and the water-soluble filtrate of Lithospermum erythrorhizon.

[0020] In step S51, the pretreatment of the comfrey extract involves adding propylene glycol, followed by heating and filtration to remove black spots, resulting in a finished product that meets quality standards and ranges from "greenish-yellow to brownish-yellow". Without this process, the resulting ointment will contain some black spots, and the finished product may have a purplish-red hue.

[0021] Furthermore, in preparing the emulsion phases containing the lipid-soluble and water-soluble filtrates of Lithospermum erythrorhizon, an oil-phase matrix and an aqueous-phase matrix are first prepared separately. The aqueous-phase matrix is ​​supplemented with excipients sodium dodecyl sulfate and polyethylene glycol. The Lithospermum erythrorhizon extract is obtained by percolating with ethanol and recovering the ethanol. The resulting external wound ointment matrix is ​​an oil-in-water type, prepared by mixing the aqueous and oil-phase matrices. The Lithospermum erythrorhizon extract is first prepared into water-soluble and lipid-soluble filtrates, which are then mixed with the aqueous and oil-phase matrices respectively. Based on the principle of "like dissolves like," this method yields a product with better stability, forming a more stable oil-in-water emulsion system. This ensures the external wound ointment remains stable even after long-term storage, without hydration. The matrix is ​​supplemented with sodium dodecyl sulfate and polyethylene glycol. Sodium dodecyl sulfate is an anionic surfactant, and polyethylene glycol has good water solubility and good compatibility with many organic components, resulting in a product with good stability.

[0022] Preferably, in step S51, propylene glycol is added to the comfrey extract heated to 50-70°C, and then heated to 80-100°C under normal pressure; after stirring, the mixture is filtered through a 400-mesh sieve for 4-6 minutes. Using these parameters results in better pretreatment and minimizes the appearance of black spots.

[0023] Preferably, in step S52, the mixture is heated to 78-82°C and stirred until completely melted, and the temperature is maintained at 78-82°C while stirring evenly under constant temperature; in step S53, the mixture is heated to 80-100°C, filtered, and the filtrate is collected and filtered through a mesh of 200-400.

[0024] Preferably, in step S54, the oil phase matrix and the aqueous phase matrix are mixed at a temperature of 78-82℃ and a vacuum degree ≤ -0.05 MPa. During stirring and homogenization, the stirring speed is 43-47 rpm, and homogenization is performed twice, each time for 8-12 minutes. The oil matrix and the aqueous matrix are mixed under heating conditions at a temperature of 80℃. Furthermore, the vacuum degree needs to be controlled below -0.05 MPa to obtain a high-quality emulsion phase containing both the lipid-soluble and water-soluble filtrates of *Lithospermum erythrorhizon*.

[0025] Preferably, step S1 includes the following steps: placing 72.00 kg of cleaned Lithospermum erythrorhizon in a percolation container, adding 350.00-370.00 kg of 95% ethanol, soaking for 48 hours, percolating until the Lithospermum erythrorhizon in the percolation container is exposed above the liquid surface, then adding 140.00-148.00 kg of 95% ethanol to continue percolation, collecting all the percolate, and then vacuum concentrating it at 0.05-0.07 MPa and 58-62°C to obtain the Lithospermum erythrorhizon extract with a relative density of 1.20-1.30.

[0026] Preferably, step S2 includes the following steps: S21. Place 72.00 kg of cleaned Sanguisorba officinalis, 72.00 kg of cleaned Rheum palmatum and 72.00 kg of cleaned Gardenia jasminoides in an extraction container, add 1500-1900 kg of hot drinking water, heat to 96-100℃ and extract for 2 hours, add 1100-1500 kg of hot drinking water a second time, extract for 1.5 hours, combine the two extracts and filter;

[0027] S22. The filtered extract is concentrated under vacuum to obtain a water-extracted extract of acetic acid with a relative density of 1.10 to 1.20;

[0028] S23. Place the water-extracted methyl ester extract in an alcohol precipitation container, add 3 times the weight of the water-extracted methyl ester extract with a concentration of 95% ethanol, stir evenly, let stand for 48 hours, take the supernatant and sieve it, recover the ethanol until there is no alcohol odor, and continue to concentrate until the methyl ester extract with a relative density of 1.25 is obtained.

[0029] Preferably, step S3 includes the following steps: S31. Place 72.00 kg of cleaned Scutellaria baicalensis in an extraction container, add 560-600 kg of hot drinking water, heat to 96-100℃ and extract for 2 hours, add 410-450 kg of hot drinking water a second time, extract for 1.5 hours, combine the two extracts and filter.

[0030] S32. The filtered extract is concentrated under vacuum to obtain a water extract B with a relative density of 1.10 to 1.20;

[0031] S33. Place the water-extracted B material extract into an alcohol precipitation container, add 3 times the weight of the water-extracted B material extract with a concentration of 95% ethanol, stir evenly, let stand for 48 hours, take the supernatant and sieve it, recover the ethanol until there is no alcohol odor, and continue to concentrate until the B material extract with a relative density of 1.25 is obtained.

[0032] Preferably, step S4 includes the following steps: S41. Place 72.00 kg of clean Phellodendron bark in an extraction container, add 560-600 kg of hot drinking water, heat to 96-100℃ and extract for 2 hours, add 410-450 kg of hot drinking water a second time, extract for 1.5 hours, combine the two extracts and filter.

[0033] S42. The filtered extract is concentrated under vacuum to obtain a water-extracted acrylic extract with a relative density of 1.10 to 1.20;

[0034] S43. Place the water-extracted acrylic extract into an alcohol precipitation container, add 3 times the weight of the water-extracted acrylic extract with 95% ethanol, stir evenly, let stand for 48 hours, take the supernatant and sieve it, recover the ethanol until there is no alcohol odor, and continue to concentrate until the acrylic extract with a relative density of 1.25 is obtained.

[0035] Preferably, in step S6, the extract A, extract B, and extract C are heated to 78-82°C in a weight ratio of 1:(0.6-0.8):(0.4-0.6), diluted with 9.50-10.50 kg of heated purified water, and filtered through a 200-mesh filter. The homogenization time during stirring and homogenization is 8-12 min, and the stirring speed is 43-47 rpm. The stirring and homogenization after cooling specifically includes the following steps: when the temperature drops to 68-72°C, homogenize for 8-12 min; continue stirring until the temperature drops to 36-40°C, homogenize for 8-12 min, and obtain the external injury drug. First, add the heated and diluted extract A to the emulsion phase containing the lipid-soluble filtrate and water-soluble filtrate of Lithospermum erythrorhizon, then add extracts B and C. During the stirring and homogenization process, the temperature of the mixture will continuously decrease. Finally, when it decreases to 36-40℃, homogenize for 8-12 minutes to obtain the external injury drug.

[0036] The method for preparing the trauma medication in this application has the following beneficial effects:

[0037] 1. In this method, Scutellaria baicalensis and Phellodendron chinense are extracted separately to prepare extract B (Scutellaria baicalensis extract) and extract C (Phellodendron chinense extract), which can reduce the precipitation.

[0038] 2. In the preparation of the emulsion phase containing the fat-soluble and water-soluble filtrates of Lithospermum erythrorhizon, the Lithospermum erythrorhizon extract is pretreated by heating and filtration to remove black spots, resulting in a finished product that meets quality standards and is "greenish-yellow to brownish-yellow". Furthermore, in preparing the emulsion phase containing the fat-soluble and water-soluble filtrates of Lithospermum erythrorhizon, an oil phase matrix and an aqueous phase matrix are prepared separately. By adding excipients sodium dodecyl sulfate and polyethylene glycol to the aqueous phase matrix, a more stable oil-in-water emulsion system can be formed, ensuring that the prepared external wound medicine remains stable even after long-term storage without hydration. Detailed Implementation

[0039] To make the objectives, technical solutions, and advantages of the embodiments of this application clearer, the technical solutions in the embodiments of this application will be clearly and completely described below. Where specific conditions are not specified in the embodiments, conventional conditions or conditions recommended by the manufacturer shall apply. Reagents or instruments whose manufacturers are not specified are all conventional products that can be purchased commercially.

[0040] This application proposes a method for preparing an external injury drug, comprising the following steps:

[0041] S1. Preparation of Lithospermum extract: 72.00 kg of cleaned Lithospermum is evenly packed into a percolation tank, ensuring uniform density. When adding 350.00-370.00 kg of 95% ethanol, air between the herbs should be removed as much as possible. The 95% ethanol should be 2-3 cm above the surface of the herbs. Soak for 48 hours, then slowly percolate (percolation speed of 100 ml / min) until the Lithospermum in the percolation tank is exposed above the liquid surface. Then, add 140.00-148.00 kg of 95% ethanol and continue percolating. After collecting all the percolate, send it to a concentration tank to recover the ethanol. Place the percolate in a vacuum concentration pot, turn on the steam, and recover the ethanol until there is no alcohol odor. Continue to concentrate until the relative density is 1.20-1.30, i.e., 24-33 Baume degrees (60℃), which is the Lithospermum extract.

[0042] S2. Place the water-extracted medicinal materials (72.00 kg of cleaned Sanguisorba officinalis, 72.00 kg of cleaned Rheum palmatum, and 72.00 kg of cleaned Gardenia jasminoides) into a multi-functional extraction tank, add 1500-1900 kg of hot drinking water, heat to 100℃, and extract for 2 hours; add 1100-1500 kg of hot drinking water a second time, and extract for 1.5 hours; combine the two extracts, filter, and send the filtrate to a storage tank. During the above extraction process, the temperature inside the extraction tank should be maintained at 96-100℃. Then, in a vacuum concentrator, concentrate the (material A) filtrate under reduced pressure to a water-extracted medicinal material extract with a relative density of 1.10-1.20, i.e., 13.5-24 Baume degrees (80℃). Place the water-extracted nail extract into an alcohol precipitation tank, add 95% ethanol at a concentration of 3 times the volume of the extract, and stir while adding ethanol until the mixture is homogeneous. Let it stand for 48 hours. After sieving the supernatant, recover the ethanol until there is no alcohol odor, and continue to concentrate it to a relative density of about 1.25, that is, a Baume degree of 29 (80℃) for the nail extract.

[0043] S3. Place the water-extractable herb (72.00 kg of cleaned Scutellaria baicalensis) into a multi-functional extraction tank, add 560-600 kg of hot drinking water, heat to 96-100℃, and extract for 2 hours; add 410-450 kg of hot drinking water a second time, and extract for 1.5 hours; combine the two extracts, filter, and transfer the filtrate to a storage tank. During the above extraction process, the temperature inside the extraction tank should be maintained at 96-100℃. Then, concentrate the (batch B) filtrate in a vacuum concentrator to a water-extractable extract with a relative density of 1.10-1.20, i.e., 13.5-24 Baume degrees (80℃). Place the water-extractable extract into an alcohol precipitation tank, add 95% ethanol at three times the volume of the extract, stirring continuously until homogeneous, and let stand for 48 hours. After sieving the supernatant, the ethanol was recovered until there was no alcohol odor, and the mixture was further concentrated to a relative density of 1.25, or 29 Baumé (80°C), which is the extract of material B.

[0044] S4. Place the water-extracted phellodendron bark (72.00 kg) into a multi-functional extraction tank, add 560-600 kg of hot drinking water, heat to 100℃, and extract for 2 hours; add 410-450 kg of hot drinking water a second time, and extract for 1.5 hours; combine the two extracts, filter, and transfer the filtrate to a storage tank. The temperature inside the extraction tank should be maintained at 96-100℃ during the above extraction process. Then, concentrate the (phellodendron bark) filtrate in a vacuum concentrator to a water-extracted phellodendron bark extract with a relative density of 1.10-1.20, i.e., 13.5-24 Baume degrees (80℃). Place the water-extracted phellodendron bark extract into an alcohol precipitation tank, add 95% ethanol at 3 times the volume of the extract, stirring while adding ethanol until the mixture is homogeneous, let stand for 48 hours, take the supernatant, sieve it, recover the ethanol until there is no alcohol odor, and continue to concentrate to a phellodendron bark extract with a relative density of approximately 1.25, i.e., 29 Baume degrees (80℃).

[0045] S51. Heat the extract of Lithospermum erythrorhizon to 50-70℃ to evaporate the ethanol. Add 4.56-5.04 kg of propylene glycol and heat at 80-100℃ under normal pressure for 1.75-2.25 h. Stir for more than 5 minutes and filter through 400 mesh to obtain the water-soluble filtrate of Lithospermum erythrorhizon. Add 4.56-5.04 kg of liquid paraffin to the remaining filter residue, stir for more than 5 minutes, and filter through 400 mesh. Avoid pouring the residual liquid and filter residue from the bottom of the pot into the filter during filtration to obtain the fat-soluble filtrate of Lithospermum erythrorhizon.

[0046] S52. Take 11.40-12.60 kg of glyceryl monostearate, 8.36-9.24 kg of stearic acid, 1.14-1.26 kg of lanolin, 4.56-5.04 kg of stearyl alcohol, 4.94-5.46 kg of liquid paraffin, and 0.011-0.013 kg of ethylparaben and add them to the oil phase pot. Set the heating temperature to 80℃ and heat and stir until completely melted. Maintain the temperature at 100℃. Add 4.3-4.7 kg of limonene fat-soluble filtrate and 0.57-0.63 kg of borneol and stir evenly. Transfer the mixture to an emulsification tank and maintain the temperature at 80℃.

[0047] S53. Take 2.28-2.52 kg of sodium dodecyl sulfate (new excipient), 0.340-0.380 kg of polyethylene glycol (new excipient), 0.340-0.380 kg of polysorbate-80, 0.340-0.380 kg of potassium sorbate, and 57.00-63.00 kg of purified water and add them to the aqueous phase pot. Mix well. Set the heating temperature to 100℃. When the temperature reaches 80℃, start stirring. When foaming occurs, add purified water in small amounts several times (the total amount of purified water added here is 20.00 kg). Stop stirring or heating if foaming occurs too quickly. Finally, add the water-soluble filtrate of Lithospermum erythrorhizon to defoam and stir well. After stopping stirring and heating, filter the aqueous phase through 200 mesh and 400 mesh successively and collect the filtrate. Put the filtered aqueous phase back into the aqueous phase pot and heat to 80℃ without stirring during heating. After reaching 100℃, transfer it to the emulsification tank.

[0048] S54. Maintain the temperature at 78-82℃, evacuate to ≤-0.05Mpa, mix the oil phase matrix and the water phase matrix, stir and homogenize, stirring at a speed of 43-47rpm, homogenize at least twice, each time for 8-12min.

[0049] S6. The extracts A, B, and C are diluted with 9.50-10.50 kg of heated purified water, and then filtered through a 200-mesh filter. Next, the filtrate of extract A is first drawn into an emulsifying tank, homogenized while stirring, for 8-12 minutes. After homogenization, the filtrates of extracts B and C are drawn into the emulsifying tank in the same manner, homogenized while stirring, for 8-12 minutes. Stirring continues until the temperature drops to 68-72℃, then homogenization continues for 8-12 minutes. Stirring continues until the temperature slowly decreases to 36-40℃, then homogenization continues for 8-12 minutes before discharge to obtain the external wound medicine. The stirring speed is 43-47 rpm.

[0050] The technical solution of the present invention will be further described in detail below with reference to specific embodiments. It should be understood that the following embodiments are only used to explain the present invention and are not intended to limit the present invention.

[0051] Example 1

[0052] A method for preparing an external injury medication includes the following steps:

[0053] S1. Preparation of Lithospermum extract: 7.20 kg of cleaned Lithospermum is evenly packed into a percolation tank, ensuring uniform density. When adding 36.00 kg of 95% ethanol, air between the herbs should be removed as much as possible. The 95% ethanol should be 2 cm above the surface of the herbs. Soak for 48 hours, then slowly percolate (percolation rate of 10 ml / min) until the Lithospermum in the percolation tank is exposed above the liquid surface. Then, add 14.40 kg of 95% ethanol and continue percolating. After collecting all the percolate, send it to a concentration tank to recover the ethanol. Place the percolate in a vacuum concentration pot, turn on the steam, and recover the ethanol until there is no alcohol odor. Continue to concentrate until the relative density is 1.20, i.e., 24 Baume degrees (60℃), which is the Lithospermum extract.

[0054] S2. Place the water-extracted medicinal materials (7.20 kg of cleaned Sanguisorba officinalis, 7.20 kg of cleaned Rheum palmatum, and 7.20 kg of cleaned Gardenia jasminoides) into a multi-functional extraction tank, add 170 kg of hot drinking water, heat to 100°C, and extract for 2 hours; add 130 kg of hot drinking water a second time and extract for 1.5 hours; combine the two extracts, filter, and send the filtrate to a storage tank. The temperature inside the extraction tank should be maintained at 98°C during the above extraction process. Then, concentrate the (material A) filtrate under reduced pressure in a vacuum concentrator to a water-extracted medicinal material extract with a relative density of 1.10, i.e., 13.5 Baume degrees (80°C). Place the water-extracted medicinal material extract into an alcohol precipitation tank, add 95% ethanol at 3 times the volume of the extract, stirring while adding ethanol until the mixture is homogeneous, and let it stand for 48 hours; after sieving the supernatant, recover the ethanol until there is no alcohol odor, and continue to concentrate to a medicinal material extract with a relative density of approximately 1.25, i.e., 29 Baume degrees (80°C).

[0055] S3. Place the water-extracted herb (7.20 kg of cleaned Scutellaria baicalensis) into a multi-functional extraction tank, add 58 kg of hot drinking water, heat to 100°C, and extract for 2 hours; add 43 kg of hot drinking water a second time, and extract for 1.5 hours; combine the two extracts, filter, and transfer the filtrate to a storage tank. The temperature inside the extraction tank should be maintained at 98°C throughout the extraction process. Then, concentrate the (batch B) filtrate in a vacuum concentrator to a water-extracted herb extract with a relative density of 1.10, i.e., 13.5 Baume degrees (80°C). Place the water-extracted herb extract into an alcohol precipitation tank, add 95% ethanol at three times the volume of the extract, stirring continuously until homogeneous, and let stand for 48 hours. Sieve the supernatant, recover the ethanol until no alcohol odor remains, and continue concentrating to a herb extract with a relative density of 1.25, i.e., 29 Baume degrees (80°C).

[0056] S4. Place the water-extracted phellodendron bark (7.20 kg) into a multi-functional extraction tank, add 58 kg of hot drinking water, heat to 100°C, and extract for 2 hours; add 43 kg of hot drinking water a second time, and extract for 1.5 hours; combine the two extracts, filter, and transfer the filtrate to a storage tank. The temperature inside the extraction tank should be maintained at 98°C during the above extraction process. Then, concentrate the (phellodendron bark) filtrate in a vacuum concentrator to a water-extracted phellodendron bark extract with a relative density of 1.10, i.e., 13.5 Baume degrees (80°C). Place the water-extracted phellodendron bark extract into an alcohol precipitation tank, add 95% ethanol at 3 times the volume of the extract, stirring continuously until homogeneous, let stand for 48 hours, take the supernatant, sieve, and recover the ethanol until there is no alcohol odor. Continue to concentrate to a phellodendron bark extract with a relative density of approximately 1.25, i.e., 29 Baume degrees (80°C).

[0057] S51. Heat the extract of Lithospermum erythrorhizon to 55°C to evaporate the ethanol, add 0.48 kg of propylene glycol, heat at 87°C under normal pressure for 2 hours, stir for 5 minutes, and filter through 400 mesh to obtain the water-soluble filtrate of Lithospermum erythrorhizon; add 0.48 kg of liquid paraffin to the remaining filter residue, stir for 5 minutes, and filter through 400 mesh. Avoid pouring the residual liquid and filter residue from the bottom of the pot into the filter during filtration to obtain the fat-soluble filtrate of Lithospermum erythrorhizon.

[0058] S52. Take 1.20 kg of glyceryl monostearate, 0.88 kg of stearic acid, 0.120000 kg of lanolin, 0.48 kg of stearyl alcohol, 0.52 kg of liquid paraffin, and 0.0012 kg of ethylparaben and add them to the oil phase pot. Set the heating temperature to 80°C and heat and stir until completely melted. Maintain the temperature above 100°C. Add the lipid-soluble filtrate of comfrey and 0.06 kg of borneol and stir evenly. Transfer the mixture to an emulsification tank and maintain the temperature at 80°C.

[0059] S53. Take 0.24 kg of sodium dodecyl sulfate (new excipient), 0.036 kg of polyethylene glycol (new excipient), 0.036 kg of polysorbate-80, 0.036 kg of potassium sorbate, and 4.00 kg of purified water and add them to the aqueous phase pot. Mix well. Set the heating temperature to 100℃. When the temperature reaches 80℃, start stirring. When foaming occurs, add purified water in small amounts several times (total amount of purified water added: 2.00 kg). Stop stirring or heating if foaming occurs too quickly. Finally, add the water-soluble filtrate of Lithospermum erythrorhizon to defoam and stir well. After stopping stirring and heating, filter the aqueous phase through 200 mesh and 400 mesh filters and collect the filtrate. Put the filtered aqueous phase back into the aqueous phase pot and heat to 80℃ without stirring during heating. After reaching 100℃, transfer it to the emulsification tank.

[0060] S54. Maintain the temperature at 80℃, evacuate to ≤-0.05Mpa, mix the oil phase matrix and the water phase matrix, stir and homogenize at a stirring speed of 45rpm, homogenize twice, 10 minutes each time.

[0061] S6. Extracts A, B, and C were diluted with 1.01 kg of heated purified water, and then filtered through a 200-mesh filter. The filtrate from extract A was first drawn into an emulsifying tank, homogenized while stirring, for 10 minutes. After homogenization, the filtrates from extracts B and C were drawn into the emulsifying tank in the same manner, homogenized while stirring, for 10 minutes. Stirring continued until the temperature dropped to 70°C, then homogenized for another 10 minutes. Stirring continued until the temperature slowly decreased to 38°C, then homogenized for another 10 minutes before discharging to obtain the external wound medicine. The stirring speed was 45 rpm.

[0062] Example 2

[0063] A method for preparing an external injury medication includes the following steps:

[0064] S1. Preparation of Lithospermum extract: 72.00 kg of cleaned Lithospermum is evenly packed into a percolation tank, ensuring uniform tightness. When adding 360.00 kg of 95% ethanol, air between the herbs should be removed as much as possible. The 95% ethanol should be 3 cm above the surface of the herbs. Soak for 48 hours, then slowly percolate (percolation speed is 100 ml / min) until the Lithospermum in the percolation tank is exposed above the liquid surface. Then add 144.00 kg of 95% ethanol and continue percolating. After collecting all the percolate, send it to a concentration tank to recover the ethanol. Place the percolate in a vacuum concentration pot, turn on the steam, and recover the ethanol until there is no alcohol odor. Continue to concentrate until the relative density is 1.20, i.e., 24 Baume degrees (60℃), which is the Lithospermum extract.

[0065] S2. Place the water-extracted medicinal materials (72.00 kg of cleaned Sanguisorba officinalis, 72.00 kg of cleaned Rheum palmatum, and 72.00 kg of cleaned Gardenia jasminoides) into a multi-functional extraction tank, add 1700 kg of hot drinking water, heat to 100°C, and extract for 2 hours; add 1300 kg of hot drinking water a second time and extract for 1.5 hours; combine the two extracts, filter, and send the filtrate to a storage tank. The temperature inside the extraction tank should be maintained at 100°C during the above extraction process. Then, concentrate the (material A) filtrate under reduced pressure in a vacuum concentrator to a water-extracted medicinal material extract with a relative density of 1.10, i.e., 13.5 Baume degrees (80°C). Place the water-extracted nail extract into an alcohol precipitation tank, add 95% ethanol at a concentration of 3 times the volume of the extract, and stir while adding ethanol until the mixture is homogeneous. Let it stand for 48 hours. After sieving the supernatant, recover the ethanol until there is no alcohol odor, and continue to concentrate it to a relative density of about 1.25, that is, a Baume degree of 29 (80℃) for the nail extract.

[0066] S3. Place the water-extracted herb (72.00 kg of cleaned Scutellaria baicalensis) into a multi-functional extraction tank, add 580 kg of hot drinking water, heat to 100°C, and extract for 2 hours; add 430 kg of hot drinking water a second time, and extract for 1.5 hours; combine the two extracts, filter, and transfer the filtrate to a storage tank. The temperature inside the extraction tank should be maintained at 100°C throughout the extraction process. Then, concentrate the (batch B) filtrate in a vacuum concentrator to a water-extracted herb extract with a relative density of 1.10, i.e., 13.5 Baume degrees (80°C). Place the water-extracted herb extract into an alcohol precipitation tank, add 95% ethanol at three times the volume of the extract, stirring continuously until homogeneous, and let stand for 48 hours. Sieve the supernatant, recover the ethanol until no alcohol odor remains, and continue concentrating to a herb extract with a relative density of 1.25, i.e., 29 Baume degrees (80°C).

[0067] S4. Place the water-extracted phellodendron bark (72.00 kg) into a multi-functional extraction tank, add 580 kg of hot drinking water, heat to 100°C, and extract for 2 hours; add 430 kg of hot drinking water a second time, and extract for 1.5 hours; combine the two extracts, filter, and transfer the filtrate to a storage tank. The temperature inside the extraction tank should be maintained at 100°C during the above extraction process. Then, concentrate the (phellodendron bark) filtrate in a vacuum concentrator to a water-extracted phellodendron bark extract with a relative density of 1.10, i.e., 13.5 Baume degrees (80°C). Place the water-extracted phellodendron bark extract into an alcohol precipitation tank, add 95% ethanol at 3 times the volume of the extract, stirring continuously until homogeneous, let stand for 48 hours, take the supernatant, sieve, and recover the ethanol until there is no alcohol odor. Continue to concentrate to a phellodendron bark extract with a relative density of approximately 1.25, i.e., 29 Baume degrees (80°C).

[0068] S51. Heat the extract of Lithospermum erythrorhizon to 70°C to evaporate the ethanol, add 4.8 kg of propylene glycol, heat at 90°C under normal pressure for 2 hours, stir for 5 minutes, and filter through 400 mesh to obtain the water-soluble filtrate of Lithospermum erythrorhizon; add 4.8 kg of liquid paraffin to the remaining filter residue, stir for 5 minutes, and filter through 400 mesh. Avoid pouring the residual liquid and filter residue from the bottom of the pot into the filter during filtration to obtain the fat-soluble filtrate of Lithospermum erythrorhizon.

[0069] S52. Take 12.00 kg of glyceryl monostearate, 8.80 kg of stearic acid, 1.20000 kg of lanolin, 4.80 kg of stearyl alcohol, 5.20 kg of liquid paraffin and 0.01200 kg of ethylparaben and add them to the oil phase pot. Set the heating temperature to 80℃ and heat and stir until completely melted. Maintain the temperature above 100℃. Add the lipid-soluble filtrate of comfrey and 0.6 kg of borneol and stir evenly. Transfer to an emulsification tank and maintain the temperature at 80℃.

[0070] S53. Take 2.40 kg of sodium dodecyl sulfate (new excipient), 0.360 kg of polyethylene glycol (new excipient), 0.360 kg of polysorbate-80, 0.360 kg of potassium sorbate, and 40.00 kg of purified water and add them to the aqueous phase pot. Mix well. Set the heating temperature to 100℃. When the temperature reaches 80℃, start stirring. When foaming occurs, add purified water in small amounts several times (total amount of purified water added: 20.00 kg). Stop stirring or heating if foaming occurs too quickly. Finally, add the water-soluble filtrate of Lithospermum erythrorhizon to defoam and stir well. After stopping stirring and heating, filter the aqueous phase through 200 mesh and 400 mesh filters and collect the filtrate. Put the filtered aqueous phase back into the aqueous phase pot and heat to 80℃ without stirring during heating. After reaching 100℃, transfer it to the emulsification tank.

[0071] S54. Maintain the temperature at 80℃, evacuate to ≤-0.05Mpa, mix the oil phase matrix and the water phase matrix, stir and homogenize at a stirring speed of 45rpm, homogenize twice, 10 minutes each time.

[0072] S6. Extracts A, B, and C are diluted with 10.10 kg of heated purified water, and then filtered through a 200-mesh filter. Next, the filtrate of extract A is drawn into an emulsifying tank, homogenized while stirring, for 10 minutes. After homogenization, the filtrates of extracts B and C are drawn into the emulsifying tank in the same manner, homogenized while stirring, for 10 minutes. Stirring continues until the temperature drops to 70°C, then homogenization continues for 10 minutes. Stirring continues until the temperature slowly decreases to 40°C, then homogenization continues for 10 minutes before discharging to obtain the external wound medicine. The stirring speed is 45 rpm.

[0073] Example 2

[0074] A method for preparing an external injury medication includes the following steps:

[0075] S1. Preparation of Lithospermum extract: 7.20 kg of cleaned Lithospermum is evenly packed into a percolation tank, ensuring uniform density. When adding 36.00 kg of 95% ethanol, air between the herbs should be removed as much as possible. The 95% ethanol should be 2 cm above the surface of the herbs. Soak for 48 hours, then slowly percolate (percolation rate of 10 ml / min) until the Lithospermum in the percolation tank is exposed above the liquid surface. Then, add 14.40 kg of 95% ethanol and continue percolating. After collecting all the percolate, send it to a concentration tank to recover the ethanol. Place the percolate in a vacuum concentration pot, turn on the steam, and recover the ethanol until there is no alcohol odor. Continue to concentrate until the relative density is 1.20, i.e., 24 Baume degrees (60℃), which is the Lithospermum extract.

[0076] S2. Place the water-extracted medicinal materials (7.20 kg of cleaned Sanguisorba officinalis, 7.20 kg of cleaned Rheum palmatum, and 7.20 kg of cleaned Gardenia jasminoides) into a multi-functional extraction tank, add 170 kg of hot drinking water, heat to 100°C, and extract for 2 hours; add 130 kg of hot drinking water a second time and extract for 1.5 hours; combine the two extracts, filter, and send the filtrate to a storage tank. The temperature inside the extraction tank should be maintained at 98°C during the above extraction process. Then, concentrate the (material A) filtrate under reduced pressure in a vacuum concentrator to a water-extracted medicinal material extract with a relative density of 1.10, i.e., 13.5 Baume degrees (80°C). Place the water-extracted medicinal material extract into an alcohol precipitation tank, add 95% ethanol at 3 times the volume of the extract, stirring while adding ethanol until the mixture is homogeneous, and let it stand for 48 hours; after sieving the supernatant, recover the ethanol until there is no alcohol odor, and continue to concentrate to a medicinal material extract with a relative density of approximately 1.25, i.e., 29 Baume degrees (80°C).

[0077] S3. Place the water-extracted herb (7.20 kg of cleaned Scutellaria baicalensis) into a multi-functional extraction tank, add 58 kg of hot drinking water, heat to 100°C, and extract for 2 hours; add 43 kg of hot drinking water a second time, and extract for 1.5 hours; combine the two extracts, filter, and transfer the filtrate to a storage tank. The temperature inside the extraction tank should be maintained at 98°C throughout the extraction process. Then, concentrate the (batch B) filtrate in a vacuum concentrator to a water-extracted herb extract with a relative density of 1.10, i.e., 13.5 Baume degrees (80°C). Place the water-extracted herb extract into an alcohol precipitation tank, add 95% ethanol at three times the volume of the extract, stirring continuously until homogeneous, and let stand for 48 hours. Sieve the supernatant, recover the ethanol until no alcohol odor remains, and continue concentrating to a herb extract with a relative density of 1.25, i.e., 29 Baume degrees (80°C).

[0078] S4. Place the water-extracted phellodendron bark (7.20 kg) into a multi-functional extraction tank, add 58 kg of hot drinking water, heat to 100°C, and extract for 2 hours; add 43 kg of hot drinking water a second time, and extract for 1.5 hours; combine the two extracts, filter, and transfer the filtrate to a storage tank. The temperature inside the extraction tank should be maintained at 98°C during the above extraction process. Then, concentrate the (phellodendron bark) filtrate in a vacuum concentrator to a water-extracted phellodendron bark extract with a relative density of 1.10, i.e., 13.5 Baume degrees (80°C). Place the water-extracted phellodendron bark extract into an alcohol precipitation tank, add 95% ethanol at 3 times the volume of the extract, stirring continuously until homogeneous, let stand for 48 hours, take the supernatant, sieve, and recover the ethanol until there is no alcohol odor. Continue to concentrate to a phellodendron bark extract with a relative density of approximately 1.25, i.e., 29 Baume degrees (80°C).

[0079] S51. Heat the extract of Lithospermum erythrorhizon to 55°C to evaporate the ethanol, add 0.48 kg of propylene glycol, heat at 87°C under normal pressure for 2 hours, stir for 5 minutes, and filter through 400 mesh to obtain the water-soluble filtrate of Lithospermum erythrorhizon; add 0.48 kg of liquid paraffin to the remaining filter residue, stir for 5 minutes, and filter through 400 mesh. Avoid pouring the residual liquid and filter residue from the bottom of the pot into the filter during filtration to obtain the fat-soluble filtrate of Lithospermum erythrorhizon.

[0080] S52. Take 1.20 kg of glyceryl monostearate, 0.88 kg of stearic acid, 0.120000 kg of lanolin, 0.48 kg of stearyl alcohol, 0.52 kg of liquid paraffin, and 0.0012 kg of ethylparaben and add them to the oil phase pot. Set the heating temperature to 80°C and heat and stir until completely melted. Maintain the temperature above 100°C. Add the lipid-soluble filtrate of comfrey and 0.06 kg of borneol and stir evenly. Transfer the mixture to an emulsification tank and maintain the temperature at 80°C.

[0081] S53. Take 0.24 kg of sodium dodecyl sulfate (new excipient), 0.036 kg of polyethylene glycol (new excipient), 0.036 kg of polysorbate-80, 0.036 kg of potassium sorbate, and 4.00 kg of purified water and add them to the aqueous phase pot. Mix well. Set the heating temperature to 100℃. When the temperature reaches 80℃, start stirring. When foaming occurs, add purified water in small amounts several times (total amount of purified water added: 2.00 kg). Stop stirring or heating if foaming occurs too quickly. Finally, add the water-soluble filtrate of Lithospermum erythrorhizon to defoam and stir well. After stopping stirring and heating, filter the aqueous phase through 200 mesh and 400 mesh filters and collect the filtrate. Put the filtered aqueous phase back into the aqueous phase pot and heat to 80℃ without stirring during heating. After reaching 100℃, transfer it to the emulsification tank.

[0082] S54. Maintain the temperature at 80℃, evacuate to ≤-0.05Mpa, mix the oil phase matrix and the water phase matrix, stir and homogenize at a stirring speed of 45rpm, homogenize twice, 10 minutes each time.

[0083] S6. Extracts A, B, and C were diluted with 1.01 kg of heated purified water, and then filtered through a 200-mesh filter. The filtrate from extract A was first drawn into an emulsifying tank, homogenized while stirring, for 10 minutes. After homogenization, the filtrates from extracts B and C were drawn into the emulsifying tank in the same manner, homogenized while stirring, for 10 minutes. Stirring continued until the temperature dropped to 70°C, then homogenized for another 10 minutes. Stirring continued until the temperature slowly decreased to 38°C, then homogenized for another 10 minutes before discharging to obtain the external wound medicine. The stirring speed was 45 rpm.

[0084] Example 3

[0085] A method for preparing an external injury medication includes the following steps:

[0086] S1. Preparation of Lithospermum extract: 36.00 kg of cleaned Lithospermum is evenly packed into a percolation tank, ensuring uniform density. When adding 180.00 kg of 95% ethanol, air between the herbs should be removed as much as possible. The 95% ethanol should be 3 cm above the surface of the herbs. Soak for 48 hours, then slowly percolate (percolation speed of 50 ml / min) until the Lithospermum in the percolation tank is exposed above the liquid surface. Then, add 72.00 kg of 95% ethanol and continue percolating. After collecting all the percolate, send it to a concentration tank to recover the ethanol. Place the percolate in a vacuum concentration pot, turn on the steam, and recover the ethanol until there is no alcohol odor. Continue to concentrate until the relative density is 1.20, i.e., 24 Baume degrees (60℃), which is the Lithospermum extract.

[0087] S2. Place the water-extracted medicinal materials (36.00 kg of cleaned Sanguisorba officinalis, 36.00 kg of cleaned Rheum palmatum, and 36.00 kg of cleaned Gardenia jasminoides) into a multi-functional extraction tank, add 850 kg of hot drinking water, heat to 100°C, and extract for 2 hours; add 650 kg of hot drinking water a second time and extract for 1.5 hours; combine the two extracts, filter, and send the filtrate to a storage tank. The temperature inside the extraction tank should be maintained at 100°C during the above extraction process. Then, concentrate the (material A) filtrate under reduced pressure in a vacuum concentrator to a water-extracted medicinal material extract with a relative density of 1.10, i.e., 13.5 Baume degrees (80°C). Place the water-extracted medicinal material extract into an alcohol precipitation tank, add 95% ethanol at 3 times the volume of the extract, stirring while adding ethanol until the mixture is homogeneous, and let it stand for 48 hours; after sieving the supernatant, recover the ethanol until there is no alcohol odor, and continue to concentrate to a medicinal material extract with a relative density of approximately 1.25, i.e., 29 Baume degrees (80°C).

[0088] S3. Place the water-extracted herb (36.00 kg of cleaned Scutellaria baicalensis) into a multi-functional extraction tank, add 290 kg of hot drinking water, heat to 100°C, and extract for 2 hours; add 215 kg of hot drinking water a second time, and extract for 1.5 hours; combine the two extracts, filter, and transfer the filtrate to a storage tank. The temperature inside the extraction tank should be maintained at 100°C throughout the extraction process. Then, concentrate the (batch B) filtrate in a vacuum concentrator to a water-extracted herb extract with a relative density of 1.10, i.e., 13.5 Baume degrees (80°C). Place the water-extracted herb extract into an alcohol precipitation tank, add 95% ethanol at three times the volume of the extract, stirring continuously until homogeneous, and let stand for 48 hours. Sieve the supernatant, recover the ethanol until no alcohol odor remains, and continue concentrating to a herb extract with a relative density of 1.25, i.e., 29 Baume degrees (80°C).

[0089] S4. Place the water-extracted phellodendron bark (36.00 kg) into a multi-functional extraction tank, add 290 kg of hot drinking water, heat to 100°C, and extract for 2 hours; add 215 kg of hot drinking water a second time and extract for 1.5 hours; combine the two extracts, filter, and transfer the filtrate to a storage tank. The temperature inside the extraction tank should be maintained at 100°C during the above extraction process. Then, concentrate the (phellodendron bark) filtrate in a vacuum concentrator to a water-extracted phellodendron bark extract with a relative density of 1.10, i.e., 13.5 Baume degrees (80°C). Place the water-extracted phellodendron bark extract into an alcohol precipitation tank, add 95% ethanol at 3 times the volume of the extract, stirring continuously until homogeneous, let stand for 48 hours, take the supernatant, sieve, and recover the ethanol until there is no alcohol odor. Continue to concentrate to a phellodendron bark extract with a relative density of approximately 1.25, i.e., 29 Baume degrees (80°C).

[0090] S51. Heat the extract of Lithospermum erythrorhizon to 65°C to evaporate the ethanol, add 2.4 kg of propylene glycol, heat at 100°C under normal pressure for 2 hours, stir for 5 minutes, and filter through 400 mesh to obtain the water-soluble filtrate of Lithospermum erythrorhizon; add 2.4 kg of liquid paraffin to the remaining filter residue, stir for 5 minutes, and filter through 400 mesh. Avoid pouring the residual liquid and filter residue from the bottom of the pot into the filter during filtration to obtain the fat-soluble filtrate of Lithospermum erythrorhizon.

[0091] S52. Take 6.00 kg of glyceryl monostearate, 4.40 kg of stearic acid, 0.60 kg of lanolin, 2.40 kg of stearyl alcohol, 2.60 kg of liquid paraffin, and 0.006 kg of ethylparaben and add them to the oil phase pot. Set the heating temperature to 80°C and heat and stir until completely melted. Maintain the temperature above 100°C. Add the lipid-soluble filtrate of comfrey and 0.3 kg of borneol and stir evenly. Transfer the mixture to an emulsification tank and maintain the temperature at 80°C.

[0092] S53. Take 1.20 kg of sodium dodecyl sulfate (new excipient), 0.180 kg of polyethylene glycol (new excipient), 0.18 kg of polysorbate-80, 0.18 kg of potassium sorbate, and 20.00 kg of purified water and add them to the aqueous phase pot. Mix well. Set the heating temperature to 100℃. When the temperature reaches 80℃, start stirring. When foaming occurs, add purified water in small amounts several times (total amount of purified water added: 10.00 kg). Stop stirring or heating if foaming occurs too quickly. Finally, add the water-soluble filtrate of Lithospermum erythrorhizon to defoam and stir well. After stopping stirring and heating, filter the aqueous phase through 200 mesh and 400 mesh filters and collect the filtrate. Put the filtered aqueous phase back into the aqueous phase pot and heat to 80℃ without stirring during heating. After reaching 100℃, transfer it to the emulsification tank.

[0093] S54. Maintain the temperature at 80℃, evacuate to ≤-0.05Mpa, mix the oil phase matrix and the water phase matrix, stir and homogenize at a stirring speed of 45rpm, homogenize twice, 10 minutes each time.

[0094] S6. Extracts A, B, and C were diluted with 5.05 kg of heated purified water, and then filtered through a 200-mesh filter. The filtrate of extract A was first drawn into an emulsifying tank, homogenized while stirring, for 10 minutes. After homogenization, the filtrates of extracts B and C were drawn into the emulsifying tank in the same manner, homogenized while stirring, for 10 minutes. Stirring continued until the temperature dropped to 70°C, then homogenized for another 10 minutes. Stirring continued until the temperature slowly decreased to 39°C, then homogenized for another 10 minutes before discharging to obtain the external wound medicine. The stirring speed was 45 rpm.

[0095] Comparative Example 1

[0096] The preparation steps and parameters in this comparative example are the same as those in Example 1. The difference is that the Scutellaria baicalensis and Phellodendron chinense in steps S3 and S4 are mixed and extracted simultaneously. Specifically, 72.00 kg of clean Scutellaria baicalensis and 72.00 kg of clean Phellodendron chinense are put into a multi-functional extraction tank, 1160 kg of hot drinking water is added, the mixture is heated to 100°C, and extracted for 2 hours. Then, 860 kg of hot drinking water is added for the second extraction and extracted for 1.5 hours. The remaining steps are the same.

[0097] Comparative Example 2

[0098] In this comparative example, the preparation steps and parameters are the same as in Example 1, except that step S5 (i.e., S51-S54) is omitted. The subsequent steps are consistent with the preparation process of the external injury ointment in the pharmacopoeia. That is, borneol is dissolved in liquid paraffin to obtain a borneol solution. Glycerin monostearate, triethanolamine, polysorbate 80, liquid paraffin, stearyl alcohol, lanolin, stearic acid, propylene glycol, ethylparaben, and potassium sorbate are used to make a matrix. Lithospermum erythrorhizon extract, extract A, extract B, extract C, and borneol solution are added to the matrix and mixed well to prepare the external injury medicine.

[0099] Comparative Example 3

[0100] In this comparative example, the preparation steps and parameters are the same as in Example 1, except that no pretreatment step is performed and the comfrey extract is directly added to the matrix. All other steps and parameters are consistent with those in Example 1.

[0101] Comparative Example 4

[0102] The preparation steps and parameters in this comparative example are the same as those in Example 1. The difference is that in step S53, sodium dodecyl sulfate and polyethylene glycol are not added. Instead, polysorbate-80, potassium sorbate and purified water are directly added to the aqueous phase pot, heated and stirred.

[0103] Comparative Example 5

[0104] The preparation steps and parameters in this comparative example are the same as those in Example 1, except that only one excipient, sodium dodecyl sulfate, is added, i.e., polyethylene glycol is not added. All other steps and parameters remain the same.

[0105] Comparative Example 6

[0106] The preparation steps and parameters in this comparative example are the same as those in Example 1, except that only one auxiliary material, polyethylene glycol, is added, i.e., sodium dodecyl sulfate is not added. All other steps and parameters remain the same.

[0107] Comparative Example 7

[0108] In this comparative example, the preparation steps and parameters are the same as in Example 1, except that sodium dodecyl sulfate and polyethylene glycol are replaced with poloxamer and 2,6-di-tert-butyl-p-cresol, respectively, while the remaining steps and parameters remain the same.

[0109] The trauma medications obtained in Examples 1-3 and Comparative Examples 1-7 were subjected to performance testing. The specific test results are shown in the table below:

[0110]

[0111]

[0112] Note: In the prior patent claiming priority, the test results for whether there were "black spots" in the finished product of the trauma medicine in Example 2 were "very few batches". This is mainly due to the unstable and unskilled operation of the operators. In fact, there are no "black spots".

[0113] The trauma medication prepared according to Example 1 of this scheme is a standard (greenish-yellow to) brownish-yellow color, and "black spots" are rarely observed during the preparation process, except in very few batches. Testing showed that it remained stable for 6 months, and even 1-2 years, after preparation without any stratification.

[0114] The test results above show that when Scutellaria baicalensis and Phellodendron amurense were mixed and extracted and concentrated to make an extract in Comparative Example 1, the flavonoids in Scutellaria baicalensis and the alkaloids in Phellodendron amurense were prone to precipitation, which affected the properties and stability of the finished product. However, in Examples 1-3, the extracts of Scutellaria baicalensis and Phellodendron amurense were made separately, which avoided the above situation.

[0115] Comparative Example 2, prepared using conventional methods from the pharmacopoeia, produced an external injury medication with more black spots than Example 1, and its overall color was brick red. Its stability was also inferior to that of Example 1.

[0116] Comparative Example 3 omitted the pretreatment step, and the resulting trauma medication had more black spots than Example 1, and the overall color was dark brown, which was not the standard color. Since Comparative Example 3 only used one new excipient - sodium dodecyl sulfate, its stability was also not as good as that of Example 1.

[0117] Comparative Example 4, without adding any new excipients, showed stratification upon completion of preparation and after 6 months of storage, indicating that its stability was not as good as that of this method.

[0118] The properties and stability of the trauma medications prepared in Comparative Example 5 (with only one added excipient - sodium dodecyl sulfate), Comparative Example 6 (with only one added excipient - polyethylene glycol), and Comparative Example 7 (with sodium dodecyl sulfate and polyethylene glycol replaced by poloxamer and 2,6-di-tert-butyl-p-cresol, respectively) were not as good as those prepared in Example 1.

[0119] The above description is only a preferred embodiment of this application and does not limit the patent scope of this application. All equivalent structural transformations made using the description of this application under the inventive concept of this application, or direct / indirect applications in other related technical fields, are included within the patent protection scope of this application.

Claims

1. A method for preparing a trauma drug, characterized in that, Includes the following steps: S1. Preparation of Lithospermum erythrorhizon extract: 72.00 kg of cleaned Lithospermum erythrorhizon was placed in a percolation container, and 350.00-370.00 kg of 95% ethanol was added. The mixture was soaked for 48 hours. After the Lithospermum erythrorhizon was exposed above the liquid surface, another 140.00-148.00 kg of 95% ethanol was added to continue percolation. All the percolate was collected and then concentrated under vacuum to obtain the Lithospermum erythrorhizon extract with a relative density of 1.20-1.

30. S2. A water-extracted extract of the medicinal materials is prepared from Sanguisorba officinalis, Rheum palmatum, and Gardenia jasminoides. S21. Place 72.00 kg of cleaned Sanguisorba officinalis, 72.00 kg of cleaned Rheum palmatum, and 72.00 kg of cleaned Gardenia jasminoides in an extraction container, add 1500-1900 kg of hot drinking water, heat to 96-100℃ and extract for 2 hours, add 1100-1500 kg of hot drinking water a second time and extract for 1.5 hours, combine the two extracts and filter. S22. The filtered extract is concentrated under vacuum to obtain a water-extracted extract of acetic acid with a relative density of 1.10 to 1.20; S23. Place the water-extracted methyl ester extract in an alcohol precipitation container, add 3 times the weight of the water-extracted methyl ester extract with a concentration of 95% ethanol, stir evenly and let stand for 48 hours, take the supernatant and sieve it, recover the ethanol until there is no alcohol odor, and continue to concentrate until the methyl ester extract with a relative density of 1.25 is obtained. S3. Extraction of ingredient B is performed by water extraction of ingredient B, wherein the ingredient B is Scutellaria baicalensis: S31. Place 72.00 kg of cleaned Scutellaria baicalensis in an extraction container, add 560-600 kg of hot drinking water, heat to 96-100℃ and extract for 2 hours, then add 410-450 kg of hot drinking water a second time and extract for 1.5 hours. Combine the two extracts and filter. S32. The filtered extract is concentrated under vacuum to obtain a water extract B with a relative density of 1.10 to 1.20; S33. Place the water-extracted B material extract into an alcohol precipitation container, add 3 times the weight of the water-extracted B material extract with a concentration of 95% ethanol, stir evenly, let stand for 48 hours, take the supernatant and sieve it, recover the ethanol until there is no alcohol odor, and continue to concentrate until the B material extract with a relative density of 1.25 is obtained. S4. A resin extract is prepared by water extraction of the resinous medicinal material, wherein the resinous medicinal material is Phellodendron bark. S41. Place 72.00 kg of cleaned Phellodendron bark into an extraction container, add 560-600 kg of hot drinking water, heat to 96-100℃ and extract for 2 hours, then add 410-450 kg of hot drinking water a second time and extract for 1.5 hours. Combine the two extracts and filter. S42. The filtered extract is concentrated under vacuum to obtain a water-extracted acrylic extract with a relative density of 1.10 to 1.20; S43. Place the water-extracted acrylic extract into an alcohol precipitation container, add 3 times the weight of the water-extracted acrylic extract with 95% ethanol, stir evenly, let stand for 48 hours, take the supernatant and sieve it, recover the ethanol until there is no alcohol odor, and continue to concentrate until the acrylic extract with a relative density of 1.25 is obtained. S5. Pretreatment of the comfrey extract yields an emulsion phase containing comfrey fat-soluble filtrate and comfrey water-soluble filtrate: S51. Add 4.56-5.04 kg of propylene glycol to 1-2 kg of heated Lithospermum erythrorhizon extract, heat at normal pressure for 1.75-2.25 h, stir and filter to obtain 4.0-4.4 kg of the water-soluble filtrate of Lithospermum erythrorhizon; add 4.56-5.04 kg of liquid paraffin to the filtered residue, stir and filter to obtain 4.3-4.7 kg of the fat-soluble filtrate of Lithospermum erythrorhizon. S52. Add 11.40-12.60 kg of glyceryl monostearate, 8.36-9.24 kg of stearic acid, 1.14-1.26 kg of lanolin, 4.56-5.04 kg of stearyl alcohol, 4.94-5.46 kg of liquid paraffin, and 0.011-0.013 kg of ethylparaben to an oil phase pot, heat and stir until completely melted, then add 4.3-4.7 kg of the lipid-soluble filtrate of the comfrey root and 0.57-0.63 kg of borneol, and stir evenly at a constant temperature to obtain the oil phase matrix; S53. Add 2.28-2.52 kg of sodium dodecyl sulfate, 0.340-0.380 kg of polyethylene glycol, 0.340-0.380 kg of polysorbate-80, 0.340-0.380 kg of potassium sorbate, and 57.00-63.00 kg of purified water to an aqueous phase pot, heat and stir, then add 4.0-4.4 kg of the water-soluble filtrate of Lithospermum erythrorhizon and stir evenly. After filtration, collect the filtrate, put the filtrate back into the aqueous phase pot and heat to obtain an aqueous phase matrix; S54. The oil phase matrix and the aqueous phase matrix are mixed at a weight ratio of 1:1.8-2, stirred and homogenized to obtain the emulsion phase containing the lipid-soluble filtrate of Lithospermum erythrorhizon and the water-soluble filtrate of Lithospermum erythrorhizon; S6. The extract A, extract B, and extract C are heated separately in a weight ratio of 1:(0.6-0.8):(0.4-0.6), diluted with purified water, and filtered. The filtrate of extract A is first added to the emulsion phase containing the lipid-soluble filtrate and water-soluble filtrate of Lithospermum erythrorhizon, and stirred and homogenized. Then, the filtrate of extract B and the filtrate of extract C are added, stirred and homogenized, cooled, stirred and homogenized to obtain the external injury drug.

2. The method for preparing an external injury drug as described in claim 1, characterized in that, In step S51, propylene glycol is added to the comfrey extract heated to 50-70°C, and then heated to 80-100°C under normal pressure. After stirring, the mixture is filtered through a 400-mesh screen for 4-6 minutes.

3. The method for preparing an external injury drug as described in claim 1, characterized in that, In step S52, heat to 78-82℃ and stir until completely melted. Maintain the temperature of 78-82℃ while stirring evenly under constant temperature. In step S53, the mixture is heated to 80-100℃, filtered, and the filtrate is collected and filtered through a mesh of 200-400.

4. The method for preparing a trauma drug as described in claim 1, characterized in that, In step S54, at a temperature of 78-82℃ and a vacuum degree of ≤-0.05Mpa, the oil phase matrix and the aqueous phase matrix are mixed, stirred and homogenized at a stirring speed of 43-47rpm, and homogenized at least twice, each time for 8-12min.

5. The method for preparing the trauma medication as described in claim 1, characterized in that, In step S6, the extract A, extract B, and extract C are heated to 78-82°C, diluted with 9.50-10.50 kg of heated purified water, and filtered through a 200-mesh filter. The homogenization time during stirring and homogenization was 8-12 min, and the stirring speed was 43-47 rpm. The process of cooling, stirring, and homogenizing includes the following steps: when the temperature drops to 68-72℃, homogenize for 8-12 minutes; continue stirring until the temperature drops to 36-40℃, homogenize for 8-12 minutes to obtain the external injury drug.

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