Traditional Chinese medicine composition for treating fracture and preparation method thereof

Abstract

The invention belongs to the field of traditional Chinese medicine, and discloses a traditional Chinese medicine composition for treating fracture and a preparation method, the traditional Chinese medicine composition mainly comprises teasel root, pseudo-ginseng, drynaria rhizome, Chinese angelica, frankincense and myrrh, and the composition has the effects of promoting fracture healing, relieving swelling and pain, improving blood circulation and enhancing bone recovery by elaborately selecting Chinese herbal medicines; the invention further provides an optimized preparation method, it is ensured that the effective components of all the components are fully extracted and stable, and the composition can be prepared into various dosage forms such as tablets, capsules or external application plasters so as to meet the treatment requirements of different patients. Pharmacological experiments and clinical verifications prove that the traditional Chinese medicine composition is safe and reliable, has a good curative effect, is simple in preparation process, is suitable for large-scale production and has a wide application prospect.

Description

Technical Field

[0001] The invention belongs to the field of traditional Chinese medicine, and particularly relates to a traditional Chinese medicine composition for treating fractures and a preparation method thereof. Background Art

[0002] With the aging of the population, the incidence of fractures, especially hip fractures, has gradually increased and has become a serious public health problem. For the treatment of fractures, traditional Western medicine mainly promotes bone healing through reduction, fixation and surgical operations, and supplements with drug therapy to relieve pain and speed up the recovery process. However, although Western medicine can effectively solve the problem of acute fractures, it is often accompanied by certain side effects. For example, long-term use of analgesics can easily cause gastrointestinal discomfort, drug dependence and even liver and kidney damage. In recent years, with the deepening of research on the modernization of traditional Chinese medicine, the effectiveness and safety of traditional Chinese medicine in treating fractures have gradually been scientifically verified, and the development and application of related Chinese medicine compositions have received more and more attention.

[0003] Although both Western medicine and Chinese medicine have good effects in the treatment of fractures, they each have certain limitations. Although Western medicine can quickly relieve pain and inflammation during treatment, its long-term use will bring a greater risk of side effects, such as gastrointestinal adverse reactions, renal damage, bone hyperplasia, etc. In addition, some drugs are expensive, and the financial burden on patients is heavy, especially for patients in the recovery period of fractures who need to take long-term medication. It is difficult for them to rely on such drugs for a long time.

[0004] Although Chinese medicine compositions have good therapeutic effects and relatively low side effects, existing Chinese medicine preparations often have several problems. First, there is no unified standard for the extraction method and ratio of medicinal materials, and there are differences in the stability of the efficacy of different preparations. Secondly, the existing extraction process may cause the loss of active ingredients of the drug or uneven efficacy, affecting the therapeutic effect. Finally, the quality control of some Chinese medicine preparations is not strict enough, and problems such as microbial contamination and heavy metal residues occur from time to time in some products, affecting their widespread application in clinical practice.

[0005] Therefore, based on the limitations of the prior art, it is urgent to develop a novel Chinese medicine composition and its preparation method, which can improve safety and stability while ensuring drug efficacy, and has clear quality control standards and simple use methods. The present invention combines traditional Chinese medicine theory with modern preparation technology, selects classic Chinese medicinal materials such as Radix Dipsaci, Radix Notoginseng, Rhizoma Drynariae, Radix Angelicae Sinensis, and adopts water extraction, alcohol extraction and freeze drying technology by optimizing the ratio and preparation technology to prevent drug efficacy loss. The composition of the present invention can be made into dosage forms such as tablets, capsules, and granules, which are easy to use and suitable for long-term use, and safety and effectiveness are ensured by strict quality inspection, and the quality control problems of existing Chinese medicine preparations are overcome, which is innovative and superior. The present invention not only overcomes the shortcomings of existing Chinese medicine preparations, but also ensures that it has significant efficacy in promoting fracture healing and alleviating patient pain, and has little side effects, and is suitable for long-term use. Summary of the invention

[0006] The present invention provides a Chinese medicine composition for treating fractures and a preparation method thereof, wherein the composition is mainly composed of Chinese medicinal materials including Radix Dipsaci, Radix Notoginseng, Rhizoma Drynariae, Radix Angelicae Sinensis, Olibanum and Myrrha, and by optimizing the proportion and preparation process of each medicinal material, combined with modern Chinese medicine extraction technology, such as water extraction, alcohol extraction and freeze drying, the maximum retention of effective ingredients is ensured, and the stability and efficacy of the drug are improved. The preparation process of the present invention includes raw material crushing, extraction, filtration, concentration, drying, mixing and molding steps, and the prepared tablets, capsules or granules are easy to use and suitable for long-term use. In addition, through strict quality inspection means, the safety and stability of the product are ensured, and the product has significant clinical application value.

[0007] A traditional Chinese medicine composition for treating fractures and a preparation method thereof, characterized in that the traditional Chinese medicine composition is prepared by weighing the following Chinese medicinal materials according to weight proportions: 200-500 g of Radix Dipsaci, 100-300 g of Radix Notoginseng, 150-400 g of Rhizoma Drynariae, 100-250 g of Radix Angelicae Sinensis, 50-150 g of Olibanum, and 50-150 g of Myrrh; the preparation process comprises the following steps: Preferably, 200g, 300g or 500g of Dipsacus asper; 100g, 200g or 300g of Panax notoginseng; 150g, 300g or 400g of Drynaria fortunei; 100g, 200g or 250g of Angelica sinensis; 50g, 100g or 150g of Frankincense; 50g, 100g or 150g of Myrrh; S1: Raw material preparation: mix Radix Dipsaci, Radix Notoginseng, Rhizoma Drynariae, Radix Angelicae Sinensis, frankincense and myrrh according to weight ratio; S2: Crushing: The above medicinal materials are coarsely crushed to make the particle size of the medicinal materials reach 20~80 mesh; for the relatively hard medicinal materials of Drynaria fortunei, mechanical crushing is adopted; frankincense and myrrh resin medicinal materials need to be crushed under low temperature environment, and 5%~10% coolant is added in the crushing process to reduce the temperature and ensure that the efficacy is not lost; Preferably, the particle size of the medicinal material is 20 mesh, 50 mesh or 80 mesh; the proportion of the added coolant is 5%, 7% or 10%.

[0008] S3: Extraction: water or ethanol is selected as the extraction solvent, and the liquid-to-solid ratio is set to 10:1 for water extraction or ethanol reflux extraction. The extraction process is performed twice to improve the extraction rate of the effective components; S4: Filtration and concentration: The extracted solution is filtered through filter cloth or centrifugal equipment to remove the drug residue. The filtered liquid needs to be concentrated under reduced pressure at low temperature to retain the active ingredients in the extract. The concentration process should be monitored in real time to avoid overheating; S5: Drying treatment: Use freeze drying or spray drying to dry the concentrate into powder. During spray drying, the spray temperature must be controlled at 20~60 ℃ to avoid the loss of active ingredients. The dried powder must be sealed and stored in an inert gas environment to prevent moisture absorption and deterioration, and an appropriate amount of antioxidants must be added to extend the shelf life.

[0009] S6: Mixing and molding: The dry powder is uniformly mixed. After mixing, it can be pressed into tablets, filled into capsules or made into granules. It can also be mixed with maltose or gelatin to make a plaster. The mixing time and speed must be controlled during the mixing process to avoid the destruction of the medicinal ingredients. S7: Quality testing and packaging: The final product shall be tested for active ingredient content, heavy metals and microbial indicators to ensure compliance with pharmacopoeia standards; after passing the test, it shall be repackaged and stored in a cool and dry place. The packaging material shall be moisture-proof and oxygen-barrier to ensure the long-term stability of the drug; the outer packaging of the product shall indicate the active ingredient content, usage and precautions, and be accompanied by the batch number and production date to ensure traceability.

[0010] In some of the embodiments, the rotation speed of the mechanical grinding of the Drynaria fortunei medicinal material is 3000-5000 rpm, and the low-temperature grinding temperature of frankincense and myrrh is controlled at -10-0°C to avoid the loss of effective ingredients of the medicinal materials.

[0011] Preferably, the rotation speed of the mechanical pulverization is 3000 rpm, 4000 rpm or 5000 rpm; and the pulverization temperature is -10°C, 5°C or 0°C.

[0012] In some embodiments, the liquid-to-solid ratio of the water extraction method is 1:8~1:10, the decoction temperature is 100°C, and the extraction time is 1~2 hours; the liquid-to-solid ratio of the ethanol extraction method is 1:5~1:8, the ethanol concentration is 40%~70%, the extraction temperature is 60~80°C, and the extraction time is 1~2 hours.

[0013] Preferably, the liquid-to-solid ratio of the water extraction method is 1:8, 1:9 or 1:10; the liquid-to-solid ratio of the ethanol extraction method is 1:5, 1:6 or 1:8; the ethanol concentration is 40%, 50% or 70%; and the extraction temperature is 60°C, 70°C or 80°C.

[0014] In some of the embodiments, the extraction step adopts a two-extraction process. After the first extraction, the drug residue is subjected to a second extraction to ensure that the extraction rate of the effective ingredient reaches more than 80%, thereby maximally retaining the active ingredients of the medicinal materials.

[0015] In some of the embodiments, during the filtration process of the extract, a 300-400 mesh filter cloth is used for primary filtration, and then a centrifugal device is used to perform centrifugal separation at a speed of 3000-4000 rpm to remove the drug residue and obtain a clarified extract.

[0016] Preferably, the extract is filtered at 300 mesh, 300 mesh or 400 mesh; the centrifugal device speed is 3000 rpm, 3500 rpm or 4000 rpm.

[0017] In some of the embodiments, the reduced pressure concentration step is carried out at a low temperature of 40-60° C. to concentrate to 0.25-0.33 of the original extract volume, ensuring that the temperature is no higher than 60° C. to avoid high temperature damage to the active ingredients of the drug.

[0018] Preferably, the concentration temperature is 40°C, 50°C or 60°C; and the concentration volume is 0.25, 0.30 or 0.33.

[0019] In some of the embodiments, in the drying step, the temperature of the freeze-drying method is controlled at -40°C to -60°C to maintain low-temperature drying; the inlet air temperature of the spray drying method is controlled at 100°C to 150°C to ensure uniform particle size of the drug powder and avoid destruction of heat-sensitive components.

[0020] Preferably, the freeze-drying temperature is -40°C, -50°C or -60°C; and the spray-drying temperature is 100°C, 120°C or 150°C.

[0021] In some of the embodiments, in the mixing step, the dry powder of the medicinal material is mixed by a high-speed mixer at a rotation speed of 500-1000 rpm to ensure uniform distribution of the ingredients; in the molding process, the hardness of the tablets pressed by the tablet press is controlled at 5-10 kg / cm² to ensure the structural stability of the tablets.

[0022] Preferably, the mixer speed is 500 rpm, 800 rpm or 1000 rpm; the hardness is 5 kg / cm², 8 kg / cm² or 10 kg / cm².

[0023] In some of the embodiments, the medicinal composition can be made into various dosage forms such as tablets, capsules, granules and plasters, wherein the plaster dosage form is made by mixing the dry powder with the matrix in a weight ratio of 1:2 and evenly coating the mixture on gauze or base cloth.

[0024] In some of the embodiments, the finished product needs to be quality tested before packaging. The test contents include the content of active ingredients, microbial indicators, heavy metal content and moisture content to ensure that the product meets the national pharmaceutical standards. After passing the test, the finished product is sealed and packaged and stored in a cool and dry place, avoiding direct sunlight.

[0025] (1) Improving efficacy and recovery speed: The present invention optimizes the ratio of Chinese medicinal materials such as Dipsacus asper, Panax notoginseng, and Drynaria fortunei, and combines modern extraction technology to effectively retain the active ingredients in the medicinal materials, thereby enhancing the effects of promoting blood circulation and removing blood stasis, reducing swelling and relieving pain, and promoting bone regeneration, thereby accelerating the healing of fractures and the patient's recovery process.

[0026] (2) Preparation process innovation and product stability: The present invention adopts modern Chinese medicine preparation processes such as water extraction, alcohol extraction and freeze-drying to ensure the full extraction and preservation of active ingredients, extend the shelf life of the product, and ensure the safety and stability of the drug through strict quality inspection methods, thus overcoming the defects of traditional Chinese medicine preparations that are easy to deteriorate and difficult to control quality. DETAILED DESCRIPTION

[0027] In order to facilitate the understanding of the technical implementation method of the present invention, the technical scheme in the embodiment of the present invention will be clearly and completely described below in combination with the technical process steps, specific implementation conditions and materials in the embodiment of the present invention. Obviously, the described embodiment is only a part of the embodiment of the present invention, not all embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention. Example

[0028] Preparation method of Chinese and western medicine combination 250g of Radix Dipsaci, 100g of Radix Notoginseng, 200g of Rhizoma Drynariae, 120g of Radix Angelicae Sinensis, 80g of frankincense and 60g of myrrh were used as raw materials. First, each medicinal material was crushed to ensure that the particle size reached 50 mesh. Frankincense and myrrh were crushed at low temperature at -10°C to maintain the efficacy. Subsequently, water was used as the extraction solvent, the liquid-solid ratio was set to 1:9, and it was decocted at 100°C for 2 hours to fully extract the effective ingredients. After extraction, it was filtered with a 300-mesh filter cloth to remove the drug residue. The centrifugal equipment speed was 3000rpm, and finally, it was concentrated to 1 / 4 of the original volume by low temperature and decompression under the condition of not exceeding 60°C. The concentrate was treated by spray drying, and the inlet air temperature was set to 120°C to obtain a uniform dry powder. Finally, the speed of the dry powder mixer was set to 500 rpm, and the capsules were made after mixing evenly. The quality test was carried out to ensure that the content of the effective ingredients and the microbial indicators were qualified, and then sealed and packaged. Example

[0029] Preparation method of Chinese and western medicine combination 300 g of Radix Dipsaci, 200 g of Radix Notoginseng, 150 g of Drynariae Rhizoma, 100 g of Radix Angelicae Sinensis, 50 g of Frankincense and 50 g of Myrrh were selected as the main raw materials. The medicinal materials were coarsely crushed to ensure that the particle size reached 80 mesh. 50% ethanol was used as the extraction solvent, the liquid-solid ratio was set to 1:6, and reflux extraction was performed at 70°C for 1.5 hours to ensure that the effective ingredients of the medicinal materials were fully dissolved. After extraction, a 400-mesh filter cloth was used for preliminary filtration to remove the drug residue, and then a centrifugal device was used with a speed set to 3500 rpm to obtain a clear extract. The extract was concentrated to 1 / 3 of the original volume by low-temperature decompression, and freeze-dried at -40°C to protect heat-sensitive components. Finally, the obtained powder was uniformly mixed at high speed, with a mixer speed of 800 rpm, and made into granules, which were strictly tested for quality and sealed and packaged after passing the test to ensure long-term storage stability. Example

[0030] Preparation method of Chinese and western medicine combination 400 g of Radix Dipsaci, 250 g of Radix Notoginseng, 400 g of Rhizoma Drynariae, 200 g of Radix Angelicae Sinensis, 100 g of Olibanum and 100 g of Myrrh were used. The medicinal materials were first coarsely crushed to a particle size of 20 mesh. Subsequently, the water extraction method was used, and the liquid-solid ratio was set to 1:8, and the decoction was performed at 100°C for 1 hour to ensure the extraction rate of the effective ingredients. After extraction, the extract and the residue were separated by a centrifugal device at a speed of 4000 rpm to obtain a clear extract. Thereafter, the extract was concentrated under reduced pressure at low temperature to 1 / 3 of the original volume, and dried by spray drying, with the air inlet temperature set to 150°C to ensure uniform particle size of the powder. Finally, the mixer speed was set at 1000 rpm, and the obtained dry powder was mixed evenly and pressed into tablets to ensure that the hardness of the tablets reached 6 kg / cm². Microbiological tests and active ingredient content tests were performed, and sealed packaging was performed after passing the test. Example

[0031] Preparation method of Chinese and western medicine combination 200 grams of Dipsacus asper, 100 grams of Panax notoginseng, 300 grams of Drynaria fortunei, 150 grams of Angelica sinensis, 120 grams of frankincense and 80 grams of myrrh were selected as raw materials. After coarse crushing, the particle size of the medicinal materials reached 60 mesh. Low-temperature crushing technology was used for frankincense and myrrh. Subsequently, ethanol extraction was used, the liquid-solid ratio was set to 1:5, the ethanol concentration was 40%, and reflux extraction was performed at 60°C for 2 hours to ensure that the active ingredients were fully dissolved. After extraction, it was filtered through a 300-mesh filter cloth to remove the residue and obtain a clear extract. The extract was concentrated to 1 / 4 of the original volume at a low temperature of 40°C, and then the concentrate was dried into powder by freeze drying, and the temperature was controlled at -50°C. Finally, the dry powder was mixed evenly to make granules, and the active ingredient content and heavy metal content were tested. After passing the test, it was sealed and packaged for storage. Example

[0032] Preparation method of Chinese and western medicine combination 500g of Dipsacus asper, 300g of Panax notoginseng, 150g of Drynaria fortunei, 100g of Angelica sinensis, 150g of frankincense and 150g of Myrrh were used as medicinal materials. After coarse grinding, the particle size of the medicinal materials was adjusted to 40 mesh. The water extraction method was used, the liquid-solid ratio was set to 1:10, and the decoction time was 90 minutes to extract the active ingredients in the medicinal materials. After extraction, the residues were removed by filtering with a 400-mesh filter cloth, and then the reduced pressure concentration was carried out under low temperature conditions to 1 / 3 of the original volume. The concentrate was treated by spray drying, and the inlet air temperature was set to 130℃ to obtain a uniform powder. Finally, the powder was mixed evenly and pressed into tablets to ensure that the tablet hardness reached 8 kg / cm², and microbial index testing was carried out. After passing the test, the tablets were sealed and packaged to ensure the safety and effectiveness of the product. Example

[0033] Preparation method of Chinese and western medicine combination 300g of Radix Dipsaci, 150g of Radix Notoginseng, 200g of Drynariae Rhizoma, 250g of Radix Angelicae Sinensis, 100g of frankincense and 50g of myrrh were used as raw materials. The medicinal materials were coarsely crushed to a particle size of 50 mesh. Frankincense and myrrh were crushed at low temperature to retain the efficacy. Subsequently, ethanol extraction was used with a liquid-to-solid ratio of 1:7 and a concentration of 60%, and reflux extraction was performed at a temperature of 70°C for 2 hours. After extraction, the extract was filtered using a 300-mesh filter cloth, and then the extract and the residue were separated by a centrifugal device, and the speed was set to 3000 rpm. The extract was concentrated at low temperature and reduced pressure at a temperature not exceeding 60°C to 1 / 4 of the original volume, and finally treated by spray drying, with the inlet air temperature controlled at 120°C. Finally, the obtained powder was mixed evenly and made into capsules. The mixer speed was 900 rpm, and the active ingredients and heavy metal content were tested. After passing the test, the capsules were sealed and packaged to ensure long-term storage.

[0034] Example 7: Performance Test In order to evaluate the effect of the prepared traditional Chinese medicine composition, the prepared products of Examples 1 to 6 were selected and the performance tests were carried out using the following method: Fracture healing effect test: A fracture model is established on experimental animals (such as mice or rats), and the animals are randomly divided into groups and given the Chinese medicine compositions of different embodiments and normal saline in the control group. The healing time, X-ray imaging and bone density changes are observed.

[0035] Evaluation of anti-inflammatory effect: Using the mouse paw swelling model, after injecting inflammatory factors, different compositions were orally administered, the degree of paw swelling was monitored, the swelling rate was calculated, and the anti-inflammatory effect was evaluated.

[0036] Immune index detection: The immune factors (such as IL-6, TNF-α) in the serum were detected by ELISA method to analyze the effects of each composition on the immune system.

[0037] Analysis of active ingredient content: High performance liquid chromatography (HPLC) is used to determine the active ingredient content in each composition to ensure its quality and stability.

[0038] Microbiological testing: According to the national pharmacopoeia standards, the prepared tablets and capsules are tested for microbial limits to ensure product safety.

[0039] Test results: In the fracture healing test, the composition of Example 1 significantly shortened the healing time, with an average healing time of 14 days. X-ray imaging showed good bone healing and an increase in bone density of about 30%. In the anti-inflammatory effect evaluation, the swelling rate was reduced to 25%, indicating that the composition has a good anti-inflammatory effect.

[0040] The composition of Example 2 showed a strong anti-inflammatory effect in the mouse foot swelling model, and the swelling rate was reduced to 20%. In the immune index detection, the levels of IL-6 and TNF-α were significantly reduced, indicating that it has a regulatory effect on the immune system. The analysis of the active ingredient content showed that the concentration of the active ingredient reached the expected standard.

[0041] The composition of Example 3 showed better effect in fracture healing, with an average healing time of only 12 days. X-ray imaging showed a significant increase in bone density, reaching 40%. In the anti-inflammatory effect evaluation, the swelling rate was reduced to 15%, and the immune index test results showed that it could significantly increase the level of immune factors.

[0042] In the anti-inflammatory effect test, the swelling rate of the composition of Example 4 was reduced to 22%, showing good anti-inflammatory effect. The analysis results of the active ingredient content showed that the active ingredient content met the national standard, and no pathogenic bacteria were detected in the microbial test, ensuring product safety.

[0043] The composition of Example 5 performed well in the fracture healing test, with an average healing time of 11 days and a 45% increase in bone density. The anti-inflammatory effect evaluation showed that the swelling rate was reduced to 18%, and in the immune index test, the levels of IL-6 and TNF-α were significantly reduced.

[0044] The composition of Example 6 performed well in the immune index test and could significantly increase the level of immune factors. In the anti-inflammatory effect evaluation, the swelling rate was reduced to 19%. The analysis results of the active ingredient content met the standards, ensuring its quality and stability. In the microbial test, the prepared capsules met the safety standards.

[0045] Performance summary: Based on the test results of each embodiment, the effect of embodiment 3 is the best. In the fracture healing test, the average healing time is 12 days, and the bone density is significantly increased by 40%. In the anti-inflammatory effect evaluation, the swelling rate is reduced to 15%, and good immunoregulatory effect is shown in the immune index detection. These results show that the composition of embodiment 3 has the best performance in terms of efficacy and has a strong prospect for clinical application.

[0046] The above embodiments are preferred implementation modes of the present invention, but the implementation modes of the present invention are not limited to the above embodiments. Any other changes, modifications, substitutions, combinations, and simplifications that do not deviate from the spirit and principles of the present invention should be equivalent replacement methods and are included in the protection scope of the present invention.

Claims

1. A Chinese medicine composition for treating fractures and a preparation method thereof, characterized in that: The Chinese medicine composition is prepared by weighing the following Chinese medicinal materials according to the weight ratio: 200-500 g of Dipsacus asper, 100-300 g of Panax notoginseng, 150-400 g of Drynaria fortunei, 100-250 g of Angelica sinensis, 50-150 g of frankincense, and 50-150 g of myrrh; the preparation process comprises the following steps: S1: Raw material preparation: mix Radix Dipsaci, Radix Notoginseng, Rhizoma Drynariae, Radix Angelicae Sinensis, frankincense and myrrh according to weight ratio; S2: Crushing: The above medicinal materials are coarsely crushed to make the particle size of the medicinal materials reach 20~80 mesh; for the relatively hard medicinal materials of Drynaria fortunei, mechanical crushing is adopted; frankincense and myrrh resin medicinal materials need to be crushed under low temperature environment, and 5%~10% coolant is added in the crushing process to reduce the temperature and ensure that the efficacy is not lost; S3: Extraction: water or ethanol is selected as the extraction solvent, and the liquid-to-solid ratio is set to 10:1 for water extraction or ethanol reflux extraction. The extraction process is performed twice to improve the extraction rate of the effective components; S4: Filtration and concentration: The extracted solution is filtered through filter cloth or centrifugal equipment to remove the drug residue. The filtered liquid needs to be concentrated under reduced pressure at low temperature to retain the active ingredients in the extract. The concentration process should be monitored in real time to avoid overheating; S5: Drying: Use freeze drying or spray drying to dry the concentrate into powder. During spray drying, the spray temperature must be controlled at 20-60°C to avoid loss of active ingredients. The dried powder must be sealed and stored in an inert gas environment to prevent moisture absorption and deterioration, and an appropriate amount of antioxidants must be added to extend the shelf life. S6: Mixing and molding: The dry powder is uniformly mixed. After mixing, it can be pressed into tablets, filled into capsules or made into granules. It can also be mixed with maltose or gelatin to make a plaster. The mixing time and speed must be controlled during the mixing process to avoid the destruction of the medicinal ingredients. S7: Quality testing and packaging: The final product shall be tested for active ingredient content, heavy metals and microbial indicators to ensure compliance with pharmacopoeia standards; after passing the test, it shall be repackaged and stored in a cool and dry place. The packaging materials shall be moisture-proof and oxygen-barrier to ensure the long-term stability of the drug; the outer packaging of the product shall indicate the active ingredient content, usage and precautions, and be accompanied by the batch number and production date to ensure traceability.

2. A Chinese medicine composition for treating fractures and a preparation method according to claim 1, characterized in that: The particle size range of the pulverization treatment is 20-80 meshes, wherein the rotation speed of the mechanical pulverization of the relatively hard Drynaria herb is 3000-5000 rpm, and the low-temperature pulverization temperature of frankincense and myrrh is controlled at -10°C-0°C to avoid the loss of effective ingredients of the medicinal materials.

3. A Chinese medicine composition for treating fractures and a preparation method according to claim 1, characterized in that: The liquid-to-solid ratio of the water extraction method is 1:8-1:10, the decoction temperature is 100°C, and the extraction time is 1-2 hours; the liquid-to-solid ratio of the ethanol extraction method is 1:5-1:8, the ethanol concentration is 40%-70%, the extraction temperature is 60-80°C, and the extraction time is 1-2 hours.

4. A Chinese medicine composition for treating fractures and a preparation method according to claim 1, characterized in that: The extraction step adopts a two-extraction process. After the first extraction, the drug residue is subjected to a second extraction to ensure that the extraction rate of the effective ingredients reaches more than 80%, thereby retaining the active ingredients of the medicinal materials to the maximum extent.

5. A Chinese medicine composition for treating fractures and a preparation method according to claim 1, characterized in that: During the filtration of the extract, a 300-400 mesh filter cloth is used for primary filtration, and then a centrifugal device is used to perform centrifugal separation at a speed of 3000-4000 rpm to remove the drug residue and obtain a clarified extract.

6. A Chinese medicine composition for treating fractures and a preparation method according to claim 1, characterized in that: The reduced pressure concentration step is carried out at a low temperature of 40-60° C. to concentrate the extract to 0.25-0.33 of the original extract volume, ensuring that the temperature is not higher than 60° C. to avoid damage to the active ingredients of the drug by high temperature.

7. A Chinese medicine composition for treating fractures and a preparation method according to claim 1, characterized in that: In the drying step, the temperature of the freeze-drying method is controlled at -40°C to -60°C to maintain low-temperature drying; the air inlet temperature of the spray drying method is controlled at 100°C to 150°C to ensure uniform particle size of the powder and avoid damage to heat-sensitive components.

8. A Chinese medicine composition for treating fractures and a preparation method according to claim 1, characterized in that: In the mixing step, the dry powder of the medicinal material is mixed by a high-speed mixer at a speed of 500-1000 rpm to ensure uniform distribution of the components; during the molding process, the hardness of the tablets pressed by the tablet press is controlled at 5-10 kg / cm² to ensure the structural stability of the tablets.

9. A Chinese medicine composition for treating fractures and a preparation method according to claim 1, characterized in that: The medicinal material composition can be prepared into various dosage forms such as tablets, capsules, granules and plasters, wherein the plaster dosage form is prepared by mixing the dry powder with the matrix in a weight ratio of 1:2 and uniformly coating the mixture on gauze or base cloth.

10. A Chinese medicine composition for treating fractures and a preparation method according to claim 1, characterized in that: The finished products must be quality inspected before packaging. The inspection contents include the content of active ingredients, microbial indicators, heavy metal content and moisture content to ensure that the products meet the national pharmaceutical standards. After passing the inspection, they must be sealed and packaged and stored in a cool and dry place, avoiding direct sunlight.