A mongolian medicine spray for treating bone injury and a preparation method thereof
By preparing a standardized Mongolian medicine spray and utilizing Mongolian medicine raw materials and ethanol solution extraction technology, the problem of unstable efficacy of Western medicine and traditional Mongolian medicine preparations in the treatment of bone injuries has been solved, achieving the effects of rapid swelling reduction, pain relief, and fracture healing.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- ORDOS MONGOLIAN MEDICINE HOSPITAL (ORDOS MONGOLIAN MEDICINE RES INST)
- Filing Date
- 2026-01-05
- Publication Date
- 2026-05-15
AI Technical Summary
When treating bone injuries, existing topical medications have limited effectiveness with Western medicine preparations, while traditional Mongolian medicine preparations lack standardized procedures, resulting in unstable efficacy and poor consistency.
Using Mongolian medicinal materials such as Panax notoginseng, safflower, Ligusticum chuanxiong, Angelica sinensis, Paeonia lactiflora, cinnamon, tangerine peel, Eucommia ulmoides, and Citrus reticulata peel, combined with ethanol solution extraction and standardized processes, a Mongolian medicine spray is prepared. Transdermal penetration enhancers, surfactants, and antioxidants are added to ensure uniform dissolution and stability of the active ingredients.
It achieves rapid reduction of swelling and pain, promotes fracture healing and soft tissue repair, and is safe and convenient to use with reliable and consistent efficacy.
Smart Images
Figure CN121445805B_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of traditional Chinese medicine preparation technology, specifically to a Mongolian medicine spray for treating bone injuries and its preparation method. Background Technology
[0002] Closed fractures, soft tissue injuries, and other common orthopedic conditions are often accompanied by pain, swelling, and limited mobility. Improper treatment can easily hinder functional recovery. Currently, commonly used topical medications for these conditions have the following shortcomings: First, Western topical preparations (such as analgesics and anti-inflammatory drugs) primarily aim to relieve symptoms and have limited effectiveness in promoting bone regeneration or soft tissue repair. Second, while traditional Mongolian medicine and other ethnic minority medicine topical preparations theoretically emphasize "promoting blood circulation and removing blood stasis, regulating both tendons and bones," in practice, their formulations and dosages often rely on experience, with unclear preparation process parameters and a lack of standardized procedures. This leads to differences in the dissolution and stability of active ingredients between different batches of products, thus affecting the reliability and consistency of efficacy. Summary of the Invention
[0003] In view of the shortcomings of the existing technology, the present invention provides a Mongolian medicine spray that can quickly reduce swelling and relieve pain, promote fracture healing and soft tissue repair, and has a standardized preparation process and stable quality, as well as its preparation method.
[0004] To solve the above-mentioned technical problems, the present invention adopts the following technical solution:
[0005] This invention provides a Mongolian medicine spray for treating bone injuries, comprising an active ingredient and pharmaceutically acceptable excipients; the active ingredient is an extract obtained by extracting the following raw materials in parts by weight: 120-150 parts of Panax notoginseng, 60-80 parts of Angelica sinensis, 10-15 parts of Carthamus tinctorius, 60-80 parts of Paeonia lactiflora, 40-60 parts of Cinnamomum cassia, 80-100 parts of Ligusticum chuanxiong, 30-50 parts of Citrus reticulata peel, 90-110 parts of Eucommia ulmoides, and 30-50 parts of Citrus reticulata peel with 55%-65% ethanol solution; the excipients include one or more of transdermal penetration enhancers, surfactants, humectants, and antioxidants.
[0006] Preferably, the raw materials are in the following weight proportions: 135 parts Panax notoginseng, 70 parts Angelica sinensis, 13 parts Carthamus tinctorius, 70 parts Paeonia lactiflora, 50 parts Cinnamomum cassia, 90 parts Ligusticum chuanxiong, 40 parts Citrus reticulata peel, 100 parts Eucommia ulmoides, and 40 parts Citrus reticulata peel.
[0007] Preferably, the surfactant is polysorbate 80, the humectant is glycerin, and the antioxidant is sodium bisulfite.
[0008] Preferably, the transdermal penetration enhancer is one or more of menthol, azone, and borneol.
[0009] The present invention also provides a method for preparing the Mongolian medicine spray, comprising the following steps: S1, pretreatment of medicinal materials: weigh nine kinds of medicinal materials according to the proportion, clean and wash them, dry them and then crush them into coarse particles with a particle size of 0.8-1.0 mm; S2, sealed extraction: place the coarse particles of medicinal materials in a container, add 55%-65% ethanol solution by volume to completely immerse them, seal the container, and let it stand for 60-84 hours at 15-25℃ under light-proof conditions; S3, mixing and post-treatment: after the extraction is completed, stir and mix for 10-20 minutes, and then let it stand for 1-3 hours; S4, filtration and filling: take the supernatant from S3, add the excipients, filter it through a 0.22μm microporous membrane, and fill it to obtain the Mongolian medicine spray.
[0010] Preferably, based on the total volume of the final drug solution, the transdermal penetration enhancer is 0.1% to 0.5%, the surfactant is 0.2% to 1.0%, the humectant is 1.0% to 3.0%, and the antioxidant is 0.01% to 0.1%.
[0011] Preferably, in step S2, the mass-to-volume ratio of the medicinal material to the ethanol solution is 30-40 g / L.
[0012] Finally, this invention provides the use of a Mongolian medicine spray in the preparation of a medicament for treating closed fractures and / or soft tissue injuries.
[0013] The beneficial effects of this invention include:
[0014] 1. Scientifically formulated with synergistic effects: This formula uses Panax notoginseng, safflower, and Ligusticum chuanxiong to invigorate blood and remove blood stasis; Angelica sinensis to nourish blood and promote circulation; Paeonia lactiflora to clear heat and cool blood; Cinnamomum cassia to warm the meridians and unblock the vessels; Citrus reticulata and Citrus aurantium to regulate qi and relieve stagnation; and Eucommia ulmoides to strengthen tendons and bones. The combination of these herbs achieves the effects of invigorating blood, relieving pain, and promoting tendon and bone healing, while also addressing the "blood stasis and heat" in the acute phase of injury and the "deficiency and cold" in the recovery phase, which is consistent with the pathological process of bone injury repair.
[0015] 2. Standardized process and controllable quality: By clearly defining core process parameters such as the particle size of medicinal materials, the ethanol concentration of the extraction solvent, and the extraction temperature and time, traditional experience is transformed into a quantifiable and repeatable standardized process, ensuring the stable and consistent dissolution rate of effective components in different batches of products, thereby guaranteeing the reliability of efficacy.
[0016] 3. The formulation is rationally designed and safe and convenient to use: Utilizing an ethanol-water mixed solvent, it can simultaneously and efficiently extract both fat-soluble and water-soluble active ingredients. This results in a topical spray that can be applied directly to the affected area, avoiding the first-pass effect. It is easy to use and has low irritation to intact skin. Attached Figure Description
[0017] Figure 1 : 7-day serum ALP level test results;
[0018] Figure 2 : Graph showing the results of serum ALP level detection over 14 days;
[0019] Figure 3 : 7-day serum BMP-2 level test results;
[0020] Figure 4 : Graph showing the results of serum BMP-2 level detection over 14 days. Detailed Implementation
[0021] This invention is illustrated by the following embodiments, but the scope of the invention is not limited thereto. Unless otherwise specified, the methods described in this invention employ conventional experimental techniques in the art, and the reagents and materials used are commercially available. Unless otherwise stated, the percentage of excipients added in this invention refers to the mass-volume percentage concentration (w / v) based on the total volume of the final drug solution.
[0022] Example 1
[0023] Take the following ingredients: 135g Panax notoginseng, 70g Angelica sinensis, 13g Carthamus tinctorius, 70g Paeonia lactiflora, 50g Cinnamomum cassia, 90g Ligusticum chuanxiong, 40g Citrus reticulata peel, 100g Eucommia ulmoides, and 40g Citrus reticulata peel.
[0024] The preparation steps are as follows: S1. Pretreatment of medicinal materials: Clean and wash the above nine medicinal materials. Among them, the number of heads of Panax notoginseng should be 15-20 and the length of tubular flowers of safflower should be 1-2cm. Dry them in a cool and ventilated place until the moisture content is about ≤8%. The medicinal materials are pulverized using a pulverizer, and coarse particles with a particle size of 0.8-1.0 mm are selected for later use; S2, Solvent preparation: 17.3 L of 60% ethanol solution is prepared for later use; S3, Extraction: The coarse particles of medicinal materials are placed in a ceramic jar, the above solvent is added, and the mixture is stirred to completely submerge the medicinal materials. After sealing the container, it is placed in a light-proof environment at 20°C and allowed to stand for 72 hours for extraction; S4, Post-processing and filling: After extraction, the liquid is stirred moderately for 15 minutes, and then allowed to stand for 2 hours to settle. The supernatant is taken and filtered through a 0.22 μm microporous membrane to obtain a clear extract. Menthol 0.3%, polysorbate 80 0.6%, glycerin 2.0%, and sodium bisulfite 0.06% are added, and the mixture is filtered through a 0.22 μm microporous membrane. Under clean conditions, the final liquid is filled into suitable spray containers and sealed to obtain the Mongolian medicine spray of the present invention.
[0025] Example 2
[0026] Take the following ingredients: 120g Panax notoginseng, 60g Angelica sinensis, 10g Carthamus tinctorius, 60g Paeonia lactiflora, 40g Cinnamomum cassia, 80g Ligusticum chuanxiong, 30g Citrus reticulata peel, 90g Eucommia ulmoides, and 30g Citrus reticulata peel.
[0027] The preparation steps are as follows: S1. Pretreatment of medicinal materials: Clean and wash the above nine medicinal materials. Among them, the number of heads of Panax notoginseng should be 15-20 and the length of tubular flowers of safflower should be 1-2cm. Dry them in a cool and ventilated place until the moisture content is about ≤8%. The medicinal materials are pulverized using a pulverizer, and coarse particles with a particle size of 0.8-1.0 mm are selected for later use; S2, Solvent preparation: 17.3 L of 55% ethanol solution is prepared for later use; S3, Extraction: The coarse particles of medicinal materials are placed in a ceramic jar, the above solvent is added, and the mixture is stirred to completely submerge the medicinal materials. After sealing the container, it is placed in a light-proof environment at 15°C and allowed to stand for 60 hours for extraction; S4, Post-processing and filling: After extraction, the liquid is stirred moderately for 15 minutes, and then allowed to stand for 2 hours to settle. The supernatant is taken and filtered through a 0.22 μm microporous membrane to obtain a clear extract. 0.1% azone, 0.2% polysorbate 80, 1.0% glycerol, and 0.01% sodium bisulfite are added, and the mixture is filtered through a 0.22 μm microporous membrane. Under clean conditions, the final liquid is filled into suitable spray containers and sealed to obtain the Mongolian medicine spray of the present invention.
[0028] Example 3
[0029] Take the following ingredients: 150g Panax notoginseng, 80g Angelica sinensis, 15g Carthamus tinctorius, 80g Paeonia lactiflora, 60g Cinnamomum cassia, 100g Ligusticum chuanxiong, 50g Citrus reticulata peel, 110g Eucommia ulmoides, and 50g Citrus reticulata peel.
[0030] The preparation steps are as follows: S1. Pretreatment of medicinal materials: Clean and wash the above nine medicinal materials. Among them, the number of heads of Panax notoginseng should be 15-20 and the length of tubular flowers of safflower should be 1-2cm. Dry them in a cool and ventilated place until the moisture content is about ≤8%. The medicinal materials are pulverized using a pulverizer, and coarse particles with a particle size of 0.8-1.0 mm are selected for later use; S2, Solvent preparation: 17.4 L of 65% ethanol solution is prepared for later use; S3, Extraction: The coarse particles of medicinal materials are placed in a ceramic jar, the above solvent is added, and the mixture is stirred to completely submerge the medicinal materials. After sealing the container, it is placed in a light-proof environment at 25°C and allowed to stand for 84 hours for extraction; S4, Post-processing and filling: After extraction, the liquid is stirred moderately for 15 minutes, and then allowed to stand for 2 hours to settle. The supernatant is taken and filtered through a 0.22 μm microporous membrane to obtain a clear extract. 0.5% borneol, 1.0% polysorbate 80, 3.0% glycerol, and 0.1% sodium bisulfite are added, and the mixture is filtered through a 0.22 μm microporous membrane. Under clean conditions, the final liquid is filled into suitable spray containers and sealed to obtain the Mongolian medicine spray of the present invention.
[0031] Comparative Example 1
[0032] Compared with Example 1, the raw materials are omitted, except for green tangerine peel and dried tangerine peel, while the rest are the same as in Example 1.
[0033] Comparative Example 2
[0034] Compared with Example 1, Eucommia ulmoides is omitted from the raw materials, while the rest is the same as in Example 1.
[0035] Comparative Example 3
[0036] Compared with Example 1, safflower is omitted from the raw materials, while the rest are the same as in Example 1.
[0037] Comparative Example 4
[0038] Compared with Example 1, Panax notoginseng was replaced with ginseng, and everything else was the same as in Example 1.
[0039] Comparative Example 5
[0040] In Example 1, the amount of safflower used in the raw materials was 5g, while the rest was the same as in Example 1.
[0041] Comparative Example 6
[0042] Compared with Example 1, the extraction time was shortened to 24 hours, and other aspects were the same as in Example 1.
[0043] Comparative Example 7
[0044] Compared with Example 1, the solvent was changed to 40% ethanol, and everything else was the same as in Example 1.
[0045] Comparative Example 8
[0046] Compared with Example 1, the medicinal materials were pulverized into fine powder with a particle size of less than 0.1 mm, but otherwise the same as in Example 1.
[0047] Experimental Example 1: Skin Irritation Test
[0048] 1. Experimental Methods
[0049] Healthy mice were selected, and intact skin areas and damaged skin areas were prepared on both sides of their spine. The sprays prepared in Examples 1, 2, and 3 of this invention were used as test samples, physiological saline as a negative control, and 8% sodium sulfide solution as a positive control, and were applied to the corresponding areas respectively. A single dose was administered and observed for 24 hours, followed by multiple doses and observations.
[0050] The scoring criteria are as follows:
[0051] Erythema formation: 0 points: no erythema; 1 point: slight erythema (barely visible);
[0052] 2 points: Obvious erythema (pale red, clearly visible); 3 points: Moderate to severe erythema (bright red or dark red); 4 points: Purplish-red erythema with slight eschar formation.
[0053] Edema formation: 0 points: no edema; 1 point: mild edema (barely visible, only thickened in skin folds); 2 points: mild edema (clearly visible, with raised outline); 3 points: moderate edema (raised to about 1 mm); 4 points: severe edema (raised to more than 1 mm, extending beyond the contact area).
[0054] 2. Experimental Results
[0055] Table 1 Skin irritation test
[0056]
[0057] The rating is expressed as: "1 / 0" means 1 point for erythema and 0 points for edema.
[0058] The results show that the spray prepared according to the process of the present invention has low irritation and high safety.
[0059] Experiment Example 2: Study on the Healing-Promoting Effect on Fracture Model Animals
[0060] 1. Experimental Methods
[0061] Healthy adult rats were surgically used to establish a standard closed radial fracture model and randomly divided into 13 groups: groups 1-3 of this invention, groups 1-8 of comparative examples, a positive control group of commercially available bone-setting ointment, and a model control group of physiological saline. Each group consisted of 8 rats. The corresponding medication was sprayed twice daily onto the fracture site for 28 consecutive days. The model control group received an equal volume of physiological saline.
[0062] X-ray imaging: X-rays were taken on postoperative days 7, 14, and 28. The Lane-Sandhu scoring method was used to assess callus formation. The Lane-Sandhu scoring method is a standardized imaging scoring system widely used to assess the healing of experimental fractures. Its scoring criteria typically include: callus formation (0-4 points), fracture line clarity (0-4 points), and bone remodeling status (0-3 points), with a total score of 0-11 points. The higher the score, the better the healing.
[0063] Serum biochemical markers were tested: Blood samples were taken on the 7th and 14th days after surgery to detect the levels of alkaline phosphatase (ALP) and bone morphogenetic protein-2 (BMP-2) in the serum.
[0064] 2. Experimental Results
[0065] Table 2 Results of the Lane-Sandhu scoring method
[0066]
[0067] Table 2 shows that the callus growth scores of Examples 1-3 were all higher than those of all comparative groups and comparable to those of the positive control group. Specifically, the absence of green tangerine peel, dried tangerine peel (Comparative Example 1), Eucommia ulmoides (Comparative Example 2), or insufficient dosage of safflower (Comparative Example 5) all led to significantly lower scores, indicating that the synergistic effect of the qi-regulating, bone-strengthening, and blood-activating components in the compound is crucial for promoting bone healing. Furthermore, insufficient extraction time (Comparative Example 6), excessively low ethanol concentration (Comparative Example 7), or excessively fine herbal powder (Comparative Example 8) also reduced the efficacy, verifying the necessity of the process parameters defined in this invention for the full and balanced extraction of effective components.
[0068] Serum biochemical marker test results as follows Figure 1-4 As shown, the serum ALP and BMP-2 levels in rats in Examples 1-3 showed the highest peaks and longest durations on postoperative days 7 and 14. The peak levels in each comparative group were lower than those in Examples 1-3, indicating a weakened ability to promote osteoblast activity and induce osteogenic differentiation.
[0069] Experimental Example 3: Typical Case
[0070] Case 1: A 35-year-old male patient presented with an ankle sprain. Physical examination revealed significant swelling and ecchymosis on the lateral side of the right ankle, limited range of motion, and a visual analog scale (VAS) score of 7 for pain. The spray of this invention was applied topically three times daily. At the follow-up visit three days later, the swelling and ecchymosis had significantly subsided, the VAS score had decreased to 2, and joint mobility had improved. Case 2: A 58-year-old female patient was diagnosed with a closed fracture of the distal radius of the left arm, which was closed and then immobilized with a plaster cast. During the immobilization period, the spray of this invention was applied topically twice daily to the area corresponding to the fracture. A follow-up X-ray four weeks later showed a blurred fracture line with continuous callus formation. The patient reported that the swelling and pain at the fracture site significantly decreased after one week of medication.
[0071] The above description represents the preferred embodiments of the present invention. It should be noted that those skilled in the art can make various improvements and modifications without departing from the principles of the present invention, and these improvements and modifications should also be considered within the scope of protection of the present invention.
Claims
1. A Mongolian medicine spray for treating bone injuries, characterized in that, It is composed of an active ingredient and pharmaceutically acceptable excipients; the active ingredient is an extract obtained by extracting the following raw materials in parts by weight with an ethanol solution of 55%-65% by volume: Panax notoginseng 135 parts, Angelica sinensis 70 parts, Carthamus tinctorius 13 parts, Paeonia lactiflora 70 parts, Cinnamomum cassia 50 parts, Ligusticum chuanxiong 90 parts, Citrus reticulata 40 parts, Eucommia ulmoides 100 parts, Citrus reticulata 40 parts; the excipients include one or more of transdermal penetration enhancers, surfactants, humectants and antioxidants.
2. The Mongolian medicine spray according to claim 1, characterized in that, The surfactant is polysorbate 80, the humectant is glycerin, and the antioxidant is sodium bisulfite.
3. The Mongolian medicine spray according to claim 1, characterized in that, The transdermal penetration enhancer is one or more of menthol, azone, and borneol.
4. A method for preparing the Mongolian medicine spray according to any one of claims 1-3, characterized in that, Includes the following steps: S1. Pre-treatment of medicinal materials: Weigh out nine kinds of medicinal materials according to the proportion, clean and wash them, dry them and then crush them into coarse particles with a particle size of 0.8-1.0 mm. S2. Sealed extraction: Place the coarse particles of the medicinal material in a container, add 55%-65% ethanol solution to completely submerge them, seal, and let stand for 60-84 hours at 15-25℃ in the dark. S3. Mixing and post-treatment: After extraction, stir and mix for 10-20 minutes, then let stand for 1-3 hours; S4. Filtration and filling: Take the supernatant from S3, add the excipients, filter through a 0.22μm microporous membrane, and fill to obtain the Mongolian medicine spray.
5. The preparation method according to claim 4, characterized in that, Based on the total volume of the final drug solution, the transdermal penetration enhancer is 0.1%–0.5%, the surfactant is 0.2%–1.0%, the humectant is 1.0%–3.0%, and the antioxidant is 0.01%–0.1%.
6. The preparation method according to claim 4, characterized in that, In step S2, the mass-to-volume ratio of the medicinal material to the ethanol solution is 30-40 g / L.
7. Use of the Mongolian medicine spray as described in any one of claims 1-3 in the preparation of a medicament for treating closed fractures and / or soft tissue injuries.