A bone-setting and tendon-repairing capsule and a preparation method thereof

Abstract

This invention relates to the field of traditional Chinese medicine preparations, specifically to a bone-setting and tendon-repairing capsule and its preparation method. The capsule is made from the following raw materials in the indicated weight ratios: frankincense 250-350g, myrrh 250-350g, tortoise shell 250-350g, angelica sinensis 150-250g, gourd tea 250-350g, *Homalomena occulta* 150-250g, *Centella asiatica* 250-350g, *Eucommia ulmoides* leaf 150-250g, dragon's blood 250-350g, and melon seeds 250-350g. The preparation method of this formula includes the following steps: S1: cleaning and pretreatment; S2: drying; S3: pulverizing; S4: mixing; S5: capsule filling; S6: polishing and packaging. The beneficial effects are: it is used to treat fractures and tendon injuries, and has the effects of promoting bone healing, relieving pain, and promoting bone healing; it has significant efficacy and is convenient to take; the formula is scientific, treating both the symptoms and the root cause; it has a rapid onset of action and a definite curative effect; the dosage form is advanced and convenient to take; and it has high safety.

Description

Technical Field

[0001] The present invention relates to the technical field of traditional Chinese medicine preparations, and particularly to a Bone-Bonding and Muscle-Connecting Capsule and its preparation method. Background Art

[0002] Orthopedic diseases such as fractures and traumatic injuries are common and frequently-occurring diseases in clinical practice. According to traditional Chinese medicine theory, after "bone fracture and muscle injury", the qi and blood circulation is blocked, blood stasis and qi stagnation occur, and the tendons and bones lose nourishment. Therefore, the basic principles of treatment are promoting blood circulation to remove blood stasis, reducing swelling and relieving pain, bone-bonding and muscle-connecting, and tonifying the liver and kidney.

[0003] Currently, there are various proprietary Chinese medicines for treating fractures and muscle injuries on the market, such as Dieda Pills, Sanqi Shangyao Tablets, Yunnan Baiyao Capsules, etc. Although these drugs have certain curative effects, there are still some deficiencies. For example, some drugs have strong blood-activating and stasis-removing effects but weak effects of tonifying the liver and kidney and promoting bone healing; some drugs have obvious pain-relieving effects but a longer overall healing period; some drugs have a complex formula, high cost, or poor taste, resulting in poor patient compliance.

[0004] Therefore, it is of great clinical significance and market value to develop a new traditional Chinese medicine preparation with a scientific formula, definite curative effect, quick onset, which can significantly shorten the fracture healing period, treat both the symptoms and the root causes, and is convenient to take. Summary of the Invention

[0005] To overcome the technical defects in the prior art and effectively solve the technical problems in the background art, the present invention provides the following technical solutions:

[0006] A Bone-Bonding and Muscle-Connecting Capsule is made from the following raw materials in the following weight ratios: 250 - 350 grams of frankincense, 250 - 350 grams of myrrh, 250 - 350 grams of tortoise plastron, 150 - 250 grams of angelica sinensis, 250 - 350 grams of tadehagi triquetrum, 150 - 250 grams of homalomena occulta, 250 - 350 grams of centella asiatica, 150 - 250 grams of eucommia ulmoides leaves, 250 - 350 grams of dragon's blood resin, 250 - 350 grams of muskmelon seeds, 150 - 250 grams of panax notoginseng powder, 250 - 350 grams of bauhinia bark, 250 - 350 grams of fossilized swallows, 150 - 250 grams of schisandra chinensis, 120 - 240 grams of cornelian cherry fruit, 180 - 300 grams of black sesame seeds, 60 - 100 grams of cassia twig, 40 - 80 grams of psoralea corylifolia, 120 - 240 grams of prepared rehmannia root.

[0007] As a preferred technical solution of the present invention, it is made from the following raw materials in the following weight ratios: 300 grams of frankincense, 300 grams of myrrh, 300 grams of tortoise plastron, 200 grams of angelica sinensis, 300 grams of tadehagi triquetrum, 200 grams of homalomena occulta, 300 grams of centella asiatica, 200 grams of eucommia ulmoides leaves, 300 grams of dragon's blood resin, 300 grams of muskmelon seeds, 200 grams of panax notoginseng powder, 300 grams of bauhinia bark, 300 grams of fossilized swallows, 200 grams of schisandra chinensis, 180 grams of cornelian cherry fruit, 240 grams of black sesame seeds, 80 grams of cassia twig, 60 grams of psoralea corylifolia, 180 grams of prepared rehmannia root.

[0008] As a preferred technical solution of the present invention, it is made from the following raw materials in the indicated weight ratios: 250g frankincense, 350g myrrh, 250g processed tortoise shell, 250g angelica, 250g gourd tea, 250g Homalomena occulta, 350g Centella asiatica, 150g eucommia leaves, 250g dragon's blood, 350g melon seeds, 150g Panax notoginseng powder, 350g Bauhinia bark, 250g processed swallow's nest, 250g Schisandra chinensis, 120g Cornus officinalis, 300g black sesame, 60g cinnamon twig, 80g Psoralea corylifolia, and 120g Rehmannia glutinosa.

[0009] As a preferred technical solution of the present invention, it is made from the following raw materials in the indicated weight ratios: 350g frankincense, 250g myrrh, 350g processed tortoise shell, 150g angelica, 350g gourd tea, 150g Homalomena occulta, 250g Centella asiatica, 250g Eucommia ulmoides leaves, 350g dragon's blood, 250g melon seeds, 250g Panax notoginseng powder, 250g Bauhinia purpurea bark, 350g processed swallow's nest, 150g Schisandra chinensis, 240g Cornus officinalis, 180g black sesame, 100g cinnamon twig, 40g Psoralea corylifolia, and 240g Rehmannia glutinosa.

[0010] As a preferred technical solution of the present invention, it is made from the following raw materials in the indicated weight ratios: 300g frankincense, 300g myrrh, 300g processed tortoise shell, 200g angelica, 300g gourd tea, 200g Homalomena occulta, 300g Centella asiatica, 200g Eucommia ulmoides leaves, 300g dragon's blood, 300g melon seeds, 200g Panax notoginseng powder, 300g Bauhinia purpurea bark, 300g processed oyster shell, 200g Schisandra chinensis, 180g Cornus officinalis, 240g black sesame, 80g cinnamon twig, 60g Psoralea corylifolia, and 180g Rehmannia glutinosa.

[0011] A method for preparing a bone-healing and tendon-repairing capsule includes the following steps:

[0012] 1. Cleaning and Pre-treatment: Weigh each medicinal material according to the above proportions, and remove non-medicinal parts and impurities. Among them, tortoise shell and rock oyster shell need to be processed (such as sand scalding and vinegar quenching) before use; Rehmannia glutinosa is processed into slices.

[0013] 2. Drying: Dry the cleaned medicinal materials at a low temperature below 60℃ until the moisture content is less than 8%.

[0014] 3. Grinding: Mix all the dried medicinal materials evenly, put them into a grinder, and grind them into fine powder that can pass through a 100-mesh sieve.

[0015] 4. Mixing: Place the pulverized fine powder in a three-dimensional mixer and mix for 30-45 minutes until the color is uniform.

[0016] 5. Capsule filling: The well-mixed powder is filled into No. 0 capsule shells using a fully automatic capsule filling machine, with each capsule containing approximately 0.5 grams of powder.

[0017] 6. Polishing and Packaging: Polish the filled capsules with a capsule polishing machine to remove the powder adsorbed on the surface, then pack them into bottles and seal them to obtain the finished product.

[0018] The dosage and administration of the capsules of this invention are as follows: oral administration, 6-7 capsules each time, 2-3 times a day. The course of treatment depends on the fracture healing process, usually 4-6 weeks as one course of treatment.

[0019] Compared with existing technologies, the beneficial effects of this invention are: This invention provides a bone-healing and tendon-repairing capsule with significant therapeutic effects and convenient administration, used to treat fractures and tendon injuries, and has the effects of promoting bone and tendon healing, relieving pain, and promoting bone healing. Specifically, it has the following significant advantages:

[0020] 1. Scientifically formulated, addressing both symptoms and root cause: This formula integrates numerous blood-activating, stasis-removing, bone-healing, and liver- and kidney-tonifying drugs, combining both purgative and tonifying approaches. It targets both the symptoms of "blood stasis" and the root cause of "liver and kidney deficiency and malnourishment of tendons and bones," resulting in a comprehensive therapeutic effect.

[0021] 2. Fast onset of action and definite curative effect: The powerful blood-activating and pain-relieving drugs such as Panax notoginseng, myrrh, and dragon's blood in the formula can quickly relieve pain and swelling; tortoise shell, eucommia bark, and melon seeds can effectively promote fracture healing and shorten the course of treatment.

[0022] 3. Advanced dosage form and convenient administration: The capsule dosage form masks the unpleasant odor of traditional Chinese medicine, has an acceptable taste, accurate dosage, and is easy to carry and take, thus improving patient compliance.

[0023] 4. High safety: The entire formula consists of commonly used traditional Chinese medicines, with reasonable compatibility and no obvious toxic side effects, making it safe for clinical application.

[0024] The medicinal properties of the formulation components in this invention, according to traditional Chinese medicine principles of principal, assistant, adjuvant, and guide herbs, are analyzed as follows:

[0025] The principal ingredients are: Panax notoginseng powder, frankincense, myrrh, and dragon's blood. Panax notoginseng disperses blood stasis, stops bleeding, reduces swelling, and relieves pain, making it an essential medicine for traumatology; frankincense and myrrh invigorate blood circulation, promote qi flow, and relieve pain; dragon's blood invigorates blood circulation, disperses blood stasis, relieves pain, and stops bleeding. The four ingredients combined powerfully invigorate blood circulation, remove blood stasis, reduce swelling, and relieve pain, targeting the core pathogenesis of "blood stasis" after fractures and tendon injuries, and together they form the principal ingredients.

[0026] Assistant herbs: Angelica sinensis, Rehmannia glutinosa (processed), tortoise plastron, Eucommia ulmoides leaf, Psoralea corylifolia, Cucurbita melon seeds, Cornus officinalis. Angelica sinensis nourishes and invigorates blood; Rehmannia glutinosa and tortoise plastron nourish yin and kidneys, replenish essence and marrow; Eucommia ulmoides leaf and Psoralea corylifolia tonify the liver and kidneys, strengthen tendons and bones; Cucurbita melon seeds relax muscles and promote bone healing; Cornus officinalis tonifies the liver and kidneys, and astringes and consolidates. This group of herbs assists the principal herbs, enhancing their effects of invigorating and nourishing blood, tonifying the liver and kidneys, and promoting bone healing and tendon healing; hence, they are the assistant herbs.

[0027] Adjuvant herbs: Gourd tea, Centella asiatica, Bauhinia bark, Homalomena occulta, Cinnamon twig, Saltpeter, Schisandra chinensis, Black sesame. Gourd tea and Centella asiatica clear heat and dampness, detoxify and reduce swelling; Bauhinia bark invigorates blood circulation, regulates menstruation, reduces swelling and detoxifies; Homalomena occulta dispels wind and dampness, strengthens muscles and bones; Cinnamon twig warms and unblocks meridians, assists yang and promotes qi; Saltpeter removes damp heat and promotes urination; Schisandra chinensis invigorates qi and generates fluids, tonifies the kidneys and calms the mind; Black sesame tonifies the liver and kidneys, and benefits essence and blood. This group of herbs either assists the principal and assistant herbs, treats concurrent symptoms (such as damp heat), or harmonizes the properties of the herbs to prevent the principal and assistant herbs from being too warming and drying; all are adjuvant herbs.

[0028] Guiding medicine: Cinnamon twig also serves as a guiding medicine, directing other medicines directly to the affected area (the meridians of the limbs).

[0029] In summary, the combined effects of these herbs are to promote blood circulation, remove blood stasis, reduce swelling and relieve pain, promote bone healing and tendon repair, and nourish the liver and kidneys. Detailed Implementation

[0030] To make the objectives, technical solutions, and advantages of this invention clearer, the technical solutions in the embodiments of this invention will be described more clearly and completely below. Obviously, the described embodiments are only some embodiments of this invention, and not all embodiments. Based on the embodiments of this invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this invention.

[0031] Example 1:

[0032] Weigh out the following raw materials: 300g frankincense, 300g myrrh, 300g processed tortoise shell, 200g angelica, 300g gourd tea, 200g Homalomena occulta, 300g Centella asiatica, 200g Eucommia ulmoides leaves, 300g dragon's blood, 300g melon seeds, 200g Panax notoginseng powder, 300g Bauhinia bark, 300g processed oyster shell, 200g Schisandra chinensis, 180g Cornus officinalis, 240g black sesame seeds, 80g cinnamon twig, 60g Psoralea corylifolia, and 180g Rehmannia glutinosa.

[0033] Preparation: The above-mentioned medicinal materials are cleaned, dried at low temperature, mixed evenly, and pulverized into a fine powder that passes through a 100-mesh sieve. After the powder is thoroughly mixed, it is filled into No. 0 capsule shells using a fully automatic capsule filling machine, with each capsule containing 0.5 grams. After polishing and packaging, 1000 capsules of bone-setting and tendon-repairing capsules are obtained.

[0034] Example 2:

[0035] Weigh out the following raw materials: 250g frankincense, 350g myrrh, 250g processed tortoise shell, 250g angelica, 250g gourd tea, 250g Homalomena occulta, 350g centella asiatica, 150g eucommia leaves, 250g dragon's blood, 350g melon seeds, 150g Panax notoginseng powder, 350g Bauhinia bark, 250g processed oyster shell, 250g Schisandra chinensis, 120g Cornus officinalis, 300g black sesame, 60g cinnamon twig, 80g psoralea corylifolia, and 120g Rehmannia glutinosa.

[0036] The preparation method is the same as in Example 1.

[0037] Example 3:

[0038] Weigh out the raw materials: 350g frankincense, 250g myrrh, 350g processed tortoise shell, 150g angelica, 350g gourd tea, 150g Homalomena occulta, 250g centella asiatica, 250g eucommia ulmoides leaves, 350g dragon's blood, 250g melon seeds, 250g Panax notoginseng powder, 250g Bauhinia bark, 350g processed oyster shell, 150g schisandra chinensis, 240g cornus officinalis, 180g black sesame seeds, 100g cinnamon twig, 40g psoralea corylifolia, and 240g rehmannia glutinosa.

[0039] The preparation method is the same as in Example 1.

[0040] Example 4:

[0041] Weigh out the following raw materials: 300g frankincense, 300g myrrh, 300g processed tortoise shell, 200g angelica, 300g gourd tea, 200g Homalomena occulta, 300g Centella asiatica, 200g Eucommia ulmoides leaves, 300g dragon's blood, 300g melon seeds, 200g Panax notoginseng powder, 300g Bauhinia bark, 300g processed oyster shell, 200g Schisandra chinensis, 180g Cornus officinalis, 240g black sesame seeds, 80g cinnamon twig, 60g Psoralea corylifolia, and 180g Rehmannia glutinosa.

[0042] The preparation method is the same as in Example 1.

[0043] Experimental example: To demonstrate the clinical efficacy of the capsules of this invention, the following comparative study was conducted.

[0044] 1. Study subjects: 120 patients with fresh closed fractures were randomly divided into an experimental group (60 cases, who took the capsules prepared in Example 1 of this invention) and a control group (60 cases, who took a commercially available brand of bone-setting tablets).

[0045] 2. Treatment methods: Both groups of patients underwent routine reduction and fixation. The experimental group received oral administration of the capsules of this invention, 7 capsules each time, 3 times a day. The control group received bone-setting tablets according to the instructions. One course of treatment lasted 4 weeks, and a total of 2 courses were observed.

[0046] 3. Efficacy Criteria: Refer to the efficacy evaluation criteria for fractures in the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine". Cured: Fracture healed, with satisfactory alignment, and complete or basic functional recovery; Improved: Fracture aligned well, but healing is slow, and functional recovery is acceptable; Not Healed: Fracture does not heal or heals malunion, resulting in functional impairment.

[0047] result:

[0048]

[0049] Statistical analysis showed that the total effective rate of the experimental group was significantly higher than that of the control group (P<0.05).

[0050] 5. Comparison of pain reduction time and swelling reduction time:

[0051] Pain relief time: The average time in the experimental group was (5.2±1.8) days, while the average time in the control group was (7.1±2.3) days. The time in the experimental group was significantly shorter than that in the control group (P<0.01).

[0052] Swelling subsidence time: The average time in the experimental group was (6.5±2.1) days, while the average time in the control group was (8.9±2.6) days. The time in the experimental group was significantly shorter than that in the control group (P<0.01).

[0053] 6. Comparison of callus formation time (X-ray observation):

[0054] The average time for callus formation to begin in the experimental group was (14.5±3.2) days, while that in the control group was (18.2±4.1) days. The experimental group was superior to the control group (P<0.05).

[0055] Conclusion: The bone-healing and tendon-regenerating capsules provided by this invention are significantly more effective than the control drug in promoting fracture healing, relieving pain and swelling, and have a faster onset of action and a higher overall effective rate, showing good prospects for clinical application.

[0056] Although embodiments of the invention have been shown and described, it will be understood by those skilled in the art that various changes, modifications, substitutions and alterations can be made to these embodiments without departing from the principles and spirit of the invention, the scope of which is defined by the appended claims and their equivalents.

Claims

1. A bone-setting and tendon-repairing capsule, characterized in that: Made from the following raw materials in the indicated weight ratios: Frankincense 250-350g, Myrrh 250-350g, Tortoise plastron 250-350g, Angelica sinensis 150-250g, Gourd tea 250-350g, Homalomena occulta 150-250g, Centella asiatica 250-350g, Eucommia ulmoides leaves 150-250g, Dragon's blood 250-350g, Melon seeds 250-350g, Panax notoginseng powder 150-250g, Bauhinia purpurea bark 250-350g, Swallow's blood 250-350g, Schisandra chinensis 150-250g, Cornus officinalis 120-240g, Black sesame 180-300g, Cinnamomum cassia twig 60-100g, Psoralea corylifolia 40-80g, Rehmannia glutinosa 120-240g.

2. The bone-setting and tendon-repairing capsule according to claim 1, characterized in that: Made from the following raw materials in the indicated weight ratios: 300g frankincense, 300g myrrh, 300g tortoise shell, 200g angelica, 300g gourd tea, 200g *Homalomena occulta*, 300g centella asiatica, 200g eucommia leaves, 300g dragon's blood, 300g melon seeds, 200g notoginseng powder, 300g *Bauhinia purpurea* bark, 300g swallow's nest, 200g schisandra, 180g cornus officinalis, 240g black sesame, 80g cinnamon twig, 60g psoralea corylifolia, and 180g rehmannia glutinosa.

3. The bone-setting and tendon-repairing capsule according to claim 1, characterized in that: Made from the following raw materials in the indicated weight ratios: 250g frankincense, 350g myrrh, 250g processed tortoise shell, 250g angelica, 250g gourd tea, 250g *Homalomena occulta*, 350g *Centella asiatica*, 150g eucommia leaves, 250g dragon's blood, 350g melon seeds, 150g notoginseng powder, 350g *Bauhinia purpurea* bark, 250g processed swallow's nest, 250g schisandra, 120g cornus officinalis, 300g black sesame, 60g cinnamon twig, 80g psoralea corylifolia, and 120g prepared rehmannia root.

4. The bone-setting and tendon-repairing capsule according to claim 1, characterized in that: Made from the following raw materials in the indicated weight ratios: 350g frankincense, 250g myrrh, 350g processed tortoise shell, 150g angelica, 350g gourd tea, 150g *Homalomena occulta*, 250g *Centella asiatica*, 250g *Eucommia ulmoides* leaves, 350g dragon's blood, 250g melon seeds, 250g *Panax notoginseng* powder, 250g *Bauhinia purpurea* bark, 350g processed *Schisandra chinensis*, 150g *Schisandra chinensis*, 240g *Cornus officinalis*, 180g black sesame seeds, 100g cinnamon twig, 40g *Psoralea corylifolia*, and 240g *Rehmannia glutinosa*.

5. The bone-setting and tendon-repairing capsule according to claim 1, characterized in that: Made from the following raw materials in the indicated weight ratios: 300g frankincense, 300g myrrh, 300g processed tortoise shell, 200g angelica, 300g gourd tea, 200g *Homalomena occulta*, 300g *Centella asiatica*, 200g *Eucommia ulmoides* leaves, 300g dragon's blood, 300g melon seeds, 200g *Panax notoginseng* powder, 300g *Bauhinia purpurea* bark, 300g processed *Schisandra chinensis*, 200g *Schisandra chinensis*, 180g *Cornus officinalis*, 240g black sesame seeds, 80g cinnamon twig, 60g *Psoralea corylifolia*, and 180g *Rehmannia glutinosa*.

6. The method for preparing the bone-setting and tendon-repairing capsule according to any one of claims 1-5, characterized in that: Includes the following steps: S1: Cleaning and pretreatment: Weigh each medicinal material according to the above proportions and remove non-medicinal parts and impurities; S2: Drying: Dry the cleaned medicinal materials at a low temperature below 60℃ until the moisture content is less than 8%; S3: Grinding: Mix all the dried medicinal materials evenly, put them into a grinder, and grind them into fine powder that can pass through a 100-mesh sieve; S4: Mixing: Place the pulverized fine powder in a three-dimensional mixer and mix for 30-45 minutes until the color is uniform. S5: Capsule filling: The evenly mixed powder is filled into the capsule shell using a fully automatic capsule filling machine, with each capsule containing 0.5 grams of powder. S6: Polishing and Packaging: Polish the filled capsules with a capsule polishing machine to remove the powder adsorbed on the surface, then pack them into bottles and seal them to obtain the finished product.

7. The method for preparing the bone-setting and tendon-repairing capsule according to claim 6, characterized in that: In step S1, the tortoise shell and the stone swallow need to be processed before use, and the prepared Rehmannia glutinosa is a processed medicinal slice.

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