Tongli capsule and preparation process thereof
By preparing Tongli Capsules in capsule form, the problems of administration, portability, and efficacy of traditional Chinese medicine preparations have been solved. It achieves portability, rapid onset of action, and high bioavailability, and ensures the uniformity and stability of traditional Chinese medicine preparations. It is suitable for symptoms such as fractures, joint dislocations, and joint pain.
Patent Information
- Application Number
- CN202610572656.3
- Authority / Receiving Office
- CN · China
- Patent Type
- Applications(China)
- Current Assignee / Owner
- Filing Date
- 2026-04-28
- Publication Date
- 2026-06-23
AI Technical Summary
Existing Chinese medicine preparations have problems such as inconvenience in decoction, difficulty in taking and carrying, slow onset of action, difficulty in controlling dosage, single formula, and difficulty in guaranteeing quality stability. In particular, traditional dosage forms such as decoctions, pills, and powders have shortcomings in terms of administration, portability, and efficacy.
The capsule formulation uses a combination of fourteen traditional Chinese medicines, including Eupolyphaga sinensis. The capsules are prepared through standardized processes such as drying, pulverizing, mixing, sieving, and filling to ensure uniformity and stability. The quality is controlled by thin-layer chromatography.
It achieves the portability and precise dosage of capsule formulation, rapid drug efficacy, masked drug odor, and high bioavailability. It is suitable for conditions such as fractures, joint dislocations, and joint pain, and ensures product consistency and quality stability.
Smart Images
Figure CN122251501A_ABST
Abstract
Description
Technical Field
[0001] This invention relates to the field of traditional Chinese medicine preparation technology, and in particular to a Tongli capsule and its preparation process. Background Technology
[0002] Tongli Capsules are a compound traditional Chinese medicine preparation composed of various Chinese herbs. They have the effects of dispelling wind, relaxing muscles and tendons, and promoting blood circulation. Clinically, they are mainly used for the later stages of fractures and joint dislocations, as well as joint pain, synovitis, and other symptoms, such as limb dysfunction or loss, numbness and contracture, difficulty in flexion and extension of joints, heaviness in the waist and legs, and swelling and pain at the injury site.
[0003] In existing technologies, traditional Chinese medicine preparations used to treat such conditions mostly adopt traditional dosage forms such as decoctions, pills, and powders. However, traditional dosage forms have the following shortcomings: First, decoctions are inconvenient to prepare, difficult to take and carry, resulting in poor patient compliance; second, pills and powders often have a slow onset of action, and the dosage is not easy to control precisely; third, some preparations have a single formula, making it difficult to achieve multiple effects such as dispelling wind and dampness, promoting blood circulation and removing blood stasis, and relaxing muscles and tendons, thus limiting their clinical applicability; fourth, there is a lack of systematic quality control standards, making it difficult to guarantee batch-to-batch consistency and quality stability.
[0004] Furthermore, if the process parameters are not properly controlled during the pulverization and drying of traditional Chinese medicine raw materials containing volatile or heat-sensitive components, the effective components can easily be lost, affecting the efficacy. How to optimize the preparation process to retain the effective components to the maximum extent while ensuring the uniformity and stability of the formulation is a technical problem that urgently needs to be solved in this field. Summary of the Invention
[0005] Given that existing Chinese medicine preparations for treating such conditions mostly employ traditional dosage forms such as decoctions, pills, and powders, these traditional dosage forms have the following shortcomings: First, decoctions are inconvenient to prepare, difficult to carry, and have poor patient compliance; second, pills and powders often have a slow onset of action, and the dosage is not easy to control precisely; third, some preparations have a single formulation, making it difficult to achieve multiple effects such as dispelling wind and dampness, promoting blood circulation and removing blood stasis, and relaxing muscles and tendons, thus limiting their clinical applicability; fourth, the lack of systematic quality control standards makes it difficult to guarantee batch-to-batch consistency and quality stability. Therefore, this invention was proposed.
[0006] Therefore, the purpose of this invention is to provide a Tongli capsule, the purpose of which is that: by adopting a capsule dosage form, the contents are a uniform fine powder, which is convenient to take, accurate in dosage, has high bioavailability, and good patient compliance. Compared with decoctions, capsules do not require decoction, making them easier to carry and store; compared with pills and powders, capsules can mask the unpleasant odor of the drug, and disintegrate rapidly, resulting in a faster onset of action.
[0007] To solve the above-mentioned technical problems, the present invention provides the following technical solution: a Tongli capsule, comprising ingredients made from the following raw materials: Ground beetle, processed arisaema, vinegar-processed frankincense, vinegar-processed myrrh, dragon bone, angelica dahurica, safflower, peony root, notopterygium root, angelica sinensis, saposhnikovia root, cimicifuga rhizome, chuanxiong rhizome, and acorus calamus; The active pharmaceutical ingredient is dried, pulverized, mixed, and then filled into a capsule shell to form a capsule.
[0008] In a preferred embodiment of the Tongli capsules of the present invention, the weight parts of each raw material are as follows: 5-15 parts of ground beetle, 7-18 parts of processed arisaema, 20-35 parts of vinegar-processed frankincense, 15-24 parts of vinegar-processed myrrh, 13-121 parts of dragon bone, 22-37 parts of angelica dahurica, 15-20 parts of angelica sinensis, 22-31 parts of safflower, 21-36 parts of notopterygium incisum, 10-20 parts of angelica sinensis, 19-29 parts of saposhnikovia divaricata, 25-35 parts of cimicifuga foetida, 18-25 parts of chuanxiong rhizome, and 21-31 parts of acorus calamus.
[0009] As a preferred embodiment of the Tongli capsule of the present invention, the contents of the capsule are a brown powder having at least one of the following thin-layer chromatographic identification characteristics: (a) Take the contents of this product, add methanol to prepare a test solution, and separately take Saposhnikovia divaricata reference material to prepare a reference material solution. Perform thin-layer chromatography test. In the chromatogram of the test solution, spots of the same color appear at the corresponding positions as in the chromatogram of the reference material. (b) Take the contents of this product, add ether to prepare a test solution, and separately prepare a mixed reference solution of imperatorin reference standard and isoimperatorin reference standard. Perform thin-layer chromatography test. In the chromatogram of the test sample, fluorescent spots of the same color appear at the corresponding positions as in the chromatogram of the reference standard.
[0010] As a preferred embodiment of the preparation process of the Tongli capsules described in this invention, the process includes the following steps: Step 1, Ingredient Preparation: Weigh each raw material according to the prescription amount; Step 2, Mixing and Grinding: Mix all the raw materials and grind them into a fine powder; Step 3, Drying: Dry the pulverized fine powder; Step 4: Sifting: Sift the dried fine powder. Step 5, Filling: Fill the capsule shell with the sieved fine powder to obtain the final product.
[0011] In a preferred embodiment of the preparation process of the Tongli capsules of the present invention, in step 2, the pulverization is a mixed pulverization, and the pulverized material is passed through an 80-120 mesh sieve.
[0012] In a preferred embodiment of the preparation process of the Tongli capsules of the present invention, the drying temperature in step 3 is 50-70°C.
[0013] As a preferred embodiment of the Tongli capsules of the present invention, the capsules are 0.2-0.3g per capsule.
[0014] As a preferred embodiment of the Tongli capsules of the present invention, the usage and dosage of the capsules are as follows: take 4-8 capsules with warm water after meals, 2-4 times a day.
[0015] Compared with the prior art, the present invention has at least the following beneficial effects: 1. This invention uses fourteen kinds of traditional Chinese medicine as raw materials, following the treatment principles of traditional Chinese medicine such as dispelling wind and dampness, relaxing muscles and tendons, and promoting blood circulation and removing blood stasis. Among them, safflower, chuanxiong, frankincense, myrrh, and ground beetle promote blood circulation, remove blood stasis, unblock the meridians, and relieve pain; saposhnikovia, notopterygium, angelica, and fanghai dispel wind and dampness, disperse cold, and relieve pain; cimicifuga and acorus tatarinowii dispel wind and open the orifices; angelica sinensis nourishes blood and promotes blood circulation; dragon bone calms the mind and relieves pain; and processed arisaema dries dampness, resolves phlegm, dispels wind, and relieves spasms. The drugs work synergistically to dispel wind, relax muscles and tendons, and promote blood circulation. It has significant efficacy for diseases caused by wind-cold-dampness obstructing the meridians, such as late-stage fractures and joint dislocations, joint pain, and synovitis. Moreover, it uses a capsule dosage form with uniform fine powder as the contents, which is convenient to take, accurate in dosage, has high bioavailability, and good patient compliance. Compared to decoctions, capsules do not require decocting and are easy to carry and store; compared to pills and powders, capsules can mask the unpleasant odor of the medicine and disintegrate quickly, thus taking effect faster.
[0016] 2. This invention ensures product uniformity and stability through standardized processes including ingredient preparation, mixing, drying, pulverizing, sieving, and filling. By employing appropriate drying temperatures and particle sizes (sieving), high-quality formulation production is achieved while maintaining the stability of the active pharmaceutical ingredients.
[0017] 3. This invention establishes a thin-layer chromatography identification method, including chromatographic comparison with reference medicinal materials and reference standards, which effectively ensures the authenticity and quality stability of the product, meets the quality control requirements of modern Chinese medicine preparations, and is clearly applicable to the late stage of fracture and joint dislocation, joint pain, synovitis, etc., with symptoms such as limb dysfunction or loss, numbness and contracture, difficulty in joint flexion and extension, heaviness in the waist and legs, swelling and pain at the injury site, etc., which belong to the wind-cold-dampness obstruction of the meridians type, providing an effective treatment option for common sequelae symptoms in orthopedics. Attached Figure Description
[0018] Figure 1 This is a schematic diagram of the preparation process of the Tongli capsule of the present invention. Detailed Implementation
[0019] To make the above-mentioned objects, features and advantages of the present invention more apparent and understandable, the specific embodiments of the present invention will be described in detail below with reference to the accompanying drawings.
[0020] The Tongli Capsule of this invention comprises the following raw materials: ground beetle, prepared arisaema, vinegar-processed frankincense, vinegar-processed myrrh, dragon bone, angelica dahurica, safflower, safflower, notopterygium incisum, angelica sinensis, saposhnikovia divaricata, cimicifuga foetida, chuanxiong rhizome, and acorus tatarinowii, totaling fourteen Chinese medicinal herbs.
[0021] In a broad embodiment, the weight parts of the above-mentioned raw materials may be: 5-15 parts of ground beetle, 7-18 parts of processed arisaema, 20-35 parts of vinegar-processed frankincense, 15-24 parts of vinegar-processed myrrh, 13-121 parts of dragon bone, 22-37 parts of angelica dahurica, 15-20 parts of angelica sinensis, 22-31 parts of safflower, 21-36 parts of notopterygium incisum, 10-20 parts of angelica sinensis, 19-29 parts of saposhnikovia divaricata, 25-35 parts of cimicifuga foetida, 18-25 parts of chuanxiong rhizome, and 21-31 parts of acorus tatarinowii.
[0022] II. Preparation Process The preparation process of the Tongli capsule of the present invention includes the following steps: (1) Ingredients Weigh the following raw materials according to the prescription: Eupolyphaga sinensis, processed Arisaema heterophyllum, vinegar-processed frankincense, vinegar-processed myrrh, dragon bone, Angelica dahurica, Panax quinquefolius, safflower, Notopterygium incisum, Angelica sinensis, Saposhnikovia divaricata, Cimicifuga foetida, Ligusticum chuanxiong, and Acorus tatarinowii. All raw materials should be processed medicinal slices or herbs that meet the standards of the Pharmacopoeia.
[0023] (2) Mixing and grinding Mix all weighed raw materials thoroughly, then pulverize them. A mixed pulverization method can be used, where all the herbs are mixed and pulverized together to ensure uniform distribution of the components. The fineness of the pulverized material should meet the requirements for sieving.
[0024] In a preferred embodiment, the powder is pulverized and then passed through an 80-120 mesh sieve. More preferably, it is passed through a 100 mesh sieve to ensure uniform particle size, which is beneficial for subsequent mixing and filling, while ensuring the dissolution and bioavailability of the drug in vivo.
[0025] (3) Drying The pulverized powder is then dried to remove excess moisture, prevent mold growth, and extend shelf life. The drying temperature should be controlled within a suitable range to avoid damaging heat-sensitive components due to high temperatures.
[0026] In a general embodiment, the drying temperature is 50-70°C. In a preferred embodiment, the drying temperature is 60±2°C. This low-temperature drying condition can effectively protect the volatile components in the medicinal materials (such as the volatile oil in Saposhnikovia divaricata and ligustilide in Ligusticum chuanxiong) from loss due to high temperatures.
[0027] (4) Sieving The dried fine powder is sieved again to remove any lumps or agglomerates that may have formed during the drying process, ensuring the uniformity and flowability of the powder.
[0028] In a preferred embodiment, the sieve mesh size is 80-120 mesh, more preferably 100 mesh.
[0029] (5) Filling The sieved, uniform fine powder is then filled into the capsule shells. The filling process should be carried out in a clean environment to ensure compliance with Good Manufacturing Practices (GMP) requirements.
[0030] In a preferred embodiment, filling is performed using an automated capsule filling machine to ensure that the fill volume variation complies with pharmacopoeia requirements. After filling, the capsules undergo visual inspection and fill volume variation checks, and defective capsules are discarded.
[0031] (6) Packaging The filled capsules are then packaged into inner and outer packaging. Inner packaging typically uses pharmaceutical-grade PVC rigid sheets and aluminum foil blister packs, or pharmaceutical-grade plastic bottles; outer packaging uses cardboard boxes with labels affixed or printed, indicating information such as the drug name, specifications, batch number, production date, and expiration date.
[0032] III. Quality Control 1. Characteristics The Tongli capsules prepared according to the above process contain a brown powder with a bitter taste and a fragrant odor.
[0033] 2. Thin-layer chromatography identification The Tongli capsules of the present invention have at least one of the following thin-layer chromatographic identification characteristics: (a) Identification of windproof Take an appropriate amount of the contents of this product (e.g., 10g), add 20-30ml of methanol, sonicate for 15-30 minutes, filter, evaporate the filtrate to dryness, dissolve the residue in 1ml of methanol to obtain the test solution. Prepare a reference solution using the same method with a separate sample of *Saposhnikovia divaricata*. Perform thin-layer chromatography (General Chapter 0502 of the Chinese Pharmacopoeia). Apply 5-10μl each of the test solution and the reference solution to the same silica gel G thin-layer plate. Develop using petroleum ether (60-90℃)-ethyl acetate (17:1) as the developing solvent. Remove the plate, air dry, spray with 5% vanillin-sulfuric acid solution, and heat at 105℃ until the spots are clearly visible. The chromatogram of the test sample should show spots of the same color at the corresponding positions as the chromatogram of the reference sample.
[0034] (b) Identification of imperatorin and isoimperatorin Take an appropriate amount of the contents of this product (e.g., 10g), add 20ml of diethyl ether, soak for 30-60 minutes, sonicate for 5-10 minutes, filter, evaporate the filtrate to dryness, dissolve the residue in 1ml of ethyl acetate to obtain the test solution. Separately, prepare a mixed solution containing 1mg of each of imperatorin and isoimperatorin reference standards in ethyl acetate to obtain the reference solution. Perform thin-layer chromatography, applying 5μl of each of the above two solutions separately to the same silica gel G thin-layer plate. Develop the plate using petroleum ether (30-60℃)-diethyl ether (3:2) as the developing solvent. Remove the plate, air dry, and examine under ultraviolet light (365nm). The test sample chromatogram should show fluorescent spots of the same color at the corresponding positions as the reference chromatogram.
[0035] The above two identification features can be used alone or in combination to comprehensively control product quality. The identification of Saposhnikovia divaricata mainly targets the authenticity of the Saposhnikovia divaricata herb in the formula, while the identification of imperatorin and isoimperatorin mainly targets Angelica dahurica or related herbs that may be contained in the formula (Angelica dahurica contains coumarin components such as imperatorin and isoimperatorin).
[0036] IV. Specifications, Usage and Dosage 1. Specifications In one specific embodiment, the packaging specifications are: PVC bottle, 90 capsules per bottle (0.25g × 90 capsules).
[0037] 2. Usage and Dosage In a preferred embodiment, the dosage and administration are as follows: take 6 pills with warm water after meals, 3 times a day. The dosage for children should be reduced as directed by a physician.
[0038] 3. Contraindications and Precautions Contraindications: Not for use by pregnant women or those allergic to traditional Chinese medicine.
[0039] Precautions: Avoid fishy and spicy foods; use with caution in patients with impaired liver or kidney function; this preparation is for use only within this medical institution.
[0040] V. Specific Preparation Examples Prescription: 10g of ground beetle, 10g of prepared arisaema, 10g of vinegar-processed frankincense, 10g of vinegar-processed myrrh, 10g of dragon bone, 10g of angelica dahurica, 10g of angelica sinensis, 10g of safflower, 10g of notopterygium incisum, 10g of angelica sinensis, 10g of saposhnikovia divaricata, 10g of cimicifuga foetida, 10g of chuanxiong rhizome, and 10g of acorus tatarinowii. (Prepared in equal parts by weight; scale up proportionally for batch sizes) Preparation process: (1) Ingredients: Weigh the above fourteen raw materials accurately according to the prescription.
[0041] (2) Mixing and pulverizing: Mix the weighed raw materials evenly and put them into a pulverizer for mixing and pulverizing. During the pulverizing process, pay attention to controlling the equipment temperature to avoid overheating and loss of volatile components. The pulverized coarse powder is ready for use.
[0042] (3) Drying: Dry the pulverized coarse powder at 60±2℃ until the moisture content meets the requirements of the pharmacopoeia (usually not exceeding 9%).
[0043] (4) Sieving: Pass the dried powder through a 100-mesh sieve to remove coarse particles and lumps, and obtain uniform fine powder.
[0044] (5) Filling: The sieved fine powder is filled into gelatin capsule shells using an automatic capsule filling machine, with each capsule containing 0.25g. During the filling process, the filling volume difference is checked regularly to ensure compliance with the pharmacopoeia requirements.
[0045] (6) Packaging: Pack the filled capsules into inner packaging (PVC bottle, 90 capsules per bottle) and outer packaging (cardboard box), and affix labels indicating product information.
[0046] V. Specific Preparation Examples Example
[0047] Prescription: 11g of ground beetle, 14g of prepared arisaema, 28g of vinegar-processed frankincense, 22g of vinegar-processed myrrh, 17g of dragon bone, 28g of angelica dahurica, 17g of angelica sinensis, 28g of safflower, 28g of notopterygium incisum, 17g of angelica sinensis, 28g of saposhnikovia divaricata, 28g of cimicifuga foetida, 22g of chuanxiong rhizome, and 28g of acorus tatarinowii. (Prepared in equal parts by weight; scale up proportionally for batch sizes) Preparation process: (1) Ingredients: Weigh the above fourteen raw materials accurately according to the prescription.
[0048] (2) Mixing and pulverizing: Mix the weighed raw materials evenly and put them into a pulverizer for mixing and pulverizing. During the pulverizing process, pay attention to controlling the equipment temperature to avoid overheating and loss of volatile components. The pulverized coarse powder is ready for use.
[0049] (3) Drying: Dry the pulverized coarse powder at 60±2℃ until the moisture content meets the requirements of the pharmacopoeia (usually not exceeding 9%).
[0050] (4) Sieving: Pass the dried powder through a 100-mesh sieve to remove coarse particles and lumps, and obtain uniform fine powder.
[0051] (5) Filling: The sieved fine powder is filled into gelatin capsule shells using an automatic capsule filling machine, with each capsule containing 0.25g. During the filling process, the filling volume difference is checked regularly to ensure compliance with the pharmacopoeia requirements.
[0052] (6) Packaging: Pack the filled capsules into inner packaging (PVC bottle, 90 capsules per bottle) and outer packaging (cardboard box), and affix labels indicating product information.
[0053] VI. Indications and Scope of Application The Tongli capsules described in this invention have the following functions and indications: dispelling wind, relaxing muscles and tendons, and promoting blood circulation. They are used to treat late-stage fractures and joint dislocations, joint pain, synovitis, etc. They are suitable for the following symptoms: limb dysfunction or loss, numbness and contracture, difficulty in joint flexion and extension, heaviness in the lower back and legs, swelling and pain at the injury site, and migratory pain. The tongue is pale and dark, with a white coating, and the pulse is wiry and tense. This syndrome belongs to the wind-cold-dampness obstruction of the meridians type.
[0054] VII. Process Environment Requirements Referring to the production process flow chart, the preparation process of this invention is carried out in different production areas: General production area: Ingredient preparation, outer packaging and other processes are carried out in the general production area, and operators are required to wear general work clothes.
[0055] Class D production area: Mixing, drying, crushing, sieving, filling, inner packaging and other processes are carried out in the Class D clean area. Operators must wear cleanroom suits and the environment must meet the corresponding cleanliness requirements (such as dust particle count, microbial limits, etc.).
[0056] Materials: All materials (raw materials, excipients, capsule shells, packaging materials) must be inspected and qualified before they can be used.
[0057] It should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention and are not intended to limit it. Although the present invention has been described in detail with reference to preferred embodiments, those skilled in the art should understand that modifications or equivalent substitutions can be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention, and all such modifications or substitutions should be covered within the scope of the claims of the present invention.
Claims
1. A type of vasodilator capsule, characterized in that, Made from the following raw materials: Ground beetle, processed arisaema, vinegar-processed frankincense, vinegar-processed myrrh, dragon bone, angelica dahurica, safflower, peony root, notopterygium root, angelica sinensis, saposhnikovia root, cimicifuga rhizome, chuanxiong rhizome, and acorus calamus; The active pharmaceutical ingredient is dried, pulverized, mixed, and then filled into a capsule shell to form a capsule.
2. The Tongli capsule according to claim 1, characterized in that: The weight parts of each active pharmaceutical ingredient are as follows: 5-15 parts of ground beetle, 7-18 parts of processed arisaema, 20-35 parts of vinegar-processed frankincense, 15-24 parts of vinegar-processed myrrh, 13-121 parts of dragon bone, 22-37 parts of angelica dahurica, 15-20 parts of angelica sinensis, 22-31 parts of safflower, 21-36 parts of notopterygium incisum, 10-20 parts of angelica sinensis, 19-29 parts of saposhnikovia divaricata, 25-35 parts of cimicifuga foetida, 18-25 parts of chuanxiong rhizome, and 21-31 parts of acorus calamus.
3. The Tongli capsule according to claim 2, characterized in that: The contents of the capsule are a brown powder that has at least one of the following thin-layer chromatographic identification characteristics: (a) Take the contents of this product, add methanol to prepare a test solution, and separately take Saposhnikovia divaricata reference material to prepare a reference material solution. Perform thin-layer chromatography test. In the chromatogram of the test solution, spots of the same color appear at the corresponding positions as in the chromatogram of the reference material. (b) Take the contents of this product, add ether to prepare a test solution, and separately prepare a mixed reference solution of imperatorin reference standard and isoimperatorin reference standard. Perform thin-layer chromatography test. In the chromatogram of the test sample, fluorescent spots of the same color appear at the corresponding positions as in the chromatogram of the reference standard.
4. A preparation process for Tongli capsules as described in any one of claims 1 to 3, characterized in that, Includes the following steps: Step 1, Ingredient Preparation: Weigh each raw material according to the prescription amount; Step 2, Mixing and Grinding: Mix all the raw materials and grind them into a fine powder; Step 3, Drying: Dry the pulverized fine powder; Step 4: Sifting: Sift the dried fine powder. Step 5, Filling: Fill the capsule shell with the sieved fine powder to obtain the final product.
5. The preparation process of Tongli capsules according to claim 4, characterized in that: In step 2, the pulverization is a mixed pulverization, and the pulverized material is passed through an 80-120 mesh sieve.
6. The preparation process of Tongli capsules according to claim 5, characterized in that: In step 3, the drying temperature is 50-70℃.
7. The Tongli capsule according to claim 1, characterized in that: The capsules are packaged in portions of 0.2-0.3g each.
8. The Tongli capsule according to claim 7, characterized in that: The capsules are to be taken with warm water after meals, 4-8 capsules each time, 2-4 times a day.