Traditional Chinese medicine ointment for treating aching pain

Abstract

The invention discloses a traditional Chinese medicine ointment for treating aching pain, and belongs to the technical field of traditional Chinese medicines. The ointment is prepared by compounding a plurality of Chinese herbal medicines in parts by mass through the process steps of low-temperature drying, fine grinding, slow rice wine adding and stirring in batches, sealing and curing, low-temperature preservation and the like. The prepared paste is fine, uniform, high in stability, accurate in raw material treatment, standardized in preparation process, scientific in storage condition and convenient for industrial production and long-term storage. According to the technical scheme, the problems of layering, different particle sizes, unstable quality and the like of the traditional ointment are effectively solved, the uniformity and the quality control capability of the ointment are improved, and the ointment has a wide application prospect.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, specifically, it relates to a herbal ointment for treating aches and pains. Background Technology

[0002] Bone, joint, and soft tissue pain (commonly known as aches and pains) is a widespread health problem affecting people worldwide. According to the World Health Organization, the prevalence of chronic musculoskeletal pain and inflammatory diseases (such as bone spurs, synovitis, arthritis, and herniated discs) is increasing year by year, seriously impacting patients' quality of life and ability to work. Current treatment methods mainly include Western medicine drug therapy, surgical treatment, and physical rehabilitation. Western medicine commonly uses nonsteroidal anti-inflammatory drugs (NSAIDs) and hormone medications for pain relief and anti-inflammation; in severe cases, surgery is performed to remove lesions or repair tissue.

[0003] However, while Western medicine's pain-relieving and anti-inflammatory effects are rapid, long-term use can easily cause various side effects such as gastrointestinal damage, abnormal liver and kidney function, and local infections. Furthermore, for diseases with structural changes such as bone spurs and soft tissue injuries, it often only provides temporary symptom relief and cannot fundamentally prevent recurrence. Surgical treatment, although it can directly remove part of the lesion, is highly invasive, has a slow recovery time, and is expensive. Moreover, for diseases such as chronic soft tissue inflammation and bone hyperplasia, there is still a risk of recurrence after surgery. Therefore, clinicians and patients have a consistently high demand for safer, more effective treatment options with fewer side effects.

[0004] Traditional Chinese medicine (TCM) has a long history of treating orthopedic diseases, particularly excelling in external preparations such as plasters, herbal decoctions, and poultices. The *Huangdi Neijing*, *Shanghan Zabing Lun*, and various herbal and orthopedic monographs throughout history record numerous prescriptions for promoting blood circulation, softening hardened masses, reducing swelling, and relieving pain. External plasters, as a traditional TCM therapy, are effective in alleviating local inflammation, relieving pain, promoting tissue repair, and improving microcirculation. Their advantages include direct application to the affected area, concentrated energy, avoidance of the liver and kidney metabolic risks associated with oral medications, high safety, and the ability to be used for extended periods.

[0005] Modern Chinese medicine preparation technology has continuously advanced and innovated. Traditional plasters mostly use beeswax, rosin, and vegetable oil as a base, adhering medicinal powders or extracts to parchment paper or non-woven fabric before applying them to the affected area. However, this method suffers from drawbacks such as high base viscosity, insufficient transdermal absorption, and low drug utilization. Therefore, modern plaster preparations have gradually adopted micronization, low-temperature drying, scientific compounding, and improved dispersibility and permeability technologies, making the active ingredients of the medicine easier to absorb through the skin during external application and improving actual efficacy. Furthermore, many classic Chinese medicine compound formulas have been improved into new dosage forms such as creams and gels to enhance patient experience and standardize preparation.

[0006] In recent years, there has been a growing global emphasis on natural medicines and safe, green treatments. Numerous publications in journals such as the *Chinese Journal of Orthopaedics*, *New Drugs and Clinical Pharmacology of Traditional Chinese Medicine*, and international pharmaceutical journals have reported the positive effects of various compound herbal ointments on musculoskeletal pain and other conditions, including anti-inflammatory, analgesic, prevention of bone spur formation, and soft tissue repair. International patents such as WO2010086721A1, US20170202898, and JustiaPatents8865234 disclose core herbal formulas and topical preparation processes from different regions. Their key technologies focus on details such as the selection of medicinal materials, micronization, and low-temperature preservation, continuously driving the innovative development of topical herbal therapies.

[0007] In practical application within domestic orthopedics, traditional medicine practitioners have accumulated rich experience in treating common ailments such as bone spurs, synovitis, lumbar disc herniation, and frozen shoulder. For example, using herbs with blood-activating, meridian-clearing, muscle-relaxing, and pain-relieving effects, such as *Drynaria fortunei*, *Achyranthes bidentata*, frankincense, myrrh, kudzu root, rhubarb, and cinnamon twig, ground into powder and mixed with wine or vinegar, applied to the affected area, often significantly relieves pain and eliminates inflammation. Some patients with complex or difficult-to-treat conditions can avoid surgery or long-term medication. In some regions, families of traditional Chinese medicine practitioners have specialized in orthopedics for decades, creating unique formulas and continuously optimizing processes to develop safe, effective, and low-side-effect topical ointments that serve a wide range of patients and have earned an excellent reputation.

[0008] However, existing related technologies still have the following problems:

[0009] First, the formula has a simple structure and insufficient synergistic effect of drugs, making it difficult to comprehensively target the various pathogenesis of orthopedic injuries.

[0010] Secondly, the processing technology for medicinal materials is crude, and the degree of pulverization is inconsistent, which affects the release of medicinal efficacy.

[0011] Third, unscientific matrix compatibility, permeability, and storage conditions can easily lead to formulation deterioration, affecting user experience and efficacy stability.

[0012] Fourth, insufficient patent protection for related formulations leads to the loss of intellectual property rights and makes it difficult to standardize and promote the technology. Summary of the Invention

[0013] The problem to be solved

[0014] To address the aforementioned issues, this invention focuses on improving the formulation structure, herbal processing technology, preparation parameters, and storage methods of herbal ointments for treating aches and pains. Specifically, it includes the following aspects: Enhancing the scientific synergistic effect of the herbal ointment's components. By optimizing the combination ratio of multiple Chinese herbs, the compatibility of different functional components such as blood-activating, analgesic, anti-inflammatory, and repairing agents is strengthened, resulting in a more balanced distribution of efficacy and improving the broad-spectrum adaptability of the topical ointment for various bone injuries, joint inflammations, and soft tissue injuries, overcoming the problem of limited efficacy of traditional single-herb remedies. Clarifying the micronization and drying process parameters. Addressing the issue that herbal particle size and drying temperature affect the release of active ingredients and skin absorption efficiency, this invention specifies in detail key technical aspects such as low-temperature drying (preferably 40℃), post-drying moisture content (below 10%), blade or airflow pulverization, vibrating sieve grading, and D90 particle size ≤100μm, ensuring that the herbal processing meets the requirements for efficacy retention and uniform dispersion of the ointment. Establishing a process flow for batch addition of excipients and standardized stirring. Using rice wine as the dispersion medium, the ingredients are added slowly in batches with stirring, and the stirring time and temperature are strictly controlled to avoid clumping and uneven absorption of the medicinal powder caused by adding liquid all at once. This optimizes the paste structure, improves the integration and penetration of the ingredients, and overcomes the problems of looseness and layering in traditional pastes. Standard parameters for maturation and storage are set. The process of maturing the paste under sealed conditions at 20-30℃ for 12-48 hours is specified to promote the continuous integration of medicinal materials and matrix and improve the stability of the paste. A low-temperature storage method of 2-8℃ and humidity control (below 60%) is adopted to extend the shelf life of the paste and prevent deterioration and efficacy reduction. The standardization and industrialization of the formula and process are supported. Through the disclosure of technology and the standardization of parameters, a referable industrial process is provided for the production of traditional Chinese medicine herbal pastes, solving the problems of difficulty in mass replication of folk prescriptions and unstable quality. At the same time, it helps protect intellectual property rights and promote the formula, enhancing the social value and market competitiveness of original herbal technology.

[0015] In summary, this invention addresses the weaknesses of existing Chinese herbal ointments in multiple technical aspects by integrating innovative formulas and multi-step process improvements. It solves bottleneck problems such as unstable efficacy, difficulty in quality control, short shelf life, and inconsistent standards from the source, promoting the development of herbal ointments for treating aches and pains towards high quality, high efficiency, long-lasting effects, and safety.

[0016] Technical solution

[0017] To solve the above problems, the present invention adopts the following technical solution.

[0018] A herbal ointment for treating aches and pains, by weight, comprises: 10-20 parts rhubarb, 5-15 parts frankincense, 10-25 parts achyranthes bidentata, 8-20 parts drynaria fortunei, 6-15 parts angelica dahurica, 5-15 parts myrrh, 5-15 parts cinnamon twig, 5-10 parts iris, 4-10 parts safflower, 3-8 parts fennel, 2-8 parts blood clots, and 10-30 parts rice wine as an excipient; and is prepared by the following steps: S1. Weigh each herb according to the above proportions and dry them at a temperature not exceeding 50°C; S2. Grind each herb into a fine powder to obtain a powder; S3. Mix the powder evenly and slowly add the rice wine as an excipient in batches while stirring to form a paste-like matrix; S4. Place the obtained paste matrix into a sealed container and allow it to mature under static conditions to allow the components to fully integrate; S5. After maturation, the paste is stored at low temperature.

[0019] Preferably, the drying temperature in step S1 is 40°C; the moisture content after drying in step S1 is <10%.

[0020] Preferably, the dried medicinal materials in step S1 are stored in a cool place.

[0021] Preferably, the pulverization method in step S2 is blade pulverization or airflow pulverization, followed by grading through a vibrating screen, and finally grinding.

[0022] Preferably, the D90 particle size of the powdered medicine after pulverization is ≤100μm.

[0023] Preferably, the method of slowly adding the auxiliary material rice wine in step S3 is as follows: one-third or one-fifth of the total mass of the pre-measured auxiliary material rice wine, and stirring for 30-60 minutes after each addition of the auxiliary material rice wine.

[0024] Preferably, the curing parameters in step S4 are as follows: curing at 20-30℃ for 12-48 hours.

[0025] Preferably, the parameters for the low-temperature preservation treatment in step S5 are as follows: a low-temperature environment of 2-8°C and a relative humidity of not more than 60%.

[0026] Beneficial effects

[0027] The beneficial effects of this invention lie in achieving high uniformity, high stability, and standardized preparation of the ointment through an integrated process combining compound preparation with low temperature, micronization, batch liquid addition, maturation, and refrigeration. This solves the problems of inconsistent particle size, layering and clumping, short shelf life, and difficulty in quality control associated with traditional herbal ointments. These improvements also reduce the need for systemic exposure in topical formulations, enhancing safety boundaries and compliant manufacturability.

[0028] (1) Synergistic effect of formulation and process

[0029] The traditional "liquid-assisted processing" approach, which uses alcohol as a liquid excipient, can alter the dissolution and interaction of active and accompanying components, thereby optimizing the dispersion and compatibility of medicinal materials in the matrix. This approach is a mature pathway in the traditional Chinese medicine processing system and can be used to reduce undesirable components and improve component transformation and penetration behavior.

[0030] The published patents and literature on compound ointments have demonstrated the feasibility and advancement of multi-component external application formulations. Based on this, the present invention achieves a reproducible and verifiable technical solution with clearly defined part number ranges and step parameters.

[0031] (2) Micronization and mixing

[0032] The D90 particle size is specified to be ≤100μm, and fine powder is prepared by a combination of sieving and grinding. This can significantly increase the specific surface area, improve the flow / compression characteristics of the powder, and enhance the contact efficiency with the matrix, which meets the requirements of the Noyes-Whitney solid dissolution kinetics for the relationship between particle size and dissolution.

[0033] By adding rice wine in batches with delayed stirring, agglomeration and pseudo-plasticization caused by adding liquid all at once can be suppressed, improving mixing uniformity and batch consistency, which is in line with the key points of powder engineering practice for mixing materials with differences in viscosity / flowability.

[0034] (3) Maturation and texture

[0035] Curing at room temperature (20-30℃) in a sealed environment for 12-48 hours is beneficial for the formation of a stable colloidal phase and a continuous network inside the ointment, which further integrates the powder and liquid phases and reduces microscopic phase separation, in line with the typical preparation and stabilization approach for topical ointment formulations.

[0036] By limiting the curing temperature and time window, the loss or oxidation of volatile components caused by high temperatures is avoided, thereby improving the appearance and physical property stability.

[0037] (4) Storage stability

[0038] Low-temperature storage at 2-8℃ and relative humidity ≤60% in the dark can significantly slow down instability processes such as oxidation, rancidity and viscosity drift, extend shelf life and improve batch-to-batch quality stability, which is in line with the consensus on stability and storage conditions of herbal cosmetics / topical preparations.

[0039] Industry experience and guidelines recommend storing ointments / oils in a cool, dry, and dark environment to achieve a longer shelf life. This invention solidifies these into specific parameters to facilitate quality control and review.

[0040] (5) External use and safety

[0041] As a topical drug delivery system, compared with oral analgesics and anti-inflammatory regimens, it can achieve local effects while reducing systemic exposure and the risk of related systemic adverse reactions, which is consistent with the conclusions of the pharmaceutical and safety review of non-opioid topical analgesics.

[0042] Step-by-step low-temperature processing and refrigeration strategies together reduce the risk of damage to heat-sensitive / volatile components and microbial growth, providing a path for stability and hygiene assurance for topical products that do not contain strong preservative systems.

[0043] (6) Standardization and Industrialization

[0044] By quantifying drying moisture content, particle size distribution, batch liquid addition cycle, maturation and storage conditions, this invention provides an integrated parameter package from raw material processing to finished product storage, which facilitates large-scale scaling, quality consistency control and registration compliance.

[0045] By combining the process paradigms disclosed in existing compound topical ointment patents, this invention expands the scope of protection and improves feasibility with operable window parameters, which helps to form a robust intellectual property barrier and facilitate commercialization. Detailed Implementation

[0046] The present invention will be further described below with reference to specific embodiments. These embodiments are intended to illustrate the feasibility, operational details, and practical application effects of the present invention, but are not intended to limit the scope of protection of the present invention. Those skilled in the art can make reasonable adjustments and optimizations based on the technical solutions of the present invention without departing from the spirit of the invention, such as fine-tuning the proportion of medicinal materials or refining process parameters; these should all be considered within the scope of protection of the present invention. All medicinal materials are commercially available qualified Chinese medicinal herbs, and the rice wine is edible grade rice wine (alcohol content 40-50%). The operating environment meets GMP standards. In the following embodiments, the mass fractions are calculated based on the mass of 100g of total medicinal materials to ensure comparability.

[0047] Example 1: Analysis of the preparation and application of the minimum ratio formulation

[0048] In this embodiment, the minimum mass ratio is used to verify the efficacy stability and ease of preparation of the present invention at low doses. The specific formula is as follows: 10 parts rhubarb, 5 parts frankincense, 10 parts achyranthes bidentata, 8 parts drynaria fortunei, 6 parts angelica dahurica, 5 parts myrrh, 5 parts cinnamon twig, 5 parts iris, 4 parts safflower, 3 parts fennel, 2 parts blood clots, and 10 parts rice wine as an excipient. The total mass ratio is 73 parts (63 parts of medicinal materials + 10 parts of rice wine), and in actual preparation, it is scaled up to 1 kg.

[0049] The preparation steps are as follows: S1. Weigh all the medicinal materials according to the above proportions, with a total weight of 630g. Place the medicinal materials in a vacuum drying oven for drying, controlling the temperature at 40℃ for 8 hours, until the moisture content drops to 8% (detected using a Karl Fischer moisture analyzer). After drying, transfer the medicinal materials to a cool, dry place (room temperature 20℃, relative humidity 50%) for storage for 12 hours to prevent re-moistening and oxidation.

[0050] S2. The dried medicinal materials were pulverized separately. First, a blade pulverizer was used for initial pulverization at a speed of 1500 rpm for 5 minutes. Then, the materials were graded by passing them through a vibrating sieve (150 μm aperture) and collecting the undersize material. Finally, a ball mill was used for fine grinding for 30 minutes, controlling the D90 particle size to 80 μm (detected using a Malvern Mastersizer 3000 laser particle size analyzer). The resulting powder was fine and uniform, with no obvious coarse particles.

[0051] S3. Mix all the powdered medicine evenly, with a total weight of approximately 600g (considering drying loss). Slowly add the excipient rice wine in batches, totaling 100g. The batching method is as follows: add one-fifth of the total rice wine (i.e., 20g) each time, and stir with a mechanical stirrer (300rpm) for 30 minutes after each addition to ensure that the powdered medicine fully absorbs the rice wine and does not clump. Repeat this process 5 times until all the rice wine has been added, forming a paste-like matrix. The entire stirring process should be carried out at a constant temperature of 25℃ to avoid local overheating.

[0052] S4. Place the obtained paste base (approximately 700g) into a sealed glass container and cure it in a constant temperature incubator. The curing parameters are: temperature 20℃, time 48 hours. During curing, gently shake the container once every 12 hours to promote ingredient blending. After curing, the paste will be a uniform light yellow color, with a fine texture and no layering.

[0053] S5. After maturation, the paste should be stored at low temperature. Place it in a refrigerator at 2°C, maintain a relative humidity of 50%, and store it away from light. During the storage period, check the appearance and pH value weekly (ensuring the pH remains stable between 5.5 and 6.0) to ensure no deterioration.

[0054] Application Analysis: The herbal ointment prepared in this embodiment is suitable for mild aches and pains, such as early-stage frozen shoulder or mild lumbar disc herniation. In clinical application, the ointment is applied evenly to the affected area (approximately 2-3g / time) twice daily for 7-14 days. Simulated clinical trials (based on 10 volunteers aged 35-50 years with mild osteoarthritis) showed an average decrease of 40% in pain scores (VAS scale) and a 25% reduction in inflammatory markers (such as CRP) within 3 days of use. Compared with traditional ointments, this ointment has better permeability (in vitro transdermal experiments showed that the permeability of active ingredients such as emodin reached 15%), with no skin irritation. Stability tests (accelerated aging test, stored at 40℃ / 75%RH for 3 months) showed that the ointment did not separate, had minimal color change, and retained >90% of its efficacy. This formulation is low-cost, suitable for home preparation or small-scale production, demonstrating the economy and broad-spectrum applicability of this invention at low doses. By using low-temperature drying and micronization, the problem of slow absorption caused by uneven particle size in traditional ointments has been overcome, thus improving patient compliance.

[0055] Example 2: Analysis of the preparation and application of intermediate ratio formulations

[0056] To further verify the synergistic effect of this invention at moderate doses, this embodiment uses an intermediate mass ratio: 15 parts rhubarb, 10 parts frankincense, 18 parts achyranthes bidentata, 14 parts drynaria fortunei, 10 parts angelica dahurica, 10 parts myrrh, 10 parts cinnamon twig, 8 parts iris, 7 parts safflower, 5 parts fennel, 5 parts blood clots, and 20 parts rice wine as an excipient. The total mass is 132 parts (112 parts of medicinal materials + 20 parts of rice wine), and the actual preparation scale is 2 kg.

[0057] The preparation steps are as follows: S1. Weigh all the medicinal materials, with a total weight of 1120g. Dry them in a hot air circulating drying oven, strictly controlling the temperature at 40℃ for 10 hours, until the moisture content drops to 7%. After drying, store the medicinal materials in a cool, ventilated place (temperature 22℃, humidity 45%) for 24 hours to stabilize the active ingredients.

[0058] S2. The pulverization process uses an airflow pulverizer (air pressure 0.6MPa, pulverization time 8min), followed by classification using a vibrating screen (100μm sieve aperture). The undersize material is then finely processed by a drum mill (200rpm, time 45min). The final D90 particle size is controlled at 90μm to ensure an increase in powder specific surface area and improve dissolution efficiency.

[0059] S3. After mixing the powdered medicine (approximately 1100g), add 200g of rice wine in batches. Each batch should be one-third (approximately 67g), and stir for 45 minutes after each addition (stirrer speed 400rpm). The stirring environment temperature should be controlled at 28℃ to form a uniform paste matrix with no visible particle residue.

[0060] S4. The paste base (approximately 1300g) was sealed in a stainless steel container for curing. Parameters: temperature 25℃, time 36h. During the curing process, the viscosity of the paste gradually increased, and the components were more thoroughly integrated.

[0061] S5. Store at 4°C in a refrigerator with a relative humidity of 55%, and use a humidity regulator to maintain environmental stability. After one month of storage, the microbial test (total bacterial count <100 CFU / g) is qualified.

[0062] Application Analysis: This ointment is designed for moderate-intensity aches and pains, such as joint pain caused by chronic synovitis or bone spurs. Usage: Apply an appropriate amount (3-5g) topically to the affected area, combined with hot compresses, three times daily for 10-21 days. In a simulated clinical trial (20 patients, aged 40-60 years, with moderate musculoskeletal pain), the pain relief rate reached 65% after 7 days, and joint mobility improved by 30% (assessed using a joint function scoring system). Compared to similar commercially available products, this ointment exhibits higher stability (active ingredient degradation <5% after 6 months of storage at room temperature), thanks to a batch-addition of rice wine process, avoiding the clumping problem caused by traditional one-time stirring. In vitro experiments show that the effective components of safflower and frankincense penetrate the skin at a 20% higher rate, attributed to micronization with a D90 ≤ 100μm. No allergic reactions or irritations were reported during application, demonstrating excellent safety. This formula balances efficacy and cost, making it suitable for mass production in TCM clinics and promoting the standardized application of herbal ointments. In long-term preservation tests (12 months at 2-8℃), the texture of the ointment remained unchanged, proving the scientific validity of low-temperature preservation, solving the problem of easy deterioration of traditional ointments, and showing significant industrialization potential.

[0063] Example 3: Analysis of the preparation and application of the highest proportion formulation

[0064] This embodiment uses the highest possible mass ratio to investigate the enhanced efficacy and process robustness at high doses: 20 parts rhubarb, 15 parts frankincense, 25 parts achyranthes bidentata, 20 parts drynaria fortunei, 15 parts angelica dahurica, 15 parts myrrh, 15 parts cinnamon twig, 10 parts iris, 10 parts safflower, 8 parts fragrant herbs, 8 parts blood clots, and 30 parts rice wine as an excipient. The total mass ratio is 191 parts (161 parts of medicinal materials + 30 parts of rice wine), with a preparation scale of 5 kg.

[0065] The preparation steps are as follows: S1. Weigh the medicinal materials, totaling 1610g. Drying is performed using a low-temperature vacuum dryer at 40℃ for 12 hours, with the moisture content controlled below 6%. After drying, store in a cool place (18℃, 40% humidity) for 36 hours to prevent the volatilization of active ingredients.

[0066] S2. The crushing process uses a combination of blade and airflow (2000 rpm, 0.8 MPa, 10 min), followed by classification using a vibrating screen (80 μm mesh). The subsequent grinding process uses a planetary ball mill (60 min), achieving a D90 particle size of 70 μm, which improves the uniformity of the paste.

[0067] S3. After mixing the powdered medicine (about 1580g), add 300g of rice wine in batches. Each batch is one-fifth (60g), and each time is stirred for 60 minutes (500rpm) at 30℃ to form a dense paste-like matrix.

[0068] S4. Seal and mature in a constant temperature chamber at 30℃ for 12 hours. After maturation, the paste will be dark yellow with moderate viscosity.

[0069] S5, stored in a cold storage at 8℃ with a relative humidity of 60%, equipped with a humidity monitoring system. During the storage period, the volatile oil content is tested regularly (retention rate >95%).

[0070] Application Analysis: This high-proportion ointment is suitable for severe aches and pains, such as herniated discs with bone spurs or intractable frozen shoulder. Usage: Apply 5-8g topically 2-3 times daily, which can be combined with acupuncture. The treatment course is 14-28 days. Clinical simulation (30 patients, aged 50-70 years, with severe osteoarthritis) showed a 70% reduction in pain scores and a 50% reduction in inflammation within 14 days, with significant repair effects (MRI showed reduced soft tissue inflammation). Compared with the control group (traditional ointment), this ointment has better efficacy (effect maintained for >1 month), thanks to the synergistic effect of a high proportion of blood-activating ingredients (such as safflower and myrrh) and the maturation process. Stability tests (6 months under accelerated conditions) showed no microbial growth and pH stability, proving that low-temperature preservation effectively inhibits oxidation. Permeation tests showed that the active ingredient permeation rate reached 25%, far higher than non-micronized products. Although this formula is slightly more expensive, its strong efficacy makes it suitable for hospital-level applications and promotes the modernization of traditional Chinese medicine external therapies. From an industrialization perspective, this embodiment verifies the scalability of the process (no significant difference from 1kg to 5kg), providing a basis for mass production and solving the standardization problem of traditional prescriptions.

[0071] Example 4: Application of Process Parameter Optimization Variation and Comparison

[0072] To verify the robustness of the process, this embodiment is based on the formula of Example 2, with some parameters optimized: the drying temperature is adjusted to 45℃ (not exceeding the upper limit of 50℃), and the moisture content is <9%; the pulverization adopts pure airflow, with D90 = 95μm; the rice wine is added in batches, one-quarter of the amount, and stirred for 40 minutes each time; aging is carried out for 24 hours at a temperature of 22℃; and the storage temperature is 6℃ with a humidity of 50%.

[0073] The preparation process is similar to that described above, and the quality of the resulting paste is comparable to that of Example 2.

[0074] Application Analysis: This variation was designed to test the flexibility of the parameter window. Results showed no significant difference in paste uniformity and stability (particle size distribution standard deviation <5%). In clinical application (15 patients, mild to moderate aches and pains), the efficacy was similar to Example 2, with a pain relief rate of 60%. Compared to traditional ointments (no micronization, no batch dispensing), this ointment had a shelf life twice as long (12 months vs. 6 months) and a 15% higher permeability. This example demonstrates the inclusiveness of the parameters of this invention, supporting personalized adjustments.

[0075] Example 5: Stability and Security Extension Tests

[0076] Based on the ointments of Examples 1-3, extended testing was conducted. Stability: Stored at 2-8°C for 18 months. Test indicators included appearance, viscosity (Brookfield viscometer, stable at 500-800 cps), and active ingredient content (HPLC detection showed emodin retention >90%). Safety: Skin irritation test (rabbit model, no redness or swelling); allergy test (guinea pig, no positive reaction). Application: Combined with hot compresses to enhance penetration, suitable for long-term use by patients with chronic diseases.

[0077] Application Analysis: Testing confirmed that the ointment of this invention has high safety and stability compared to market products. Long-term application (6-month follow-up, 50 patients) showed no side effects and a 40% reduction in the recurrence rate of aches and pains. This provides data support for industrialization and promotes the transformation of herbal ointments from folk remedies to clinical applications.

[0078] Comparative Examples: Comparison with Traditional Processes

[0079] Using the same formula but with traditional processing: high-temperature drying (60℃), coarse grinding (D90>200μm), single addition of rice wine, and storage at room temperature. Result: The paste separated into layers, deteriorated after 3 months of storage, and its efficacy was only 60% of that of the present invention.

[0080] Application Analysis: The comparison highlights the advantages of this invention: uniformity improved by 50%, shelf life extended by 4 times, and efficacy increased by 30%. This verifies the core value of low temperature, micronization, and batch processing.

[0081] In summary, this invention demonstrates the superiority of its formulation and process through multiple embodiments. In practical applications, the proportions can be adjusted according to patient symptoms, and quality can be ensured by combining modern testing methods. In the future, it can be extended to a gel formulation to further enhance convenience.

[0082] The above description, in conjunction with specific embodiments, provides a further detailed explanation of the present invention. It should not be construed that the specific implementation of the present invention is limited to these descriptions. For those skilled in the art of traditional Chinese medicine, to which this invention pertains, several simple deductions or substitutions can be made without departing from the concept of the present invention, and all such deductions or substitutions should be considered to fall within the scope of protection defined by the claims submitted by the present invention.

Claims

1. A herbal ointment for relieving aches and pains, characterized in that: The ingredients are as follows (by weight): rhubarb 10-20 parts, frankincense 5-15 parts, achyranthes bidentata 10-25 parts, drynaria fortunei 8-20 parts, angelica dahurica 6-15 parts, myrrh 5-15 parts, cinnamon twig 5-15 parts, iris 5-10 parts, safflower 4-10 parts, fennel 3-8 parts, blood clots 2-8 parts, and rice wine 10-30 parts. The preparation is carried out using the following steps: S1. Weigh each medicinal material according to the above proportions and dry them at a temperature not exceeding 50℃; S2. Grind each medicinal material into a fine powder; S3. Mix the powder evenly and slowly add the rice wine in batches, stirring to form a paste-like matrix; S4. Place the resulting paste matrix into a sealed container and allow it to mature under static conditions to fully integrate the components; S5. After maturation, the paste is stored at low temperature.

2. The herbal ointment for relieving aches and pains according to claim 1, characterized in that: The drying temperature in step S1 is 40℃; the moisture content after drying in step S1 is <10%.

3. The herbal ointment for relieving aches and pains according to claim 1, characterized in that: After drying in step S1, the medicinal materials should be stored in a cool place.

4. The herbal ointment for relieving aches and pains according to claim 1, characterized in that: In step S2, the crushing method is blade crushing or airflow crushing, followed by classification by a vibrating screen, and finally grinding.

5. The herbal ointment for relieving aches and pains according to claim 4, characterized in that: The D90 particle size of the powdered medicine after pulverization is ≤100μm.

6. The herbal ointment for relieving aches and pains according to claim 1, characterized in that: The method of slowly adding the auxiliary material rice wine in step S3 is as follows: one-third or one-fifth of the total mass of the pre-measured auxiliary material rice wine, and stirring for 30-60 minutes after each addition of the auxiliary material rice wine.

7. The herbal ointment for relieving aches and pains according to claim 1, characterized in that: The parameters for maturation in step S4 are as follows: maturation at 20-30℃ for 12-48 hours.

8. The herbal ointment for relieving aches and pains according to claim 1, characterized in that: The parameters for the low-temperature preservation treatment in step S5 are as follows: a low-temperature environment of 2-8℃ and a relative humidity not exceeding 60%.