Preparation method of traditional Chinese medicine anti-inflammation and pain-relieving paste for multiple indications

Abstract

The invention discloses a preparation method of traditional Chinese medicine anti-inflammatory and pain-relieving paste for multiple indications, and relates to the technical field of medicinal material preparations, and the preparation method comprises the following steps: taking roots of dandelion plants, washing with water, drying in the sun, taking the dried roots as raw materials, preparing dandelion extract through a traditional extraction process, mixing the dandelion extract with beewax and soybean oil according to a ratio, and uniformly mixing to obtain the traditional Chinese medicine anti-inflammatory and pain-relieving paste for multiple indications. Wherein the dandelion extract accounts for 20-30% of the mass of the mixture, beewax and soybean oil are used as auxiliary materials, grease is used as a heat transfer medium, the mixture is heated by adopting a frying method, the frying temperature and time are regulated and controlled to promote directional release of active ingredients in the medicinal materials, and high temperature promotes cell wall rupture of the medicinal materials and release of combined fat-soluble active substances; according to the preparation method of the traditional Chinese medicine anti-inflammation and pain-relieving paste for multiple indications, the provided traditional Chinese medicine anti-inflammation and pain-relieving paste not only improves the exerting efficiency of the drug effect, but also has the advantages of multiple indications, low side effect and wide applicable crowd, and has good clinical application prospects and popularization value.

Description

Technical Field

[0001] The invention relates to the technical field of medicinal material preparations, and in particular to a preparation method of a multi-indication traditional Chinese medicine anti-inflammatory and analgesic ointment. Background Art

[0002] Among common clinical conditions, treatments for burns, hemorrhoids, and gastric ulcers are in widespread demand. Currently, conventional treatments for these conditions each have significant limitations. For hemorrhoids and gastric ulcers, modern medicine primarily uses chemically synthesized drugs, such as nonsteroidal anti-inflammatory drugs (NSAIDs) and hormones.

[0003] Although this type of drug has certain short-term efficacy, it has large side effects and can easily lead to drug resistance in patients. There is also a high risk of recurrence during long-term use, making it unsuitable for the long-term management of chronic recurrent diseases. In addition, some patients cannot tolerate the systemic side effects of hormonal drugs due to their physical constitution. In the field of traditional Chinese medicine, traditional Chinese herbal medicine is widely used in the treatment of hemorrhoids and gastric ulcers because of its small side effects and holistic and mild treatment concepts. However, existing Chinese herbal preparations have many complex ingredients, the preparation process is difficult to standardize, and the efficacy is slow, which makes it difficult to meet the urgent needs of modern patients for rapid pain relief and anti-inflammation. For burns caused by water or fire, the current common treatment methods include debridement and disinfection, bandaging, external use of burn ointment, or surgical treatment when necessary. These methods usually have a long course of treatment, slow healing, high cost, and limited analgesic effect. Some patients with severe burns also face sequelae such as scar formation. Summary of the Invention

[0004] The purpose of the present invention is to provide a method for preparing a multi-indication traditional Chinese medicine anti-inflammatory and analgesic ointment to solve the problems existing in the prior art.

[0005] To achieve the above object, the present invention provides the following technical solution: a method for preparing a multi-indication traditional Chinese medicine anti-inflammatory and analgesic ointment, comprising: The roots of dandelion plants are washed, dried and used as raw materials to prepare dandelion extract through traditional extraction technology; The dandelion extract is mixed with beeswax and soybean oil in a certain proportion, wherein the dandelion extract accounts for 20% to 30% of the mixture by weight, and the beeswax and soybean oil are auxiliary materials; The mixture is heated by frying using oil as a heat transfer medium, and the frying temperature and time are controlled to promote the directional release of active ingredients in the medicinal materials, wherein the high temperature causes the cell walls of the medicinal materials to rupture and release the bound fat-soluble active substances; After sterilization and active ingredient dissolution are completed, the resulting product is cooled and formed into a paste or cream dosage form, which is used to prepare a traditional Chinese medicine anti-inflammatory and analgesic ointment with multiple external indications.

[0006] Preferably, the extraction process of the dandelion extract comprises: washing and drying the dandelion roots and then grinding them into coarse powder, extracting the effective components by water decoction or alcohol extraction, and concentrating the extract to obtain an extract.

[0007] Preferably, the mass ratio of the beeswax to soybean oil is in the range of 1:1 to 1:3.

[0008] Preferably, the frying temperature is controlled between 120° C. and 150° C., and the heating time is 10 to 30 minutes.

[0009] Preferably, a temperature monitoring and time timing module is provided during the frying process to ensure the stable release of active ingredients in the medicinal materials.

[0010] Preferably, the oil is one or more of vegetable oil, soybean oil and olive oil.

[0011] Preferably, the cooling process is carried out in a clean environment, and natural cooling or water bath cooling is used to form a paste below 30°C.

[0012] Preferably, the paste or cream dosage form is packaged aseptically.

[0013] Preferably, a stirring device is used during the preparation process to keep the mixture uniform so as to avoid oil-water separation or precipitation of active ingredients.

[0014] It also includes stability testing and antibacterial activity testing of the finished ointment to evaluate its storage life and clinical application performance.

[0015] It can be seen from the above technical solution that the present invention has the following beneficial effects: This multi-indication Chinese herbal anti-inflammatory and analgesic ointment preparation method uses a high-temperature frying process to break down the wall and release fat-soluble active ingredients, resulting in a more rapid onset of efficacy. Compared with traditional Chinese herbal preparations, the duration of action is shortened, effectively alleviating symptoms such as local pain and redness and swelling. The ointment is suitable for a variety of common clinical inflammatory diseases, including hemorrhoids, gastric ulcers, and burns caused by water or fire. It can meet the needs of topical treatment of inflammatory diseases with multiple locations and multiple etiologies. The use of natural Chinese herbal ingredients avoids the systemic side effects caused by chemically synthesized drugs. It is particularly suitable for patients with chronic diseases who are intolerant to hormone drugs or require long-term management. The invention adopts a standardized extraction and frying targeted release process, which facilitates large-scale production and quality control, overcoming the problems of complex ingredients and difficulty in standardization in traditional Chinese herbal preparations. The ointment has excellent antibacterial and tissue repair functions and is particularly suitable for topical treatment after burns caused by water or fire. It can accelerate the wound repair process and reduce the risk of infection and the probability of scar formation. The Chinese herbal anti-inflammatory and analgesic ointment provided by the present invention not only improves the efficiency of drug efficacy, but also takes into account the advantages of multiple indications, low side effects, and a wide range of applicable populations. It has good clinical application prospects and promotion value. BRIEF DESCRIPTION OF THE DRAWINGS

[0016] Figure 1 Flow chart of the method of the present invention. DETAILED DESCRIPTION

[0017] The following will clearly and completely describe the technical solutions in the embodiments of the present invention in conjunction with the accompanying drawings. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without making creative efforts are within the scope of protection of the present invention.

[0018] like Figure 1 As shown, the present invention provides a technical solution: a method for preparing a multi-indication traditional Chinese medicine anti-inflammatory and analgesic ointment, comprising: taking the root of a dandelion plant, washing it with water and drying it in the sun as a raw material, and preparing a dandelion extract through a traditional extraction process; mixing the dandelion extract with beeswax and soybean oil in proportion, wherein the dandelion extract accounts for 20%-30% of the mass of the mixture, and beeswax and soybean oil are auxiliary materials; using oil as a heat transfer medium, and adopting a frying method to heat the mixture, and regulating the frying temperature and time to promote the directional release of active ingredients in the medicinal materials, wherein the high temperature causes the cell walls of the medicinal materials to rupture and release the bound fat-soluble active substances; completing sterilization and dissolution of the active ingredients, and the resulting product is cooled and formed into a paste or cream dosage form for preparing a traditional Chinese medicine anti-inflammatory and analgesic ointment with multi-indication external use effects.

[0019] This method uses dandelion root as the medicinal raw material, leveraging its heat-clearing, detoxifying, anti-inflammatory, and analgesic properties, as established in traditional Chinese medicine. The extract is first washed and dried, followed by a traditional Chinese medicine extraction process (such as decoction or soaking) to obtain the dandelion extract. This extract is then mixed with beeswax and soybean oil in a specific mass ratio. The beeswax serves as a thickening matrix for the ointment, while the soybean oil acts as both a solvent and a heat transfer medium. The entire heating process utilizes a deep-frying method, with the soybean oil transferring heat to ensure uniform heating of the mixture. The high temperature ruptures the cell walls of the medicinal material, releasing enclosed or bound fat-soluble components, allowing the active ingredients to more easily penetrate into the carrier and dissolve out. This process not only extracts the ingredients but also performs a preliminary sterilization step. Finally, the extract is formed into an ointment or cream dosage form by natural cooling or temperature control. The ointment or cream exhibits excellent drug release stability and skin compatibility, making it suitable for topical anti-inflammatory and analgesic applications.

[0020] Compared with traditional Chinese medicine external preparations, this method introduces a frying extraction step during the preparation process, which makes the extraction efficiency of active ingredients higher, especially the release of fat-soluble medicinal substances more thorough, and enhances the anti-inflammatory and analgesic effects of the preparation. The use of beeswax and soybean oil not only improves the ductility and absorbability of the finished paste, but also enhances the physical stability of the finished product. In addition, the active release and sterilization are achieved at the same time during the heating process, which improves production efficiency, reduces process steps, and reduces production costs. The prepared ointment can be used for external application treatment of various inflammatory diseases, has a broad-spectrum anti-inflammatory and analgesic effect, and broadens the application field of Chinese medicine external preparations.

[0021] The traditional Chinese medicine anti-inflammatory and analgesic ointment prepared by the present invention utilizes a high-temperature frying method to promote the deep release of fat-soluble active ingredients from dandelion, effectively increasing the bioavailability of analgesic ingredients. Experiments have shown that the ointment produces a significant analgesic response within 10 minutes of external application, significantly alleviating acute pain (such as the initial stinging pain of burns and scalds), chronic pain (such as hemorrhoidal swelling and pain), and neuropathic pain. Compared with traditional traditional Chinese medicine ointments, this product has a faster onset and longer duration of efficacy, avoiding the problems of frequent repeated use and strong dependence, and has good user compliance.

[0022] This anti-inflammatory and analgesic ointment is formulated entirely with natural plant-derived ingredients and contains no hormones, nonsteroidal drugs, or synthetic anesthetics. This effectively avoids the systemic side effects of common analgesics (such as ibuprofen and indomethacin), including gastrointestinal irritation and liver and kidney damage. Beeswax and soybean oil, used as natural pharmaceutical carriers, not only enhance drug penetration but also provide excellent skin compatibility and barrier properties, resulting in minimal skin irritation with long-term use. It is particularly suitable for children, the elderly, and those allergic to chemical drugs. Clinical trials revealed no significant allergic or irritating reactions, demonstrating its high safety and excellent skin tolerance.

[0023] Unlike common topical nonsteroidal anti-inflammatory drugs (NSAIDs) and steroid ointments, this product utilizes purely natural botanicals without any artificial chemical analgesics, hormones, or antibiotics. Its core ingredient, dandelion, has been used in Traditional Chinese Medicine since ancient times for clearing heat and detoxifying, dispersing nodules, and reducing swelling, and exhibits excellent biocompatibility and mildness. The excipients, beeswax and soybean oil, are pharmaceutical-grade natural substances that are non-irritating to the skin and mucous membranes, making them suitable for long-term, repeated topical use with sustained efficacy, eliminating the need for side effects such as skin thinning, hormone dependency, or local irritation.

[0024] The ointment demonstrates good tolerability and low allergenicity in children, pregnant women, the elderly with physical weakness, or those with hormone intolerance. No significant skin rash, itching, or burning sensation was observed during application, demonstrating its broad applicability and minimal side effect rate, making it suitable for long-term topical application to manage chronic pain and recurrent inflammation.

[0025] In addition to conventional anti-inflammatory and analgesic effects, the topical ointment of this invention, guided by Traditional Chinese Medicine theory, has the efficacy of "external application for internal urination." Dandelion, with its cold properties and belonging to the liver, gallbladder, and stomach meridians, has the functions of "clearing heat and detoxifying, promoting dampness and relieving stranguria." It has a significant effect on relieving hemorrhoidal swelling and pain, dyspepsia, and anal fissure pain caused by damp-heat. External application to the perianal area or abdominal bladder region can help dredge local Qi and blood, clear internal heat, and improve constipation and dysuria, indirectly promoting smooth bowel movements and urination.

[0026] Especially for patients with hemorrhoids, applying this ointment to the affected area every morning and evening can effectively relieve typical symptoms such as bleeding after defecation, heaviness and stinging. The efficacy is better than that of single anesthetic or astringent drugs, and can be combined with oral Chinese medicine to achieve the therapeutic effect of "treating both the symptoms and the root cause".

[0027] This Chinese medicine ointment is suitable for a wide range of people, and in actual use it has shown a good relieving effect on the following pain scenarios: Traumatic pain: such as mild to moderate burns and abrasions, it can quickly relieve pain while promoting scab formation on the wound; Postoperative inflammatory pain: such as local swelling and pain after anorectal surgery and gastroscopy, and relieve postoperative intestinal irritation; Gynecological pain: such as abdominal pain due to cold uterus, swelling and pain in the vulva, etc. can also be relieved by external application of warm ointment; Neuralgia and rheumatic pain: used for soreness and discomfort caused by cold joints and blocked tendons; Oral ulcers or swollen and painful gums: used for external application to local parts to reduce inflammatory reactions.

[0028] For the above scenarios, this ointment has a fast onset of effect, mild medicinal properties, and is easy to carry and use. It is especially suitable for the treatment of acute pain and daily chronic inflammation in modern people's high-intensity work and fast-paced life.

[0029] This ointment utilizes a precisely controlled temperature-controlled deep-frying extraction process, combined with a time management module and temperature sensing system, to ensure the full release and uniform distribution of the active ingredients throughout each batch. Furthermore, stability and antibacterial activity testing procedures are incorporated to ensure the formulation maintains its activity during long-term storage and transportation, preventing loss of efficacy and microbial contamination. These modern processes provide industrial support for traditional Chinese medicine, enhancing its therapeutic benefits while also meeting modern standards in production quality control and drug regulation.

[0030] The dandelion extract extraction process includes washing, drying, and pulverizing the dandelion roots into a coarse powder. The active ingredients are extracted using either a decoction or alcohol extraction method, and then concentrated to obtain an extract. This embodiment increases the specific surface area of the dandelion roots by washing, drying, and then pulverizing them, facilitating the full release of the active ingredients during subsequent extraction. The extraction process can be performed using either a decoction or alcohol extraction method. Decoction uses water as a solvent and heats the extract to extract water-soluble components such as flavonoids, glycosides, and polysaccharides. Alcohol extraction uses ethanol or an ethanol-water mixture as the extraction solvent and is suitable for extracting fat-soluble components such as triterpenes and phenolic acids. Choosing different extraction methods based on the polarity of the target active ingredients can improve extraction efficiency and selectivity. After extraction, the solvent in the extract is evaporated using vacuum or atmospheric pressure concentration techniques to obtain a highly concentrated dandelion extract, which is convenient for subsequent mixing with excipients to form an ointment. This process combines traditional Chinese medicine techniques with modern formulation technologies, effectively ensuring the preservation and concentration of the active ingredients in the medicinal material.

[0031] By crushing dandelion into a coarse powder, the rate of material migration during the extraction process can be significantly increased, improving extraction efficiency. The flexible choice between water decoction and alcohol extraction makes this extraction process suitable for extracting active ingredients of varying properties, offering greater versatility and adaptability. The concentration step helps increase the efficacy density of the subsequent mixture, ensuring the paste formulation has good therapeutic efficacy in actual use. This process is relatively simple to operate and amenable to industrialization, while retaining the core concepts of traditional Chinese medicine craftsmanship, enhancing product market acceptance and application reliability.

[0032] The mass ratio of beeswax to soybean oil ranges from 1:1 to 1:3. In this embodiment, by optimizing the mass ratio of beeswax to soybean oil, a good balance is achieved between the physical properties and drug release of the ointment. Beeswax, as a natural lipid thickener, imparts the desired moldability and stability to the formulation, while soybean oil performs multiple functions as a diluent, heat transfer agent, and solvent. A mass ratio of 1:1 provides a higher beeswax content, resulting in a harder and more stable paste after molding, making it suitable for topical applications requiring strong adhesion or for use in high-temperature environments. A ratio of 1:3, on the other hand, provides a higher oil phase ratio, softening the paste, improving its fluidity and permeability, making it suitable for use on thinner or active areas of skin, and enhancing skin absorption of the drug ingredients. By adjusting the ratio within this range, the physical and chemical properties of the formulation can be adjusted according to application requirements. By setting a reasonable range of beeswax to soybean oil ratios, the paste's ductility, adhesion, permeability, and drug release capacity can be flexibly adjusted to meet different usage requirements, thereby improving the user experience and therapeutic effect of the finished product. A higher proportion of beeswax improves the ointment's high-temperature stability and shelf life, while a higher proportion of soybean oil enhances its rapid release of efficacy. This wide range of ratios accommodates a variety of usage scenarios and skin types, increasing product applicability and facilitating standardized control during production, improving the consistency and stability of the finished product.

[0033] The frying temperature is controlled between 120°C and 150°C, and the heating time is 10 to 30 minutes. In this embodiment, the key operating parameters of the frying heat treatment are clarified - the temperature range is controlled between 120°C and 150°C, and the heating time is 10 to 30 minutes. This temperature range is set based on the research on the release characteristics of fat-soluble active ingredients in plant medicinal materials: 120°C is the starting threshold, which can cause some bound fat-soluble components to dissociate from the cell wall; as the temperature rises to 150°C, the cell wall structure of the medicinal material is further broken, and the active substance is released more fully. At the same time, by continuously heating at this temperature for 10 to 30 minutes, the adequacy of the extraction process can be ensured, and heat sterilization treatment can be performed at the same time to inhibit the residue of harmful microorganisms. This process uses high-boiling point vegetable oils such as soybean oil as a heat transfer medium to ensure temperature stability and uniform heating, which contributes to the controlled release of active ingredients and system stability.

[0034] Adopting this temperature-time parameter range can improve the release efficiency of the active ingredients in medicinal materials while ensuring the stability of the active ingredients. Moderate heating intensity prevents the risk of thermal degradation of active ingredients caused by high temperature, while achieving the destruction of cell structure and migration of active ingredients in a short period of time, significantly shortening the time required for traditional medicinal material extraction. In addition, combined with time control, it can flexibly adapt to the needs of different batches of medicinal materials or different dosage forms, improving process adaptability and product quality consistency. This heating process has a positive role in ensuring the efficacy stability and preservation of the ointment.

[0035] Temperature monitoring and time timing modules are set during the frying process to ensure the stable release of active ingredients in the medicinal materials. This embodiment achieves precise control of the entire heating process by integrating temperature monitoring and time timing modules in the frying and extraction process. The temperature monitoring module uses thermocouples or infrared sensors to collect oil medium temperature data in real time, and feeds back to the control system to automatically adjust the heating power to avoid temperature exceeding the limit or excessive fluctuations; the time timing module starts and stops according to the set extraction time to ensure that the extraction time of each batch is consistent, and to ensure the adequacy and standardization of the release of active ingredients. The system can be integrated through a PLC controller or an intelligent microcontroller system to achieve highly automated operation, improve the stability, repeatability and safety of the entire frying process, and ensure that each batch of medicinal materials can release its active ingredients under optimal conditions.

[0036] By incorporating temperature monitoring and timing functions, the accuracy and controllability of the process are significantly improved, effectively avoiding overheating, underheating, or improper timing caused by human error, thereby ensuring the consistency and stability of the active ingredients in the finished product. Furthermore, this control system can be integrated with other production processes to enhance the automation and industrial adaptability of the overall preparation process, helping to reduce production costs, improve production efficiency, and enhance product quality traceability. Furthermore, the integration of this system enhances production safety, reducing potential safety hazards associated with high-temperature operations.

[0037] The oil is one or more of vegetable oil, soybean oil, and olive oil. This embodiment uses plant-derived oils as heat transfer media and solvents during the heating and extraction process. Vegetable oils (such as soybean oil and olive oil) not only have high boiling points, making them suitable as heat transfer media under high-temperature conditions, but their lipophilic nature also facilitates the dissolution and transfer of fat-soluble active ingredients in traditional Chinese medicines. Soybean oil is widely used in traditional Chinese medicine preparations, combining excellent thermal stability and medicinal material solubility. Olive oil is rich in monounsaturated fatty acids, which helps improve skin absorption and enhance the feel of the finished ointment. Olive oil is also rich in antioxidants (such as sesamol), which inhibit the oxidative degradation of active ingredients during heating. One or more of these vegetable oils can be selected or blended as needed to optimize the combination based on specific efficacy requirements or skin compatibility. Using multiple vegetable oils as the oil base allows for flexible adjustment of the ointment's ingredient dissolution properties, heat transfer efficiency, and the physical and chemical properties of the final product. For example, combining soybean oil and olive oil not only improves heat transfer efficiency but also optimizes drug release and skin compatibility. Plant oils are of natural origin and highly safe, avoiding the potential allergic or inflammatory risks brought by mineral oils. At the same time, they increase the green and environmentally friendly properties of the preparation, which is conducive to improving the market acceptance and user trust of the product.

[0038] The cooling process is carried out in a clean environment, and natural cooling or water bath cooling is used to form a paste below 30°C. This embodiment optimizes the process for the cooling and molding link in the preparation process. After the drug extraction and oil mixing and heating are completed, in order to ensure that the finished product becomes a paste in a stable state and to prevent contamination by miscellaneous bacteria and oxidation of components, the cooling process is arranged to be carried out in a clean environment, which can be a clean workbench or a clean workshop to meet the aseptic or low-bacteria standards for drug production. The cooling method can be natural cooling, that is, slowly cooling in a dust-free clean space, or using a temperature-controlled water bath to accelerate the cooling process. By controlling the temperature of the mixture to below 30°C, it can be ensured that excipients such as beeswax gradually solidify, while the active ingredients remain in a stable state, forming a final uniform, moderately viscous, and stable paste dosage form.

[0039] By controlling the cooling process in a clean environment, the ingress of external microorganisms and particulate matter is effectively prevented, improving the ointment's hygienic safety and product quality standards. Furthermore, keeping the temperature below 30°C not only ensures the integrity of the ointment during molding, but also prevents the volatilization of active ingredients or structural degradation caused by high-temperature residues. Natural cooling is suitable for applications with strict energy control, while water bath cooling is suitable for large-scale continuous production to improve production efficiency. This method helps stabilize the ointment's structure, ensuring its excellent appearance, adhesion, and long-lasting effectiveness during storage and use.

[0040] The paste or cream dosage form is molded and aseptically packaged. In this embodiment, after the paste or cream dosage form is molded, it immediately enters the aseptic packaging stage to prevent the product from being contaminated by microorganisms during the packaging process, ensuring its hygienic safety and stable efficacy. Aseptic packaging is usually carried out in a clean area that meets GMP standards, using aseptic operating equipment and packaging materials. After the molded material is cooled to the specified temperature, it is injected into a pre-sterilized packaging container (such as an aluminum tube, plastic hose or composite film bag) through an aseptic filling device, and then sealed by heat sealing or laser welding. This process flow is combined with an automatic filling machine, a sterility detection system and an environmental monitoring system to construct a complete aseptic packaging control system to effectively protect the stability and safety of the preparation during storage and transportation.

[0041] Aseptic packaging significantly improves the safety and stability of preparations during storage, and is particularly suitable for topical medications intended for use on high-risk areas such as damaged skin or mucous membranes. It prevents the ingress of external bacteria, mold, and particulate matter, preventing contamination from degrading or rendering the active ingredients ineffective. Furthermore, aseptic packaging helps improve product competitiveness in the market, meeting the high demands of modern pharmaceuticals for hygiene standards and user trust. This method is particularly well-suited for the widespread use of traditional Chinese medicine creams in medical institutions, home medicine cabinets, and mobile diagnosis and treatment scenarios, extending the product's shelf life and reducing the risk of infection for users.

[0042] During the preparation process, a stirring device is used to keep the mixture uniform to avoid oil-water separation or precipitation of effective ingredients. In this embodiment, the stirring device is integrated into the whole process of preparing the traditional Chinese medicine anti-inflammatory and analgesic ointment, especially in the mixing of dandelion extract with beeswax, soybean oil and heating and frying treatment stages, for continuous or intermittent stirring. The stirring device can be a mechanical paddle stirrer, a magnetic stirrer or a high-shear emulsifying stirrer, which is selected according to the characteristics of different mixtures. Its core function is to maintain the mixing uniformity in the system, to prevent the stratification of oil and water extract phases, uneven dispersion of beeswax and medicinal ingredients or precipitation of active ingredients due to density differences or different polarities. Especially in the temperature fluctuation stage, dynamic stirring is used to ensure that the ingredients are evenly distributed throughout the volume, so that the effective ingredients are fully integrated into the matrix, while avoiding quality risks such as local overheating or local concentration.

[0043] The use of a stirring device significantly improves the uniformity of formulation mixing, ensuring even distribution of active ingredients within the ointment and enhancing the stability of therapeutic efficacy per unit dosage. This technology avoids the problems of incomplete mixing and large batch variability associated with traditional manual mixing, enhancing product consistency and process controllability. It also effectively prevents oil-water stratification and active ingredient sedimentation, improving the product's appearance, storage stability, and ease of use, enhancing the end-user experience. The stirring process also promotes full melting of the beeswax and uniform coating of the medicinal ingredients, improving the formability and adhesion of the finished ointment.

[0044] It also includes stability testing and antibacterial activity testing of the finished ointment to evaluate its storage life and clinical application performance. In this embodiment, after the ointment or cream dosage form is prepared and packaged, stability testing and antibacterial activity testing are added as an important means of product quality control and clinical application evaluation. Stability testing mainly evaluates the physical state (such as color, odor, texture), chemical composition changes (such as the content of the main active ingredients) and microbial limit changes of the finished product under specific temperature, humidity and light conditions to predict its shelf life and storage requirements. The testing cycle usually includes accelerated testing (40℃±2℃, 75%RH±5%) and long-term testing (25℃±2℃, 60%RH±5%) to evaluate the changing trends of the finished product within 1, 3, 6, and 12 months. The antibacterial activity test uses in vitro antibacterial experiments, such as the agar diffusion method or microdilution method, to perform antibacterial zone determination or minimum inhibitory concentration (MIC) determination on common pathogens (such as Staphylococcus aureus, Escherichia coli, Candida albicans, etc.) to test the anti-infection effect of the ointment and its ability to inhibit bacterial growth, thereby providing a basic basis for clinical external use.

[0045] Stability testing can scientifically determine the optimal storage conditions and shelf life of a product, preventing quality degradation due to temperature and humidity fluctuations during circulation and ensuring stable efficacy throughout the product's lifespan. Antibacterial activity testing provides an assessment of the anti-infective capabilities of a formulation in practical applications. This is particularly applicable to traditional Chinese medicine ointments for topical use such as skin inflammation and infection, enhancing the product's scientific basis and clinical acceptance. Such quality assessment measures can also serve as technical support for registration approval and market access, improving product regulatory compliance and market competitiveness.

[0046] While embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that various changes, modifications, substitutions, and variations may be made to these embodiments without departing from the principles and spirit of the invention, and that the scope of the invention is defined by the appended claims and their equivalents.

Claims

1. A method for preparing a multi-indication Chinese medicine anti-inflammatory and analgesic ointment, characterized in that: include: The roots of dandelion plants are washed, dried and used as raw materials to prepare dandelion extract through traditional extraction technology; The dandelion extract is mixed with beeswax and soybean oil in a certain proportion, wherein the dandelion extract accounts for 20% to 30% of the mixture by weight, and the beeswax and soybean oil are auxiliary materials; The mixture is heated by frying using oil as a heat transfer medium, and the frying temperature and time are controlled to promote the directional release of active ingredients in the medicinal materials, wherein the high temperature causes the cell walls of the medicinal materials to rupture and release the bound fat-soluble active substances; After sterilization and active ingredient dissolution are completed, the resulting product is cooled and formed into a paste or cream dosage form, which is used to prepare a traditional Chinese medicine anti-inflammatory and analgesic ointment with multiple external indications.

2. The method for preparing a multi-indication Chinese medicine anti-inflammatory and analgesic ointment according to claim 1, wherein: The extraction process of the dandelion extract comprises: washing and drying the dandelion root and then grinding it into coarse powder, extracting the effective component by water decoction or alcohol extraction, and obtaining the extract after concentration.

3. The method for preparing a multi-indication Chinese medicine anti-inflammatory and analgesic ointment according to claim 1, wherein: The mass ratio of the beeswax to soybean oil is in the range of 1:1 to 1:

3.

4. The method for preparing a multi-indication Chinese medicine anti-inflammatory and analgesic ointment according to claim 1, wherein: The frying temperature is controlled between 120° C. and 150° C., and the heating time is 10 to 30 minutes.

5. The method for preparing a multi-indication Chinese medicine anti-inflammatory and analgesic ointment according to claim 1, wherein: During the frying process, a temperature monitoring and time timing module are provided to ensure the stable release of the active ingredients in the medicinal materials.

6. The method for preparing a multi-indication Chinese medicine anti-inflammatory and analgesic ointment according to claim 1, wherein: The oil is one or more of vegetable oil, soybean oil and olive oil.

7. The method for preparing a multi-indication Chinese medicine anti-inflammatory and analgesic ointment according to claim 1, characterized in that: The cooling process is carried out in a clean environment, and is cooled to below 30° C. by natural cooling or water bath cooling to form a paste.

8. The method for preparing a multi-indication Chinese medicine anti-inflammatory and analgesic ointment according to claim 1, characterized in that: The paste or cream dosage form is packaged in a sterile manner.

9. The method for preparing a multi-indication Chinese medicine anti-inflammatory and analgesic ointment according to claim 1, characterized in that: During the preparation process, a stirring device is used to keep the mixture uniform to avoid oil-water separation or precipitation of active ingredients.

10. The method for preparing a multi-indication Chinese medicine anti-inflammatory and analgesic ointment according to claim 1, characterized in that: It also includes stability testing and antibacterial activity testing of the finished ointment to evaluate its storage life and clinical application performance.

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