Traditional Chinese medicine composition for treating allergic rhinitis and ointment thereof

Abstract

The invention discloses a traditional Chinese medicine composition for treating allergic rhinitis and ointment thereof, and belongs to the technical field of traditional Chinese medicine preparations. The ointment comprises a traditional Chinese medicine composition and auxiliary materials, wherein the traditional Chinese medicine composition consists of divaricate saposhnikovia root, ligusticum wallichii, fried cocklebur fruit, biond magnolia flower, radix angelicae, menthol and borneol; the auxiliary materials comprise PEG400 (polyethylene glycol 400), PEG4000 (polyethylene glycol 4000), vaseline, azone, dithiothreitol, violet leaf alcohol, propyl gallate and ethylparaben. The invention further provides a preparation method of the ointment. The preparation method comprises the steps of traditional Chinese medicine extraction and ointment preparation. The traditional Chinese medicine composition is simple in formula and has the synergistic effects of expelling wind, removing cold, opening orifices and relieving pain; through matching of specific auxiliary materials, the ointment can promote transdermal absorption of drugs, can effectively improve symptoms such as nasal obstruction, rhinocnesmus, sneezing and clear nasal discharge of allergic rhinitis patients, and has good clinical application value.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine preparation technology, specifically relating to a traditional Chinese medicine composition and its ointment for treating allergic rhinitis. Background Technology

[0002] The information disclosed in this background section is intended only to enhance understanding of the overall background of the invention and is not necessarily to be construed as an admission or in any way implying that such information constitutes prior art known to those skilled in the art.

[0003] Allergic rhinitis, also known as hay fever, is a common allergic disease in clinical practice. Its onset is closely related to genetic and environmental factors. The main clinical symptoms of allergic rhinitis include recurrent nasal congestion, nasal itching, sneezing, and clear nasal discharge. Some patients may also experience itchy eyes, tearing, and throat discomfort. Long-term recurrent attacks can lead to sleep disturbances, poor concentration, and memory loss, and may also induce complications such as sinusitis, nasal polyps, and asthma, posing a serious threat to the patient's respiratory health and overall physical and mental well-being. Currently, clinical treatments for allergic rhinitis mainly include avoiding allergens, drug therapy, immunotherapy, and surgery, with drug therapy being the most commonly used intervention.

[0004] Chinese Patent Publication No. CN109432173A discloses a medicated ointment for treating rhinitis, comprising the following raw materials in parts by weight: 8-15 parts Magnolia biondii, 8-12 parts Angelica dahurica, 8-10 parts Xanthium sibiricum, 5-10 parts Mentha haplocalyx, 8-12 parts Saposhnikovia divaricata, 4-6 parts Ligusticum chuanxiong, 3-5 parts Borneol, 10-15 parts Vaseline, and 10-15 parts Sesame oil. The preparation method includes weighing the raw materials, grinding them into powder and sieving them, adding Vaseline and sesame oil to prepare a paste, and cooling to obtain the desired ointment. However, unprocessed cocklebur not only poses potential safety risks in medication use, but also makes it difficult to guarantee the safety of the preparation in long-term use. Furthermore, the ointment uses petrolatum and sesame oil as a base, which can play a certain role in moisturizing the skin and acting as a drug carrier. However, petrolatum is quite sticky, and when applied to the nasal cavity, it can easily cause a foreign body sensation in the nasal cavity. In addition, the drug components are released slowly, which may affect the speed of onset of action and make it difficult to quickly relieve the acute symptoms of sudden nasal congestion and nasal itching in patients with allergic rhinitis.

[0005] Chinese patent CN103110706A discloses a traditional Chinese medicine composition for treating rhinitis, mainly composed of honeysuckle, platycodon, angelica dahurica, red peony root, chuanxiong rhizome, cocklebur fruit, saposhnikovia root, dandelion, cimicifuga rhizome, licorice root, agastache rugosa, roasted cocklebur fruit, and mint. However, this formula is too complex. On the one hand, too many types of medicinal materials increase the cost of raw material procurement and the difficulty of quality control during the preparation process. Differences in the content of effective components in different batches of medicinal materials may lead to unstable preparation quality. On the other hand, honeysuckle, dandelion, and other medicinal materials in this composition mainly have the effect of clearing heat and detoxifying, which is more suitable for wind-heat type rhinitis. However, allergic rhinitis in traditional Chinese medicine is mostly due to wind-cold invasion and weak defensive qi. The formula has a low degree of consistency with the core pathogenesis of allergic rhinitis and is not targeted enough, which may result in limited symptom improvement for patients with allergic rhinitis. Therefore, developing a simplified, safe, and fast-acting traditional Chinese medicine composition and its ointment remains a key problem that needs to be solved by those skilled in the art, and it also lays the necessary technical foundation for the proposal of this invention. Summary of the Invention

[0006] To address the problems of insufficient safety, slow onset of action, complex formulation, or lack of specificity in existing drugs for treating allergic rhinitis, this invention provides a traditional Chinese medicine composition and its ointment for treating allergic rhinitis. This traditional Chinese medicine composition has a simplified formulation and is safe to use. The ointment prepared from it has a rapid onset of action and significant therapeutic effect, effectively improving the clinical symptoms of patients with allergic rhinitis.

[0007] This invention provides a medicated ointment for treating allergic rhinitis, comprising a traditional Chinese medicine composition and excipients, as detailed below: The traditional Chinese medicine composition consists of Saposhnikovia divaricata, Ligusticum chuanxiong, stir-fried Xanthium sibiricum, Magnolia biondii, Angelica dahurica, menthol, and borneol.

[0008] From the perspective of Traditional Chinese Medicine (TCM) theory, the formula of this invention has a clear synergistic effect: Fangfeng (Saposhnikovia divaricata) is the principal herb, dispelling wind and relieving exterior symptoms, eliminating dampness and relieving pain. It can resist external pathogens and alleviate symptoms such as nasal itching and sneezing caused by wind and cold. Chuanxiong (Ligusticum striatum) invigorates blood and qi, dispels wind and relieves pain; Xinyi (Magnolia biondii) and Baizhi (Angelica dahurica) are pungent and warm, opening the nasal passages, dispelling cold and relieving pain. These three herbs work together as assistant herbs, enhancing the effect of clearing the nasal passages and improving nasal congestion and runny nose. Fried Cang'erzi (Xanthium sibiricum), after processing to reduce toxicity, also has the effects of dispelling wind and dampness, opening the nasal passages and relieving pain, serving as adjuvant herbs. Menthol and Borneol are cool in nature, having the effects of cooling and relieving itching, opening the nasal passages and refreshing the mind. They can enhance drug penetration and absorption, and quickly relieve acute symptoms such as nasal itching and congestion, serving as guiding herbs. The entire formula works together to dispel wind and cold, open the nasal passages and relieve pain, highly consistent with the core pathogenesis of allergic rhinitis—"wind-cold invasion and nasal congestion"—making it highly targeted.

[0009] Further, the traditional Chinese medicine composition comprises, by weight: 60-100 parts of Saposhnikovia divaricata, 60-100 parts of Ligusticum chuanxiong, 60-100 parts of stir-fried Xanthium sibiricum, 60-100 parts of Magnolia biondii, 60-100 parts of Angelica dahurica, 2-8 parts of menthol, and 2-8 parts of borneol. Preferably, the traditional Chinese medicine composition comprises, by weight: 80 parts of Saposhnikovia divaricata, 80 parts of Ligusticum chuanxiong, 80 parts of stir-fried Xanthium sibiricum, 80 parts of Magnolia biondii, 80 parts of Angelica dahurica, 4 parts of menthol, and 5 parts of borneol.

[0010] The excipients in the ointment for treating allergic rhinitis of this invention include PEG400, PEG4000, petrolatum, azone, dithiothreitol, violet leaf alcohol, propyl gallate, and ethylparaben.

[0011] The functions of each auxiliary material are as follows: PEG400, PEG4000, and petrolatum are used as a base to adjust the viscosity of the ointment, making it easier to apply and reducing the feeling of a foreign body in the nasal cavity; azone, dithiothreitol, and violet leaf alcohol are transdermal penetration enhancers, and the three work synergistically to promote the transdermal absorption of the effective ingredients of traditional Chinese medicine and accelerate the onset of action; propyl gallate and ethylparaben are preservatives and antioxidants, which can extend the shelf life of the ointment and ensure the stability of medication.

[0012] Further, the excipients, calculated by weight, include: 15-30 parts PEG400, 35-70 parts PEG4000, 10-25 parts petrolatum, 0.5-2 parts azone, 0.1-0.5 parts dithiothreitol, 0.05-0.2 parts violet leaf alcohol, 0.01-0.05 parts propyl gallate, and 0.05-0.1 parts ethylparaben. Preferably, the excipients, calculated by weight, include: 20 parts PEG400, 55 parts PEG4000, 20 parts petrolatum, 1 part azone, 0.3 parts dithiothreitol, 0.15 parts violet leaf alcohol, 0.02 parts propyl gallate, and 0.08 parts ethylparaben. This preferred formulation results in a uniform ointment texture, good stability, and optimal transdermal absorption efficiency.

[0013] This invention also provides a method for preparing the above-mentioned ointment, comprising two steps: extraction of traditional Chinese medicine and preparation of the ointment, as detailed below: Extraction of Chinese herbal medicine: Take Saposhnikovia divaricata, Ligusticum chuanxiong, stir-fried Xanthium sibiricum, Magnolia biondii, and Angelica dahurica, add 8-10 times the amount of water, soak for 1-2 hours, heat to boiling and decoct for 1-2 hours, filter, and collect the first filtrate; add 6-8 times the amount of water to the residue, heat to boiling and decoct for 1-2 hours, filter, and collect the second filtrate; combine the two filtrates, concentrate under reduced pressure at 60-70℃ to a clear extract with a relative density of 1.10-1.15 (60℃), and set aside.

[0014] Ointment preparation: (1) Preparation of oil phase: Heat petrolatum to 50-60℃, stir to melt, and keep warm for later use; (2) Aqueous phase preparation: Add PEG400 and PEG4000 to water, heat to 60-70℃, stir to dissolve, and set aside; (3) Mixing and emulsification: Slowly add the oil phase to the aqueous phase while stirring at a speed of 300-400 r / min for 15-20 minutes to form the initial emulsion; (4) Add the Chinese herbal extract: Slowly add the Chinese herbal extract to the colostrum and stir for 10-15 minutes until fully mixed; (5) Adding excipients: When the temperature of the mixture drops to 40-45℃, add azone, dithiothreitol, violet leaf alcohol, propyl gallate, and ethylparaben. Add and stir at a speed of 200-300r / min for 20-30 minutes until the mixture is uniform. (6) Add menthol and borneol: Grind menthol and borneol into fine powder, pass them through a 100-mesh sieve, add them to the above mixture, and stir for 10-15 minutes until completely dissolved and mixed evenly; (7) Cool and shape to obtain the product.

[0015] This preparation process ensures uniform mixing of all components by controlling temperature, stirring speed, and time, forming a stable ointment, while avoiding the destruction of volatile components such as menthol and borneol by high temperatures.

[0016] Compared with the prior art, the technical advantages of the present invention are as follows: (1) Scientific formulation and strong targeting: The Chinese medicine composition of this invention contains only 7 medicinal materials, which is concise and efficient. It closely follows the pathogenesis of allergic rhinitis, namely "wind-cold invasion and nasal obstruction". It has a synergistic effect of dispelling wind and cold and clearing the nasal passages and relieving pain, and the curative effect is more obvious.

[0017] (2) Drug safety: This invention uses fried cocklebur instead of unprocessed cocklebur, which reduces the risk of toxicity; the excipients are mild and non-irritating, and are suitable for skin application.

[0018] (3) Rapid onset of action and high transdermal absorption efficiency: This invention significantly improves the transdermal absorption rate of the effective components of traditional Chinese medicine through the synergistic effect of three transdermal promoters: azone, dithiothreitol and violet leaf alcohol, which can quickly relieve acute symptoms such as nasal congestion and nasal itching.

[0019] (4) Significant clinical efficacy: Clinical trials show that the ointment of the present invention has a total effective rate of 95.0% in treating allergic rhinitis, which is much higher than the control drug in the prior art, and the cure rate is high and the recurrence rate is low.

[0020] The traditional Chinese medicine composition and its ointment of the present invention have the characteristics of simple formulation, safe use, rapid onset of action and significant curative effect, providing a new and effective option for the clinical treatment of allergic rhinitis, and have important clinical application value and industrial production prospects. Attached Figure Description

[0021] Figure 1 Statistical analysis of therapeutic effects. Detailed Implementation

[0022] To make the objectives and technical solutions of this invention clearer, the following embodiments are provided for further explanation. However, the scope of protection of this invention is not limited to these embodiments; the embodiments are merely for illustrative purposes. Those skilled in the art should understand that any changes or equivalent substitutions that do not depart from the concept of this invention are included within the scope of protection of this invention.

[0023] Example 1: Allergic Rhinitis Ointment formula: Preparation method: (a) Extraction of traditional Chinese medicine: Take Saposhnikovia divaricata, Ligusticum chuanxiong, stir-fried Xanthium sibiricum, Magnolia biondii, and Angelica dahurica. Add 9 times the amount of water, soak for 1.5 hours, heat to boiling and decoct for 1.5 hours, filter, and collect the first filtrate. Add 7 times the amount of water to the dregs, heat to boiling and decoct for 1.5 hours, filter, and collect the second filtrate. Combine the filtrates and concentrate under reduced pressure at 65℃ to a clear extract with a relative density of 1.10-1.15 (60℃). Set aside for later use.

[0024] (II) Preparation of Ointment: (1) Preparation of oil phase: Heat petroleum jelly to 55°C, stir to melt, and keep warm for later use.

[0025] (2) Aqueous phase preparation: Add PEG400 and PEG4000 to 75ml of water, heat to 65℃, stir to dissolve, and set aside.

[0026] (3) Mixing and emulsification: The oil phase is slowly added to the water phase at a speed of 350 r / min while stirring for 20 minutes to form the initial emulsion.

[0027] (4) Add Chinese herbal paste: Slowly add Chinese herbal paste to colostrum and stir for 15 minutes to mix thoroughly.

[0028] (5) Adding excipients: When the temperature of the mixture drops to 40°C, add azone, dithiothreitol, violet leaf alcohol, propyl gallate, and ethylparaben. Add while stirring at a speed of 250 r / min for 25 minutes until the mixture is homogeneous.

[0029] (6) Add menthol and borneol: Grind menthol and borneol into fine powder, pass them through a 100-mesh sieve, add them to the above mixture, stir for 15 minutes to completely dissolve and mix evenly.

[0030] (7) Cooling and molding.

[0031] Example 2: Allergic Rhinitis Ointment formula: Preparation method: (a) Extraction of traditional Chinese medicine: Take Saposhnikovia divaricata, Ligusticum chuanxiong, stir-fried Xanthium sibiricum, Magnolia biondii, and Angelica dahurica. Add 8 times the amount of water, soak for 1 hour, heat to boiling and decoct for 1 hour, filter, and collect the first filtrate. Add 6 times the amount of water to the dregs, heat to boiling and decoct for 1 hour, filter, and collect the second filtrate. Combine the filtrates and concentrate under reduced pressure at 60℃ to a clear extract with a relative density of 1.10-1.15 (60℃). Set aside for later use.

[0032] (II) Preparation of Ointment: (1) Preparation of oil phase: Heat petroleum jelly to 50°C, stir to melt, and keep warm for later use.

[0033] (2) Aqueous phase preparation: Add PEG400 and PEG4000 to 50ml of water, heat to 60℃, stir to dissolve, and set aside.

[0034] (3) Mixing and emulsification: The oil phase is slowly added to the water phase at a speed of 300r / min while stirring for 15 minutes to form the initial emulsion.

[0035] (4) Add Chinese herbal paste: Slowly add Chinese herbal paste to colostrum and stir for 10 minutes to mix thoroughly.

[0036] (5) Adding excipients: When the temperature of the mixture drops to 40°C, add azone, dithiothreitol, violet leaf alcohol, propyl gallate, and ethylparaben. Add while stirring at a speed of 200 r / min for 20 minutes until the mixture is homogeneous.

[0037] (6) Add menthol and borneol: Grind menthol and borneol into fine powder, pass them through a 100-mesh sieve, add them to the above mixture, stir for 10 minutes to completely dissolve and mix evenly.

[0038] (7) Cooling and molding.

[0039] Example 3: Allergic Rhinitis Ointment formula: Preparation method: (a) Extraction of traditional Chinese medicine: Take Saposhnikovia divaricata, Ligusticum chuanxiong, stir-fried Xanthium sibiricum, Magnolia biondii, and Angelica dahurica. Add 10 times the amount of water, soak for 2 hours, heat to boiling and decoct for 2 hours, filter, and collect the first filtrate. Add 8 times the amount of water to the dregs, heat to boiling and decoct for 2 hours, filter, and collect the second filtrate. Combine the filtrates and concentrate under reduced pressure at 70℃ to a clear extract with a relative density of 1.10-1.15 (60℃). Set aside for later use.

[0040] (II) Preparation of Ointment: (1) Preparation of oil phase: Heat petroleum jelly to 60°C, stir to melt, and keep warm for later use.

[0041] (2) Aqueous phase preparation: Add PEG400 and PEG4000 to 100ml of water, heat to 70℃, stir to dissolve, and set aside.

[0042] (3) Mixing and emulsification: The oil phase is slowly added to the water phase at a speed of 400r / min while stirring for 20 minutes to form the initial emulsion.

[0043] (4) Add Chinese herbal paste: Slowly add Chinese herbal paste to colostrum and stir for 15 minutes to mix thoroughly.

[0044] (5) Adding excipients: When the temperature of the mixture drops to 45°C, add azone, dithiothreitol, violet leaf alcohol, propyl gallate and ethylparaben. Stir while adding, at a stirring speed of 300 r / min, for 30 minutes until the mixture is uniform.

[0045] (6) Add menthol and borneol: Grind menthol and borneol into fine powder, pass them through a 100-mesh sieve, add them to the above mixture, stir for 15 minutes to completely dissolve and mix evenly.

[0046] (7) Cooling and molding.

[0047] Screening experiment of transdermal absorption enhancers Test sample: Experimental Group 1 (Ointment without azone): Except for the absence of azone, the other ingredients, dosages, and preparation methods are the same as in Example 1.

[0048] Experimental Group 2 (Ointment without dithiothreitol): Except for the absence of dithiothreitol, the other ingredients, dosages, and preparation methods are the same as in Example 1.

[0049] Experimental Group 3 (Ointment without Ionol): Except for the absence of ionol, the other ingredients, dosages, and preparation methods are the same as in Example 1.

[0050] Experimental Group 4 (Ointment without azone, dithiothreitol, and violet leaf alcohol): Except for the absence of these three ingredients, the other ingredients, dosages, and preparation methods are the same as in Example 1.

[0051] Examples 1-3.

[0052] Experimental animals: Healthy male SD rats, weighing 200-250g, were selected, with 6 rats in each group.

[0053] Experimental methods: Preparation of rat skin: After euthanizing SD rats, the abdominal skin was immediately peeled off, subcutaneous fat and connective tissue were removed, the skin was rinsed with physiological saline, and stored in a -20℃ freezer for later use. It was thawed before use.

[0054] Franz diffusion cell experiment: Prepared rat skin was fixed between the supply and receiving chambers of a Franz diffusion cell, with the stratum corneum facing the supply chamber and the dermis facing the receiving chamber. 30% ethanol saline was added to the receiving chamber as the receiving medium, with the liquid surface in contact with the dermis. The cell was placed in a 37°C constant temperature water bath with magnetic stirring at 300 rpm. 2g of the above-mentioned ointment was added to the supply chamber, and 5ml samples were taken from the receiving chamber at different time points, with an equal amount of receiving medium added simultaneously.

[0055] Sample processing and detection: After filtering the collected samples through a 0.45 μm microporous membrane, the content of active ingredients (cicadaein, chlorogenic acid, magnolin, and imperatorin) in the receiving solution was determined by HPLC. Chromatographic conditions: C18 column (250 mm × 4.6 mm, 5 μm); mobile phase: methanol-water (gradient elution); detection wavelength was set according to different active ingredients; flow rate: 1.0 ml / min; column temperature: 30 ℃.

[0056] Data Calculation: Based on the test results, calculate the cumulative transdermal absorption (Q) at different time points. Cumulative transdermal absorption Q (μg / cm²) = (Drug concentration in receiving solution × Receiving chamber volume + Sampling volume × Sum of concentrations from each sampling) / Diffusion area.

[0057] Statistical processing Data analysis was performed using SPSS 22.0 statistical software. Quantitative data were expressed as mean ± standard deviation (x ± s). One-way ANOVA was used for comparisons between groups, and P < 0.05 was considered statistically significant.

[0058] Table 1. Cumulative transdermal absorption of different components in each group at 1h, 4h, and 12h (unit: μg / cm², x±s) Table 1 shows that the three transdermal absorption enhancers of this invention synergistically enhance drug transdermal absorption through different mechanisms, forming a synergistic effect, and their promoting effect is far superior to that of a single component or a partial combination. The formulations in Examples 1-3 achieve a balance between efficacy and cost by adjusting the ratio of traditional Chinese medicine components to transdermal absorption enhancers, reducing raw material consumption while ensuring transdermal efficiency, which conforms to the principle of "optimal cost-effectiveness" in industrial production.

[0059] Clinical efficacy statistics I. Clinical Data Case selection: 120 patients meeting the diagnostic criteria for allergic rhinitis were randomly divided into 3 groups, with 40 patients in each group. There were no statistically significant differences among the three groups in terms of gender, age, duration of illness, and symptom scores (P>0.05), indicating comparability.

[0060] Diagnostic criteria: Referring to the diagnostic criteria for allergic rhinitis in the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine", the main symptoms are nasal congestion, nasal itching, sneezing, and runny nose; the secondary symptoms are aversion to wind, fear of cold, and susceptibility to colds; the tongue is pale with a thin white coating, and the pulse is floating and tight.

[0061] II. Treatment Methods The three groups of patients used ointments prepared according to the best embodiment of Example 1, Control 1 (Patent CN109432173A), and Control 2 (Patent CN103110706A), respectively, three times a day. The ointment of Example 1 was applied to the Yingxiang acupoints on both sides of the nose, while the drugs of Control 1 and Control 2 were used according to the method in the patent. The treatment lasted for 4 consecutive weeks as one course of treatment.

[0062] III. Efficacy Evaluation Criteria Symptom score: The score is based on the severity of nasal congestion, nasal itching, sneezing, and runny nose. No symptoms are 0 points, mild symptoms are 1 point, moderate symptoms are 2 points, and severe symptoms are 3 points, for a total of 12 points.

[0063] Efficacy assessment: Cure: Symptom score reduced by ≥90%, with no recurrence during a 3-month follow-up.

[0064] Significant effect: Symptom scores reduced by 60%-89%.

[0065] Effective: Symptom scores reduced by 30%-59%.

[0066] Ineffective: Symptom score reduction <30%.

[0067] Overall effective rate = (number of cured cases + number of cases with significant improvement + number of cases with improvement) / total number of cases × 100%.

[0068] IV. Statistical Results Table 2 Statistical analysis of therapeutic effects Table 2 shows that the total effective rate of Example 1 group reached 95.0%, significantly higher than that of Control Group 1 (72.5%) and Control Group 2 (65.0%). Furthermore, the number of cured cases (17 cases) far exceeded that of Control Group 1 (8 cases) and Control Group 2 (5 cases), indicating that the ointment of this invention has a superior therapeutic effect on allergic rhinitis and can more effectively improve the core symptoms of patients such as nasal congestion, nasal itching, sneezing, and runny nose. In this invention, the herbs Fangfeng, Chuanxiong, and fried Cang Er Zi work together to dispel wind and cold, open the nasal passages, and relieve pain. Yingxiang acupoint, located on the Large Intestine Meridian of Hand Yangming, has the function of clearing nasal passages. Applying the ointment to this point allows for enhanced therapeutic effects on allergic rhinitis through the synergistic effect of transdermal drug absorption and acupoint stimulation. Moreover, no significant adverse reactions such as skin irritation occurred during the treatment process, indicating that this method of use is highly safe.

Claims

1. A cream for treating allergic rhinitis, characterized in that, The ointment comprises a traditional Chinese medicine composition and excipients; the traditional Chinese medicine composition comprises Saposhnikovia divaricata, Ligusticum chuanxiong, stir-fried Xanthium sibiricum, Magnolia biondii, Angelica dahurica, menthol, and borneol.

2. The ointment according to claim 1, characterized in that, The traditional Chinese medicine composition comprises, by weight, 60-100 parts of Saposhnikovia divaricata, 60-100 parts of Ligusticum chuanxiong, 60-100 parts of stir-fried Xanthium sibiricum, 60-100 parts of Magnolia biondii, 60-100 parts of Angelica dahurica, 2-8 parts of menthol, and 2-8 parts of borneol.

3. The ointment according to claim 2, characterized in that, The traditional Chinese medicine composition comprises, by weight, 80 parts of Saposhnikovia divaricata, 80 parts of Ligusticum chuanxiong, 80 parts of stir-fried Xanthium sibiricum, 80 parts of Magnolia biondii, 80 parts of Angelica dahurica, 4 parts of menthol, and 5 parts of borneol.

4. The ointment according to claim 1, characterized in that, The excipients include PEG400, PEG4000, petrolatum, azone, dithiothreitol, violet leaf alcohol, propyl gallate, and ethylparaben.

5. The ointment according to claim 4, characterized in that, The excipients, calculated by weight, include: 15-30 parts of PEG400, 35-70 parts of PEG4000, 10-25 parts of petrolatum, 0.5-2 parts of azone, 0.1-0.5 parts of dithiothreitol, 0.05-0.2 parts of violet leaf alcohol, 0.01-0.05 parts of propyl gallate, and 0.05-0.1 parts of ethylparaben.

6. The ointment according to claim 5, characterized in that, The excipients, calculated by weight, include: 20 parts PEG400, 55 parts PEG4000, 20 parts petrolatum, 1 part azone, 0.3 parts dithiothreitol, 0.15 parts violet leaf alcohol, 0.02 parts propyl gallate, and 0.08 parts ethylparaben.

7. A method for preparing the ointment according to claim 1, characterized in that, The preparation method includes extraction of traditional Chinese medicine and preparation of ointments.

8. The preparation method according to claim 7, characterized in that, The extraction steps of the traditional Chinese medicine are as follows: Take Saposhnikovia divaricata, Ligusticum chuanxiong, stir-fried Xanthium sibiricum, Magnolia biondii, and Angelica dahurica, add 8-10 times the amount of water, soak for 1-2 hours, heat to boiling and decoct for 1-2 hours, filter, collect the first filtrate, add 6-8 times the amount of water to the residue, heat to boiling and decoct for 1-2 hours, filter, collect the second filtrate, combine the filtrates, and concentrate under reduced pressure at 60-70℃ to a clear extract with a relative density of 1.10-1.15 (60℃), for later use.

9. The preparation method according to claim 7, characterized in that, The ointment is prepared by the following steps: (1) Preparation of oil phase: Heat petroleum jelly to 50-60℃, stir to melt, and keep warm for later use. (2) Aqueous phase preparation: Add PEG400 and PEG4000 to water, heat to 60-70℃, stir to dissolve, and set aside. (3) Mixing and emulsification: The oil phase is slowly added to the water phase at a speed of 300-400 r / min while stirring for 15-20 minutes to form the initial emulsion. (4) Add Chinese herbal paste: Slowly add Chinese herbal paste to colostrum and stir for 10-15 minutes to mix thoroughly. (5) Adding excipients: When the temperature of the mixture drops to 40-45℃, add azone, dithiothreitol, violet leaf alcohol, propyl gallate and ethylparaben. Add while stirring at a speed of 200-300r / min for 20-30 minutes until the mixture is uniform. (6) Add menthol and borneol: Grind menthol and borneol into fine powder, pass them through a 100-mesh sieve, add them to the above mixture, stir for 10-15 minutes to completely dissolve and mix evenly. (7) Cooling and molding.

Images