Traditional Chinese medicine composition and traditional Chinese medicine liniment for treating primary dysmenorrhea

Abstract

The application discloses a traditional Chinese medicine composition and a traditional Chinese medicine ointment for treating primary dysmenorrhea, and relates to the technical field of traditional Chinese medicines. The traditional Chinese medicine composition for treating primary dysmenorrhea comprises the following raw materials in parts by weight: 25-35 parts of angelica sinensis, 25-35 parts of semen stercorei, 15-25 parts of corydalis, 15-25 parts of cumin, 15-25 parts of five musk, 10-20 parts of ginger, 10-20 parts of cassia bark, 5-10 parts of asarum, 5-10 parts of ramulus cinnamomi and 5-10 parts of curcuma zedoary. The application has the advantages of reasonable compatibility, rich raw materials, effective combination between components, convenient use, good effect, innovation in treating primary dysmenorrhea, good popularization and application value and practical clinical significance.

Description

Technical Field

[0001] This invention relates to the field of traditional Chinese medicine technology, and in particular to a traditional Chinese medicine composition and a traditional Chinese medicine ointment for treating primary dysmenorrhea. Background Technology

[0002] Primary dysmenorrhea refers to lower abdominal and lumbosacral pain in women during the perimenstrual period, without any organic lesions in the pelvic cavity. Some patients also experience symptoms such as lower back pain and cold extremities. Primary dysmenorrhea is common in young women, usually occurring within 1-2 years after menarche. Despite its high incidence, some women have misconceptions about the disease, believing that "dysmenorrhea is a normal physiological phenomenon," or they do not receive professional and standardized treatment due to factors such as difficulty accessing medical care or economic costs, leading to prolonged and recurrent symptoms. In addition, the combined effects of increased life pressure, irregular work and rest schedules, and frequent mood swings in modern society can further lead to endocrine disorders, decreased ovarian function, and other physiological abnormalities in some patients, seriously affecting their work efficiency, study performance, and normal interpersonal relationships, thus reducing their quality of life.

[0003] Modern medicine believes that the pathogenesis of primary dysmenorrhea is related to factors such as nerves, genes, immunity, psychology, and society, as well as abnormal uterine contraction function and endocrine metabolism. Studies show that fluctuations in estrogen and progesterone levels can cause endometrial thickening, heavy menstrual flow, and prolonged cycles, which can lead to dysmenorrhea. Currently, the main treatment for primary dysmenorrhea is to relieve clinical symptoms with oral prostaglandin synthase inhibitors and contraceptives, but these drugs have significant side effects and the condition is prone to recurrence. In addition, there are reports of surgical procedures such as uterine nerve resection and presacral nerve resection for treating refractory primary dysmenorrhea, but these procedures carry risks of significant trauma, postoperative complications such as pelvic adhesions and bowel dysfunction, and potential impact on fertility. Therefore, they are only suitable for a very small number of severe cases where drug treatment is ineffective and cannot be promoted as a routine treatment option.

[0004] Traditional Chinese medicine (TCM) has a long history of treating primary dysmenorrhea, and its effectiveness has been confirmed by numerous clinical studies. Compared with Western medicine, it has advantages such as high safety, fewer side effects, and a holistic approach to conditioning the body. Currently, commonly used TCM therapies include oral / external herbal medicine, moxibustion, acupoint application, cupping, and auricular acupressure. TCM treatment is based on syndrome differentiation and treatment, tailoring personalized plans to the patient's menstrual cycle characteristics and constitution. It can alleviate pain while regulating the body's Qi, blood, Yin, and Yang balance, improving the condition from its root cause. However, existing TCM therapies still have significant limitations: First, the treatment course is long, with most patients needing 3-6 consecutive menstrual cycles to achieve stable results, requiring long-term patient adherence. Second, treatment convenience is insufficient; for example, moxibustion and cupping require professional physician operation, oral herbal medicine needs to be prepared by decoction, and acupoint application carries the risk of skin allergies and its adhesion is affected by activity. Third, treatment costs are high; long-term professional treatment and medication costs increase the economic burden on patients. All of these factors seriously affect patient treatment compliance and limit the clinical application and promotion of TCM therapies.

[0005] Therefore, in response to the problems of large side effects, high recurrence rate and narrow applicability of Western medicine in the current treatment of primary dysmenorrhea, and long treatment courses, poor compliance and lack of convenience of traditional Chinese medicine, it is important to explore a treatment plan that is less painful, inexpensive, easy to operate, reliable in efficacy and safe, especially new preparations based on the theory of traditional Chinese medicine. This has become an important issue that needs to be solved in gynecological clinics and has important clinical value and social significance. Summary of the Invention

[0006] To address the technical problems existing in the prior art, embodiments of the present invention provide a traditional Chinese medicine composition and a traditional Chinese medicine ointment for treating primary dysmenorrhea. The technical solution is as follows:

[0007] A traditional Chinese medicine composition for treating primary dysmenorrhea, the composition comprising the following raw materials in parts by weight: Angelica sinensis 25-35 parts, Impatiens balsamina 25-35 parts, Corydalis yanhusuo 15-25 parts, Foeniculum vulgare 15-25 parts, Trogopterus xanthipes 15-25 parts, Zingiber officinale (processed) 10-20 parts, Cinnamomum cassia 10-20 parts, Asarum heterotropoides 5-10 parts, Cinnamomum cassia twig 5-10 parts, Curcuma zedoaria 5-10 parts.

[0008] A traditional Chinese medicine ointment for treating primary dysmenorrhea, comprising the following ingredients in parts by weight: Angelica sinensis 25-35 parts, Impatiens balsamina 25-35 parts, Corydalis yanhusuo 15-25 parts, Foeniculum vulgare 15-25 parts, Trogopterus xanthipes 15-25 parts, Zingiber officinale (processed) 10-20 parts, Cinnamomum cassia 10-20 parts, Asarum heterotropoides 5-10 parts, Cinnamomum cassia twig 5-10 parts, Curcuma zedoaria 5-10 parts, Vaseline 18-22 parts, Palmitic acid 22-24 parts, Jojoba oil 3.6-6 parts, Glyceryl tristearate 12-14 parts, Propylene glycol 28-32 parts, Tween 20 5-7 parts, Water 100-110 parts, Azone 4-6 parts, and Methylparaben 0.4-0.6 parts.

[0009] Optionally, the herbal ointment contains the following ingredients in parts by weight: 25 parts Angelica sinensis, 25 parts Impatiens balsamina, 15 parts Corydalis yanhusuo, 15 parts Foeniculum vulgare, 15 parts Trogopterus xanthipes, 10 parts Zingiber officinale (processed), 10 parts Cinnamomum cassia, 5 parts Asarum heterotropoides, 5 parts Cinnamomum cassia twig, 5 parts Curcuma zedoaria, 18 parts Vaseline, 22 parts Palmitic acid, 3.6 parts Jojoba oil, 12 parts Glyceryl tristearate, 28 parts Propylene glycol, 5 parts Tween 20, 100 parts Water, 4 parts Azone, and 0.4 parts Methylparaben.

[0010] Optionally, the herbal ointment contains the following ingredients in parts by weight: 30 parts Angelica sinensis, 30 parts Impatiens balsamina, 20 parts Corydalis yanhusuo, 20 parts Foeniculum vulgare, 20 parts Trogopterus xanthipes, 15 parts Zingiber officinale (processed), 15 parts Cinnamomum cassia, 7 parts Asarum heterotropoides, 8 parts Cinnamomum cassia twig, 8 parts Curcuma zedoaria, 20 parts Vaseline, 23 parts Palmitic acid, 5 parts Jojoba oil, 13 parts Glyceryl tristearate, 30 parts Propylene glycol, 6 parts Tween 20, 105 parts Water, 5 parts Azone, and 0.5 parts Methylparaben.

[0011] Optionally, the herbal ointment contains the following ingredients in parts by weight: 35 parts Angelica sinensis, 35 parts Impatiens balsamina, 25 parts Corydalis yanhusuo, 25 parts Foeniculum vulgare, 25 parts Trogopterus xanthipes, 20 parts Zingiber officinale (processed), 20 parts Cinnamomum cassia, 10 parts Asarum heterotropoides, 10 parts Cinnamomum cassia twig, 10 parts Curcuma zedoaria, 22 parts Vaseline, 24 parts Palmitic acid, 6 parts Jojoba oil, 14 parts Glyceryl tristearate, 32 parts Propylene glycol, 7 parts Tween 20, 110 parts Water, 6 parts Azone, and 0.6 parts Methylparaben.

[0012] The preparation method of the traditional Chinese medicine ointment for treating primary dysmenorrhea includes the following steps:

[0013] 1) Pre-processing of Chinese medicine: After cleaning and drying the Angelica sinensis, Impatiens balsamina, Corydalis yanhusuo, Foeniculum vulgare, Trogopterus xanthipes, Zingiber officinale, Cinnamomum cassia, Asarum sieboldii, Cinnamomum cassia twig, and Curcuma zedoaria, grind them into coarse powder, then extract them with alcohol and concentrate them into an extract.

[0014] 2) Oil phase preparation: Take petrolatum, palmitic acid, jojoba oil and triglyceride, place them in a heating container, heat to 70℃-80℃, so that they are completely melted and mixed evenly;

[0015] 3) Aqueous phase preparation: Add propylene glycol, Tween 20, and methylparaben to water, stir to dissolve, and heat to 70℃-80℃.

[0016] 4) Mixing and emulsification: While stirring, slowly add the aqueous phase to the oil phase and continue stirring until a uniform emulsion is formed;

[0017] 5) Add Chinese herbal medicine and azone: After the temperature of the above emulsion drops to 50℃-60℃, add the Chinese herbal medicine extract and azone, and stir thoroughly.

[0018] 6) Filling and storage: Fill the prepared ointment into suitable containers while it is still hot, seal it after cooling, and store it in a cool and dry place.

[0019] Optionally, in step 1), the coarse powder of traditional Chinese medicine is powder that has passed through a 60-mesh sieve.

[0020] Optionally, in step 1), the alcohol extraction is performed by adding 7-9 times the amount of 75% ethanol to the crude Chinese herbal medicine powder, refluxing and extracting twice, each time for 1-2 hours, combining the extracts, and concentrating under reduced pressure to obtain an extract with a relative density of 1.20-1.25 at 45°C.

[0021] Optionally, in step 1), the alcohol extraction is performed by adding 8 times the amount of 75% ethanol to the crude powder of traditional Chinese medicine, refluxing and extracting twice, each time for 1.5 hours, combining the extracts, and concentrating under reduced pressure to obtain an extract with a relative density of 1.20-1.25 at 45°C.

[0022] Optionally, in steps 4) and 5), the stirring method is to use an electric stirrer with a stirring speed of 190-250 rpm and a stirring time of 20-30 min.

[0023] The beneficial effects of the technical solutions provided in the embodiments of the present invention include at least the following:

[0024] This invention features a reasonable formulation, abundant raw materials, and an effective combination of components, enabling the entire formula to work synergistically to warm the meridians, promote blood circulation, regulate menstruation, and relieve pain. It is effective in treating primary dysmenorrhea, is easy to use, and has good results. It is an innovation in the treatment of primary dysmenorrhea and has good application value and practical clinical significance.

[0025] In the formulation of this invention:

[0026] Angelica sinensis: sweet, pungent, and warm. It enters the liver, heart, and spleen meridians. It nourishes and invigorates blood, regulates menstruation, and relieves pain. It is used for irregular menstruation, amenorrhea, dysmenorrhea, abdominal masses, and abdominal pain due to deficiency and cold.

[0027] Acute-acting herb: Bitter, pungent, and warm. It enters the kidney, liver, and lung meridians. It invigorates blood circulation, removes blood stasis, relieves pain, and stops bleeding. Used for amenorrhea and dysmenorrhea.

[0028] Corydalis Rhizome: Bitter, pungent, and warm. It enters the liver and spleen meridians. It invigorates blood circulation, removes blood stasis, regulates qi, and relieves pain. It is used for irregular menstruation, abdominal masses, and prolonged lochia.

[0029] Fennel seeds: pungent, warm. Enters the liver, kidney, spleen, and stomach meridians. Dispels cold and relieves pain, regulates qi and harmonizes the stomach. Used for dysmenorrhea and lower abdominal pain due to cold.

[0030] Wulingzhi: Sweet and warm. Enters the Liver meridian. Promotes blood circulation, relieves pain, removes blood stasis, and stops bleeding. Used for dysmenorrhea, postpartum blood stasis, and abdominal pain.

[0031] Prepared ginger: Bitter, warm. Enters the spleen and liver meridians. Warms the meridians to stop bleeding, warms the middle jiao to relieve pain. Used for metrorrhagia and abdominal pain.

[0032] Cinnamon: Sweet and pungent, very hot in nature. It enters the kidney, spleen, heart, and liver meridians. It warms the yang, dispels cold, invigorates blood circulation, and unblocks the meridians. It is used for irregular menstruation and lower abdominal pain due to cold.

[0033] Asarum: Pungent, warm, slightly toxic. Enters the lung, kidney, and heart meridians. Disperses wind-cold, warms the meridians, and relieves pain. Used for dysmenorrhea and irregular menstruation.

[0034] Cinnamon twig: Sweet, pungent, and warm. It enters the heart, lung, and bladder meridians. It warms and unblocks the meridians, and assists yang in the transformation of qi. It is used for dysmenorrhea.

[0035] Curcuma zedoaria: pungent, bitter, and warm. It enters the liver and spleen meridians. It breaks up blood stasis, promotes qi circulation, eliminates stagnation, and relieves pain. It is used for dysmenorrhea, amenorrhea, and postpartum lochia.

[0036] The effective combination of the above-mentioned drugs supports each other. Angelica sinensis and Impatiens balsamina, with their core effects of "tonifying blood, promoting blood circulation, removing blood stasis, and relieving pain," serve as the principal drugs in the treatment. They can directly eliminate cold stagnation and blood stasis in the uterus and the Chong and Ren meridians, alleviating the disease from its cause. At the same time, they can clear the stagnation of Qi and blood in the uterus of patients with primary dysmenorrhea, improving the poor flow of menstrual blood, and laying the foundation for the whole formula to "warm the meridians, promote blood circulation, regulate menstruation, and relieve pain."

[0037] Corydalis rhizome, fennel seed, and Trogopterus dung are used as assistant herbs. Corydalis rhizome can improve blood stasis around the uterus, acting as the principal herb to "resolve blood stasis and relieve pain," clearing the channels of blood and qi. It also works synergistically with the principal herb to remove stagnant pathogens from the meridians, alleviating the core pain symptoms of primary dysmenorrhea. Fennel seed enhances the warming and dispersing effect of the principal herb on cold pathogens in the lower abdomen, directly relieving accompanying symptoms such as lower abdominal pain, aversion to cold, and cold limbs. Its spleen and stomach meridian properties guide the medicinal effects to harmonize the spleen and stomach, preventing damage to their function from blood-activating drugs. Trogopterus dung works synergistically with the principal herb to strengthen its blood-stasis-resolving power, assisting in clearing the Chong and Ren meridians and relieving uterine congestion and swelling. For dysmenorrhea patients with blood stasis during menstruation, it forms a synergistic chain of "dispersing cold, resolving blood stasis, and regulating qi" with Corydalis rhizome and fennel seed, comprehensively assisting the principal herb in enhancing its analgesic effect.

[0038] Prepared ginger and cinnamon are used as adjuvants. Prepared ginger is good at "warming the meridians and stopping bleeding, warming the middle and relieving pain," and can work with the principal and assistant herbs to continuously warm and dispel cold pathogens in the uterus, enhancing the effect of warming the meridians and promoting blood circulation. In particular, the effect of "warming the middle and relieving pain" directly targets the symptoms of abdominal pain that is relieved by warmth and pressure in the case of dysmenorrhea caused by deficiency and cold. Cinnamon can warm and tonify kidney yang and protect the body's vital energy, preventing the blood-activating herbs from depleting the body's yang energy. Its "blood-activating and meridian-promoting" effect works synergistically with the assistant herbs Corydalis and Trogopterus xanthipes to enhance the warming and blood-circulating power of the formula. The two work together to form a "warming yang-dispelling cold-strengthening" effect, which not only strengthens the effect of warming the meridians and dispelling cold, but also restrains the harshness of the principal herbs, preventing them from breaking blood stasis and damaging the body's vital energy.

[0039] Asarum, cinnamon twig, and turmeric are used as guiding herbs. Asarum assists the principal and assistant herbs in continuously clearing the uterus and meridians, relieving menstrual cramps accompanied by cold extremities. Its pungent and warm properties guide the medicinal power directly to the affected area in the uterus, preventing the medicinal power from diffusing. Cinnamon twig enhances the warming and meridian-clearing power of the formula, improving symptoms such as poor menstrual flow, lower abdominal pain, and stiffness caused by cold stagnation and blood stasis. Turmeric has a strong blood-breaking and qi-regulating effect, which can enhance the effect of the principal and assistant herbs in clearing stubborn blood stasis, especially for dysmenorrhea caused by long-term qi and blood stasis. At the same time, it can harmonize the properties of all the herbs in the formula, ensuring that tonification and purgation are combined, and that warming and clearing are moderate, so that the medicinal effect is precisely applied to the affected area.

[0040] The base components of the ointment / rubbing agent in this invention, their properties, and functions are as follows:

[0041] Petrolatum, also known as petrolatum, is a semi-liquid mixture composed of alkane hydrocarbons and saturated hydrocarbons, purified through petroleum fractionation. In ointment bases, this component exhibits a triple core function: First, with its excellent lubrication, moisturizing, and occlusive properties, it forms a dense protective film on the skin surface, effectively locking in epidermal moisture, softening the stratum corneum, and creating a favorable local microenvironment for drug components to penetrate the skin barrier; second, its chemical stability prevents oxidation, hydrolysis, and other deterioration reactions, significantly delaying quality deterioration during storage and extending product shelf life; third, by adjusting the consistency of the base system, it optimizes the spreadability and skin adhesion of the ointment, preventing clumping or easy dripping during application and improving ease of use.

[0042] Palmitic acid is one of the most widely distributed fatty acids in nature. It is a white crystalline solid at room temperature and is water-insoluble, existing primarily as a glyceride in natural oils. As a key functional component of ointment bases, its role is mainly twofold: Firstly, by enhancing the viscosity and consistency of the base system, it thickens and stabilizes the ointment, maintaining a uniform and delicate texture. This facilitates the formation of a continuous film during application and reduces loss during use. Secondly, its inherent lubricating and moisturizing properties help regulate the skin feel of the base, while simultaneously promoting the uniform dispersion and slow release of active pharmaceutical ingredients within the base, ensuring continuous absorption of the medication by the skin and indirectly enhancing the overall efficacy of the formulation.

[0043] Jojoba oil is a natural liquid wax extracted from the seeds of the jojoba plant. Rich in vitamin E and various essential fatty acids (such as linoleic acid and oleic acid), it possesses excellent skincare and health benefits. In ointments, this component's advantages lie in skin barrier repair and gentle care: Firstly, its composition is similar to human sebum, deeply nourishing the skin and filling lipid gaps in the damaged skin barrier, effectively relieving discomfort caused by dry skin and external stimuli (such as friction and environmental dryness). Secondly, its natural anti-inflammatory properties soothe local skin inflammation, improve the skin condition of affected areas, and reduce the risk of redness and stinging after application, making it an ideal base ingredient that balances safety and functionality.

[0044] Tristearate: Synthesized from glycerol and stearic acid via esterification, this ester compound possesses excellent chemical stability and physical spreadability. In ointment bases, this component serves a dual function of "controlled drug release + skin feel optimization": on the one hand, its molecular structure enhances the adhesion of drug components to the skin surface, slowing down the release rate of the drug from the base to the skin, achieving a "sustaining release" effect and prolonging the duration of drug action; on the other hand, its lubricity and flexibility improve the "roughness" of the ointment during application, enhancing skin comfort, while its mild moisturizing effect helps soften the stratum corneum, further promoting drug penetration. Furthermore, this component is stable, resistant to degradation and deterioration, and highly compatible with other base components, adapting to the formulation requirements of various topical preparations and helping to extend the shelf life of ointments.

[0045] Propylene glycol is a commonly used organic functional component in ointments and medicated creams, serving a dual role as both a solvent and a humectant. Its excellent solubility and penetrability promote the uniform dispersion of water-soluble and fat-soluble active pharmaceutical ingredients within the matrix, preventing drug particle aggregation. It also enhances the absorption efficiency of the drug by the stratum corneum, shortening the onset time of the drug's effects. Simultaneously, its moisturizing properties effectively prevent moisture loss and hardening of the ointment during storage (e.g., in dry environments) and use, maintaining a uniform texture. Furthermore, propylene glycol possesses certain antibacterial activity, helping to inhibit microbial growth while enhancing the chemical stability of drug components during storage, reducing drug degradation, and ensuring the efficacy of the formulation.

[0046] Water: As a basic solvent and matrix component in ointments, water effectively dissolves water-soluble active pharmaceutical ingredients, ensuring their uniform dispersion within the system. In the formulation, water adjusts the consistency and viscosity parameters of the ointment, optimizing the application feel and user experience. Simultaneously, it works synergistically with other matrix components such as oils and emulsifiers to construct a stable cream dispersion system, significantly enhancing the physical stability and spreadability of the ointment, and providing structural support for the penetration and absorption of drug components.

[0047] Azone: A chemically synthesized transdermal absorption enhancer, its core value lies in significantly improving the skin penetration efficiency of drug components. It interacts with the lipid bilayer of the stratum corneum, altering the lipid arrangement (e.g., disrupting the tight lipid packing), reducing the permeability resistance of the skin barrier, thereby increasing the transdermal penetration rate and bioavailability of drugs. Furthermore, this component is mild and has low irritation to normal skin, making it suitable for various topical formulations. It can effectively enhance the efficacy and onset speed of ointments and shorten the "time to effect" after medication.

[0048] Methylparaben: A synthetic broad-spectrum preservative with highly effective antibacterial and antifungal activity, it is a key component ensuring the storage safety of ointments. Its mechanism of action involves inhibiting the cell metabolism and proliferation of microorganisms (such as bacteria and fungi), preventing microbial growth in the ointment and thus significantly extending its shelf life. This component has three major advantages: First, it is chemically stable, maintaining activity over a wide pH range and adapting to the pH environment of most ointments; second, it has good water solubility, easily achieving uniform dispersion in the matrix, avoiding "preservative failure" due to insufficient local concentration; and third, its application safety has been fully verified, and it is widely used in cosmetics, pharmaceuticals, and food. Within reasonable dosage ranges conforming to national standards, it can effectively avoid the risk of skin irritation.

[0049] This invention provides a traditional Chinese medicine ointment for treating primary dysmenorrhea and its preparation method, which can effectively promote the recovery of patients with primary dysmenorrhea, has no side effects, and is low in cost, making it suitable for widespread use. Detailed Implementation

[0050] The technical solutions of the present invention will be described below with reference to the embodiments.

[0051] In this invention, ointment massage is one of the external treatment methods in Traditional Chinese Medicine. It uses a medicinal ointment as a medium, combined with massage techniques, to act on the body surface or acupoints, achieving therapeutic and health-preserving purposes by warming and unblocking the meridians and regulating qi and blood. Ointment massage preparation refers to the ointment used during ointment massage.

[0052] The core pathogenesis of primary dysmenorrhea is cold congealing in the meridians and blood stasis obstructing the interior, which is consistent with the understanding of primary dysmenorrhea by ancient physicians. The *Zhu Bing Yuan Hou Lun* (Treatise on the Causes and Symptoms of Various Diseases) clearly states: "Women who experience abdominal pain during menstruation suffer from blood and qi deficiency due to overwork, leading to weakness and exposure to wind and cold, which then invades the uterine vessels… The wind and cold clash with the blood and qi, thus causing pain." This statement directly points to the core cause of cold invasion and blood and qi stagnation, laying the foundation for later generations' understanding of the pathogenesis of "cold congealing leading to blood stasis." Ancient physicians often diagnosed dysmenorrhea from the perspectives of the internal organs, qi and blood, and the six pathogenic factors, and all of them focused on the relationship between "cold stagnation" and "blood stasis": From the perspective of the internal organs, primary dysmenorrhea is mainly related to the liver, spleen, and kidneys. The liver is responsible for regulating the flow of qi and blood. When cold pathogens invade the liver, the liver's function of regulating the flow of qi and blood is impaired, and qi stagnation over time leads to blood stasis. The spleen is responsible for transporting and transforming qi and blood. When the spleen is deficient and fails to transport and transform qi and blood, the production of qi and blood is insufficient. Combined with the stagnation of cold pathogens, it is easy to cause both qi and blood deficiency and blood stasis. The kidneys are responsible for warming the uterus. When kidney yang is insufficient, cold pathogens are generated internally, stagnate in the meridians of the uterus, and aggravate blood stasis. Ultimately, all of these lead to poor circulation of qi and blood in the uterus, resulting in "pain due to obstruction" or "pain due to lack of nourishment" due to insufficient qi and blood. From the perspective of Qi and Blood differentiation, women's physiological characteristic of "excessive Qi and insufficient Blood" makes them prone to deficiency and stagnation. The invasion of cold pathogens further exacerbates this condition—cold congeals blood stasis. This not only causes stagnation of Qi and Blood in the Chong and Ren meridians and the uterus, leading to blood stasis, but also depletes Yang Qi, resulting in insufficient Qi and Blood production. Consequently, the Chong and Ren meridians and the uterus are deprived of nourishment. The combination of these two factors induces or aggravates primary dysmenorrhea. From the perspective of the Six Evils, cold pathogens are the primary pathogenic factor of primary dysmenorrhea. For example, consuming cold foods or drinks, wading through cold water, or blindly pursuing fashion by exposing the navel or ankles during or around menstruation can easily allow cold pathogens to enter the uterus, causing spasms in the uterine meridians and stagnation of Qi and Blood, ultimately leading to menstrual cramps. This is the typical pathological process of cold congealing the meridians and internal obstruction of blood stasis causing pain.

[0053] Therefore, this invention effectively combines traditional Chinese medicine prescriptions, with each drug supporting the other. Angelica sinensis and Impatiens balsamina are the principal herbs, Corydalis yanhusuo, Foeniculum vulgare, and Trogopterus xanthipes are the assistant herbs, Zingiber officinale and Cinnamomum cassia are the adjuvant herbs, and Asarum sieboldii, Cinnamomum cassia, and Curcuma zedoaria are the guiding herbs.

[0054] To make the technical problems, technical solutions and advantages of the present invention clearer, a detailed description will be given below in conjunction with specific embodiments.

[0055] Example 1

[0056] A traditional Chinese medicine ointment for treating primary dysmenorrhea comprises the following ingredients in parts by weight: Angelica sinensis 25 parts, Impatiens balsamina 25 parts, Corydalis yanhusuo 15 parts, Foeniculum vulgare 15 parts, Trogopterus xanthipes 15 parts, Zingiber officinale (processed) 10 parts, Cinnamomum cassia 10 parts, Asarum heterotropoides 5 parts, Cinnamomum cassia twig 5 parts, Curcuma zedoaria 5 parts, Vaseline 18 parts, Palmitic acid 22 parts, Jojoba oil 3.6 parts, Glyceryl tristearate 12 parts, Propylene glycol 28 parts, Tween 20 5 parts, Water 100 parts (the amount of water used here is the amount of water used in the preparation of the aqueous phase of the matrix), Azone 4 parts, and Methylparaben 0.4 parts.

[0057] The preparation method includes the following steps:

[0058] 1) Pre-processing of Chinese medicine: After cleaning and drying the Angelica sinensis, Impatiens balsamina, Corydalis yanhusuo, Foeniculum vulgare, Trogopterus xanthipes, Zingiber officinale, Cinnamomum cassia, Asarum sieboldii, Cinnamomum cassia twig, and Curcuma zedoaria, grind them into coarse powder, then extract them with alcohol and concentrate them into an extract.

[0059] 2) Oil phase preparation: Take petrolatum, palmitic acid, jojoba oil and triglyceride, place them in a heating container, heat in a water bath to 70°C, so that they are completely melted and mixed evenly;

[0060] 3) Aqueous phase preparation: Add propylene glycol, Tween 20, and methylparaben to water, stir to dissolve, and heat to 70°C.

[0061] 4) Mixing and emulsification: While stirring, slowly add the aqueous phase to the oil phase and continue stirring until a uniform emulsion is formed;

[0062] 5) Add Chinese herbal medicine and azone: After the temperature of the above emulsion drops to 50℃, add the Chinese herbal medicine extract and azone, and stir thoroughly.

[0063] 6) Filling and storage: Fill the prepared ointment into suitable containers while it is still hot, seal it after cooling, and store it in a cool and dry place.

[0064] In step 1), the coarse powder of traditional Chinese medicine is powder that has passed through a 60-mesh sieve.

[0065] In step 1), the alcohol extraction is performed by adding 7 times the amount of 75% ethanol to the crude powder of Chinese medicine, refluxing and extracting twice, each time for 2 hours, combining the extracts, and concentrating under reduced pressure to obtain an extract with a relative density of 1.20-1.25 at 45°C.

[0066] In steps 4) and 5), the stirring method is electric stirring, the stirring speed is 190 rpm, and the stirring time is 30 min.

[0067] Example 2

[0068] A traditional Chinese medicine ointment for treating primary dysmenorrhea comprises the following ingredients in parts by weight: Angelica sinensis 30 parts, Impatiens balsamina 30 parts, Corydalis yanhusuo 20 parts, Foeniculum vulgare 20 parts, Trogopterus xanthipes 20 parts, Zingiber officinale (processed) 15 parts, Cinnamomum cassia 15 parts, Asarum heterotropoides 7 parts, Cinnamomum cassia twig 8 parts, Curcuma zedoaria 8 parts, Vaseline 20 parts, Palmitic acid 23 parts, Jojoba oil 5 parts, Glyceryl tristearate 13 parts, Propylene glycol 30 parts, Tween 206 parts, Water 105 parts (the amount of water used here is the amount of water used in the preparation of the aqueous phase of the matrix), Azone 5 parts, and Methylparaben 0.5 parts.

[0069] The preparation method includes the following steps:

[0070] 1) Pre-processing of Chinese medicine: After cleaning and drying the Angelica sinensis, Impatiens balsamina, Corydalis yanhusuo, Foeniculum vulgare, Trogopterus xanthipes, Zingiber officinale, Cinnamomum cassia, Asarum sieboldii, Cinnamomum cassia twig, and Curcuma zedoaria, grind them into coarse powder, then extract them with alcohol and concentrate them into an extract.

[0071] 2) Oil phase preparation: Take petrolatum, palmitic acid, jojoba oil and triglyceride, place them in a heating container, heat in a water bath to 75°C, so that they are completely melted and mixed evenly;

[0072] 3) Aqueous phase preparation: Add propylene glycol, Tween 20, and methylparaben to water, stir to dissolve, and heat to 75°C.

[0073] 4) Mixing and emulsification: While stirring, slowly add the aqueous phase to the oil phase and continue stirring until a uniform emulsion is formed;

[0074] 5) Add Chinese herbal medicine and azone: After the temperature of the above emulsion drops to 55℃, add the Chinese herbal medicine extract and azone, and stir thoroughly.

[0075] 6) Filling and storage: Fill the prepared ointment into suitable containers while it is still hot, seal it after cooling, and store it in a cool and dry place.

[0076] In step 1), the alcohol extraction is performed by adding 8 times the amount of 75% ethanol to the crude powder of Chinese medicine, refluxing and extracting twice, each time for 1.5 hours, combining the extracts, and concentrating under reduced pressure to obtain an extract with a relative density of 1.20-1.25 at 45°C.

[0077] In steps 4) and 5), the stirring method is electric stirring, the stirring speed is 230 rpm, and the stirring time is 25 min.

[0078] Example 3

[0079] A traditional Chinese medicine ointment for treating primary dysmenorrhea comprises the following ingredients in parts by weight: Angelica sinensis 35 parts, Impatiens balsamina 35 parts, Corydalis yanhusuo 25 parts, Foeniculum vulgare 25 parts, Trogopterus xanthipes 25 parts, Zingiber officinale (processed) 20 parts, Cinnamomum cassia 20 parts, Asarum heterotropoides 10 parts, Cinnamomum cassia twig 10 parts, Curcuma zedoaria 10 parts, Vaseline 22 parts, Palmitic acid 24 parts, Jojoba oil 6 parts, Glyceryl tristearate 14 parts, Propylene glycol 32 parts, Tween 20 7 parts, Water 110 parts (the amount of water used here is the amount of water used in the preparation of the aqueous phase of the matrix), Azone 6 parts, and Methylparaben 0.6 parts.

[0080] The preparation method includes the following steps:

[0081] 1) Pre-processing of Chinese medicine: After cleaning and drying the Angelica sinensis, Impatiens balsamina, Corydalis yanhusuo, Foeniculum vulgare, Trogopterus xanthipes, Zingiber officinale, Cinnamomum cassia, Asarum sieboldii, Cinnamomum cassia twig, and Curcuma zedoaria, grind them into coarse powder, then extract them with alcohol and concentrate them into an extract.

[0082] 2) Oil phase preparation: Take petrolatum, palmitic acid, jojoba oil and triglyceride, place them in a heating container, heat in a water bath to 80°C, so that they are completely melted and mixed evenly;

[0083] 3) Aqueous phase preparation: Add propylene glycol, Tween 20, and methylparaben to water, stir to dissolve, and heat to 80°C.

[0084] 4) Mixing and emulsification: While stirring, slowly add the aqueous phase to the oil phase and continue stirring until a uniform emulsion is formed;

[0085] 5) Add Chinese herbal medicine and azone: After the temperature of the above emulsion drops to 60℃, add the Chinese herbal medicine extract and azone, and stir thoroughly.

[0086] 6) Filling and storage: Fill the prepared ointment into suitable containers while it is still hot, seal it after cooling, and store it in a cool and dry place.

[0087] In step 1), the alcohol extraction is performed by adding 9 times the amount of 75% ethanol to the crude powder of Chinese medicine, refluxing and extracting twice, each time for 1 hour, combining the extracts, and concentrating under reduced pressure to obtain an extract with a relative density of 1.20-1.25 at 45°C.

[0088] In steps 4) and 5), the stirring method is electric stirrer, the stirring speed is 250 rpm, and the stirring time is 20 min.

[0089] The formula works synergistically to warm the meridians, promote blood circulation, regulate menstruation, and relieve pain. It is effective in treating primary dysmenorrhea and has achieved satisfactory and beneficial results in clinical trials. Relevant clinical trial data are as follows:

[0090] I. Safety tests (including acute dermal toxicity test, skin irritation test, skin allergy test, and eye irritation test)

[0091] The following tests are based on the traditional Chinese medicine ointment of Example 1. The test results of Examples 2-3 or other embodiments of the present invention are similar to those of Example 1, and will not be repeated here.

[0092] 1. Acute toxicity test

[0093] Relevant research data shows that in this experiment, 10 healthy rabbits were selected to conduct skin toxicity limit tests on the traditional Chinese medicine ointment prepared in Example 1 of this invention, and the dosage was set at 5000 mg / kg.

[0094] During the preparation phase of the experiment, the rabbits' backs were treated with hair removal 24 hours before drug administration: the hair was first initially shaved off with a razor, and then the remaining hair was thoroughly removed with hair removal cream, ensuring that the hair removal area covered approximately 10% of the rabbit's body surface area. After hair removal, the condition of the rabbit's back skin was carefully examined. If there was any skin damage, redness, or other injuries, the rabbit would be excluded from the intact skin toxicity test to ensure the reliability of the experimental data.

[0095] When administering the medication, the herbal ointment of Example 1 of this invention is evenly applied to the hairless area on the back of the rabbit. After application, the area is covered with sterile gauze and then fixed with non-irritating medical tape to prevent the medication from falling off or the rabbit scratching and interfering with the efficacy.

[0096] Twenty-four hours after drug administration, the gauze and adhesive tape on the rabbit's back were removed, and the plucked area was gently rinsed with warm water to thoroughly remove any residual drug. The rabbit was then placed in the observation phase. The observation indicators mainly included two categories: changes in the rabbit's body weight and systemic physiological responses, specifically fur luster, eye and mucous membrane condition, respiratory rate and rhythm, daily activity behavior, and muscle tone levels. Simultaneously, close monitoring was conducted for typical toxic reaction symptoms such as tremors, spasms, convulsions, salivation, diarrhea, lethargy, and coma. If any rabbit died during the experiment, an immediate autopsy was performed. If the autopsy revealed significant abnormalities in the tissues and organs, further histopathological analysis was required to identify potential lesions.

[0097] The experimental results showed that, under the limit test conditions of 5000 mg / kg, no obvious toxic reactions were observed in any of the experimental rabbits, and no deaths occurred. Continued observation showed that the experimental rabbits did not exhibit any signs of poisoning; their fur was smooth, their eyes and mucous membranes were normal, their breathing was stable, their behavior was active, and their muscle tone was normal. No toxicity-related symptoms such as tremors, spasms, or convulsions were observed. As can be seen from the data in Table 1, although the rabbits' weight increased to some extent during the experiment, this difference in weight gain was not statistically significant.

[0098] Table 1. Weight record of rabbits before and after drug administration (n=10)

[0099]

[0100] Therefore, based on the results of the acute dermal toxicity test and the drug toxicity classification standards of the traditional Chinese medicine ointment of Example 1 of the present invention, the traditional Chinese medicine ointment of Example 1 of the present invention should be a non-toxic drug.

[0101] 2. Skin irritation test

[0102] (1) Single skin irritation test

[0103] This study selected 12 healthy experimental rabbits and randomly divided them into two groups (6 rabbits in each group): an intact skin group and an damaged skin group. The aim was to compare the stimulating effect of traditional Chinese medicine ointment on different skin conditions.

[0104] During the preparation phase of the experiment, the rabbits' backs were treated with hair removal 24 hours before drug administration: the hair was first initially shaved off with a razor, and then the remaining hair was thoroughly removed with hair removal cream, ensuring that the hair removal area covered approximately 10% of the rabbit's body surface area. After hair removal, the condition of the rabbit's back skin was carefully examined. If there was any skin damage, redness, or other injuries, the rabbit would be excluded from the intact skin toxicity test to ensure the reliability of the experimental data.

[0105] When administering the medication, the herbal ointment of Example 1 of this invention is evenly applied to the hairless area on the back of the rabbit. After application, the area is covered with sterile gauze and then fixed with non-irritating medical tape to prevent the medication from falling off or the rabbit scratching and interfering with the efficacy.

[0106] Twenty-four hours after drug administration, the gauze and adhesive tape on the rabbit's back were removed, and the plucked area was gently rinsed with warm water to thoroughly remove any residual drug. The rabbit was then placed in the observation phase. The observation indicators mainly included two categories: changes in the rabbit's body weight and systemic physiological responses, specifically fur luster, eye and mucous membrane condition, respiratory rate and rhythm, daily activity behavior, and muscle tone levels. Simultaneously, close monitoring was conducted for typical toxic reaction symptoms such as tremors, spasms, convulsions, salivation, diarrhea, lethargy, and coma. If any rabbit died during the experiment, an immediate autopsy was performed. If the autopsy revealed significant abnormalities in the tissues and organs, further histopathological analysis was required to identify potential lesions.

[0107] The results of the skin irritation test were determined using a standardized scoring method: the average score for each group was calculated using the formula "Irritation Score = (Total Score for Erythema Formation + Total Score for Edema Formation) ÷ Number of Animals". Specific scoring criteria for skin irritation reactions are shown in Table 2, and the grading criteria for skin irritation intensity are shown in Table 3.

[0108] Table 2 Scoring criteria for the degree of skin irritation reaction

[0109]

[0110] Table 3. Evaluation Criteria for Skin Irritation Intensity

[0111]

[0112] This study employed a grouped control design, dividing experimental animals into two main groups: an intact skin group and a damaged skin group. Each group was further divided into four parallel experimental areas: a blank control group, a saline control group, a blank matrix group for the herbal ointment from Example 1, and an administration group for the herbal ointment from Example 1. Dynamic observation of all experimental areas was conducted continuously for 72 hours starting from the first administration of the single skin irritation test.

[0113] Results from the intact skin group showed that the skin irritation scores of each test area remained in the range of 0 to 0.49 within the 72-hour observation period. Based on the skin irritation intensity grading standard, the preparation was determined to be non-irritating to intact skin.

[0114] In the damaged skin group, rabbits that received no treatment and were only treated with saline showed mild erythema and edema in all four test areas one hour after the test substance was removed, but the skin irritation scores remained in the range of 0 to 0.49.

[0115] In Example 1, the rabbits in the ointment and liniment group and the blank matrix group also showed mild erythema and edema 1 hour after administration. However, the above symptoms basically subsided after 48 hours. The skin irritation score was between 0 and 0.49 throughout the process, which met the criteria for non-irritation.

[0116] Based on the statistical data in Table 4, it can be concluded that the herbal ointment of Example 1 of the present invention has no single-contact irritation to the skin of the experimental rabbits.

[0117] Table 4 Results of a single skin irritation test of the herbal ointment of Example 1 of the present invention (n=6)

[0118]

[0119] Note: a represents the blank area without any treatment; b represents the saline area; c represents the blank matrix area of ​​the traditional Chinese medicine ointment in Example 1 of the present invention; d represents the traditional Chinese medicine ointment area in Example 1 of the present invention.

[0120] (2) Repeated skin irritation tests

[0121] This study's multiple skin irritation tests also included intact skin and damaged skin groups. The grouping method and basic operating procedures were consistent with the single skin irritation test. The key difference lay in the dosing cycle and observation duration: a continuous dosing program was initiated 24 hours after the single administration, with daily administration following the same protocol for 7 consecutive days. After the last administration, the skin of the rabbits in each group was visually observed at 1 hour, 24 hours, 48 ​​hours, and 72 hours for signs of irritation such as erythema and edema. The recovery process and duration of the irritation symptoms were recorded simultaneously. The evaluation criteria and calculation methods for skin irritation results were the same as those for the single skin irritation test.

[0122] In practice, the experimental grouping was exactly the same as that of the single skin irritation test. In addition to continuous administration for 7 days, a skin symptom observation period was added 1 hour after each administration. After the last administration, a continuous observation period of 72 hours was continued to comprehensively evaluate the long-term effects of the drug on the skin.

[0123] The results showed that the skin irritation score of each test area in the intact skin group remained at 0 during the 7-day continuous administration period. According to the evaluation criteria, this score corresponds to the non-irritation level.

[0124] The reactions of different areas in the damaged skin group varied: In the blank area and saline area, some experimental rabbits showed transient mild erythema and edema 1 hour after administration on the first day of administration, but the symptoms basically subsided completely as administration continued until the third day; In the blank matrix area of ​​the ointment in Example 1, mild erythema and edema were visible on the skin of the experimental rabbits 1 hour after administration on the first day, and the symptoms basically disappeared after 4 consecutive days of administration; In the ointment area of ​​Example 1, mild erythema and edema also appeared 1 hour after administration on the first day, but the rate of regression was faster, and the symptoms basically subsided after 4 consecutive days of administration.

[0125] Based on the data in Tables 5 and 6, it can be seen that even after applying the herbal ointment from Example 1 to the skin of the experimental rabbits for 7 consecutive days, the final skin irritation score was still within the range of 0 to 0.49, further confirming that the herbal ointment is a non-irritating substance.

[0126] Table 5. Results of multiple skin irritation tests on the herbal ointment of Example 1 of the present invention (n=6)

[0127]

[0128] Note: a represents the blank area without any treatment; b represents the saline area; c represents the blank matrix area of ​​the traditional Chinese medicine ointment in Example 1 of the present invention; d represents the traditional Chinese medicine ointment area in Example 1 of the present invention.

[0129] Table 6. Evaluation of the Intensity of Multiple Skin Irritation Tests of the Herbal Ointment of Example 1 of the Present Invention (n=6)

[0130]

[0131] Note: a represents the blank area without any treatment; b represents the saline area; c represents the blank matrix area of ​​the traditional Chinese medicine ointment in Example 1 of the present invention; d represents the traditional Chinese medicine ointment area in Example 1 of the present invention.

[0132] 3. Skin allergy test

[0133] This study selected 12 healthy rabbits, with a weight controlled at (2.0±0.5) kg, regardless of sex. 24 hours before administration, all rabbits underwent hair removal on their backs, ensuring a hair removal area of ​​approximately 3cm × 3cm on each side. The rabbits were then randomly divided into three groups with the following treatment protocols: the positive control group received the positive sensitizer 2-mercaptobenzothiazole (sensitization concentration 1%, challenge concentration 0.1%, solvent: 70% ethanol); the blank matrix group received the blank matrix of the traditional Chinese medicine ointment / massage preparation of Example 1 of this invention; and the traditional Chinese medicine ointment / massage preparation group received the traditional Chinese medicine ointment / massage preparation of Example 1 of this invention.

[0134] The test consists of two stages: sensitization contact and stimulation contact. The specific procedure is as follows:

[0135] 1. Sensitization Contact: Apply the corresponding test substance (1 ml for liquid and 1 g for paste) to the bald area on the left back of each group of experimental rabbits according to their assigned groups. Secure the substance using appropriate methods such as gauze wrapping or non-irritating adhesive tape to ensure close contact with the skin. Remove the substance after 6 hours of continuous contact to complete the first sensitization. Repeat sensitization on day 7 and day 14 of the experiment using the same dosage, fixation method, and contact duration, for a total of 3 sensitizations.

[0136] 2. Challenge Exposure: Fourteen days after the last sensitization, the challenge phase began. The corresponding test substance, at the same dose as in the sensitization phase, was applied to the bald area on the right back of each group of rabbits. The application was removed after 6 hours. Skin reactions were observed immediately after removal, and subsequently again at 1 hour, 24 hours, 48 ​​hours, and 72 hours. The presence of allergic reactions such as erythema, edema, and papules was recorded, and the skin reaction was graded according to the scoring criteria in Table 7.

[0137] Formula for calculating the average response: Average response = (Total score for erythema formation + Total score for edema formation) / Total number of animals.

[0138] After skin scoring, the experimental results were compared between the experimental and control groups of rabbits to determine the nature of the allergic reaction to the test substance. Table 7 was used to assess the sensitization intensity and calculate the sensitization rate. Sensitization rate = Total number of animals exhibiting skin erythema or edema (regardless of severity) ÷ Total number of test animals × 100%.

[0139] Table 7 Scoring criteria for the severity of skin allergic reactions

[0140]

[0141] Table 8. Evaluation Criteria for Skin Sensitization

[0142]

[0143] After the stimulation contact was completed, the covering gauze was removed and the treatment area was cleaned with warm water. The occurrence of skin erythema and edema was observed at four time points: 1h, 24h, 48h and 72h. For detailed experimental data, please refer to Tables 9 and 10.

[0144] The experimental results showed that, within the 72-hour observation period after stimulation, neither the herbal ointment group nor the blank matrix group of Example 1 of the present invention showed any allergic reactions such as erythema or edema on the skin of the experimental rabbits. The skin allergy reaction scores were all 0 points, and the sensitization rate was 0%.

[0145] The positive control group exhibited varying degrees of erythema and edema within 72 hours after drug withdrawal: the skin allergy reaction score was 2 points at 1 hour after stimulation; 2 points and 1.75 points at 24 hours and 48 hours, respectively; and the score decreased to 1.5 points at 72 hours. Regarding the sensitization rate, the positive control group achieved 75% sensitization within 24 hours after stimulation, and 50% at both 48 hours and 72 hours.

[0146] Statistical analysis showed that, compared with the positive drug group, the skin sensitization of the herbal ointment of Example 1 of this invention was significantly reduced within 48 hours after stimulation (P<0.05). Throughout the entire experimental period, no systemic allergic reactions such as asthma or unsteady gait were observed in any of the experimental groups. These results confirm that the herbal ointment of Example 1 of this invention has no sensitizing effect on the skin of experimental rabbits during the 72-hour observation period.

[0147] Table 9. Skin allergy score results of the traditional Chinese medicine ointment of Example 1 of the present invention (n=4)

[0148]

[0149] Note: * indicates P<0.05 compared to the positive drug group.

[0150] Table 10 Evaluation results of skin allergy reaction intensity of the traditional Chinese medicine ointment of Example 1 of the present invention (n=4)

[0151]

[0152] 4. Eye stimulation test

[0153] Twelve healthy rabbits (weighing 2.0 ± 0.5 kg, male or female) were randomly divided into two groups of six each: a blank matrix group and a herbal ointment group (Example 1 of this invention), using a self-controlled left-right comparison method. Baseline examinations were performed on both eyes of all rabbits 24 hours prior to the experiment. 0.1 g of the test drug was applied to one eye of each rabbit, and 0.1 ml of physiological saline was instilled into the other eye. After application, the eyelids were gently closed for approximately 10 seconds. Local ocular irritation was observed at 1, 2, 4, 24, 48, and 72 hours post-administration. Ocular irritation was scored according to the criteria in Table 11: the scores for each type of irritation in one eye were summed to obtain the total score for that eye. The average total score for each group (sum of total scores / number of animals) was then calculated. Finally, the degree of ocular irritation was determined according to the criteria in Table 12.

[0154] Table 11 Ocular Stimulation Response Score Sheet

[0155]

[0156] Table 12 Evaluation Criteria for Eye Stimulation Response

[0157]

[0158] Before initiating the eye irritation test, researchers conducted a preliminary examination of the eyes of all experimental rabbits using sodium fluorescein ophthalmic test strips. The preliminary examination results showed that the eyes of all experimental rabbits were in good condition, and no abnormal lesions or damage were found.

[0159] In the saline control group, the average stimulation response scores at 1h, 2h, 4h, 24h, 48h, and 72h after drug administration were 0, 0, 0, 0, 0, and 0, respectively. Throughout the 1-72h observation period, the eyes of the rabbits in this group maintained a normal physiological state: the cornea had good transparency without any cloudiness; the iris structure was clear and showed good light reflex; the conjunctival vessels had normal course and morphology without congestion or dilation; there was no eyelid edema, and no abnormal ocular secretions were observed.

[0160] The average stimulus response scores of the blank matrix control group at the above time points were 0.83, 1, 0.83, 0.33, 0, and 0, respectively; while the corresponding scores of the test drug group were 1.5, 2.16, 2.5, 0.67, 0.33, and 0, respectively. One hour after administration, a few rabbits in both the blank matrix group and the test drug group exhibited mild eyelid edema, conjunctival vascular congestion, and a small amount of ocular discharge. However, as the observation period was extended to 72 hours, all of these mild abnormal reactions completely subsided, and the rabbits' eyes returned to a normal physiological state.

[0161] In summary, during the observation period of 1-72 hours after administration, the traditional Chinese medicine ointment and its blank matrix prepared in Example 1 of this invention did not produce significant irritation to the eyes of the experimental rabbits.

[0162] II. Clinical Trials

[0163] 1. Materials and Methods

[0164] 1.1 Object

[0165] Forty patients with primary dysmenorrhea were admitted to the Third Affiliated Hospital of Henan University of Traditional Chinese Medicine from July to November 2025. They were randomly divided into a control group and the experimental group of this invention.

[0166] 1.2 Diagnostic criteria

[0167] According to the diagnostic criteria for primary dysmenorrhea in the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine", the inclusion criteria must meet the following two points: ① Secondary abdominal pain caused by organic diseases such as endometriosis and adenomyosis has been ruled out through systematic examination; ② The onset of symptoms is clearly related to the menstrual cycle, with periodic lower abdominal pain as the main manifestation, which may be accompanied by discomfort such as lower back pain and weakness, and in severe cases, it can affect normal work and life functions.

[0168] 1.3 Inclusion Criteria

[0169] ① Meets the clinical diagnostic criteria for primary dysmenorrhea, and the main symptoms of dysmenorrhea and related accompanying symptoms have appeared continuously for no less than 3 menstrual cycles;

[0170] ② The age range of female subjects is 16 to 35 years old (including the two thresholds of 16 and 35 years old).

[0171] ③ The menstrual cycle maintains a regular physiological rhythm, exhibiting a natural cycle of one cycle per month, and possesses normal ovulation function;

[0172] ④ The subjects did not use oral contraceptives or insert intrauterine devices such as intrauterine devices;

[0173] ⑤ Within 3 months prior to enrollment, the patient had not received any drug intervention or other related treatments for dysmenorrhea;

[0174] ⑥ The participants or their legal guardians have signed a written informed consent form and voluntarily participated in this study.

[0175] 1.4 Exclusion Criteria

[0176] ① Patients whose pelvic organic lesions such as endometriosis and uterine fibroids are confirmed by imaging examinations, and who are clearly diagnosed by Western medicine as having secondary dysmenorrhea;

[0177] ②Women who are pregnant or breastfeeding, as well as women of childbearing age who are planning to become pregnant in the near future;

[0178] ③ Patients with serious cardiovascular and cerebrovascular diseases, malignant tumors, or other life-threatening primary systemic diseases;

[0179] ④ Individuals suffering from mental disorders or acute infectious diseases;

[0180] Patients with skin lesions such as broken skin or rashes, or those with other diseases that make them unsuitable for massage therapy;

[0181] ⑤ Patients who are receiving other treatment interventions for dysmenorrhea or other related conditions during the same period.

[0182] 1.5 Rejection Criteria

[0183] ①Incomplete clinical data may interfere with the evaluation of efficacy and safety, resulting in patients who cannot be accurately diagnosed;

[0184] ② Patients with poor adherence to the study protocol who did not follow the study protocol, making it impossible to accurately assess the efficacy and safety of the study;

[0185] ③ Patients who use other drugs without authorization during the study period, or receive treatment interventions outside of this study, may affect the determination of the authenticity of the study results.

[0186] 1.6 Treatment Plan

[0187] ① The patient lies supine, and the practitioner sits beside the patient and applies massage techniques to the abdomen for about 5 minutes.

[0188] ② Continuing from the previous method, use the palm kneading method on the abdomen for 5 minutes;

[0189] ③Then, use the kneading method to stimulate the Qihai, Guanyuan, and Sanyinjiao acupoints respectively, for 1 minute each;

[0190] ④ The patient is placed in a prone position, and the practitioner stands at the side of the body, using the one-finger pushing or kneading method to apply the technique to acupoints such as Liver Shu and Spleen Shu on the back for 1 minute per acupoint;

[0191] ⑤ Continuing from the previous step, use the 㨰 method to operate on both sides of the spine and the lumbosacral region for about 5 minutes;

[0192] ⑥ Finally, apply the rubbing technique to the Baliao acupoints for about 5 minutes.

[0193] The experimental group of this invention: Based on the control group, 2-3g of the traditional Chinese medicine ointment prepared in Example 2 of this invention was applied externally to the lower abdomen using the rubbing method.

[0194] Treatment methods for the control group and the experimental group of this invention: treatment begins one week before menstruation, once a day, 7 times a week, for 3 consecutive menstrual cycles.

[0195] 1.7 Criteria for Evaluating Therapeutic Effect

[0196] Cure: Abdominal pain and other symptoms disappear, and there is no recurrence after 3 menstrual cycles of stopping treatment;

[0197] Significant effect: Abdominal pain symptoms are significantly reduced, other symptoms are improved, and the patient is able to continue working without taking painkillers;

[0198] Effective: Abdominal pain symptoms are relieved, other symptoms improve, and patients can continue working after taking oral painkillers;

[0199] Ineffective: No change in abdominal pain or symptoms.

[0200] Overall effective rate = (cured + significantly effective + effective) / total number of cases × 100%.

[0201] 2. Results

[0202] The experimental group of this invention: 2 cases were cured, 7 cases showed significant improvement, 9 cases were effective, and 2 cases were ineffective, with a total effective rate of 90.00%.

[0203] Control group: 1 case cured, 4 cases significantly effective, 10 cases effective, and 5 cases ineffective, with a total effective rate of 75.00%. No significant adverse reactions or abnormalities were observed throughout the treatment process. Long-term clinical practice has shown that applying the herbal ointments prepared in other embodiments can achieve the same or similar therapeutic effects, which will not be detailed further.

[0204] 3. Typical Cases

[0205] Example 1:

[0206] Liu, female, 15 years old, from Kaifeng, Henan Province

[0207] Ms. Gao, female, 15 years old, a student. She had her first menstruation at age 14, and developed dysmenorrhea six months later. At the time of her initial consultation, she had been menstruating for 3 days. From the day before her period until the start of her period, she experienced recurrent lower abdominal cramping, accompanied by a preference for warmth and pressure, scanty menstrual flow, and nausea and vomiting during pain attacks. She was treated with the herbal ointment of this invention applied to her lower abdomen. After two menstrual cycles, the pain significantly decreased. She continued the treatment for 5 months, and the dysmenorrhea did not recur.

[0208] Example 2:

[0209] Ms. Chen, 29 years old, from Xinyang, Henan Province

[0210] The patient presented primarily with periodic premenstrual lower abdominal pain, diagnosed as primary dysmenorrhea at another hospital. Her medical history revealed that she experienced severe, tender lower abdominal pain one day before menstruation, accompanied by cyanosis, cold extremities, and general weakness. These symptoms recurred regularly with her menstrual cycle. After five consecutive menstrual cycles of treatment with the topical application of the herbal ointment of this invention to the abdomen, her dysmenorrhea symptoms essentially disappeared, and her clinical symptoms significantly improved.

[0211] Example 3:

[0212] Ms. Wu, female, 22 years old, from Zhoukou, Henan Province

[0213] The patient experienced menarche at age 14, and had been experiencing dysmenorrhea since then. The pain was most severe on the first day of menstruation and lasted for about 4 days. She also experienced a cold, aching pain in her lower abdomen, which was relieved by applying heat but worsened by pressure. She also had scanty menstrual flow and dark menstrual blood. She was diagnosed with primary dysmenorrhea. After two menstrual cycles of treatment with the herbal ointment of this invention, the patient's dysmenorrhea was significantly reduced, and the accompanying symptoms also improved. After six consecutive menstrual cycles of treatment, the dysmenorrhea symptoms completely disappeared, and the menstrual flow and color returned to normal levels.

[0214] Comparative Example 1

[0215] This invention can be effectively applied to the clinical treatment of primary dysmenorrhea. Through targeted efficacy comparison studies with similar traditional Chinese medicines, and verified by clinical trials, it has achieved satisfactory and beneficial technical effects. Relevant clinical trial data are as follows:

[0216] 1. Materials and Methods

[0217] 1.1 Object

[0218] Sixty-six patients with primary dysmenorrhea admitted to the Third Affiliated Hospital of Henan University of Traditional Chinese Medicine between January and April 2026 were selected according to the inclusion and exclusion criteria. They were randomly divided into the experimental group and the control group of this invention.

[0219] 1.2 Diagnostic criteria

[0220] According to the diagnostic criteria for primary dysmenorrhea in the "Standards for Diagnosis and Efficacy of Diseases and Syndromes in Traditional Chinese Medicine", the inclusion criteria must meet the following two points: ① Secondary abdominal pain caused by organic diseases such as endometriosis and adenomyosis has been ruled out through systematic examination; ② The onset of symptoms is clearly related to the menstrual cycle, with periodic lower abdominal pain as the main manifestation, which may be accompanied by discomfort such as lower back pain and weakness, and in severe cases, it can affect normal work and life functions.

[0221] 1.3 Inclusion Criteria

[0222] ① Meets the clinical diagnostic criteria for primary dysmenorrhea, and the main symptoms of dysmenorrhea and related accompanying symptoms have appeared continuously for no less than 3 menstrual cycles;

[0223] ② The age range of female subjects is 16 to 35 years old (including the two thresholds of 16 and 35 years old).

[0224] ③ The menstrual cycle maintains a regular physiological rhythm, exhibiting a natural cycle of one cycle per month, and possesses normal ovulation function;

[0225] ④ The subjects did not use oral contraceptives or insert intrauterine devices such as intrauterine devices;

[0226] ⑤ Within 3 months prior to enrollment, the patient had not received any drug intervention or other related treatments for dysmenorrhea;

[0227] ⑥ The participants or their legal guardians have signed a written informed consent form and voluntarily participated in this study.

[0228] 1.4 Exclusion Criteria

[0229] ① Patients whose pelvic organic lesions such as endometriosis and uterine fibroids are confirmed by imaging examinations, and who are clearly diagnosed by Western medicine as having secondary dysmenorrhea;

[0230] ②Women who are pregnant or breastfeeding, as well as women of childbearing age who are planning to become pregnant in the near future;

[0231] ③ Patients with serious cardiovascular and cerebrovascular diseases, malignant tumors, or other life-threatening primary systemic diseases;

[0232] ④ Individuals suffering from mental disorders or acute infectious diseases;

[0233] Patients with skin lesions such as broken skin or rashes, or those with other diseases that make them unsuitable for massage therapy;

[0234] ⑤ Patients who are receiving other treatment interventions for dysmenorrhea or other related conditions during the same period.

[0235] 1.5 Rejection Criteria

[0236] ①Incomplete clinical data may interfere with the evaluation of efficacy and safety, resulting in patients who cannot be accurately diagnosed;

[0237] ② Patients with poor adherence to the study protocol who did not follow the study protocol, making it impossible to accurately assess the efficacy and safety of the study;

[0238] ③ Patients who use other drugs without authorization during the study period, or receive treatment interventions outside of this study, may affect the determination of the authenticity of the study results.

[0239] 1.6 Treatment Plan

[0240] The experimental group of this invention: 2-3g of the traditional Chinese medicine ointment prepared in Example 2 of this invention was applied externally to the lower abdomen.

[0241] Control group: One patch of warming meridian and relieving pain plaster (Lansu, Jiaozuo Union Medical Materials Co., Ltd.: 4cm*6cm*8 patches / box, National Drug Approval Number: B20020496) was applied to the lower abdomen.

[0242] The intervention treatment methods for the experimental group and the control group of this invention are as follows: treatment begins one week before menstruation, twice a day, 14 times a week, for 3 consecutive menstrual cycles.

[0243] 1.7 Criteria for Evaluating Therapeutic Effect

[0244] Cure: Abdominal pain and related accompanying symptoms have completely disappeared, and the condition has not recurred for three consecutive menstrual cycles;

[0245] Significant effect: Abdominal pain is significantly relieved, and related accompanying symptoms are significantly reduced;

[0246] Effective: Abdominal pain was relieved, and related accompanying symptoms improved;

[0247] Ineffective: No significant improvement or worsening of dysmenorrhea after the course of treatment.

[0248] Overall effective rate = (cured + significantly effective + effective) / total number of cases × 100%.

[0249] 2. Results

[0250] In the experimental group of this invention: 2 cases were cured, 9 cases showed significant improvement, 12 cases showed improvement, and 13 cases were ineffective, with a total effective rate of 69.70%; in the control group: 1 case was cured, 7 cases showed significant improvement, 11 cases showed improvement, and 14 cases were ineffective, with a total effective rate of 57.58%. Clinical practice has shown that applying the herbal ointments prepared in other embodiments can achieve the same or similar therapeutic effects, which will not be detailed further.

[0251] This invention features a scientifically sound formula, abundant raw materials, convenient use, and good efficacy. The entire formula works synergistically to warm the meridians, promote blood circulation, regulate menstruation, and relieve pain. It can effectively alleviate the clinical symptoms of patients with primary dysmenorrhea. It is an innovation in the treatment of primary dysmenorrhea and has good application value and practical clinical significance.

[0252] The above description is merely a specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any variations or substitutions that can be easily conceived by those skilled in the art within the technical scope disclosed in the present invention should be included within the scope of protection of the present invention. Therefore, the scope of protection of the present invention should be determined by the scope of the claims.

Claims

1. A traditional Chinese medicine composition for treating primary dysmenorrhea, characterized in that, The traditional Chinese medicine composition comprises the following raw materials in parts by weight: Angelica sinensis 25-35 parts, Impatiens balsamina 25-35 parts, Corydalis yanhusuo 15-25 parts, Foeniculum vulgare 15-25 parts, Trogopterus xanthipes 15-25 parts, Zingiber officinale (processed) 10-20 parts, Cinnamomum cassia 10-20 parts, Asarum heterotropoides 5-10 parts, Cinnamomum cassia twig 5-10 parts, Curcuma zedoaria 5-10 parts.

2. A traditional Chinese medicine ointment massage agent for treating primary dysmenorrhea, characterized in that, The herbal ointment contains the following ingredients in parts by weight: Angelica sinensis 25-35 parts, Impatiens balsamina 25-35 parts, Corydalis yanhusuo 15-25 parts, Foeniculum vulgare 15-25 parts, Trogopterus xanthipes 15-25 parts, Zingiber officinale (processed) 10-20 parts, Cinnamomum cassia 10-20 parts, Asarum heterotropoides 5-10 parts, Cinnamomum cassia twig 5-10 parts, Curcuma zedoaria 5-10 parts, Vaseline 18-22 parts, Palmitic acid 22-24 parts, Jojoba oil 3.6-6 parts, Glyceryl tristearate 12-14 parts, Propylene glycol 28-32 parts, Tween 20 5-7 parts, Water 100-110 parts, Azone 4-6 parts, and Methylparaben 0.4-0.6 parts.

3. The Chinese medicine ointment rubbing agent for treating primary dysmenorrhea according to claim 2, characterized in that, The herbal ointment contains the following ingredients in parts by weight: Angelica sinensis 25 parts, Impatiens balsamina 25 parts, Corydalis yanhusuo 15 parts, Foeniculum vulgare 15 parts, Trogopterus xanthipes 15 parts, Zingiber officinale (processed) 10 parts, Cinnamomum cassia 10 parts, Asarum heterotropoides 5 parts, Cinnamomum cassia twig 5 parts, Curcuma zedoaria 5 parts, Vaseline 18 parts, Palmitic acid 22 parts, Jojoba oil 3.6 parts, Glyceryl tristearate 12 parts, Propylene glycol 28 parts, Tween 20 5 parts, Water 100 parts, Azone 4 parts, Methylparaben 0.4 parts.

4. The Chinese medicine ointment rubbing agent for treating primary dysmenorrhea according to claim 2, characterized in that, The herbal ointment contains the following ingredients in parts by weight: Angelica sinensis 30 parts, Impatiens balsamina 30 parts, Corydalis yanhusuo 20 parts, Foeniculum vulgare 20 parts, Trogopterus xanthipes 20 parts, Zingiber officinale (processed) 15 parts, Cinnamomum cassia 15 parts, Asarum heterotropoides 7 parts, Cinnamomum cassia twig 8 parts, Curcuma zedoaria 8 parts, Vaseline 20 parts, Palmitic acid 23 parts, Jojoba oil 5 parts, Glyceryl tristearate 13 parts, Propylene glycol 30 parts, Tween 20 6 parts, Water 105 parts, Azone 5 parts, and Methylparaben 0.5 parts.

5. The Chinese medicine ointment rubbing agent for treating primary dysmenorrhea according to claim 2, characterized in that, The herbal ointment contains the following ingredients in parts by weight: Angelica sinensis 35 parts, Impatiens balsamina 35 parts, Corydalis yanhusuo 25 parts, Foeniculum vulgare 25 parts, Trogopterus xanthipes 25 parts, Zingiber officinale (processed) 20 parts, Cinnamomum cassia 20 parts, Asarum heterotropoides 10 parts, Cinnamomum cassia twig 10 parts, Curcuma zedoaria 10 parts, Vaseline 22 parts, Palmitic acid 24 parts, Jojoba oil 6 parts, Glyceryl tristearate 14 parts, Propylene glycol 32 parts, Tween 20 7 parts, Water 110 parts, Azone 6 parts, and Methylparaben 0.6 parts.

6. The preparation method of the traditional Chinese medicine ointment massage agent for treating primary dysmenorrhea according to any one of claims 2-5, characterized in that, The preparation method includes the following steps: 1) Pre-processing of Chinese medicine: After cleaning and drying the Angelica sinensis, Impatiens balsamina, Corydalis yanhusuo, Foeniculum vulgare, Trogopterus xanthipes, Zingiber officinale, Cinnamomum cassia, Asarum sieboldii, Cinnamomum cassia twig, and Curcuma zedoaria, grind them into coarse powder, then extract them with alcohol and concentrate them into an extract. 2) Oil phase preparation: Take petrolatum, palmitic acid, jojoba oil and triglyceride, place them in a heating container, heat to 70℃-80℃, so that they are completely melted and mixed evenly; 3) Aqueous phase preparation: Add propylene glycol, Tween 20, and methylparaben to water, stir to dissolve, and heat to 70℃-80℃. 4) Mixing and emulsification: While stirring, slowly add the aqueous phase to the oil phase and continue stirring until a uniform emulsion is formed; 5) Add Chinese herbal medicine and azone: After the temperature of the above emulsion drops to 50℃-60℃, add the Chinese herbal medicine extract and azone, and stir thoroughly. 6) Filling and storage: Fill the prepared ointment into suitable containers while it is still hot, seal it after cooling, and store it in a cool and dry place.

7. The method for preparing the traditional Chinese medicine ointment for treating primary dysmenorrhea according to claim 6, characterized in that, In step 1), the coarse powder of traditional Chinese medicine is powder that has passed through a 60-mesh sieve.

8. The preparation method of the Chinese medicine ointment massage agent for treating primary dysmenorrhea according to claim 6, characterized in that, In step 1), the alcohol extraction is performed by adding 7-9 times the amount of 75% ethanol to the crude Chinese herbal medicine powder, refluxing and extracting twice, each time for 1-2 hours, combining the extracts, and concentrating under reduced pressure to obtain an extract with a relative density of 1.20-1.25 at 45°C.

9. The preparation method of the Chinese medicine ointment massage agent for treating primary dysmenorrhea according to claim 8, characterized in that, In step 1), the alcohol extraction is performed by adding 8 times the amount of 75% ethanol to the crude powder of Chinese medicine, refluxing and extracting twice, each time for 1.5 hours, combining the extracts, and concentrating under reduced pressure to obtain an extract with a relative density of 1.20-1.25 at 45°C.

10. The preparation method of the Chinese medicine ointment massage agent for treating primary dysmenorrhea according to claim 6, characterized in that, In steps 4) and 5), the stirring method is electric stirring, the stirring speed is 190-250 rpm, and the stirring time is 20-30 min.

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