A traditional Chinese medicine composition for treating endometritis and a preparation method thereof

Abstract

The application belongs to the technical field of traditional Chinese medicine compound, and discloses a traditional Chinese medicine composition for treating endometritis and a preparation method thereof. The traditional Chinese medicine compound is composed of the following components: 15-25 parts of Astragalus membranaceus, 10-20 parts of Atractylodes, 10-20 parts of Sargentodoxa, 20-30 parts of Psychotria asiatica and 5-15 parts of Cyperus rotundus. The preparation method is as follows: the components are weighed and dissolved in 6 times of water for 40 minutes; the soaked components are boiled with a strong fire and then changed to a weak fire for 35 minutes, and then the medicinal liquid is taken out; 4 times of water is added, boiled with a strong fire and then changed to a weak fire for 30 minutes, and then the medicinal liquid is taken out; the two medicinal liquids are mixed and stored in a refrigerator for standby. The traditional Chinese medicine compound has the effects of benefiting qi, clearing heat and dampness, promoting blood circulation to remove blood stasis and regulating qi to stop pain, and is used for treating and preventing endometritis caused by deficiency of healthy qi, dampness-heat and blood stasis, has a remarkable effect, is mild in nature and has no toxic side effects.

Description

Technical Field

[0001] This invention belongs to the field of traditional Chinese medicine technology, and in particular relates to a traditional Chinese medicine composition for treating endometritis and its preparation method. Background Technology

[0002] Endometritis is a common gynecological infectious disease of the reproductive system, referring to the inflammatory response of the uterine lining caused by pathogens. Based on the course of the disease, it can be divided into acute endometritis and chronic endometritis. Acute endometritis often presents clinically as lower abdominal pain, fever, increased vaginal discharge with an unpleasant odor, and in severe cases, chills, high fever, and other systemic symptoms may occur. Chronic endometritis often presents as persistent lower abdominal distension, lumbosacral pain, menstrual irregularities, increased menstrual bleeding, prolonged menstrual periods, and some patients may also experience abnormal vaginal discharge and dyspareunia, seriously affecting the patient's physical and mental health and quality of life.

[0003] The pathogenesis of endometritis is complex, mainly related to pathogen infection. Common pathogens include bacteria, fungi, mycoplasma, and chlamydia. In addition, a history of intrauterine procedures (such as induced abortion, curettage, and insertion of intrauterine devices), retained products of conception after childbirth, unsafe sexual practices, and decreased immunity are all important predisposing factors. If acute endometritis is not treated promptly or thoroughly, it can easily develop into chronic endometritis. Long-term, persistent endometritis can also lead to complications such as salpingitis, pelvic inflammatory disease, and intrauterine adhesions, and may even affect fertility, leading to serious consequences such as infertility or ectopic pregnancy.

[0004] Currently, Western medicine treats endometritis primarily with anti-infection measures. Antibiotics are commonly used during acute flare-ups, while chronic cases are treated with a combination of anti-inflammatory and physical therapy approaches. However, long-term or inappropriate use of antibiotics can easily lead to drug resistance and gut microbiota imbalance. Furthermore, antibiotics have limited effectiveness in treating chronic endometritis and fail to fundamentally improve the patient's overall health and the local inflammatory environment.

[0005] Traditional Chinese medicine (TCM) possesses unique advantages in treating endometritis, emphasizing a holistic approach and syndrome differentiation, addressing both the root cause and symptoms. TCM classifies endometritis under categories such as "leukorrhea," "abdominal pain," and "abdominal masses," and its pathogenesis is often related to deficiency of vital energy (Qi), damp-heat stagnation, and qi and blood stasis. Insufficient vital energy makes one susceptible to external pathogens, while damp-heat and blood stasis obstruct the uterus, leading to poor blood and qi circulation and subsequently a series of symptoms. Current TCM formulas for treating endometritis often focus on clearing heat and dampness or detoxifying, with some formulas being quite potent and potentially damaging the spleen and stomach with long-term use. Furthermore, they lack precise formulations targeting the core pathogenesis of "deficiency of vital energy and damp-heat stagnation," resulting in suboptimal efficacy and failing to meet clinical treatment needs.

[0006] Based on the above analysis, the urgent technical problems that need to be solved in the existing technology are:

[0007] (1) Western medicine treatment mainly uses antibiotics, which are prone to drug resistance and intestinal flora imbalance, and have extremely limited efficacy in treating chronic endometritis.

[0008] (2) Existing Chinese medicine prescriptions mostly focus on treating a single pathogenesis (such as clearing heat and dampness or clearing heat and detoxifying), and the combination is not precise enough. Some prescriptions have strong medicinal properties, and long-term use can easily damage the body. The overall efficacy needs to be improved. Summary of the Invention

[0009] To address the problems existing in the prior art, this invention provides a traditional Chinese medicine composition for treating endometritis and its preparation method.

[0010] The present invention is achieved as follows: a traditional Chinese medicine composition for treating endometritis, wherein the components of the traditional Chinese medicine compound, by weight, include: 15-25 parts of Astragalus membranaceus, 10-20 parts of Atractylodes macrocephala, 10-20 parts of Perilla frutescens, 20-30 parts of Smilax china, and 5-15 parts of Cyperus rotundus.

[0011] Furthermore, the traditional Chinese medicine composition for treating endometritis comprises, by weight parts: 15 parts Astragalus membranaceus, 10 parts Atractylodes macrocephala, 10 parts Perilla frutescens, 20 parts Smilax china, and 5 parts Cyperus rotundus.

[0012] Furthermore, the traditional Chinese medicine composition for treating endometritis comprises, by weight parts: 20 parts Astragalus membranaceus, 15 parts Atractylodes macrocephala, 15 parts Perilla frutescens, 25 parts Smilax china, and 10 parts Cyperus rotundus.

[0013] Furthermore, the traditional Chinese medicine composition for treating endometritis comprises, by weight parts: 25 parts Astragalus membranaceus, 20 parts Atractylodes macrocephala, 20 parts Perilla frutescens, 30 parts Smilax china, and 15 parts Cyperus rotundus.

[0014] Another object of the present invention is to provide a method for preparing a traditional Chinese medicine composition for treating endometritis, the preparation method being as follows:

[0015] S1: Weigh out each component of the traditional Chinese medicine compound and soak each component in 6 times the amount of water for 40 minutes;

[0016] S2: After soaking, bring each component to a boil over high heat, then simmer over low heat for 35 minutes. Filter the liquid and keep the dregs.

[0017] S3: Add 4 times the amount of water to the dregs again, bring to a boil over high heat, then simmer over low heat for 30 minutes, filter and remove the liquid.

[0018] S4: Mix the two solutions, let them stand and cool, then dispense and store in the refrigerator for later use.

[0019] Another objective of this invention is to provide a method of using the traditional Chinese medicine composition for treating endometritis. The method of use is as follows: one dose per day, divided into two warm doses, once in the morning and once in the evening, with each dose being 150-200ml; continuous use for 7-15 days constitutes one course of treatment, and the number of courses can be adjusted according to the condition.

[0020] Another objective of this invention is to provide a traditional Chinese medicine compound for improving menstrual disorders caused by endometritis, which is prepared from the above-mentioned traditional Chinese medicine composition for treating endometritis.

[0021] Another objective of this invention is to provide a traditional Chinese medicine preparation for treating endometritis. The preparation uses the traditional Chinese medicine composition for treating endometritis. This compound can be used to prepare various types of traditional Chinese medicine preparations, including but not limited to decoctions, granules, capsules, tablets, pills, or ointments.

[0022] Based on the above technical solutions and the technical problems solved, the advantages and positive effects of the technical solution to be protected by this invention are as follows:

[0023] The traditional Chinese medicine composition for treating endometritis provided by this invention is precisely formulated, with mild medicinal properties, balancing the need to strengthen the body's resistance and eliminate pathogens, and has no obvious toxic side effects. This compound uses Astragalus membranaceus and Atractylodes macrocephala to invigorate Qi and strengthen the body's resistance, enhancing immunity and fundamentally resisting pathogen invasion; it uses Bloodwort vine and Smilax glabra to invigorate blood circulation, remove blood stasis, clear heat and dampness, precisely targeting the core pathogenesis of damp-heat stagnation and clearing heat from the uterus; and it uses Cyperus rotundus to regulate Qi and relieve pain, harmonizing Qi and blood, and improving symptoms such as abdominal pain and distension. The entire formula works synergistically to invigorate Qi, clear heat and dampness, invigorate blood circulation, remove blood stasis, regulate Qi, and relieve pain, achieving both symptomatic and root-cause treatment.

[0024] The traditional Chinese medicine compound provided by this invention has a synergistic effect among its components, resulting in significantly better efficacy than single-component formulas. Through scientific formulation, Astragalus membranaceus and Atractylodes macrocephala enhance the effects of invigorating qi and strengthening the spleen, thereby boosting the body's vital energy and immunity; Perilla frutescens and Smilax china strengthen the effects of promoting blood circulation, removing blood stasis, clearing heat and dampness, effectively eliminating damp-heat inflammation in the uterine cavity; Cyperus rotundus regulates qi and promotes blood circulation, assisting the blood-activating and stasis-removing herbs in their effects. The components work together synergistically, and their therapeutic effect far exceeds the cumulative effect of single components, rapidly relieving patients' clinical symptoms and improving the inflammatory environment of the endometrium.

[0025] The method for preparing traditional Chinese medicine compound provided by this invention is simple, easy to implement, and convenient to operate. It can retain the effective components of each component to the greatest extent and has a low cost, making it suitable for clinical promotion and home preparation. At the same time, the components used in this compound are all commonly used traditional Chinese medicines with wide availability, which further reduces treatment costs and alleviates the economic burden on patients.

[0026] (1) The expected benefits and commercial value of the technical solution of this invention after transformation are as follows: First, significant clinical transformation benefits. This compound can be developed into various dosage forms such as decoction pieces, granules, and capsules, adapting to different clinical scenarios and patient needs. After being launched on the market, it can cover gynecology departments of hospitals at all levels, maternal and child health care institutions, and primary medical institutions, targeting the needs of endometritis treatment and infection prevention after intrauterine procedures. It is estimated that the annual sales can reach tens of millions of yuan. Second, outstanding extended industrial value. Dietary supplements (such as soup ingredients and tea drinks) developed based on the compound can enter the health and wellness market and broaden the consumer group; at the same time, the simplified preparation method facilitates large-scale production, which can reduce production costs, increase profit margins, and form a diversified profit model of "pharmaceuticals + health products". Third, strong long-term market competitiveness. Compared with Western medicine and existing Chinese medicine prescriptions, this compound has advantages such as superior efficacy, high safety, and low cost, which can easily gain the recognition of clinicians and patients, gradually expand market share, and can extend the product life cycle through continuous technological iteration to develop derivative products, bringing stable and continuous economic benefits to enterprises. In addition, technology transfer can drive the development of upstream and downstream industries such as Chinese herbal medicine planting, processing, and pharmaceutical equipment, creating indirect economic benefits and employment opportunities, and possessing both commercial and social value.

[0027] (2) The technical solution of this invention fills a technical gap in the domestic and international industry: Currently, for the treatment of endometritis (especially chronic endometritis), Western medicine lacks safe and effective solutions, and existing Chinese medicine prescriptions mostly focus on a single pathogenesis (such as clearing heat and dampness or clearing heat and detoxifying), without forming a precise compatibility system of "tonifying qi and supporting the body's resistance + clearing heat and dampness + promoting blood circulation and removing blood stasis + regulating qi and relieving pain". According to the search, there are currently no reports on Chinese medicine compound prescriptions that use Astragalus membranaceus, Atractylodes macrocephala, Perilla frutescens, Smilax china, and Cyperus rotundus as core components to treat endometritis based on the core pathogenesis of "deficiency of vital qi and damp-heat stagnation", nor are there any similar Chinese medicine preparations that have multiple effects such as treating and preventing infection after intrauterine procedures and improving menstrual disorders. This invention is the first to construct a compound compatibility scheme that takes into account both tonifying the body's resistance and eliminating pathogenic factors, and clarifies the optimal quality ratio of each component and the standardized preparation process, filling a technical gap in the field of precision treatment of endometritis at home and abroad, and providing a new technical paradigm for the standardized and regulated development of Chinese medicine compound prescriptions for the treatment of reproductive system infectious diseases.

[0028] (3) The technical solution of this invention solves a long-standing technical problem that people have long desired to solve but have never been able to achieve: For a long time, there have been three major problems in the treatment of endometritis: First, the efficacy of Western medicine in treating chronic endometritis is extremely limited, and it is easy to produce side effects such as drug resistance and dysbiosis. This problem has plagued clinical practice for many years but there is no effective solution; Second, the existing Chinese medicine prescriptions are not precise enough. They either focus on clearing heat and dampness or clearing heat and detoxifying while ignoring the deficiency of vital energy, or the medicines are too strong and easily damage the body, making it difficult to achieve both symptomatic and root cause treatment; Third, there is a lack of drugs that have both therapeutic and preventive effects. Infection prevention after intrauterine procedures still relies on antibiotics, which poses a safety hazard. This invention addresses the above problems by achieving the simultaneous treatment of tonifying qi and strengthening the body and eliminating pathogens through precise prescription. It not only significantly improves the therapeutic effect of endometritis but also avoids the side effects of Western medicine and the drawbacks of traditional Chinese medicine. At the same time, it can be used for infection prevention after intrauterine procedures, successfully solving the technical bottleneck that has long been difficult to overcome in this field and meeting the urgent clinical needs.

[0029] (4) The technical solution of this invention overcomes technical biases: There are two major technical biases in the industry: First, it is believed that traditional Chinese medicine compound prescriptions can only relieve symptoms of infectious diseases and cannot achieve the anti-inflammatory and antibacterial effects of Western medicine. Moreover, the mechanism of action is vague and difficult to standardize and promote. Second, it is believed that "the combination of qi-tonifying and righteous-strengthening traditional Chinese medicines and heat-clearing and blood-activating traditional Chinese medicines is easy to hinder each other and affect the efficacy," which leads to the avoidance of such combinations in existing prescriptions. This invention has proven through rigorous clinical trials that the total effective rate of the compound prescription is 95.0%, which is significantly better than the Western medicine control group, and there are no obvious adverse reactions. It has clarified its core functions of anti-inflammatory, antibacterial, and immune-enhancing effects. At the same time, through pharmacological analysis and component synergistic effect studies, it has been confirmed that the combination of Astragalus membranaceus, Atractylodes macrocephala, and other herbs such as Bloodwort Vine and Smilax glabra not only does not affect each other, but also enhances the overall efficacy through synergistic effects. This solution breaks the industry's cognitive limitations on the treatment of infectious diseases with traditional Chinese medicine compound prescriptions, overcomes the bias of combining traditional Chinese medicines with different effects, and provides strong theoretical and practical support for the scientific combination and clinical application of traditional Chinese medicine compound prescriptions.

[0030] The significant advancement of this invention lies in its approach: it goes beyond simply converting existing traditional Chinese medicine prescriptions into conventional dosage forms. Instead, based on a unified process of water extraction, filtration, and vacuum concentration, it specifies the relative density of the concentrate, excipient ratios, drying temperature, moisture control, sieving and granulation, and forming conditions for granules, capsules, tablets, concentrated water-honey pills, and decoctions. This allows the same prescription to be adapted to multiple dosage forms while maintaining formulation conformability, ease of administration, and production controllability. Compared to the traditional method of preparing decoctions on the spot, this invention improves the utilization of medicinal materials and the standardization of formulations, reducing the inconvenience of administration, storage, and portability. Its unexpected technical effect is that, through segmented control of relative density from 1.12 to 1.30 and the coordination of different excipient systems, the concentrate can meet the process requirements for granulation, capsule filling, tablet compression, pill shaping, and decoction preparation, avoiding the problem of a single extract state being unable to accommodate multiple dosage forms. This achieves a synergistic adaptation effect between the prescription extract and the dosage form process. Attached Figure Description

[0031] Figure 1 This is a flowchart illustrating the preparation method of the traditional Chinese medicine composition for treating endometritis provided in this embodiment of the invention. Detailed Implementation

[0032] To make the objectives, technical solutions, and advantages of this invention clearer, the invention will be further described in detail below with reference to embodiments. It should be understood that the specific embodiments described herein are merely illustrative and not intended to limit the invention.

[0033] This invention provides a traditional Chinese medicine composition for treating endometritis and its preparation method. The compound is precisely formulated and has mild medicinal properties. It has the effects of invigorating qi and strengthening the body, clearing heat and removing dampness, promoting blood circulation and removing blood stasis, regulating qi and relieving pain. It can improve the condition of patients with endometritis and has no obvious toxic side effects, making it suitable for long-term conditioning.

[0034] This invention provides a traditional Chinese medicine composition for treating endometritis. The composition comprises 15-25 parts Astragalus membranaceus, 10-20 parts Atractylodes macrocephala, 10-20 parts Perilla frutescens, 20-30 parts Smilax china, and 5-15 parts Cyperus rotundus. The preparation method is simple, and the therapeutic effect is significant.

[0035] The traditional Chinese medicine composition for treating endometritis comprises, by weight parts: 15 parts Astragalus membranaceus, 10 parts Atractylodes macrocephala, 10 parts Perilla frutescens, 20 parts Smilax china, and 5 parts Cyperus rotundus.

[0036] The traditional Chinese medicine composition for treating endometritis comprises, by weight parts: 20 parts Astragalus membranaceus, 15 parts Atractylodes macrocephala, 15 parts Perilla frutescens, 25 parts Smilax china, and 10 parts Cyperus rotundus.

[0037] The traditional Chinese medicine composition for treating endometritis comprises, by weight parts: 25 parts Astragalus membranaceus, 20 parts Atractylodes macrocephala, 20 parts Perilla frutescens, 30 parts Smilax china, and 15 parts Cyperus rotundus.

[0038] like Figure 1 As shown in the embodiment of the present invention, the preparation method of the traditional Chinese medicine composition for treating endometritis is as follows:

[0039] S1: Weigh out each component of the Chinese herbal medicine compound, add each component to 6 times the amount of water and soak for 40 minutes to ensure that the herbal medicine is fully soaked, so as to facilitate the extraction of effective components;

[0040] S2: Place the soaked components in a decoction container, bring to a boil over high heat, then simmer over low heat for 35 minutes. Filter the liquid and keep the dregs.

[0041] S3: Add 4 times the amount of water to the remaining dregs, bring to a boil over high heat, then simmer over low heat for 30 minutes, filter and remove the liquid.

[0042] S4: Mix the two decoctions thoroughly, let them stand and cool, then divide them into portions and store them in the refrigerator for later use.

[0043] The method for preparing a traditional Chinese medicine composition for treating endometritis provided in this invention is based on the theory of overall regulation and synergistic effect of multiple components in traditional Chinese medicine compound prescriptions. Through a scientific decoction process, the effective components in the traditional Chinese medicine decoction pieces with anti-inflammatory, antibacterial, heat-clearing and detoxifying, blood-activating and stasis-removing and immune-regulating effects are extracted and retained to the maximum extent, thereby providing a stable, repeatable and reliable traditional Chinese medicine preparation basis for subsequent clinical applications.

[0044] In step S1, the herbal decoction pieces are weighed and soaked in 6 times their volume of water for 40 minutes. The core principle is to use water as a solvent to allow the tissue structure of the decoction pieces to fully absorb water and swell, softening the cell walls and increasing the intercellular spaces, thus creating favorable conditions for the outward diffusion of active ingredients during subsequent heating. Sufficient soaking not only helps release water-soluble active ingredients (such as alkaloids, glycosides, organic acids, and polysaccharides) but also reduces component loss caused by excessive internal and external temperature differences during decoction, thereby improving overall extraction efficiency.

[0045] Step S2 employs a "high heat to boil – low heat to simmer" method for the first decoction, embodying a combination of traditional Chinese medicine's heat control and modern extraction concepts. High heat rapidly brings the herbs to a boil, effectively disrupting the cell structure and allowing the active ingredients to dissolve quickly. Then, a low heat is used for a sustained 35-minute decoction, promoting full dissolution of the active ingredients and maintaining chemical stability under relatively mild and stable temperatures, preventing degradation of heat-sensitive components due to prolonged high temperatures. Filtering the liquid and retaining the dregs ensures the purity of the initial extract and preserves the material basis for subsequent secondary extractions.

[0046] Step S3 involves adding four times the amount of water to the dregs for a second decoction. The principle behind this is to fully recover the active ingredients that were not completely released or had a slow diffusion rate during the first decoction. The second decoction reduces the amount of water used and the decoction time, thus improving the utilization rate of raw materials and avoiding excessive extraction of impurities. This "gradient extraction" through two decoctions allows for comprehensive coverage of multiple active ingredients in the compound formula, enhancing the overall efficacy of the preparation.

[0047] In step S4, the decoctions obtained from the two decoctions are mixed, cooled, and packaged. The working principle is to achieve a balanced integration of the effective components obtained from different decoction stages, resulting in a more stable composition and more uniform concentration distribution in the final preparation. Refrigeration can effectively inhibit microbial growth and oxidative degradation of components, maintaining the physicochemical stability and biological activity of the traditional Chinese medicine compound.

[0048] The preparation method of this invention achieves efficient extraction and synergistic retention of the effective components of traditional Chinese medicine compound through reasonable soaking ratio, multi-stage decoction process and heat control, providing a basis for traditional Chinese medicine preparations with stable efficacy, high safety and suitable for clinical application in the treatment of endometritis.

[0049] The method of using the traditional Chinese medicine composition for treating endometritis is as follows: one dose per day, divided into two warm doses, once in the morning and once in the evening, each dose being 150-200ml; continuous use for 7-15 days constitutes one course of treatment, and the number of courses can be adjusted according to the condition.

[0050] The pharmacological analysis of each component of the traditional Chinese medicine composition for treating endometritis provided in this embodiment of the invention is as follows:

[0051] Astragalus, slightly warm in nature and sweet in taste, enters the spleen and lung meridians. It has the effects of tonifying qi and raising yang, consolidating the exterior and stopping sweating, promoting diuresis and reducing swelling, and promoting pus drainage and detoxification. The *Compendium of Materia Medica* records: "Astragalus is a medicine that tonifies the lungs and strengthens the spleen, strengthens the defensive qi and astringes sweat, and dispels wind and toxins." Modern pharmacological studies have shown that astragalus contains various effective components such as astragalus polysaccharides and astragalus saponins, which have significant effects on enhancing immunity, anti-inflammation, antibacterial, and antioxidant properties. It can improve the body's resistance to pathogens and reduce the damage of inflammatory reactions to the endometrium.

[0052] Atractylodes macrocephala, warm in nature and sweet and bitter in taste, enters the spleen and stomach meridians. It has the effects of strengthening the spleen and replenishing qi, drying dampness and promoting diuresis, stopping sweating, and calming the fetus. The "Compendium of Materia Medica" records: "Atractylodes macrocephala is the best medicine for tonifying the spleen and stomach." Modern pharmacological studies show that Atractylodes macrocephala contains volatile oils, polysaccharides, and other components, which have the effects of regulating intestinal flora, enhancing immunity, anti-inflammation, and anti-oxidation. When combined with Astragalus membranaceus, it can further enhance the effects of replenishing qi and strengthening the body, improving the constitution of patients with qi deficiency.

[0053] Blood-activating vine (Sanguisorba officinalis) is slightly cold in nature and bitter in taste. It enters the liver meridian and has the effects of activating blood circulation, removing blood stasis, clearing heat and detoxifying, dispelling wind and relieving pain. It is often used to treat pain, rheumatic pain, sores, and carbuncles caused by blood stasis. Modern pharmacological studies have shown that blood-activating vine contains flavonoids, phenols, and other components, which have significant effects in activating blood circulation, removing blood stasis, anti-inflammation, and antibacterial properties. It can improve blood circulation in the uterine cavity, promote the discharge of stagnant blood, and reduce inflammatory infiltration of the endometrium.

[0054] *Smilax glabra*, a herb with neutral properties, sweet and slightly bitter taste, enters the liver and kidney meridians. It has the effects of clearing heat and detoxifying, resolving dampness and reducing swelling, and promoting blood circulation and removing blood stasis. It is a commonly used traditional Chinese medicine for treating gynecological inflammation. *Guizhou Folk Medicine* records: "*Smilax glabra*, neutral in nature, sweet and slightly bitter taste, treats metrorrhagia, leukorrhea, gonorrhea, scrofula, and traumatic injuries." Modern pharmacological studies show that *Smilax glabra* contains diosgenin and other components, possessing strong anti-inflammatory, antibacterial, and antiviral effects. It can effectively inhibit the growth and reproduction of various pathogenic bacteria and reduce the inflammatory response of the endometrium, making it particularly suitable for endometritis caused by damp-heat stagnation.

[0055] Cyperus rotundus, neutral in nature, pungent, slightly bitter, and sweet in taste, enters the liver, spleen, and triple burner meridians. It has the effects of soothing the liver and relieving depression, regulating qi and relieving chest tightness, regulating menstruation and relieving pain, and is hailed as "the general manager of qi-related diseases and the chief physician of gynecology." The Compendium of Materia Medica records: "Cyperus rotundus benefits the triple burner, relieves six types of depression, eliminates food stagnation, phlegm accumulation, abdominal distension, beriberi, and relieves pain in the heart, abdomen, limbs, head, eyes, teeth, and ears." Modern pharmacological studies have shown that Cyperus rotundus contains volatile oils, flavonoids, and other components, possessing anti-inflammatory, analgesic, and smooth muscle contraction regulating effects. It can relieve lower abdominal pain and bloating symptoms in patients with endometritis, while also harmonizing qi and blood and improving menstrual disorders.

[0056] The traditional Chinese medicine composition for treating endometritis provided by this invention can be used to prepare various types of traditional Chinese medicine preparations, including but not limited to decoctions, granules, capsules, tablets, pills, ointments, etc., as well as dietary adjuvants for improving endometritis, such as soup ingredients and tea drinks.

[0057] Example 1: Preparation method of traditional Chinese medicine composition for treating endometritis

[0058] 1.1 Preparation of Decoction: The traditional Chinese medicine composition for treating endometritis provided in this embodiment of the invention consists of the following components by weight: Astragalus membranaceus 20 parts, Atractylodes macrocephala 15 parts, Perilla frutescens 15 parts, Smilax china 25 parts, and Cyperus rotundus 10 parts. Preparation method of the above-mentioned traditional Chinese medicine composition for treating endometritis: Weigh each of the above-mentioned medicinal components, add each component to 6 times the amount of water and soak for 40 minutes; place the soaked components in a decoction pot, bring to a boil over high heat, then simmer over low heat for 35 minutes, filter and remove the decoction; add 4 times the amount of water to the dregs again, bring to a boil over high heat, then simmer over low heat for 30 minutes, filter and remove the decoction; mix the two decoctions, let stand and cool, then divide into portions and store in the refrigerator for later use.

[0059] Instructions for use: Take one dose daily, divided into two warm doses, once in the morning and once in the evening, 150ml each time. For patients with acute endometritis, one course of treatment is 7 consecutive days; for patients with chronic endometritis, one course of treatment is 15 consecutive days.

[0060] This compound medicine has a mild effect, combining the functions of invigorating qi and strengthening the body, clearing heat and removing dampness, promoting blood circulation and removing blood stasis, and regulating qi and relieving pain. It can effectively improve the clinical symptoms of patients with endometritis and has no obvious toxic side effects.

[0061] 1.2 Preparation of Granules: Following the proportions in Example 1.1, weigh 10 kg of the medicinal materials. First, add 8 times the total weight of drinking water and heat to decoct for 1.5 hours, then filter the liquid. Next, add 6 times the amount of water to the dregs and decoct for another 1.5 hours, then filter the liquid. Combine the two filtrates, filter through multiple layers of gauze and filter paper, and concentrate under reduced pressure at 60°C to a relative density of 1.12 g / cm³. 3 The thick paste was obtained in total, approximately 3.5 kg.

[0062] Take the above-mentioned thick paste, add 2.8 kg of dextrin (equivalent to 80% of the paste's mass) as a molding excipient, and 0.5 kg of steviol glycosides as a flavoring agent (accounting for 1% of the total weight of the dried granules). Mix thoroughly in a mixer, granulate using wet granulation technology, and dry in a 60℃ hot air circulating oven until the moisture content is ≤8%. After granulation, package into 10 g packets to obtain granules. Dosage: One packet three times a day, dissolved in boiling water.

[0063] 1.3 Preparation of Capsules: A thick paste was prepared according to the method in Example 1.2, dried, pulverized into a fine powder, and passed through a 100-mesh sieve. The powder was then filled into capsule shells to form capsules with a density of 0.4g per capsule. The dosage is 4-6 capsules three times a day, orally.

[0064] 1.4 Tablet Preparation: ① Prepare a thick paste and fine granules according to the granule preparation method in 1.2. Add appropriate excipients to the fine powder, including a diluent (e.g., microcrystalline cellulose, starch, or lactose, at a dosage of 1 times the mass of the active pharmaceutical ingredient), a binder (e.g., hydroxypropyl methylcellulose solution or povidone solution, with a volume concentration of 10%, at a dosage of 0.2 times the mass of the active pharmaceutical ingredient), and a disintegrant (e.g., crospovidone or sodium carboxymethyl starch, at a dosage of 0.1 times the mass of the active pharmaceutical ingredient). First, mix the active pharmaceutical ingredient, diluent, and disintegrant in a three-dimensional motion mixer for 15 minutes. Then add the binder and stir until homogeneous to form a soft mass. ② Granulation and Drying: Place the soft mass in a gyratory granulator and granulate using a 14-16 mesh sieve to obtain wet granules. Place the wet granules in a fluidized bed dryer and dry at 70°C until the moisture content of the granules drops to 5%, obtaining dry granules. ③ Granulation and Mixing: Place the dry granules in a gyratory granulator and granulate them through a 16-18 mesh sieve. Then add magnesium stearate as a lubricant, at a dosage of 0.03 times the mass of the active pharmaceutical ingredient. Mix in a three-dimensional motion mixer for 10 minutes to obtain tablet granules. ④ Tableting: Place the tablet granules in a rotary tablet press, set the tablet weight to 0.5 g / tablet, and compress at a speed of 20-30 rpm to obtain a semi-finished tablet product. ⑤ Coating: Place the semi-finished tablet product in a high-efficiency coating machine and coat it with a stomach-soluble coating material, hydroxypropyl methylcellulose or acrylic resin IV. The amount of coating material is 3% of the mass of the semi-finished tablet product (i.e., the tablet core). The coating temperature is 50℃, and the coating time is 60 minutes, until the tablet surface is smooth and the color is uniform. Take 4 tablets twice daily with warm water. The course of treatment is the same as for decoction.

[0065] Preparation of 1.5 pills (concentrated water-honey pills): Weigh all medicinal materials according to the proportions in Example 1.1, with a total weight of 10 kg. Add 8 times (first decoction) and 6 times (second decoction) of water respectively, and decoct twice, 1.5 hours each time. Combine the decoctions, filter, and concentrate the filtrate to a relative density of 1.25 g / cm³ at 60°C. 3 The thick extract is prepared by mixing the thick extract with an appropriate amount of refined honey (the mass ratio of extract to refined honey is 5:4), forming a soft mass, shaping it into pills, and drying it below 70℃ to obtain pills. Each 10 pills weigh approximately 2g. The dosage is 6g (30 pills) three times a day, taken with warm water.

[0066] 1.6 Preparation of the ointment (decoction): Weigh all medicinal materials according to the proportions in Example 1.1, with a total weight of 5 kg. Add 8 times (first decoction) and 6 times (second decoction) of water respectively, and decoct twice, 2 hours each time. Combine the decoctions, filter, and let the filtrate stand to settle for 24 hours. Take the supernatant and concentrate it to a relative density of 1.30 g / cm³ at 60°C. 3 The clear paste is prepared by adding an equal amount of refined honey, heating over low heat, and stirring constantly until fully mixed. The mixture is then reduced to a thick paste. To take, dissolve 15g of the paste in warm water and take twice daily.

[0067] Example 2 (Clinical Application Case)

[0068] Case 1: Acute endometritis

[0069] The patient was a 28-year-old woman who presented with severe lower abdominal pain, fever (38.9°C), and increased vaginal discharge with an unpleasant odor after an induced abortion. She was diagnosed with acute endometritis. She was treated with the traditional Chinese medicine compound formula of this invention, one dose daily, taken twice daily. After three days of treatment, her temperature returned to normal, her lower abdominal pain significantly subsided, and the odor of her vaginal discharge lessened. After seven days, all clinical symptoms completely disappeared, and a follow-up examination showed that the endometritis had resolved and she was cured.

[0070] Case 2: Chronic endometritis

[0071] The patient was a 35-year-old woman who had experienced recurrent lower abdominal distension, lumbosacral pain, prolonged menstrual periods (lasting 10-12 days), and increased vaginal discharge for over a year postpartum. She was diagnosed with chronic endometritis, and antibiotic treatment was ineffective. She was treated with the traditional Chinese medicine compound formula of this invention, one dose daily, divided into two warm administrations, for 15 consecutive days as one course of treatment, for a total of two courses. After the first course of treatment, the patient's lower abdominal distension and lumbosacral pain symptoms were significantly reduced, and her menstrual period shortened to 8 days. After the second course of treatment, all clinical symptoms completely disappeared, and follow-up examination showed that the endometrial morphology had returned to normal. No recurrence was observed during a 6-month follow-up.

[0072] Case 3: Infection prevention after intrauterine procedures

[0073] The patient was a 32-year-old woman who underwent hysteroscopic myomectomy for uterine fibroids. Post-operatively, to prevent endometritis, she was treated with the traditional Chinese medicine compound of this invention, one dose daily, divided into two warm administrations, for five consecutive days. Post-operatively, the patient did not experience lower abdominal pain, fever, abnormal vaginal discharge, or other symptoms of infection, and recovered well. Follow-up examinations showed no inflammatory reaction in the uterine cavity.

[0074] Evidence related to the technical effects obtained by the embodiments of the present invention.

[0075] (a) Clinical Trials

[0076] 1. Materials and Methods

[0077] 1.1 General Information Patients with endometritis treated at the Famous Doctors' Clinic of Hubei Provincial Maternal and Child Health Hospital from March 2021 to February 2024 were selected as the study subjects and randomly divided into an observation group and a control group using a random number table. There were 40 patients in the observation group and 38 patients in the control group who met the study criteria, for a total of 78 patients in both groups. In the observation group, the age range was 22-45 years, with a mean age of (32.15±4.23) years, including 18 cases of acute endometritis and 22 cases of chronic endometritis. In the control group, the age range was 23-44 years, with a mean age of (31.87±4.11) years, including 17 cases of acute endometritis and 21 cases of chronic endometritis. There were no statistically significant differences in general characteristics between the two groups (P>0.05), indicating comparability.

[0078] 1.2 Diagnostic criteria were based on the diagnostic criteria for endometritis in Obstetrics and Gynecology (9th edition): Acute endometritis: Symptoms included lower abdominal pain, fever, increased vaginal discharge with an odor, gynecological examination showed significant uterine tenderness, elevated white blood cell count in routine blood tests, and pathogenic bacteria detected in cervical secretion culture; Chronic endometritis: Symptoms included persistent lower abdominal distension, lumbosacral pain, and menstrual irregularities, gynecological examination showed uterine tenderness, and hysteroscopy revealed endometrial congestion, edema, and erosion-like changes.

[0079] 1.3 Inclusion criteria: meeting the above diagnostic criteria for endometritis; aged 20-45 years; voluntarily participating in this study and signing an informed consent form; and not having used antibiotics or other medications for treating endometritis within one week prior to treatment.

[0080] 1.4 Exclusion criteria: Patients with other gynecological diseases such as salpingitis, pelvic inflammatory disease, and ovarian cysts; patients with severe liver and kidney dysfunction, cardiovascular disease, immune system disease, or other systemic diseases; patients allergic to any component of the compound formula of this invention; pregnant or lactating women; patients with poor compliance who are unable to complete the treatment.

[0081] 1.5 Treatment Methods: The observation group received the traditional Chinese medicine compound of this invention, consisting of 20 parts Astragalus membranaceus, 15 parts Atractylodes macrocephala, 15 parts Perilla frutescens, 25 parts Smilax china, and 10 parts Cyperus rotundus. The decoction was prepared uniformly by the hospital's decoction room, using the same method as in Example 1. One dose was taken daily, divided into two warm doses. Acute patients received the medication for 7 days as one course of treatment, while chronic patients received it for 15 days as one course. The control group received the following medications: Patients with acute endometritis were given cefixime dispersible tablets (100mg / tablet) orally, one tablet twice daily for 7 days; patients with chronic endometritis were given metronidazole tablets (0.2g / tablet) orally, one tablet three times daily for 15 days.

[0082] 1.6 Criteria for Evaluating Therapeutic Effect: Cured: Clinical symptoms completely disappeared, and gynecological examination and related auxiliary examinations showed complete resolution of inflammation; Significantly Effective: Clinical symptoms significantly improved, and gynecological examination and related auxiliary examinations showed significant reduction in inflammation; Effective: Clinical symptoms somewhat relieved, and gynecological examination and related auxiliary examinations showed some degree of reduction in inflammation; Ineffective: Clinical symptoms showed no improvement or even worsened, and gynecological examination and related auxiliary examinations showed no change in inflammation. Total Effective Rate = (Number of Cured Cases + Number of Significantly Effective Cases + Number of Effective Cases) / Total Number of Cases × 100%.

[0083] 1.7 Statistical Methods SPSS 25.0 statistical software was used for data analysis. Quantitative data were expressed as (x±s), and comparisons were performed using the t-test; categorical data were expressed as percentages (%), and comparisons were performed using the chi-square test. 2 Test. P < 0.05 is considered statistically significant.

[0084] 2 Results

[0085] 2.1 Comparison of Clinical Efficacy Between the Two Groups In the observation group, 22 cases were cured, 12 cases showed significant improvement, 4 cases showed improvement, and 2 cases showed no effect, with a total effective rate of 95.0%. In the control group, 15 cases were cured, 10 cases showed significant improvement, 5 cases showed improvement, and 8 cases showed no effect, with a total effective rate of 78.9%. The difference in total effective rate between the two groups was statistically significant (P < 0.05), indicating that the observation group's efficacy was significantly better than that of the control group. (See Table 1)

[0086] Table 1 Comparison of clinical efficacy between the two groups

[0087]

[0088] Note: * Compared with the control group, P < 0.05.

[0089] 2.2 Comparison of symptom relief time between the two groups: The symptom relief time for patients with acute endometritis in the observation group was (3.21±1.05) days, while that in the control group was (4.87±1.23) days; the symptom relief time for patients with chronic endometritis in the observation group was (8.52±2.11) days, while that in the control group was (12.34±2.56) days. The symptom relief time in the observation group was significantly shorter than that in the control group, and the difference was statistically significant (P<0.05). (See Table 2)

[0090] Table 2 Comparison of symptom relief time between the two groups (days)

[0091]

[0092] Note: * Compared with the control group, P < 0.05.

[0093] 2.3 Comparison of adverse reactions between the two groups: No significant adverse reactions occurred in the observation group during treatment; in the control group, 6 patients experienced adverse reactions, including 3 cases of gastrointestinal discomfort (nausea, abdominal distension), 2 cases of dizziness, and 1 case of rash, with an adverse reaction rate of 15.8%. The difference in the incidence of adverse reactions between the two groups was statistically significant (P<0.05), indicating that the observation group had higher safety.

[0094] 3. Discussion

[0095] The core pathogenesis of endometritis lies in "deficiency of vital energy and stagnation of damp-heat." Insufficient vital energy makes the body susceptible to pathogen invasion. Damp-heat and blood stasis obstruct the uterus, leading to poor blood circulation and subsequently causing symptoms such as pain and abnormal discharge. Based on this pathogenesis, the herbal compound of this invention precisely combines Astragalus membranaceus and Atractylodes macrocephala to tonify vital energy and strengthen the body's immunity; *Gynostemma pentaphyllum* and *Smilax china* to invigorate blood circulation, remove blood stasis, clear heat and dampness, and eliminate stagnant heat in the uterus; and *Cyperus rotundus* to regulate qi, relieve pain, and harmonize qi and blood. The entire formula addresses both the root cause and the symptoms, achieving a synergistic therapeutic effect.

[0096] Clinical trial results showed that the total effective rate in the observation group was significantly higher than that in the control group, the symptom relief time was significantly shorter, and no significant adverse reactions occurred. This indicates that the traditional Chinese medicine compound of this invention is effective in treating endometritis, can quickly relieve patient symptoms, has high safety, and is superior to traditional Western medicine treatment. The components of this compound are all commonly used traditional Chinese medicines, with mild medicinal properties and no obvious toxic side effects. It is suitable for endometritis patients at different stages of the disease, especially for the conditioning of patients with chronic endometritis. It can also be used for infection prevention after intrauterine procedures, and has broad clinical application value.

[0097] 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 modifications, equivalent substitutions, and improvements made by those skilled in the art within the scope of the technology disclosed in the present invention, and within the spirit and principles of the present invention, should be covered within the scope of protection of the present invention.

Claims

1. A traditional Chinese medicine composition for treating endometritis, characterized in that, The traditional Chinese medicine compound components, by weight, include: 15-25 parts Astragalus membranaceus, 10-20 parts Atractylodes macrocephala, 10-20 parts Perilla frutescens, 20-30 parts Smilax china, and 5-15 parts Cyperus rotundus.

2. The traditional Chinese medicine composition for treating endometritis as described in claim 1, characterized in that, The traditional Chinese medicine composition for treating endometritis comprises, by weight parts: 15 parts Astragalus membranaceus, 10 parts Atractylodes macrocephala, 10 parts Perilla frutescens, 20 parts Smilax china, and 5 parts Cyperus rotundus.

3. The traditional Chinese medicine composition for treating endometritis as described in claim 1, characterized in that, The traditional Chinese medicine composition for treating endometritis comprises, by weight parts: 20 parts Astragalus membranaceus, 15 parts Atractylodes macrocephala, 15 parts Perilla frutescens, 25 parts Smilax china, and 10 parts Cyperus rotundus.

4. The traditional Chinese medicine composition for treating endometritis as described in claim 1, characterized in that, The traditional Chinese medicine composition for treating endometritis comprises, by weight parts: 25 parts Astragalus membranaceus, 20 parts Atractylodes macrocephala, 20 parts Perilla frutescens, 30 parts Smilax china, and 15 parts Cyperus rotundus.

5. A method for preparing a traditional Chinese medicine composition for treating endometritis as described in claims 1-4, characterized in that, The preparation method is as follows: S1: Weigh out each component of the traditional Chinese medicine compound and soak each component in 6 times the amount of water for 40 minutes; S2: After soaking, bring each component to a boil over high heat, then simmer over low heat for 35 minutes. Filter the liquid and keep the dregs. S3: Add 4 times the amount of water to the dregs again, bring to a boil over high heat, then simmer over low heat for 30 minutes, filter and remove the liquid. S4: Mix the two solutions, let them stand and cool, then dispense and store in the refrigerator for later use.

6. A traditional Chinese medicine compound for improving menstrual disorders caused by endometritis, characterized in that, This compound is prepared from the traditional Chinese medicine composition for treating endometritis as described in any one of claims 1-4.

7. A traditional Chinese medicine preparation for treating endometritis, characterized in that, The traditional Chinese medicine composition for treating endometritis according to any one of claims 1-4 can be used to prepare various types of traditional Chinese medicine preparations, including but not limited to decoctions, granules, capsules, tablets, pills or ointments.

8. A method for preparing the traditional Chinese medicine preparation according to claim 7, characterized in that, The process includes the following steps: Weigh each medicinal material according to the prescription ratio, add water and decoct twice. For the first decoction, add drinking water at a ratio of 8 times the total mass of the medicinal materials, heat and decoct for 1.5 hours, and filter the liquid. For the second decoction, add drinking water at a ratio of 6 times the total mass of the medicinal materials to the dregs, heat and decoct for 1.5 hours, and filter the liquid. Combine the two filtrates, filter through gauze and filter paper, and concentrate under reduced pressure at 60°C to obtain a concentrate with a relative density of 1.12 to 1.

30. Mix the concentrate with pharmaceutically acceptable excipients to prepare granules, capsules, tablets, concentrated water-honey pills, or decoction pastes.

9. The method for preparing a traditional Chinese medicine preparation according to claim 8, characterized in that, When preparing granules, a thick paste with a relative density of 1.12 is mixed with 80% dextrin by weight of the paste, and steviol glycosides are added as a flavoring agent. After stirring evenly, wet granulation is performed, and the mixture is dried in a hot air circulating oven at 60°C until the moisture content is no higher than 8%. After granulation, the granules are packaged to obtain granules. When preparing capsules, the thick paste is dried, pulverized into fine powder, and passed through a 100-mesh sieve. The resulting powder is filled into capsule shells to obtain capsules with a content of 0.4g per capsule. When preparing tablets, the thick paste or fine powder is mixed with a diluent and a disintegrant for 15 minutes, and a binder with a volume concentration of 10% is added to form a soft mass. The mass is granulated through a 14-16 mesh sieve, dried at 70°C until the moisture content of the granules is 5%, granulated again through a 16-18 mesh sieve, magnesium stearate is added, and the mixture is mixed for 10 minutes before tableting. The tablets are then coated with a gastrointestinal coating material to obtain coated tablets.

10. The method for preparing a traditional Chinese medicine preparation according to claim 8, characterized in that, When preparing concentrated water-honey pills, the combined filtrate is concentrated to a thick extract with a relative density of 1.25 at 60°C. The thick extract is mixed with refined honey at a mass ratio of 5:4 to form a soft material, which is then made into pills and dried at a temperature below 70°C to obtain concentrated water-honey pills. When preparing a decoction, the combined filtrate is filtered and allowed to stand for 24 hours to settle. The supernatant is taken and concentrated to a clear extract with a relative density of 1.30 at 60°C. Refined honey of the same mass as the clear extract is added, and the mixture is heated over a low flame and stirred until homogeneous. The extract is then collected to obtain the decoction.

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