Traditional Chinese medicine composition for treating menorrhagia and preparation thereof

Abstract

The invention particularly relates to a traditional Chinese medicine composition for treating menorrhagia and a preparation process of the traditional Chinese medicine composition. The traditional Chinese medicine composition is prepared from the following raw materials: 10-20 parts of herba ecliptae, 5-15 parts of semen cuscutae, 5-15 parts of fructus ligustri lucidi, 5-15 parts of rhizoma dryopteris crassirhizomae, 10-30 parts of radix scutellariae, 5-15 parts of radix sanguisorbae, 10-30 parts of radix angelicae sinensis, 1-9 parts of rhizoma cyperi, 1-9 parts of fructus forsythiae, 1-9 parts of vinegar turtle shell, 1-9 parts of semen trichosanthis, 1-9 parts of radix gentianae macrophyllae, 5-15 parts of radix astragali, 8-15 parts of rhizoma atractylodis macrocephalae and 10-25 parts of radix glycyrrhizae. The traditional Chinese medicine composition solves the problems of excessive menstruation and blood-heat syndrome in traditional Chinese medicine differentiation, has good safety and compliance, and has a good market application prospect.

Description

Technical Field

[0001] The invention belongs to the technical field of traditional Chinese medicines, and particularly relates to a traditional Chinese medicine composition for treating menorrhagia caused by spleen and kidney yang deficiency, dampness, turbidity and blood stasis, and a preparation thereof. Background Art

[0002] Menorrhagia refers to regular menstrual cycles with significantly greater than normal bleeding volume (usually >80 mL / cycle), or a subjective perception of significantly increased bleeding, which can severely impact a woman's quality of life. Its etiology is complex, involving multiple factors, including endocrine disorders, uterine structural abnormalities, coagulation disorders, and systemic diseases. Ovulatory dysfunctional uterine bleeding (ODUB) is a common cause of menorrhagia, primarily due to luteal insufficiency or an imbalance in the local prostaglandin (PG) ratio in the endometrium. Prostaglandin E2 (PGE2) and prostaglandin F2α (PGF2α) regulate vasoconstriction and relaxation. An elevated PGE2 / PGF2α ratio can lead to vasodilation and decreased platelet aggregation, thereby increasing bleeding volume. Furthermore, elevated estrogen levels or relative progesterone deficiency can promote endometrial thickening, increasing bleeding during shedding.

[0003] According to Traditional Chinese Medicine (TCM), the pathogenesis of menorrhagia is primarily related to imbalances in Qi and blood, and dysfunctional organ function. Specifically, kidney Qi deficiency leads to a lack of control, while liver blood deficiency impairs blood storage, resulting in a loss of control of the Chong and Ren meridians. Alternatively, excess Yang can lead to excessive blood flow, or blood stasis can prevent new blood from returning to the meridians. These pathological changes ultimately lead to excessive menstrual bleeding and menorrhagia. Modern medicine primarily utilizes two main treatment strategies: pharmacological intervention and surgical intervention. Drug therapy primarily relies on hormonal regulation, but long-term use can cause adverse reactions such as endocrine disruption. While surgical intervention can rapidly control symptoms, it is often invasive and requires a long recovery period. In comparison, Traditional Chinese Medicine (TCM) utilizes holistic approaches and syndrome differentiation to address symptoms, focusing on restoring balance while improving symptoms. This approach offers advantages such as proven efficacy, minimal side effects, and a low recurrence rate.

[0004] There are few drugs for treating such diseases, for example: Chinese patent CN103316246A discloses a traditional Chinese medicine composition for treating menorrhagia, which is composed of astragalus, pseudoginseng, stir-fried atractylodes, poria, complanatus, dipsacus, mistletoe, cyperus, angelica, tangerine peel, charcoal cimicifuga, palm charcoal, sanguisorba officinalis, agrimony, imperata rhizome, moutan bark, red peony root, bletilla striata, raw rehmannia root, northern adenophora, and raw licorice in a certain weight ratio. It has the effects of replenishing qi and blood, promoting blood circulation and removing blood stasis, regulating menstruation and consolidating Chong, invigorating qi and strengthening the spleen, replenishing blood and stopping bleeding, and can effectively treat menorrhagia. Chinese patent CN109925495A discloses a traditional Chinese medicine composition for treating adenomyosis and its use. The composition comprises a combination of raw materials, including salvia miltiorrhiza, cinnamon twig, roasted ginger, notoginseng powder, turmeric, chicken's gizzard lining, coix seed, processed cyperus rotundus, white peony root, and Chinese yam, in a specific weight ratio. The composition has a significant therapeutic effect on dysmenorrhea, pelvic pain, and heavy menstruation caused by adenomyosis.

[0005] Current clinical practice demonstrates that single Western medications or existing Traditional Chinese Medicine (TCM) often fail to fully address menorrhagia and its associated conditions. Therefore, exploring effective, pure TCM herbal remedies, leveraging the unique strengths of each herb to create complementary treatment options, has become a key focus of current clinical research. This approach aligns with the principles of modern precision medicine while also upholding the holistic approach of TCM, providing patients with enhanced treatment options. Summary of the Invention

[0006] The invention discloses a Chinese medicine composition for treating menorrhagia, which has the characteristics of definite efficacy, small side effects, convenient administration and low price. In practical application, the effect of the invention is superior to that of the prior art.

[0007] Specifically, the technical solution of the present invention is achieved as follows.

[0008] The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 2-8 parts of thistle charcoal, 2-8 parts of malt charcoal, 10-20 parts of Ecliptae, 5-15 parts of Cuscuta seeds, 5-15 parts of Ligustrum lucidum fruits, 5-15 parts of Cyperus rotundus, 10-30 parts of Scutellaria baicalensis, 5-15 parts of Sanguisorba officinalis, 10-30 parts of Angelica sinensis, 1-9 parts of Cyperus rotundus, 1-9 parts of Forsythia suspensa, 1-9 parts of Vinegar-suckling Carapace, 1-9 parts of Trichosanthes fruits, 1-9 parts of Gentiana macrophylla, 5-15 parts of Astragalus membranaceus, 8-15 parts of Atractylodes macrocephala, and 10-25 parts of Licorice.

[0009] In a preferred embodiment of the present invention, the Chinese medicine composition is made from the following raw materials in parts by weight: 8 parts of thistle charcoal, 8 parts of malt charcoal, 10 parts of Ecliptae, 5 parts of Cuscuta seeds, 5 parts of Ligustrum lucidum fruits, 5 parts of Cyperus rotundus, 10 parts of Scutellaria baicalensis, 5 parts of Sanguisorba officinalis, 10 parts of Angelica sinensis, 1 part of Cyperus rotundus, 1 part of Forsythia suspensa, 1 part of Vinegar-suckling Carapace, 1 part of Trichosanthes fruit, 1 part of Gentiana macrophylla, 5 parts of Astragalus, 8 parts of Atractylodes macrocephala, and 10 parts of Licorice.

[0010] In a preferred embodiment of the present invention, the Chinese medicine composition is made from the following raw materials in parts by weight: 5 parts of thistle charcoal, 5 parts of malt charcoal, 20 parts of Ecliptae, 15 parts of Cuscuta seeds, 15 parts of Ligustrum lucidum fruits, 15 parts of Cyperus rotundus, 30 parts of Scutellaria baicalensis, 15 parts of Sanguisorba officinalis, 30 parts of Angelica sinensis, 9 parts of Cyperus rotundus, 9 parts of Forsythia suspensa, 9 parts of Vinegar-soaked Trichosanthes fruit, 9 parts of Trichosanthes kirilowii, 9 parts of Gentiana macrophylla, 15 parts of Astragalus membranaceus, 15 parts of Atractylodes macrocephala, and 25 parts of Licorice.

[0011] In a preferred embodiment of the present invention, the Chinese medicine composition is made from the following raw materials in parts by weight: 5 parts of thistle charcoal, 5 parts of malt charcoal, 15 parts of Ecliptae, 10 parts of Cuscuta seeds, 10 parts of Ligustrum lucidum fruits, 10 parts of Cyperus rotundus, 20 parts of Scutellaria baicalensis, 10 parts of Sanguisorba officinalis, 20 parts of Angelica sinensis, 5 parts of Cyperus rotundus, 5 parts of Forsythia suspensa, 5 parts of Vinegar-suckling Carapace, 5 parts of Trichosanthes fruits, 5 parts of Gentiana macrophylla, 10 parts of Astragalus, 10 parts of Atractylodes macrocephala, and 15 parts of Licorice.

[0012] Furthermore, the preparation method of the described thistle charcoal is as follows: crush and weigh the thistle and put it into a crucible, cover the crucible mouth with aluminum foil, cover the lid tightly, and place it in a muffle furnace for carbonization from 25°C to 70°C, the heating process is 10 minutes, and maintained at 70°C for 15 minutes; then increase the temperature from 70°C to 400°C, the heating process is 30 minutes and maintained for 40 minutes, after the temperature drops to 25-30°C, open the muffle furnace door, and take out the crucible, the product in the crucible is the thistle charcoal; boil the thistle charcoal in a water bath with 10 times the amount of deionized water for 3 times, each time for 20 minutes, and then filter and concentrate with a 0.22μm microporous filter membrane. Then, deionized water is used as the dialysis medium, and the concentrated solution is dialyzed for 5 days with a 1000D dialysis membrane, and the solution in the bag is taken out to obtain the small thistle charcoal; the preparation process of the malt charcoal is as follows: the malt is crushed and weighed and put into a crucible, the crucible mouth is covered with aluminum foil, the lid is tightly closed, and the charcoal is placed in a muffle furnace and carbonized from 25°C to 70°C, the heating process is 10 minutes, and it is maintained at 70°C for 15 minutes; then it is raised from 70°C to 400°C, the heating process is 30 minutes and maintained for 40 minutes, and after it is reduced to 25-30°C, the furnace door of the muffle furnace is opened and the crucible is taken out, and the product in the crucible is malt charcoal; the malt charcoal is decocted in a water bath with 10 times the amount of deionized water for 3 times, each time for 20 minutes, and then filtered with a 0.22μm microporous filter membrane and concentrated. Then, deionized water is used as the dialysis medium, and the concentrated solution is dialyzed for 5 days with a 1000D dialysis membrane, and the solution in the bag is taken out to obtain the malt charcoal.

[0013] Furthermore, the Chinese medicine composition of the present invention and excipients are prepared into a pharmaceutical dosage form; the pharmaceutical dosage form is any one of granules, mixtures, decoctions, oral liquids, and pills. Generally speaking, in terms of medicines, especially Chinese medicines, decoctions are basically formed first and then into dosage forms such as granules or capsules.

[0014] Furthermore, the preparation process of the granules is as follows:

[0015] (1) Grind the weight parts of Vinegar Carapace and Sanguisorba officinalis into ultrafine powder, add Cuscuta chinensis, Ligustrum lucidum, Forsythia suspensa, Atractylodes macrocephala, and Trichosanthes fruit, add 90% or more ethanol and reflux extract twice, add 20-30 times the amount for the first time and 10-20 times the amount for the second time, each time for 1-2 hours, filter separately, combine the filtrate, and use the filtrate and the residue for later use;

[0016] (2) Take the medicinal materials of Eclipta prostrata, Cyperus rotundus, Gentiana macrophylla, Scutellaria baicalensis, Angelica sinensis, Cyperus rotundus, Astragalus membranaceus, and Licorice root, soak them in hot water at 40-55°C for 2 hours, extract the volatile oil using a volatile oil extractor, and set aside the volatile oil and the medicinal residue;

[0017] (3) Weighing the prepared thistle charcoal and malt charcoal in parts by weight for later use;

[0018] (4) Take the medicinal residues from step (1) and step (2), add 10-15 volume of water and extract twice, each time for 10-20 minutes, combine the two water extracts and set aside;

[0019] (5) The filtrate from step (1) and the aqueous extract from step (4) are combined and concentrated into a thick paste having a relative density of 1.30-1.35, the charcoal of thistle and the malt charcoal from step (4) are added, dried and crushed, aspartame and dextrin excipients are added, mixed, granulated, dried, granulated, sprayed with the volatile oil from step (2), granulated, and bagged to obtain granules. The amount of aspartame and dextrin excipients used can be determined by a person skilled in the art as needed, and the experiment can be conducted without exceeding the pharmacopoeial standards.

[0020] At the same time, aspartame as a sweetener can be replaced with flavorings such as sucralose; pastes can be replaced with auxiliary materials such as sucrose and glucose

[0021] Furthermore, the present invention is used clinically for treating menorrhagia, wherein menorrhagia refers to uterine bleeding due to ovulatory dysfunction.

[0022] Furthermore, the present invention is used clinically in treating menorrhagia, wherein the menorrhagia is caused by blood-heat syndrome according to TCM diagnosis.

[0023] Compared with the prior art, the prescription of the present invention is clear and hits the mechanism. The prescription of each Chinese medicinal material of the present invention strictly follows the principle of monarch, minister, assistant and envoy compatibility of traditional Chinese medicine. The monarch medicine in the side is small thistle charcoal and malt charcoal to form a hemostatic gold combination, which plays the dual effect of cooling blood and stopping bleeding and strengthening the spleen and regulating blood; the ministerial medicine is with Eclipta prostrata and Scutellaria baicalensis as the core of clearing heat and cooling blood, with Cuscuta chinensis and Ligustrum lucidum nourishing the kidney and strengthening the foundation, and Rhizoma Cyperi and Radix Sanguisorbae enhance the hemostatic function; the adjuvant medicine is with Angelica sinensis, Rhizoma Cyperi, Fructus Forsythiae, Carapax Trichosanthis, Fructus Gentianae, Radix Astragali and Atractylodes macrocephala as the whole conditioning system, and the main effect on hemostasis is not too strong, among which Angelica sinensis-Rhizoma Cyperi replenishes qi and invigorates qi, realizes blood circulation without hurting the vital energy to function, adopts Licorice as the making medicine, harmonizes various medicines, and plays a role. The preparation method of the granules of the Chinese medicine composition provided by the present invention is simple and operable, and has broad market application prospects. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] Figure 1 : From the comparison of the hemostatic time of the embodiments of the present invention, it can be seen that the hemostatic effects of Examples 2-4 are significantly better than those of Comparative Examples 1-4, with significant differences (P<0.05 or P<0.01).

[0025] Figure 2 : From the comparison of the coagulation time of the embodiments of the present invention, it can be seen that the coagulation effects of Examples 2-4 are significantly better than those of Comparative Examples 1-4, with significant differences (P<0.05 or P<0.01).

[0026] Figure 3 : Pharmacological effect experiment of Example 2 of the present invention: The granules of Example 2 can restore the uterine index to a level close to normal, indicating that it can effectively improve the pathological state of the uterus.

[0027] Figure 4 : Pharmacological effect experiment of Example 2 of the present invention. In terms of brown fat index, the model group was significantly higher than the blank control group (p < 0.05), while the Example 2 group restored it to the normal range, indicating that this solution can bidirectionally regulate energy metabolism. DETAILED DESCRIPTION

[0028] In order to make the purpose and technical solution of the present invention more clear, the present invention is further described below in conjunction with the embodiments, but the scope of protection of the present invention is not limited to these embodiments, and the embodiments are only used to illustrate the present invention. It should be understood by those skilled in the art that any changes or equivalent substitutions that do not deviate from the concept of the present invention are included in the scope of protection of the present invention.

[0029] Example 1: Preparation of thistle charcoal and malt charcoal

[0030] 1. Preparation process of thistle charcoal:

[0031] 1) crushing and weighing the chicory and placing it into a crucible, covering the crucible mouth with aluminum foil, closing the lid tightly, and placing it in a muffle furnace for carbonization. The temperature is raised from 25° C. to 70° C. for 10 minutes and maintained at 70° C. for 15 minutes; then the temperature is raised from 70° C. to 400° C. for 30 minutes and maintained at 40 minutes. After the temperature is reduced to 25-30° C., the muffle furnace door is opened and the crucible is taken out. The product in the crucible is crude chicory charcoal;

[0032] 2) Decoct the charcoal in a water bath with 10 times the amount of deionized water three times for 20 minutes each time. Filter through a 0.22 μm microporous filter and concentrate. Then, dialyze the concentrate using a 1000D dialysis membrane for 5 days using deionized water as the dialysis medium. Remove the solution from the bag to obtain the refined charcoal.

[0033] 2. Preparation process of malt charcoal:

[0034] 1) The malt is crushed and weighed and then loaded into a crucible. The crucible mouth is covered with aluminum foil, the lid is tightly closed, and the crucible is placed in a muffle furnace for carbonization. The temperature is raised from 25°C to 70°C for 10 minutes and maintained at 70°C for 15 minutes; then the temperature is raised from 70°C to 400°C for 30 minutes and maintained for 40 minutes. After the temperature is reduced to 25-30°C, the door of the muffle furnace is opened and the crucible is taken out. The product in the crucible is malt charcoal;

[0035] 2) Decoct the malt charcoal in a water bath with 10 times the amount of deionized water for three times, 20 minutes each time. Filter through a 0.22 μm microporous filter and concentrate. Then, dialyze the concentrate using a 1000D dialysis membrane with deionized water for five days. Remove the solution from the bag to obtain the malt charcoal.

[0036] Example 2: A Chinese medicine composition for treating heavy menstruation, wherein the Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0037]

[0038]

[0039] The preparation process is:

[0040] (1) Grind the weight parts of Vinegar Carapace and Sanguisorba officinalis into ultrafine powder, add Cuscuta chinensis, Ligustrum lucidum, Forsythia suspensa, Atractylodes macrocephala, and Trichosanthes fruit, add 95% ethanol, and reflux extract twice, add 25 times the amount for the first time and 15 times the amount for the second time, the first time for 2 hours and the second time for 1 hour, filter them separately, combine the filtrate, and use the filtrate and the medicinal residue for later use;

[0041] (2) Take the medicinal materials of Eclipta prostrata, Cyperus rotundus, Gentiana macrophylla, Scutellaria baicalensis, Angelica sinensis, Cyperus rotundus, Astragalus membranaceus, and Licorice root, soak them in hot water at 40-55°C for 2 hours, extract the volatile oil using a volatile oil extractor, and set aside the volatile oil and the medicinal residue;

[0042] (3) Weigh the prepared portions of thistle charcoal and malt charcoal in Example 1 for later use;

[0043] (4) Take the medicinal residues from step (1) and step (2), add 13% water and extract twice, each time for 10-20 minutes, combine the two water extracts and set aside;

[0044] (5) The filtrate from step (1) and the aqueous extract from step (4) are combined and concentrated into a thick paste having a relative density of 1.33, to which the charcoal of thistle and malt charcoal from step (4) are added, dried and crushed, aspartame and dextrin as auxiliary materials are added, mixed, granulated, dried, granulated, sprayed with the volatile oil from step (2), granulated, and bagged to obtain granules (10 g per bag, totaling 100 g). Aspartame accounts for 0.25% of the total weight, and the remainder is dextrin.

[0045] Example 3: A Chinese medicine composition for treating heavy menstruation, wherein the Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0046]

[0047]

[0048] The preparation process is:

[0049] (1) Grind the weight parts of Vinegar Carapace and Sanguisorba officinalis into ultrafine powder, add Cuscuta chinensis, Ligustrum lucidum, Forsythia suspensa, Atractylodes macrocephala, and Trichosanthes fruit, add 90% ethanol, and reflux extract twice, add 20 times the amount for the first time and 10 times the amount for the second time, the first time for 2 hours and the second time for 1 hour, filter them separately, combine the filtrate, and use the filtrate and the medicinal residue for later use;

[0050] (2) Take the medicinal materials of Eclipta prostrata, Cyperus rotundus, Gentiana macrophylla, Scutellaria baicalensis, Angelica sinensis, Cyperus rotundus, Astragalus membranaceus, and Licorice root, soak them in 40°C hot water for 2 hours, extract the volatile oil using a volatile oil extractor, and set aside the volatile oil and the medicinal residue;

[0051] (3) Weigh the prepared portions of thistle charcoal and malt charcoal in Example 1 for later use;

[0052] (4) Take the medicinal residues from step (1) and step (2), add 10 volumes of water and extract twice, each time for 10 minutes, combine the two water extracts and set aside;

[0053] (5) The filtrate from step (1) and the aqueous extract from step (4) are combined and concentrated into a thick paste having a relative density of 1.30, to which the charcoal of thistle and the charcoal of malt from step (4) are added, dried and crushed, aspartame and dextrin as auxiliary materials are added, mixed, granulated, dried, granulated, sprayed with the volatile oil from step (2), granulated, and bagged to obtain granules (10 g per bag, totaling 100 g). Aspartame accounts for 0.25% of the total weight, and the remainder is dextrin.

[0054] Example 4: A Chinese medicine composition for treating heavy menstruation, wherein the Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0055]

[0056]

[0057] The preparation process is:

[0058] (1) Grind the weight parts of Carapace of Vinegar-Pickled Trionycis and Radix Sanguisorbae into ultrafine powder, add Cuscuta Seed, Ligustrum Lucidum Fruit, Forsythia suspensa, Atractylodes macrocephala, and Fructus Trichosanthis with 100% ethanol, and reflux extract twice, 30 times the amount for the first time and 20 times the amount for the second time, for 2 hours for the first time and 1 hour for the second time, filter them separately, combine the filtrates, and use the filtrate and the medicinal residue for later use;

[0059] (2) Take the medicinal materials of Eclipta prostrata, Cyperus rotundus, Gentiana macrophylla, Scutellaria baicalensis, Angelica sinensis, Cyperus rotundus, Astragalus membranaceus, and Licorice root, soak them in 55°C hot water for 2 hours, extract the volatile oil using a volatile oil extractor, and set aside the volatile oil and the medicinal residue;

[0060] (3) Weigh the prepared portions of thistle charcoal and malt charcoal in Example 1 for later use;

[0061] (4) Take the medicinal residues from step (1) and step (2), add 15% water and extract twice, each time for 20 minutes, combine the two water extracts and set aside;

[0062] (5) The filtrate from step (1) and the aqueous extract from step (4) are combined and concentrated into a thick paste having a relative density of 1.35, to which the charcoal of thistle and the charcoal of malt from step (4) are added, dried and crushed, aspartame and dextrin as auxiliary materials are added, mixed, granulated, dried, granulated, sprayed with the volatile oil from step (2), granulated, and bagged to obtain granules (10 g per bag, totaling 100 g). Aspartame accounts for 0.25% of the total weight, and the remainder is dextrin.

[0063] Comparative Example 1: A traditional Chinese medicine composition for treating heavy menstruation, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0064] Element Weight (g) Thistle charcoal 8 Eclipta prostrata 11 Cuscuta australis 9 Ligustrum lucidum 9 Mianma Guanzhong 9 Scutellaria baicalensis 17 Sanguisorba officinalis 15 Angelica 17 Cyperus rotundus 12 Forsythia 15 Vinegar-soaked turtle shell 5 Trichosanthes seeds 8 Gentiana macrophylla 12 Astragalus 25 Atractylodes macrocephala 25 Licorice 16

[0065] The preparation process refers to the process of Example 2.

[0066] Comparative Example 2: A traditional Chinese medicine composition for treating heavy menstruation, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0067]

[0068]

[0069] The preparation process refers to the process of Example 2, and the process of Sanguisorba officinalis charcoal refers to the preparation process of Cirsium truncatum charcoal.

[0070] Comparative Example 3: A traditional Chinese medicine composition for treating heavy menstruation, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0071] Element Weight (g) Thistle charcoal 4 Malt charcoal 11 Eclipta prostrata 5 Cuscuta australis 15 Ligustrum lucidum 15 Mianma Guanzhong 15 Scutellaria baicalensis 15 Sanguisorba officinalis 9 Angelica 10 Cyperus rotundus 17 Forsythia 22 Vinegar-soaked turtle shell 5 Trichosanthes seeds 15 Gentiana macrophylla 20 Astragalus 15 Atractylodes macrocephala 15 Licorice 11

[0072] The preparation process refers to the process of Example 2.

[0073] Comparative Example 4: A traditional Chinese medicine composition for treating heavy menstruation, wherein the traditional Chinese medicine composition is prepared from the following raw materials in parts by weight:

[0074]

[0075]

[0076] The preparation process refers to the process of Example 2.

[0077] 1. Statistical Analysis of Clinical Efficacy

[0078] 1 Research subjects

[0079] All cases were from patients with adenomyosis and menorrhagia who were admitted to our hospital between May 2024 and May 2025. Statistical analysis showed that the two groups were well balanced in terms of age, endometrial thickness, and basal hormone levels before the experiment, with no significant differences between the two groups and no significant differences between the two groups (P>0.05).

[0080] 2 Case selection

[0081] 2.1 Traditional Chinese Medicine Diagnostic Criteria

[0082] The criteria for Qi deficiency and blood stasis syndrome in the "Guidelines for the Diagnosis and Treatment of Common Gynecological Diseases in Traditional Chinese Medicine" require the presence of three or more of the primary symptoms (heavy, pale, and watery menstrual flow, or the presence of blood clots) and the secondary symptoms (pale and dull complexion; fatigue, shortness of breath, laziness to speak; poor appetite and loose stools; abdominal pain during menstruation; and anal distension), combined with the tongue and pulse (pale, distended tongue with teeth marks on the edges and tip, thin white fur, and a deep, wiry pulse) for a diagnosis.

[0083] 2.2 Western medicine diagnostic criteria

[0084] The relevant criteria for adenomyosis in the "Diagnosis and Treatment of Modern Obstetrics and Gynecology (9th Edition)" are accompanied by symptoms of menorrhagia and are confirmed by gynecological examinations. Inclusion criteria: (1) Patients who meet the above-mentioned diagnostic criteria of traditional Chinese medicine and Western medicine; (2) Patients aged 25 to 50 years, with normal menstrual cycles and not yet menopausal; (3) Patients who are informed and agree to the design of this study and voluntarily participate in the study; (4) Patients with good treatment compliance and no language communication barriers; (5) Patients who have not used drugs or other therapies for adenomyosis in the past 3 months.

[0085] 2.3 Exclusion criteria:

[0086] (1) Patients with ovarian malignant tumors, pelvic inflammatory masses, uterine fibroids, and primary dysmenorrhea; (2) Patients with menorrhagia caused by other reasons; (3) Patients with serious cardiovascular diseases, liver, kidney and hematopoietic system diseases; (4) Patients with allergic constitutions; (5) Pregnant and lactating women; (6) Patients with combined serious primary diseases and mental illnesses, etc.

[0087] 3 Treatment options

[0088] 3.1 Randomization

[0089] Control group: Oral administration of mifepristone tablets (specification: 25 mg, national medicine standard number H20143063, Beijing Farmostar Pharmaceutical Technology Co., Ltd.), 25 mg / time, once / d, starting time: the first day of each menstrual period, for three consecutive menstrual cycles.

[0090] Treatment group: granules prepared in Example 2, 10 g / time, 3 times / day starting from 1 week before menstruation, taken for 14 days, and continuously treated for 3 menstrual cycles.

[0091] The two groups used contraception during the treatment period.

[0092] 3.2 TCM Syndrome Indicators

[0093] TCM syndrome score Before and after treatment, the patients' TCM syndromes were evaluated according to relevant standards, including menstrual blood volume and menstrual blood color and quality (score range 0-6 points).

[0094] 3.3 Uterine indicators

[0095] Before and after treatment, the thickness of the endometrium and the length of each diameter of the uterus (anteroposterior diameter, superior-inferior diameter, and left-right diameter) were measured using a transvaginal color Doppler ultrasound diagnostic apparatus (GE, USA, model: LOGIQ E8).

[0096] 3.4 Comparison of endometrial thickness (mm)

[0097] Figure 1After treatment, the endometrial thickness of the experimental group was significantly higher than that of the control group, with a statistically significant difference (p < 0.05). This suggests that Chinese herbal medicine treatment may have a positive effect on the growth or recovery of the endometrium, which in turn demonstrates the significant therapeutic effect of the experimental composition of the present invention.

[0098] 4. Statistical Analysis

[0099] Statistical methods t test and The statistical software used in this study was SPSS 17.0. When P < 0.05, it indicates that the difference is significant.

[0100] 5. Results Analysis

[0101] 5.1 Menstrual volume score (points)

[0102] Table 1 Menstrual volume score (points, )

[0103]

[0104]

[0105] Note: @@There is a significant difference compared with before treatment (p<0.01); ## There was a significant difference compared with before treatment (p<0.05)

[0106] Table 1 shows that there was no significant difference in the scores between the two groups before treatment (p>0.05), indicating that the groups were balanced. After treatment, the menstrual volume was significantly reduced (p<0.01). At the same time, there was a significant difference between the control group and the experimental group after treatment (p<0.05).

[0107] 5.2 Menstrual period (d)

[0108] Table 2 Menstrual period (d, )

[0109] Before treatment After treatment control group 28 8.77±0.36 <![CDATA[6.11±0.58 @@ ]]> experimental group 28 8.92±0.29 <![CDATA[4.42±0.63 @@# ]]>

[0110] Note: @@ has significant difference compared with before treatment (p<0.01); # has significant difference compared with before treatment (p<0.05)

[0111] Table 2 shows that there was no significant difference in the scores between the two groups before treatment (p>0.05), indicating that the groups were balanced. After treatment, the number of days of menstruation was significantly reduced (p<0.01). At the same time, there was a significant difference between the control group and the experimental group after treatment (p<0.05).

[0112] 5.3 Endometrial thickness (mm)

[0113] Table 3 Endometrial thickness (mm, )

[0114] Before treatment After treatment control group 28 8.02±0.83 <![CDATA[5.89±0.65 @@ ]]> experimental group 28 8.01±0.79 <![CDATA[4.63±0.51 @@# ]]>

[0115] Note: @@ has significant difference compared with before treatment (p<0.01); # has significant difference compared with before treatment (p<0.05)

[0116] Table 3 shows that there was no significant difference in the scores between the two groups before treatment (p>0.05), indicating that the groups were balanced. After treatment, the endometrial thickness was significantly thinner (p<0.01). At the same time, there was a significant difference between the control group and the experimental group after treatment (p<0.05).

[0117] 2. The pharmacodynamics and clinical experimental designs of Examples 2-4 of the granules of the present invention are as follows:

[0118] Eighty female Kunming mice weighing 20 ± 2 g were obtained (license number: SYXK(Lu)20230031). All samples were collected and maintained at the Affiliated Hospital of Shandong University of Traditional Chinese Medicine. The mice were randomly divided into eight groups of 10 mice each. The housing environment was well-ventilated, with a temperature of 20–24°C and a relative humidity of 40%–79%. Animal care and sacrifice were conducted in accordance with the Guide for the Care and Use of Laboratory Animals.

[0119] 1.1 Blood coagulation time measurement experiment

[0120] 1.1.1 Coagulation time measurement experiment

[0121] Each group was gavaged three times a day, morning, noon, and evening, with 0.35 g / kg administered orally each time. The blank control group was gavaged with the same volume of normal saline daily. Forty minutes after administration on the third day, blood was collected from the mouse eye using a capillary glass tube with an inner diameter of 1 mm inserted into the medial canthus of the mouse eye to the posterior bulbar venous plexus. Blood was collected from a distance of more than 5 cm. A small section of the capillary glass tube was broken off every 15 seconds to check for the presence of blood clots. The time from blood collection to the appearance of blood clots was the clotting time. The time from blood collection to the appearance of blood clots was the clotting time.

[0122] 1.1.2 Coagulation time measurement experiment

[0123] After dosing on the fourth day, mice in each group were placed in a 20 ml syringe and sealed with tape to expose the tail. 40 minutes after dosing, the tail was cut 3 mm from the tip with sharp scissors. The timer was started after the blood overflowed by itself. The blood was absorbed with filter paper every 30 seconds until the bleeding stopped naturally (no blood was absorbed by the filter paper). This was the bleeding time.

[0124] 2. Statistical Analysis

[0125] The experimental data were analyzed using GraphPad Prism 9.0 statistical software, and the results were expressed as mean ± standard deviation. One-way ANOVA was used to analyze the differences between the groups, and P < 0.05 was considered statistically significant.

[0126] 3. Results Analysis

[0127] from Figure 1 and 2 As can be seen from the experimental data, Examples 2-4 demonstrated significantly superior technical effects in both hemostasis and coagulation compared to Comparative Examples 1-4. In terms of hemostasis time, the Example group had a significant therapeutic effect compared to the Comparative Example; coagulation time also showed a similar trend: the Example group was approximately 49%-52% shorter than the control group, with a significant difference (P < 0.05 or P < 0.01).

[0128] III. Pharmacological Efficacy Example 2 Study on the Ovarian Protective Effect of Example 2 on Improving Kidney Yin Deficiency in Rats

[0129] 1. Experimental Animals

[0130] SPF female Sprague-Dawley rats, weighing 60–70 g, 6–8 weeks of age, and weighing 180–220 g, were housed and collected at the Affiliated Hospital of Shandong University of Traditional Chinese Medicine under license number SYXK(Lu)20230031. The animals were housed in a well-ventilated environment maintained at a temperature of 20–24°C and a relative humidity of 40%–79%. Animal care and sacrifice were conducted in accordance with the Guide for the Care and Use of Laboratory Animals.

[0131] 2. Establishment of Kidney Yin Deficiency Model in Rats and Grouping and Drug Administration

[0132] After three days of adaptive feeding, vaginal cytology was performed on the rats starting at 8:00 AM daily. The rats were observed under a light microscope for one week, and 36 healthy female rats with regular estrous cycles were selected for the formal experiment. Twenty-four rats were randomly selected using a random number table to establish a kidney yin deficiency model in rats. These rats were given thyroid tablets (150 mg / kg / day) and reserpine (0.25 mg / kg / day) by gavage for 21 consecutive days. Successful modeling was considered achieved when the rats developed polydipsia, dark urine, or dry stools. The remaining 12 rats served as a blank control group and received an equal dose of normal saline by gavage daily for 21 consecutive days.

[0133] The rats with successful modeling were randomly divided into a model group and an Example 2 group, with 12 rats in each group. The rats in the Example 2 group were given the human equivalent dose of Example 2 by gavage. Each group received 0.18 g / kg of the drug three times daily, morning, noon, and evening. The blank control group and the model group received 2 ml of normal saline by gavage for 15 days. After the completion of the drug administration, the rats in each group were anesthetized and collected after metestrus. Four rats from each group were randomly selected for vascular perfusion. The remaining rats were bled from the abdominal aorta and sacrificed. The interspinal brown fat and uterus of the rats were removed, washed with normal saline, wiped dry, weighed, and fixed in 4% paraformaldehyde.

[0134] 3. Uterine and brown fat index measurement

[0135] The rat uterus and intervertebral brown fat were collected, and the uterine index and brown fat (BAT) index were calculated according to the following formula:

[0136] Uterine index = uterine wet weight (mg) / body weight (g) × 100%;

[0137] BAT index=brown fat wet weight (mg) / body weight (g)×100%.

[0138] 4. Statistical Processing

[0139] The experimental data were analyzed using GraphPad Prism 9.0 statistical software, and the results were expressed as mean ± standard deviation. One-way ANOVA was used to analyze the differences between the groups, and P < 0.05 was considered statistically significant.

[0140] 5. Results Analysis

[0141] from Figure 3 and Figure 4 As can be seen, the granules in Example 2 demonstrated significant technical advantages in regulating the uterine index and brown fat index. The uterine index in the model group was significantly lower than that in the blank control group (p < 0.05), indicating that the disease model was successfully established; while Example 2 restored the uterine index to near-normal levels, demonstrating its effectiveness in improving uterine pathology. The brown fat index in the model group was significantly higher than that in the blank control group (p < 0.05), while that in Example 2 returned to the normal range, demonstrating that this approach can bidirectionally regulate energy metabolism.

Claims

1. A Chinese medicine composition for treating heavy menstruation, characterized in that: The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 2-8 parts of thistle charcoal, 2-8 parts of malt charcoal, 10-20 parts of Ecliptae, 5-15 parts of Cuscuta seeds, 5-15 parts of Ligustrum lucidum fruits, 5-15 parts of Cyperus rotundus, 10-30 parts of Scutellaria baicalensis, 5-15 parts of Sanguisorba officinalis, 10-30 parts of Angelica sinensis, 1-9 parts of Cyperus rotundus, 1-9 parts of Forsythia suspensa, 1-9 parts of Vinegar-suckling Carapace, 1-9 parts of Trichosanthes fruits, 1-9 parts of Gentiana macrophylla, 5-15 parts of Astragalus membranaceus, 8-15 parts of Atractylodes macrocephala, and 10-25 parts of Licorice.

2. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 2 parts of thistle charcoal, 2 parts of malt charcoal, 10 parts of Ecliptae, 5 parts of Cuscuta seeds, 5 parts of Ligustrum lucidum fruits, 5 parts of Cyperus rotundus, 10 parts of Scutellaria baicalensis, 5 parts of Sanguisorba officinalis, 10 parts of Angelica sinensis, 1 part of Cyperus rotundus, 1 part of Forsythia suspensa, 1 part of Vinegar-suckling Carapace, 1 part of Trichosanthes fruit, 1 part of Gentiana macrophylla, 5 parts of Astragalus, 8 parts of Atractylodes macrocephala, and 10 parts of Licorice.

3. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 8 parts of thistle charcoal, 8 parts of malt charcoal, 20 parts of Ecliptae, 15 parts of Cuscuta seeds, 15 parts of Ligustrum lucidum fruits, 15 parts of Cyperus rotundus, 30 parts of Scutellaria baicalensis, 15 parts of Sanguisorba officinalis, 30 parts of Angelica sinensis, 9 parts of Cyperus rotundus, 9 parts of Forsythia suspensa, 9 parts of Vinegar-soaked Tricotide Carapace, 9 parts of Trichosanthes fruits, 9 parts of Gentiana macrophylla, 15 parts of Astragalus membranaceus, 15 parts of Atractylodes macrocephala, and 25 parts of Licorice.

4. The Chinese medicine composition according to claim 1, characterized in that The traditional Chinese medicine composition is prepared from the following raw materials in parts by weight: 5 parts of thistle charcoal, 5 parts of malt charcoal, 15 parts of Ecliptae, 10 parts of Cuscuta seeds, 10 parts of Ligustrum lucidum fruits, 10 parts of Cyperus rotundus, 20 parts of Scutellaria baicalensis, 10 parts of Sanguisorba officinalis, 20 parts of Angelica sinensis, 5 parts of Cyperus rotundus, 5 parts of Forsythia suspensa, 5 parts of Vinegar-suckling Carapace, 5 parts of Trichosanthes fruits, 5 parts of Gentiana macrophylla, 10 parts of Astragalus membranaceus, 10 parts of Atractylodes macrocephala, and 15 parts of Licorice.

5. The Chinese medicine composition according to any one of claims 1 to 4, characterized in that The traditional Chinese medicine composition and auxiliary materials are prepared into a pharmaceutical dosage form.

6. The Chinese medicine composition according to claim 5, characterized in that The drug dosage form is any one of granules, mixtures, decoctions, oral liquids and pills.

7. The Chinese medicine composition according to claim 1, characterized in that The heavy menstrual flow refers to ovulatory dysfunctional uterine bleeding.

8. The Chinese medicine composition according to any one of claims 1 to 4, characterized in that The heavy menstrual flow mentioned here refers to the heavy menstrual flow in patients with blood-heat syndrome.

9. The Chinese medicine composition according to claim 6, characterized in that The preparation process of the granules is as follows: (1) Grind the weight parts of Vinegar Carapace and Sanguisorba officinalis into ultrafine powder, add Cuscuta chinensis, Ligustrum lucidum, Forsythia suspensa, Atractylodes macrocephala, and Trichosanthes fruit, add 90% or more ethanol and reflux extract twice, add 20-30 times the amount for the first time and 10-20 times the amount for the second time, each time for 1-2 hours, filter separately, combine the filtrate, and use the filtrate and the residue for later use; (2) Take the medicinal materials of Eclipta prostrata, Cyperus rotundus, Gentiana macrophylla, Scutellaria baicalensis, Angelica sinensis, Cyperus rotundus, Astragalus membranaceus, and Licorice root, soak them in hot water at 40-55°C for 2 hours, extract the volatile oil using a volatile oil extractor, and set aside the volatile oil and the medicinal residue; (3) Weighing the prepared thistle charcoal and malt charcoal in parts by weight for later use; (4) Take the medicinal residues from step (1) and step (2), add 10-15 volume of water and extract twice, each time for 10-20 minutes, combine the two water extracts and set aside; (5) The filtrate of step (1) and the water extract of step (4) are combined and concentrated into a thick paste with a relative density of 1.30-1.35, the charcoal of thistle and malt charcoal of step (4) are added, dried and crushed, aspartame and dextrin excipients are added, mixed, granulated, dried, granulated, sprayed with the volatile oil of step (2), granulated, and bagged to obtain granules.

10. The Chinese medicine composition according to claim 6, characterized in that The preparation method of the citronella charcoal comprises the following steps: crushing and weighing the citronella charcoal and then putting it into a crucible; covering the crucible mouth with aluminum foil, closing the lid tightly, and placing the crucible in a muffle furnace for carbonization; heating the temperature from 25° C. to 70° C. for 10 minutes and maintaining the temperature at 70° C. for 15 minutes; then heating the temperature from 70° C. to 400° C. for 30 minutes and maintaining the temperature at 40 minutes; after cooling the temperature to 25-30° C., opening the door of the muffle furnace and taking out the crucible; boiling the citronella charcoal in a water bath with 10 times the amount of deionized water for 3 times, each time for 20 minutes, and then filtering and concentrating the charcoal with a 0.22 μm microporous filter membrane; and then dialysis the charcoal with deionized water as a dialysis medium, and purifying the concentrated solution with 100 μm of water. 0D dialysis membrane dialyze for 5 days, take out the solution in the bag, which is small thistle charcoal; the preparation process of malt charcoal: the malt is crushed and weighed and put into a crucible, the crucible mouth is covered with aluminum foil, the lid is tightly closed, and the carbonization is carried out in a muffle furnace from 25 ° C to 70 ° C, the heating process is 10 minutes, and it is maintained at 70 ° C for 15 minutes; then from 70 ° C to 400 ° C, the heating process is 30 minutes and maintained for 40 minutes, and after it is reduced to 25-30 ° C, the furnace door of the muffle furnace is opened and the crucible is taken out. The product in the crucible is malt charcoal; the malt charcoal is decocted in a water bath with 10 times the amount of deionized water for 3 times, each time for 20 minutes, and then filtered with a 0.22 μm microporous filter membrane and concentrated. Then, deionized water is used as the dialysis medium, and the concentrate is dialyzed with a 1000D dialysis membrane for 5 days, and the solution in the bag is taken out, which is malt charcoal.

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