A traditional Chinese medicine leijia composition for regulating hypomenorrhea, a preparation method and application thereof

Abstract

The application belongs to the field of medicine, and particularly relates to a traditional Chinese medicine Lijia composition for regulating oligomenorrhea, a preparation method and application thereof. The traditional Chinese medicine Lijia composition is combined according to the basic theory of monarch, minister, assistant and guide, and the medicinal property characteristics of Lijia, and can jointly play the effects of drying dampness, promoting blood circulation to remove blood stasis, invigorating the spleen and tonifying the kidney, and regulating the Chong and Ren meridians. After the patient takes the composition, the menstrual cycle can be prolonged, the PBAC score can be increased, the serum FSH and LH levels can be significantly reduced, the estradiol and progesterone can be significantly increased, and the oligomenorrhea symptoms of the patient can be significantly improved.

Description

Technical Field

[0001] This invention belongs to the field of medicine, specifically relating to a traditional Chinese medicine composition for regulating scanty menstruation, its preparation method, and its application. Background Technology

[0002] Oligomenorrhea is a common type of menstrual disorder, with an incidence rate of approximately 8.8%. This condition can adversely affect female fertility and significantly damage her physical and mental health. Depending on the stage of onset, oligomenorrhea occurring during puberty or reproductive years can progress to amenorrhea, while its occurrence during menopause often indicates the approaching menopause stage. The clinical characteristics of oligomenorrhea include a generally normal menstrual cycle, but significantly reduced menstrual flow (less than 5 ml), or even spotting; or a shortened menstrual period of less than two days with significantly reduced flow, severely impacting the patient's daily life and work capacity. For women of reproductive age, if effective intervention is not received in a timely manner, this condition has a high probability of developing into amenorrhea. Furthermore, due to decreased endometrial receptivity and insufficient nutritional support, it can lead to fertility problems, manifesting as infertility. Even if pregnancy is successful, it is prone to serious adverse pregnancy outcomes such as miscarriage or intrauterine fetal death due to abnormal endometrial microenvironment and insufficient supply of substances required for embryonic development. In clinical practice, oligomenorrhea often occurs secondary to various common gynecological diseases, such as intrauterine adhesions, polycystic ovary syndrome, thyroid dysfunction, hyperprolactinemia, and decreased ovarian reserve. Therefore, actively identifying and treating oligomenorrhea in a standardized manner is of great clinical significance for maintaining women's reproductive health and improving prognosis. Summary of the Invention

[0003] This invention provides a traditional Chinese medicine composition for treating scanty menstruation, its preparation method, and its application. It can significantly improve the symptoms of scanty menstruation, with rapid effect and high cure rate.

[0004] The technical solution of this invention is implemented as follows:

[0005] A traditional Chinese medicine composition for regulating scanty menstruation, each dose comprising the following components by weight: Atractylodes lancea 10-15g, Pinellia ternata 5-10g, Atractylodes macrocephala (fried) 10-15g, Sargentodoxa cuneata 10-20g, Salvia miltiorrhiza 10-20g, Ligusticum chuanxiong 5-15g, Fritillaria thunbergii 10-15g, Spatholobus suberectus 15-25g, Poria cocos 10-20g, Ficus hirta 15-25g, Crataegus pinnatifida 10-14g, Dipsacus asper 10-14g, Cuscuta chinensis 10-14g, Coix lacryma-jobi 20-40g, Angelica sinensis 5-15g, and Achyranthes bidentata 10-20g.

[0006] Furthermore, each dose of the aforementioned traditional Chinese medicine composition comprises the following components by weight: Atractylodes lancea 12g, Pinellia ternata 9g, Atractylodes macrocephala (fried) 12g, Sargentodoxa cuneata 15g, Salvia miltiorrhiza 15g, Ligusticum chuanxiong 10g, Fritillaria thunbergii 12g, Spatholobus suberectus 20g, Poria cocos 15g, Ficus hirta 20g, Crataegus pinnatifida 12g, Dipsacus asper 12g, Cuscuta chinensis 12g, Coix lacryma-jobi 30g, Angelica sinensis 10g, and Achyranthes bidentata 15g.

[0007] The preparation method of the aforementioned traditional Chinese medicine Li medicine composition includes the following steps:

[0008] Take the prescribed amounts of Atractylodes lancea, Pinellia ternata, stir-fried Atractylodes macrocephala, Sargentodoxa cuneata, Salvia miltiorrhiza, Ligusticum chuanxiong, Fritillaria thunbergii, Spatholobus suberectus, Poria cocos, Ficus hirta, Crataegus pinnatifida, Dipsacus asper, Cuscuta chinensis, Coix lacryma-jobi, Angelica sinensis, and Achyranthes bidentata, add water and decoct, then take the filtrate.

[0009] Furthermore, the amount of water added is 2-5 cm above the surface of the medicinal materials, the decoction time is 20-40 minutes, and the decoction is repeated 2-3 times.

[0010] A preparation for regulating scanty menstruation contains the above-mentioned traditional Chinese medicine Li medicine composition.

[0011] Furthermore, the preparation is an oral preparation, such as a decoction, granules, tablets, pills, capsules, etc.

[0012] The above-mentioned traditional Chinese medicine composition or preparation is used in the preparation of drugs for regulating scanty menstruation.

[0013] The above-mentioned traditional Chinese medicine composition or preparation is used in the preparation of preparations that reduce the TCM syndrome score of patients with oligomenorrhea, increase menstrual flow, prolong menstrual period, increase PBAC score, reduce follicle-stimulating hormone level, reduce luteinizing hormone level, increase estradiol level and / or increase progesterone level.

[0014] Furthermore, in the aforementioned application, the traditional Chinese medicine composition or preparation is taken once daily, divided into 2-3 doses, and discontinued during menstruation.

[0015] Furthermore, the aforementioned application refers to the use of the traditional Chinese medicine Li medicine composition or preparation in combination with Western medicine treatment.

[0016] Beneficial effects:

[0017] The traditional Chinese medicine composition of Li herbs described in this invention is based on the fundamental theories of the four roles of principal, assistant, adjuvant, and guide in traditional Chinese medicine, combined with the medicinal properties of Li herbs. Atractylodes lancea, Pinellia ternata, stir-fried Atractylodes macrocephala, and Spatholobus suberectus are the principal herbs, targeting the core pathogenesis of "phlegm-dampness and blood stasis" in this disease, playing a role in drying dampness, resolving phlegm, and clearing blood stasis. Atractylodes lancea and Pinellia ternata dry dampness and resolve phlegm to prevent the source of phlegm production; stir-fried Atractylodes macrocephala strengthens the spleen to aid in dampness resolution; Spatholobus suberectus clears heat, detoxifies, invigorates blood, and clears blood stasis. The four herbs combined remove phlegm-dampness and blood stasis in the uterus, directly addressing the key pathogenesis. Salvia miltiorrhiza, Ligusticum chuanxiong, Fritillaria thunbergii, and Spatholobus suberectus are the assistant herbs, assisting the principal herbs in invigorating blood, removing blood stasis, and promoting qi circulation. Salvia miltiorrhiza invigorates blood and regulates menstruation; Ligusticum chuanxiong is a qi-regulating herb in the blood, promoting qi and blood circulation; Fritillaria thunbergii clears heat, resolves phlegm, and dissipates nodules; Spatholobus suberectus nourishes blood, invigorates blood, and relaxes muscles and tendons. The four herbs work together to enhance the principal herb's ability to invigorate blood, remove blood stasis, resolve phlegm, and unblock the meridians, thus ensuring smooth blood flow and the proper menstrual flow. Poria, Ficus hirta, hawthorn, Dipsacus asper, Cuscuta chinensis, and Coix lacryma-jobi serve as adjuvant herbs, addressing both the root cause and symptoms of the disease, strengthening the spleen, eliminating dampness, and tonifying the kidneys. Poria and Coix lacryma-jobi strengthen the spleen and eliminate dampness, preventing its accumulation; Ficus hirta tonifies qi and strengthens the spleen; hawthorn promotes digestion, resolves stagnation, and invigorates blood, all working together to aid the spleen and stomach in their function and eliminate the source of phlegm. Dipsacus asper and Cuscuta chinensis tonify the liver and kidneys, regulate the Chong and Ren meridians, and strengthen the foundation of essence and blood. All the herbs work on the spleen and kidneys, supporting the body's vital energy to expel pathogens. Angelica sinensis and Achyranthes bidentata serve as guiding herbs, nourishing blood, regulating menstruation, and guiding blood downwards. Angelica sinensis tonifies and invigorates blood, regulates menstruation, and relieves pain, making it an essential herb in gynecology; Achyranthes bidentata tonifies the liver and kidneys, removes blood stasis, and unblocks menstruation, guiding all the herbs and qi and blood downwards directly to the uterus. The combined use of these two herbs harmonizes the effects of other herbs and guides the overall medicinal power of the formula to the Chong and Ren meridians, allowing menstrual blood to flow smoothly. This combination of herbs addresses both the root cause and symptoms, treating phlegm and blood stasis simultaneously, and employing a balanced approach of tonification and purgation. The formula uses herbs that dry dampness and resolve phlegm to treat the symptoms, herbs that strengthen the spleen and kidneys to address the root cause, and herbs that invigorate blood and unblock the meridians to promote blood circulation. The entire formula is based on the three major pathogenesis of "phlegm-dampness, blood stasis, and kidney deficiency." It clears the source by drying dampness and resolving phlegm, unblocks the pathways by invigorating blood and removing blood stasis, and replenishes the blood in the Chong and Ren meridians, ensuring that the blood in the Chong and Ren meridians is not obstructed, allowing the blood to overflow naturally and restoring regular menstruation. This combination fully embodies the TCM therapeutic principle of "treating the root cause by addressing the symptoms, and clearing the source by addressing the blockage." It targets patients with scanty menstruation who suffer from phlegm and blood stasis, kidney deficiency, and blood deficiency, achieving a synergistic effect of "unblocking" and "tonifying," ultimately treating both the root cause and symptoms, harmonizing the Chong and Ren meridians, and restoring normal menstrual flow. After taking the medication, patients experienced prolonged menstrual cycles, increased PBAC scores, significantly reduced serum FSH and LH levels, and significantly increased estradiol and progesterone levels, which significantly improved symptoms of oligomenorrhea. Detailed Implementation

[0018] The present invention will be further described below with reference to specific embodiments to better understand the invention. Where specific techniques or conditions are not specified in the embodiments, they shall be performed in accordance with the techniques or conditions described in the literature in this field or according to the product instructions. Reagents or instruments whose manufacturers are not specified are all conventional products that can be obtained commercially.

[0019] Example 1

[0020] A traditional Chinese medicine composition for regulating scanty menstruation, each dose comprising the following components by weight: Atractylodes lancea 10g, Pinellia ternata 5g, Atractylodes macrocephala (fried) 10g, Sargentodoxa cuneata 10g, Salvia miltiorrhiza 10g, Ligusticum chuanxiong 5g, Fritillaria thunbergii 10g, Spatholobus suberectus 15g, Poria cocos 10g, Ficus hirta 15g, Crataegus pinnatifida 10g, Dipsacus asper 10g, Cuscuta chinensis 10g, Coix lacryma-jobi 20g, Angelica sinensis 5g, Achyranthes bidentata 10g.

[0021] The preparation method of the aforementioned traditional Chinese medicine Li medicine composition includes the following steps:

[0022] Take the prescribed amounts of Atractylodes lancea, Pinellia ternata, Atractylodes macrocephala (fried), Sargentodoxa cuneata, Salvia miltiorrhiza, Ligusticum chuanxiong, Fritillaria thunbergii, Spatholobus suberectus, Poria cocos, Ficus hirta, Crataegus pinnatifida, Dipsacus asper, Cuscuta chinensis, Coix lacryma-jobi, Angelica sinensis, and Achyranthes bidentata. Add water to cover the herbs by 2-5 cm. Decoction for 20-40 minutes, repeat 2-3 times, and collect the filtrate.

[0023] Example 2

[0024] A traditional Chinese medicine composition for regulating scanty menstruation, each dose comprising the following components by weight: Atractylodes lancea 12g, Pinellia ternata 9g, Atractylodes macrocephala (fried) 12g, Sargentodoxa cuneata 15g, Salvia miltiorrhiza 15g, Ligusticum chuanxiong 10g, Fritillaria thunbergii 12g, Spatholobus suberectus 20g, Poria cocos 15g, Ficus hirta 20g, Crataegus pinnatifida 12g, Dipsacus asper 12g, Cuscuta chinensis 12g, Coix lacryma-jobi 30g, Angelica sinensis 10g, and Achyranthes bidentata 15g.

[0025] The preparation method of the aforementioned traditional Chinese medicine Li medicine composition includes the following steps:

[0026] Take the prescribed amounts of Atractylodes lancea, Pinellia ternata, Atractylodes macrocephala (fried), Sargentodoxa cuneata, Salvia miltiorrhiza, Ligusticum chuanxiong, Fritillaria thunbergii, Spatholobus suberectus, Poria cocos, Ficus hirta, Crataegus pinnatifida, Dipsacus asper, Cuscuta chinensis, Coix lacryma-jobi, Angelica sinensis, and Achyranthes bidentata. Add water to cover the herbs by 2-5 cm. Decoction for 20-40 minutes, repeat 2-3 times, and collect the filtrate.

[0027] Example 3

[0028] A traditional Chinese medicine composition for regulating scanty menstruation, each dose comprising the following components by weight: Atractylodes lancea 15g, Pinellia ternata 10g, Atractylodes macrocephala 15g, Sargentodoxa cuneata 20g, Salvia miltiorrhiza 20g, Ligusticum chuanxiong 15g, Fritillaria thunbergii 15g, Spatholobus suberectus 25g, Poria cocos 20g, Ficus hirta 25g, Crataegus pinnatifida 14g, Dipsacus asper 14g, Cuscuta chinensis 14g, Coix lacryma-jobi 40g, Angelica sinensis 15g, Achyranthes bidentata 20g.

[0029] The preparation method of the aforementioned traditional Chinese medicine Li medicine composition includes the following steps:

[0030] Take the prescribed amounts of Atractylodes lancea, Pinellia ternata, Atractylodes macrocephala (fried), Sargentodoxa cuneata, Salvia miltiorrhiza, Ligusticum chuanxiong, Fritillaria thunbergii, Spatholobus suberectus, Poria cocos, Ficus hirta, Crataegus pinnatifida, Dipsacus asper, Cuscuta chinensis, Coix lacryma-jobi, Angelica sinensis, and Achyranthes bidentata. Add water to cover the herbs by 2-5 cm. Decoction for 20-40 minutes, repeat 2-3 times, and collect the filtrate.

[0031] Example 4

[0032] A preparation for regulating scanty menstruation contains the aforementioned traditional Chinese medicine composition. The preparation is an oral preparation, such as a decoction, granules, tablets, pills, capsules, etc.

[0033] I. Clinical efficacy study of the composition described in this invention

[0034] 1. Clinical trials

[0035] 1.1 General Information

[0036] Seventy-two patients with oligomenorrhea who visited the First Affiliated Hospital of Hainan Medical University between April 2022 and May 2025 were randomly divided into a traditional Chinese medicine (TCM) group (n=36) and a control group (n=36). There were no statistically significant differences in menstrual cycle and other data between the two groups (P>0.05, see Table 1).

[0037]

[0038] Inclusion criteria: ① Western medicine diagnosis meeting the criteria of *Obstetrics and Gynecology* (10th edition), specifically no obvious abnormalities in the menstrual cycle, but menstrual flow <20mL or menstrual period <2 days, even spotting, and duration ≥3 menstrual cycles; ② Traditional Chinese medicine diagnosis meeting the diagnostic criteria for scanty menstruation in *Traditional Chinese Medicine Gynecology* (11th edition), including phlegm-blood stasis syndrome with scanty menstrual flow, dark color or blood clots, and irregular menstruation. Patients may be overweight or previously overweight but now thin, experiencing chest tightness, epigastric fullness, heaviness in the head and body, profuse white and thick vaginal discharge, or menstrual abdominal pain, stabbing pain aggravated by pressure. The tongue is purplish-dark or has petechiae or ecchymosis, the tongue coating is white and greasy or thick and greasy, and the pulse is wiry and slippery or deep and hesitant. ③ Patients accepted the study protocol and signed informed consent.

[0039] Exclusion criteria: ① Pregnant, lactating, or perimenopausal women; ② Women with organic lesions such as uterine fibroids, endometrial cancer, or intrauterine adhesions; ③ Women with endocrine disorders such as hyperthyroidism, diabetes, or Cushing's syndrome; ④ Women with dysfunction of vital organs such as the liver and kidneys; ⑤ Women with hematological diseases; ⑥ Women who have used medications that affect hormones or menstruation within the past 3 months; ⑦ Women with ovarian dysfunction.

[0040] 1.2 Intervention methods

[0041] Control group: Received conventional Western medicine treatment. Specifically, estradiol valerate tablets (Zhejiang Xianju Pharmaceutical, H20020299, 2mg), orally, 1mg once daily, starting on day 5 of menstruation for 21 consecutive days; progesterone capsules (Zhejiang Xianju Pharmaceutical, H20041902, 50mg), orally, 100mg once daily, starting on day 15 of menstruation for 10 consecutive days. One menstrual cycle constituted one course of treatment, with a total of 3 courses.

[0042] Traditional Chinese Medicine (TCM) Li Medicine Group: In addition to the treatment given to the control group, this group received a self-formulated TCM Li medicine compound prescription. The TCM Li medicine compound prescription consisted of: Atractylodes lancea 12g, Pinellia ternata 9g, Atractylodes macrocephala (fried) 12g, Sargentodoxa cuneata 15g, Salvia miltiorrhiza 15g, Ligusticum chuanxiong 10g, Fritillaria thunbergii 12g, Spatholobus suberectus 20g, Poria cocos 15g, Ficus hirta 20g, Crataegus pinnatifida 12g, Dipsacus asper 12g, Cuscuta chinensis 12g, Coix lacryma-jobi 30g, Angelica sinensis 10g, and Achyranthes bidentata 15g. Administration: Decocted in water, the filtrate is taken in 200mL doses twice daily, morning and evening, once a day. Medication was discontinued during menstruation. One menstrual cycle constituted one course of treatment, with a total of three courses.

[0043] 1.3 Evaluation of Clinical Efficacy

[0044] Clinical efficacy: Evaluation was conducted according to the *Standards for Diagnosis and Efficacy of Traditional Chinese Medicine Diseases and Syndromes*. Cure: Patient symptoms essentially disappeared, TCM syndrome score decreased by >90%, and menstrual flow returned to normal; Significant improvement: Symptoms significantly improved, 60% < TCM syndrome score reduction ≤90%, menstrual flow increased by >1 / 3; Effective: Symptoms improved, 30% < TCM syndrome score reduction ≤60%, and menstrual flow increased by <1 / 3; Ineffective: The above standards were not met. Total effective rate = (Number of cured cases + Number of significantly effective cases + Number of effective cases) / Total number of cases × 100%.

[0045] Traditional Chinese Medicine (TCM) syndrome scoring: After three courses of treatment, the main syndromes (scanty menstrual flow, dark purple menstrual blood with clots, menstrual cramps, chest tightness and epigastric fullness, and heaviness in the limbs) were quantitatively scored according to the "Standards for Diagnosis and Efficacy of TCM Diseases and Syndromes". A Likert 4-point scoring system was used, with scores ranging from 0 to 3 for "None", "Mild", "Moderate", and "Severe" respectively, and the total score was calculated. A higher score indicates a more severe condition.

[0046] Menstrual flow and period assessment: Menstrual flow was assessed using a Pictorial Blood Loss Assessment Chart (PBAC) during the last menstrual period before treatment and the first menstrual period after treatment. Assessment method: The same brand and size of sanitary napkins were used for all patients. The area of ​​blood staining on the sanitary napkin and the size of blood clots were measured during menstruation. Blood staining area: 1 point for <1 / 3, 5 points for 1 / 3–3 / 5, and 20 points for >3 / 5 of the sanitary napkin area; Blood clot size: 1 point for <1 yuan coin size and 5 points for ≥1 yuan coin size. All scores for the menstrual period were summed to obtain the total menstrual flow score. A score <25 was considered insufficient menstrual flow. Menstrual cycles and the number of days of menstruation were recorded for both groups before and after treatment.

[0047] Serum sex hormone levels: 5 mL of fasting peripheral venous blood was collected from the patient on the morning of day 7 of the menstrual cycle before treatment and during the third treatment course. Sample processing and detection methods were as follows: centrifugation at 3000 r / min, room temperature, centrifugation radius 10 cm, for 10 minutes. After serum separation, the samples were stored at -80℃. Follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), and progesterone (P) were detected using a chemiluminescent immunoassay analyzer (Roche, Cobas E601). The kits used were purchased from Beijing Jingmei Pharmaceutical Co., Ltd., and all procedures were strictly performed according to the manufacturer's instructions.

[0048] 1.4 Research Results

[0049] 1.4.1 Clinical efficacy

[0050] Retrospective study results (Tables 2 and 3) showed that, compared with conventional treatment, there was no significant difference in the overall clinical effective rate of this product for patients with oligomenorrhea (P > 0.05). However, the overall significant effective rate of this product was higher than that of the control group, and the difference was statistically significant (P < 0.05). There was no significant difference in TCM syndrome scores before treatment (P > 0.05). After treatment, both this product and conventional treatment significantly reduced the TCM syndrome scores of patients (P < 0.01), but the reduction in TCM syndrome scores was more significant with this product (P < 0.01).

[0051]

[0052]

[0053] 1.4.2 Clinical efficacy

[0054] The menstrual cycle, menstrual period, PBAC, and serum sex hormone levels of the two groups before and after treatment are shown in Tables 4 and 5. Before treatment, there were no significant differences in menstrual cycle, menstrual period, PBAC, and serum sex hormone levels (P > 0.05). After treatment, there were no significant changes in menstrual cycle in either group, but menstrual periods were significantly prolonged (P < 0.05), and PBAC scores increased (P < 0.05). This product was more effective than the conventional treatment group (P < 0.05). Serum sex hormone levels showed that after the intervention, serum FSH and LH levels in the Liang group were significantly reduced, while E2 and P levels were significantly increased (P < 0.05). This product was more effective than the conventional treatment group (P < 0.05). These results suggest that rapid onset of action, high cure rate, and good efficacy are potential advantages of this treatment regimen for oligomenorrhea.

[0055]

[0056]

[0057] II. Comparison of the therapeutic effects of the combination in animal experiments

[0058] Given that insufficient estrogen secretion due to ovarian insufficiency is one of the core pathogenesis of oligomenorrhea, this study used a classic rat model of ovarian insufficiency to evaluate the regulatory effects of the traditional Chinese medicine formula Li Yao Fang and its components on key hormone indicators in the model rats.

[0059] 2.1 Laboratory Animals

[0060] Fifty adult female Wistar rats, aged eight weeks and weighing 250±20g (purchased from Hunan Slack Jingda Experimental Animal Co., Ltd., quality certificate number: 430727201101514646), of SPF grade, were used. The animals were housed at the Animal Experiment Center of Hainan Medical University. All procedures and animal experiments were approved by the Ethics Committee of Hainan Medical University (2025 Animal Ethics Pre-review No.). <1138> Animals were housed at 20-25℃ and 50±5% humidity, with free access to food and water. All procedures and experiments were approved by the Ethics Committee of Hainan Medical University.

[0061] 2.2 Reagent and Drug Preparation

[0062] Reagents: Rat FSH, LH, E2, AMH enzyme-linked immunosorbent assay kit (Thermo Fisher Scientific, USA); chloral hydrate, liquid nitrogen, OCT embedding medium, ethanol-acetic acid-formaldehyde fixative, 1% ammonia, 0.7% eosin staining solution, 70% ethanol, 80% ethanol, 90% ethanol, xylene; physiological saline (Shenzhen Ruiward Life Science Technology Co., Ltd.). Cyclophosphamide for injection (Jiangsu Shengdi Pharmaceutical Co., Ltd.).

[0063] The traditional Chinese medicine granules were prepared at the First Affiliated Hospital of Hainan Medical University. The original formula consisted of: Atractylodes lancea 12g, Pinellia ternata 9g, Atractylodes macrocephala (fried) 12g, Sargentodoxa cuneata 15g, Salvia miltiorrhiza 15g, Ligusticum chuanxiong 10g, Fritillaria thunbergii 12g, Spatholobus suberectus 20g, Poria cocos 15g, Ficus hirta 20g, Crataegus pinnatifida 12g, Dipsacus asper 12g, Cuscuta chinensis 12g, Coix lacryma-jobi 30g, Angelica sinensis 10g, and Achyranthes bidentata 15g. Formula group 1 consisted of: Atractylodes lancea 12g, Pinellia ternata 9g, Atractylodes macrocephala (fried) 12g, Ligusticum chuanxiong 10g, Coix lacryma-jobi 30g, and Angelica sinensis 10g. Formula group 2 consisted of: Atractylodes lancea 12g, Pinellia ternata 9g, Atractylodes macrocephala (fried) 12g, Ligusticum chuanxiong 10g, Coix lacryma-jobi 30g, Angelica sinensis 10g, Ficus hirta 20g, and Spatholobus suberectus 20g. Formula 3: Atractylodes lancea 12g, Pinellia ternata 9g, Atractylodes macrocephala (fried) 12g, Sargentodoxa cuneata 15g, Salvia miltiorrhiza 15g, Ligusticum chuanxiong 10g, Fritillaria thunbergii 12g, Poria cocos 15g, Crataegus pinnatifida 12g, Dipsacus asper 12g, Cuscuta chinensis 12g, Coix lacryma-jobi 30g, Angelica sinensis 10g, Achyranthes bidentata 15g. The preparation method is the same as the general preparation method disclosed in this invention.

[0064] 2.3 Modeling and Intervention

[0065] After 3 days of acclimatization and 10 days of estrous cycle observation, 40 rats were randomly selected to establish an animal model of ovarian insufficiency via intraperitoneal injection of cyclophosphamide. The specific steps were as follows: On day 1 after acclimatization training, rats were injected intraperitoneally with 50 mg / kg cyclophosphamide. -1 Cyclophosphamide was administered, then the dose was reduced by half and injected once daily for one week. During the modeling period, rats were kept in sterile cages and allowed free access to food and movement. Vaginal smears were taken daily to observe the estrous cycle. Successful modeling was indicated when the estrous cycle of the modeling group rats became irregular and abnormal levels of sex hormones were detected in the serum. The remaining 10 rats served as the control group, receiving the same volume of physiological saline intraperitoneally daily throughout the modeling period. One week after modeling, the successfully modeled rats were randomly divided into four groups: model group, self-prescribed formula group, formula splitting group 1, formula splitting group 2, and formula splitting group 3. The dosage of the herbal medicine for the self-prescribed formula group, formula splitting group 1, formula splitting group 2, and formula splitting group 3 was calculated using the human-animal dosage conversion method. The blank group and model group received the same volume of physiological saline by gavage once daily for 30 consecutive days. Serum was collected from each group of rats.

[0066] 2.4 Detection

[0067] Serum samples from each group were thawed on ice and centrifuged at 12,000 r / min for 20 min (centrifugation radius 8.5 cm) at 4 ℃. The supernatant was collected. 1 mL of FSH, LH, E2, and FSH standards were added to standard tubes and allowed to stand for 10 min to dissolve completely. The samples were serially diluted 2-fold to prepare standards of different concentrations. After adding samples and sealing the plates, the plates were incubated at 37 ℃ for 90 min. After adding enzyme and washing, 100 μL of enzyme conjugate working solution was added to each well. The plates were then sealed and incubated at 37 ℃ for 30 min. After washing again, substrate solution was added, and the plates were sealed with a sealing membrane and incubated at 37 ℃ for 15 min for color development. The reaction was terminated by adding stop solution. The absorbance (OD value) of each well was measured at 450 nm within 15 min. A standard curve and standard equation were plotted, and the concentration of each sample was calculated.

[0068] 2.5 Results

[0069] The serum estrogen levels of rats in each group are shown in Table 6. After modeling, FSH and LH levels increased, while E2 and AMH levels decreased in SD rats (P < 0.05). Compared with the model group, the original formula group, the split formula group 1, split formula group 2, and split formula group 3 all restored serum estrogen levels in SD rats (P < 0.05). Compared with the original formula group, FSH and LH levels in split formula groups 1, 2, and 3 were increased to varying degrees, while E2 and AMH levels were significantly decreased (P < 0.05). Therefore, the original formula group showed better recovery effects than split formula groups 1, 2, and 3. The results of the animal experiment on split formula suggest that the rational combination of the medicinal materials in this product produced a synergistic effect, significantly enhancing the effect of restoring estrogen levels.

[0070]

[0071] The specific embodiments of the present invention have been described in detail above, but they are merely examples, and the present invention is not limited to the specific embodiments described above. For those skilled in the art, any equivalent modifications and substitutions to the present invention are also within the scope of the present invention. Therefore, all equivalent transformations and modifications made without departing from the spirit and scope of the present invention should be covered within the scope of the present invention.

Claims

1. A traditional Chinese medicine composition for regulating scanty menstruation, characterized in that, Each dose comprises the following components by weight: Atractylodes lancea 10-15g, Pinellia ternata 5-10g, Atractylodes macrocephala (fried) 10-15g, Sargentodoxa cuneata 10-20g, Salvia miltiorrhiza 10-20g, Ligusticum chuanxiong 5-15g, Fritillaria thunbergii 10-15g, Spatholobus suberectus 15-25g, Poria cocos 10-20g, Ficus hirta 15-25g, Crataegus pinnatifida 10-14g, Dipsacus asper 10-14g, Cuscuta chinensis 10-14g, Coix lacryma-jobi 20-40g, Angelica sinensis 5-15g, and Achyranthes bidentata 10-20g.

2. The traditional Chinese medicine composition for regulating scanty menstruation as described in claim 1, characterized in that, The aforementioned traditional Chinese medicine composition comprises the following components by weight per dose: Atractylodes lancea 12g, Pinellia ternata 9g, Atractylodes macrocephala (fried) 12g, Sargentodoxa cuneata 15g, Salvia miltiorrhiza 15g, Ligusticum chuanxiong 10g, Fritillaria thunbergii 12g, Spatholobus suberectus 20g, Poria cocos 15g, Ficus hirta 20g, Crataegus pinnatifida 12g, Dipsacus asper 12g, Cuscuta chinensis 12g, Coix lacryma-jobi 30g, Angelica sinensis 10g, and Achyranthes bidentata 15g.

3. A method for preparing the composition according to claim 1 or 2, comprising the following steps: Take the prescribed amounts of Atractylodes lancea, Pinellia ternata, stir-fried Atractylodes macrocephala, Sargentodoxa cuneata, Salvia miltiorrhiza, Ligusticum chuanxiong, Fritillaria thunbergii, Spatholobus suberectus, Poria cocos, Ficus hirta, Crataegus pinnatifida, Dipsacus asper, Cuscuta chinensis, Coix lacryma-jobi, Angelica sinensis, and Achyranthes bidentata, add water and decoct, then take the filtrate.

4. The preparation method according to claim 3, characterized in that, The amount of water added should be 2-5cm above the surface of the medicinal materials, the decoction time should be 20-40 minutes, and the decoction should be repeated 2-3 times.

5. A preparation for regulating scanty menstruation, characterized in that, It contains the composition according to claim 1 or 2.

6. The formulation as described in claim 5, characterized in that, The preparation described is an oral preparation.

7. The formulation according to claim 6, characterized in that, The oral preparations mentioned are decoctions, granules, tablets, pills, or capsules.

8. The use of the composition of claim 1 or 2 or the preparation of any one of claims 5-7 in the preparation of a preparation for regulating oligomenorrhea, reducing the TCM syndrome score of patients with oligomenorrhea, increasing menstrual flow, prolonging menstrual period, increasing PBAC score, reducing follicle-stimulating hormone level, reducing luteinizing hormone level, increasing estradiol level and / or increasing progesterone level.

9. The application as described in claim 8, characterized in that, The aforementioned traditional Chinese medicine composition or preparation is taken once daily, divided into 2-3 doses, and should be discontinued during menstruation.

10. The application as described in claim 8, characterized in that, The aforementioned traditional Chinese medicine composition or preparation is used in combination with Western medicine treatment.

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