A pharmaceutical composition for treating gynecological disorders, preparation and application thereof

Abstract

The application discloses a medicine composition for treating women's visceral excitement, and a preparation and application thereof, and belongs to the field of traditional Chinese medicines. The medicine composition is composed of the following components in parts by weight: 20-40 parts of lily, 13-26 parts of prepared rehmannia, 13-26 parts of ginseng, 5-10 parts of white peony root, and 15-30 parts of Wanzhenshen. The medicine composition can be added with pharmaceutically acceptable excipients to prepare a preparation. The medicine composition and the preparation can be used for treating women's visceral excitement.

Description

Technical Field

[0001] The present invention belongs to the field of traditional Chinese medicine, and particularly relates to a pharmaceutical composition for treating hysteria in women, its preparations and applications. Background Art

[0002] Hysteria is caused by insufficiency of yin in the viscera, disharmony of visceral qi, and confusion of the mind. Clinically, it is a type of mental disorder manifested as mental trance, crying with grief, frequent yawning, excessive thinking, mood swings, restlessness, sighing, sleep disorders, transient flushing and sweating, or palpitations. "Emotional disorders", "menopausal or perimenopausal emotional disorders", "menopausal or perimenopausal syndrome" and other diseases with the above manifestations in Western medicine can be treated by syndrome differentiation.

[0003] In recent years, both modern medicine and traditional medicine have been committed to researching the clinical diagnosis and treatment of such diseases in order to achieve better treatment effects. With the acceleration of the pace of life and the increase of social pressure, the incidence of hysteria has gradually increased, and emotional changes in perimenopausal women are more common. At present, hormone therapy is the main means for the mental and psychological symptoms of perimenopausal syndrome in Western medicine, and sedatives, antidepressants, and anti-anxiety drugs are also commonly used drugs. However, these drugs have many contraindications, limited scope of applicable populations, and need to be strictly evaluated before use. In addition, the adverse reactions and side effects of the drugs are relatively large. For example, hormone therapy may increase the risk of breast cancer and endometrial cancer, and sedatives, antidepressants, and anti-anxiety drugs often cause adverse reactions of gastrointestinal disorders. Therefore, developing a drug with a wide range of applicable populations and high safety for treating hysteria (perimenopausal syndrome) is required in the industry. The inventor summarized years of clinical experience in traditional Chinese medicine and achieved good clinical efficacy in treating hysteria with the composition of the present invention, which has a wide range of applicable populations and high safety. Summary of the Invention

[0004] Aiming at the deficiencies of the existing technology, the purpose of the present invention is to provide a pharmaceutical composition for treating hysteria in women, its preparations and applications. The pharmaceutical composition described in the present invention has a good therapeutic effect on hysteria in women.

[0005] The purpose of the present invention is achieved through the following technical solutions:

[0006] A pharmaceutical composition for treating hysteria in women, comprising the following components in parts by weight: 20 - 40 parts of lilium brownii, 13 - 26 parts of processed polygonum multiflorum, 13 - 26 parts of ginseng, 5 - 10 parts of white peony root, and 15 - 30 parts of crepis lignea.

[0007] Preferably, the pharmaceutical composition for treating hysteria in women comprises the following components in parts by weight: 25 - 35 parts of lilium brownii, 16 - 23 parts of processed polygonum multiflorum, 16 - 23 parts of ginseng, 6 - 9 parts of white peony root, and 18 - 26 parts of crepis lignea.

[0008] Preferably, the pharmaceutical composition for treating hysteria in women comprises the following components in parts by weight: 28-32 parts of lily bulb, 18-20 parts of prepared Polygonum multiflorum, 18-20 parts of ginseng, 7-8 parts of white peony root, and 20-23 parts of *Polygonum multiflorum*.

[0009] The formulation of the pharmaceutical composition for treating hysteria in women is prepared by adding pharmaceutically acceptable excipients to the pharmaceutical composition. Preferably, the formulation is in the form of a decoction, granules, capsules, or pills prepared according to conventional methods.

[0010] The pharmaceutical composition and preparation described above for treating hysteria in women can be used to prepare a medicine for treating hysteria in women.

[0011] Irritability is caused by insufficient Yin in the internal organs, with insufficient Yin in the heart being the primary cause. This invention heavily utilizes lily bulb as the principal ingredient. Lily bulb is sweet and cold in nature, enters the heart meridian, and has the effect of nourishing heart Yin and calming the mind. Irritability is caused by deficiency of essence and blood, leading to insufficient nourishment of the five internal organs. Prepared Polygonum multiflorum, ginseng, and white peony root are used as assistant ingredients. Prepared Polygonum multiflorum enters the heart, liver, and kidney meridians, replenishing liver and kidney Yin, benefiting essence and blood, and assisting the principal ingredient in nourishing Yin. Ginseng enters the heart and kidney meridians, nourishing blood and calming the mind, assisting the principal ingredient in calming the mind. White peony root nourishes blood and astringes Yin. These three assistant ingredients work together to assist the principal ingredient. This formula has the effects of nourishing essence and blood, replenishing true yin, and calming the mind. Yunnan is known as the "Kingdom of Plants" and is rich in medicinal plant resources. This formula uses Wan Zhang Shen, a traditional Yunnan ethnic medicine, as an adjuvant. It is sweet and neutral in taste and very warm in nature. The "Diannan Materia Medica" records that it is "non-toxic and treats various deficiencies and injuries, five types of fatigue and seven types of injury, qi and blood deficiency, dizziness, tinnitus, palpitations and anxiety." Wan Zhang Shen has the effect of replenishing deficiency. In this formula, it can assist other herbs in replenishing heart yin and nourishing essence and blood. The whole formula is simple and effective, and together they can achieve the effects of nourishing heart yin and calming the mind.

[0012] Compared with the prior art, the beneficial effects of the present invention are as follows:

[0013] 1. Definite clinical efficacy: The total effective rate of the drug composition of this invention in treating hysteria (perimenopausal syndrome) in women reached 93.3% (60 cases in clinical observation), of which the cure rate was 25% and the significant efficacy rate was 43.3%. Specific cases show that it significantly improves the core symptoms such as "sadness and wanting to cry, hot flashes and sweating, insomnia and palpitations".

[0014] 2. High safety and wide applicability: In a clinical observation of a total of 60 patients over 4 treatment courses (64 days), no drug-related adverse reactions such as liver or kidney damage or gastrointestinal disturbances occurred in any of them (see safety observation results for details). Compared with existing hormone therapies that may increase the risk of breast cancer and antidepressants that commonly cause gastrointestinal reactions, the composition of this invention provides a safer option for patients who are not suitable for or do not wish to receive hormone / psychiatric drug treatment.

[0015] 3. Innovative Formula: This invention breaks through the traditional approach of treating hysteria in women with "Gan Mai Da Zao Tang" and other similar formulas. For the first time, it combines the Yunnan ethnic folk medicine "Wan Zhang Shen" (the root of Crepis lignea in the Asteraceae family) with lily, prepared Polygonum multiflorum, ginseng, and white peony root. The whole formula works together to nourish the heart yin and calm the mind, reflecting the combination of ethnic medicine and modern TCM theory. Detailed Implementation

[0016] The present invention will be further described below with reference to the embodiments, but the present invention is not limited to the embodiments.

[0017] Example 1

[0018] A pharmaceutical composition for treating hysteria in women, comprising the following components: 30g of lily bulb, 20g of prepared Polygonum multiflorum, 20g of ginseng, 8g of white peony root, and 25g of *Smilax china*.

[0019] Example 2

[0020] A pharmaceutical composition for treating hysteria in women, comprising the following components: 20g of lily bulb, 13g of prepared Polygonum multiflorum, 13g of ginseng, 5g of white peony root, and 15g of *Smilax china*.

[0021] Example 3

[0022] A pharmaceutical composition for treating hysteria in women, comprising the following components: 40g of lily bulb, 26g of prepared Polygonum multiflorum, 26g of ginseng, 10g of white peony root, and 30g of *Smilax china*.

[0023] Example 4

[0024] A formulation of a pharmaceutical composition for treating hysteria in women, comprising taking any one of the pharmaceutical compositions described in Examples 1-3 and mixing all the ingredients to prepare a decoction, granules, capsules or pills or other preparations.

[0025] Example 5

[0026] A capsule formulation of a pharmaceutical composition for treating hysteria in women is prepared according to the following steps:

[0027] (1) Mix all the medicinal ingredients together, grind them into a fine powder, and pass them through an 80-mesh sieve;

[0028] (2) Use a powder drying sterilizer to sterilize at 120°C for 25 minutes;

[0029] (3) After sterilization, the drying stage begins, with a drying time of 30 minutes (the temperature is reduced from 120℃ to 60℃).

[0030] (4) After drying, the fine powder is passed through a 16-mesh sieve, mixed evenly, and then filled into capsule shells to obtain the final product.

[0031] Application Example—Clinical observation of the use of the pharmaceutical composition of the present invention in the treatment of hysteria in women.

[0032] I. Research Methods

[0033] Patients who met the inclusion criteria for perimenopausal syndrome within the past two years were selected and treated with the drug composition described in this invention. The clinical efficacy and adverse reactions were observed.

[0034] II. Research Subjects

[0035] Patients with hysteria in women (perimenopause syndrome).

[0036] III. Diagnostic Criteria

[0037] (I) Traditional Chinese Medicine Diagnostic Criteria (Guidelines for the Diagnosis and Treatment of Zang-Zao in Traditional Chinese Medicine)

[0038] Refer to the "Guidelines for Clinical Diagnosis and Treatment of Mental Disorders in Traditional Chinese Medicine" and "Traditional Chinese Medicine Mental Disorders", etc.

[0039] Main symptoms: mental confusion, sadness and wanting to cry, frequent yawning, and excessive thinking;

[0040] Secondary symptoms: such as mood swings, restlessness, sighing, insomnia, transient hot flashes and sweating, or palpitations.

[0041] Medical history, triggers, and high-risk groups: Many patients have a history of recurrent attacks, which are often triggered by emotional stress or unfavorable factors. It is often related to physical constitution and is more common in women, but can also occur in men, especially in menopausal or perimenopausal age groups. A definitive diagnosis can be made by considering the main symptoms, secondary symptoms, medical history, and triggers.

[0042] (II) Western Medicine Diagnostic Criteria

[0043] Referring to the diagnostic criteria for perimenopausal syndrome in the ninth edition of Obstetrics and Gynecology:

[0044] (1) Medical history

[0045] (2) Symptoms

[0046] Menstrual disorders: irregular menstrual cycles, prolonged menstrual periods, and increased or decreased menstrual flow.

[0047] Vasomotor symptoms: The main symptom is hot flashes, characterized by repeated, brief episodes of redness on the face, neck, and chest, accompanied by heat, followed by sweating, which generally lasts 1-3 minutes.

[0048] Symptoms of autonomic nervous system dysfunction: Common symptoms include palpitations, dizziness, headache, insomnia, and tinnitus.

[0049] Neuropsychiatric symptoms: often manifested as poor concentration and large mood swings, such as agitation, irritability, anxiety, depression, and inability to control oneself.

[0050] Urogenital symptoms: mainly manifested as atrophy of the urogenital tract, including vaginal dryness, difficulty in sexual intercourse, and recurrent vaginal infections, as well as recurrent urinary tract infections such as difficulty urinating, painful urination, and urinary urgency.

[0051] Osteoporosis: Half of women over 50 will develop postmenopausal osteoporosis, which usually occurs within 5-10 years after menopause.

[0052] (3) Laboratory tests

[0053] Serum FSH and E levels: During the menopausal transition, a serum FSH level >10 U / L indicates decreased ovarian reserve. Amenorrhea, FSH >40 U / L, and E <10-20 pg / ml indicate ovarian failure.

[0054] Anti-Miller hormone (AMH) measurement: AAMH levels as low as 1.1 ng / ml indicate decreased ovarian reserve; levels below 0.2 ng / ml indicate impending menopause; AMH is generally undetectable after menopause.

[0055] In clinical practice, diagnosis is not difficult based on the patient's medical history and clinical manifestations, and laboratory tests can help in the diagnosis.

[0056] IV. Inclusion Criteria

[0057] 1. Meets the diagnostic criteria of Traditional Chinese Medicine;

[0058] 2. Meets the diagnostic criteria of Western medicine and presents with neuropsychiatric symptoms as the main clinical manifestation;

[0059] 3. Women aged 45-60;

[0060] 4. Patients who sign the informed consent form for treatment, follow the doctor's instructions for the course of treatment, and cooperate with follow-up visits.

[0061] V. Exclusion Criteria

[0062] (1) Patients currently taking hormone medications, patients with mental illnesses, cancer patients, etc.;

[0063] (2) Patients with liver damage, acute or chronic renal failure, renal insufficiency, etc. who are not suitable for taking the medication;

[0064] (3) History of allergy to the drugs used in this trial or history of liver damage;

[0065] (4) Those who are pregnant or have plans to become pregnant within the past six months.

[0066] VI. Elimination Criteria

[0067] (1) Patients who suddenly develop other illnesses and need to terminate treatment;

[0068] (2) Physical discomfort, drug allergy, or liver damage caused by taking the medication;

[0069] (3) Failure to take medication on time, failure to follow doctor's orders, and poor compliance affect the efficacy of the medication;

[0070] (4) Those who are unable to continue treatment due to their own reasons.

[0071] VII. Dosage (Capsules)

[0072] Oral administration. Take 4-8 pills 3 times a day. One course of treatment is 2 weeks, and 4 courses of treatment are required.

[0073] VIII. Criteria for Evaluating Therapeutic Effect

[0074] Formulated with reference to the efficacy evaluation standards of the "Guiding Principles for Clinical Research of New Traditional Chinese Medicine Drugs":

[0075] The efficacy index N = (pre-treatment score - post-treatment score) / pre-treatment score × 100% (nimodipine method);

[0076] Cure: Clinical symptoms have basically improved, and the efficacy index is ≥95%;

[0077] Significantly effective: Clinical symptoms are significantly improved, with 70% ≤ efficacy index < 95%;

[0078] Effective: Clinical symptoms improved, with 30% ≤ efficacy index < 70%;

[0079] Ineffective: No improvement in clinical symptoms, efficacy index <30%;

[0080] Overall effective rate = (cured + significantly effective + effective) / total number of cases × 100%.

[0081] IX. Summary of Clinical Efficacy

[0082] This study observed a total of 60 valid cases. Among them, 18 were aged 45-50 years, 22 were aged 50-55 years, and 10 were aged 55-60 years.

[0083] The pharmaceutical composition described in this application was used to treat 60 women with hysteria. After four courses of treatment (64 days), 15 cases (25%) were cured, 26 cases (43.3%) showed significant improvement, 15 cases (25%) showed improvement, and 4 cases (6.7%) showed no improvement. The total effective rate was 93.3% (see Table 1).

[0084] Table 1. Statistical Table of Clinical Efficacy

[0085]

[0086] 10. Case Studies

[0087] 1. Ms. Li, 57 years old, presented on May 21, 2023, with a history of "low mood, hot flashes and excessive sweating, and insomnia for six months." She reported experiencing frequent low moods without any obvious cause for the past six months, sometimes feeling sad and wanting to cry. She also experienced hot flashes and sweating in the afternoon and at night, difficulty falling asleep, frequent awakenings during the night, and daytime mental confusion. She had previously consulted a tertiary hospital and was diagnosed with "perimenopausal syndrome," receiving hormone therapy. However, the side effects were significant, and the symptoms recurred after discontinuation of the medication. She then sought treatment from Traditional Chinese Medicine (TCM). Current symptoms include: low mood, frequent feelings of sadness and wanting to cry, hot flashes and sweating in the afternoon and at night, difficulty falling asleep and frequent awakenings at night, daytime mental confusion, normal bowel movements, poor appetite, red tongue tip, white tongue coating, and a deep, wiry pulse. She had no significant past medical history. The TCM diagnosis was "hysteria in women." The drug composition described in Example 3 was prepared into capsules according to the preparation method in Example 5. After four courses of treatment, the patient reported that her symptoms had largely disappeared. A one-month follow-up showed no recurrence.

[0088] 2. Ms. Xiong, 48 years old, presented on October 22, 2023, with a history of "irritability, hot flashes and sweating, and lethargy for over three months." She reported that three months prior, she had an argument over family matters, after which she gradually began experiencing mood swings, irritability, hot flashes and sweating, especially during the day and night, frequent insomnia, vivid dreams, and lethargy upon waking. She had previously consulted a hospital and undergone various examinations (reports unavailable, details unknown), but no substantial lesions were found. The doctor diagnosed her with "perimenopausal syndrome" and recommended oral medication. Unwilling to undergo Western medicine treatment, she sought traditional Chinese medicine treatment at the outpatient clinic. Her current symptoms include: unstable emotions, alternating periods of irritability and depression, frequent sighing, hot flashes and sweating during the day and night, insomnia and vivid dreams, lethargy upon waking, frequent fatigue, constipation, normal urination, poor appetite, pale tongue with yellow coating, and a deep, wiry pulse. She had no significant past medical history. The patient was diagnosed with "hysteria in women" according to traditional Chinese medicine. The drug composition of Example 1 was prepared into capsules according to the preparation method of Example 5. After 4 courses of treatment, the patient reported significant improvement in symptoms.

[0089] 3. Ms. Zhang, 54 years old, presented on December 18, 2023, with a history of "depression, insomnia, and palpitations for one year." She reported experiencing insomnia, frequent awakenings at night, hot flashes and sweating, daytime fatigue, and frequent palpitations after menstrual irregularities began a year prior. She had previously consulted a county hospital (no examination report available) and was treated with sleeping pills, which provided some relief. However, the symptoms recurred after discontinuing the medication, and she frequently experienced depression, fatigue, and dizziness. She then consulted a tertiary hospital, where hormone tests and other examinations led to a diagnosis of "perimenopausal syndrome." Hormone therapy improved her menstrual irregularities, but the depression, insomnia, and palpitations did not significantly improve. She then sought traditional Chinese medicine treatment at the outpatient clinic. Current symptoms include: depression, insomnia with hot flashes and sweating, daytime fatigue, occasional palpitations, frequent fatigue, loose stools, normal urination, normal appetite, pale red tongue with white coating, and a thready, wiry pulse. She has no significant past medical history. The patient was diagnosed with "hysteria in women" using traditional Chinese medicine. The drug composition of Example 3 was prepared into capsules according to the preparation method of Example 5. After 4 courses of treatment, the patient's symptoms improved. After 2 more courses of treatment, the patient's symptoms basically disappeared. A follow-up of 1 month showed no recurrence.

[0090] The above cases are only a portion of those observed in clinical practice, and the drug compositions used are only a portion of those compositions. In actual clinical use, the dosage of specific drugs in the drug compositions can be arbitrarily selected within the scope of this invention, depending on the different clinical symptoms of the patients.

Claims

1. A pharmaceutical composition for treating hysteria in women, characterized in that, By weight, it consists of the following components: 20-40 parts lily bulb, 13-26 parts prepared Polygonum multiflorum, 13-26 parts ginseng, 5-10 parts white peony root, and 15-30 parts deep-rooted herbs.

2. A formulation of the pharmaceutical composition for treating hysteria in women according to claim 1, characterized in that, The pharmaceutical composition is formulated by adding pharmaceutically acceptable excipients.

3. The formulation of the pharmaceutical composition for treating hysteria in women according to claim 2, characterized in that, The preparation is a decoction, granules, capsules, or pills.

4. A method for preparing a capsule of the pharmaceutical composition for treating hysteria in women as described in claim 3, characterized in that, Includes the following steps: (1) Mix all the medicinal ingredients together, grind them into a fine powder, and pass them through an 80-mesh sieve; (2) Use a powder drying sterilizer to perform moist heat sterilization at 118℃~123℃ for 25-30 minutes; (3) After sterilization, proceed to the drying stage, drying time 25-35 minutes until the temperature drops to 60℃; (4) After drying, the fine powder is passed through a 14-16 mesh sieve, mixed evenly, and then filled into capsule shells to obtain the final product.

5. The use of the pharmaceutical composition of claim 1 for treating hysteria in women in the preparation of a medicament for treating hysteria in women.

6. The use of a formulation of the pharmaceutical composition for treating hysteria in women according to claim 2 in the preparation of a medicament for treating hysteria in women.

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