Composition for relieving or improving premenstrual syndrome and pharmaceutical preparation

Abstract

The invention discloses a composition for relieving or improving premenstrual syndrome and a pharmaceutical preparation. The composition comprises vitamin B, mineral substances and plant extracts, according to the composition based on multi-mechanism synergy, natural components (such as Sanjiang berry and pleurotus citrinopileatus substances) with clear pharmacology are selected and scientifically matched with essential nutrients (calcium, magnesium and B vitamins), and three major core pathological links of hormone disorder, neurotransmitter imbalance and nutrition deficiency are synchronously regulated; the traditional Chinese medicine composition is used for solving the problem of hormone level disorder caused by premenstrual syndromes of women, relieving emotion and body discomfort symptoms caused by the premenstrual syndromes PMS and greatly relieving body, behavior and emotion symptoms caused by the premenstrual syndromes PMS, has no side effects in the prior art, and does not need hormone therapy or psychotropic drugs.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of medicine, in particular to a composition and a pharmaceutical preparation for relieving or improving premenstrual syndrome. BACKGROUND

[0002] Premenstrual syndrome (PMS) is a neuroendocrine disorder that occurs periodically in women of childbearing age, with a global incidence of up to 75-80%, of which 3-8% progress to severe premenstrual dysphoric disorder (PMDD). The clinical manifestations include emotional symptoms (anxiety, depression, irritability), somatic symptoms (breast pain, headache, edema) and behavioral cognitive disorders, resulting in a 45% increase in patient work absenteeism and a significant decrease in quality of life. Its pathogenesis is closely related to the changes in hormone levels during the menstrual cycle of women, especially the fluctuations in estrogen and progesterone, which can lead to neurotransmitter imbalance and physiological and psychological reactions in the body.

[0003] Currently, the treatment methods for premenstrual syndrome mainly include drug therapy and non-drug therapy. In terms of drug therapy, commonly used western medicines include antidepressants, anxiolytics, diuretics, etc., but these drugs often have certain side effects, such as drowsiness, dizziness, gastrointestinal discomfort, etc., and long-term use may cause adverse effects on the body. Hormonal drugs (such as oral contraceptives) may even cause thrombosis risk. Traditional Chinese medicines such as compound preparations (such as Xiaoyao San derivative) can soothe the liver and regulate qi, but have complex components, high standardization difficulty, and insufficient efficacy stability. Non-drug treatment methods include psychological therapy, dietary adjustment, exercise, etc., but these methods have limited effect and require long-term adherence by patients, making it difficult to meet the needs of patients for rapid relief of symptoms.

[0004] It can be seen that the existing PMS treatment technology has defects, mainly in the aspects of insufficient safety, single efficacy, and limited application scenarios.

[0005] From the perspective of safety, western medicines have significant side effects, such as electrolyte imbalance caused by diuretics, and increased liver and kidney function burden caused by long-term use of antidepressants; and some natural extracts (such as saw palmetto) even induce hot flashes and night sweats similar to menopausal syndrome.

[0006] Existing solutions mainly target a single mechanism (such as pain relief or mood regulation), lacking coordinated regulation of the "hormone-neurotransmitter-nutrient metabolism" multi-dimensional pathway; Chinese herbal compound (such as angelica, salvia) has multiple target effects, but the bioavailability of active ingredients is low, making it difficult to quantify the threshold for efficacy.

[0007] Prescription drugs require physician supervision, while food-based supplements (such as vitamin tablets) lack evidence-based medical support and have ambiguous efficacy claims. SUMMARY

[0008] The purpose of this invention is to provide a composition and pharmaceutical preparation for relieving or improving premenstrual syndrome (PMS). This invention is based on a multi-mechanism synergistic composition, which scientifically combines carefully selected pharmacologically known natural ingredients (such as chasteberry and golden pine nut) with essential nutrients (calcium, magnesium, and B vitamins) to simultaneously regulate the three core pathological links of hormonal imbalance, neurotransmitter imbalance, and nutritional deficiency. It can significantly alleviate the physical, behavioral, and emotional symptoms caused by PMS in women, without any of the side effects of existing technologies, and without requiring hormone therapy or psychotropic drugs.

[0009] In order to achieve the above-mentioned objectives of the present invention, the following technical solution is adopted:

[0010] The first aspect of the present invention provides a composition for relieving or improving premenstrual syndrome, the composition comprising B vitamins, minerals and plant extracts.

[0011] Preferably, the mass ratio of vitamins, minerals and plant extracts in group B is (1-10):(500-600):(50-70).

[0012] Preferably, the vitamins in group B are vitamin B6 and / or vitamin B12.

[0013] Preferably, the mass ratio of vitamin B6 to vitamin B12 is (40-60):1.

[0014] Preferably, the mineral is a magnesium salt and / or a calcium salt.

[0015] Preferably, the magnesium salt is magnesium glycine.

[0016] Preferably, the calcium salt is calcium citrate.

[0017] Preferably, the plant extract is chasteberry extract and / or golden top pine extract.

[0018] A second aspect of the present invention provides a pharmaceutical formulation for relieving or improving premenstrual syndrome, the pharmaceutical formulation comprising the composition and pharmaceutically acceptable excipients.

[0019] Preferably, the dosage form of the pharmaceutical preparation includes powder, granules, liquid preparation, capsules, and tablets.

[0020] Compared with the prior art, the beneficial effects of the present invention include at least the following:

[0021] This invention is based on a multi-mechanism synergistic composition. By carefully selecting pharmacologically known natural ingredients (such as chasteberry and golden pine needles) and scientifically combining them with essential nutrients (calcium, magnesium, and B vitamins), it simultaneously regulates three core pathological aspects: hormonal imbalance, neurotransmitter imbalance, and nutritional deficiency. It is used to solve the problem of hormonal imbalance caused by premenstrual syndrome (PMS) in women, and to alleviate the emotional and physical discomfort symptoms caused by PMS. It can significantly alleviate the physical, behavioral, and emotional symptoms caused by PMS in women, without any of the side effects of existing technologies, and without requiring hormone therapy or psychotropic drugs. Detailed Implementation

[0022] The embodiments of the technical solution of the present invention will be described in detail below with reference to the examples. The following embodiments are only used to illustrate the technical solution of the present invention more clearly, and are therefore only examples, and should not be used to limit the scope of protection of the present invention.

[0023] It should be noted that, unless otherwise stated, the technical or scientific terms used in this application should have the ordinary meaning as understood by one of ordinary skill in the art to which this invention pertains.

[0024] The inventors of this application have surprisingly discovered that by combining at least one B vitamin, mineral, and at least one plant extract in the form of the pharmaceutical composition of this invention, the physical, emotional, and behavioral symptoms of women affected by premenstrual syndrome (PMS) can be significantly reduced without the need for hormone therapy, administration of analgesics and antidepressants (which have known side effects such as stomach pain or ulcers and possible liver or kidney problems), and avoidance of any other invasive procedures.

[0025] Therefore, embodiments of the present invention provide a composition for relieving or improving premenstrual syndrome, the composition comprising B vitamins, minerals and plant extracts.

[0026] Unbound by any theoretical framework, the inventors have discovered that premenstrual syndrome (PMS) can be treated by counteracting its inflammatory state. Therefore, surprisingly, the compositions of this invention can alleviate the physiological, emotional, and physical symptoms of discomfort in women caused by PMS, yielding surprising results as shown in the experimental section.

[0027] In some embodiments, the mass ratio of the vitamins, minerals and plant extracts in group B is (1-10):(500-600):(50-70).

[0028] The compositions used in this invention contain at least one B vitamin. B vitamins are a diverse family of water-soluble vitamins with varied structures and functions. Most are nitrogen-containing organic compounds, including heterocyclic compounds (such as pyridine, imidazole, pyrimidine, and thiazole rings) and some containing aromatic or heterocyclic amine groups. They generally function as coenzymes or precursors of enzymes. Among the B vitamins according to this invention, vitamin B6 (pyridoxine) and vitamin B12 (cobalamin) are preferred; more preferably, vitamin B6 is in the form of pyridoxal phosphate, and vitamin B12 is in the form of methylcobalamin.

[0029] In some embodiments, the group B vitamins may be vitamin B6 and / or vitamin B12.

[0030] In some embodiments, the mass ratio of vitamin B6 to vitamin B12 can be (40-60):1.

[0031] In some embodiments, the mineral is a magnesium salt and / or a calcium salt.

[0032] In one embodiment, the magnesium salt is magnesium glycine.

[0033] In one embodiment, the calcium salt is calcium citrate.

[0034] In one embodiment, the mass ratio of magnesium glycine to calcium citrate is (5-7):5;

[0035] In some embodiments, the plant extract may be chasteberry extract and / or golden top pine extract.

[0036] In one embodiment, the mass ratio of chasteberry extract to golden pine extract is (4-6):1.

[0037] Another embodiment of the present invention provides a pharmaceutical formulation for relieving or improving premenstrual syndrome, the pharmaceutical formulation comprising the composition and pharmaceutically acceptable excipients.

[0038] The present invention does not impose strict limitations on the dosage form of the pharmaceutical preparation. Those skilled in the art can make conventional selections according to actual needs. In one embodiment, the dosage form of the pharmaceutical preparation can be powder, granules, liquid preparation, capsules or tablets.

[0039] In one embodiment, the pharmaceutically acceptable excipient includes an excipient selected from at least one of microcrystalline cellulose and magnesium stearate.

[0040] The technical solution of the present invention will be further described in detail below through specific embodiments.

[0041] The raw materials used in the following embodiments are as follows:

[0042] Chasteberry extract: sourced from Gansu Yishengxiang Biotechnology Co., Ltd.;

[0043] Golden Top Pleurotus ostreatus extract: sourced from Lanzhou Waterles Biotechnology Co., Ltd.

[0044] Example 1

[0045] This embodiment is a composition for relieving or improving premenstrual syndrome, the composition comprising B vitamins, minerals and plant extracts;

[0046] In Group B, the mass ratio of vitamins, minerals, and plant extracts is 1:500:50;

[0047] Group B vitamins consist of vitamin B6 and vitamin B12 in a mass ratio of 40:1;

[0048] The minerals are magnesium glycine and calcium citrate in a mass ratio of 1:1;

[0049] The plant extracts are chasteberry extract and / or golden top pine extract in a mass ratio of 4:1.

[0050] Example 2

[0051] This embodiment is a composition for relieving or improving premenstrual syndrome, the composition comprising B vitamins, minerals and plant extracts;

[0052] In Group B, the mass ratio of vitamins, minerals, and plant extracts is 10:600:70;

[0053] Group B vitamins consist of vitamin B6 and vitamin B12 in a mass ratio of 60:1;

[0054] The minerals are magnesium glycine and calcium citrate in a mass ratio of 7:5;

[0055] The plant extracts are chasteberry extract and / or golden top pine extract in a mass ratio of 6:1.

[0056] Example 3

[0057] This embodiment is a composition for relieving or improving premenstrual syndrome, the composition comprising B vitamins, minerals and plant extracts;

[0058] Among them, the mass ratio of vitamins, minerals and plant extracts in group B is 2.55:550:60;

[0059] Group B vitamins consist of vitamin B6 and vitamin B12 in a mass ratio of 50:1;

[0060] The minerals are magnesium glycine and calcium citrate in a mass ratio of 6:5;

[0061] The plant extracts are chasteberry extract and / or golden top pine extract in a mass ratio of 5:1.

[0062] Example 4

[0063] This embodiment is a pharmaceutical preparation for relieving or improving premenstrual syndrome. The pharmaceutical preparation includes the composition and excipients of Example 1, wherein the mass ratio of the composition to the excipients is 4:1.

[0064] According to parts by weight, the excipient consists of 60 parts microcrystalline cellulose and 5 parts magnesium stearate;

[0065] The above-mentioned pharmaceutical preparation is prepared by the following method:

[0066] The composition and excipients are mixed and then filled into capsules to obtain a pharmaceutical formulation in capsule form.

[0067] Example 5

[0068] This embodiment is a pharmaceutical preparation for relieving or improving premenstrual syndrome. The pharmaceutical preparation includes the composition and excipients of Example 2, wherein the mass ratio of the composition to the excipients is 5:1.

[0069] According to parts by weight, the excipient consists of 60 parts microcrystalline cellulose and 5 parts magnesium stearate;

[0070] The above-mentioned pharmaceutical preparation is prepared by the following method:

[0071] The composition and excipients are mixed and then filled into capsules to obtain a pharmaceutical formulation in capsule form.

[0072] Example 6

[0073] This embodiment is a pharmaceutical preparation for relieving or improving premenstrual syndrome. The pharmaceutical preparation includes the composition of Example 3 and excipients, wherein the mass ratio of the composition to the excipients is 4.5:1.

[0074] According to parts by weight, the excipient consists of 60 parts microcrystalline cellulose and 5 parts magnesium stearate;

[0075] The above-mentioned pharmaceutical preparation is prepared by the following method:

[0076] The composition and excipients are mixed and then filled into capsules to obtain a pharmaceutical formulation in capsule form.

[0077] Experimental Example

[0078] This experimental example is an efficacy test of the pharmaceutical formulation of the present invention in relieving premenstrual syndrome (PMS) in the form of capsules, as described in Example 6.

[0079] I. Experimental Subjects

[0080] A total of 60 cases were included in the clinical observation, with 40 cases in the treatment group and 40 cases in the control group. The patients were defined as those aged 18-40 years with premenstrual tension syndrome. The age, course of disease, and severity of disease were basically the same between the groups, with no significant differences, and the groups were comparable.

[0081] II. Experimental Methods

[0082] A randomized, double-blind, parallel-controlled trial was conducted. The treatment group received the pharmaceutical preparation of Example 1 (Example 6 of this invention), orally, one capsule twice daily for three weeks as one course of treatment, observed for three consecutive menstrual cycles. The control group received a placebo, orally, one capsule twice daily for three weeks as one course of treatment, observed for three consecutive menstrual cycles. All patients discontinued all medications and other treatments related to the treatment of this disease during the treatment period.

[0083] III. Diagnostic Criteria

[0084] To compare the effects of capsule use on patients, the Daily Symptom Severity Scale (DRSP) was used. Subjects were instructed to complete a daily questionnaire related to their symptoms using a semi-quantitative scale rated from 0 to 5 over the following three menstrual cycles. Each symptom was rated from 0 to 5.

[0085] The following scoring method will be used to measure the comparison before and after medication:

[0086] Asymptomatic = 0 points: No symptoms are present;

[0087] Very mild = 1 point: Symptoms exist but need to be actively discovered by oneself / reminded to discover them;

[0088] Mild = 2 points: Symptoms are present but can be ignored;

[0089] Moderate = 3 points: Symptoms can be clearly noticed by oneself;

[0090] Severe = 4 points: Affects daily life and work;

[0091] Extremely severe = 5 points: Severely affects daily life;

[0092] The patient's emotional and physiological symptoms are shown in Table 1;

[0093] Table 1

[0094]

[0095]

[0096] IV. Trial Case Criteria

[0097] 1. Inclusion criteria for cases

[0098] Patients aged 18-40 years who meet the diagnostic criteria for this disease can be included in the trial after signing an informed consent form. Among them, no fewer than two-thirds must have moderate to severe disease.

[0099] 2. Exclusion criteria

[0100] (1) Women under 18 years of age or over 40 years of age who are experiencing menstrual disorders during puberty or menopause, or who have allergies or are allergic to this drug.

[0101] (2) Patients with stage II or higher hypertension, visual impairment, vestibular dysfunction (Meniere's syndrome), breast tumors, chronic colitis or intestinal tumors could not be ruled out.

[0102] (3) Patients with serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system diseases, or mental illness.

[0103] (4) Those who do not meet the inclusion criteria, do not take medication as prescribed, cannot be judged on efficacy, or have incomplete data that affects the judgment of efficacy or safety.

[0104] 3. Criteria for Terminating the Test

[0105] (1) Patients who develop other serious complications during the trial.

[0106] (2) Patients who experience serious adverse reactions during the trial and whose trial should be stopped according to the doctor's judgment.

[0107] (3) Patients who failed to adhere to treatment for reasons other than therapeutic efficacy and voluntarily withdrew from the trial.

[0108] 4. Criteria for exclusion and dropout of cases

[0109] (1) Patients who were unable to complete the trial for any reason and withdrew from the trial midway, or who used drugs that were not allowed to be used together in this trial, were all dropout cases.

[0110] (2) Patients who are mistakenly included but do not meet the inclusion criteria of this clinical study protocol should be excluded.

[0111] 4. Criteria for Evaluating Therapeutic Effect

[0112] (1) Clinical cure: clinical symptoms disappear, clinical score recovers to 0, basal body temperature or endocrine test is basically normal, and there is no recurrence after 3 menstrual cycles after treatment.

[0113] (2) Significant effect: The main symptoms improved significantly, the clinical score dropped to less than 1 / 2 of the pre-treatment level, the basal body temperature or endocrine measurement was close to normal, and the condition did not worsen during the three menstrual cycles observed after the treatment.

[0114] (3) Effective: The main symptoms were controlled and the severity was reduced. The clinical score dropped to 1 / 2-3 / 4 of the pre-treatment score. Although some symptoms recurred after the treatment, they were less severe than before the treatment.

[0115] (4) Ineffective: Clinical symptoms do not improve or worsen.

[0116] V. Treatment results are shown in Tables 2 and 3:

[0117] Table 2

[0118]

[0119]

[0120]

[0121] Table 3

[0122]

[0123]

[0124]

[0125] From Tables 2 and 3, we can see that:

[0126] The results of the randomized, double-blind, parallel-controlled trial described in the examples demonstrate that the composition for alleviating or improving premenstrual syndrome (PMS) provided by this invention exhibits significantly superior clinical efficacy compared to placebo in practical applications. During observation over three complete menstrual cycles, in the placebo group, only a small percentage of patients experienced symptom relief to asymptomatic levels (score 0) in the main emotional symptoms such as depression, sadness, hopelessness, anxiety, mood swings, irritability, and loss of control. Most patients still exhibited moderate to severe symptoms (scores 2-4). For example, regarding "depression / sadness" symptoms, only 5 patients in the placebo group were completely asymptomatic, while after taking the composition of this invention, as many as 35 patients achieved asymptomatic relief, and the proportion of patients with moderate to severe symptoms (score 3 or higher) was extremely small, significantly better than the control group.

[0127] Regarding physiological symptoms, such as difficulty concentrating, breast tenderness, and headache, the number of asymptomatic patients in the placebo group was around 6, while about 30 patients taking the composition of this invention achieved a completely asymptomatic state, which was significantly higher than that in the placebo group, and the number of cases of severe and extremely severe symptoms was significantly reduced.

[0128] Comprehensive statistical results show that the composition of the present invention can simultaneously improve multiple dimensions of emotional and physiological symptoms. Subjects gradually changed from moderate to severe symptoms (most scores of 2 or above) in the early stage of treatment to mild or even no symptoms at all, significantly improving the patients' quality of daily life and work, and no obvious adverse reactions were observed.

[0129] Therefore, it can be seen that the present invention, through the scientific combination of B vitamins, magnesium, calcium and natural plant active ingredients such as chasteberry and golden oyster mushroom, can effectively regulate the hormone levels and neurotransmitter balance in PMS patients, exert multiple effects such as sedation, mood stabilization and relief of physical discomfort, and make up for the shortcomings of existing treatments such as insufficient safety, single mechanism and poor compliance, and has strong promotion and application value.

[0130] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention, and they should all be covered within the scope of the claims and specification of the present invention.

Claims

1. A composition for relieving or improving premenstrual syndrome, characterized in that, The composition includes group B vitamins, minerals, and plant extracts.

2. The composition according to claim 1, characterized in that, The mass ratio of vitamins, minerals and plant extracts in Group B is (1-10):(500-600):(50-70).

3. The composition according to claim 1 or 2, characterized in that, The vitamins in group B are vitamin B6 and / or vitamin B12.

4. The composition according to claim 3, characterized in that, The mass ratio of vitamin B6 to vitamin B12 is (40-60):

1.

5. The composition according to claim 1 or 2, characterized in that, The minerals are magnesium salts and / or calcium salts.

6. The composition according to claim 5, characterized in that, The magnesium salt is magnesium glycine.

7. The composition according to claim 5, characterized in that, The calcium salt is calcium citrate.

8. The composition according to claim 1, characterized in that, The plant extracts are chasteberry extract and / or golden top pine extract.

9. A pharmaceutical preparation for relieving or improving premenstrual syndrome, characterized in that, The pharmaceutical preparation comprises the composition of any one of claims 1 to 8 and pharmaceutically acceptable excipients.

10. The pharmaceutical preparation according to claim 9, characterized in that, The dosage forms of the pharmaceutical preparations include powders, granules, liquid preparations, capsules, and tablets.

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