An anti-premature ovarian failure nursing composition, an anti-premature ovarian failure nursing solution and a preparation method thereof

Abstract

The present invention belongs to the technical field of pharmaceutical preparations, and specifically relates to an anti-premature ovarian failure nursing composition, an anti-premature ovarian failure nursing solution and a preparation method thereof. The composition comprises the following components in parts by weight: 0.5-4 parts of ovarian anti-aging agent, 0.2-4 parts of vaginal firming agent, 1-3 parts of bactericidal and anti-inflammatory agent, and 0.5-2 parts of adenosine triphosphate; the ovarian anti-aging agent comprises kudzu root extract, dodder seed extract, millettia extract, and yam root extract; the vaginal firming agent comprises gallnut extract, pomegranate peel extract, lime fruit extract, cornus extract, Centella asiatica extract, propylene glycol, antimicrobial peptides and water. The anti-premature ovarian failure nursing composition of the present invention can effectively alleviate the symptoms of ovarian function decline, improve ovarian microcirculation dysfunction, and open up a new method for preventing or treating stubborn premature ovarian failure.

Description

Technical Field

[0001] The invention belongs to the technical field of pharmaceutical preparations, and in particular relates to an anti-premature ovarian failure nursing composition, an anti-premature ovarian failure nursing solution and a preparation method thereof. Background Art

[0002] The ovaries are the source of female life and play a very important role in female physiological health. Their main functions are as follows: (1) secreting hormones and managing physiological cycles; (2) storing eggs and ovulating, controlling reproductive function; (3) regulating endocrine, affecting health and beauty; (4) protecting cardiovascular and cerebrovascular and bone health. However, the ovaries are the first organs to age in the human body. Women's ovarian function declines rapidly after the age of 45-50. The decline of ovarian function and the decrease in estrogen secretion caused by autoimmune ovarian damage, viral infection or medical factors will lead to premature ovarian failure, which will cause women to experience amenorrhea and infertility, as well as clinical symptoms such as flushing, hot sweats, mood swings, reduced vaginal discharge, insomnia, poor appetite, low libido, vaginal dryness, and gastrointestinal dysfunction. In addition, osteoporosis, cardiovascular disease, Alzheimer's disease and other diseases will occur early, seriously affecting the quality of life of patients. Therefore, resisting premature ovarian failure is a difficult problem that modern medicine needs to solve urgently.

[0003] Modern medicine mostly uses immunosuppressants such as glucocorticoids and estrogen replacement therapy to treat and prevent premature ovarian failure. However, long-term use of hormones not only increases the risk of cervical cancer and breast cancer, but also produces many serious side effects, such as cervical cancer, breast cancer, hypertension, hyperglycemia, osteoporosis, abnormal fat mobilization, and digestive and endocrine system disorders. Therefore, the safety, acceptability and effectiveness of long-term use are questioned.

[0004] Therefore, there is an urgent need to research and develop a safe and stable female intimate care product that can prevent or treat premature ovarian failure and the symptoms of vaginal and cervical mucosal atrophy, thinning, relaxation, dryness, etc. caused by premature ovarian failure, so as to promote female reproductive health. Summary of the invention

[0005] The purpose of the present invention is to overcome the shortcomings and deficiencies of the prior art and provide an anti-premature ovarian failure care composition, an anti-premature ovarian failure care solution and a preparation method thereof, so as to effectively alleviate the symptoms of ovarian dysfunction, improve ovarian microcirculation dysfunction, and open up a new method for the prevention or treatment of stubborn premature ovarian failure.

[0006] To achieve the above objectives, the technical solutions adopted by the present invention include:

[0007] In a first aspect, the present invention provides an anti-premature ovarian failure care composition, characterized in that the anti-premature ovarian failure care composition comprises the following components in parts by weight: 0.5-4 parts of an ovarian anti-aging agent, 0.2-4 parts of a vaginal firming agent, 1-3 parts of a bactericidal and anti-inflammatory agent, and 0.5-2 parts of adenosine triphosphate; the ovarian anti-aging agent comprises kudzu root extract, dodder seed extract, millettia spatholobi extract, yam root extract, linseed oil, tocopherol, thiamine hydrochloride, pyridoxine, oregano leaf extract, and lactic acid bacteria fermentation product; the vaginal firming agent comprises gallnut extract, pomegranate peel extract, sour orange fruit extract, cornus officinalis extract, Centella asiatica extract, propylene glycol, lactic acid bacteria fermentation product, and water.

[0008] The invention adopts four plant extracts, namely, kudzu root extract, dodder seed extract, millettia spatholobi extract and yam root extract, and compound them with other components to prepare the ovarian anti-aging agent. Among them, the kudzu root extract is rich in isoflavones and is a phytoestrogen that is most similar to the estrogen secreted by the human body in molecular structure. It preemptively binds to the estrogen receptor in the body and has a mild effect, helping women activate the ovaries and regulate the estrogen balance in the body; the dodder seed extract promotes the recovery of hypothalamic-pituitary gonadotropin function, improves the responsiveness of the pituitary and ovaries to hormones, promotes the development of follicles, enhances the number and function of ovarian hormone receptors, and has estrogen-like activity; the millettia spatholobi extract is rich in lignans and is a natural phytoestrogen that can achieve bidirectional regulation; the yam root extract is rich in diosgenin, which is an indispensable substance for the body's estrogen conversion and can promote the synthesis of hormones in the body; when the above plant extracts are scientifically matched, the four cooperate with each other, can synergistically regulate the human blood estrogen level, and can effectively alleviate the symptoms of premature ovarian failure.

[0009] In addition, the vaginal firming agent prepared by compounding multiple substances such as gallnut extract, pomegranate peel extract, sour orange fruit extract, cornus officinalis extract, Centella asiatica extract, etc. can effectively induce vaginal contraction and tightening, and help repair inner mucosal damage, enhance the vitality of cell basal layer cells, and improve the body's immune defense function.

[0010] Adenosine triphosphate can provide energy for cell metabolism, promote the repair and regeneration of various cells in the body, and enhance cell metabolic activity.

[0011] After a large number of experiments and investigations, it was found that the present invention compounds ovarian anti-aging agents and vaginal firming agents containing specific components with adenosine triphosphate and bactericidal and anti-inflammatory agents within a limited dosage range. The prepared anti-premature ovarian failure care composition can effectively alleviate ovarian function decline and improve ovarian microcirculation dysfunction when administered to the vagina. It can quickly alleviate symptoms such as atrophy and thinning of the vagina and cervical mucosa, reduced secretions, vaginal dryness, weak resistance, etc. caused by premature ovarian failure, with significant therapeutic effects. The therapeutic effects are stable and consolidated after cure, and the recurrence rate is low. It has opened up a new method for the prevention or treatment of stubborn premature ovarian failure, and can effectively alleviate or treat gynecological vaginal diseases induced by premature ovarian failure, promote the recovery of vaginal elasticity and firmness, and achieve antibacterial and cleaning effects, thereby maintaining women's reproductive health.

[0012] Preferably, the anti-premature ovarian failure care composition comprises the following components in parts by weight: 2.5-3.5 parts of ovarian anti-aging agent, 3-4 parts of vaginal firming agent, 1.5-2.5 parts of bactericidal and anti-inflammatory agent, and 0.8-1.2 parts of adenosine triphosphate.

[0013] Preferably, the anti-premature ovarian failure care composition comprises the following components in parts by weight: 3 parts of ovarian anti-aging agent, 4 parts of vaginal firming agent, 2 parts of bactericidal and anti-inflammatory agent, and 1 part of adenosine triphosphate.

[0014] The inventors have found through experiments that when the weight parts of each component in the anti-premature ovarian failure care composition are at the optimal values ​​described in the present invention, the anti-premature ovarian failure care solution product prepared from the composition has significant effects on restoring the menstrual period and menstrual volume of patients with premature ovarian failure. After a certain course of treatment, the follicle-stimulating hormone (FSH) in the patient's body is significantly lower than that before treatment, while the serum estradiol (E2) content is increased. Therefore, it has significant effects on alleviating or treating the symptoms of premature ovarian failure. In addition, it has good therapeutic effects on problems such as vaginal relaxation, dryness, and mucosal damage caused by premature ovarian failure, thereby better protecting the ovaries.

[0015] The inventors also explored the dosage of each raw material and found that if the dosage of the ovarian anti-aging agent, vaginal firming agent and adenosine triphosphate raw material is too small or the total dosage of the three is too small, the synergistic effect is not obvious. If the dosage of the raw materials is too large or the total dosage of the three is too large, antagonism may occur, which will also lead to a decrease in the anti-aging effect. This shows that the above-mentioned raw materials have a more ideal synergistic effect when they are within the specified range of the present invention.

[0016] Preferably, the bactericidal and anti-inflammatory agent is a compound of lactic acid bacteria fermentation products, propylene glycol and water.

[0017] Preferably, the mass ratio of the lactic acid bacteria fermentation product, propylene glycol and water is (3-5):(10-12):(4-6).

[0018] The present invention adopts lactic acid bacteria fermentation products as bactericidal and anti-inflammatory agents applied to the anti-premature ovarian failure care composition of the present invention, which can effectively inhibit the growth of harmful bacteria such as Escherichia coli, Staphylococcus aureus and Candida albicans, and can enhance the immune function of the skin, and has significant anti-inflammatory, antipruritic, moisturizing and repairing effects.

[0019] Preferably, the ovarian anti-aging agent comprises the following components in percentage by mass: 10-15% of kudzu root extract, 10-15% of dodder seed extract, 5-10% of millettia extract, 5-10% of yam root extract, 5-10% of linseed oil, 3-10% of tocopherol, 3-10% of thiamine hydrochloride, 3-10% of pyridoxine, 1-5% of oregano leaf extract, 0.5-2% of lactic acid bacteria fermentation product and the balance of propylene glycol;

[0020] The vaginal tightening agent comprises the following components in percentage by mass: 5-20% of gallnut extract, 5-15% of pomegranate peel extract, 3-15% of sour orange fruit extract, 3-15% of cornus officinalis extract, 1-10% of Centella asiatica extract, 0.2-3% of lactic acid bacteria fermentation product, 10-20% of propylene glycol and the balance of water.

[0021] Among them, the representative ovarian anti-aging agent is HOReovary+, which includes the following components in percentage by mass: 12% kudzu root extract, 12% dodder seed extract, 8% millettia spatholobi extract, 8% yam root extract, 8% linseed oil, 5% tocopherol, 5% thiamine hydrochloride, 5% pyridoxine, 1.8% oregano leaf extract, 1.2% lactic acid bacteria fermentation product and 34% propylene glycol.

[0022] Among them, the representative vaginal tightening agent is GuardLove, which includes the following components in the following mass percentages: 20% gallnut extract, 10% pomegranate peel extract, 10% lime fruit extract, 10% cornus officinalis extract, 7% Centella asiatica extract, 18% propylene glycol, 1% lactic acid bacteria fermentation product and 24% water.

[0023] Through experimental research, it was found that when the above-mentioned ovarian anti-aging agent and vaginal firming agent products are used, the anti-premature ovarian failure care composition prepared by compounding the two with the adenosine triphosphate and other components described in the present invention can make the anti-premature ovarian failure care liquid product have excellent anti-ovarian function decline effect, and effectively alleviate gynecological vaginal diseases induced by premature ovarian failure, and promote the recovery of vaginal elasticity and firmness.

[0024] In a second aspect, the present invention provides an anti-premature ovarian failure care solution, comprising the anti-premature ovarian failure care composition.

[0025] Preferably, the mass percentage of the anti-premature ovarian failure care composition in the anti-premature ovarian failure care solution is 2.2-13%.

[0026] Preferably, the anti-premature ovarian failure care solution also includes the following components in percentage by mass: poloxamer 0.5-4%, riboflavin 1-3%, plant hormones 2-6%, cosolvent 20-30%, bactericide 0.02-0.07%, solubilizer 0.5-1%, bactericidal and antipruritic agent 1-4%, surfactant 0.2-0.8%, pH regulator 5-6% and the balance water.

[0027] Preferably, the plant hormone includes at least one of Pueraria root extract, Chlorella extract, Aloe vera leaf extract and Glycine max seed extract; the co-solvent includes at least one of glycerin and propylene glycol; the bactericide includes benzalkonium chloride; the solubilizer includes at least one of Tween 20, Cocoether-7, PPG-1-PEG-9 lauryl glycol ether and PEG-40 hydrogenated castor oil; the bactericidal and antipruritic agent includes at least one of oxymatrine and magnolia glycoside; the surfactant includes disodium cocoamphodiacetate; and the pH adjuster includes lactic acid.

[0028] In a third aspect, the present invention provides a method for preparing the anti-premature ovarian failure care solution, comprising the following steps:

[0029] (1) placing poloxamer and a cosolvent in an emulsifying pot, homogenizing and stirring for 3-7 minutes, at a homogenizing speed of 37-40 rpm / min and a stirring speed of 20-30 rpm / min, then adding water, homogenizing 2-4 times, each time for 2-4 minutes, at a homogenizing speed of 38-42 rpm / min and a stirring speed of 20-25 rpm / min, then heating to 90° C. and keeping warm for 35-45 minutes to obtain a mixture I;

[0030] (2) stirring and mixing the solubilizer and the bactericide to obtain a mixture II, cooling the mixture I to 40-50° C. and adding the mixture II, and then adding adenosine triphosphate, bactericidal and antipruritic agents, riboflavin, and plant hormones, stirring and mixing to obtain a mixture III;

[0031] (3) stirring and mixing the cosolvent, the surfactant and the bactericidal and anti-inflammatory agent, stirring and mixing the cosolvent, the vaginal firming agent and the solubilizing agent, stirring and mixing the cosolvent and the ovarian anti-aging agent, and then sequentially adding the three mixtures into the mixture III to obtain a mixture IV;

[0032] (4) Adding a pH adjuster to the mixture IV and continuing stirring for 10-20 minutes to obtain the anti-premature ovarian failure care solution.

[0033] Preferably, the pH value of the anti-premature ovarian failure care solution is controlled to be 4.2-5.

[0034] More preferably, the pH value of the anti-premature ovarian failure care solution is controlled to be 4.5.

[0035] The inventors have found through experimental research that when the pH value of the prepared anti-premature ovarian failure care solution is controlled within the above-mentioned preferred range, when the drug is administered to the vagina, it can better balance the pH value of the female private parts, thereby inhibiting the proliferation of harmful bacteria and improving the self-cleaning ability of the vagina, thereby protecting the ovaries to a certain extent.

[0036] Compared with the prior art, the present invention has the following beneficial effects:

[0037] The present invention compounds an ovarian anti-aging agent and a vaginal firming agent containing specific components with adenosine triphosphate and a bactericidal and anti-inflammatory agent within a limited dosage range. The prepared anti-premature ovarian failure care composition can effectively alleviate ovarian function decline and improve ovarian microcirculation dysfunction when administered to the vagina, and can quickly alleviate symptoms such as atrophy and thinning of the vagina and cervical mucosa, reduced secretions, vaginal dryness, weak resistance, etc. caused by premature ovarian failure, with significant therapeutic effects, and the therapeutic effects are stable and consolidated after cure, with a low recurrence rate. It has opened up a new method for preventing or treating stubborn premature ovarian failure, and can effectively alleviate or treat gynecological vaginal diseases induced by premature ovarian failure, promote the recovery of vaginal elasticity and firmness, and achieve antibacterial and cleaning effects, thereby maintaining female reproductive health. BRIEF DESCRIPTION OF THE DRAWINGS

[0038] Figure 1 Comparison pictures of the genitals of subjects with premature ovarian failure 30 days before (Figure A) and 30 days after (Figure B) use of the anti-premature ovarian failure care solution described in Example 5. DETAILED DESCRIPTION

[0039] To better illustrate the purpose, technical solutions and advantages of the present invention, the present invention will be further described below in conjunction with specific embodiments. It should be understood by those skilled in the art that the specific embodiments described herein are only used to explain the present invention and are not intended to limit the present invention.

[0040] In this application, when it comes to numerical ranges, unless otherwise specified, the above numerical ranges are deemed to be continuous and include the minimum and maximum values ​​of the range, as well as each value between such minimum and maximum values. Further, when a range refers to an integer, each integer between the minimum and maximum values ​​of the range is included. In addition, when multiple ranges are provided to describe features or characteristics, the ranges can be merged. In other words, unless otherwise specified, all ranges disclosed herein should be understood to include any and all subranges included therein.

[0041] Unless otherwise specified, all raw materials involved in the following examples and comparative examples are commercially available general materials, and the component raw materials used in each parallel experiment are of the same kind; unless otherwise specified, the preparation method of the preparation is prepared by directly mixing the components using a conventional method.

[0042] The ovarian anti-aging agent described in the embodiment of the present invention is HOReovary+, which includes the following components in percentage by mass: 12% of kudzu root extract, 12% of dodder seed extract, 8% of millettia spatholobi extract, 8% of yam root extract, 8% of linseed oil, 5% of tocopherol, 5% of thiamine hydrochloride, 5% of pyridoxine, 1.8% of oregano leaf extract, 1.2% of lactic acid bacteria fermentation product and 34% of propylene glycol;

[0043] The vaginal firming agent is GuardLove, which includes the following components in percentage by mass: 20% of gallnut extract, 10% of pomegranate peel extract, 10% of sour orange fruit extract, 10% of cornus officinalis extract, 7% of Centella asiatica extract, 18% of propylene glycol, 1% of lactic acid bacteria fermentation product, and 24% of water;

[0044] The bactericidal and anti-inflammatory agent comprises the following components in percentage by mass: 20% of lactic acid bacteria fermentation product, 55% of propylene glycol and 25% of water;

[0045] The plant hormones include plant hormones I and plant hormones II, wherein the plant hormones I include kudzu root extract, chlorella extract, and aloe vera leaf extract, and the mass ratio of the kudzu root extract, the chlorella extract, and the aloe vera leaf extract is 3:1:1; the plant hormones II include soybean seed extract; the mass ratio of the plant hormones I and II is (1-3): (1-3);

[0046] The usage ratio of coconut ether-7, PPG-1-PEG-9 lauryl glycol ether and PEG-40 hydrogenated castor oil in the solubilizer is (3-5): (3-5): (1-2).

[0047] Examples 1-7

[0048] Table 1: Formula of the anti-premature ovarian failure care solution described in Examples 1-7 (mass percentage %)

[0049]

[0050]

[0051] Comparative Examples 1-9

[0052] Table 2: Formula of the anti-premature ovarian failure care solution described in Comparative Examples 1-9 (mass percentage %)

[0053]

[0054]

[0055] Comparative Example 10

[0056] This comparative example provides an anti-premature ovarian failure care solution, which is different from Example 5 in that: in the ovarian anti-aging agent, the kudzu root extract and the Millettia spatholobi extract are replaced with water, and the other components and contents are the same.

[0057] Comparative Example 11

[0058] This comparative example provides an anti-premature ovarian failure care solution, which is different from Example 5 in that: in the ovarian anti-aging agent, the dodder seed extract and the Dioscorea root extract are replaced with water, and the other components and contents are the same.

[0059] Comparative Example 12

[0060] This comparative example provides an anti-premature ovarian failure care solution, which is different from Example 5 in that: in the ovarian anti-aging agent, the Cuscuta seed extract, the Millettia spatholobi extract and the Dioscorea root extract are replaced with water, and the other components and contents are the same.

[0061] The preparation method of the anti-premature ovarian failure care solution described in Examples 1-7 and Comparative Examples 1-12 comprises the following steps:

[0062] (1) placing poloxamer and a cosolvent in an emulsifying pot, homogenizing and stirring for 3-7 minutes, at a homogenizing speed of 37-40 rpm / min and a stirring speed of 20-30 rpm / min, then adding water, homogenizing 2-4 times, each time for 2-4 minutes, at a homogenizing speed of 38-42 rpm / min and a stirring speed of 20-25 rpm / min, then heating to 90° C. and keeping warm for 35-45 minutes to obtain a mixture I;

[0063] (2) stirring and mixing the solubilizer and the bactericide to obtain a mixture II, cooling the mixture I to 40-50° C. and adding the mixture II, and then adding adenosine triphosphate, bactericidal and antipruritic agents, riboflavin, and plant hormones, stirring and mixing to obtain a mixture III;

[0064] (3) stirring and mixing the cosolvent, the surfactant and the bactericidal and anti-inflammatory agent, stirring and mixing the cosolvent, the vaginal firming agent and the solubilizing agent, stirring and mixing the cosolvent and the ovarian anti-aging agent, and then sequentially adding the three mixtures into the mixture III to obtain a mixture IV;

[0065] (4) adding a pH regulator to the mixture IV and continuing stirring for 10-20 min to obtain the anti-premature ovarian failure care solution;

[0066] The pH value of the anti-premature ovarian failure care solution is controlled to be 4.2-5.

[0067] Effect example

[0068] 1. In vitro antibacterial test

[0069] The anti-premature ovarian failure care solutions prepared in Examples 1-7 and Comparative Examples 1-12 were used as samples, and antibacterial tests on Staphylococcus aureus, Escherichia coli and Candida albicans were performed respectively to explore the antibacterial effect of the care solution products on harmful bacteria. The specific method is as follows.

[0070] 1. Test strains

[0071] (1) Staphylococcus aureus ATCC 6538, source: ATCC, 4th generation;

[0072] (2) Escherichia coli 8099, source: Guangdong Microbiological Culture Collection Center, 4th generation;

[0073] (3) Candida albicans ATCC 10231, source: ATCC, 4th generation.

[0074] 2. Detection method

[0075] (1) Testing basis: Appendix C of GB 15979-2002 Hygiene Standard for Disposable Hygiene Products;

[0076] (2) Test conditions: test environment temperature 20.2-23.8°C, relative humidity 50-53% HR, exposure time 20 min;

[0077] (3) Evaluation criteria: If the antibacterial rate is >50%-90%, the product has a strong antibacterial effect; if the antibacterial rate is >90%, the product has a strong antibacterial effect.

[0078] The antibacterial results are shown in Table 4.

[0079] Table 4

[0080]

[0081]

[0082] 2. Animal testing

[0083] (1) Establishment of mouse premature ovarian failure model: 100 female mice aged 5-6 weeks with normal estrous cycle were selected and intraperitoneally injected with 30 mg / kg cyclophosphamide every day for 5 consecutive days to establish the premature ovarian failure model;

[0084] (2) Drug treatment: The 100 premature aging model mice were divided into 20 groups, with 5 mice in each group. The anti-premature ovarian failure care solutions prepared in Examples 1-7 and Comparative Examples 1-12 were administered by gavage, and the remaining group was used as a model control group and was administered with normal saline at a dosage of 50 mg / kg, once a day, for 4 consecutive weeks. Five normal mice were then selected and gavaged with normal saline according to the above-mentioned administration method as a normal control group.

[0085] (3) Evaluation index: The progesterone and estradiol (E2) content of mice with premature ovarian failure model was detected: blood was collected from the mouse eyeballs, incubated in a 37°C water bath for 2 hours, and then centrifuged at 3000r / min for 10 minutes. The supernatant was taken and the progesterone reflex immunoassay kit and estradiol radioimmunoassay kit were used to measure the progesterone and E2 content in the serum. The results were analyzed using SPSS23.0 statistical software, and the data were expressed as mean ± standard deviation. The specific results are shown in Table 5.

[0086] Table 5

[0087]

[0088]

[0089] As can be seen from Table 5, compared with the normal control group, the progesterone and E2 levels in the serum of the mice in the model control group were significantly reduced, indicating that the premature ovarian failure model was successfully established; and compared with the model control group, the anti-premature ovarian failure care solution prepared in Examples 1-7 can significantly increase the progesterone and E2 levels in the serum of the mice, indicating that the specific components used in the anti-premature ovarian failure care composition of the present invention are scientifically matched, and the components interact with each other, so that the anti-premature ovarian failure care solution finally prepared has significant synergistic synergy in regulating the progesterone and E2 levels in the serum, thereby effectively alleviating or treating the symptoms of ovarian dysfunction, with significant effects, and has no adverse effects on the vital signs of the mice during the experiment.

[0090] 3. Clinical trials

[0091] (1) Subjects: 130 patients with premature ovarian failure aged 25-40 years with oligomenorrhea or amenorrhea for 6-20 months were selected. Most of the 130 patients had varying degrees of menopausal symptoms such as restlessness, insomnia, loss of appetite, hot flashes, night sweats, vaginal dryness, looseness, and decreased libido. The average serum FSH of the 130 patients was ≥54.3 IU / L, and the average E2 was ≤52.6 pmol / L.

[0092] (2) Diagnostic criteria: According to the "Guidelines for Clinical Diagnosis and Treatment of Gynecology in Traditional Chinese Medicine - Premature Ovarian Failure": 1. Infrequent menstruation, decreasing menstrual flow or amenorrhea before the age of 40; 2. Serum FSH (gonadotropin) ≥ 40 IU / L for more than two times; 3. E2 (serum estradiol) ≤ 73.2 pmol / L.

[0093] (3) Group treatment: 130 patients were divided into 13 groups, with 10 patients in each group. The anti-premature ovarian failure care solutions prepared in Example 5 and Comparative Examples 1-12 were used as samples and administered to the patients' vagina. The patients were placed in a supine position with their buttocks raised by 15-25 cm. The care solution was applied deep into the vagina with an insertion depth of 9-10 cm. 2-3 mL of the solution was administered, and the patient maintained the position for 20-30 min as much as possible. The treatment was continued for 30 days.

[0094] (4) Evaluation criteria:

[0095] 1. Adjust the menstrual cycle efficacy

[0096] Refer to the "Guidelines for Clinical Research on New Chinese Medicines for the Treatment of Menstrual Disorders" (China Medical Science and Technology Press, 2002). Cured: Menstrual period returns to normal, menstrual cycle and menstrual volume are normal; Significantly effective: Menstrual period returns to normal, menstrual cycle and menstrual volume are basically normal; Effective: Menstruation can come regularly; Ineffective: There is no change in menstrual period, cycle and menstrual volume.

[0097] 2. Evaluation criteria for TCM syndrome efficacy

[0098] The efficacy of TCM syndromes is determined by the syndrome efficacy rate. Cured: All symptoms disappear after treatment, and the syndrome score value decreases by ≥95%; markedly effective: All symptoms are significantly alleviated after treatment, and the syndrome score value decreases by ≥70%, <95%; effective: All symptoms are alleviated after treatment, and the syndrome score value decreases by ≥30%, <70%; ineffective: All symptoms are not alleviated or are aggravated after treatment, and the syndrome score value decreases by <30%.

[0099] 3. Evaluation criteria for physical and chemical indicators

[0100] Cured: blood FSH ≤ 10U / L after treatment; markedly effective: 10U / L<blood FSH<40U / L after treatment; effective: blood FSH ≥ 40U / L after treatment, with a downward trend, but lower than before treatment; ineffective: no change or increase in hormone levels after treatment.

[0101] The specific results are shown in Table 6.

[0102] Table 6

[0103]

[0104]

[0105]

[0106] From the results in Table 6, it can be seen that the anti-premature ovarian failure care composition prepared by using specific components of the present invention has a significant effect on restoring the menstrual period and normal menstrual volume of patients with premature ovarian failure when it is administered vaginally when it is made into a care solution product. After a certain course of treatment, the follicle-stimulating hormone (FSH) in the patient's body is significantly lower than that before treatment, while the serum estradiol (E2) content is increased. Therefore, it has a significant effect on relieving or treating the symptoms of premature ovarian failure. In addition, it has a good therapeutic effect on the problems of vaginal relaxation, dryness, and loss of libido caused by premature ovarian failure.

[0107] Figure 1 A and B are comparison pictures of the genitals of subjects with premature ovarian failure 30 days before and 30 days after using the anti-premature ovarian failure care solution described in Example 5 of the present invention, respectively. After using the care solution product, the subjects' cervical atrophy and dryness were effectively improved, and the menstrual volume was significantly normalized, with significant therapeutic effect.

[0108] 4. Typical cases:

[0109] Example 1: Ms. Xiu, 40 years old, a patient with premature ovarian failure, recurrent vaginitis, discomfort during sexual life, lower abdominal pain, and scanty menstruation. After using the anti-premature ovarian failure care solution of the present invention for two months, her secretions became transparent and clean, her sexual life was more satisfying than before, her menstrual flow was also particularly good, and her mood became more stable and peaceful.

[0110] Example 2: Ms. Bai, 38 years old, a patient with premature ovarian failure, vaginitis and vaginal adhesion, had not had sexual intercourse for 10 years, felt pain when the vaginal dilator was put into the vagina, had contact bleeding, and could not dilate the vagina. After using the anti-premature ovarian failure care solution of the present invention for two months, the mucosa gradually felt pink and tender, and there was no obvious pain when the vaginal dilator was put into the vagina. After three months of use, the vagina could be dilated normally, the vaginal dryness phenomenon was significantly improved, and sexual intercourse was gradually resumed.

[0111] Finally, it should be noted that the above embodiments are only used to illustrate the technical solution of the present invention rather than to limit the scope of protection of the present invention. Although the present invention has been described in detail with reference to the preferred embodiments, those skilled in the art should understand that the technical solution of the present invention can be modified or replaced by equivalents without departing from the essence and scope of the technical solution of the present invention.

Claims

1. An anti-premature ovarian failure care composition, characterized in that: The anti-premature ovarian failure nursing composition is composed of the following components in parts by weight: 0.5-4 parts of ovarian anti-aging agent, 0.2-4 parts of vaginal firming agent, 1-3 parts of bactericidal and anti-inflammatory agent, and 0.5-2 parts of adenosine triphosphate; The ovarian anti-aging agent comprises the following components in percentage by mass: 10-15% of kudzu root extract, 10-15% of dodder seed extract, 5-10% of millettia spatholobi extract, 5-10% of yam root extract, 5-10% of linseed oil, 3-10% of tocopherol, 3-10% of thiamine hydrochloride, 3-10% of pyridoxine, 1-5% of oregano leaf extract, 0.5-2% of lactic acid bacteria fermentation product and the balance of propylene glycol; The vaginal tightening agent comprises the following components in percentage by mass: 5-20% of gallnut extract, 5-15% of pomegranate peel extract, 3-15% of sour orange fruit extract, 3-15% of cornus officinalis extract, 1-10% of Centella asiatica extract, 0.2-3% of lactic acid bacteria fermentation product, 10-20% of propylene glycol and the balance of water; The bactericidal and anti-inflammatory agent is a compound of lactic acid bacteria fermentation products, propylene glycol and water, and the mass ratio of the lactic acid bacteria fermentation products, propylene glycol and water is (3-5): (10-12): (4-6).

2. The anti-premature ovarian failure nursing composition according to claim 1, characterized in that: The anti-premature ovarian failure nursing composition consists of the following components in parts by weight: 2.5-3.5 parts of ovarian anti-aging agent, 3-4 parts of vaginal firming agent, 1.5-2.5 parts of bactericidal and anti-inflammatory agent, and 0.8-1.2 parts of adenosine triphosphate.

3. The anti-premature ovarian failure nursing composition according to claim 2, characterized in that: The anti-premature ovarian failure nursing composition is composed of the following components in parts by weight: 3 parts of ovarian anti-aging agent, 4 parts of vaginal firming agent, 2 parts of bactericidal and anti-inflammatory agent, and 1 part of adenosine triphosphate.

4. An anti-premature ovarian failure care solution, characterized in that: The invention comprises the anti-premature ovarian failure care composition according to any one of claims 1 to 3.

5. The anti-premature ovarian failure care solution according to claim 4, characterized in that: The mass percentage of the anti-premature ovarian failure care composition in the anti-premature ovarian failure care solution is 2.2-13%.

6. The anti-premature ovarian failure care solution according to claim 4, characterized in that: The anti-premature ovarian failure care solution also includes the following components in percentage by weight: poloxamer 0.5-4%, riboflavin 1-3%, plant hormones 2-6%, cosolvent 20-30%, bactericide 0.02-0.07%, solubilizer 0.5-1%, bactericidal and antipruritic agent 1-4%, surfactant 0.2-0.8%, pH regulator 5-6% and the balance of water; The plant hormone is a compound of kudzu root extract, chlorella extract, aloe vera leaf extract and wild soybean seed extract.

7. The anti-premature ovarian failure care solution according to claim 6, characterized in that: The cosolvents are glycerol and propylene glycol; The bactericide is benzalkonium chloride; The solubilizing agents are Tween 20, coco ether-7, PPG-1-PEG-9 lauryl glycol ether and PEG-40 hydrogenated castor oil; The bactericidal and antipruritic agents are oxymatrine and magnolin; The surfactant is disodium cocoamphodiacetate; The pH adjuster is lactic acid.

8. The method for preparing the anti-premature ovarian failure care solution according to any one of claims 4 to 7, characterized in that: The following steps are involved: (1) Place poloxamer and cosolvent in an emulsifier, homogenize and stir for 3-7 minutes, the homogenization speed is 37-40 rpm / min, and the stirring speed is 20-30 rpm / min, then add water, homogenize 2-4 times, each time for 2-4 minutes, the homogenization speed is 38-42 rpm / min, and the stirring speed is 20-25 rpm / min, then heat to 90°C, keep warm for 35-45 minutes, and obtain mixture I; (2) stirring and mixing the solubilizer and the bactericide to obtain a mixture II, cooling the mixture I to 40-50° C. and adding the mixture II, and then adding adenosine triphosphate, bactericidal and antipruritic agents, riboflavin, and plant hormones, stirring and mixing to obtain a mixture III; (3) stirring and mixing the cosolvent, the surfactant and the bactericidal and anti-inflammatory agent, stirring and mixing the cosolvent, the vaginal firming agent and the solubilizing agent, stirring and mixing the cosolvent and the ovarian anti-aging agent, and then sequentially adding the three mixtures into mixture III to obtain mixture IV; (4) adding a pH regulator to the mixture IV and continuing stirring for 10-20 minutes to obtain the anti-premature ovarian failure care solution; The pH value of the anti-premature ovarian failure care solution is controlled to be 4.2-5.

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