A gel composition for improving female reproductive health and its preparation method and application

Abstract

The present invention provides a gel composition for improving female reproductive health, and its preparation method and application. The raw materials for preparing the gel composition include: 8-50 parts of active ingredients, 0.2-3 parts of gel material, 5-30 parts of moisturizer and 100-500 parts of water; wherein the active ingredients include ginseng extract, angelica extract and green tea extract. The present invention creatively combines ginseng extract, angelica extract and green tea extract to improve female reproductive health. The three ingredients complement each other and can synergize. Through the synergistic effect between the components, the active ingredient obtained by the combination has significant effects of promoting uterine involution, promoting lochia discharge, inhibiting bacteria and inflammation, and relieving pain. In addition, the present invention also creatively uses the active ingredients in the preparation of the gel product. The gel product is combined with the osmotic effect of ultrasound to promote the absorption of the active ingredients by the body and further enhance the use effect of the active ingredients.

Description

Technical Field

[0001] The present invention belongs to the technical field of ultrasound gel materials, and in particular relates to a gel composition for improving female reproductive health, and a preparation method and application thereof. Background Art

[0002] The female reproductive system includes the uterus, ovaries, and fallopian tubes. Pregnancy and childbirth significantly impact the reproductive system. Focusing on uterine involution and preventing and treating reproductive system infections is crucial for improving women's reproductive health. The uterus undergoes the most significant changes during the postpartum period. After delivery of the fetus and its appendages, the uterus gradually contracts to its non-pregnant state, a process called uterine involution. When this contraction process is impaired, preventing the uterus from returning to its non-pregnant state as expected, this is considered postpartum uterine involution failure. The incidence of uterine involution failure is relatively high in my country. Sichuan Provincial Maternal and Child Health Hospital and Sichuan Provincial Women and Children's Hospital conducted postpartum health examinations on 988 women attending their postpartum care clinics and found a high rate of uterine involution failure in 39.37%.

[0003] Currently, there are many rehabilitation methods for poor uterine involution, such as oxytocin injection or oral medication to enhance uterine contractions, oral Chinese medicine, acupuncture, massage, microwave or ultrashort wave therapy, infrared therapy, etc.

[0004] CN109289019A discloses a research method for promoting postpartum uterine involution by combining a traditional Chinese medicine prescription with a postpartum rehabilitation apparatus. The traditional Chinese medicine prescription comprises 15g of angelica sinensis, 10g of chuanxiong, 8g of peach kernel, 5g of roasted ginger, 30g of motherwort, 15g of white peony root, 10g of radix achyranthis Bidentatae, 20g of Poria cocos, 10g of atractylodes macrocephala, 10g of fructus aurantii, 15g of prepared rehmannia, and 5g of roasted liquorice. The research method for promoting postpartum uterine involution by combining a traditional Chinese medicine prescription with a postpartum rehabilitation apparatus is to conduct a clinical observation on promoting postpartum uterine involution by combining a traditional Chinese medicine prescription with a postpartum rehabilitation apparatus; 120 women with normal full-term delivery were selected and divided into three groups. After delivery, they were given a self-developed traditional Chinese medicine prescription; a postpartum rehabilitation apparatus; and a combination of a traditional Chinese medicine prescription and a postpartum rehabilitation apparatus for treatment, and the efficacy of the three therapies on uterine involution was compared.

[0005] CN101879184A discloses a pharmaceutical composition for improving reproductive capacity, its preparation method, and its use. The pharmaceutical composition comprises vitamin E, coenzyme Q10, and / or selenium. As a novel, highly effective antioxidant, the pharmaceutical composition can be used in pharmaceuticals and health products for preventing and treating reproductive disorders induced by oxidative stress, endocrine disorders, or environmental factors.

[0006] Ultrasound is a mechanical wave with an extremely short wavelength, typically less than 2 centimeters in air. When ultrasound propagates through a medium, its intensity decreases with distance, indicating that the ultrasonic energy is absorbed as it passes through the medium, exerting certain mechanical, thermal, and cavitational effects. Ultrasound acts on human tissue, producing mechanical, thermal, and cavitational effects. These effects accelerate blood flow in localized tissues, improve circulation, increase vascular wall peristalsis, enhance cell membrane permeability, redistribute ions, stimulate metabolism, reduce hydrogen ion concentration in tissues, increase pH, enhance enzyme activity, strengthen tissue regeneration and repair, relax muscles, reduce muscle tone, and reduce or alleviate pain. Ultrasound therapy should be used in conjunction with gel. The drug-penetrating effect of ultrasound promotes the absorption of the active ingredients in the gel. Ultrasound therapy products are currently widely used to assist in improving women's reproductive health. Therefore, optimizing ultrasound gel and further enhancing the reproductive health benefits of ultrasound therapy products is essential. Summary of the Invention

[0007] In view of the deficiencies in the prior art, the present invention aims to provide a gel composition, a preparation method and an application thereof, and specifically to provide a gel composition for improving female reproductive health, a preparation method and an application thereof.

[0008] In order to achieve the purpose of the invention, the present invention adopts the following technical solutions:

[0009] In a first aspect, the present invention provides a gel composition for improving female reproductive health. The gel composition is prepared from raw materials, by weight, comprising: 8-50 parts active ingredient, 0.2-3 parts gel material, 5-30 parts moisturizer, and 100-500 parts water. The active ingredients include ginseng extract, angelica extract, and green tea extract.

[0010] The mass parts of the active ingredient can be 8 parts, 15 parts, 22 parts, 29 parts, 36 parts, 43 parts or 50 parts, etc.

[0011] The mass fraction of the gel material can be 0.2 parts, 0.5 parts, 0.8 parts, 1.1 parts, 1.4 parts, 1.7 parts, 2 parts, 2.3 parts, 2.6 parts, 2.9 parts or 3 parts, etc.

[0012] The mass parts of the moisturizing agent can be 5 parts, 9 parts, 13 parts, 17 parts, 21 parts, 25 parts, 29 parts or 30 parts, etc.

[0013] The mass fraction of the water can be 100 parts, 140 parts, 180 parts, 220 parts, 260 parts, 300 parts, 340 parts, 380 parts, 420 parts, 460 parts or 500 parts, etc.

[0014] Other specific point values ​​within the above numerical ranges can be selected and will not be described in detail here.

[0015] The active ingredients of the present invention include ginseng extract. Ginseng has the effects of greatly replenishing vital energy, restoring pulse and strengthening deficiency, nourishing spleen and lung, promoting fluid and nourishing blood, calming the mind and improving intelligence. In addition to the effects of lowering blood sugar and blood lipids, ginseng glycopeptides also have the functions of anti-inflammatory, analgesic, protecting nerve cells, anti-apoptosis, and improving collagen cross-linking. It can replenish deficiency and qi, inhibit bacteria and anti-inflammation, increase resistance, relieve uterine contraction pain, and protect damaged uterine cells. Angelica sinensis contains various amino acids, volatile oils, as well as n-butene, lactone, niacin, ferulic acid and semiterpenoid compounds, and also contains vitamin A, vitamin E and various minerals. Angelica sinensis has the effects of nourishing blood, regulating menstruation and relieving pain, moisturizing and lubricating the intestines. Angelica sinensis can effectively help the soft uterus to contract after childbirth to stop bleeding and promote the discharge of lochia; green tea contains tea polyphenols, catechins, chlorophyll, caffeine, amino acids, vitamins and other ingredients. Among them, tea polyphenols not only have the functions of quenching thirst, refreshing, delaying aging, anti-tumor and anti-radiation, but also have obvious antibacterial effects. The inhibition rate of Escherichia coli, Staphylococcus aureus, Pseudomonas aeruginosa, Proteus mirabilis, Bacillus subtilis and Streptococcus pneumoniae is more than 97.5%.

[0016] The present invention creatively combines ginseng extract, angelica extract, and green tea extract to improve female reproductive health. The three ingredients complement each other and synergize to create a synergistic effect. Through the synergistic effect between the components, the resulting active ingredient has significant effects in promoting uterine involution, promoting lochia discharge, inhibiting bacteria and inflammation, and relieving pain. Furthermore, the present invention creatively incorporates the active ingredients into a gel product. The gel product, combined with the penetration of ultrasound, promotes absorption of the active ingredients in the gel, further enhancing the effectiveness of the active ingredients and avoiding the low absorption rate of oral tonics in postpartum women due to weak gastrointestinal function.

[0017] Preferably, the mass ratio of the ginseng extract, the angelica extract and the green tea extract is (0.8-8):1:(0.5-6).

[0018] The specific numerical value in the (0.8-8) can be selected from 0.8, 1, 2, 3, 4, 5, 6, 7 or 8, etc.

[0019] The specific numerical value in the (0.5-6) ​​can be selected from 0.5, 1, 2, 3, 4, 5 or 6, etc.

[0020] Other specific point values ​​within the above numerical ranges can be selected and will not be described in detail here.

[0021] When the mass ratio of the three components of ginseng extract, angelica extract and green tea extract in the active ingredients of the present invention is specifically selected as (0.8-8):1:(0.5-6), the active ingredients have more significant effects of promoting uterine involution, promoting lochia discharge, inhibiting bacteria and inflammation, and relieving pain.

[0022] Preferably, the active ingredient further includes Chuanxiong extract.

[0023] The active ingredients of the present invention also include Chuanxiong extract. Chuanxiong contains volatile oil (components such as phthalide and its dimer), alkaloids, organic acids and polysaccharides, and has the effects of promoting qi and relieving depression, dispelling wind and dampness, and promoting blood circulation and relieving pain. The addition of Chuanxiong extract to the gel composition of the present invention can better enhance the analgesic effect of the gel composition and promote uterine involution and lochia discharge.

[0024] Preferably, the mass ratio of the ginseng extract, the angelica extract, the green tea extract and the Chuanxiong extract is (0.8-8):1:(0.5-6):(0.2-10).

[0025] The specific numerical value in the (0.8-8) can be selected from 0.8, 1, 2, 3, 4, 5, 6, 7 or 8, etc.

[0026] The specific numerical value in the (0.5-6) ​​can be selected from 0.5, 1, 2, 3, 4, 5 or 6, etc.

[0027] The specific numerical value in the (0.2-10) can be selected from 0.2, 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10, etc.

[0028] Other specific point values ​​within the above numerical ranges can be selected and will not be described in detail here.

[0029] Preferably, the gel material includes any one of hydroxyethyl cellulose, carbomer 940, hydroxypropyl cellulose, hyaluronic acid or chitosan, or a combination of at least two of them. The combination of at least two includes, for example, a combination of hydroxyethyl cellulose and carbomer 940, a combination of carbomer 940 and hydroxypropyl cellulose, a combination of hyaluronic acid and chitosan, etc. Any other combination can be selected and will not be described here one by one.

[0030] Preferably, the gel material comprises Carbomer 940.

[0031] Preferably, the humectant comprises glycerin and / or propylene glycol.

[0032] Preferably, the gel composition further comprises a preservative, and the preservative comprises any one or a combination of at least two of ethylparaben, sodium benzoate, benzalkonium bromide, or sorbic acid. The combination of at least two comprises, for example, a combination of ethylparaben and benzalkonium bromide, a combination of benzalkonium bromide and sodium benzoate, a combination of ethylparaben and sodium benzoate, etc. Any other combinations are also possible and will not be detailed here.

[0033] In a second aspect, the present invention provides a method for preparing the gel composition for improving female reproductive health as described in the first aspect, the preparation method comprising: (1) mixing water with the gel material, and allowing the mixture to stand to obtain a gel material solution; and (2) mixing the moisturizer, the active ingredient, the gel material solution, and water to obtain the gel composition for improving female reproductive health.

[0034] The preparation method of the gel composition involved in the present invention is simple and easy to operate, and is very suitable for large-scale industrial production. First, water and gel material are mixed to obtain a gel material solution, and the gel material solution is then mixed with active ingredients, a moisturizer, and water to obtain the gel composition for improving female reproductive health.

[0035] Preferably, the mass ratio of water to gel material in step (1) is (80-200):1.

[0036] The specific numerical value in (80-200) can be selected as 80, 90, 100, 110, 120, 130, 140, 150, 160, 170, 180, 190 or 200, etc. Other specific point values ​​within the above numerical ranges can be selected and will not be described here one by one.

[0037] Preferably, the mass ratio of water to gel material solution in step (2) is (0.4-2):1;

[0038] The specific numerical value in the (0.4-2) can be selected as 0.4, 0.8, 1.1, 1.4, 1.7, 1.9 or 2, etc. Other specific point values ​​within the above numerical ranges can be selected, and they will not be detailed here.

[0039] Preferably, the standing time in step (1) is 3-8h, for example, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 7.5h or 8h, etc. Other specific point values ​​within the above numerical ranges can be selected and will not be described here one by one.

[0040] Preferably, the extraction method of the ginseng extract in the active ingredient in step (2) comprises: chopping the ginseng and soaking it in an ethanol-water solution a, refluxing the extract, concentrating the ethanol extract, drying, and sieving to obtain the ginseng extract.

[0041] Preferably, the volume fraction of ethanol in the ethanol aqueous solution a is 80-95%.

[0042] The specific values ​​of 80-95% can be 80%, 82%, 84%, 86%, 88%, 90%, 92% or 95%, etc. Other specific values ​​within the above numerical ranges can be selected and will not be described in detail here.

[0043] Preferably, the reflux extraction is repeated 1-3 times, wherein the 1-3 times include 1 time, 2 times and 3 times.

[0044] Preferably, the mesh number of the sieve for screening is 70-90 mesh, such as 70 mesh, 75 mesh, 80 mesh, 85 mesh or 90 mesh, and other specific point values ​​within the above numerical ranges can be selected, which will not be repeated here.

[0045] Preferably, the extraction method of the angelica extract in the active ingredient comprises: chopping the angelica and soaking it in an ethanol aqueous solution b, refluxing the extract, concentrating the ethanol extract, drying, and sieving to obtain the angelica extract.

[0046] Preferably, the volume fraction of ethanol in the ethanol aqueous solution b is 60-80%.

[0047] The specific values ​​of 60-80% can be 60%, 62%, 64%, 66%, 68%, 70%, 72%, 74%, 76%, 78% or 80%, etc. Other specific values ​​within the above numerical ranges can be selected and will not be detailed here.

[0048] Preferably, the reflux extraction is repeated 1-3 times, wherein the 1-3 times include 1 time, 2 times and 3 times.

[0049] Preferably, the mesh number of the sieve for screening is 70-90 mesh, such as 70 mesh, 75 mesh, 80 mesh, 85 mesh or 90 mesh, and other specific point values ​​within the above numerical ranges can be selected, which will not be repeated here.

[0050] Preferably, the method for extracting the green tea extract in the active ingredient in step (2) comprises: boiling green tea with water for 3-8 hours, filtering, concentrating the filtrate, drying, and sieving to obtain the green tea extract.

[0051] Preferably, the decoction and filtration are repeated 1-3 times, wherein the 1-3 times include 1 time, 2 times and 3 times.

[0052] Preferably, the mesh number of the sieve is 70-90 mesh, for example, 70 mesh, 75 mesh, 80 mesh, 85 mesh or 90 mesh, and other specific values ​​within the above numerical ranges can be selected, which will not be repeated here.

[0053] Preferably, the preparation method of the active ingredient also includes a method for extracting Chuanxiong extract, which comprises: chopping Chuanxiong and soaking it in ethanol aqueous solution c, refluxing extraction, concentrating the ethanol extract, drying, and sieving to obtain the Chuanxiong extract.

[0054] Preferably, the volume fraction of ethanol in the ethanol aqueous solution c is 80-90%.

[0055] The specific values ​​of 80-90% can be 80%, 82%, 84%, 86%, 88% or 90%, etc. Other specific values ​​within the above numerical ranges can be selected and will not be described in detail here.

[0056] Preferably, the reflux extraction is repeated 1-3 times, wherein the 1-3 times include 1 time, 2 times and 3 times.

[0057] Preferably, the mesh number of the sieve for screening is 70-90 mesh, such as 70 mesh, 75 mesh, 80 mesh, 85 mesh or 90 mesh, and other specific point values ​​within the above numerical ranges can be selected, which will not be repeated here.

[0058] During the preparation of the ginseng extract, angelica extract and ligusticum chuanxiong extract of the present invention, when the volume fractions of the ethanol aqueous solution are 80-95%, 60-80% and 80-90% respectively, the gel composition has a stronger effect on uterine restoration and has better analgesic and antibacterial effects.

[0059] In a third aspect, the present invention provides use of the gel composition for improving female reproductive health as described in the first aspect in preparing female reproductive health products.

[0060] Preferably, the use locations of the gel composition include Guanyuan acupoint, Shenque acupoint, Zhongji acupoint, Gongyi acupoint, Xuehai acupoint, Sanyinjiao acupoint, Shenshu acupoint or any one or a combination of at least two of other acupoints located in the lower abdomen area. The combination of at least two includes, for example, a combination of Guanyuan acupoint and Shenque acupoint, a combination of Guanyuan acupoint and Zhongji acupoint, a combination of Gongyi acupoint and Xuehai acupoint, etc. Any other combination can be selected and will not be described here one by one.

[0061] Preferably, the application site of the gel composition includes Guanyuan acupoint and / or Shenque acupoint.

[0062] Compared with the prior art, the present invention has the following beneficial effects:

[0063] The present invention creatively combines ginseng extract, angelica extract, and green tea extract to improve female reproductive health. The three ingredients complement each other and synergize to create a synergistic effect. Through the synergistic effect between the components, the resulting active ingredient has significant effects in promoting uterine involution, promoting lochia discharge, inhibiting bacteria and inflammation, and relieving pain. Furthermore, the present invention creatively incorporates the active ingredients into a gel product. The gel product, combined with the penetration of ultrasound, promotes absorption of the active ingredients in the gel, further enhancing the effectiveness of the active ingredients and avoiding the low absorption rate of oral tonics in postpartum women due to weak gastrointestinal function. DETAILED DESCRIPTION

[0064] The technical solution of the present invention is further described below by way of specific embodiments. It should be understood by those skilled in the art that the embodiments are only provided to help understand the present invention and should not be regarded as specific limitations of the present invention.

[0065] If no specific techniques or conditions are specified in the examples, the experiments were carried out according to the techniques or conditions described in the literature in the field or according to the product instructions. If no manufacturer is specified for the reagents or instruments used, they are all conventional products that can be purchased through regular channels.

[0066] Preparation Example 1

[0067] This preparation example provides a ginseng extract, and the preparation method thereof is as follows: chop the ginseng, soak it in a 90% ethanol aqueous solution for 30 hours, reflux extract it three times, each time for 2 hours, concentrate the ethanol extract under reduced pressure, dry it at 80°C, and sieve it through an 80-mesh sieve to obtain the ginseng extract.

[0068] Preparation Example 2

[0069] This preparation example provides a ginseng extract, and the preparation method thereof is as follows: chop the ginseng, soak it in a 75% ethanol aqueous solution for 30 hours, reflux extract three times, each time for 2 hours, concentrate the ethanol extract under reduced pressure, dry it at 80°C, and sieve it through an 80-mesh sieve to obtain the ginseng extract.

[0070] Preparation Example 3

[0071] This preparation example provides a ginseng extract, and the preparation method thereof is as follows: chop the ginseng, soak it in a 98% ethanol aqueous solution for 30 hours, reflux extract three times, each time for 2 hours, concentrate the ethanol extract under reduced pressure, dry it at 80°C, and sieve it through an 80-mesh sieve to obtain the ginseng extract.

[0072] Preparation Example 4

[0073] This preparation example provides an angelica extract, and the preparation method is as follows: mince the angelica and soak it in a 70% ethanol aqueous solution for 30 hours, reflux extract three times, each time for 2 hours, concentrate the ethanol extract under reduced pressure, dry it at 80°C, and sieve it through an 80-mesh sieve to obtain the angelica extract.

[0074] Preparation Example 5

[0075] This preparation example provides an angelica extract, and the preparation method is as follows: mince the angelica and soak it in a 50% ethanol aqueous solution for 30 hours, reflux extract three times, each time for 2 hours, concentrate the ethanol extract under reduced pressure, dry it at 80°C, and sieve it through an 80-mesh sieve to obtain the angelica extract.

[0076] Preparation Example 6

[0077] This preparation example provides an angelica extract, and the preparation method is as follows: mince the angelica and soak it in a 90% ethanol aqueous solution for 30 hours, reflux extract three times, each time for 2 hours, concentrate the ethanol extract under reduced pressure, dry it at 80°C, and sieve it through an 80-mesh sieve to obtain the angelica extract.

[0078] Preparation Example 7

[0079] This preparation example provides a Chuanxiong extract, and the preparation method is as follows: chop the Chuanxiong and soak it in 85% ethanol aqueous solution for 30 hours, reflux extract 3 times, each time for 2 hours, concentrate the ethanol extract under reduced pressure, dry it at 80°C, and sieve it with an 80-mesh sieve to obtain the Chuanxiong extract.

[0080] Preparation Example 8

[0081] This preparation example provides a Chuanxiong extract, and the preparation method is as follows: chop the Chuanxiong and soak it in a 75% ethanol aqueous solution for 30 hours, reflux extract three times, each time for 2 hours, concentrate the ethanol extract under reduced pressure, dry it at 80°C, and sieve it through an 80-mesh sieve to obtain the Chuanxiong extract.

[0082] Preparation Example 9

[0083] This preparation example provides a Chuanxiong extract, and the preparation method is as follows: chop the Chuanxiong and soak it in a 95% ethanol aqueous solution for 30 hours, reflux extract three times, each time for 2 hours, concentrate the ethanol extract under reduced pressure, dry it at 80°C, and sieve it through an 80-mesh sieve to obtain the Chuanxiong extract.

[0084] Preparation Example 10

[0085] This preparation example provides a green tea extract, and the preparation method thereof is as follows: green tea is decocted with water for 6 hours, decocted and filtered, and repeated three times; the filtrate is concentrated, dried at 80° C., and sieved through an 80-mesh sieve to obtain the green tea extract.

[0086] Example 1

[0087] This embodiment provides a gel composition for improving female reproductive health, and the preparation method thereof is as follows: first, each raw material is sterilized at high temperature and high pressure; then, 100 parts of water and 1 part of carbomer 940 are mixed, and the mixture is allowed to stand to obtain 101 parts of carbomer 940 solution; 20 parts of glycerin, 10 parts of ginseng extract prepared in Preparation Example 1, 5 parts of angelica extract prepared in Preparation Example 4, 3 parts of green tea extract prepared in Preparation Example 10, 2 parts of Chuanxiong extract prepared in Preparation Example 7, 101 parts of carbomer 940 solution, and 80 parts of water are mixed to obtain the gel composition for improving female reproductive health.

[0088] Example 2

[0089] This embodiment provides a gel composition for improving female reproductive health, and the preparation method thereof is as follows: first, each raw material is sterilized at high temperature and high pressure, and then 80 parts of water and 0.5 parts of carbomer 940 are mixed and allowed to stand to obtain 80.5 parts of carbomer 940 solution; 5 parts of glycerin, 4 parts of ginseng extract prepared in Preparation Example 1, 5 parts of angelica extract prepared in Preparation Example 4, 20 parts of green tea extract prepared in Preparation Example 10, 1 part of Chuanxiong extract prepared in Preparation Example 7, 80.5 parts of carbomer 940 solution and 80 parts of water are mixed to obtain the gel composition for improving female reproductive health.

[0090] Example 3

[0091] This embodiment provides a gel composition for improving female reproductive health, and the preparation method thereof is as follows: first, each raw material is sterilized at high temperature and high pressure; then, 200 parts of water and 2 parts of carbomer 940 are mixed and allowed to stand to obtain 202 parts of carbomer 940 solution; 30 parts of propylene glycol, 16 parts of ginseng extract prepared in Preparation Example 1, 2 parts of angelica extract prepared in Preparation Example 4, 1 part of green tea extract prepared in Preparation Example 10, 2 parts of Chuanxiong extract prepared in Preparation Example 7, 202 parts of carbomer 940 solution and 110 parts of water are mixed to obtain the gel composition for improving female reproductive health.

[0092] Example 4

[0093] This embodiment provides a gel composition for improving female reproductive health. The preparation method thereof differs from that of Example 1 only in that 10 parts of the ginseng extract prepared in Preparation Example 1, 5 parts of the angelica extract prepared in Preparation Example 4, 3 parts of the green tea extract prepared in Preparation Example 10, and 2 parts of the Chuanxiong extract prepared in Preparation Example 7 are replaced with 11.1 parts of the ginseng extract prepared in Preparation Example 1, 5.6 parts of the angelica extract prepared in Preparation Example 4, and 3.3 parts of the green tea extract prepared in Preparation Example 10. The rest is the same as in Example 1.

[0094] Example 5

[0095] This embodiment provides a gel composition for improving female reproductive health. The preparation method thereof is the same as that of Example 1 except that one part of Carbomer 940 in the raw materials is replaced with one part of chitosan. The rest is the same as that of Example 1.

[0096] Example 6

[0097] This embodiment provides a gel composition for improving female reproductive health. The preparation method thereof differs from that of Example 1 only in that 10 parts of the ginseng extract prepared in Preparation Example 1, 5 parts of the angelica extract prepared in Preparation Example 4, and 3 parts of the green tea extract prepared in Preparation Example 10 are replaced with 1 part of the ginseng extract prepared in Preparation Example 1, 2 parts of the angelica extract prepared in Preparation Example 4, and 15 parts of the green tea extract prepared in Preparation Example 10. The rest is the same as in Example 1.

[0098] Example 7

[0099] This embodiment provides a gel composition for improving female reproductive health. The preparation method thereof differs from that of Example 1 only in that 10 parts of the ginseng extract prepared in Preparation Example 1, 5 parts of the angelica extract prepared in Preparation Example 4, and 3 parts of the green tea extract prepared in Preparation Example 10 are replaced with 16 parts of the ginseng extract prepared in Preparation Example 1, 1.5 parts of the angelica extract prepared in Preparation Example 4, and 0.5 parts of the green tea extract prepared in Preparation Example 10. The rest is the same as in Example 1.

[0100] Example 8

[0101] This embodiment provides a gel composition for improving female reproductive health. The preparation method thereof differs from that of Example 1 only in that 10 parts of the ginseng extract prepared in Preparation Example 1, 5 parts of the angelica extract prepared in Preparation Example 4, 3 parts of the green tea extract prepared in Preparation Example 10, and 2 parts of the Chuanxiong extract prepared in Preparation Example 7 in the raw materials are replaced with 10 parts of the ginseng extract prepared in Preparation Example 2, 5 parts of the angelica extract prepared in Preparation Example 5, 3 parts of the green tea extract prepared in Preparation Example 10, and 2 parts of the Chuanxiong extract prepared in Preparation Example 8.

[0102] Example 9

[0103] This embodiment provides a gel composition for improving female reproductive health. The preparation method thereof differs from that of Example 1 only in that 10 parts of the ginseng extract prepared in Preparation Example 1, 5 parts of the angelica extract prepared in Preparation Example 4, 3 parts of the green tea extract prepared in Preparation Example 10, and 2 parts of the Chuanxiong extract prepared in Preparation Example 7 in the raw materials are replaced with 10 parts of the ginseng extract prepared in Preparation Example 3, 5 parts of the angelica extract prepared in Preparation Example 6, 3 parts of the green tea extract prepared in Preparation Example 10, and 2 parts of the Chuanxiong extract prepared in Preparation Example 9.

[0104] Comparative Example 1

[0105] This comparative example provides a gel composition for improving female reproductive health. The preparation method thereof differs from that of Example 1 only in that 10 parts of the ginseng extract prepared in Preparation Example 1, 5 parts of the angelica extract prepared in Preparation Example 4, and 3 parts of the green tea extract prepared in Preparation Example 10 in the raw materials are replaced with 11.25 parts of the angelica extract prepared in Preparation Example 4 and 6.75 parts of the green tea extract prepared in Preparation Example 10. The rest is the same as in Example 1.

[0106] Comparative Example 2

[0107] This comparative example provides a gel composition for improving female reproductive health. The preparation method thereof differs from that of Example 1 only in that 10 parts of the ginseng extract prepared in Preparation Example 1, 5 parts of the angelica extract prepared in Preparation Example 4, and 3 parts of the green tea extract prepared in Preparation Example 10 in the raw materials are replaced with 13.85 parts of the ginseng extract prepared in Preparation Example 1 and 4.15 parts of the green tea extract prepared in Preparation Example 10. The rest is the same as in Example 1.

[0108] Comparative Example 3

[0109] This comparative example provides a gel composition for improving female reproductive health. The preparation method thereof differs from that of Example 1 only in that 10 parts of the ginseng extract prepared in Preparation Example 1, 5 parts of the angelica extract prepared in Preparation Example 4, and 3 parts of the green tea extract prepared in Preparation Example 10 are replaced with 12 parts of the ginseng extract prepared in Preparation Example 1 and 6 parts of the angelica extract prepared in Preparation Example 4. The rest is the same as in Example 1.

[0110] Comparative Example 4

[0111] This comparative example provides a gel composition for improving female reproductive health. The preparation method thereof differs from that of Example 1 only in that 10 parts of the ginseng extract prepared in Preparation Example 1, 5 parts of the angelica extract prepared in Preparation Example 4, and 3 parts of the green tea extract prepared in Preparation Example 10 are replaced with 18 parts of the ginseng extract prepared in Preparation Example 1. The rest is the same as in Example 1.

[0112] Comparative Example 5

[0113] This comparative example provides a gel composition for improving female reproductive health. The preparation method thereof differs from that of Example 1 only in that 10 parts of the ginseng extract prepared in Preparation Example 1, 5 parts of the angelica extract prepared in Preparation Example 4, and 3 parts of the green tea extract prepared in Preparation Example 10 are replaced with 18 parts of the angelica extract prepared in Preparation Example 4. The rest is the same as in Example 1.

[0114] Comparative Example 6

[0115] This comparative example provides a gel composition for improving female reproductive health. The preparation method thereof differs from that of Example 1 only in that 10 parts of the ginseng extract prepared in Preparation Example 1, 5 parts of the angelica extract prepared in Preparation Example 4, and 3 parts of the green tea extract prepared in Preparation Example 10 in the raw materials are replaced with 18 parts of the green tea extract prepared in Preparation Example 10. The rest is the same as in Example 1.

[0116] Comparative Example 7

[0117] This comparative example provides a gel composition for improving female reproductive health. The preparation method thereof differs from that of Example 1 only in that 10 parts of the ginseng extract prepared in Preparation Example 1, 5 parts of the angelica extract prepared in Preparation Example 4, 3 parts of the green tea extract prepared in Preparation Example 10, and 2 parts of the Chuanxiong extract prepared in Preparation Example 7 in the raw materials are replaced with 20 parts of the Chuanxiong extract prepared in Preparation Example 7. The rest is the same as in Example 1.

[0118] Test Example 1

[0119] The gel compositions prepared in Examples 1-9 and Comparative Examples 1-7 were evaluated for their uterine involution and analgesic properties. The specific evaluation method was as follows: the gel compositions prepared in Examples 1-9 and Comparative Examples 1-7 were used in conjunction with an ultrasonic therapy device, and 170 volunteers jointly evaluated the uterine involution, lochia discharge, and analgesic properties of the gel compositions. (1) Volunteer selection criteria: Selection criteria for women undergoing natural childbirth: a. All women had indications for natural childbirth; b. Coagulation function and blood routine tests were within the normal range; c. Exclusion criteria were established: patients with blood system diseases, immune system diseases, infectious diseases, etc.; patients with uterine diseases such as uterine fibroids, uterine scars, and those who had undergone cesarean sections; and patients with dysfunction of important organs such as the heart, liver, kidney, and lung were excluded. Selection criteria for cesarean section mothers: a. All mothers have indications for cesarean section; b. Coagulation function and blood routine tests are within the normal range; c. Exclusion criteria are established: patients with blood system diseases, immune system diseases, infectious diseases, etc.; uterine diseases such as uterine fibroids, scarred uterus, uterine cysts, and those with previous cesarean section; those with insufficiency of important organs such as heart, liver, kidney, and lung are excluded. A total of 85 full-term natural delivery mothers and 85 full-term cesarean section mothers were selected. (2) 170 volunteers were divided into 17 groups, each group including 5 full-term natural delivery mothers and 5 full-term cesarean section mothers. Group 1 used the commercially available Xishikang medical ultrasound coupling agent (Luwei Medical Equipment No. 20170002), and Groups 2-17 used the gel compositions prepared in Examples 1-9 and Comparative Examples 1-7 in turn, of which Group 1 was the blank group. (3) Volunteers began treatment 24 hours after delivery, once a day, for 10 consecutive days. The specific operation was as follows: the gel composition was combined with an ultrasonic physiotherapy device to stimulate the surface projection area of ​​the uterine fundus and uterine horn of the parturient for 30 minutes continuously. The ultrasonic intensity was 2.5W / cm 2(4) The therapeutic effect of the gel composition was evaluated by calculating the difference rate based on the average of the sum of the decrease in the height of the uterine fundus during the first 7 days after delivery, the pain level on the 3rd day, and the duration of lochia in each group, wherein the pain level was evaluated according to the VAS numerical grading method, and the difference rate = the data of each example or comparative example / the data of Example 1.

[0120] Table 1

[0121]

[0122]

[0123] As can be seen from the data in Table 1, the active ingredient in Example 4 does not contain Chuanxiong extract. Compared with Example 1, the volunteers' lochia lasted longer, the pain symptoms were more severe, and the height of the uterine fundus dropped less in the first 7 days, indicating that the combination of Chuanxiong extract with ginseng extract, angelica extract, and green tea extract has better uterine involution and analgesic effects; the mass ratio of ginseng extract, angelica extract, and green tea extract in Examples 6 and 7 was outside the preferred range, and the degree of uterine fundus drop was less than that in Example 1, the lochia lasted longer, and the pain symptoms were more obvious. The results showed that when the mass ratio of ginseng extract, angelica extract and green tea extract was within the range of (0.8-8):1:(0.5-6), the promoting effect on uterine involution was stronger and the analgesic effect was better. In the preparation process of the gel composition of Examples 8 and 9, the volume fraction of the ethanol aqueous solution used when extracting the three components of ginseng extract, angelica extract and Chuanxiong extract was outside the preferred range. The volunteers in the groups of Examples 8 and 9 had longer lochia duration and more obvious pain than those in Example 1, indicating that when the ginseng extract, angelica extract and Chuanxiong extract were used, the lochia duration was longer and the pain was more obvious. When the extract is used in an ethanol aqueous solution with a volume fraction of 80-95%, 60-80%, and 80-90%, respectively, the gel composition has a stronger effect on uterine restoration and analgesia; the raw materials for the preparation of the active ingredients of Comparative Examples 1-3 lack ginseng extract, angelica extract, and green tea extract, respectively. Compared with Example 1, the volunteers of Comparative Examples 1-3 have a slow rate of uterine fundus descent, slow lochia clearance, and more severe pain, indicating that the absence of any of the three components of ginseng extract, angelica extract, and green tea extract will weaken the gel composition's effect of promoting uterine restoration and analgesia; the active ingredients in Comparative Examples 4-6 contain only one of the three components of ginseng extract, angelica extract, and green tea extract. Compared with Example 1, the rate of uterine fundus descent is slower, the lochia clearance effect is worse, and the pain relief is not obvious compared with the blank group, indicating that only one of the three components of ginseng extract, angelica extract, and green tea extract cannot fully exert the function of the gel composition, and the three components must be used in combination to maximize their efficacy in promoting postpartum uterine recovery and relieving pain. In Comparative Example 7, the active ingredient contains only Chuanxiong extract. Compared with Example 1, its uterine recovery rate is slower and the lochia duration is longer, indicating that when the active ingredient contains only Chuanxiong extract, the gel composition cannot fully exert the effect of promoting the recovery of the uterine state and promoting the discharge of lochia.

[0124] Test Example 2

[0125] The antibacterial performance of the gel compositions prepared in Examples 1-9 and Comparative Examples 1-7 was evaluated. The specific evaluation method was as follows: (1) PBS buffer was used to prepare a gel composition with a concentration of 10 6coli (ATCC25922) suspension at 100 μL of CFU / mL; (2) 100 μL of the E. coli suspension in (1) was dripped onto the center of the LB solid plate and evenly spread; (3) Under a sterile environment, a filter paper with a diameter of 6 mm was dried in an oven using tweezers for 1 hour, and then immersed in the gel composition prepared in Examples 1-9 and Comparative Examples 1-7 for 20 minutes, and then attached to a solid plate containing bacteria. Each example or comparative example corresponds to one plate, and three positions are set on one plate, each position corresponding to one filter paper; (4) The bacteria-containing plate with the filter paper attached was placed upside down in a 37°C constant temperature incubator and cultured for 24 hours; (5) After taking out, the diameter of the antibacterial zone of the filter paper was measured using a vernier caliper, the average value was calculated, and the difference in antibacterial performance was calculated, the difference in antibacterial performance = the diameter of the antibacterial zone of each example or comparative example / the diameter of the antibacterial zone of Example 1 × 100%, and the antibacterial performance of each example and the comparative example was compared using the difference in antibacterial performance.

[0126] Table 2

[0127] Differences in antibacterial performance Example 1 100％ Example 2 96％ Example 3 89％ Example 4 90％ Example 5 78％ Example 6 88％ Example 7 82％ Example 8 70％ Example 9 65％ Comparative Example 1 41％ Comparative Example 2 60％ Comparative Example 3 42％ Comparative Example 4 37％ Comparative Example 5 25％ Comparative Example 6 52％ Comparative Example 7 23％

[0128] As can be seen from the data in Table 2, compared with Example 1, Example 5 uses chitosan instead of carbomer 940 as the gel material, and its antibacterial performance is worse than that of Example 1, indicating that when carbomer 940 is used as the gel material, the antibacterial effect of the gel composition is better; in the preparation process of the gel composition of Examples 8 and 9, when extracting the three components of ginseng extract, angelica extract and Chuanxiong extract, the volume fraction of the ethanol aqueous solution used is outside the preferred range. Examples 8 and 9 have higher antibacterial efficiency than Example 1, indicating that when the ginseng extract, angelica extract and Chuanxiong extract use ethanol aqueous solution with a volume fraction of 80-95%, 60-80% and 80-90% respectively , the gel composition has a stronger antibacterial and anti-inflammatory effect; the raw materials for preparing the active ingredients of comparative examples 1-3 lack ginseng extract, angelica extract and green tea extract respectively, and the antibacterial properties corresponding to comparative examples 1-3 are worse than those in Example 1, indicating that the absence of any of the three components of ginseng extract, angelica extract and green tea extract will weaken the antibacterial effect of the gel composition; the active ingredients in comparative examples 4-6 only contain one of the three components of ginseng extract, angelica extract and green tea extract, and their antibacterial properties are even worse, indicating that the synergistic effect of only containing the three components of ginseng extract, angelica extract and green tea extract can maximize its antibacterial effect.

[0129] The preferred embodiments of the present invention are described in detail above. However, the present invention is not limited to the specific details in the above embodiments. Within the technical concept of the present invention, various simple modifications can be made to the technical solution of the present invention, and these simple modifications all fall within the scope of protection of the present invention.

[0130] It should also be noted that the various specific technical features described in the above specific embodiments can be combined in any appropriate manner without contradiction. In order to avoid unnecessary repetition, the present invention will not further describe various possible combinations.

Claims

1. A gel composition for improving female reproductive health, characterized in that: The raw materials for preparing the gel composition include, by mass, 8-50 parts of active ingredients, 0.2-3 parts of gel material, 5-30 parts of moisturizing agent and 100-500 parts of water; The active ingredients are composed of ginseng extract, angelica extract, green tea extract and Chuanxiong extract; The mass ratio of the ginseng extract, the angelica extract, the green tea extract and the Chuanxiong extract is (0.8-8):1:(0.5-6):(0.2-10).

2. The gel composition for improving female reproductive health according to claim 1, wherein: The gel material includes any one of hydroxyethyl cellulose, carbomer 940, hydroxypropyl cellulose, hyaluronic acid or chitosan, or a combination of at least two of them.

3. The gel composition for improving female reproductive health according to claim 2, wherein: The gel material includes Carbomer 940.

4. The gel composition for improving female reproductive health according to claim 1, wherein: The humectant includes glycerin and / or propylene glycol.

5. The gel composition for improving female reproductive health according to claim 1, wherein: The gel composition further includes a preservative, which includes any one of ethylparaben, sodium benzoate, benzalkonium bromide or sorbic acid, or a combination of at least two thereof.

6. The method for preparing the gel composition for improving female reproductive health according to any one of claims 1 to 5, characterized in that: The preparation method comprises: (1) mixing water and the gel material, and allowing to stand to obtain a gel material solution; (2) Mixing the moisturizing agent, the active ingredient, the gel material solution and water to obtain the gel composition for improving female reproductive health.

7. The method for preparing the gel composition for improving female reproductive health according to claim 6, wherein: The mass ratio of water to gel material in step (1) is (80-200):

1.

8. The method for preparing the gel composition for improving female reproductive health according to claim 6, wherein: The mass ratio of water to gel material solution in step (2) is (0.4-2):

1.

9. The method for preparing the gel composition for improving female reproductive health according to claim 6, wherein: The standing time in step (1) is 3-8 hours.

10. The method for preparing the gel composition for improving female reproductive health according to claim 6, wherein: The method for extracting the ginseng extract from the active ingredient in step (2) comprises: chopping the ginseng and soaking it in an ethanol-water solution a, refluxing the extract, concentrating the ethanol extract, drying, and sieving to obtain the ginseng extract.

11. The method for preparing the gel composition for improving female reproductive health according to claim 10, wherein: The volume fraction of ethanol in the ethanol aqueous solution a is 80-95%.

12. The method for preparing the gel composition for improving female reproductive health according to claim 10, wherein: The reflux extraction is repeated 1-3 times.

13. The method for preparing the gel composition for improving female reproductive health according to claim 10, wherein: The mesh number of the sieve is 70-90 meshes.

14. The method for preparing the gel composition for improving female reproductive health according to claim 6, wherein: The extraction method of the angelica extract in the active ingredient in step (2) comprises: chopping the angelica and soaking it in an ethanol aqueous solution b, refluxing the extract, concentrating the ethanol extract, drying, and sieving to obtain the angelica extract.

15. The method for preparing the gel composition for improving female reproductive health according to claim 14, wherein: The volume fraction of ethanol in the ethanol aqueous solution b is 60-80%.

16. The method for preparing the gel composition for improving female reproductive health according to claim 14, wherein: The reflux extraction is repeated 1-3 times.

17. The method for preparing the gel composition for improving female reproductive health according to claim 14, wherein: The mesh number of the sieve is 70-90 meshes.

18. The method for preparing the gel composition for improving female reproductive health according to claim 6, wherein: The method for extracting the green tea extract in the active ingredient in step (2) comprises: boiling green tea with water for 3-8 hours, filtering, concentrating the filtrate, drying, and sieving to obtain the green tea extract.

19. The method for preparing the gel composition for improving female reproductive health according to claim 18, wherein: The decoction and filtration are repeated 1-3 times.

20. The method for preparing the gel composition for improving female reproductive health according to claim 18, wherein: The mesh number of the sieve is 70-90 meshes.

21. The method for preparing the gel composition for improving female reproductive health according to claim 6, wherein: The extraction method of the Chuanxiong extract in the active ingredient in step (2) comprises: chopping the Chuanxiong and soaking it in an ethanol aqueous solution c, refluxing the extract, concentrating the ethanol extract, drying, and sieving to obtain the Chuanxiong extract.

22. The method for preparing the gel composition for improving female reproductive health according to claim 21, wherein: The volume fraction of ethanol in the ethanol aqueous solution c is 80-90%.

23. The method for preparing the gel composition for improving female reproductive health according to claim 21, wherein: The reflux extraction is repeated 1-3 times.

24. The method for preparing the gel composition for improving female reproductive health according to claim 21, wherein: The mesh number of the sieve is 70-90 meshes.

25. Use of the gel composition for improving female reproductive health according to any one of claims 1 to 5 in the preparation of female reproductive health products.

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