A black tiger palace of warm uterus and blood stasis regulating postpartum repair of external use nursing gel and preparation method

Abstract

The application discloses a black tiger uterus-warming blood-stasis-removing menstruation-regulating postpartum-repairing external use nursing gel and a preparation method thereof, and belongs to the technical field of external use nursing gels. The gel is prepared from black tiger root extract as a monarch drug, combined with angelica extract, chuanxiong extract and motherwort extract as an efficacy core, supplemented with moxa leaf temperature-sensing factor, sodium hyaluronate and carbomer-triethanolamine gel matrix, and prepared according to a specific mass percentage ratio. The application solves the problems of single efficacy, poor use experience and insufficient safety of existing external use uterus-warming and postpartum-repairing products, realizes three effects of uterus-warming, cold dispelling, qi-promoting and blood-stasis-removing and postpartum-repairing, has the characteristics of fast transdermal absorption, non-greasy, non-clothes-staining, mildness and safety, and can be directly used in menstrual period and postpartum-repairing period, and is suitable for daily, menstrual and postpartum multiple scene use.

Description

Technical Field

[0001] This invention relates to the field of external care gel technology, and in particular to a black tiger-shaped external care gel for warming the uterus, removing blood stasis, regulating menstruation, and postpartum repair, as well as its preparation method. Background Technology

[0002] Menstrual cramps due to cold uterus are a very common physiological problem among women. Its main clinical manifestations include lower abdominal pain during menstruation, pain relieved by warmth, poor menstrual flow, dark menstrual blood with clots, and in severe cases, it can affect a woman's normal work and life. Postpartum women, due to the loss of qi and blood and internal blood stasis during childbirth, often experience problems such as incomplete lochia, lower abdominal distension, and slow uterine involution. Improper care can easily lead to subsequent gynecological discomfort and affect postpartum recovery.

[0003] Currently, the variety of topical products on the market for treating menstrual cramps and postpartum recovery due to cold uterus is relatively limited, mainly including heating patches, massage oils, and traditional plasters. Among them, heating patches, while providing a temporary warming sensation, have drawbacks such as being prone to burning the skin and causing allergic reactions; massage oils are greasy when used, easily staining clothing, and the active ingredients are slowly absorbed through the skin, resulting in a delayed onset of action; traditional plasters have poor breathability, easily attract lint after application, have low wearing comfort, and can easily lead to stuffy and uncomfortable skin with long-term use.

[0004] In summary, existing topical products generally suffer from problems such as limited efficacy, poor user experience, and insufficient safety. The market lacks a specialized topical care gel that is gentle and non-irritating, absorbs quickly through the skin, is non-greasy, can be applied directly during menstruation and postpartum, and has the dual effects of warming the uterus, dispelling cold, removing blood stasis, relieving pain, and assisting in postpartum recovery. Therefore, developing a topical gel that solves the above problems has significant market value and application significance. Summary of the Invention

[0005] In response to the technical shortcomings of existing external products for warming the uterus and postpartum repair, such as limited efficacy, slow transdermal absorption, greasiness, staining on clothing, insufficient safety, and inability to simultaneously meet the needs of menstruation and postpartum repair, this invention provides a safe, gentle, and rapidly absorbed external care gel that does not stain clothing and is suitable for use during menstruation and postpartum repair. It achieves a three-in-one effect of warming the uterus and dispelling cold, promoting qi circulation and removing blood stasis, and postpartum repair, filling the market gap of existing products and meeting the care needs of women at different physiological stages.

[0006] This Black Tiger Warming Uterus, Blood Stasis Removing, Menstrual Regulating, and Postpartum Repair External Care Gel comprises the following components by weight percentage: Black tiger root extract 15%–25%, Angelica sinensis extract 4%–8%, Ligusticum chuanxiong extract 2%–6%, Leonurus japonicus extract 3%–7%, Artemisia argyi temperature-sensitive factor 0.5%–2%, the balance being gel matrix and water.

[0007] Furthermore, the black tiger root extract is prepared using a supercritical CO2 low-temperature extraction process with the following extraction conditions: pressure 25 MPa, temperature 45 °C, and lignan content ≥8% in the extract.

[0008] Furthermore, the matrix of the gel is a carbomer-triethanolamine system, with a pH value controlled at 5.8–6.8, preferably 6.0–6.5.

[0009] Furthermore, the gel is in the form of a rollerball applicator or a tube applicator, preferably a rollerball applicator.

[0010] Further, by mass percentage, it includes the following components: 20% black tiger root extract, 6% angelica extract, 4% chuanxiong extract, 5% motherwort extract, 1% mugwort temperature-sensitive factor, 0.3% sodium hyaluronate, 0.8% carbomer, 0.5% 1,2-hexanediol, triethanolamine to adjust pH to 6.0–6.5, and purified water to make up to 100%.

[0011] The preparation method of the above-mentioned topical care gel includes the following steps: (1) Preparation of aqueous phase: Carbomer was added to purified water, swollen overnight, and stirred evenly to obtain the aqueous phase; (2) Low temperature mixing: In an environment below 40℃, black tiger root extract, angelica extract, chuanxiong extract, motherwort extract and mugwort temperature-sensitive factor are mixed evenly to obtain an efficacy mixture; (3) Mixing and homogenizing: Add the efficacy mixture obtained in step (2) to the aqueous phase obtained in step (1), stir and homogenize for 5 minutes to obtain the mixture; (4) Adjust pH: Add triethanolamine dropwise to the mixture obtained in step (3) to adjust the pH to 5.8–6.8 to form a gel; (5) Adding excipients at low temperature: Cool the gel obtained in step (4) to below 35°C, add sodium hyaluronate and 1,2-hexanediol, and stir evenly; (6) Filling: Fill and seal the gel obtained in step (5) using a ball bottle or tube to obtain the finished product.

[0012] The beneficial effects of this invention are as follows: 1. Outstanding originality, filling a market gap: For the first time, high-content black tiger root extract is applied to a topical gel for warming the uterus, removing blood stasis, regulating menstruation, and postpartum repair. With black tiger root extract as the principal ingredient, combined with extracts of angelica, chuanxiong, and motherwort, it achieves a three-in-one effect of warming the uterus and dispelling cold, promoting qi circulation and removing blood stasis, and postpartum repair. This solves the problem of single efficacy of existing products and fills the market gap for a special topical gel that has both warming and blood stasis removal effects and can be used for both menstruation and postpartum. It has unique technological innovation. 2. Fast transdermal absorption and excellent user experience: The hydrogel matrix combined with small molecule plant extracts has a refreshing and delicate texture. It dries and becomes non-greasy within 5 minutes after application and does not stain clothes, solving the shortcomings of traditional massage oils being greasy and plasters being sticky. At the same time, the small molecule active ingredients can be quickly absorbed through the skin, taking effect rapidly without the need for long-term massage, making it convenient to use. 3. Mild and safe, with a wide range of applications: The gel of this invention has been verified to be non-irritating through rabbit skin irritation test; the vaginal mucosa irritation test has verified to be extremely mild, with high safety. It can be used directly during menstruation and can be started 2 weeks postpartum, making it suitable for women at different physiological stages. 4. Convenient to use and suitable for multiple scenarios: It uses a roller ball bottle or tube for filling. The roller ball design allows for one-handed application without the need for washing, making it easy to operate. The tube design makes it easy to carry and control the dosage, making it suitable for various scenarios such as daily care, relieving menstrual cramps, and postpartum recovery, meeting the care needs of women at different times. Attached Figure Description

[0013] To more clearly illustrate the technical solutions of the embodiments of the present invention, the accompanying drawings used in the embodiments will be briefly introduced below. It should be understood that the following drawings only show some embodiments of the present invention and should not be regarded as a limitation of the scope. For those skilled in the art, other related drawings can be obtained based on these drawings without creative effort.

[0014] Figure 1 This is a flowchart of the preparation method of the present invention. Detailed Implementation

[0015] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0016] A black tiger-shaped external care gel for warming the uterus, removing blood stasis, regulating menstruation, and postpartum repair, comprising the following components by weight percentage: Black tiger root extract: 15%–25%, as the principal ingredient, it undertakes the core functions of promoting qi and blood circulation, dispelling cold and relieving pain. Its extraction process directly affects the overall efficacy of the gel. Angelica sinensis extract: 4%–8%, as an adjuvant, has the effects of nourishing blood, promoting blood circulation, regulating menstruation and removing blood stasis. It can assist black tiger root extract in enhancing the effects of promoting qi circulation and removing blood stasis, while improving the problem of postpartum qi and blood deficiency. Ligusticum chuanxiong extract: 2%–6%, as an adjuvant, can promote blood circulation, dispel wind and relieve pain. When combined with Angelica sinensis, it can further enhance the effects of regulating menstruation, removing blood stasis, and relieving dysmenorrhea. Motherwort extract: 3%–7%, has the effects of removing blood stasis and promoting new blood production, regulating menstruation and promoting the discharge of lochia after childbirth, accelerating uterine involution and helping postpartum recovery; Artemisia argyi warming factor: 0.5%–2%, which can warm the meridians and dispel cold, promote qi circulation and relieve pain, while providing a gentle and lasting warming sensation to relieve lower abdominal pain caused by uterine cold and improve user comfort; Sodium hyaluronate: 0.2%–0.5%, has good moisturizing and repairing effects, can reduce the irritation of plant extracts to the skin, improve the gentleness of the gel, and enhance the skin's absorption of active ingredients; Carbomer: 0.6%–1.0%, as the main component of the gel matrix, has good thickening and emulsifying effects, which can make the gel texture uniform and stable; Triethanolamine: in appropriate amounts, used to adjust the pH of the gel to 5.8–6.8, making it close to the pH of human skin, further enhancing its gentleness, while forming a stable gel system with carbomer; 1,2-Hexanediol: 0.4%–0.8%, as a preservative, can effectively inhibit the growth and reproduction of microorganisms in the gel, extend the product's shelf life, and is highly safe and does not irritate the skin; Purified water: Add to 100% as a solvent to dissolve all components, making the gel texture uniform and easy to apply.

[0017] The functions of each raw material are explained in detail below: Black Tiger Root Extract: As the principal ingredient, its core active component is lignans, which have significant effects in promoting blood circulation, dispelling cold, and relieving pain. It can be directly applied to the dysmenorrhea caused by cold in the uterus to relieve pain and improve symptoms of poor menstrual flow. At the same time, it can help promote the dissipation of postpartum blood stasis. Its content and extraction process directly determine the core efficacy of the gel. The supercritical CO2 low-temperature extraction process can maximize the preservation of its active components and avoid high temperature damage to active substances. Compared with existing extraction methods, the extraction rate of active components is higher and the purity is better. The lignan content in the extract is ≥8%, ensuring stable and reliable efficacy. Angelica extract: As an auxiliary medicine, it is rich in effective ingredients such as angelica polysaccharide and ferulic acid. It has the effects of nourishing blood, promoting blood circulation, regulating menstruation and removing blood stasis. It can assist black tiger root extract in enhancing the effects of promoting qi circulation, removing blood stasis and relieving dysmenorrhea. At the same time, it can replenish qi and blood and promote physical recovery, which is in line with the characteristics of postpartum women with qi and blood deficiency. Ligusticum chuanxiong extract: As an auxiliary medicine, it contains effective ingredients such as ligustrazine, which can promote blood circulation, dispel wind and relieve pain. When used in combination with Angelica sinensis, it can enhance the effects of regulating menstruation, removing blood stasis and relieving lower abdominal distension. It is especially suitable for discomfort caused by postpartum blood stasis. Motherwort extract: Contains effective ingredients such as leonurine and stachydrine, which have the effects of removing blood stasis and promoting new blood production, regulating menstruation and promoting blood circulation. It can promote the discharge of postpartum lochia, accelerate uterine contraction and involution, solve the problems of incomplete postpartum lochia and slow uterine involution, and help the body recover after childbirth. Artemisia argyi warming factor: It is refined from Artemisia argyi extract and has the effects of warming the meridians and dispelling cold, promoting qi circulation and relieving pain. At the same time, it can provide a gentle and long-lasting warming sensation. It can relieve lower abdominal pain caused by uterine cold without high temperature stimulation, improve the comfort of use, and has no risk of burns. Sodium hyaluronate: It has excellent moisturizing and repairing effects. It can form a protective film on the skin surface to lock in moisture, while reducing the irritation of plant extracts to the skin, improving the gentleness of the gel, avoiding skin allergies, and enhancing the skin's transdermal absorption of active ingredients. Carbomer-triethanolamine system: As a gel matrix, carbomer has good thickening and emulsifying properties, which can make the gel texture uniform, delicate and easy to apply; triethanolamine can not only adjust the pH value of the gel to the suitable range of human skin, but also react with carbomer to form a stable gel system, ensuring that the gel does not separate or precipitate during storage, thus improving product stability. 1,2-Hexanediol: As a safe and effective preservative, it can effectively inhibit the growth and reproduction of bacteria, fungi and other microorganisms, extend the shelf life of products, and is gentle and non-irritating to the skin, meeting the safety requirements of topical care products. Purified water: As a solvent, it dissolves the components, making the gel texture uniform and easy to apply, while avoiding the impact of impurities on the product's efficacy and safety.

[0018] The key extraction process of this invention: Black tiger root extract is prepared using supercritical CO2 low-temperature extraction. This process has advantages such as high extraction efficiency, no solvent residue, and low-temperature protection of active ingredients. Specific process conditions are: pressure 25 MPa, temperature 45°C. Under these conditions, the lignans in black tiger root can be fully extracted, with a lignan content ≥8% in the extract, ensuring the stable and reliable core efficacy of the gel. Compared to traditional solvent extraction methods, this extraction process increases the extraction rate of active ingredients by more than 30%, leaves no solvent residue, and is safer, meeting the quality requirements for topical care products.

[0019] The preparation method of the topical care gel of the present invention includes the following specific steps: 1. Preparation of aqueous phase: Carbomer was added to purified water, stirred evenly, and left to swell overnight to ensure that the carbomer was fully swollen. The next day, it was stirred evenly again to obtain an aqueous phase with uniform texture and no particles. 2. Low-temperature mixing: Place the black tiger root extract, angelica extract, chuanxiong extract, motherwort extract and mugwort temperature-sensitive factor into a mixing container, and stir and mix evenly in a low-temperature environment below 40℃ to obtain an efficacy mixture; low-temperature mixing can avoid high temperature from destroying the effective components of each extract and ensure stable efficacy. 3. Mixing and homogenizing: Slowly add the efficacy mixture obtained in step (2) to the aqueous phase obtained in step (1) while stirring. After the addition is complete, homogenize for 5 minutes using a homogenizer. The homogenization speed is controlled at 2000–3000 r / min to ensure that the efficacy components are fully mixed with the aqueous phase to form a homogeneous mixture. 4. Adjust pH: Slowly add triethanolamine dropwise to the mixture obtained in step (3) while stirring. At the same time, use a pH meter to monitor the pH value until the pH value is adjusted to 5.8–6.8 (optimal is 6.0–6.5). At this time, the mixture forms a uniform and delicate gel. 5. Low-temperature addition of excipients: Cool the gel obtained in step (4) to below 35°C, add sodium hyaluronate and 1,2-hexanediol, stir evenly to ensure that the excipients are fully dissolved and there are no particles left; adding excipients at low temperature can avoid the destruction of the activity of sodium hyaluronate, and at the same time ensure that 1,2-hexanediol is evenly dispersed and plays an antiseptic role. 6. Filling: Fill the gel obtained in step (5) into a rollerball bottle or a tube, seal it after filling, and sterilize it to obtain the finished product. The rollerball bottle design allows for one-handed application without washing, making it convenient to use; the tube design makes it easy to carry and control the dosage.

[0020] Example 1 (Optimal Example) This embodiment prepares 1000g of Black Tiger Warming Uterus, Blood Stasis Removing, Menstrual Regulating, and Postpartum Repair External Care Gel, formulated according to the following mass percentage ratio: Black tiger root extract 20% (200g), Angelica sinensis extract 6% (60g), Ligusticum chuanxiong extract 4% (40g), Leonurus japonicus extract 5% (50g), Artemisia argyi temperature-sensitive factor 1% (10g), sodium hyaluronate 0.3% (3g), carbomer 0.8% (8g), 1,2-hexanediol 0.5% (5g), appropriate amount of triethanolamine, purified water to make up to 1000g.

[0021] The preparation method is as follows: 1. Preparation of aqueous phase: Add 8g of carbomer to 624g of purified water, stir well and let it swell overnight. Stir well again the next day to obtain the aqueous phase. 2. Low-temperature mixing: Place 200g of black tiger root extract, 60g of angelica extract, 40g of chuanxiong extract, 50g of motherwort extract, and 10g of mugwort temperature-sensitive factor into a mixing container, and stir and mix evenly at 35℃ to obtain an efficacy mixture. 3. Mixing and homogenization: Slowly add the functional mixture to the aqueous phase while stirring. After the addition is complete, homogenize using a homogenizer at 2500 r / min for 5 min to obtain the mixture. 4. Adjust pH: Slowly add triethanolamine dropwise to the mixture while stirring, and monitor the pH value until the pH is adjusted to 6.3 and a uniform gel is formed; 5. Low-temperature addition of excipients: Cool the gel to 32℃, add 3g sodium hyaluronate and 5g 1,2-hexanediol, and stir until homogeneous; 6. Filling: The product is filled using ball-bearing bottles, sealed, and then sterilized at 121℃ for 15 minutes to obtain the finished product.

[0022] The performance test results of the gel prepared in this embodiment are as follows: Appearance: The texture is uniform and delicate, appearing as a light brown, semi-transparent gel, odorless and free of particles; pH value: 6.3, which meets the requirement of 5.8–6.8; Viscosity: 8500 mPa•s (25℃), spreads smoothly without dripping; Centrifugation stability: After centrifugation at 3000 rpm for 30 min, there was no stratification or precipitation; Accelerated stability testing: After 6 months of storage at 40℃ and 75%RH, there were no significant changes in product properties and pH value, and the change rate of black tiger lignan content was 3.2% < 5%. Skin irritation test: After application to rabbit skin, there was no redness, swelling, or itching, indicating no irritation. Example

[0023] This embodiment prepares 1000g of Black Tiger Warming Uterus, Blood Stasis Removing, Menstrual Regulating, and Postpartum Repair External Care Gel, formulated according to the following mass percentage ratio: Black tiger root extract 15% (150g), Angelica sinensis extract 4% (40g), Ligusticum chuanxiong extract 2% (20g), Leonurus japonicus extract 3% (30g), Artemisia argyi temperature-sensitive factor 0.5% (5g), sodium hyaluronate 0.2% (2g), carbomer 0.6% (6g), 1,2-hexanediol 0.4% (4g), triethanolamine as needed, purified water to make up to 1000g.

[0024] The preparation method is as follows: 1. Preparation of aqueous phase: Add 6g of carbomer to 742.8g of purified water, stir well and let it swell overnight. Stir well again the next day to obtain the aqueous phase; 2. Low-temperature mixing: Place 150g of black tiger root extract, 40g of angelica extract, 20g of chuanxiong extract, 30g of motherwort extract, and 5g of mugwort temperature-sensitive factor into a mixing container, and stir and mix evenly at 38℃ to obtain an efficacy mixture. 3. Mixing and homogenization: Slowly add the functional mixture to the aqueous phase while stirring. After the addition is complete, homogenize using a homogenizer at 2000 r / min for 5 min to obtain the mixture. 4. Adjust pH: Slowly add triethanolamine dropwise to the mixture while stirring, and monitor the pH value until the pH is adjusted to 5.8 and a uniform gel is formed; 5. Low-temperature addition of excipients: Cool the gel to 30℃, add 2g sodium hyaluronate and 4g 1,2-hexanediol, and stir until homogeneous; 6. Filling: The product is filled using a soft tube, sealed, and then sterilized at 121℃ for 15 minutes to obtain the finished product.

[0025] The performance test results of the gel prepared in this embodiment are as follows: Appearance: The texture is uniform and delicate, appearing as a light brown, semi-transparent gel, odorless and free of particles; pH value: 5.8, which meets the requirement of 5.8–6.8; Viscosity: 7200 mPa•s (25℃), spreads smoothly without dripping; Centrifugation stability: After centrifugation at 3000 rpm for 30 min, there was no stratification or precipitation; Accelerated stability testing: After 6 months of storage at 40℃ and 75%RH, there were no significant changes in product properties or pH value, and the change rate of black tiger lignan content was 4.5% < 5%. Skin irritation test: After application to rabbit skin, no redness, swelling, or itching was observed, indicating no irritation. Example

[0026] This embodiment prepares 1000g of Black Tiger Warming Uterus, Blood Stasis Removing, Menstrual Regulating, and Postpartum Repair External Care Gel, formulated according to the following mass percentage ratio: Black tiger root extract 25% (250g), Angelica sinensis extract 8% (80g), Ligusticum chuanxiong extract 6% (60g), Leonurus japonicus extract 7% (70g), Artemisia argyi temperature-sensitive factor 2% (20g), sodium hyaluronate 0.5% (5g), carbomer 1.0% (10g), 1,2-hexanediol 0.8% (8g), triethanolamine as needed, purified water to make up to 1000g.

[0027] The preparation method is as follows: 1. Preparation of aqueous phase: Add 10g of carbomer to 506.2g of purified water, stir well and let it swell overnight. Stir well again the next day to obtain the aqueous phase; 2. Low-temperature mixing: Place 250g of black tiger root extract, 80g of angelica extract, 60g of chuanxiong extract, 70g of motherwort extract, and 20g of mugwort temperature-sensitive factor into a mixing container, and stir and mix evenly at 32℃ to obtain an efficacy mixture. 3. Mixing and homogenization: Slowly add the functional mixture to the aqueous phase while stirring. After the addition is complete, homogenize using a homogenizer at 3000 r / min for 5 min to obtain the mixture. 4. Adjust pH: Slowly add triethanolamine dropwise to the mixture while stirring, and monitor the pH value until the pH is adjusted to 6.8 and a uniform gel is formed; 5. Low-temperature addition of excipients: Cool the gel to 34℃, add 5g sodium hyaluronate and 8g 1,2-hexanediol, and stir until homogeneous; 6. Filling: The product is filled using ball-bearing bottles, sealed, and then sterilized at 121℃ for 15 minutes to obtain the finished product.

[0028] The performance test results of the gel prepared in this embodiment are as follows: Appearance: The texture is uniform and delicate, appearing as a brown, semi-transparent gel, odorless and free of particles; pH value: 6.8, which meets the requirement of 5.8–6.8; Viscosity: 9800 mPa•s (25℃), spreads smoothly without dripping; Centrifugation stability: After centrifugation at 3000 rpm for 30 min, there was no stratification or precipitation; Accelerated stability testing: After 6 months of storage at 40℃ and 75%RH, there were no significant changes in product properties and pH value, and the change rate of black tiger lignan content was 4.8% < 5%. Skin irritation test: After application to rabbit skin, there was no redness, swelling, or itching, indicating no irritation.

[0029] Application examples Application Example 1: For women with severe dysmenorrhea Fifty women with severe dysmenorrhea (Menstrual pain score of 7–10) aged 18–35 years were selected. The gel prepared in Example 1 was used. The gel was applied to the lower abdomen 3 days before menstruation, twice a day, with an amount of about 2g each time. The gel was used continuously during menstruation for 3 consecutive menstrual cycles.

[0030] Effects of use: After starting use 3 days before menstruation, the cold pain in the lower abdomen was significantly relieved; the VAS pain score during menstruation decreased from an average of 8.2 points to 3.1 points, with 42 women's pain scores dropping to below 4 points, showing a significant relief effect; symptoms such as poor menstrual flow, dark color and clots were significantly improved, with no adverse reactions such as skin allergies or irritation.

[0031] Application Example 2: For women who have given birth vaginally. Thirty women aged 22–38 years who had given birth vaginally and were 3 weeks postpartum were selected. All of them had problems such as prolonged lochia, lower abdominal distension, and slow uterine involution. The gel prepared in Example 1 was applied to the lower abdomen and the Baliao acupoints once a day, with each application amount of about 3g, for 2 consecutive weeks.

[0032] Results: After one week of use, the lochia discharge rate of 27 women was significantly accelerated; after two weeks of use, the lochia of all women was basically cleared, the feeling of heaviness in the lower abdomen was significantly reduced, the uterus involution was good, and there were no adverse reactions such as skin irritation or allergies, indicating high safety.

[0033] Application Example 3: Daily care for individuals with cold uterus constitution Forty women aged 20–40 with a cold uterus constitution (who usually feel cold in their lower abdomen and occasionally experience menstrual cramps) were selected. The gel prepared in Example 1 was applied to their lower abdomen once a day, with each application amount being approximately 1.5g, and the treatment was continued for one month.

[0034] Results: After one month of use, 36 women experienced significant improvement in their lower abdominal coldness symptoms, reduced or eliminated menstrual cramps, and showed no abnormalities in their skin condition. The gel felt refreshing on the skin, did not stain clothing, and provided a good user experience.

[0035] The above description is only a preferred embodiment of the present invention and is not intended to limit the present invention. Any modifications, equivalent substitutions and improvements made within the spirit and principles of the present invention should be included within the protection scope of the present invention.

Claims

1. A type of external care gel for warming the uterus, removing blood stasis, regulating menstruation, and postpartum repair, characterized in that: By mass percentage, it includes the following components: Black tiger root extract 15%–25%, Angelica sinensis extract 4%–8%, Ligusticum chuanxiong extract 2%–6%, Leonurus japonicus extract 3%–7%, Artemisia argyi temperature-sensitive factor 0.5%–2%, the balance being gel matrix and water.

2. The topical care gel according to claim 1, characterized in that, By weight percentage, it includes the following components: 15%–25% black tiger root extract, 4%–8% angelica extract, 2%–6% chuanxiong extract, 3%–7% motherwort extract, 0.5%–2% mugwort temperature-sensitive factor, 0.2%–0.5% sodium hyaluronate, 0.6%–1.0% carbomer, 0.4%–0.8% 1,2-hexanediol, and appropriate amount of triethanolamine (to adjust pH to 5.8–6.8), with purified water to make up to 100%.

3. The topical care gel according to claim 2, characterized in that, The black tiger root extract was prepared using a supercritical CO2 low-temperature extraction process. The extraction conditions were: pressure 25 MPa, temperature 45 °C, and the lignan content in the extract was ≥8%.

4. The topical care gel according to claim 2, characterized in that, The gel matrix is ​​a carbomer-triethanolamine system with a pH value controlled between 5.8 and 6.8, preferably between 6.0 and 6.

5.

5. The topical care gel according to claim 2, characterized in that, The gel is in the form of a rollerball applicator or a tube applicator, preferably a rollerball applicator.

6. The topical care gel according to claim 2, characterized in that, By weight percentage, it includes the following components: 20% black tiger root extract, 6% angelica extract, 4% chuanxiong extract, 5% motherwort extract, 1% mugwort temperature-sensitive factor, 0.3% sodium hyaluronate, 0.8% carbomer, 0.5% 1,2-hexanediol, triethanolamine to adjust pH to 6.0–6.5, and purified water to make up to 100%.

7. A method for preparing the topical care gel according to any one of claims 1–6, characterized in that, Includes the following steps: (1) Preparation of aqueous phase: Carbomer was added to purified water, swollen overnight, and stirred evenly to obtain the aqueous phase; (2) Low temperature mixing: In an environment below 40℃, black tiger root extract, angelica extract, chuanxiong extract, motherwort extract and mugwort temperature-sensitive factor are mixed evenly to obtain an efficacy mixture; (3) Mixing and homogenizing: Add the efficacy mixture obtained in step (2) to the aqueous phase obtained in step (1), stir and homogenize for 5 minutes to obtain the mixture; (4) Adjust pH: Add triethanolamine dropwise to the mixture obtained in step (3) to adjust the pH to 5.8–6.8 to form a gel; (5) Adding excipients at low temperature: Cool the gel obtained in step (4) to below 35°C, add sodium hyaluronate and 1,2-hexanediol, and stir evenly; (6) Filling: Fill and seal the gel obtained in step (5) using a ball bottle or tube to obtain the finished product.

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