LU102669B1

LU102669B1 - Anti-aging soft capsule for menopausal women and preparation method therefor

Info

Publication number: LU102669B1
Application number: LU102669A
Authority: LU
Inventors: Jinglong Wang; Yuanlong Zang; Dandan Zheng; Hongjing Cui
Original assignee: Univ Zaozhuang
Priority date: 2019-07-18
Filing date: 2020-06-03
Publication date: 2021-03-29
Also published as: WO2021008265A1; CN110237117A

Abstract

An anti-aging soft capsule for women during menopause and a preparation method thereof are provided. The soft capsule is composed of a capsule content and a capsule shell. The capsule content is composed of soy isoflavone extract powder, pomegranate seed oil, Limonium bicoior extract, a suspending agent and a wetting agent. The capsule shell is made of gelatin, plasticizer, colorant and water. The colorant is composed of white pigment and milk chocolate brown pigment. The soft capsule has the functions of antioxidant and alleviating menopausal symptoms. Moreover, the soft capsule can supplement vital energy and nourish blood for women, enabling women to have rosy and shiny appearance, smooth and elastic skin, and improved physical fitness.

Description

ai 5209 LU102669 ANTI-AGING SOFT CAPSULE FOR WOMEN DURING MENOPAUSE AND

PREPARATION METHOD THEREOF Technical field

[0001] The present invention relates to an anti-aging soft capsule for women during menopause and a preparation method thereof, and belongs to the technical field of pharmaceutical preparations and health care products. Background

[0002] Studies have shown that women after reaching a certain age are prone to undergoing changes on their physiological characteristics, such as decreased estrogen secretion and reduced in vivo free radical scavenging ability. These changes lead to a decline in women's quality of life, accelerate women's aging, and even cause the occurrence of diseases, which is commonly known as menopause. Menopausal syndrome is a group of symptoms of autonomic nervous system dysfunction accompanied by neuropsychological symptoms, which occur in perimenopause and postmenopause women due to diminished ovarian function, decreased estrogen levels, elevated gonadotropin levels and mal-adaption of patients in the endocrine readjustment. Modern medical research has found that a woman has over 400 estrogen receptors in her body. These receptors controlled and dominated by estrogen are distributed in almost all her tissues and organs. Once the estrogen secreted in the body decreases, degenerative changes may be triggered in the tissues and organs, thereby causing a series of symptoms

[0003] In recent years, the discovered phytoestrogens such as soy isoflavones have become a new option for the treatment of menopausal syndrome. Soy isoflavones are a class of biologically active substances with estrogen-hke effects in soybeans, including 12 compounds in total, and accounting for about 0 2% to 0.4% of the whole soybean. Studies have shown that soy isoflavones possess a variety of pharmacological activities. In addition to estrogen-like effects. they have significant functions on prevention of osteoporosis, anti- inflammatory, antioxidant, anti-tumor, and reduction of the incidence of multiple estrogen- dependent diseases in the human body. Although the estrogenic activity of soy isoflavones is very weak, only reaching one-thousandth to one ten-thousandth of the activity of original estrogen estradiol in the human body, it can still serve as an exogenous estrogen supplement to produce estrogen-like effects. Soy isoflavone therapy is an exogenous supplemental therapy of an alternative estrogen in nature, which can reduce the incidence i i 2 LU102669 51 5209 of diseases associated with low estrogen levels to a certain extent, but women's physical fitness and aging are less improved.

Summary of the invention

[0004] In view of the problems existing in the prior art, the present invention provides an anti-aging soft capsule for women during menopause. Pomegranate seed oil used as a matrix of the soft capsule is combined with soy isoflavones and a Limonium bicolor extract to make a capsule content, which can resist the damage induced by free radicals and inflammation in the human body, and concurrently delay aging as well as effectively supplement women's vital energy and nourish blood, so as to significantly relief the symptoms of menopausal women, make their skin smooth, firm, elastic and radiant, and enable women to regain self-confidence.

[0005] The present invention further provides a preparation method of the anti-aging soft capsule for women during menopause.

[0006] The present invention adopts the following technical solutions.

[0007] An anti-aging soft capsule for women during menopause 1s composed of a capsule content and a capsule shell. The weight ratio of the capsule content is: soy isoflavone extract powder: pomegranate seed oil: Limoniurn bicolor extract: a suspending agent. a wetting agent = 5; (85-92): (5-8). (2-8). (1-7). The capsule shell is made of gelatin, plasticizer, colorant and water. The weight ratio of the gelatin, the plasticizer and the water is: 1: (0 3-0.7): 1. The colorant is composed of white pigment and milk chocolate brown pigment, wherein the white pigment 1s 0.05% of the weight of the gelatin, and the milk chocolate brown pigment is 0.5% of the weight of the gelatin.

[0008] Preferably, the Limonium bicolor extract is prepared by the following method, including: cutting Limonium bicolor into small segments, adding tenfold amount of water therein, then processing with 80 kHz ultrasound for 30 minutes and finally adding papain for enzymolysis. The enzymolysis is carried out at a temperature of 60°C for 1-2 hours. After the enzymolysis is completed, a filtration is performed to obtain a filirate, which is then concentrated under reduced pressure to obtain a concentrated solution with a relative density of 1.3 at 80°C, followed by vacuum freeze-drying to form powder.

[0609] Preferably, the adding amount of the papain is 80 U/g.

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[0010] Preferably, the suspending agent is one or more of beeswax, insect wax, soybean lecithin, and glyceryl monostearate.

[0011] Preferably, the wetting agent is one or more of Tween, Span, and soybean lecithin.

[0012] Preferably, the plasticizer is one of sorbitol, propylene glycol, glycerin, and low molecular weight polyethylene glycol.

[0013] A preparation method of the anti-aging soft capsule for women during menopause, including the following steps:

[0014] (1) preparation of the capsule content: quantitatively weighing appropriate amounts of the pomegranate seed oil, the suspending agent, and the wetting agent, heating to completely melt the suspending agent and the wetting agent into the pomegranate seed oil, stirring and mixing uniformly, and adding soy isoflavone dry extract powder that was sieved through 150-mesh sieve and the Limonium bicolor extract therein after cooling, followed by stirring evenly, grinding, standing, and maintaining at 45°C to remove bubbles for subsequent use,

[0015] (2) preparation of the capsule shell: presetting the temperature of the water bath interlayer of a vacuum stirrer to 90°C’, adding a certain amount of distilled water, then adding the white pigment and milk chocolate brown pigment, and stirring evenly, foliowed by adding the plasticizer and gelatin successively to the vacuum stirrer when the temperature in the vacuum stirrer reaches 85°C, stirring and melting to form a uniform glue liquid, then adjusting the temperature of the water bath interlayer of the vacuum stirrer to (55+5) ©, maintaining the temperature and standing for 12 hours to obtain the glue liquid for subsequent use; and

[0016] (3) pelleting with a conventional process, shaping and drying, washing and drying, picking up. and packaging. to obtain the product of the present invention

[0017] Pomegranate seeds have a relatively high oil content In the fatty acids among the pomegranate seed oil, unsaturated fatty acids account for 95.67%, and saturated fatty acids account for only 4.33%, with punicic acid accounting for 81.62% of the unsaturated fatty acids. The chemical name of the punicic acid is cis-9, trans-1%, cis-13-

Bl.-5209 octadecatrienoic acid. The punicic acid is highly reactive, and is a very Unique and effective antioxidant that can resist inflammation and oxygen free radical damage, delay aging, prevent atherosclerosis and slow down carcinogenesis Pomegranate seed oil is natural omega-3 healthy oil that is very good for human body, accounting for 13% to 23% of pomegranate seeds, and exhibiting good medicinal and nutritional value. Polyphenols, as a component of pomegranate seed oil, enable the pomegranate seed oil to have the effect of anti-human breast cancer in vitro. Pomegranate seed extract can function as estrogen to some extent, which is therefore suitable for clinical treatment of diseases associated with menopause, and has a certain inhibitory effect on bone turnover caused by oophorectomy. Other studies have shown that pomegranate seed oil has a certain inhibitory effect on human breast cancer cells and skin cancer, and even has certain preventive and therapeutic effects on skin cancer.

[0018] Limonium bicolor, also known as Kochia scoparia, Silene forunei Vis., and Latouchea fokienensis, is one of the plants of Linoniurm Mill genus of Plumbaginaceae and is a perennial herb. About 300 species of Limonium Milt resources are distributed worldwide, of which 17-18 species are distributed in North China, Northeast, Northwest and coastal areas of China. There are 3 species distributed in Hebet Province, namely Limonium bicolor, Limonium aureum and Limonium sinense. Among them, Limonium bicolor is the most representative and has high ornamental and ecological values In addition, Limonium bicolor has a significant medicinal value. The whole Limonium bicolor can be used as medicine, and tastes sweet and slightly bitter and astringent.

[0019] The beneficial effects of the present invention are described as follows. According to the present invention, the pomegranate seed oil is used as the matrix of the soft capsule, combined with soy isoflavones and Limoniim bicolor extract. The three function synergistically, not only exerting effects of antioxidation, anti-aging and relieving symptoms of menopause, but also significantly supplementing vital energy and nourishing blood for women, making women radiant, having good appearance, smooth and elastic skin and improved physical fitness. The effect of the soft capsule of the present invention is better than that of common soy isoflavone capsules in the market. In the soft capsule prepared by the present invention, the content of soy isoflavones is about 5%, that is, 25 mg/capsule. It is recommended to take two capsules a day, and the total content thereof is higher than that of the common soy isoflavone soft capsules in the market.

sL-5209 > LU102669 Detailed Description

[0020] The present invention will be further described in detail below in conjunction with specific examples.

[0021] Example 1 {0022} An anti-aging soft capsule for women during menopause was composed of a capsule content and a capsule shell. The weight ratio of the capsule content was: soy isoflavone extract powder: pomegranate seed oil: Limonium bicolor extract. suspending agent: wetting agent = 5: 85: 5: 2: 1. The capsule shell was made of gelatin, plasticizer, colorant and water, the weight ratio of the gelatin, the plasticizer and water was: 1; (0.3-

0.7): 1; the colorant was composed of white pigment and milk chocolate brown pigment, wherein the white pigment was 0.05% by weight of the gelatin, and the milk chocolate brown pigment was 0.5% by weight of the gelatin. The preparation method of the above soft capsule was as follows.

[0023] (1} Preparation of the capsule content: appropriate amounts of the pomegranate seed oil, the suspending agent, and the wetting agent were quantitatively weighed and heated to completely melt the suspending agent and wetting agent into the pomegranate seed oil, followed by stirring and mixing uniformly. After cooling, soy isoflavone dry extract powder that was sieved through 150-mesh sieve and Limonium bicolor extract were added therein, followed by stirring evenly, grinding, standing, maintaining at 45°C’ to remove bubbles for subsequent use.

[0024] (2) Preparation of the capsule shell: the temperature of the water bath interlayer of a vacuum stirrer was preset to 90 l'. Subsequently, a certain amount of distilled water was added, followed by adding the white pigment and milk chocolate brown pigment, and then stiring evenly. When the temperature in the vacuum stirrer reaching 85°C | the plasticizer and the gelatin were successively added to the vacuum stirrer, followed by stirring to melt into a uniform glue liquid Then, the temperature of the water bath interlayer of the vacuum stirrer was adjusted to (5545) C', maintaining the temperature and standing for 12 hours to obtain the glue liquid for subsequent use.

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[0025] (3) Pelleting was performed with a conventional process, followed by shaping and drying, washing and drying, picking up, and packaging, to abtain the product of the present invention.

[0026] Example 2

[90027] An anti-aging soft capsule for women during menopause was composed of a capsule content and a capsule shell. The weight ratio of the capsule content was: soy isoflavone extract powder pomegranate seed oil: Limonium bicolor extract. suspending agent: wetting agent = 5: 90: 8: 6. 5. The capsule shell was made of gelatin, plasticizer, colorant and water: the weight ratio of the gelatin, the plasticizer and the water was: 1: (0.3-

0.7). 1; the colorant was composed of white pigment and milk chocolate brown pigment. wherein the white pigment was 0.05% by weight of the gelatin, and the milk chocolate brown pigment was 0.5% by weight of the gelatin. {0028] The preparation method of the above soft capsule was as follows.

[0029] (1) Preparation of the capsule content: appropriate amounts of the pomegranate seed oil, the suspending agent, and the wetting agent were quantitatively weighed and heated to completely melt the suspending agent and wetting agent into the pomegranate seed oil, followed by stirring and mixing uniformly. After cooling, soy isoflavone dry extract powder that was sieved through 150-mesh sieve and Limonium bicolor extract were added therein, followed by strring evenly, grinding. standing, maintaining at 45% to remove bubbles for subsequent use. (0030] (2) Preparation of the capsule shell: the temperature of the water bath interlayer of a vacuum stirrer was preset to SOC. Subsequently, a certain amount of distilled water was added, followed by adding the white pigment and milk chocolate brown pigment, and then stirring evenly. When the temperature in the vacuum stirrer reaching 85%, the plasticizer and the gelatin were successively added to the vacuum stirrer, followed by stirring to melt into a uniform glue liquid. Then, the temperature of the water bath interlayer of the vacuum stirrer was adjusted to (55+5) ©, maintaining at the temperature and standing for 12 hours to obtain the glue liquid for subsequent use.

SL 5209 7 LU102669

[0031] (3) Pelleting was performed with a conventional process, followed by shaping and drying, washing and drying, picking up. and packaging, to obtain the product of the present invention.

[0032] Example 3

[0033] An anti-aging soft capsule for women during menopause was composed of a capsule content and a capsule shell. The weight ratio of the capsule content is: soy isoflavone extract powder: pomegranate seed oil: Limonium bicolor extract suspending agent. wetting agent = 5: 92: 10: 8: 7. The capsule shell is made of gelatin, plasticizer, colorant and water, the weight ratio of the gelatin, the plasticizer and the water was: 1: {0.3-

0.7) 1; the colorant was composed of white pigment and milk chocolate brown pigment, wherein the white pigment was 0.05% by weight of the gelatin, and the milk chocolate brown pigment was 0.5% by weight of the gelatin. The preparation method of the above soft capsule was as follows.

[0034] (1) Preparation of the capsule content: appropriate amounts of the pomegranate seed oil, the suspending agent, and the wetting agent were quantitatively weighed and heated to completely melt the suspending agent and wetting agent into the pomegranate seed oil, followed by stirring and mixing uniformly. After cooling, soy isoflavone dry extract powder that was sieved through 150-mesh sieve and Limonium bicolor extract were added therein, followed by stirring evenly, grinding, standing, maintaining at 45°C to remove bubbles for subsequent use,

[0035] (2) Preparation of the capsule shell: the temperature of the water bath interlayer of a vacuum stirrer was preset to 90°C. Subsequently, a certain amount of distilled water was added, followed by adding the white pigment and milk chocolate brown pigment, and then stirring evenly. When the temperature in the vacuum stirrer reaching 85€, the plasticizer and the gelatin were successively added to the vacuum stirrer, followed by stirring to melt into a uniform glue liquid. Then, the temperature of the water bath interlayer of the vacuum stirrer was adjusted to (55+5} C. maintaining the temperature and standing for 12 hours to obtain the glue liquid for subsequent use.

[0036] (3) Pelleting was performed with a conventional process, followed by shaping and drying, washing and drying, picking up, and packaging, to obtain the product of the present invention

BL-5209

[0037] Comparative Example 1

[0038] À soy isoflavone soft capsule was obtained by the same preparation method with the same formulation as those described in Example 2, except that the pomegranate seed oil of Example 2 was replaced by soybean oil at equal amount.

[0039] Comparative Example 2 {0040} An anti-aging soft capsule for women during menopause was obtained by the same preparation method with the same formulation as those described in Example 2, except that the capsule content of Comparative example 2 did not include the Limonium bicolor extract.

[0041] Comparative Example 3

[0042] An anti-aging soft capsule for women during menopause was obtained by the same preparation method with the same formulation as those described in Example 2. except that the capsule content of Comparative example 3 only included the pomegranate seed oil, the suspending agent and the wetting agent.

[0043] The performance of the anti-aging soft capsule for women during menopause obtained in the above examples were tested.

[0044] Product stabiity test: the soft capsules prepared in Examples 1-3 were stored at room temperature in the dark for 1, 2, 3, 6, 12, and 18 months, respectively, and checked regularly. The appearance of each sample should not be changed. the effective constituents were tested as qualified, and the content of soy isoflavones in the samples was determined by the ultraviolet method as qualified. The results are shown in Table 1.

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[0045] Table 1 Results of stability test or | [imonathj2 3 |e IEF | 18 1, months | months | months | months months | Example 1 Sample qualified | qualified | qualified | qualified | quabfied | qualified content ! : ‘Property qualified | qualified “qualified qualified qualified “qualified a | Example 2 | Sample | qualified was ani ‘qualified | qualified | qualified content | Property} qualied | qualied | quakied | qualied | qualified | duaified | Example 3 | Sample qualified | qualified | qualified | qualified | qualified | qualified ; Property Qualified qualified qualified qualified qualified | qualified '

[0046] Disintegration time limit test: the soft capsules prepared in Examples 1-3 and Comparative Examples 1-3 were subjected to the disintegration time limit test in accordance with the Disintegration Test General Chapter 0921 of The Pharmacopoeia of the People's Republic of China 2015 Edition Four. The test results are shown in Table 2.

[0047] Table 2 Disintegration test limit results Fe Group © Time (min) C0) Example 1 | 8 TS ~~ Exampez | Ts 7 7 Example TU © Comparative Example 1 TEENS “Comparative Example 2 nn TT | Comparative Example 3 6 I.

[0048] As shown in Table 1 and Table 2, the stability and disintegration time limit of the soft capsules prepared by the present invention meet the relevant requirements of the Chinese Pharmacopoeia. The soft capsules have good stability and long shelf life up to 18 months

[0049] Toxicological experiment: a safety and toxicology evaluation was performed on the soft capsules prepared in Examples 1-3 of the present invention in accordance with the Technical Specification for Inspection and Evaluation of Health Food (2003 edition}. The test results show that the acute oral toxicity test LDs3> 10.0 kg bw; the results of three genetic toxicity tests, mouse sperm deformity test, and Ames test were all negative, and no pathogenic effect is found in the product of the present invention. After the 30-day feeding test ended. the experimental animals grew normally. and no obvious abnormality

Bi-5209 was detected in blood test, biochemical test, liver function test and histological examination compared with control group.

[0050] Research experiment on total antioxidant effect in vivo

[0051] 70 aged mice, with 35 male and 35 female, were selected and randomly divided into groups 1-7 according to their body weights. Among them, groups 1-3 were intragastrically administrated with 10 mg/kg of the soft capsules prepared in Examples 1-3 every day, respectively, groups 4-6 were intragastrically administrated with the same dose of the drugs of Comparative Example 1, Comparative Example 2 and Comparative Example 3 every day, respectively, and group 7 was the blank control group that was intragastrically administered with 10 mg/kg of distilled water every day. After 4 weeks of intragastric administration, the blood samples of each group of mice were collected by drawing eyeballs and the mice were sacrificed by dislocation. After centrifugation at 3500 r/min for 15 minutes, the separated serum was immediately placed in an eppendorf tube and stored at -20°C for later use. À determination was performed according to the method of determining total antioxidant capacity (T-AQC) in serum recommended by the kit (provided by Nanjing Jiancheng Bioengineering Institute). All data are represented by x + s, and a radom analysis of variance was carried out on antioxidant indices using statistical analysis system (SAS) statistical software. The determination results are shown in Table 3 below.

[0052] Table 3 Experimental results of T-AOC determination in mouse serum Ee Proc um 1 10 31.6+0.26"* SSSR eq a US PTT 3° ps oC 32 110.29 a 1100 (1784035 7 Ss a 10 15.440.29 | me yg m 7 esse | Note: ** compared with the blank control group, P<001. 22 a

[0053] From the data in Table 3 above, the total antioxidant capacity of the soft capsule product prepared by the present invention has very remarkable statistical significance compared with that of the blank control group.

BL-5209 n LU102669

[0054] Study on blood-nourishing effect

[0055] The effect of the product of the present invention on the red biood cells and hemoglobin of a blood deficiency mice model induced by 1-acetyl-2-phenylhydrazine was studied. 90 mice were selected and randomly divided into 9 groups, namely, blank control group, model group, Example 1-3 groups and Comparative example 1-3 groups. The administration dosage of each group is 10 mg/kg. The blank control group and the model group were administrated with equal volume of distilled water. The intragastric administration was carried out once per 24 hours for 10 consecutive days. The positive control group was administrated with compound E-jiao slurry (10 mL/kg). On the first, fourth, and seventh days of the experiment, a 2% 1-acetyl-2-phenylhydrazine physiological saline solution was respectively injected subcutaneously, with 200 mg/kg on the first day and 100 mg/kg on the fourth and seventh days. The hemolytic blood deficiency model was constructed on the ninth day of modeling. The intragastric administration was started at the same time the modeling was constructed. Blood samples were collected from the orbits of mice of each group 2 hours after the last administration to observe the general characteristics of the animals and the changes in the number of the red blood cells and the hemoglobin.

[0056] Table 4 Comparison of red blood cell count and hemoglobin content of mice in each group (x + s) © Group | Number of animals | Red blood cell | Hemoglobin (g/L) ] (n) count ( x 10% L1) Blank control group 10 8.074121 — rose © Modelgroup | 740 | 4024105 99.3+1321 | © Example1 | 10 | 6374145 | 1501+1021* | ~~ Example2 | 10 | 6.464125 155 6+9.23"* ” © Example3 | 140 | 652+132* | 157.9+835 | ‘Comparative | 10, | 5214042 | 1209+321 Example 1 “Comparative | 10 | 4294037 | 1002+625 | Example 2 | Comparative | 10 4351056 | 11064225 Example 3 | | |

[0057] The data in Table 4 above show that after the subcutaneous injection of 1-acetyl-2- phenylhydrazine, a significant decline was observed in the red blood cell count and the hemoglobin content value of the mice of model group as compared to those of mice in the blank control group. The mice were generally in poor condition, unwilling to move, lethargic, Besides, the mice had closed eyes, pale tai and ears, coarse, fluffy and dull coat, and body mass decreased with the reduction of diet and water consumption. After administering the anti-aging soft capsules for women during menopause prepared in Examples 1-3 of the present invention, the red blood cell count and hemoglobin content value of the mice were higher than those of the model group, with similar effects comparable to the compound E- jiao slurry group. The mice gradually returned to good condition, had shiny and thick coat, moved flexible, and showed slightly redness in ears and tail. As for the soft capsules prepared in Comparative Examples 1-3, they resulted in a slightly higher red blood cell count and hemoglobin content value than those of the model group, but the effect thereof was not good enough. The reason is mainly that the various constituents of the soft capsule of the present invention exhibit a synergistic effect, which is superior to the sum of effects of the three comparative examples as to blood-nourishing. The soft capsule of the present invention has excellent effects of supplementing vital energy and nourishing blood while resisting aging and oxidation, and is a health food suitable for women during menopause

[0058] Test of the anti-aging soft capsule for women during menopause of the present invention on human body

[0059] Test participant: 400 women aged 45 to 65 were selected and equally divided into 4 groups, with 100 women in each group. Women in each group have little age difference. Women with three or more symptoms from postmenopause or oligomenorrhea, loose and dull skin, obvious wrinkles, deepening of patches, hot flashes, osteoporosis, dizziness, headache, tinnitus, moodiness, etc., were diagnosed as menopause.

[0060] Test method: women in the first group consumed the soft capsule prepared in Example 2 of the present invention, with 2 capsules per day. Women in groups 2-4 consumed the soft capsules prepared in Comparative examples 1-3, respectively, with 2 capsules per day. Results were observed after 180 days of continuous testing. The specific results are shown in Table 5

BL-5209 19 LU102669

[0061] Evaluation standard:

[0062] Significant improvement: at least 4 of the symptoms from loose and dull skin, obvious wrinkles, deepening of patches, hot flashes, osteoporosis, dizziness, headache, tinnitus, moodiness, etc. have basically disappeared or mostly disappeared, and the mental state is good; {0063} Relief. at least 2 of the symptoms from loose and dull skin, obvious wrinkles, deepening of patches, hot flashes, osteoporosis, dizziness, headache, tinnitus, moodiness. etc. are remarkably decreased, the skin is gradually rosy and shiny, and the mental state is good,

[0064] Invalid: the symptoms from loose and dull skin, obvious wrinkles, deepening of patches, hot flashes, osteoporosis, dizziness, headache, tinnitus, moodiness, etc. have no obvious change or are even aggravated, and the mental state is poor.

[0066] The above test results show that the anti-aging soft capsule for women during menopause prepared by the present invention has an excellent effect on alleviating menopausal symptoms, with a total validity of 98%, which is superior to the test results of the comparative examples. Moreover, a long-term consumption of the soft capsule of the present invention by the test participant did not cause any toxic and side effects. Instead, significant blood-nourishing effect was produced, which enabled women to have rosy and shiny appearance and elastic skin for a long time. Therefore, the product of the present invention can enable middle-aged and elder women to regain the confidence of beauty and obviously improve their physical fitness.

Claims

BL-5209 CLAIMS

1. An anti-aging soft capsule for women during menopause, composed of a capsule content and a capsule shell, characterized in that, the weight ratio of the capsule content is: soy isoflavone extract powder. pomegranate seed oil, Lirnonium bicolor extract: a suspending agent: a wetting agent = 5: (85-92): (5-8): (2-8): (1-7); the capsule shell is made of gelatin, plasticizer, colorant and water; the weight ratio of the gelatin, the plasticizer and water is. 1: (0.3-0.7) 1; the colorant is composed of white pigment and milk chocolate brown pigment. wherein the white pigment is 0.05% of the weight of the gelatin. and the milk chocolate brown pigment is 0.5% of the weight of the gelatin.

2. The anti-aging soft capsule for women during menopause according to claim 1, characterized in that, the Limonium bicolor extract is prepared by the following method, including: cutting Limonium bicolor into small segments, adding tenfold amount of water therein, then processing with 80 kHz ultrasound for 30 minutes, thereafter adding papain for enzymolysis, wherein the enzymolysis is carried out at a temperature of 60% for 1-2 hours; after the enzymolysis is completed, performing a filtration to obtain a filtrate. followed by concentrating the filtrate under reduced pressure to obtain a concentrated solution with a relative density of 1.3 at 80°C", and vacuum freeze-drying to form powder.

3. The anti-aging soft capsule for women during menopause according to claim 2, characterized in that, the adding amount of the papain is 80 U/g

4. The anti-aging soft capsule for women during menopause according to claim 1. characterized in that, the suspending agent is one or more of beeswax, insect wax, soybean lecithin, and glyceryl monostearate.

The anti-aging soft capsule for women during menopause according to claim 1, characterized in that. the wetting agent is one or more of Tween, Span, and soybean lecithin.

6. The anti-aging soft capsule for women during menopause according to claim 1, characterized in that, the plasticizer is one of sorbitol, propylene glycol, glycerin, and low molecular weight polyethylene glycol.

7. A preparation method of the anti-aging soft capsule for women during menopause according to claim 1, characterized by comprising the following steps:

SL 5008 15 LU102669 {1) preparation of the capsule content. quantitatively weighing appropriate amounts of the pomegranate seed oil, the suspending agent, and the wetting agent, heating to completely melt the suspending agent and the wetting agent into the pomegranate seed oil, stirring and mixing uniformly, and adding soy isoflavone dry extract powder sieved through 150- mesh sieve and the Limonium bicolor extract therein after cooling, followed by stirring evenly, grinding, standing, and maintaining at 45°C to remove bubbles for subsequent use, (2) preparation of the capsule shell: presetting the temperature of the water bath interlayer of a vacuum stirrer to 90°C", adding a certain amount of distilled water, then adding the while pigment and milk chocolate brown pigment, and stirring evenly, followed by adding the plasticizer and gelatin successively to the vacuum stirrer when the temperature in the vacuum stirrer reaches 85 ©, stirring and melting to form a uniform glue liquid, then adjusting the temperature of the water bath interlayer of the vacuum stirrer to (5545) CC, maintaining the temperature and standing for 12 hours to obtain the glue liquid for subsequent use; and

(3) pelleting with a conventional process, shaping and drying, washing and drying,

picking up, and packaging. to obtain the product of the present invention.