Composition for treating insulin resistance and polycystic ovary syndrome and preparation method thereof

Abstract

The invention relates to a composition for treating insulin resistance and polycystic ovary syndrome. The composition comprises the following components in parts by mass: red yeast rice extract, lotus leaf extract, inositol and chiro-inositol. The invention not only conforms to the theory of monarch, minister, assistant and messenger in traditional Chinese medicine prescription through the combination of red yeast rice, lotus leaf, inositol and chiro-inositol, but also meets the requirements of different syndrome differentiation and classification by combining traditional Chinese and Western medicine to treat diseases, and achieves the effect of treating insulin resistance and polycystic ovary syndrome by accelerating the utilization and absorption of glycogen, reducing insulin level, regulating hormone level in the body and regulating glucose and lipid metabolism.

Description

Technical Field

[0001] The invention relates to the technical field of food and medicine, and in particular to a composition for treating insulin resistance and polycystic ovary syndrome and a preparation method thereof. Background Art

[0002] Polycystic Ovary Syndrome (PCOS) is a common metabolic and endocrine disease in gynecology. It often occurs in adolescence and childbearing age, with an incidence of 5% to 10%. Among them, 50% to 70% of patients are accompanied by insulin resistance (IR). The main clinical manifestations are hirsutism, acne, irregular menstruation (amenorrhea, oligomenorrhea), infertility, obesity, etc. The incidence of diabetes and cardiovascular diseases in PCOS patients is higher than that of normal women, and the causes are more complicated. Among them, IR is an important part of PCOS and increases the incidence of long-term complications.

[0003] In recent years, the role of integrated Chinese and Western medicine in the treatment of PCOS has become increasingly prominent. Among them, Western medicine treatments are mostly combined with inositol and chiro-inositol for treatment abroad, which has obvious effects in regulating hormone levels, improving oocyte quality and improving IR. There is no medical name related to PCOS. According to its different clinical symptoms, it can be classified into the categories of "infertility", "late menstruation", "amenorrhea" and "symptoms and masses". And Chinese medicine syndrome differentiation is divided into liver meridian stagnation type, phlegm and dampness obstruction type, and kidney deficiency and stasis type. The menstrual cycle adjustment therapy (according to the characteristics of the menstrual cycle, that is, premenstrual period, menstrual period, and postmenstrual period, Chinese medicine is given in stages to adjust the menstrual cycle) can improve clinical symptoms and correct endocrine disorders.

[0004] The effective ingredients of lotus leaves mainly include alkaloids and flavonoids, among which nuciferine is an isoquinoline alkaloid rich in lotus leaves and is an important component of lotus leaves in terms of pharmacological effects. Current studies have shown that nuciferine can reduce body weight, improve insulin resistance, and reduce inflammatory responses.

[0005] Red yeast rice, as recorded in Compendium of Materia Medica, has the effects of "promoting blood circulation and removing blood stasis, strengthening the spleen and digesting food". It is a traditional food that can be used as both medicine and food. It has the effects of strengthening the spleen and digesting food, and can also be used for food coloring. Modern Western medicine has verified that the heme in red yeast rice can block the cholesterol synthesis pathway and has obvious lipid-lowering biological activity. It is an ideal food for the treatment and prevention of cardiovascular and cerebrovascular diseases.

[0006] Some products on the market use lotus leaves, red yeast rice and other ingredients as raw materials, which are helpful in lowering blood sugar in the human body to a certain extent. However, the regulatory effect of the combination on insulin resistance and polycystic ovary syndrome is weak, and the shelf life of the combination is unstable and easily deteriorates, which greatly limits the application and promotion of the combination in the field of human health care.

[0007] In summary, there is an urgent need to design a composition for treating insulin resistance and polycystic ovary syndrome to solve the problems existing in the prior art. Summary of the invention

[0008] Based on this, the present invention provides a composition for treating insulin resistance and polycystic ovary syndrome to overcome the deficiencies of the prior art.

[0009] In order to solve the shortcomings of existing therapies, the purpose of the present invention is to provide a composition for treating insulin resistance and polycystic ovary syndrome and a preparation method, aiming to accelerate the utilization and absorption of glycogen, reduce insulin levels, and regulate hormone levels in the body through the combination of red yeast rice, lotus leaves, inositol, chiro-inositol, and a regulator. The composition can be used to treat insulin resistance and polycystic ovary syndrome while extending the shelf life of the composition.

[0010] An object of the present invention is to provide a composition for treating insulin resistance and polycystic ovary syndrome, the composition comprising the following components in parts by weight:

[0011]

[0012] Wherein, the surfactant is polyrhamnose and modified lecithin;

[0013] The modified lecithin is a product obtained by the reaction of lecithin and cinnamic acid.

[0014] Furthermore, the composition further comprises the following components in parts by weight:

[0015] Vitamin C 0.1-0.2 parts

[0016] Regulator 0.1-30 parts.

[0017] Further, the regulator is one or more of resistant dextrin, monk fruit extract, citric acid, hawthorn extract, corn silk extract, acerola cherry extract, cinnamon extract, tangerine peel extract, emblica extract, yam extract, rehmannia extract, cornus extract, Poria extract, white peony extract, atractylodes extract, curcuma extract, white mustard extract, salvia miltiorrhiza extract, motherwort extract, wormwood extract, rose extract, plum blossom extract, mistletoe extract, psoralea corylifolia extract, Dipsacus asper extract, Eucommia ulmoides extract, Eclipta prostrata extract, Ligustrum lucidum extract, bupleurum extract, β-carotene, astaxanthin, turmeric extract, resveratrol, and lemon flavor.

[0018] Specifically, myo-inositol (MI) and D-chiroinositol (DCI) MI and DCI are also insulin sensitizers and are components of the insulin second messenger phosphoinositol glucan. MI is converted into inositol phosphoglycan (IPG) insulin second messenger (MI-IPG) to participate in cellular glucose uptake and regulate the activity of follicle stimulating hormone. DCI is converted into IPG insulin second messenger (DCI-IPG), which plays an important role in glycogen synthesis and insulin-induced ovarian synthesis of excess androgens. In the treatment of PCOS, supplementation of MI and DCI can increase glucose uptake and utilization, enhance insulin activity, reduce insulin secretion, and thus weaken the effect of excessive insulin stimulating the ovaries to produce androgens. This can improve the regularity of the menstrual cycle, acne scores, endocrine and metabolic parameters, and insulin resistance.

[0019] The present invention also provides a method for preparing the composition for treating insulin resistance and polycystic ovary syndrome, comprising the following steps:

[0020] S1. Under the protection of nitrogen, the lecithin is heated, lactic acid and hydrogen peroxide are added, ultrasonically reacted, and purified to obtain hydroxylated lecithin;

[0021] S2. adding hydroxylated lecithin to cinnamic acid and heating the mixture to obtain modified lecithin;

[0022] S2. Mix the modified lecithin and other ingredients, sieve and mix to obtain the composition.

[0023] Furthermore, in step S1, the heating temperature is 55-75°C.

[0024] Furthermore, in step S3, the mixing time is 10-60 min.

[0025] Specifically, the composition of the present invention also has different improvement effects on the patient's body mass index (BMI), luteinizing hormone (LH), estradiol (E2), follicle stimulating hormone (FSH), testosterone (T), progesterone (P), pituitary prolactin (PRL), etc., and can holistically regulate the patient's endocrine environment and reproductive metabolic abnormalities, correct hormone disorders, reduce insulin resistance, improve the inflammatory environment, change the ovarian morphology, improve endometrial receptivity, and increase the pregnancy rate.

[0026] The present invention has the following beneficial effects:

[0027] 1. The present invention, through the combination of red yeast rice, lotus leaf, inositol and chiro-inositol, not only conforms to the theory of monarch, minister, assistant and messenger in traditional Chinese medicine prescription, but we unexpectedly found that the combination of red yeast rice, lotus leaf, inositol and chiro-inositol can meet different symptom classifications; it also follows the direction of combining traditional Chinese medicine and Western medicine to treat diseases, and accelerates the utilization and absorption of glycogen, reduces insulin levels, regulates hormone levels in the body, and regulates glucose and lipid metabolism, thereby achieving the effect of treating insulin resistance and polycystic ovary syndrome.

[0028] 2. The present invention selects polyrhamnose and modified lecithin as surfactants, introduces cinnamic acid into the lecithin by hydroxylation pretreatment, so that the modified lecithin component contains grafted cinnamic acid segments, which improves the compatibility of the modified lecithin with other components in the composition on the one hand; on the other hand, the introduction of cinnamic acid enhances the antibacterial activity of the modified lecithin, prolongs the shelf life of the composition, improves the stability of the product, and ensures the appearance of the product. DETAILED DESCRIPTION

[0029] In order to more clearly illustrate the technical solution of the present invention, the following examples are listed. Unless otherwise stated, the raw materials, reactions and post-treatment methods shown in the examples are common raw materials on the market and technical methods well known to those skilled in the art.

[0030] The words "preferred", "preferably", "more preferably", etc. in the present invention refer to embodiments of the present invention that can provide certain beneficial effects in certain circumstances. However, other embodiments may also be preferred under the same circumstances or other circumstances. In addition, the description of one or more preferred embodiments does not imply that other embodiments are not applicable, nor is it intended to exclude other embodiments from the scope of the present invention.

[0031] It should be understood that, except in any operating examples, or where otherwise indicated, all numbers expressing, for example, the amounts of ingredients used in the specification and claims should be understood to be modified in all cases by the term "about". Therefore, unless indicated to the contrary, the numerical parameters set forth in the following specification and the appended claims are approximate values ​​that vary depending on the desired properties to be obtained by the present invention.

[0032] Example 1

[0033] A composition for treating insulin resistance and polycystic ovary syndrome, comprising the following components in parts by mass:

[0034]

[0035] The method for preparing the composition for treating insulin resistance and polycystic ovary syndrome comprises the following steps:

[0036] S1. Under the protection of nitrogen, 30 g of lecithin was heated to 70 ° C, a catalytic amount of lactic acid and 20 mL of 30 wt% hydrogen peroxide were added, ultrasonically reacted for 2 h, and vacuum dried at 45 ° C to obtain hydroxylated lecithin;

[0037] S2. 1 mol of cinnamic acid was dissolved in 35 mL of dimethyl sulfoxide, and then 1 mol of the hydroxylated lecithin was added to 30 mL of deionized water, mixed, and then 1 mol of 1-(3-dimethylaminopropyl)-3-ethylcarbodiimide hydrochloride was added, the pH was adjusted to 6, stirred at 30° C. for 20 h, dialyzed with ultrapure water for 72 h (the molecular weight cutoff of the dialysis bag was 1000 Da), and vacuum freeze-dried to obtain modified lecithin;

[0038] S3-1. The modified lecithin and other ingredients were mixed for 30 min, sieved through a 100 mesh sieve, mixed, and dried at 45 ° C;

[0039] S3-2. The dried mixture is poured into the hopper of a bagging machine for bagging to obtain a composition for treating insulin resistance and polycystic ovary syndrome;

[0040] S3-3. Place the finished composition under ultraviolet light for 30 minutes and then package, box and carton it.

[0041] Example 2

[0042] A composition for treating insulin resistance and polycystic ovary syndrome, comprising the following components in parts by mass:

[0043]

[0044]

[0045] The method for preparing the composition for treating insulin resistance and polycystic ovary syndrome comprises the following steps:

[0046] S1. Under the protection of nitrogen, 30 g of lecithin was heated to 70 ° C, a catalytic amount of lactic acid and 20 mL of 30 wt% hydrogen peroxide were added, ultrasonically reacted for 2 h, and vacuum dried at 45 ° C to obtain hydroxylated lecithin;

[0047] S2. 1 mol of cinnamic acid was dissolved in 35 mL of dimethyl sulfoxide, and then 1 mol of the hydroxylated lecithin was added to 30 mL of deionized water, mixed, and then 1 mol of 1-(3-dimethylaminopropyl)-3-ethylcarbodiimide hydrochloride was added, the pH was adjusted to 6, stirred at 30° C. for 20 h, dialyzed with ultrapure water for 72 h (the molecular weight cutoff of the dialysis bag was 1000 Da), and vacuum freeze-dried to obtain modified lecithin;

[0048] S3-1. The modified lecithin and other ingredients were mixed for 30 min, sieved through a 100 mesh sieve, mixed, and dried at 45 ° C;

[0049] S3-2. The dried mixture is poured into the hopper of a bagging machine for bagging to obtain a composition for treating insulin resistance and polycystic ovary syndrome;

[0050] S3-3. Place the finished composition under ultraviolet light for 30 minutes and then package, box and carton it.

[0051] Example 3

[0052] A composition for treating insulin resistance and polycystic ovary syndrome, comprising the following components in parts by mass:

[0053]

[0054]

[0055] The method for preparing the composition for treating insulin resistance and polycystic ovary syndrome comprises the following steps:

[0056] S1. Under the protection of nitrogen, 30 g of lecithin was heated to 70 ° C, a catalytic amount of lactic acid and 20 mL of 30 wt% hydrogen peroxide were added, ultrasonically reacted for 2 h, and vacuum dried at 45 ° C to obtain hydroxylated lecithin;

[0057] S2. 1 mol of cinnamic acid was dissolved in 35 mL of dimethyl sulfoxide, and then 1 mol of the hydroxylated lecithin was added to 30 mL of deionized water, mixed, and then 1 mol of 1-(3-dimethylaminopropyl)-3-ethylcarbodiimide hydrochloride was added, the pH was adjusted to 6, stirred at 30° C. for 20 h, dialyzed with ultrapure water for 72 h (the molecular weight cutoff of the dialysis bag was 1000 Da), and vacuum freeze-dried to obtain modified lecithin;

[0058] S3-1. The modified lecithin and other ingredients were mixed for 30 min, sieved through a 100 mesh sieve, mixed, and dried at 45 ° C;

[0059] S3-2. The dried mixture is poured into the hopper of a bagging machine for bagging to obtain a composition for treating insulin resistance and polycystic ovary syndrome;

[0060] S3-3. Place the finished composition under ultraviolet light for 30 minutes and then package, box and carton it.

[0061] Comparative Example 1

[0062] In Comparative Example 1, red yeast rice extract and lotus leaf extract were removed, and other ingredients and preparation methods were the same as those in Example 1.

[0063] Comparative Example 2

[0064] In Comparative Example 2, the modified lecithin was replaced with an equal mass of conventional lecithin, and the other ingredients and preparation method were the same as those in Example 1.

[0065] Test Example 1

[0066] Stability test

[0067] Test method:

[0068] The compositions prepared in Example 1 and Comparative Examples 1-2 were sealed in bottles and placed in a 48°C environment for 3 months and then returned to room temperature of 25°C. The appearance of the compositions did not change significantly and there was no caking, indicating that the stability was acceptable.

[0069] The stability test results are shown in Table 1:

[0070] Table 1 Stability test results of the compositions of Example 1 and Comparative Examples 1-2

[0071]

[0072] According to Table 1, it can be concluded that the stability of the composition prepared in Example 1 has an ideal value; and after being placed at high temperature for a long time, the performance of the composition of the present invention is still maintained at a relatively stable level, with a small decline, indicating that the components have good compatibility and have strong antibacterial properties.

[0073] Test Example 2

[0074] The efficacy of the composition for treating insulin resistance and polycystic ovary syndrome prepared in Example 1 and Comparative Examples 1-2 was tested.

[0075] Experimental method 1: 36 SPF rats were selected to establish an insulin resistance animal model using a high-fat and high-sugar diet.

[0076] The rats were randomly divided into 12 cases in each of the embodiment and comparative examples 1-2 using a random number table. The three groups of rats were fed with a high-fat and high-sugar diet and gavaged with corresponding drugs for 12 consecutive weeks.

[0077] Then, glucose tolerance test was performed to detect blood glucose and insulin levels. The comparison of means among multiple groups was performed using analysis of variance test.

[0078]

[0079] The experimental results show that, as can be seen from Table 2 and Table 3, the plasma blood glucose and insulin levels of Example 1 of the composition for treating insulin resistance and polycystic ovary syndrome are lower than those of Comparative Examples 1-2.

[0080] Test Example 2

[0081] The compositions for treating insulin resistance and polycystic ovary syndrome prepared in Example 2 and Comparative Examples 1-2 were tested;

[0082] Test method:

[0083] A total of 120 patients with PCOS and IR were randomly divided into a study group and a control group with 40 cases in each group using a random number table. The observation period was 3 months. SPSS26.0 statistical software was used for data analysis. The measurement data were expressed as mean ± standard deviation. express.

[0084]

[0085]

[0086] It can be seen from Tables 4-6 that the insulin resistance of the group of people taking the composition for treating insulin resistance and polycystic ovary syndrome was improved to a certain extent. After 3 months of observation, the composition of Example 1 had the effect of improving insulin resistance and increasing insulin sensitivity.

[0087] It will be apparent to those skilled in the art that the present invention is not limited to the details of the exemplary embodiments described above and that the present invention can be implemented in other specific forms without departing from the spirit or essential features of the present invention. Therefore, the embodiments should be considered exemplary and non-restrictive in all respects, and the scope of the present invention is defined by the appended claims rather than the above description, and it is intended that all changes falling within the meaning and scope of the equivalent elements of the claims be included in the present invention.

[0088] In addition, it should be understood that although the present specification is described according to implementation modes, not every implementation mode contains only one independent technical solution. This description of the specification is only for the sake of clarity. Those skilled in the art should regard the specification as a whole. The technical solutions in each embodiment may also be appropriately combined to form other implementation modes that can be understood by those skilled in the art.

Claims

1. A composition for treating insulin resistance and polycystic ovary syndrome, It is characterized in that The composition comprises the following components in parts by weight: 6-10 parts of red yeast rice extract; 3-6 parts of lotus leaf extract; Myo-inositol 10-20 parts; Chiro-inositol 0.1-0.5 parts; Surfactant 0.1-10 parts; Wherein, the surfactant is polyrhamnose and modified lecithin; The preparation method of the composition comprises the following steps: S1. Under the protection of nitrogen, the lecithin is heated, lactic acid and hydrogen peroxide are added, ultrasonically reacted, and purified to obtain hydroxylated lecithin; S2. adding hydroxylated lecithin to cinnamic acid and heating the mixture to obtain modified lecithin; S3. Mix the modified lecithin and other ingredients, sieve and mix to obtain the composition.

2. The composition for treating insulin resistance and polycystic ovary syndrome according to claim 1, It is characterized in that The composition further comprises the following components in parts by weight: Vitamin C 0.1 -0.2 parts; 0.1-30 parts of regulator; The regulators are resistant dextrin and citric acid.

3. The composition for treating insulin resistance and polycystic ovary syndrome according to claim 1, wherein the preparation method of the composition is include: The sieved particle size is 0.3mm-0.013mm.

4. The composition for treating insulin resistance and polycystic ovary syndrome according to claim 1, It is characterized in that The preparation method of the composition also includes: in step S1, the heating temperature is 55-75°C.

5. The composition for treating insulin resistance and polycystic ovary syndrome according to claim 1, It is characterized in that The preparation method of the composition further comprises: in step S3, the mixing time is 10-60 minutes.

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