Magnesium and vitamin composition and application thereof

Abstract

The invention belongs to the technical field of biological medicines, and particularly relates to a magnesium and vitamin composition as well as a preparation method and application thereof. The magnesium and vitamin composition comprises the following raw materials: chelated magnesium and vitamins, the chelated magnesium is selected from amino acid chelated magnesium or organic acid chelated magnesium; the vitamins comprise fat-soluble vitamins and water-soluble vitamins. Through combined action and synergistic interaction of magnesium and vitamins, the composition can significantly reduce the number of writhing times of mice, reduce the level of PGF2alpha, increase the levels of PGE2 and NO, and significantly improve mouse dysmenorrhea caused by estradiol benzoate.

Description

TECHNICAL FIELD

[0001] The application belongs to the technical field of biological medicine, and particularly relates to a magnesium and vitamin composition and application thereof. BACKGROUND

[0002] Functional dysmenorrhea is a relatively common dysmenorrhea without pelvic organic lesions, which is mainly manifested as spastic pain in the lower abdomen and is related to the increase in the secretion of prostaglandins. There is a lack of curative drugs for the treatment of functional dysmenorrhea, and the clinical treatment is mainly symptomatic treatment of prostaglandin synthetase inhibitors, but the disease cannot be fundamentally controlled. Related studies have shown that the occurrence of functional dysmenorrhea is related to the increase in the content of arachidonic acid phospholipids, which provides an important basis for treating functional dysmenorrhea with vitamin E, because vitamin E can inhibit the release of arachidonic acid phospholipids, reduce the level of prostaglandins, and thus relieve the disease. Although vitamin E has a certain effect on the treatment of functional dysmenorrhea, there is still a lot of room for improvement in the clinical curative effect.

[0003] And studies have shown that some vitamins can help alleviate dysmenorrhea symptoms by regulating hormones, relieving inflammation or improving metabolism. However, the effect varies from person to person and has limitations in taking.

[0004] For example, patent CN108703980A discloses a composition for relieving dysmenorrhea, which comprises bioray, vitamin B1 and magnesium salt. In the technical solution provided by the application, the antioxidant effect of bioray can regulate the activity of NF-B and inhibit the activity of cyclooxygenase COX1 and COX2, effectively relieve dysmenorrhea, magnesium salt can maintain the normal relaxation of muscles and blood vessels, and vitamin B1 has the same effect as non-hormonal anti-inflammatory drugs in relieving dysmenorrhea. The three together have a synergistic complementary effect, which can quickly relieve spasm and relieve pain, and also has a long-term effect of regulating prostaglandin secretion and inflammation. However, the effect of relieving dysmenorrhea still needs to be improved.

[0005] For example, Zhu Zhongchu et al. found in the study of "Clinical Efficacy of Desogestrel Ethinylestradiol Combined with Vitamin B6 in the Treatment of Primary Dysmenorrhea" that vitamin B6 can enhance the efficacy of desogestrel ethinylestradiol, and the total effective rate can reach 96.55%. However, hormone drugs and vitamins cannot be taken for a long time.

[0006] Therefore, it is urgent to research a magnesium and vitamin composition with excellent effect in treating dysmenorrhea. SUMMARY

[0007] Based on the deficiencies of the prior art, the application aims to provide a magnesium and vitamin composition, a preparation method and application thereof.

[0008] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the subject matter of the claims belongs. Unless otherwise indicated, all patents, patent applications, publications, and other documents referred to herein are hereby incorporated by reference in their entirety. In the event of a conflict between the definitions and the meanings of terms set forth in this section and those set forth in the specification, the definitions and meanings set forth in this section control.

[0009] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the subject matter, which is claimed. In this application, the use of the singular includes the plural, unless specifically stated otherwise. It should also be noted that, unless otherwise indicated, the use of "or" in the context of describing alternatives, for example, a condition A or B, is used to mean an "inclusive or," that is, unless otherwise indicated, the phrase "A or B" means "A, or B, or both A and B." Further, the use of the term "including" as well as other forms such as "include," "includes," and "included" is not limiting.

[0010] To achieve the above object, the present application adopts the following technical solutions: In one aspect, the present application provides a magnesium and vitamin composition, comprising the following raw materials: chelated magnesium and vitamins; the chelated magnesium is selected from amino acid chelated magnesium or organic acid chelated magnesium; the vitamins include fat-soluble vitamins and water-soluble vitamins; the mass ratio of the chelated magnesium and the vitamins is 350-450:61.6-93.2.

[0011] Preferably, the amino acid chelated magnesium is selected from one or more of magnesium glycinate, magnesium taurate, magnesium L-aspartate, and magnesium lysine glycinate.

[0012] Preferably, the organic acid chelated magnesium is selected from one or more of magnesium citrate, magnesium threonate, EDTA chelated magnesium, and magnesium malate.

[0013] More preferably, the chelated magnesium is selected from magnesium threonate.

[0014] Preferably, the water-soluble vitamins are selected from at least one of vitamin B, vitamin C, and pyrroloquinoline quinone (PQQ).

[0015] More preferably, the water-soluble vitamins are vitamin B and PQQ.

[0016] Preferably, the vitamin B is selected from at least one of vitamin B1, vitamin B2, vitamin B6, vitamin B9, and vitamin B 12 .

[0017] More preferably, the vitamin B is vitamin B6, vitamin B9, and vitamin B 12 .

[0018] Preferably, the fat-soluble vitamins are selected from at least one of vitamin A, vitamin D, vitamin E, and vitamin K.

[0019] Preferably, the fat-soluble vitamin is vitamin E and / or vitamin K.

[0020] Preferably, the vitamin K is at least one selected from vitamin Kl, vitamin K2, vitamin K4.

[0021] Preferably, the vitamin D is at least one selected from vitamin Dl, vitamin D2.

[0022] Further preferably, the fat-soluble vitamin is vitamin E.

[0023] As some preferred embodiments, the magnesium and vitamin composition comprises, by weight fraction, the following raw materials: magnesium threonate 350-450 parts, vitamin B6 40-60 parts, vitamin B9 1-2 parts, vitamin B 12 0.3-0.6 parts, vitamin E 0.3-0.6 parts and PQQ 20-30 parts. 12 0.3-0.6 parts, vitamin E 0.3-0.6 parts and PQQ 20-30 parts.

[0024] As some preferred embodiments, the magnesium and vitamin composition comprises, by weight fraction, the following raw materials: magnesium threonate 350-450 parts, vitamin B6 40-60 parts, vitamin B9 1-2 parts, vitamin B 12 0.3-0.6 parts, vitamin E 0.3-0.6 parts and PQQ 20-30 parts. 12 0.3-0.6 parts, vitamin E 0.3-0.6 parts and PQQ 20-30 parts.

[0025] As some preferred embodiments, the magnesium and vitamin composition comprises, by weight fraction, the following raw materials: magnesium threonate 350-450 parts, vitamin B6 40-60 parts, vitamin B9 1-2 parts, vitamin B 12 0.3-0.6 parts, vitamin E 0.3-0.6 parts and PQQ 20-30 parts.

[0026] As some preferred embodiments, the magnesium and vitamin composition comprises, by weight fraction, the following raw materials: magnesium threonate 350-450 parts, vitamin B6 40-60 parts, vitamin B9 1-2 parts, vitamin B 12 0.3-0.6 parts, vitamin E 0.3-0.6 parts and PQQ 20-30 parts.

[0027] The present application also provides a preparation method of the above magnesium and vitamin composition, comprising the following steps: mixing the above raw materials to obtain.

[0028] Finally, the present application also provides the use of the above magnesium and vitamin composition in the preparation of a product for treating dysmenorrhea.

[0029] Preferably, the product comprises a medicine or a health product.

[0030] Preferably, the dosage form of the product is powder, tablet, pill, granule, solution, emulsion, flash release, syrup, paste, gel, capsule effervescent, spray, patch, nanodispersion, enteric, controlled release, oral dissolving film, dropping pill, soft capsule, hard capsule, oral liquid, oral spray, sublingual spray, sublingual tablet, sublingual micro-needle, chewable tablet, patch, transdermal, nanocapsule, granule, tea, soft candy, pressed candy, sustained release, nutrition bar, nutrition strip or lyophilized powder.

[0031] Preferably, the product further comprises a pharmaceutically or nutritionally acceptable excipient.

[0032] Compared with the prior art, the present application has the following beneficial effects: The present application has a positive effect on dysmenorrhea through the synergistic effect of magnesium and vitamins. It can significantly improve the dysmenorrhea caused by estradiol benzoate in mice. DETAILED DESCRIPTION

[0033] The various exemplary embodiments of the present application will now be described in detail, which should not be considered as limiting the present application, but should be understood as a more detailed description of certain aspects, characteristics and embodiments of the present application.

[0034] It should be understood that the terms described in the present application are only for describing the specific embodiments, and are not used to limit the present application. In addition, for the numerical range in the present application, it should be understood that each intermediate value between the upper limit and the lower limit of the range is also specifically disclosed. Each smaller range between any stated value or intermediate value within the stated range and any other stated value or intermediate value within the stated range is also included in the present application. The upper limit and lower limit of these smaller ranges can be independently included or excluded from the range.

[0035] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the present application pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present application, the preferred methods and materials are described. All documents mentioned in this specification are incorporated by reference to disclose and describe the methods and / or materials in connection with which the documents are cited. In the case of conflict between the content of this specification and that of any document incorporated by reference, the content of this specification prevails.

[0036] Many modifications and variations of the present application described in the specification are possible without departing from the scope or spirit of the present application, which will be apparent to those skilled in the art. Other implementations of the present application will be apparent to those skilled in the art from the specification. The specification and examples of the present application are only exemplary.

[0037] As used herein, the terms "comprises", "comprising", "includes", "including", "has", "having" or the like are open-ended terms that are intended to mean including, but not limited to.

[0038] In the following examples, the raw materials used are either commercially available or prepared by conventional methods in the art, unless otherwise specified.

[0039] Example 1 A magnesium and vitamin composition By weight parts, it comprises the following raw materials: Magnesium threonate 400 parts, Vitamin B6 50 parts, Vitamin B9 1.5 parts, Vitamin B 1 parts, Vitamin E 0.5 parts and PQQ 25 parts. 12 0.5 parts, Vitamin E 0.5 parts and PQQ 25 parts.

[0040] Example 2 A magnesium and vitamin composition By weight parts, it comprises the following raw materials: Magnesium glycinate 400 parts, Vitamin B6 50 parts, Vitamin B9 1.5 parts, Vitamin B 1 parts, Vitamin E 0.5 parts and PQQ 25 parts. 12 0.5 parts, Vitamin E 0.5 parts and PQQ 25 parts.

[0041] Example 3 A magnesium and vitamin composition By weight parts, it comprises the following raw materials: Magnesium citrate 400 parts, Vitamin B6 50 parts, Vitamin B9 1.5 parts, Vitamin B 1 parts, Vitamin E 0.5 parts and PQQ 25 parts. 12 0.5 parts, Vitamin E 0.5 parts and PQQ 25 parts.

[0042] Example 4 A magnesium and vitamin composition By weight parts, it comprises the following raw materials: Magnesium threonate 350 parts, Vitamin B6 40 parts, Vitamin B9 1 parts, Vitamin B 1 parts, Vitamin E 0.3 parts and PQQ 20 parts. 12 0.3 parts, Vitamin E 0.3 parts and PQQ 20 parts.

[0043] Example 5 A magnesium and vitamin composition By weight parts, it comprises the following raw materials: Magnesium threonate 450 parts, Vitamin B6 60 parts, Vitamin B9 2 parts, Vitamin B 1 parts, Vitamin E 0.6 parts and PQQ 30 parts. 12 0.6 parts, Vitamin E 0.6 parts and PQQ 30 parts.

[0044] Example 6 A magnesium and vitamin composition By weight parts, it comprises the following raw materials: Magnesium threonate 400 parts, Vitamin C 50 parts, Vitamin D2 1.5 parts, Vitamin K2 0.5 parts, Vitamin A 0.5 parts and PQQ 25 parts.

[0045] Comparative Example 1 The difference with Example 1 is that Magnesium threonate is replaced by Magnesium carbonate.

[0046] Comparative Example 2 The difference from Example 1 is that PQQ is replaced by nicotinic acid.

[0047] Comparative Example 3 The difference from Example 1 is that vitamin E is replaced by vitamin B 12 .

[0048] Comparative Example 4 A magnesium and vitamin composition The following raw materials are included by weight parts: 335 parts of magnesium threonate, 80 parts of vitamin B6, 10 parts of vitamin B 12 1.5 parts of vitamin E and 50 parts of PQQ.

[0049] Effect experiment Effect of a magnesium and vitamin composition on a benzoestradiol-induced dysmenorrhea model in mice 130 female ICR mice with a body weight controlled at 18-22 g were randomly selected, 10 of which were selected as a blank, and the blank group was subcutaneously injected with normal saline. The remaining 120 mice were all subcutaneously injected with benzoestradiol (10 g·kg -1 , 2 mg·mL -1 ) to induce a dysmenorrhea model, once a day for 7 consecutive days, to synchronize the uteruses of the mice. After 3 days, the vaginal smears of the mice subcutaneously injected with benzoestradiol were examined one by one to check whether the mice were in estrus, and the mice not in estrus were discarded. 110 mice meeting the standard were selected and divided into 11 groups, namely a model group, a motherwort group, Example 1-5 groups and Comparative Example 1-4 groups. Except for the blank group, the mice in the remaining groups were given the corresponding gavage solution on the fifth day after the continuous injection of benzoestradiol. The mice in Example 1-5 groups and Comparative Example 1-4 groups were respectively given 0.4 g·kg -1 of the corresponding magnesium-containing composition by gavage. The mice in the motherwort group were given 0.4 g·kg -1 of motherwort granules (purchased from Beijing Tong Ren Tang) by gavage. The continuous administration was performed for 3 days, and the gavage was performed once a day.

[0050] Forty minutes after the last administration, the mice in each group were intraperitoneally injected with oxytocin (0.1 U·10 g -1 ) to perform the writhing times test. Two hours after the last administration, the mice were sacrificed, a small amount of uterine tissue was taken, the surface moisture was absorbed, and the precise weight was measured. According to the measured 9 times the volume of ice-cold normal saline, a 10% uterine homogenate was prepared by a grinder. The homogenate was centrifuged at 3000 rpm for 10 minutes in a low-temperature 4℃ centrifuge. Then, 1 mL of supernatant was taken and stored at a low temperature below -20℃. The PGF2α, PGE2 and NO content levels in the mouse uterine homogenate were measured.

[0051] (1) Wringing times test After injection of oxytocin, the mice were put into transparent empty boxes, and the number of writhing of each group of mice in 15 minutes was determined. (2) Kit assay method ELISA kit assay: The prostaglandin F2a (PGF 2α ), prostaglandin E2 (PGE2) and nitric oxide (NO) in the mouse uterus homogenate were determined by ELISA kit according to the instructions.

[0052] The results are shown in Tables 1 and 2.

[0053] Table 1

[0054] Note: compared with the blank group, *p<0.05; compared with the model group, & p<0.05; compared with Example 1, # p<0.05.

[0055] Table 2

[0056] Note: compared with the blank group, *p<0.05; compared with the model group, & p<0.05; compared with Example 1, # p<0.05.

[0057] As can be seen from the data in Tables 1 and 2, the magnesium and vitamin composition prepared in the examples of the present application can significantly reduce the number of writhing of mice, reduce the level of PGF 2α , and increase the levels of PGE2 and NO, and has a positive therapeutic effect on dysmenorrhea.

[0058] Finally, it should be noted that the above content is only used to illustrate the technical solutions of the present application, and is not a limitation on the protection scope of the present application. Simple modifications or equivalent replacements of the technical solutions of the present application made by those skilled in the art do not deviate from the essence and scope of the technical solutions of the present application.

Claims

1. A composition of magnesium and vitamins, characterized in that, The composition comprises the following raw materials: chelated magnesium and vitamins; the chelated magnesium is selected from amino acid chelated magnesium or organic acid chelated magnesium; the vitamins comprise fat-soluble vitamins and water-soluble vitamins, and the mass ratio of the chelated magnesium to the vitamins is 350-450:61.6-93.

2.

2. The composition of claim 1, wherein, The amino acid chelated magnesium is selected from one or more of glycine magnesium, taurine magnesium, L-aspartic acid magnesium, and lysine glycine magnesium; the organic acid chelated magnesium is selected from one or more of magnesium citrate, threonic acid magnesium, EDTA chelated magnesium, and malic acid magnesium.

3. The composition of claim 1, wherein, The water-soluble vitamins are selected from at least one of vitamin B, vitamin C, and PQQ.

4. The composition of claim 3, wherein, The vitamin B is selected from at least one of vitamin B1, vitamin B2, vitamin B6, vitamin B9, vitamin B12. 12 The vitamin B is selected from at least one of vitamin B1, vitamin B2, vitamin B6, vitamin B9, vitamin B12.

5. The composition of claim 1, wherein, The fat-soluble vitamins are selected from at least one of vitamin A, vitamin D, vitamin E, and vitamin K.

6. The composition of claim 5, wherein, The vitamin K is selected from at least one of vitamin K1, vitamin K2, and vitamin K4.

7. The combination of magnesium and vitamins according to any one of claims 1 to 6, characterized in that, The chelated magnesium is magnesium threonate; the water-soluble vitamins are vitamin B6, vitamin B9, vitamin B 12 and PQQ; and the fat-soluble vitamin is vitamin E.

8. The composition of claim 7, wherein, By weight parts, including the following raw materials: magnesium threonate 350-450 parts, vitamin B6 40-60 parts, vitamin B9 1-2 parts, vitamin B 12 0.3-0.6 parts, vitamin E 0.3-0.6 parts and PQQ 20-30 parts.

9. Use of the composition of magnesium and vitamins according to any one of claims 1-8 in the preparation of a product for treating dysmenorrhea.

10. Use according to claim 9, characterized in that, The product is a pharmaceutical product.

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