A special medical purpose composition for pregnant women and its preparation method and application

Abstract

The application belongs to the technical field of nutrition, and particularly relates to a special medical composition for pregnant women and a preparation method and application thereof. The composition comprises the following components: DHA in the form of phospholipid, active folic acid, vitamin B1, vitamin B2, vitamin B6, vitamin B1, vitamin A, vitamin D, vitamin C, nicotinic acid, pantothenic acid, calcium element, iron element and zinc element. The calcium element is derived from calcium carbonate, the iron element is derived from ferrous gluconate, and the zinc element is derived from zinc sulfate. The composition provided by the application can act on the key window before pregnancy and in the early pregnancy period, and actively perform nutrition storage and metabolism regulation by using high-bioavailability key nutrients such as DHA in the form of phospholipid and active folic acid, and combining specific proportions of B vitamins, vitamin C, vitamin A, vitamin D and minerals.

Description

Technical Field

[0001] This invention belongs to the field of nutritional technology, specifically relating to a composition for special medical purposes for pregnant women, its preparation method, and its application. Background Technology

[0002] Pregnancy is a special physiological stage in a woman's life, and her nutritional status not only affects the mother's health but also directly impacts the fetus's growth and development, and even its long-term health. With changing lifestyles, the proportion of older pregnant women is rising annually, and issues such as pre-pregnancy overweight or obesity, gestational hypertension, unbalanced diets, and insufficient or imbalanced micronutrient intake are becoming increasingly prominent. These factors collectively lead to a series of nutrition-related challenges for pregnant women, including but not limited to blood pressure fluctuations, decreased metabolic regulation, and elevated homocysteine ​​levels, which may in turn affect the course and outcome of pregnancy.

[0003] Modern nutritional research indicates that the preconception and early pregnancy periods are critical windows for early life nutrition planning. Nutritional interventions during this stage are of profound significance for establishing a favorable maternal metabolic environment, supporting placental function and development, and promoting fetal health. However, most current routine prenatal nutrition products suffer from insufficient synergistic effects in their formulation design and focus primarily on support after obvious clinical symptoms have appeared, failing to fully realize the proactive nutritional support concept of "moving the intervention point forward." Summary of the Invention

[0004] To address the shortcomings of current routine prenatal nutrition products, such as insufficient synergistic effects in their formulation design and a focus on support after the onset of obvious clinical symptoms rather than fully realizing the proactive nutritional support concept of "early intervention," this invention provides a composition for special medical purposes for pregnant women, its preparation method, and its application. To achieve the above objectives, this invention adopts the following technical solution.

[0005] This invention provides a composition for special medical use by pregnant women, comprising the following components in parts by weight: Phospholipid-type DHA 0.2-0.25 parts, active folic acid 2.0×10 -4 6.0 x 10 servings -4 Servings of Vitamin B1 0.4 x 10 -3 1.0 x 10 portions -3 Servings of Vitamin B2 0.4 x 10 -3 1.0 x 10 portions -3 Servings of Vitamin B6 0.5 x 10 -3 1.5 x 10 portions -3 Vitamin B 12 1.2×10 -3 2.2 x 10 portions -3 Servings, Vitamin A 2.4×10-4 3.0 x 10 servings -4 Servings of Vitamin D 0.2 × 10⁻⁶ -5 1.0 x 10 portions -5 Servings, Vitamin C 3.0×10 -2 8.0 x 10 servings -2 4.0 x 10 parts, nicotinic acid -3 8.0 x 10 servings -3 Parts, pantothenic acid 2.0×10 -3 4.0 x 10 servings -3 0.3 to 0.6 parts calcium, 0.4 × 10⁻⁶ parts iron -2 1.0 x 10 portions -2 0.28 × 10⁻⁶ (The text abruptly ends here, likely due to an incomplete sentence or a formatting error.) -2 0.8 x 10 portions -2 share.

[0006] The calcium element is derived from calcium carbonate, the iron element from ferrous gluconate, and the zinc element from zinc sulfate.

[0007] Furthermore, the composition is in the form of tablets or capsules.

[0008] Furthermore, the composition is in the form of a powder, tablet, or capsule.

[0009] Furthermore, it also includes pharmaceutically or food-grade excipients.

[0010] Furthermore, the excipients are selected from at least one of emulsifiers, fillers, and carriers.

[0011] Furthermore, the emulsifier is selected from any one or more of soybean lecithin, glyceryl monostearate, sucrose fatty acid esters, and polysorbate.

[0012] The filler is selected from any one or more of maltodextrin, lactose, and starch.

[0013] The carrier is selected from any one or more of vegetable oils, medium-chain triglycerides, ethyl oleate, and isopropyl myristate.

[0014] The present invention also provides a method for preparing the aforementioned composition for special medical use in pregnant women, comprising the following steps: Raw material preparation: Weigh each raw material (including fat-soluble and hydrophilic components) according to the formula ratio.

[0015] Among them, fat-soluble components include phospholipid DHA, vitamin A, and vitamin D.

[0016] Hydrophilic components include active folic acid, vitamin B1, vitamin B2, vitamin B6, and vitamin B1.12 Vitamin C, niacin, pantothenic acid, calcium carbonate, ferrous gluconate, and zinc sulfate.

[0017] Mixing and homogenization (pretreatment): Phospholipid DHA, vitamin A, vitamin D and emulsifier are mixed and uniformly dispersed in the carrier to form an oil phase.

[0018] Incorporate active folic acid, vitamin B1, vitamin B2, vitamin B6, and vitamin B1. 12 Vitamin C, niacin, and pantothenic acid are dissolved in purified water to form an aqueous phase; calcium carbonate, ferrous gluconate, and zinc sulfate are added to the aqueous phase and stirred until completely dissolved.

[0019] Emulsification and embedding: The oil phase is added to the aqueous phase, and after emulsification, a uniform emulsion is formed.

[0020] Drying: The emulsion is dried to form a powder.

[0021] Molding and Packaging: The powder is mixed with the filler and compressed into tablets or filled into capsules to obtain the composition.

[0022] The present invention also provides a method for preparing the composition for special medical use by pregnant women, wherein the drying method is spray drying or freeze drying.

[0023] Furthermore, the inlet air temperature of the spray dryer is 130℃~135℃, and the outlet air temperature is 70℃~80℃.

[0024] Furthermore, the freeze-drying temperature is -45°C to -35°C, and the vacuum degree is 10Pa to 50Pa.

[0025] The present invention also provides the use of the aforementioned composition for special medical purposes for pregnant women in the preparation of special medical purpose formula foods for maintaining healthy blood pressure levels in pregnant women or supplementing prenatal nutrition.

[0026] Compared with the prior art, the present invention has the following beneficial effects: 1. This invention provides a composition for special medical use by pregnant women, comprising the following components in parts by weight: 0.2 to 0.25 parts of phospholipid-type DHA, and 2.0 × 10⁻⁶ parts of active folic acid. -4 6.0 x 10 servings -4 Servings of Vitamin B1 0.4 x 10 -3 1.0 x 10 portions -3 Servings of Vitamin B2 0.4 x 10 -3 1.0 x 10 portions -3 Servings of Vitamin B6 0.5 x 10 -3 1.5 x 10 portions -3 Vitamin B 121.2×10 -3 2.2 x 10 portions -3 Servings, Vitamin A 2.4×10 -4 3.0 x 10 servings -4 Servings of Vitamin D 0.2 × 10⁻⁶ -5 1.0 x 10 portions -5 Servings, Vitamin C 3.0×10 -2 8.0 x 10 servings -2 4.0 x 10 parts, nicotinic acid -3 8.0 x 10 servings -3 Parts, pantothenic acid 2.0×10 -3 4.0 x 10 servings -3 0.3 to 0.6 parts calcium, 0.4 × 10⁻⁶ parts iron -2 1.0 x 10 portions -2 0.28 × 10⁻⁶ (The text abruptly ends here, likely due to an incomplete sentence or a formatting error.) -2 0.8 x 10 portions -2 The calcium is derived from calcium carbonate, the iron from ferrous gluconate, and the zinc from zinc sulfate. This invention provides a composition with multi-target synergistic effects, high bioavailability, and the ability to maintain healthy blood pressure levels. This invention constructs a multi-dimensional synergistic prenatal nutritional intervention system by scientifically proportioning phospholipid DHA, active folic acid, B vitamins, vitamin A, vitamin D, vitamin C, niacin, pantothenic acid, and key nutrients such as calcium, iron, and zinc. On the one hand, it uses active folic acid (5-methyltetrahydrofolate) to replace traditional folic acid, bypassing the metabolic disorders caused by MTHFR gene polymorphism, and works synergistically with vitamin B6 and vitamin B2. 12 This combination forms a synergistic network of "one-carbon metabolic cycle," significantly improving the utilization efficiency of methylation donors and reducing the risk of neural tube defects from the source. On the other hand, the high bioavailability of phospholipid DHA, together with vitamins A and D, forms a synergistic pathway for the absorption, transport, and utilization of fat-soluble nutrients. Combined with the "metabolic engine" function of B vitamins as coenzymes for energy metabolism, and the synergistic support of calcium, iron, and zinc for bone marrow, hematopoiesis, and immunity, this achieves multi-target synergistic effects across the entire chain of nutrient absorption, transport, metabolism, and functional expression. This composition breaks through the traditional "supplement what is lacking" single-supplementation model. Through the design concept of "metabolic synergy + functional integration," it provides proactive nutritional reserves in the early stages of physiological changes during pregnancy, rather than passively intervening after symptoms appear. This truly realizes a paradigm shift from "disease treatment" to "proactive health maintenance," effectively solving the technical defects of insufficient synergistic effects and passive support in the formulation design of existing routine prenatal nutritional products.

[0027] 2. DHA supports the development of the fetal nervous and visual systems and also plays an anti-inflammatory, antioxidant, and vasomotor role in the placenta and maternal system. Triglyceride DHA and ethyl ester DHA first require liver processing to assemble into lipoproteins (mainly LDL / HDL), then are released into the bloodstream to form LPC-DHA (the preferred substrate of the blood-brain barrier active transport system), ultimately entering the brain as LPC-DHA. However, the proportion of LPC-DHA formed in the blood is often very low. In contrast, phospholipid DHA can be directly converted into LPC-DHA after digestion. After entering the liver via the portal vein, it is more efficiently retained in the phospholipid pool and more easily secreted into the bloodstream, significantly increasing the concentration of LPC-DHA in the blood. This allows for more efficient absorption and utilization by the brain via a specific transport protein (MFSD2A). Phospholipids are core structural components of cell membranes (including neuronal membranes). DHA in triglyceride and ethyl ester forms may be more readily oxidized for energy, while DHA supplemented in phospholipid form can be preferentially used by the body for the construction and repair of membrane structures. This is particularly important for the brain development of fetuses and infants, which require the construction of numerous new neural connections.

[0028] 3. Improves vascular endothelial function: Phospholipid-type DHA can promote nitric oxide (NO) synthesis, inhibit endothelin-1 (ET-1) expression, and enhance vasodilation. The fluidity, permeability, and function of membrane receptors (such as eNOS, a key enzyme in nitric oxide production) of vascular endothelial cell membranes are highly dependent on the composition of membrane phospholipids. Phospholipid-type DHA can rapidly optimize the physical and functional properties of endothelial cell membranes, thereby more effectively enhancing NO production and release, which is one of the most direct pathways to dilate blood vessels and lower blood pressure. Compared with triglyceride / ethyl ester DHA, phospholipid-type DHA can rapidly increase the DHA content in erythrocyte membranes. This can significantly increase the deformability of erythrocytes, reduce blood viscosity, thereby improving microcirculation, reducing peripheral vascular resistance, and having a positive effect on improving blood pressure (especially diastolic blood pressure).

[0029] 4. The mechanism by which hyperhomocysteinemia causes hypertension is mainly that homocysteine ​​damages vascular endothelial cells through oxidative stress, reducing the production of vasodilatory substances, decreasing vasodilation, and thus increasing blood pressure. Folic acid deficiency leads to homocysteine ​​metabolism disorders. Active folic acid (5-methyltetrahydrofolate, 5-MTHF) is a form of folic acid that does not require complex hepatic metabolism and can directly provide methyl groups, serving as a direct methyl donor in the remethylation pathway. This is particularly crucial for individuals with MTHFR gene mutations (reduced enzyme activity). Vitamin B... 12As a coenzyme for methionine synthase, it accepts a methyl group from 5-MTHF and directly catalyzes the remethylation of homocysteine ​​(Hcy) to methionine. Vitamin B6, as a coenzyme for cystathionine β-synthase (CBS), catalyzes the entry of Hcy into the transsulfurization pathway, which is crucial for initiating Hcy "detoxification and excretion." The synergistic action of these three ensures that both pathways for Hcy clearance are "fully fueled and the engines (enzymes) are functioning properly," fundamentally accelerating Hcy metabolism.

[0030] 5. Methionine is activated in the body to S-adenosylmethionine (SAMe), the most common methyl donor in the human body, used for methylation modification of DNA, neurotransmitters, and phospholipids (such as phosphatidylcholine). The efficient integration of phospholipid-type DHA into the cell membrane and its use in the synthesis of membrane phospholipids (especially phosphatidylcholine) is a process that highly consumes SAMe (i.e., consumes methyl groups). This consumption creates a strong "metabolic pull" that continuously consumes SAMe, prompting the methionine cycle to continuously replenish SAMe, thereby driving the remethylation pathway (which requires folic acid and B vitamins). 12 The high-speed operation of the enzymes allows for the recycling of more Hcy into methionine. This prevents feedback inhibition of the pathway caused by the accumulation of methylation products. Simultaneously, enzymes related to Hcy metabolism (such as methionine synthase and CBS enzyme) are located in or dependent on the cell membrane microenvironment. Phospholipid DHA, as a core structural lipid of the cell membrane, significantly increases cell membrane fluidity. A healthier membrane environment helps these enzymes maintain optimal spatial conformation and activity, thereby indirectly enhancing B... 12 The catalytic efficiency of B6-dependent enzymes. This further helps maintain normal homocysteine ​​levels and healthy blood pressure.

[0031] 6. High levels of homocysteine ​​(Hcy) can induce oxidative stress and inflammation, and inflammatory factors can further inhibit the activity of key enzymes such as MTHFR, creating a vicious cycle. Phospholipid-type DHA has powerful anti-inflammatory and anti-inflammatory effects, which can break this vicious cycle, protect Hcy metabolic enzymes from inflammatory damage, and provide a more stable physiological environment for the function of B vitamins. Attached Figure Description

[0032] Figure 1 This invention compares the pregnancy outcomes of different groups of pregnant women [n (%)]. Compared with the BM group; where, # P <0.05; compared with group E1, Δ P <0.05.

[0033] Figure 2 This refers to the safety and compliance results in this invention; wherein, compared with group E1, Δ P <0.05. Detailed Implementation

[0034] The present invention will now be described in detail with reference to the accompanying drawings and specific embodiments, but this should not be construed as limiting the invention. Unless otherwise specified, the technical means used in the following embodiments are conventional means well known to those skilled in the art, and the materials, reagents, etc. used in the following embodiments are commercially available unless otherwise specified.

[0035] Example 1 A composition for special medical use in pregnant women, comprising the following components in parts by weight: Phospholipid-type DHA 0.23 parts, active folic acid 4.0 × 10 -4 Servings of Vitamin B1 0.7 x 10 -3 Servings of Vitamin B2 0.7 x 10 -3 1 serving, Vitamin B6 1.0 × 10 -3 Vitamin B 12 1.8×10 -3 Servings, Vitamin A 2.7 x 10 -4 Servings of Vitamin D 0.6 × 10 -5 Servings, Vitamin C 5.0×10 -2 6.0 x 10 parts, nicotinic acid -3 Parts, pantothenic acid 3.0×10 -3 0.45 parts calcium and 0.7 × 10 parts iron -2 0.5 × 10⁻⁶ of zinc element -2 share.

[0036] The calcium element is derived from calcium carbonate, the iron element from ferrous gluconate, and the zinc element from zinc sulfate.

[0037] The preparation method of the above-mentioned composition for special medical purposes for pregnant women is as follows: (1) Raw material pretreatment: Weigh each raw material (including fat-soluble components and hydrophilic components) according to the formula ratio.

[0038] The fat-soluble components include phospholipid DHA, vitamin A, and vitamin D. The phospholipid DHA was purchased from Runke Biotechnology, vitamin A from Xingsha Pharmaceutical, and vitamin D from Shuangjing Pharmaceutical.

[0039] Hydrophilic components include active folic acid, vitamin B1, vitamin B2, vitamin B6, and vitamin B1. 12 Vitamin C, niacin, pantothenic acid, calcium carbonate, ferrous gluconate, and zinc sulfate.

[0040] Active folic acid was purchased from Shenzhen Xijia Biotechnology Co., Ltd.; Vitamin B1 was purchased from Shanxi Hengruida Pharmaceutical Co., Ltd. (National Drug Approval Number H14021480); Vitamin B2 was purchased from Anhui Changjiang Pharmaceutical Co., Ltd. (National Drug Approval Number H34021322); Vitamin B6 was purchased from Shanxi Xinyu Pharmaceutical Co., Ltd. (National Drug Approval Number H14021221); Vitamin B... 12 Purchased from Yunpeng Pharmaceutical Group Co., Ltd. (National Drug Approval Number H14023321); Vitamin C purchased from Xinxiang Changle Pharmaceutical Co., Ltd. (National Drug Approval Number H41021516); Niacin purchased from Shanghai Chunshi Biotechnology Co., Ltd.; Ferrous gluconate purchased from Shanghai Aladdin Biochemical Technology Co., Ltd.; Ferrous gluconate purchased from Jiangxi Dexing Baiqin Iso-VC Sodium Co., Ltd.; Zinc sulfate purchased from Jiangxi Baohai Zinc Industry Co., Ltd.

[0041] (0) Mixing and homogenization: Phospholipid DHA, vitamin A, vitamin D and emulsifier are mixed and uniformly dispersed in vegetable oil to form an oil phase; active folic acid, vitamin B1, vitamin B2, vitamin B6, vitamin B1 are mixed and homogenized ... 12 Vitamin C, niacin, and pantothenic acid are dissolved in purified water to form an aqueous phase; calcium carbonate, ferrous gluconate, and zinc sulfate are added to the aqueous phase and stirred until completely dissolved.

[0042] The emulsifier is soybean lecithin, which was purchased from Shanghai Taiwei Pharmaceutical Co., Ltd.

[0043] The vegetable oil is soybean oil, purchased from Yihai Kerry Arawana Food Group Co., Ltd.

[0044] (3) Emulsification and embedding: The oil phase is added to the aqueous phase and emulsified in a high-speed shear machine to form a uniform emulsion.

[0045] (4) Drying: The emulsion is spray-dried to make powder.

[0046] The inlet air temperature for spray drying is 130℃, and the outlet air temperature is 75℃.

[0047] (5) Molding and packaging: The powder and filler are mixed and compressed into tablets to obtain the composition for special medical use by pregnant women.

[0048] The filler is maltodextrin, which was purchased from Luzhou Biotechnology (Shandong) Co., Ltd.

[0049] Example 2 A composition for special medical use in pregnant women, comprising the following components in parts by weight: Phospholipid-type DHA 0.25 parts, active folic acid 6.0 × 10 -4 Servings of Vitamin B1 1.0 x 10 -3Servings of Vitamin B2 1.0 x 10 -3 1 serving, Vitamin B6 1.5 x 10 -3 Vitamin B 12 2.2×10 -3 Servings, Vitamin A 3.0 x 10 -4 Servings, Vitamin D 1.0 × 10 -5 8.0 x 10 servings of Vitamin C -2 8.0 x 10 parts nicotinic acid -3 Parts, pantothenic acid 4.0×10 -3 0.6 parts calcium, 1.0 × 10⁻⁶ iron -2 0.8 × 10⁻⁶ of zinc element -2 share.

[0050] The calcium element is derived from calcium carbonate, the iron element from ferrous gluconate, and the zinc element from zinc sulfate.

[0051] The preparation method of the above-mentioned composition for special medical purposes for pregnant women is the same as that in Example 1.

[0052] Example 3 A composition for special medical use in pregnant women, comprising the following components in parts by weight: Phospholipid-type DHA 0.2 parts, active folic acid 2.0 × 10 -4 Servings of Vitamin B1 0.4 x 10 -3 Servings of Vitamin B2 0.4 x 10 -3 Servings of Vitamin B6 0.5 x 10 -3 Vitamin B 12 1.2×10 -3 Servings, Vitamin A 2.4×10 -4 Servings of Vitamin D 0.2 × 10⁻⁶ -5 Servings, Vitamin C 3.0×10 -2 4.0 x 10 parts, nicotinic acid -3 Parts, pantothenic acid 2.0×10 -3 0.3 parts calcium and 0.4 × 10⁻⁶ iron -2 0.28 × 10⁻⁶ (The text abruptly ends here, likely due to an incomplete sentence or a formatting error.) -2 share.

[0053] The preparation method of the above-mentioned composition for special medical purposes for pregnant women is the same as that in Example 1.

[0054] Comparative Example 1 A composition for special medical use in pregnant women, comprising the following components in parts by weight: Triglyceride-type DHA 0.22 parts, active folic acid 4.0 × 10 -4 Servings of Vitamin B1 1.0 x 10-3 Servings of Vitamin B2 1.0 x 10 -3 1 serving, Vitamin B6 1.5 x 10 -3 Vitamin B 12 2.2×10 -3 Servings, Vitamin A 3.0 x 10 -4 Servings, Vitamin D 1.0 × 10 -5 8.0 x 10 servings of Vitamin C -2 8.0 x 10 parts nicotinic acid -3 Parts, pantothenic acid 4.0×10 -3 0.6 parts calcium, 1.0 × 10⁻⁶ iron -2 0.8 × 10 parts of zinc -2 share.

[0055] Comparative Example 2 A composition for special medical use in pregnant women, comprising the following components in parts by weight: Phospholipid DHA 0.22 parts, folic acid 4.0 × 10 -4 Servings of Vitamin B1 1.0 x 10 -3 Servings of Vitamin B2 1.0 x 10 -3 1 serving, Vitamin B6 1.5 x 10 -3 Vitamin B 12 2.2×10 -3 Servings, Vitamin A 3.0 x 10 -4 Servings, Vitamin D 1.0 × 10 -5 8.0 x 10 servings of Vitamin C -2 8.0 x 10 parts nicotinic acid -3 Parts, pantothenic acid 4.0×10 -3 0.6 parts calcium, 1.0 × 10⁻⁶ iron -2 0.8 × 10 parts of zinc -2 share.

[0056] Comparative Example 3 A composition for special medical use in pregnant women, comprising the following components in parts by weight: Triglyceride-type DHA 0.22 parts, folic acid 4.0 × 10 -4 Servings of Vitamin B1 1.0 x 10 -3 Servings of Vitamin B2 1.0 x 10 -3 1 serving, Vitamin B6 1.5 x 10 -3 Vitamin B 12 2.2×10 -3 Servings, Vitamin A 3.0 x 10 -4 Servings, Vitamin D 1.0 × 10 -58.0 x 10 servings of Vitamin C -2 8.0 x 10 parts nicotinic acid -3 Parts, pantothenic acid 4.0×10 -3 0.6 parts calcium, 1.0×10⁻² parts iron, and 0.8×10⁻² parts zinc.

[0057] To illustrate the effects of the composition prepared according to the present invention for special medical use in pregnant women, the following studies were conducted: I. Clinical Trials 1. Research Design This study employed a multicenter, randomized, double-blind, placebo-controlled prospective study design (using a common prenatal nutritional supplement). The common prenatal nutritional supplement was Elevit, purchased from a regular pharmacy.

[0058] 2. Research Subjects Those who are planning a pregnancy and have at least one high-risk factor for HDP (pre-pregnancy BMI ≥ 24 kg / m²) 2 840 women aged ≥35 years or with a history of HDP were randomly divided into 7 groups of 120 each.

[0059] Among them, the 840 women mentioned above were women who had registered and visited the obstetrics outpatient department of the hospital.

[0060] HDP stands for Hypertensive Disorder of Pregnancy.

[0061] 3. Intervention Plan Blank model group (BM group): Starting 3 months before pregnancy, take ordinary prenatal nutritional supplements orally once a day until 12 weeks of pregnancy.

[0062] Experimental group E1: The pregnant women took the composition for special medical purposes prepared in Example 1 of this invention, and the method of administration was the same as that of the blank model group BM.

[0063] Experimental group E2: The pregnant women took the composition for special medical purposes prepared in Example 2 of this invention, and the method of administration was the same as that of the blank model BM group.

[0064] Experimental group E3: The subjects took the composition for special medical purposes for pregnant women prepared in Example 3 of this invention, and the method of administration was the same as that of the blank model BM group.

[0065] Comparative Example 1 (C1 Group): The pregnant women took the composition for special medical purposes prepared in Comparative Example 1 of the present invention, and the method of administration was the same as that of the blank model BM group.

[0066] Comparative Example 2 (C2): The pregnant women took the composition for special medical purposes prepared in Comparative Example 2 of the present invention, and the method of administration was the same as that of the blank model BM group.

[0067] Comparative Example 3 (C3): The pregnant women took the composition for special medical purposes prepared in Comparative Example 3 of the present invention, and the method of administration was the same as that of the blank model BM group.

[0068] All study participants received standard preconception and prenatal care guidance.

[0069] 4. Observation indicators and time points Blood pressure: Measured at baseline (before pregnancy), 12 weeks, 24 weeks, and 36 weeks of pregnancy.

[0070] Blood homocysteine ​​(Hcy): Venous blood samples were collected at baseline, 12 weeks of gestation, and 24 weeks of gestation. The results were determined using high-performance liquid chromatography (HPLC) / chemiluminescent immunoassay.

[0071] Placental function ultrasound indicators: Uterine artery pulsatility index (UtA-PI) is measured by color Doppler ultrasound between 20 and 24 weeks of gestation, and placental growth factor (PlGF) is detected in the blood.

[0072] Pregnancy outcomes: Record the incidence of HDP (GH / PE), preterm birth rate, mode of delivery, and newborn weight.

[0073] Safety and adherence: Record adverse events (constipation, bleeding, etc.) and assess adherence through diary cards and medication counts.

[0074] 5. Statistical Analysis Quantitative data are expressed as Mean±SD, and comparisons between groups are performed using analysis of variance or nonparametric tests; categorical data are expressed as rates (%), and comparisons between groups are performed using the chi-square test. P <0.05 indicates a statistically significant difference.

[0075] 6. Clinical trial results The results of blood pressure during pregnancy are shown in Table 1.

[0076] Table 1. Changes in blood pressure during pregnancy in different groups of pregnant women (increase in systolic blood pressure, x±s, mmHg) Note: Compared with the blank model BM group, # P <0.05; compared with experimental group E1, Δ P <0.05; "+" indicates the mean plus or minus the standard deviation.

[0077] As shown in Table 1, the composition for special medical use in pregnant women of the present invention can effectively maintain blood pressure at a stable normal level. The E2 experimental group showed the most stable blood pressure throughout the entire pregnancy.

[0078] The results of blood homocysteine ​​levels are shown in Table 2.

[0079] Table 2. Changes in serum homocysteine ​​(Hcy) levels in pregnant women in each group. The decline rate is calculated as (baseline value - value at 24 weeks of gestation) / baseline value × 100%.

[0080] Compared with the blank model BM group, # P <0.05; compared with experimental group E1, Δ P <0.05.

[0081] As shown in Table 2, the composition for special medical use in pregnant women of the present invention, especially the experimental group E2, can maintain normal blood Hcy levels in pregnant women, and the effect is significantly better than that of the control group that only replaces DHA or folic acid.

[0082] Comparison of pregnancy outcomes Figure 1 As shown: Among them, compared with the blank model BM group, # P <0.05; compared with experimental group E1, Δ P <0.05.

[0083] Figure 1 The results showed that the incidence of HDP, preterm birth, and low birth weight infants in experimental groups E1 to E3, which received the present invention, was significantly lower than that in the blank model BM group (placebo group). Among them, the experimental group E2 showed the most significant effect. The control group (C1-C3) showed limited effect and no significant difference from the BM group.

[0084] Safety and compliance outcomes, such as Figure 2 As shown: Among them, compared with experimental group E1, Δ P <0.05.

[0085] Results: The adverse reaction rates in experimental groups E1 to E3 of this invention were low, and there was no increase in bleeding risk. Experimental group E2 showed the highest compliance and the lowest early withdrawal rate, indicating that it has good safety and acceptability.

[0086] The results of the aforementioned clinical trials confirm that supplementation with the composition for special medical use in pregnant women of this invention before and during early pregnancy can safely maintain healthy blood pressure in pregnant women with high-risk factors for HDP. Its mechanism of action may be related to maintaining normal serum homocysteine ​​(Hcy) levels and improving vascular endothelial function.

[0087] The experimental group, E2, demonstrated the best results. Compared to the control group using ordinary DHA or folic acid, this invention, employing a core combination of phospholipid-type DHA and active folic acid, exhibits significant advantages in maintaining healthy blood pressure during pregnancy, demonstrating the efficacy of multi-target synergistic intervention. This regimen boasts high adherence and minimal side effects, providing a practical nutritional intervention strategy for the preconception primary prevention of HDP.

[0088] In summary, the composition for special medical purposes for pregnant women provided by this invention offers a comprehensive nutritional support solution that is scientific, balanced, easily absorbed, and has synergistic effects on multiple targets, especially for pregnant women with nutritional risk factors.

[0089] It should be noted that when numerical ranges are involved in this invention, it should be understood that the two endpoints of each numerical range and any value between the two endpoints can be selected. To avoid redundancy, this invention describes preferred embodiments.

[0090] Although preferred embodiments of the invention have been described, those skilled in the art, upon learning the basic inventive concept, can make other changes and modifications to these embodiments, all of which fall within the scope of the invention.

Claims

1. A composition for special medical use by pregnant women, characterized in that, The ingredients include the following parts by weight: Phospholipid-type DHA 0.2-0.25 parts, active folic acid 2.0×10 -4 6.0 x 10 servings -4 Servings of Vitamin B1 0.4 × 10 -3 1.0 x 10 portions -3 Vitamin B2 0.4×10 -3 1.0 x 10 portions -3 Servings of Vitamin B6 0.5 x 10 -3 1.5 x 10 portions -3 Vitamin B 12 1.2×10 -3 2.2 x 10 portions -3 Servings, Vitamin A 2.4×10 -4 3.0 x 10 servings -4 Servings of Vitamin D 0.2 × 10⁻⁶ -5 1.0 x 10 portions -5 Servings, Vitamin C 3.0×10 -2 8.0 x 10 servings -2 4.0 x 10 parts, nicotinic acid -3 8.0 x 10 servings -3 Parts, pantothenic acid 2.0×10 -3 4.0 x 10 servings -3 0.3 to 0.6 parts calcium, 0.4 × 10⁻⁶ parts iron -2 1.0 x 10 portions -2 0.28 × 10⁻⁶ (The text abruptly ends here, likely due to an incomplete sentence or a formatting error.) -2 0.8 x 10 portions -2 share; The calcium element is derived from calcium carbonate, the iron element from ferrous gluconate, and the zinc element from zinc sulfate.

2. The composition for special medical use in pregnant women according to claim 1, characterized in that, The composition is in the form of tablets or capsules.

3. The composition for special medical use in pregnant women according to claim 2, characterized in that, It also includes pharmaceutically or food-grade excipients.

4. A composition for special medical use in pregnant women according to claim 3, characterized in that, The excipients are selected from at least one of emulsifiers, fillers, and carriers.

5. A composition for special medical use in pregnant women according to claim 4, characterized in that, The emulsifier is selected from any one or more of soybean lecithin, glyceryl monostearate, sucrose fatty acid ester and polysorbate; The filler is selected from any one or more of maltodextrin, lactose, and starch; The carrier is selected from any one or more of vegetable oils, medium-chain triglycerides, ethyl oleate, and isopropyl myristate.

6. A method for preparing a composition for special medical use in pregnant women as described in claim 5, characterized in that, Includes the following steps: Weigh each ingredient according to the formula proportions; Phospholipid DHA, vitamin A, and vitamin D are mixed with emulsifiers and uniformly dispersed in a carrier to form an oil phase; Incorporate active folic acid, vitamin B1, vitamin B2, vitamin B6, and vitamin B1. 12 Vitamin C, niacin, and pantothenic acid dissolve in water to form an aqueous phase; calcium carbonate, ferrous gluconate, and zinc sulfate are added to the aqueous phase and stirred until completely dissolved; The oil phase is added to the aqueous phase and emulsified to form a uniform emulsion; The emulsion is dried to form a powder; The powder is mixed with a filler and then compressed into tablets or encapsulated to obtain the composition.

7. A method for preparing a composition for special medical purposes for pregnant women according to claim 6, characterized in that, The drying method is either spray drying or freeze drying.

8. A method for preparing a composition for special medical purposes for pregnant women according to claim 7, characterized in that, The inlet air temperature of the spray dryer is 130℃~135℃, and the outlet air temperature is 70℃~80℃.

9. A method for preparing a composition for special medical purposes for pregnant women according to claim 7, characterized in that, The freeze-drying temperature is -45℃ to -35℃, and the vacuum degree is 10Pa to 50Pa.

10. The use of the composition for special medical purposes for pregnant women as described in claim 1 in the preparation of special medical purpose formula foods for maintaining healthy blood pressure levels in pregnant women or supplementing prenatal nutrition.

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