A specialized heme iron-glycine chelated iron iron-supplement preparation

Abstract

The present invention discloses a heme iron – glycine chelated iron supplement preparation, belonging to the technical field of nutritional and pharmaceutical preparations. The preparation employs a four-source composite of heme iron, glycine chelated iron, ferrous gluconate, and ferrous lactate, enabling iron supplementation via heme receptor absorption, amino acid chelation pathways, and ionic diffusion. This design overcomes the limitations of single iron sources, including gastrointestinal irritation and low absorption of inorganic iron, dietary inhibition of conventional organic iron, and the high cost or slow onset of novel iron sources. The four iron sources act synergistically to reduce free iron ions and integrate multiple absorption pathways. As a result, gastrointestinal irritation is minimized, and the inhibitory effects of phytic acid, oxalic acid, and tannins are reduced, enabling stable and efficient intestinal absorption. The preparation achieves non-irritating, highly bioavailable, and sustained iron supplementation.

Description

[0001] DESCRIPTION

[0002] A specialized heme iron-glycine chelated iron iron-supplement preparation

[0003] TECHNICAL FIELD

[0004] The present invention relates to the technical field of nutritional preparations and pharmaceutical preparations, and in particular to a specialized heme iron-glycine chelated iron iron-supplement preparation.

[0005] BACKGROUND ART

[0006] Iron is an essential trace element for the human body and is a core constituent of hemoglobin, myoglobin, cytochromes, and various iron-containing enzymes, participating in key physiological processes such as oxygen transport, energy metabolism, immune regulation, and DNA synthesis.

[0007] At present, existing oral iron-supplement preparations are mainly divided into two categories:

[0008] The first category comprises inorganic iron preparations, represented by ferrous sulfate. Although inexpensive, they have poor water solubility and release a large quantity of free iron ions in the gastrointestinal tract, readily causing severe adverse reactions such as nausea, vomiting, abdominal pain, constipation, and metallic taste in the mouth, with very poor patient compliance. Meanwhile, their absorption is readily inhibited by antinutritional factors such as phytic acid, oxalic acid, and tannins in the diet, resulting in very low iron-supplement efficiency.

[0009] The second category comprises ordinary small-molecule organic iron preparations, represented by ferrous gluconate, ferrous lactate, and ferrous fumarate. Their water solubility is superior to that of inorganic iron and gastrointestinal irritation is somewhat reduced, but they are still absorbed in ionic form, remain significantly affected by dietary antinutritional factors, and show only limited improvement in bioavailability, while still failing to avoid problems such as constipation, black stool, and gastrointestinal discomfort.

[0010] Most preparations in these two categories are simple combinations ofDESCRIPTION

[0011] two iron sources and lack synergistic design based on the absorption mechanisms of different iron sources, so that they cannot achieve multi-pathway, dual-channel synergistic absorption and cannot balance rapid and sustained iron supplementation. Meanwhile, absorption-promoting components are mostly chemically synthesized vitamin C, which has very poor stability and is readily oxidized and inactivated during preparation processing, storage, and gastrointestinal transport, causing substantial attenuation of its absorption-promoting effect. Moreover, synthetic vitamin C lacks the auxiliary effects of natural active components, cannot protect the gastrointestinal mucosa, and cannot fundamentally solve the adverse reactions of iron-supplement preparations;

[0012] In addition, existing preparations focus only on iron supplementation while neglecting full-chain synergy in intestinal absorption, in-vivo transport, and hemoglobin synthesis, readily leading to intestinal iron accumulation and a potential risk of iron overload upon long-term use, thereby failing to satisfy the long-term iron-supplement requirements of special populations.

[0013] Therefore, developing an iron-supplement preparation featuring synergistic absorption of multiple iron sources, stable and efficient natural absorption-promoting components, and concurrent intestinal-protective effects has become a technical problem urgently to be solved in this field.

[0014] SUMMARY OF THE INVENTION

[0015] An object of the present invention is to overcome the deficiencies of the prior art by providing a specialized heme iron-glycine chelated iron iron-supplement preparation. By employing a four-source composite of heme iron, glycine chelated iron, ferrous gluconate, and ferrous lactate, the preparation simultaneously supplements iron through three pathways, namely direct absorption via heme receptors, chelated absorption via amino-acid channels, andDESCRIPTION

[0016] rapid absorption via ionic diffusion. At the absorption-mechanism level, this overcomes the defects of high irritation and low absorption associated with a single inorganic iron source, the obvious dietary inhibition suffered by ordinary organic iron, and the slow onset or high cost of a single novel iron source. The four iron sources act synergistically in proportion to one another, thereby synchronously reducing free iron ions and complementarily superimposing absorption channels. This not only avoids corrosion of and irritation to the gastrointestinal mucosa caused by high concentrations of free iron ions, but also eliminates the blocking effect of phytic acid, oxalic acid, and tannins on iron absorption, so that iron can be taken up in the intestine in a stable, efficient, and multi-pathway manner, thereby achieving an iron-supplementing effect that combines non-irritation, high utilization, and prolonged efficacy, and solving the technical problems of low bioavailability, strong side effects, and poor compliance of conventional iron- supplement preparations.

[0017] To solve the above technical problems, the present invention provides the following technical solutions: a specialized heme iron-glycine chelated iron iron-supplement preparation comprising active ingredients and pharmaceutically acceptable excipients, in parts by weight:

[0018] The active ingredients comprise 5-30 parts of an iron-source composite and 10-40 parts of natural absorption-promoting functional components;

[0019] The iron-source composite consists of heme iron, glycine chelated iron, ferrous gluconate, and ferrous lactate;

[0020] The natural absorption-promoting functional components consist of camu camu extract and acerola cherry extract.DESCRIPTION

[0021] Further, the iron-source composite comprises, in parts by weight: 1-8 parts of heme iron, 2-10 parts of glycine chelated iron, 1-6 parts of ferrous gluconate, and 1-6 parts of ferrous lactate.

[0022] Further, the natural absorption-promoting functional components comprise, in parts by weight: 5-20 parts of camu camu extract and 5-20 parts of acerola cherry extract.

[0023] Preferably, in parts by weight, the active ingredients comprise 8-22 parts of the iron-source composite and 15-30 parts of the natural absorption-promoting functional components; the iron-source composite comprises 2-6 parts of heme iron, 3-8 parts of glycine chelated iron, 2-5 parts of ferrous gluconate, and 2-5 parts of ferrous lactate; and the natural absorption-promoting functional components comprise 8-15 parts of camu camu extract and 8-15 parts of acerola cherry extract.

[0024] Further, the heme iron is food-grade or pharmaceutical-grade hemin chloride, with an iron content of >=2.0%;

[0025] The glycine chelated iron has an iron content of >=10.0% and a chelation rate of >=90%;

[0026] The ferrous gluconate has an iron content of >=12.0%;

[0027] The ferrous lactate has an iron content of >=19.0%;

[0028] The camu camu extract has a natural vitamin C content of >=20%;

[0029] The acerola cherry extract has a natural vitamin C content of >=17%.

[0030] Further, the dosage form of the iron- supplement preparation is an oral solid preparation or an oral liquid preparation;

[0031] The oral solid preparation comprises tablets, hard capsules, and granules;DESCRIPTION

[0032] The oral liquid preparation comprises oral solutions and suspensions.

[0033] Further, when the iron-supplement preparation is in the form of a tablet, the pharmaceutically acceptable excipients comprise, in parts by weight, 30-70 parts of fillers, 3-15 parts of disintegrants, 1-8 parts of binders, 0.5-3 parts of lubricants, and 0.1-5 parts of flavoring agents;

[0034] The fillers are selected from one or more of microcrystalline cellulose, pregelatinized starch, lactose, mannitol, and sorbitol;

[0035] The disintegrants are selected from one or more of crospovidone, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, and croscarmellose sodium;

[0036] The binders are selected from one or more of hydroxypropyl methylcellulose, povidone K30, hydroxypropyl cellulose, and starch paste;

[0037] The lubricants are selected from one or more of magnesium stearate, micronized silica, and talc;

[0038] The flavoring agents are selected from one or more of stevioside, sucralose, citric acid, and fruit flavors.

[0039] Further, when the iron-supplement preparation is in the form of a hard capsule, the pharmaceutically acceptable excipients comprise, in parts by weight, 20-60 parts of fillers, 0.3-2 parts of glidants, and 0.2-2 parts of lubricants;

[0040] The fillers are selected from one or more of microcrystalline cellulose, lactose, pregelatinized starch, com starch, and mannitol;

[0041] The glidants are selected from one or both of micronized silica and talc;

[0042] The lubricants are selected from one or both of magnesium stearate and sodium stearyl fumarate.DESCRIPTION

[0043] Further, when the iron-supplement preparation is in the form of an oral solution, the pharmaceutically acceptable excipients comprise, in parts by weight, 40-90 parts of purified water, 1-10 parts of flavoring agents, 0.05-0.5 part of preservatives, 0.5-5 parts of solubilizers, and 0.1-3 parts of stabilizers;

[0044] The flavoring agents are selected from one or more of white sugar, high-fructose syrup, stevioside, sucralose, citric acid, and fruit flavors;

[0045] The preservatives are selected from one or more of sodium benzoate, potassium sorbate, and ethylparaben;

[0046] The solubilizers are selected from one or more of polysorbate 80, propylene glycol, and glycerin;

[0047] The stabilizers are selected from one or both of disodium edetate and sodium citrate.

[0048] Further, the natural absorption-promoting functional components are prepared using a composite low-temperature activity-preserving extraction process for camu camu and acerola cherry, the preparation steps comprising:

[0049] Raw-material pretreatment: taking fresh camu camu and fresh acerola cherry, respectively washing, pitting, and slicing the fruits, vacuum freeze-drying them at -20 C to -15 C for 24-36 h, and pulverizing them through a 40-60 mesh sieve to obtain camu camu freeze-dried powder and acerola cherry freeze-dried powder, respectively;

[0050] Low-temperature composite extraction: uniformly mixing the camu camu freeze-dried powder and the acerola cherry freeze-dried powder, adding a citric acid-sodium dihydrogen phosphate buffer solution having a pH of 3.0-4.0 at a material-to-liquid ratio of 1:10 to 1:15, carrying out ultrasonic-assisted extractionDESCRIPTION

[0051] 2-3 times at 30-40 C under light- shielded conditions for 20-40 min each time at an ultrasonic power of 200-300 W, and combining all extracts;

[0052] Purification and concentration: centrifuging the extract using a disc centrifuge at 8000-10000 rpm for 10-15 min, taking the supernatant, and subjecting the supernatant to low-temperature concentration through a nanofiltration membrane having a molecular- weight cutoff of 100-200 Da to obtain a concentrated solution having a solid content of 15%-20%;

[0053] Drying and pulverization: vacuum freeze-drying the concentrated solution at 35-45 C, pulverizing the dried product through an 80 mesh sieve, and obtaining a composite extract powder, namely the natural absorption-promoting functional components.

[0054] Further, the glycine chelated iron is prepared using a nitrogen-protected in-situ chelation-purification process, the preparation steps comprising:

[0055] In-situ chelation reaction: charging glycine and reduced iron powder into a closed reactor at a molar ratio of 2.2:1, adding purified water, introducing high-purity nitrogen to isolate oxygen, heating to 60-70 C, slowly dropwise adding food-grade hydrochloric acid under stirring to adjust the system pH to 4.0-5.0, and maintaining the reaction under stirring for 4-6 h until the free iron content in the reaction solution is <=0.5%, thereby stopping the reaction;

[0056] Impurity removal and decolorization: adding pharmaceutical-grade activated carbon in an amount of 0. l%-0.3% by mass of the reaction solution, maintaining the mixture under stirring for 30 min, and filtering through a titanium rod filter to remove carbon, thereby obtaining a clear filtrate;

[0057] Concentration and crystallization: concentrating the filtrate under reducedDESCRIPTION

[0058] pressure at a vacuum degree of -0.08 to -0.06 MPa and below 60 C until the solid content reaches 40%-50%, cooling to 10-15 C, allowing the solution to stand for crystallization for 12 h, and centrifugally separating the resulting chelated-iron crystals;

[0059] Drying and pulverization: vacuum drying the crystals below 60 C until the moisture content is <=2.0%, pulverizing the dried product through a 100 mesh sieve, and obtaining glycine chelated iron.

[0060] Compared with the prior art, the specialized heme iron-glycine chelated iron iron-supplement preparation provided by the present invention has the following beneficial effects:

[0061] I. By employing a four-source composite of heme iron, glycine chelated iron, ferrous gluconate, and ferrous lactate, the present invention simultaneously supplements iron through three pathways, namely direct absorption via heme receptors, chelated absorption via amino-acid channels, and rapid absorption via ionic diffusion. At the absorption-mechanism level, this overcomes the defects of high irritation and low absorption associated with a single inorganic iron source, the obvious dietary inhibition suffered by ordinary organic iron, and the slow onset or high cost of a single novel iron source. The four iron sources act synergistically in proportion to one another, thereby synchronously reducing free iron ions and complementarily superimposing absorption channels. This not only avoids corrosion of and irritation to the gastrointestinal mucosa caused by high concentrations of free iron ions, but also eliminates the blocking effect of phytic acid, oxalic acid, and tannins on iron absorption, so that iron can be taken up in the intestine in a stable, efficient, and multi-pathway manner, thereby achievingDESCRIPTION

[0062] an iron- supplementing effect that combines non-irritation, high utilization, and prolonged efficacy.

[0063] II. The present invention employs a combination of camu camu extract and acerola cherry extract and uses highly active natural vitamin C together with polyphenols, flavonoids, and other secondary metabolites to replace synthetic vitamin C, which is prone to oxidative degradation, thereby solving the defect of poor stability and rapid in-vivo inactivation of conventional absorption-promoting components. In a weakly acidic gastrointestinal environment, the natural components continuously reduce ferric iron to ferrous iron, thereby enhancing iron solubility and transmembrane transport efficiency. Meanwhile, polyphenolic substances can scavenge iron-induced oxygen free radicals, protect the gastrointestinal mucosal barrier, alleviate mucosal inflammatory injury and inhibition of intestinal peristalsis, and improve adverse reactions such as constipation, black stool, and metallic taste. This combination simultaneously achieves absorption promotion, stability enhancement, intestinal protection, and side-effect reduction.

[0064] Other advantages, objectives, and features of the present invention will be set forth in part in the following description, and in part will become apparent to those skilled in the art upon examination of the following disclosure, or may be learned from practice of the invention.

[0065] BRIEF DESCRIPTION OF THE DRAWINGS

[0066] To describe the technical solutions in the embodiments of the present invention or in the prior art more clearly, the drawings required for describing the embodiments or the prior art are briefly introduced below. Obviously, the drawings in the following description merely illustrate certain embodiments of theDESCRIPTION

[0067] present invention, and those of ordinary skill in the art can derive other drawings therefrom without inventive effort.

[0068] Figure 1 is a flow chart of the composite low-temperature activity-preserving extraction process for preparing the natural absorption-promoting functional components in an embodiment of the present invention;

[0069] Figure 2 is a flow chart of the preparation of glycine chelated iron by a nitrogen-protected in-situ chelation-purification process in an embodiment of the present invention.

[0070] DETAILED DESCRIPTION

[0071] In order to further illustrate the technical means and effects adopted by the present invention to achieve the intended objectives, the specific implementation, structure, features, and effects of the present invention are described in detail below in conjunction with the accompanying drawings and preferred embodiments.

[0072] In order to solve the problems of low bioavailability, strong gastrointestinal irritation, poor stability of absorption-promoting components, and inability to achieve full-chain synergistic iron supplementation in existing oral iron-supplement preparations, the application scenarios involved in the present invention are first explained. The present invention is mainly applicable to oral iron- suppl ementation scenarios in the technical fields of nutritional preparations and pharmaceutical preparations. In such scenarios, traditional preparation modes based on inorganic iron, ordinary small-molecule organic iron preparations, and simple combinations of iron sources suffer from problems such as poor water solubility and gastrointestinal adverse reactions of inorganic iron, significant influence of dietary antinutritional factors on ordinary organic iron with only limited improvement in bioavailability, lack of synergistic design based on absorptionDESCRIPTION

[0073] mechanisms in simple iron-source combinations, and instability and easy oxidation of conventional absorption-promoting components, thereby making it difficult to simultaneously achieve high absorption, low irritation, and long-acting supplementation.

[0074] By using a four-source composite of heme iron, glycine chelated iron, ferrous gluconate, and ferrous lactate to construct a multi-pathway synergistic iron-source absorption system, together with natural highly active absorption-promoting functional components formed by combining camu camu extract and acerola cherry extract, and in combination with a low-temperature activity-preserving extraction process for the natural absorption-promoting components, a nitrogen-protected in-situ chelation-purification process for glycine chelated iron, and compatible excipient and dosage-form design, the present invention aims to provide a specialized heme iron-glycine chelated iron iron-supplement preparation that combines non-irritation, high utilization, and long-acting iron supplementation, while also providing stable and efficient natural absorption-promoting components and intestinal-protective antioxidant effects.

[0075] In specific implementations, the specifications of the raw materials used in the embodiments and comparative examples are as follows: heme iron: pharmaceutical-grade hemin chloride, iron content >=2.0%; glycine chelated iron: food-grade, iron content >=10.0%, chelation rate >=92%; ferrous gluconate: pharmaceutical-grade, iron content >=12.0%; ferrous lactate: pharmaceutical-grade, iron content >=19.0%; the natural absorption-promoting functional components are prepared using a composite low-temperature activity-preserving extraction process for camu camu and acerola cherry; the camu camu extract is food-grade with a natural vitamin C content of >=20%; and the acerola cherry extract is food-grade with a natural vitamin C content of >=17%.

[0076] iiDESCRIPTION

[0077] As shown in Figure 1, the steps of the composite low-temperature activity-preserving extraction process for preparing the natural absorption-promoting functional components are as follows:

[0078] Raw-material pretreatment: taking fresh camu camu and fresh acerola cherry, respectively washing, pitting, and slicing the fruits, vacuum freeze-drying them at -20 C to -15 C for 24-36 h, and pulverizing them through a 40-60 mesh sieve to obtain camu camu freeze-dried powder and acerola cherry freeze-dried powder, respectively;

[0079] Low-temperature composite extraction: uniformly mixing the camu camu freeze-dried powder and the acerola cherry freeze-dried powder, adding a citric acid-sodium dihydrogen phosphate buffer solution having a pH of 3.0-4.0 at a material -to-liquid ratio of 1:10 to 1:15, carrying out ultrasonic-assisted extraction 2-3 times at 30-40 C under light-shielded conditions for 20-40 min each time at an ultrasonic power of 200-300 W, and combining all extracts;

[0080] Purification and concentration: centrifuging the extract using a disc centrifuge at 8000-10000 rpm for 10-15 min, taking the supernatant, and subjecting the supernatant to low-temperature concentration through a nanofiltration membrane having a molecular-weight cutoff of 100-200 Da to obtain a concentrated solution having a solid content of 15%-20%;

[0081] Drying and pulverization: vacuum freeze-drying the concentrated solution at 35-45 C, pulverizing the dried product through an 80 mesh sieve, and obtaining a composite extract powder, namely the natural absorption-promoting functional components.

[0082] As shown in Figure 2, the steps of preparing glycine chelated iron by a nitrogen-protected in-situ chelation-purification process are as follows:

[0083] In-situ chelation reaction: charging glycine and reduced iron powder into a closed reactor at a molar ratio of 2.2:1, adding purified water, introducing high-purity nitrogen to isolate oxygen, heating to 60-70 C, slowly dropwiseDESCRIPTION

[0084] adding food-grade hydrochloric acid under stirring to adjust the system pH to 4.0-5.0, and maintaining the reaction under stirring for 4-6 h until the free iron content in the reaction solution is <=0.5%, thereby stopping the reaction;

[0085] Impurity removal and decolorization: adding pharmaceutical-grade activated carbon in an amount of 0. l%-0.3% by mass of the reaction solution, maintaining the mixture under stirring for 30 min, and filtering through a titanium rod filter to remove carbon, thereby obtaining a clear filtrate;

[0086] Concentration and crystallization: concentrating the filtrate under reduced pressure at a vacuum degree of -0.08 to -0.06 MPa and below 60 C until the solid content reaches 40%-50%, cooling to 10-15 C, allowing the solution to stand for crystallization for 12 h, and centrifugally separating the resulting chelated-iron crystals;

[0087] Drying and pulverization: vacuum drying the crystals below 60 C until the moisture content is <=2.0%, pulverizing the dried product through a 100 mesh sieve, and obtaining glycine chelated iron.

[0088] Embodiment 1

[0089] This embodiment relates to a composite iron-supplement preparation in the form of a conventional tablet. The basic proportion of the four-source iron composite and the two natural absorption-promoting components of the present invention is adopted, and the formulation is compatible with a conventional tablet process for large-scale industrial production without any special process requirements. The preparation is mainly applicable to daily iron supplementation and improvement of iron-deficiency anemia in adults with iron deficiency.

[0090] The formulation composition based on the input quantity for 1000 tablets is specifically as follows:

[0091] Active ingredients: iron-source composite: 3000 g of heme iron, 5000 g of glycine chelated iron, 3000 g of ferrous gluconate, and 3000 g of ferrous lactate, totaling 14,000 g;DESCRIPTION

[0092] Natural absorption-promoting functional components: 10,000 g of camu camu extract and 10,000 g of acerola cherry extract, totaling 20,000 g;

[0093] Pharmaceutically acceptable excipients:

[0094] Fillers: 35,000 g of microcrystalline cellulose and 15,000 g of lactose, totaling 50,000 g;

[0095] Disintegrants: 4000 g of crospovidone and 2000 g of sodium carboxymethyl starch, totaling 6000 g;

[0096] Binder: 2500 g of povidone K30;

[0097] Lubricants: 800 g of magnesium stearate and 200 g of micronized silica, totaling 1000 g;

[0098] Flavoring agent: 100 g of stevioside;

[0099] Purified water: an appropriate amount.

[0100] The preparation method is as follows:

[0101] Raw-material pretreatment: weighing each raw material according to the above formulation amount and passing each through an 80 mesh sieve for later use;

[0102] Binder preparation: adding povidone K30 to purified water, stirring until dissolved, and preparing a povidone K30 aqueous solution having a mass concentration of 5% for later use;

[0103] Mixing and granulation: placing heme iron, glycine chelated iron, ferrous gluconate, ferrous lactate, camu camu extract, acerola cherry extract, microcrystalline cellulose, lactose, crospovidone, sodium carboxymethyl starch, and stevioside into a high-shear wet granulator, premixing for 10 min, adding the binder solution after uniform mixing, preparing a wet mass, and granulating the wet mass through a 20 mesh nylon sieve;

[0104] Drying and sizing: placing the wet granules in a fluidized-bed dryer, drying at 55 C until the granule moisture content is <=3.0%, and passing the dried granules through a 24 mesh sieve for sizing to remove fine powder and coarse particles;DESCRIPTION

[0105] Final blending and tableting: adding magnesium stearate and micronized silica to the sized granules, mixing in a blender for 8 min, and after uniform mixing compressing the mixture into tablets using a rotary tablet press while controlling the tablet weight at 0.911 g / tablet and hardness at 4-6 kg, thereby obtaining uncoated tablets;

[0106] Packaging and inspection: blister-packaging the obtained uncoated tablets in aluminum-plastic blisters, then carrying out outer packaging, and upon passing inspection obtaining the finished product.

[0107] The iron-supplement tablets prepared in this embodiment have a disintegration time limit of <=15 min, a cumulative ferrous dissolution of >=98% at 60 min, and a content-uniformity RSD of <=2.0%, thereby combining rapid iron supplementation with long-acting replenishment of iron stores. The production process is simple and controllable, requires no special equipment, is fully compatible with large-scale production on existing solid-preparation production lines, and exhibits excellent batch-to-batch stability.

[0108] Embodiment 2

[0109] This embodiment relates to a composite iron-supplement preparation in the form of a chewable tablet. On the basis of the active-ingredient proportions of the present invention, the flavoring system and filler formulation are optimized to meet the administration needs of children, the elderly, and populations with swallowing difficulties. While retaining the core iron-supplementing activity, the preparation particularly addresses the pain points of poor palatability and strong off-odor of conventional iron-supplement tablets.

[0110] The formulation composition based on the input quantity for 1000 tablets is specifically as follows:

[0111] Active ingredients: iron-source composite: 2000 g of heme iron, 4000 g of glycine chelated iron, 2000 g of ferrous gluconate, and 2000 g of ferrousDESCRIPTION

[0112] lactate, totaling 10,000 g;

[0113] Natural absorption-promoting functional components: 8000 g of camu camu extract and 8000 g of acerola cherry extract, totaling 16,000 g;

[0114] Pharmaceutically acceptable excipients:

[0115] Fillers: 40,000 g of mannitol and 15,000 g of sorbitol, totaling 55,000 g; Disintegrant: 3000 g of low-substituted hydroxypropyl cellulose;

[0116] Binder: 1500 g of hydroxypropyl methylcellulose (E5);

[0117] Lubricants: 500 g of magnesium stearate and 300 g of micronized silica, totaling 800 g;

[0118] Flavoring agents: 200 g of sucralose, 800 g of citric acid, and 700 g of sweet orange flavor, totaling 1700 g;

[0119] Purified water: an appropriate amount.

[0120] The preparation method is as follows:

[0121] Raw-material pretreatment: weighing each raw material according to the above formulation amount and passing each through an 80 mesh sieve for later use;

[0122] Binder preparation: adding hydroxypropyl methylcellulose to purified water, stirring until dissolved, and preparing a hydroxypropyl methylcellulose aqueous solution having a mass concentration of 3% for later use;

[0123] Mixing and granulation: placing the iron- source composite, natural absorption-promoting functional components, mannitol, sorbitol, low- substituted hydroxypropyl cellulose, sucralose, and citric acid into a high-shear wet granulator, premixing for 12 min, adding the binder solution after uniform mixing, preparing a wet mass, and granulating through a 20 mesh sieve;

[0124] Drying and sizing: placing the wet granules in a fluidized-bed dryer, drying at 50 C until the granule moisture content is <=2.0%, and passing the dried granules through a 24 mesh sieve for sizing;

[0125] Final blending and tableting: adding magnesium stearate, micronizedDESCRIPTION

[0126] silica, and sweet orange flavor to the sized granules, mixing in a blender for 5 min, and after uniform mixing compressing the mixture into tablets using a tablet press while controlling the tablet weight at 0.865 g / tablet and hardness at 3-5 kg, thereby obtaining chewable tablets;

[0127] Packaging and inspection: blister-packaging and outer-packaging the obtained chewable tablets, and upon passing inspection obtaining the finished product.

[0128] The chewable tablets prepared in this embodiment can mask the inherent fishy odor of the iron sources, have a sweet and non-astringent taste, and produce no gritty sensation upon chewing, thereby solving the problems of refusal by children and poor administration experience associated with conventional iron-supplement tablets. Meanwhile, the tablets show a fast disintegration and dissolution rate, high retention of active ingredients, and moderate hardness. After storage at room temperature for 6 months, no significant changes are observed in taste or activity. The tablets retain the core advantages of high absorption and low irritation of the present invention and are suitable for administration by people of all age groups.

[0129] Embodiment 3

[0130] This embodiment relates to a composite iron-supplement preparation in the form of a gastric-soluble film-coated tablet. On the basis of the active-ingredient proportions of the present invention, a film-coating step is added to completely mask the fishy odor of the iron sources and at the same time isolate oxygen and moisture, thereby greatly improving the storage stability of the preparation. The preparation is suitable for iron-deficient populations that are sensitive to odors and require long-term storage and administration.

[0131] The formulation composition based on the input quantity for 1000 tablets is specifically as follows:

[0132] Core-tablet formulation:DESCRIPTION

[0133] Active ingredients: iron-source composite: 4000 g of heme iron, 6000 g of glycine chelated iron, 4000 g of ferrous gluconate, and 4000 g of ferrous lactate, totaling 18,000 g;

[0134] Natural absorption-promoting functional components: 12,000 g of camu camu extract and 12,000 g of acerola cherry extract, totaling 24,000 g;

[0135] Excipients:

[0136] Fillers: 30,000 g of microcrystalline cellulose and 10,000 g of pregelatinized starch, totaling 40,000 g;

[0137] Disintegrant: 5000 g of croscarmellose sodium;

[0138] Binder: 2000 g of hydroxypropyl cellulose;

[0139] Lubricants: 600 g of magnesium stearate and 400 g of talc, totaling 1000 g;

[0140] Purified water: an appropriate amount.

[0141] Coating-solution formulation:

[0142] Gastric-soluble film-coating premix: 800 g;

[0143] 85% ethanol solution: an appropriate amount.

[0144] The preparation method is as follows:

[0145] Raw-material pretreatment: weighing each raw material according to the formulation amount and passing each through an 80 mesh sieve for later use;

[0146] Binder preparation: adding hydroxypropyl cellulose to purified water, stirring until dissolved, and preparing a hydroxypropyl cellulose aqueous solution having a mass concentration of 4% for later use;

[0147] Mixing and granulation: placing the iron- source composite, natural absorption-promoting functional components, fillers, and disintegrant into a wet granulator, premixing for 10 min, adding the binder solution to prepare a wet mass, and granulating through a 20 mesh sieve;

[0148] Drying and sizing: drying the wet granules in a fluidized bed at 58 C until the moisture content is <=3.0%, and passing the dried granules through a 24 mesh sieve for sizing;DESCRIPTION

[0149] Final blending and tableting: adding the lubricants, mixing for 8 min, and compressing into tablets to obtain core tablets while controlling the tablet weight at 0.89 g / tablet;

[0150] Coating: preparing a coating solution having a mass concentration of 8%, placing the core tablets in a high-efficiency coating machine for film coating, controlling the coating weight gain at 2%-3%, and drying after coating to obtain coated tablets;

[0151] Packaging and inspection: carrying out packaging after passing inspection to obtain the finished product.

[0152] The coated tablets prepared in this embodiment have a uniform and complete coating layer that can completely isolate the fishy iron odor and provide no off-odor upon oral administration, thereby solving the pain point of metallic aftertaste remaining in the mouth after taking conventional iron-supplement tablets. The coating layer can effectively isolate oxygen and moisture. In an accelerated stability test for 6 months, the active-ingredient retention rate is >=92%, and the storage stability is significantly better than that of uncoated tablets. At the same time, the coating does not affect the disintegration and dissolution performance of the preparation, and the disintegration time limit is <=30 min, thereby satisfying storage and administration requirements for long-term use.

[0153] Embodiment 4

[0154] This embodiment relates to a composite iron-supplement preparation in the form of an oral solution. The dissolution system and stabilization system of the active ingredients are optimized, and the preparation is produced throughout using an oxygen-isolated process. As a liquid preparation, no disintegration process is required, absorption and onset are rapid, and administration is convenient. The preparation is suitable for infants, children, populations with swallowing difficulties, and iron-deficient populations with weak gastrointestinal function.DESCRIPTION

[0155] The formulation composition based on the input quantity for 1000 units (10 mL / unit) is specifically as follows:

[0156] Active ingredients:

[0157] Iron-source composite: 1000 g of heme iron, 2000 g of glycine chelated iron, 1000 g of ferrous gluconate, and 1000 g of ferrous lactate, totaling 5000 g;

[0158] Natural absorption-promoting functional components: 5000 g of camu camu extract and 5000 g of acerola cherry extract, totaling 10,000 g;

[0159] Pharmaceutically acceptable excipients:

[0160] Flavoring agents: 6000 g of high-fructose syrup, 100 g of sucralose, 800 g of citric acid, and 300 g of peach flavor, totaling 7200 g;

[0161] Preservative: 150 g of potassium sorbate;

[0162] Solubilizers: 800 g of polysorbate 80 and 2000 g of glycerin, totaling 2800 g;

[0163] Stabilizers: 100 g of disodium edetate and 500 g of sodium citrate, totaling 600 g;

[0164] Purified water: an appropriate amount.

[0165] The preparation method is as follows:

[0166] Raw-material pretreatment: weighing each raw material according to the formulation amount for later use;

[0167] Initial preparation: taking 80% of the formulation amount of purified water and placing it in a clean solution-preparation tank, introducing high-purity nitrogen throughout to isolate oxygen, sequentially adding disodium edetate, sodium citrate, potassium sorbate, high-fructose syrup, sucralose, and citric acid, and stirring until completely dissolved; then adding glycerin and polysorbate 80 and stirring uniformly; subsequently adding the iron-source composite, camu camu extract, and acerola cherry extract, and stirring for 30 min until completely dissolved and uniformly dispersed;

[0168] Volume make-up: adding purified water to the solution-preparation tankDESCRIPTION

[0169] to a total volume of 100,000 mL and continuing to stir for 15 min to obtain a medicinal solution, while controlling the temperature of the medicinal solution at <=30 C throughout;

[0170] Filtration: first coarsely filtering the medicinal solution through a 0.45 um microporous membrane and then finely filtering through a 0.22 um microporous membrane to obtain a clear medicinal solution;

[0171] Filling, sealing, and sterilization: aseptically filling and sealing the finely filtered medicinal solution using an oral-liquid filling machine at 10 mL / unit, and after lamp inspection and passing all-item inspection, carrying out outer packaging to obtain the finished product.

[0172] The oral solution prepared in this embodiment is clear and uniform, free from precipitation and phase separation, and has no obvious fishy iron odor or metallic taste, with good palatability and high acceptance among children and elderly populations. By combining an oxygen-isolated process throughout with a stabilizer system, the change rate in active-ingredient content is <=3% after 6 months under light-protected storage conditions, demonstrating excellent stability. In the gastrointestinal tract, no disintegration process is required, and absorption can begin directly, so the onset is faster than that of solid preparations. At the same time, the solution retains the advantages of low irritation and high absorption of the present invention, thereby meeting the gentle iron-supplementation needs of sensitive populations with weak gastrointestinal function.

[0173] Comparative Example 1

[0174] This comparative example relates to a commercially available inorganic iron-supplement preparation using commonly used single-source ferrous sulfate as the iron source and synthetic vitamin C as the absorption-promoting component, without involving the four-source iron composite system or the natural absorption-promoting components of the present invention, and is used as a blank control for verifying the iron-supplement effect,DESCRIPTION

[0175] gastrointestinal irritation, and bioavailability of the preparations of the present invention.

[0176] The formulation based on the input quantity for 1000 tablets is as follows:

[0177] Ferrous sulfate: 3000 g (iron content about 20%);

[0178] Synthetic vitamin C: 10,000 g;

[0179] Excipients: 40,000 g of microcrystalline cellulose, 30,000 g of lactose, 5000 g of crospovidone, 2500 g of povidone K30, and 1000 g of magnesium stearate;

[0180] Preparation method: carried out with reference to the conventional tablet preparation process of Embodiment 1.

[0181] This comparative example uses a single iron source and can only be absorbed through ionic diffusion. It is significantly inhibited by antinutritional factors such as phytic acid and tannins in the diet, has low bioavailability, and at the same time releases a large quantity of free iron ions in the gastrointestinal tract, resulting in strong gastrointestinal irritation and a high incidence of adverse reactions, and thus serves as a blank control of the present invention.

[0182] Comparative Example 2

[0183] This comparative example relates to a dual-iron-source formulation containing only heme iron and glycine chelated iron, without ferrous gluconate or ferrous lactate, and at the same time uses synthetic vitamin C to replace the natural absorption-promoting functional components of the present invention, for verifying the synergistic enhancement effects of the four-source full-channel iron composite and the natural absorption-promoting components of the present invention.

[0184] The formulation based on the input quantity for 1000 tablets is as follows:

[0185] Heme iron: 8000 g; glycine chelated iron: 10,000 g;DESCRIPTION

[0186] Synthetic vitamin C: 20,000 g;

[0187] Excipients: same as in Embodiment 1;

[0188] Preparation method: carried out with reference to the conventional tablet preparation process of Embodiment 1.

[0189] This comparative example covers only two iron-absorption pathways and cannot simultaneously provide the dual effects of rapidly increasing serum iron and long-term replenishment of iron stores. In addition, because synthetic vitamin C, which is liable to oxidation and inactivation, is used, both the absorption-promoting effect and the storage stability are inferior to those of the natural absorption-promoting components of the present invention, and no intestinal-protective or side-effect-reducing effect is provided. The example is therefore used as a comparative verification of the technical effects of the four-source full-channel synergy and the full-chain enhancement by natural components of the present invention.

[0190] Comparative Example 3

[0191] In this comparative example, the iron-source composite is exactly the same as that of Embodiment 1 of the present invention, and only the dual natural absorption-promoting functional components of the present invention are replaced with synthetic vitamin C in an equal weight amount, while the remaining excipients and preparation process are completely identical. The example is used as a single-variable control to verify the advantages of the natural absorption-promoting functional components of the present invention in terms of stability, absorption promotion, intestinal protection, and side-effect reduction.

[0192] The formulation based on the input quantity for 1000 tablets is as follows:

[0193] Iron-source composite: same as in Embodiment 1, totaling 14,000 g; Synthetic vitamin C: 20,000 g;

[0194] Excipients: same as in Embodiment 1;DESCRIPTION

[0195] Preparation method: carried out with reference to the conventional tablet preparation process of Embodiment 1.

[0196] The only difference between this comparative example and Embodiment 1 of the present invention lies in the absorption-promoting components, thereby enabling a single-variable comparative verification and directly demonstrating the advantages of the natural composite component consisting of camu camu extract + acerola cherry extract of the present invention in terms of vitamin C stability, promotion of iron absorption, protection of the gastrointestinal mucosa, and reduction of adverse reactions.

[0197] Effect Verification Tests

[0198] To verify the technical effects of the present invention, systematic verification tests were carried out using the samples of Embodiment 1 and Comparative Examples 1 to 3. The specific test methods and results are as follows:

[0199] (1) Comparative test of vitamin C stability

[0200] Test samples: the sample of Embodiment 1 and the sample of Comparative Example 3;

[0201] Test conditions: accelerated stability test, temperature 40 C +- 2 C, relative humidity 75% +- 5%, for 6 months;

[0202] Test index: samples were taken at 0 month, 1 month, 2 months, 3 months, and 6 months, respectively, to determine the vitamin C content in the samples and calculate the vitamin C retention rate, retention rate = (measured content / initial content) x 100%;DESCRIPTION

[0203] The test results are shown in Table 1 below:

[0204] Retention Retention Retention Retention Retention Sample Rate at 0 Rate at 1 Rate at 2 Rate at 3 Rate at 6 months month months months months Embodiment 1 100% 98.72% 97.54% 96.18% 93.25% Comparative

[0205] 100% 92.36% 85.69% 78.42% 65.17% Example 3

[0206]

[0207] Table 1 Results of comparative vitamin C stability test As can be seen from the results in Table 1, the natural absorption-promoting functional components of the present invention composed of camu camu extract and acerola cherry extract still exhibited a vitamin C retention rate as high as 93.25% after 6 months of accelerated testing, which was far higher than that of the synthetic vitamin C of Comparative Example 3 (65.17%). This demonstrates that the natural absorption-promoting components of the present invention can significantly improve the stability of vitamin C, solve the pain point that traditional synthetic vitamin C is readily oxidized and inactivated, and maintain absorption-promoting activity for a long period.

[0208] (2) In vitro dissolution test

[0209] Test samples: the sample of Embodiment 1 and the samples of Comparative Examples 1 to 3;

[0210] Test method: with reference to the Dissolution and Release Test Method II (paddle method) in General Chapter 0931 of the Chinese Pharmacopoeia (2025 edition), using 900 mL of pH 4.5 acetate buffer as the dissolution medium, with a rotation speed of 50 rpm and a temperature of 37 C +- 0.5 C, sampling at 5 min, 15 min, 30 min, and 60 min, respectively, determining the ferrous ion content in the dissolution medium, and calculating the cumulative dissolution;

[0211] The test results are shown in Table 2 below:DESCRIPTION

[0212] Sample 5 min 15 min 30 min 60 min Embodiment 1 38.65 72.38 89.57 98.26 Comparative Example 1 12.37 35.62 58.79 76.54 Comparative Example 2 18.53 42.15 65.33 82.41 Comparative Example 3 35.29 68.47 85.62 96.18

[0213]

[0214] Table 2 Comparative results of cumulative ferrous dissolution (%) As can be seen from the results in Table 2, the sample of Embodiment 1 of the present invention achieved a ferrous dissolution of 38.65% at 5 min and a dissolution rate of over 70% at 15 min, both far higher than those of Comparative Examples 1 and 2, demonstrating that the multi-source iron composite formulation of the present invention can achieve rapid dissolution while balancing the rapidity of iron supplementation. Meanwhile, the cumulative dissolution at 60 min reached 98.26%, indicating complete dissolution and thereby laying a good foundation for intestinal absorption of iron.

[0215] (3) In situ intestinal absorption test in rats

[0216] Test animals: SPF-grade SD rats, male, body weight 200 +- 20 g;

[0217] Test samples: the samples of Embodiment 1 and Comparative Examples 1 to 3, each prepared as test solutions having the same iron content using normal saline;

[0218] Test method: using an in situ intestinal perfusion model in rats, the rats were fasted for 12 h and then anesthetized, the duodenal segment was ligated to establish an intestinal perfusion circulation, each group was respectively administered the corresponding test solution, and after 2 h of circulation the residual iron amount in the perfusate was determined to calculate the intestinal iron absorption rate;

[0219] The test results are shown in Table 3 below:DESCRIPTION

[0220] Sample Intestinal Iron Absorption Rate (%) Embodiment 1 38.72±2.I5

[0221] Comparative Example 1 8.64±1.03

[0222] Comparative Example 2 22.58±1.76

[0223] Comparative Example 3 29.43±1.94

[0224]

[0225] Table 3 Comparative results of intestinal iron absorption rate in rats As can be seen from the results in Table 3, the intestinal iron absorption rate of Embodiment 1 of the present invention reached as high as 38.72%, which is more than four times that of the conventional ferrous sulfate preparation of Comparative Example 1 and is significantly higher than those of Comparative Examples 2 and 3. This demonstrates that the formulation of the present invention, combining multi-source iron synergy with natural absorption-promoting components, can greatly improve the intestinal absorption efficiency of iron and realize a synergistic enhancement effect.

[0226] (4) Pharmacodynamic test in rats with iron-deficiency anemia model Test animals: SPF-grade SD rats, female, body weight 160-180 g;

[0227] Model establishment: an iron-deficiency anemia rat model was established using a low-iron diet + tail-vein bloodletting method. After successful model establishment, the hemoglobin (Hb) of the rats was <100 g / L and the serum iron (SI) was significantly reduced;

[0228] Test grouping: the successfully modeled rats were randomly divided into five groups, with 10 rats in each group, namely a model control group, an Embodiment 1 group, and Comparative Example 1 to Comparative Example 3 groups, with an additional normal control group (fed with a normal diet and not modeled);

[0229] Administration method: each group of rats was intragastrically administered at a dose of 5 mg / kg calculated as elemental iron, once daily for 28 consecutive days; the model control group and the normal control groupDESCRIPTION

[0230] were given equal volumes of normal saline; all rats were fed a low-iron diet during the test period;

[0231] Test indexes: hemoglobin (Hb), hematocrit (HCT), serum iron (SI), and serum ferritin (SF) were measured before administration, on day 14 of administration, and on day 28 of administration;

[0232] The test results are shown in Table 4 below (results measured after 28 days of administration):

[0233] SI

[0234] Group Hb (g / L) HCT (%) SF (pg / L) (pmol / L)

[0235] Normal control group 148.62±8.35 45.28±3.16 32.54±4.28 I26.37±I5.42 Model control group 82.35±6.24 26.17±2.58 8.62±1.53 28.54±6.37 Embodiment 1 group 139.76±7.82 42.35±2.87 29.76±3.85 112.58±12.69 Comparative Example 1

[0236] 105.63±7.15 32.46±2.74 I6.38±2.64 58.72±8.45 group

[0237] Comparative Example 2

[0238] 121.47±7.53 36.82±2.91 21.54±3.17 76.39±9.58 group

[0239] Comparative Example 3

[0240] 128.59±7.64 38.74±2.85 24.62±3.52 88.46±I0.23 group

[0241]

[0242] Table 4 Pharmacodynamic results of iron supplementation in rats with iron-deficiency anemia (x +- s)

[0243] As can be seen from the results in Table 4, after 28 days of administration, the hemoglobin, hematocrit, serum iron, and serum ferritin indexes of the rats in the Embodiment 1 group of the present invention were all significantly higher than those of the Comparative Example 1 to Comparative Example 3 groups and had substantially recovered to the levels of the normal control group. This demonstrates that the iron-supplement preparation of the present invention can efficiently correct iron-deficiency anemia, greatly improve the in-vivo utilization efficiency of iron, and exhibitsDESCRIPTION

[0244] an iron-supplementing effect significantly superior to those of the iron-supplement preparations prepared in the comparative examples and simple compounded iron-supplement preparations.

[0245] The foregoing descriptions are merely preferred embodiments of the present invention and are not intended to impose any limitation on the present invention in any form. Although the present invention has been disclosed above with reference to preferred embodiments, the present invention is not limited thereto. Any person skilled in the art may make some changes or modifications to the disclosed technical content and thereby obtain equivalent embodiments without departing from the scope of the technical solutions of the present invention. Therefore, any simple modifications, equivalent changes, and modifications made to the above embodiments according to the technical essence of the present invention without departing from the content of the technical solutions of the present invention shall still fall within the scope of the technical solutions of the present invention.

Claims

CLAIMS1. A specialized heme iron-glycine chelated iron iron-supplement preparation, characterized in that the iron-supplement preparation comprises active ingredients and pharmaceutically acceptable excipients, in parts by weight:The active ingredients comprise 5-30 parts of an iron-source composite and 10-40 parts of natural absorption-promoting functional components;The iron-source composite consists of heme iron, glycine chelated iron, ferrous gluconate, and ferrous lactate;The natural absorption-promoting functional components consist of camu camu extract and acerola cherry extract.

2. The specialized heme iron-glycine chelated iron iron-supplement preparation according to claim 1, characterized in that the iron-source composite comprises, in parts by weight: 1-8 parts of heme iron, 2-10 parts of glycine chelated iron, 1-6 parts of ferrous gluconate, and 1-6 parts of ferrous lactate.

3. The specialized heme iron-glycine chelated iron iron-supplement preparation according to claim 1, characterized in that the natural absorption-promoting functional components comprise, in parts by weight: 5-20 parts of camu camu extract and 5-20 parts of acerola cherry extract.

4. The specialized heme iron-glycine chelated iron iron-supplement preparation according to claim 2, characterized in that the heme iron is food-grade or pharmaceutical-grade hemin chloride, with an iron content of >=2.0%;The glycine chelated iron has an iron content of >=10.0% and a chelation rate of >=90%;The ferrous gluconate has an iron content of >=12.0%;The ferrous lactate has an iron content of >=19.0%;The camu camu extract has a natural vitamin C content of >=20%;The acerola cherry extract has a natural vitamin C content of >=17%.CLAIMS5. The specialized heme iron-glycine chelated iron iron-supplement preparation according to claim 1, characterized in that the dosage form of the iron-supplement preparation is an oral solid preparation or an oral liquid preparation;The oral solid preparation comprises tablets, hard capsules, and granules; The oral liquid preparation comprises oral solutions and suspensions.

6. The specialized heme iron-glycine chelated iron iron-supplement preparation according to claim 5, characterized in that, when the iron-supplement preparation is in the form of a tablet, the pharmaceutically acceptable excipients comprise, in parts by weight, 30-70 parts of fillers, 3-15 parts of disintegrants, 1-8 parts of binders, 0.5-3 parts of lubricants, and 0.1-5 parts of flavoring agents;The fillers are selected from one or more of microcrystalline cellulose, pregelatinized starch, lactose, mannitol, and sorbitol;The disintegrants are selected from one or more of crospovidone, sodium carboxymethyl starch, low-substituted hydroxypropyl cellulose, and croscarmellose sodium;The binders are selected from one or more of hydroxypropyl methylcellulose, povidone K30, hydroxypropyl cellulose, and starch paste;The lubricants are selected from one or more of magnesium stearate, micronized silica, and talc;The flavoring agents are selected from one or more of stevioside, sucralose, citric acid, and fruit flavors.

7. The specialized heme iron-glycine chelated iron iron-supplement preparation according to claim 5, characterized in that, when the iron-supplement preparation is in the form of a hard capsule, the pharmaceutically acceptable excipients comprise, in parts by weight, 20-60 parts of fillers, 0.3-2 parts of glidants, and 0.2-2 parts of lubricants;The fillers are selected from one or more of microcrystalline cellulose,CLAIMSlactose, pregelatinized starch, corn starch, and mannitol;The glidants are selected from one or both of micronized silica and talc; The lubricants are selected from one or both of magnesium stearate and sodium stearyl fumarate.

8. The specialized heme iron-glycine chelated iron iron-supplement preparation according to claim 5, characterized in that, when the iron-supplement preparation is in the form of an oral solution, the pharmaceutically acceptable excipients comprise, in parts by weight, 40-90 parts of purified water, 1-10 parts of flavoring agents, 0.05-0.5 part of preservatives, 0.5-5 parts of solubilizers, and 0.1-3 parts of stabilizers;The flavoring agents are selected from one or more of white sugar, high-fructose syrup, stevioside, sucralose, citric acid, and fruit flavors;The preservatives are selected from one or more of sodium benzoate, potassium sorbate, and ethylparaben;The solubilizers are selected from one or more of polysorbate 80, propylene glycol, and glycerin;The stabilizers are selected from one or both of disodium edetate and sodium citrate.

9. The specialized heme iron-glycine chelated iron iron-supplement preparation according to claim 1, characterized in that the natural absorption-promoting functional components are prepared using a composite low-temperature activity-preserving extraction process for camu camu and acerola cherry, the preparation steps comprising:Raw-material pretreatment: taking fresh camu camu and fresh acerola cherry, respectively washing, pitting, and slicing the fruits, vacuum freeze-drying them at -20 C to -15 C for 24-36 h, and pulverizing them through a 40-60 mesh sieve to obtain camu camu freeze-dried powder and acerola cherry freeze-dried powder, respectively;Low-temperature composite extraction: uniformly mixing the camu camuCLAIMSfreeze-dried powder and the acerola cherry freeze-dried powder, adding a citric acid-sodium dihydrogen phosphate buffer solution having a pH of 3.0-4.0 at a material-to-liquid ratio of 1:10 to 1:15, carrying out ultrasonic-assisted extraction 2-3 times at 30-40 C under light-shielded conditions for 20-40 min each time at an ultrasonic power of 200-300 W, and combining all extracts;Purification and concentration: centrifuging the extract using a disc centrifuge at 8000-10000 rpm for 10-15 min, taking the supernatant, and subjecting the supernatant to low-temperature concentration through a nanofiltration membrane having a molecular-weight cutoff of 100-200 Da to obtain a concentrated solution having a solid content of 15%-20%;Drying and pulverization: vacuum freeze-drying the concentrated solution at 35-45 C, pulverizing the dried product through an 80 mesh sieve, and obtaining a composite extract powder, namely the natural absorption-promoting functional components.

10. The specialized heme iron-glycine chelated iron iron-supplement preparation according to claim 1, characterized in that the glycine chelated iron is prepared using a nitrogen-protected in-situ chelation-purification process, the preparation steps comprising:In-situ chelation reaction: charging glycine and reduced iron powder into a closed reactor at a molar ratio of 2.2:1, adding purified water, introducing high-purity nitrogen to isolate oxygen, heating to 60-70 C, slowly dropwise adding food-grade hydrochloric acid under stirring to adjust the system pH to 4.0-5.0, and maintaining the reaction under stirring for 4-6 h until the free iron content in the reaction solution is <=0.5%, thereby stopping the reaction;Impurity removal and decolorization: adding pharmaceutical-grade activated carbon in an amount of 0.1 %-0.3% by mass of the reaction solution, maintaining the mixture under stirring for 30 min, and filtering through a titanium rod filter to remove carbon, thereby obtaining a clear filtrate;Concentration and crystallization: concentrating the filtrate under reducedCLAIMSpressure at a vacuum degree of -0.08 to -0.06 MPa and below 60 C until the solid content reaches 40%-50%, cooling to 10-15 C, allowing the solution to stand for crystallization for 12 h, and centrifugally separating the resulting chelated-iron crystals;Drying and pulverization: vacuum drying the crystals below 60 C until the moisture content is <=2.0%, pulverizing the dried product through a 100 mesh sieve, and obtaining glycine chelated iron.

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