JP2016065003A - Oral solid composition for iron supplementation and method for producing the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an iron-containing powder composition which can be expected to have high iron absorbency although it is solid.SOLUTION: This invention relates to an oral solid composition for iron supplementation, which is a solid composition comprising a water-insoluble iron salt and a water-soluble polymer, where, as the water-soluble polymer, at least polyvinyl pyrrolidone is comprised.SELECTED DRAWING: None

Description

  The present invention relates to a solid composition for replenishing iron in the body orally and a method for producing the same.

  In recent years, the nutritional balance is lost as the eating habits become more and more unfavorable, and the nutrients necessary for the human body tend to be deficient. Among these nutrients, iron is one of the nutrients for which lack of intake has been pointed out.

  Since iron exists in a state of being bound to hemoglobin, which is a protein in blood, it is known that when it becomes deficient, it causes anemia, malaise, and the like. Iron deficiency affects an estimated 2 billion people in the total population and is an unresolved issue worldwide, regardless of developing or developed countries. For example, in Japan, iron deficiency anemia has been identified in many women, 5-10% of adult women suffer from the disease, and a latent iron deficiency anemia reserve is found in 20 adult women. It is said to reach ~ 25%.

  In order to eliminate this iron deficiency, various iron-enriched foods or iron supplement preparations are on the market. For example, iron preparations are blended into soft drinks, powdered milk, supplements, etc., and many of the iron preparations are water-insoluble iron compounds such as ferric pyrophosphate as well as water-soluble iron compounds such as sodium iron citrate and iron sulfate. A poorly water-soluble iron compound is used.

  However, the water-soluble iron compound has a strong iron taste, and there is a problem of gastrointestinal dysfunction due to invasion of ionized iron into the stomach wall in addition to a problem in terms of oral use. On the other hand, in water-insoluble or poorly water-soluble iron compounds, the iron taste problem is improved, but the dispersion tends to agglomerate with time in the dispersion, forming a precipitate and adding appearance to food. There is a problem that it is not preferable. For this reason, various methods for improving the dispersibility of the insoluble iron salt have been proposed.

  For example, a composition for iron-reinforced food and drink characterized by containing gati gum and a water-insoluble iron salt has been proposed (Patent Document 1).

  Further, for example, 1 to 60 gum arabic (B) is added to 100 parts by weight of at least one (A) selected from the group consisting of calcium carbonate, calcium phosphate (hereinafter referred to as calcium agent) and ferric pyrophosphate. A food additive slurry composition containing parts by weight and a powder composition obtained by drying and pulverizing the slurry composition are known (Patent Document 2).

  In addition, an iron-enriched food composition (Patent Document 3) characterized by containing a water-insoluble iron salt and a chelating agent is known.

JP2009-89634 International Publication WO 98/42210 JP2007-215480

  However, these prior art compositions can obtain good dispersion stability without agglomeration even when the fine particles are stored in a slurry state for a long time, but the iron component absorption rate (hereinafter referred to as iron absorption property). There is room for further improvement. For example, since the dispersion-stabilized microparticles have a large apparent surface area, the contact area with the stomach acid is increased in the stomach, and dissolution by invasion of the stomach acid and elution of iron ions are promoted. It can be changed to an insoluble iron compound by interaction with tannin, oxalic acid, phytic acid or the like, and the absorption in the duodenum, which is the iron absorption site, is reduced. In other words, the fine particle dispersion is expected to have a relatively low iron elution amount at pH 3.0 in the duodenum, which is the absorption site, as the gastric dissolution at pH 1.2 is high. A moderate iron absorption is not obtained.

  Furthermore, when trying to solidify the slurry containing the iron component obtained by these conventional techniques, through the drying process, strong agglomeration of fine particles is unavoidable and not only fulfills the original purpose but also absorbs. It also adversely affects sex. Nevertheless, solid forms (dosage forms) are generally widely used because they are usually smaller in volume and easier to handle than dispersion forms. From such a background, it is desired to develop an iron-containing composition that is excellent in iron absorption even in a solid form.

  Therefore, the main object of the present invention is to provide an iron-containing solid composition that can be expected to have a high iron absorption even if it is a solid.

  As a result of intensive studies in view of the problems of the prior art, the present inventors have found that the above object can be achieved by blending a specific additive with a finely divided water-insoluble iron salt. It came to complete.

That is, this invention relates to the following solid composition for oral iron supplementation, and its manufacturing method.
1. A solid composition containing a water-insoluble iron salt and a water-soluble polymer, wherein the water-soluble polymer contains at least polyvinylpyrrolidone as a solid composition for oral iron supplementation.
2. Item 2. The solid composition for oral iron supplementation according to Item 1, comprising 1 to 400 parts by weight of polyvinylpyrrolidone per 100 parts by weight of a water-insoluble iron salt.
3. Item 2. The solid composition for oral iron supplementation according to Item 1, comprising 1 to 200 parts by weight of polyvinylpyrrolidone per 100 parts by weight of a water-insoluble iron salt.
4). Item 2. The solid composition for oral iron supplementation according to Item 1, wherein the water-soluble polymer further contains at least one of sodium alginate and gum arabic.
5. Item 5. The solid composition for oral iron supplementation according to Item 4, wherein the ratio of the total weight of the water-soluble polymer other than polyvinylpyrrolidone is 0.01 to 20 with respect to the weight of polyvinylpyrrolidone.
6). Item 2. The solid composition for oral iron supplementation according to Item 1, wherein a water-soluble polymer containing polyvinylpyrrolidone is interposed between solid particles of a water-insoluble iron salt.
7). A method for producing a solid composition for oral iron supplementation, comprising:
(1) A liquid mixture in which solid particles of water-insoluble iron salt are dispersed in an aqueous solution of polyvinylpyrrolidone by adding and mixing solid particles of water-insoluble iron salt and at least polyvinylpyrrolidone as a water-soluble polymer to water. The step of preparing,
(2) drying the mixed solution;
A method for producing a solid composition for oral iron supplementation, comprising:
8). Item 8. The production method according to Item 7, wherein the mixed solution is obtained by wet-grinding a suspension containing a water-insoluble iron salt and water.
9. Item 9. The method according to Item 7 or 8, wherein the water-insoluble iron salt in the mixed solution is solid particles having an average particle size of 10 µm or less.
10. Item 10. A solid composition for oral iron supplementation obtained by the production method according to any one of Items 7 to 9.

  According to the solid composition for oral iron supply of the present invention, it is possible to provide an iron-containing solid composition capable of exhibiting high iron content absorbability despite being a solid material. That is, in the present invention, in particular, a mixture obtained by adding and mixing a water-soluble polymer containing a water-insoluble iron salt and at least polyvinylpyrrolidone (hereinafter referred to as “PVP”) to water (that is, an aqueous PVP solution and water). By adopting a step of drying a mixed solution containing solid particles of an insoluble iron salt, a composition capable of exhibiting the above characteristics can be provided.

  By adopting such a process, a state in which the solid particles of the finely divided water-insoluble iron salt are highly dispersed in water and a state in which PVP is dissolved in water is created, and when this is dried, the dissolved PVP is It is considered that a solid is formed while being interposed between solid particles of a water-insoluble iron salt. In other words, the aggregation of the solid particles of the water-insoluble iron salt is effectively suppressed or prevented by the PVP, and as a result, the water-insoluble iron salt can exist in a finely divided state in the solid matter. Conceivable.

  Thereby, regarding the elution property of the water-insoluble iron salt, the iron elution property with respect to pH 1.2 water can be kept low, while the iron elution property with respect to pH 3.0 water can be enhanced. That is, when taken, the high-order structure of the water-soluble polymer effectively suppresses the elution of iron ions due to the invasion of gastric acid in the stomach, while obtaining high elution by the dissociation of the water-soluble polymer in the duodenum. Can be expected. This can provide an oral composition (oral preparation) that is less susceptible to gastrointestinal disturbances and more easily absorbs iron in the body. Such a composition can be ingested or administered as it is, and can also be incorporated into various products such as foods or supplements, pharmaceuticals, and quasi drugs.

  Moreover, according to the manufacturing method of this invention, the solid composition for oral iron supplement of this invention can be manufactured more reliably and efficiently. In particular, a composition in which PVP is interposed between particles of a water-insoluble iron salt can more reliably and efficiently produce a solid composition that can be expected to have a higher iron content absorbability.

1. Solid composition for oral iron supplementation The solid composition for oral iron supplementation according to the present invention (the composition of the present invention) includes a water-insoluble iron salt and a water-soluble polymer.

  The water-insoluble iron salt is not limited as long as it is water-insoluble (including poorly water-soluble) and pharmaceutically acceptable. The degree of water insolubility is particularly preferably an iron salt having a solubility in water (20 ° C.) of 0.1 g / 100 mL or less. Examples of such salts include ferric phosphate, ferrous phosphate, ferric pyrophosphate, ferrous pyrophosphate, ferric hydroxide, ferric oxide, and ferrous fumarate. There is at least one kind. In particular, in the present invention, at least one of ferric phosphate and ferric pyrophosphate is preferable, and ferric pyrophosphate is more preferable in terms of color tone or flavor (preference). These water-insoluble iron salts can be known or commercially available. It can also be prepared by a known production method.

  The water-insoluble iron salt is preferably used in the form of powder or slurry. The average particle diameter can be appropriately set within a range of usually 10 μm or less, but is preferably 0.9 μm or less, and more preferably 0.3 μm or less. Such an average particle diameter can be adjusted by, for example, a physical pulverization method or a neutral salt formation method. This makes it possible to further increase the iron absorption rate shown in the test examples described later. The lower limit value of the average particle diameter is not limited, but generally it may be about 0.01 μm.

  In the present invention, the water-soluble polymer contains PVP as an essential component. PVP is a polymer compound (water-soluble polymer) in which N-vinyl-2-pyrrolidone is polymerized. This compound itself is a known substance that is used as an excipient, a binder and the like in cosmetics, pharmaceuticals, foods and the like. The PVP that can be used in the present invention is not limited as long as it is water-soluble, and commercially available products can also be used. As a commercially available product, for example, PVP “K-90”, “K-120”, “K-30”, and the like manufactured by ISP Japan Co., Ltd. can be suitably used.

  The content of PVP in the composition of the present invention is not limited, but is usually 1 to 400 parts by weight, particularly 1 to 200 parts by weight, more preferably 1 to 100 parts by weight with respect to 100 parts by weight of the water-insoluble iron salt. Part. By adjusting to such a range, higher iron absorbability can be obtained.

  Examples of water-soluble polymers other than PVP include additives (food additives or pharmaceutical additives) such as proteins, polysaccharides, and synthetic polymers. Examples of the protein include gelatin and casein. Examples of the polysaccharide include alginic acid, alginates, gum arabic, and cellulose derivatives. Examples of the synthetic polymer include polyvinyl alcohol. Among these, at least one of alginic acid and salts thereof is preferable, particularly salts of alginic acid are more preferable, and sodium alginate is most preferable. By adding sodium alginate, the elution at pH 1.2 can be kept low, and the iron absorption rate can be further increased, so that good absorbability can be expressed.

  Sodium alginate is a kind of polysaccharide designated as a food additive composed of D-mannuronic acid and L-guluronic acid, and is used as a thickening polysaccharide, a gelling agent, and the like. As the sodium alginate that can be used in the present invention, a known or commercially available sodium alginate can be used regardless of the quantitative ratio and sequence of D-mannuronic acid and L-guluronic acid. In particular, those having a low viscosity (more specifically, the viscosity in a 10 wt% solution at 20 ° C. is 500 mPa · s or less) are desirable from the viewpoint of handling during production. Examples of such commercially available products include “Kimika Argin ULV-L3” manufactured by Kimika Corporation.

  Further, the ratio (weight ratio) of other water-soluble polymer to PVP (1 part by weight of PVP) is not particularly limited, but is generally preferably 0.01 to 20, more preferably 0.05 to 19. It is more preferable. By setting to the said range, an iron content absorption rate can be raised more effectively.

  The content of the water-soluble polymer can be appropriately set according to, for example, the type of the water-insoluble iron salt to be used, but generally the water-soluble polymer is 15 to 100 parts by weight of the water-insoluble iron salt. The content is preferably 200 parts by weight, more preferably 15 to 80 parts by weight, and most preferably 15 to 40 parts by weight. When the addition amount of the water-soluble polymer is less than 15 parts by weight, the desired iron absorption rate may not be obtained.

  Further, the total content of the water-insoluble iron salt and the water-soluble polymer in the composition of the present invention is not particularly limited, but is usually 60 to 100% by weight, particularly 70 to 100% by weight in the composition of the present invention. Is preferable

  The composition of the present invention may contain additives other than the water-soluble polymer as long as the effects of the present invention are not hindered. Examples thereof include additives (food additives or pharmaceutical additives) such as thickeners, stabilizers, binders, excipients, and emulsifiers. The content of the additive may be appropriately set according to the type of the additive and the like, but is usually 40% by weight or less.

  The form of the composition of the present invention may be a solid (eg, powder, granulated product, etc.), but is not simply a form in which solid particles of a water-insoluble iron salt and solid particles of a water-soluble polymer are mixed. From the standpoint of increasing the absorption rate more effectively, a form in which a water-soluble polymer is interposed between solid particles of a water-insoluble iron salt is preferable. That is, it is preferable that the solid particles of the water-insoluble iron salt are fixed with the water-soluble polymer.

  The average particle diameter when the composition of the present invention is a powder or a granulated product is not limited, but is usually within the range of 0.1 to 320 μm (preferably 60 to 200 μm), depending on the final use and the like. May be determined appropriately.

2. Method for producing solid composition for oral iron supplementation The method for producing the composition of the present invention can be obtained by mixing the above-mentioned predetermined raw materials, and in particular, a method for producing a solid composition for oral iron supplementation. (1) By adding and mixing water-insoluble iron salt solid particles and at least polyvinylpyrrolidone as a water-soluble polymer to water, the water-insoluble iron salt solid particles are dispersed in an aqueous polyvinylpyrrolidone solution. It is preferable to employ a production method including a step of preparing a mixed solution (mixed solution preparing step) and (2) a step of drying the mixed solution (drying step).

In the mixed solution preparation step, the solid particles of water-insoluble iron salt are added to the aqueous solution of polyvinyl pyrrolidone by adding and mixing at least polyvinyl pyrrolidone as water-soluble polymer and water in the mixed solution preparation step. A mixed liquid is prepared.

  First, as the water-insoluble iron salt, the compounds listed above can be suitably used, and commercially available products can also be used. Further, a water-insoluble iron salt obtained by a known synthesis method can also be used.

  The form of the water-insoluble iron salt is preferably solid particles (powder). As a method for preparing such a form of a water-insoluble iron salt, for example, a method of precipitating the water-insoluble iron salt by adding a basic salt or an aqueous solution thereof to an aqueous solution containing iron ions may be employed. More specifically, when ferric pyrophosphate is synthesized as a water-insoluble iron salt, a precipitate is obtained by mixing and stirring an aqueous solution in which sodium pyrophosphate is dissolved in warm water in an aqueous solution in which ferric chloride is dissolved. It can be suitably obtained.

  An aqueous slurry containing such a precipitate can be used as a raw material for the mixed solution. Alternatively, a dehydrated cake obtained by solid-liquid separation of the aqueous slurry can also be suitably used. The solid-liquid separation can be carried out according to a known method such as centrifugation or filter press. In addition, a pulverized product obtained by wet pulverization or dry pulverization of the aqueous slurry, dehydrated cake, or a product obtained by adjusting the water content thereof can also be used.

  The particle size of the water-insoluble iron salt in this case is not particularly limited, but it is preferable to make it as fine as possible from the standpoint of elution of the iron component (iron ion) when used as a preparation. In particular, the average particle diameter can be appropriately set within the range of usually 10 μm or less, but is preferably 0.9 μm or less, and more preferably 0.3 μm or less.

  A general method can be used as a method for micronizing the water-insoluble iron salt, but a physical crushing method is particularly preferable. As the physical crushing method, for example, a wet pulverizer such as a dyno mill, an ultra apex mill, a sand mill, a coball mill, an emulsifier / disperser such as a nanomizer, a microfluidizer, a homogenizer, an ultrasonic disperser, or the like can be used. By making the particles fine, it is possible to produce an iron-containing composition that is extremely stable even in water.

  Although the timing for carrying out the micronization is not limited, in the present invention, particularly in the step of preparing the above-mentioned mixed solution, the water-insoluble iron salt is suspended in water in advance and subjected to the micronization treatment to prepare the water-insoluble iron. It is preferable to obtain an aqueous dispersion of salt fine particles.

  Next, the method for producing the dispersion (aqueous dispersion) is not limited. For example, a) an aqueous dispersion obtained by subjecting a suspension of a water-insoluble iron salt to wet grinding, and b) It is preferable to use an aqueous dispersion containing fine particles of a water-insoluble iron salt obtained by the Japanese salt method.

  The mixture can be prepared by adding and mixing at least PVP as a water-soluble polymer to the dispersion. PVP or other water-soluble polymer may be added and mixed as it is, or may be dissolved in water in advance and added as an aqueous solution. This makes it possible to more reliably obtain a mixture in which the water-insoluble iron salt is maintained in a more dispersible state.

  In this case, as the water-soluble polymer, additives other than PVP (particularly water-soluble substances) can be blended as necessary. For example, the water-soluble polymer (such as sodium alginate) described in 1 above can be suitably mixed. What is necessary is just to adjust the mixture ratio of the water-insoluble iron salt, PVP, and other additive in the said dispersion so that it may become the ratio described in said 1.

  Further, the solid content ratio of the dispersion is not limited, and may be set as appropriate according to the type of solid content, etc., but is usually about 1 to 25% by weight, particularly 10 to 25% by weight. % Is preferable.

Drying step In the drying step, the mixture is dried. This usually gives a dry powder.

  There is no restriction | limiting in particular as the method of drying, For example, it can implement with well-known or commercially available droplet spray type dryers, such as a freeze dryer, a spray dryer, a slurry dryer. In this case, the drying temperature of the droplet spray dryer is usually 250 ° C. or lower, more preferably 130 ° C. or lower. Moreover, processing, such as a grinding | pulverization and a classification, can be performed with respect to a dried material as needed. Furthermore, the obtained dry powder can be used for food or pharmaceutical products such as tablets, pills, powders, granules, capsules and the like by subjecting the obtained dry powder to a molding treatment such as granulation, if necessary.

  In addition, the average particle size of the water-insoluble iron salt and the composition of the present invention in the present invention is measured using a laser diffraction particle size distribution measuring device Microtrac (Nikkiso Co., Ltd.).

  The features of the present invention will be described more specifically with reference to the following examples and comparative examples. However, the scope of the present invention is not limited to the examples. “%” Indicates wt%.

Examples 1-7
An iron-containing composition was prepared according to the recipe in Table 1. A ferric pyrophosphate cake having a solid content of 25% synthesized according to a known method was suspended in ion-exchanged water to obtain a suspension having a solid content of 10%. The obtained suspension was put into a wet pulverizer “DYNO-MILL” (manufactured by Shinmaru Enterprises Co., Ltd.), and water was obtained by wet pulverizing ferric pyrophosphate until the average particle size became about 0.2 μm. A dispersion was obtained. Next, PVP was added to the obtained aqueous dispersion at the blending amount shown in Table 1, heated and dissolved at 60 ° C., cooled, and then frozen at −40 ° C. to obtain a vacuum dryer “DRR320DA (manufactured by Advantech)” For 48 hours. A dry powder was thus obtained.

Comparative Examples 1-8
As Comparative Examples 1 to 8, iron-containing compositions were prepared in the same manner as in the Examples except that the conditions of the additives shown in Table 1 were changed. In addition, about Comparative Examples 1-2, it was left with the aqueous dispersion, without implementing a drying process. For Comparative Examples 3 and 4, Comparative Examples 1 and 2 were frozen at −40 ° C. in the same manner as in Example 1 and dried in a vacuum dryer for 48 hours. For Comparative Example 5, a dry powder of ferric pyrophosphate (manufactured by Paul Roman) was used.

Test example 1
The iron absorption rate of the iron-containing composition obtained in each example and comparative example was measured under the conditions shown in Table 2. It is known that the iron component is absorbed in the state of iron ions by duodenal epithelial cells, and that the iron absorption is reduced when the iron ions are eluted in the stomach. The pH in the stomach is about 1.2, and the pH in the duodenum is about 3.0. Therefore, the lower the elution amount at pH 1.2, the better. On the other hand, the higher the elution amount at pH 3.0, the better. Therefore, the iron absorption rate in the body is expressed by the following formula:
Iron absorption rate (%) = [(100−S _p1.2 ) × S _p3.0 / 100]
(However, _Sp 1.2 indicates the elution rate of iron ions at pH 1.2, and _Sp 3.0 indicates the elution rate of iron ions at pH 3.0.) The iron absorption rate into the body was hypothesized from the rate, and the iron absorption rate was determined. The results are shown in Table 3. Here, the higher the iron absorption rate, the more iron absorption in the body can be expected.

  As is clear from the results of Tables 1 and 3, the average particle diameter after resuspension of Comparative Example 1 which is an aqueous slurry and Comparative Example 3 which is a dry powder thereof is equivalent, whereas the drying of fine particles In Comparative Example 4 which is a powder, the average particle diameter after resuspension remarkably increased and aggregation was confirmed as compared with Comparative Example 2 which is an aqueous dispersion.

  Further, as is apparent from the results in Table 3, Examples 1 to 7 in which a predetermined amount of PVP is added to ferric pyrophosphate have a high iron absorption rate and are comparative examples used as known additives. It turns out that it is superior to 5-8. Moreover, in Examples 3-5, it turns out that favorable dispersibility is also acquired so that it can confirm also from the result of the average particle diameter after resuspension.

Examples 8-16
An iron-containing composition was prepared according to the formulation shown in Table 4. A ferric pyrophosphate cake having a solid concentration of 25% was suspended in ion-exchanged water to obtain a suspension having a solid concentration of 10%. The obtained suspension was put into a wet pulverizer dynomill, and ferric pyrophosphate was wet pulverized until the average particle size became about 0.2 μm to obtain an aqueous dispersion. PVP, sodium alginate, and gum arabic were added to the aqueous dispersion obtained in the amounts shown in Table 4, dissolved by heating at 60 ° C., cooled, and then frozen at −40 ° C. to prepare a vacuum dryer “DRR320DA (Advantech). For 48 hours. A dry powder was thus obtained.

  As is clear from the results in Table 5, by adding a predetermined amount of sodium alginate as in Examples 8 to 14, the dissolution rate at pH 3.0 while the dissolution rate at pH 1.2 was suppressed. It turns out that becomes high. In particular, when compared with Comparative Example 9 using sodium alginate alone, it can be seen that the combined use of PVP and sodium alginate increases the iron absorption rate more remarkably. Moreover, even if it mix | blends water-soluble polymers other than sodium alginate with PVP like Examples 15-16, it was confirmed that an iron content absorptivity can be increased. From these results, the iron-containing compositions of these examples can be expected to be used as insoluble iron preparations with little gastrointestinal damage and high iron absorption. In particular, in Examples 12 to 13, the dissolution rate at pH 1.2 could be more effectively suppressed while maintaining the average particle diameter of the raw material.

Test example 2
About Example 2 and Comparative Example 5, each iron-containing composition-added feed was fed to an iron-deficient model animal, and the bioabsorbability thereof was compared.

  Four-week-old male rats (Crl: CD ((SD), Nihon Charles River)) were allowed to freely ingest the powdered diet CE-2 (CLEA Japan, Inc.) and acclimatized for 5 days, followed by iron-deficient diet (AIN-93G). , Nippon Claire Co., Ltd.) was allowed to eat freely with ultrapure water for 2 weeks, and after 2 weeks, anemic rats were divided into 5 rats in each group, and the test substance was iron deficient so that the iron content was 300 mg / kg. The feed mixed with the feed was fed in an amount of 20 g with ultrapure water, and the rats were anesthetized with an isoflurane inhalation anesthetic (3-4% isoflurane) after 3 days and 7 days, and blood was collected from the subclavian vein. Hemoglobin concentration (Hb), serum iron in serum, total iron binding ability (TIBC) were measured, and transferrin saturation rate (TSAT) was used as an index of iron content in peripheral blood, and serum iron / TIBC × 10 Calculated in. The results are shown in Table 6.

  From the results of hemoglobin and serum iron shown in Table 6, it was confirmed that the iron-deficient state was restored to the steady state by administering each iron-containing composition-added feed. When the serum iron level is compared, the serum iron level of Example 2 is lower than that of Comparative Example 5. On the other hand, comparing TSAT, Comparative Example 5 has a low TSAT reduction rate even after the number of administration days, whereas Example 2 has a high reduction rate. Further, with respect to Hb, Example 2 is higher than Comparative Example 5. These phenomena are considered to be due to the fact that the absorption rate of iron is faster in Example 2 than in Comparative Example 5, so that the period for reaching the steady state is short and the recovery time is shortened. That is, it can be seen that Example 2 which is the product of the present invention can be expected as an iron-containing composition having high absorbability.

  According to the present invention, an iron-containing composition that exhibits high iron absorption even after drying and effectively suppresses an iron taste sensory problem caused by ionization in the oral cavity or gastrointestinal damage caused by ionized iron is used as a food or pharmaceutical product. It is expected that it can be provided as.

That is, this invention relates to the following solid composition for oral iron supplementation, and its manufacturing method.
1. A solid composition containing a water-insoluble iron salt and a water-soluble polymer, wherein the water-soluble polymer contains at least polyvinylpyrrolidone as the water-soluble polymer, and the water-soluble iron salt is contained between solid particles of the water-insoluble iron salt having an average particle size of 0.9 μm or less. A solid composition for oral iron supplementation, characterized in that a functional polymer intervenes .
2. Item 2. The solid composition for oral iron supplementation according to Item 1, comprising 1 to 400 parts by weight of polyvinylpyrrolidone per 100 parts by weight of a water-insoluble iron salt.
3. Item 2. The solid composition for oral iron supplementation according to Item 1, comprising 1 to 200 parts by weight of polyvinylpyrrolidone per 100 parts by weight of a water-insoluble iron salt.
4). Item 2. The solid composition for oral iron supplementation according to Item 1, wherein the water-soluble polymer further contains at least one of sodium alginate and gum arabic.
5. Item 5. The solid composition for oral iron supplementation according to Item 4, wherein the ratio of the total weight of the water-soluble polymer other than polyvinylpyrrolidone is 0.01 to 20 with respect to the weight of polyvinylpyrrolidone.
6). Item 2. The solid composition for oral iron supplementation according to Item 1, which is a powder or granulated product having an average particle size of 60 to 320 µm.
7). A method for producing a solid composition for oral iron supplementation, comprising:
(1) Water-insoluble iron salt solid particles having an average particle size of 0.9 μm or less in an aqueous polyvinylpyrrolidone solution by adding and mixing water-insoluble iron salt solid particles and at least polyvinylpyrrolidone as a water-soluble polymer to water. A step of preparing a liquid mixture in which is dispersed,
(2) drying the mixed solution;
A method for producing a solid composition for oral iron supplementation, comprising:
8). Item 8. The production method according to Item 7, wherein the water-insoluble iron salt is provided as an aqueous dispersion obtained by previously suspending the water-insoluble iron salt in water and subjecting it to micronization.
9. Item 9. The method according to Item 8, wherein the micronization is carried out by wet pulverizing a suspension containing a water-insoluble iron salt and water.
10. Item 10. A solid composition for oral iron supplementation obtained by the production method according to any one of Items 7 to 9.

Claims (10)

A solid composition containing a water-insoluble iron salt and a water-soluble polymer, wherein the water-soluble polymer contains at least polyvinylpyrrolidone as a solid composition for oral iron supplementation. The solid composition for oral iron supplementation according to claim 1, comprising 1 to 400 parts by weight of polyvinylpyrrolidone per 100 parts by weight of a water-insoluble iron salt. The solid composition for oral iron supplementation according to claim 1, comprising 1 to 200 parts by weight of polyvinylpyrrolidone per 100 parts by weight of a water-insoluble iron salt. The solid composition for oral iron supplementation according to claim 1, wherein the water-soluble polymer further contains at least one of sodium alginate and gum arabic. The solid composition for oral iron supplementation according to claim 4, wherein the ratio of the total weight of water-soluble polymers other than polyvinylpyrrolidone is 0.01 to 20 with respect to the weight of polyvinylpyrrolidone. The solid composition for oral iron supplementation according to claim 1, wherein a water-soluble polymer containing polyvinylpyrrolidone is interposed between solid particles of a water-insoluble iron salt. A method for producing a solid composition for oral iron supplementation, comprising:
(1) A liquid mixture in which solid particles of water-insoluble iron salt are dispersed in an aqueous solution of polyvinylpyrrolidone by adding and mixing solid particles of water-insoluble iron salt and at least polyvinylpyrrolidone as a water-soluble polymer to water. The step of preparing,
(2) drying the mixed solution;
A method for producing a solid composition for oral iron supplementation, comprising: The manufacturing method according to claim 7, wherein the mixed liquid is obtained by wet-grinding a suspension containing a water-insoluble iron salt and water. The manufacturing method of Claim 7 or 8 whose water-insoluble iron salt in the said liquid mixture is a solid particle with an average particle diameter of 10 micrometers or less. The solid composition for oral iron supplementation obtained by the manufacturing method in any one of Claims 7-9.