Ferrous succinate composition, preparation method thereof and ferrous succinate dry suspension

Abstract

The invention discloses a ferrous succinate composition which comprises ferrous succinate and carrageenan and is prepared from the ferrous succinate and the carrageenan through a co-grinding method. The invention discloses a ferrous succinate dry suspension. The ferrous succinate dry suspension comprises the ferrous succinate composition and conventional pharmaceutic adjuvants. The composition of ferrous succinate and carrageenan is prepared through a co-grinding method, on one hand, the suspension property (physical stability) of a dry suspension prepared from ferrous succinate is improved, and the sedimentation volume ratio meets the requirements of pharmacopeia; on the other hand, the carrageenan improves the stability of the ferrous succinate through surface adsorption and wrapping, and the problem that after the particle size of the ferrous succinate is reduced, ferrous iron is easily oxidized into high iron, and then absorption is affected is solved.

Description

Technical Field

[0001] The invention belongs to the field of pharmaceutical preparations and relates to a ferrous succinate composition and a preparation method thereof, and a ferrous succinate dry suspension containing the ferrous succinate composition. Background Art

[0002] Iron deficiency anemia (IDA) is a common and important health problem affecting the whole world. It is the only common nutritional deficiency in developed countries and the most common type of anemia in developing countries. It seriously affects the prognosis of chronic diseases such as tumors, digestive system diseases, chronic kidney disease and heart failure. According to WHO estimates, about 1 / 4 of the world's population suffers from anemia, mainly in preschool children and women, and most anemia is caused by iron deficiency.

[0003] Ferrous succinate is a second-generation oral organic iron preparation with the characteristics of high absorption and utilization and few gastrointestinal side effects. It is mainly used for the prevention and treatment of iron deficiency anemia. Iron is mainly absorbed in the small intestine, and the absorption of ferrous iron is significantly better than that of ferric iron. However, ferrous iron is easily oxidized to ferric iron during storage or molding, which affects the absorption of iron. At present, the ferrous succinate dosage forms available in China include ordinary tablets, sustained-release tablets and granules.

[0004] Dry suspension refers to a preparation in which a poorly soluble drug is made into a powder or granule with suitable excipients, and water is added and shaken to disperse it into a suspension for oral administration. Dry suspension has the characteristics of solid preparations being easy to carry and stable, and the advantages of liquid preparations being easy to take. It is especially suitable for children or elderly patients who have difficulty swallowing. The sedimentation volume ratio is generally used to evaluate the sedimentation stability of the suspension and the effect of the use of stabilizers. This item is checked to ensure the physical stability of the suspension.

[0005] Carrageenan, also known as carrageenan, is a natural polysaccharide plant gum made from red algae such as Eucheuma and Gelidium, extracted and processed by water or alkali solution, and is widely used in the field of medicine. Carrageenan is commonly used in various non-injectable dosage forms, including sustained-release tablets, soft capsules, suspensions, topical gels, eye drops and suppositories. In suspensions, carrageenan can form a thixotropic gel that acts as a thickener. For most suspensions, the amount of carrageenan used is about 0.4% (w / w).

[0006] Compared with the existing ferrous succinate dosage form, if ferrous succinate is made into a dry suspension, it can better meet the needs of children or elderly patients with dysphagia. Patent FR2987559 A1 discloses a pharmaceutical composition based on ferrous succinate for long-term administration, which is suitable for children and the elderly with swallowing problems, and comprises ferrous succinate and carrageenan, etc., which are poured into a container containing 50-100mL water or water-containing beverages when used, or dispersed in food, such as flour, yogurt, white cheese, and vegetable puree. However, the description does not describe the relevant suspension stability. The test results of the patentee product ferrous succinate powder (Inofer, batch number M002) show that its sedimentation volume ratio (0.14) does not meet the provisions of the Chinese Pharmacopoeia (should not be less than 0.90), and the physical stability of the obtained suspension is poor.

[0007] Generally speaking, there are two ways to improve the physical stability of drug suspensions: (1) adding suspending agents to increase the viscosity of the suspension system; (2) micronization to reduce the drug particle size (increase specific surface area).

[0008] In the process of developing ferrous succinate dry suspension, the inventors found that ferrous succinate, as a metallic iron salt, has a relatively large bulk density (1.12 g / cm 3 ), it is very easy to settle in the suspension solvent system, and it is difficult to meet the sedimentation volume ratio requirements of the Chinese Pharmacopoeia using conventional types and amounts of suspending agents; micronization technology can reduce the particle size of ferrous succinate and improve the physical stability of the suspension, but in the process of preparing the suspension, the ferrous succinate raw material is very easy to oxidize and discolor, and further stability study results show that high-iron impurities grow rapidly. The possible reason is that: due to the smaller particle size of ferrous succinate and the increase in specific surface area, it is more fully in contact with water and oxygen, and divalent iron is more easily oxidized to trivalent iron. The problems of poor physical stability and easy oxidation to high iron in the above method will further affect absorption and therapeutic effects. Therefore, in order to develop a dry suspension suitable for children or elderly patients with difficulty swallowing, it is urgent to solve the above problems. Summary of the invention

[0009] The main technical problem solved by the present invention is that when preparing ferrous succinate dry suspension, ferrous succinate is not easy to suspend and has poor stability after micronization, and ferrous iron is easily oxidized to ferrous iron. The purpose of the present invention is to provide a composition of ferrous succinate and a suspending agent, which has good suspensibility and stability; the present invention also provides a preparation method of the composition, which has a simple process and is suitable for industrial production; the present invention also provides a ferrous succinate dry suspension comprising the above composition.

[0010] The present invention provides the following technical solutions:

[0011] A ferrous succinate composition comprises ferrous succinate and carrageenan and is prepared by co-grinding the ferrous succinate and carrageenan.

[0012] The mass ratio of the ferrous succinate to carrageenan is 5:1 to 1:2.

[0013] Preferably, the mass ratio of ferrous succinate to carrageenan is 2.5:1 to 1:1.

[0014] The particle size of the ferrous succinate composition is no more than 80 μm.

[0015] Preferably, the particle size of the ferrous succinate composition is 20 to 80 μm.

[0016] More preferably, the particle size of the ferrous succinate composition is 20 to 50 μm.

[0017] Another object of the present invention is to provide a method for preparing the ferrous succinate composition, comprising the following steps:

[0018] Step (1), weighing ferrous succinate and carrageenan respectively;

[0019] Step (2), adding ferrous succinate and carrageenan into a grinding device for co-grinding;

[0020] Step (3), discharging the material, and sieving to obtain a ferrous succinate composition.

[0021] In step (2), the grinding equipment is a device with grinding and crushing function, selected from a drum grinder, a jet grinder, a multi-impact column grinder, a ball mill, a vibration mill or a hammer mill, etc., preferably a ball mill.

[0022] When the grinding equipment is a ball mill, the diameter of the grinding balls is 0.25 to 2 cm, preferably 0.5 to 1 cm; the total grinding time is not less than 2 hours, preferably 4 to 8 hours; the rotation speed frequency during grinding is 10 to 30 Hz, preferably 15 to 25 Hz.

[0023] In step (3), preferably, the mixture is sieved through a 150-mesh sieve.

[0024] Another object of the present invention is to provide a ferrous succinate dry suspension, wherein the dry suspension comprises the ferrous succinate composition and conventional pharmaceutical excipients.

[0025] The pharmaceutical excipients may be one or more combinations of diluents, flavoring agents, pH regulators, etc.

[0026] The diluent is one or more combinations of mannitol, microcrystalline cellulose, lactose, calcium hydrogen phosphate, talcum powder, starch, sucrose and the like.

[0027] The flavor corrector is one or more combinations of saccharin sodium, steviol glycoside, xylitol, erythritol, sucrose, aspartame, fruit essence, etc.

[0028] The pH regulator is succinic acid (i.e. succinic acid) or citric acid.

[0029] Specifically, a ferrous succinate dry suspension is prepared from the following components in parts by weight: 6 to 60 parts of a ferrous succinate composition, 78 to 16 parts of a diluent, 5 to 20 parts of a pH regulator, and 1 to 4 parts of a flavoring agent.

[0030] Preferably, the ferrous succinate dry suspension is made of the following components in parts by weight: 14 parts of ferrous succinate composition, 74 parts of diluent, 10 parts of pH regulator, and 2 parts of flavoring agent.

[0031] Another object of the present invention is to provide a preparation process of the ferrous succinate dry suspension, comprising the following steps:

[0032] Step (1), pretreatment: weigh the raw and auxiliary materials in proportion and sieve them respectively;

[0033] Step (2), premixing: uniformly mixing the ferrous succinate composition and a diluent of equal mass to obtain a premixed material;

[0034] Step (3), total mixing: adding the remaining amount of diluent, pH adjuster and flavoring agent to the premixed material obtained in step (2), and mixing evenly;

[0035] Step (4), filling: filling the powder obtained in step (3) into bags.

[0036] In step (1), the raw and auxiliary materials are respectively sieved through an 80-mesh sieve.

[0037] The minimum packaging unit of the ferrous succinate dry suspension of the invention contains 50 to 200 mg of medicine.

[0038] Beneficial effects of the present invention:

[0039] The invention prepares the composition of ferrous succinate and carrageenan by a co-grinding method, which improves the suspension property (physical stability) of the dry suspension prepared from ferrous succinate on the one hand, so that the sedimentation volume ratio meets the requirements of the pharmacopoeia; on the other hand, carrageenan improves the stability of ferrous succinate by surface adsorption or encapsulation, and avoids the problem that ferrous iron is easily oxidized into ferrous iron after the particle size of ferrous succinate becomes smaller, thereby affecting absorption. BRIEF DESCRIPTION OF THE DRAWINGS

[0040] Figure 1Comparison of light microscope photographs of ferrous succinate composition B and ferrous succinate physical mixture a (100 times). DETAILED DESCRIPTION

[0041] The technical solution of the present invention is further illustrated by the following specific implementation modes.

[0042] Example 1

[0043] Ferrous succinate composition A

[0044] 100 g of ferrous succinate and 20 g of carrageenan (the mass ratio of ferrous succinate to carrageenan is 5:1) were weighed respectively, mixed, and placed in a ball mill for co-grinding. The ball mill parameters were as follows: ball diameter 0.5 cm, grinding time: 6 h, rotation frequency: 20 Hz; after grinding, the material was discharged and passed through a 150-mesh stainless steel sieve to obtain a ferrous succinate composition A.

[0045] Example 2

[0046] Ferrous succinate composition B

[0047] 100 g of ferrous succinate and 40 g of carrageenan (the mass ratio of ferrous succinate to carrageenan is 2.5:1) were weighed respectively, mixed, and placed in a ball mill for co-grinding. The ball mill parameters were: ball diameter 0.5 cm, grinding time: 6 h, rotation frequency: 20 Hz; after the grinding, the material was discharged and passed through a 150-mesh stainless steel sieve to obtain ferrous succinate composition B.

[0048] Example 3

[0049] Ferrous Succinate Composition C

[0050] Weigh 100 g of ferrous succinate and 80 g of carrageenan (the mass ratio of ferrous succinate to carrageenan is 1.25:1) respectively, mix them, and place them in a ball mill for co-grinding. The ball mill parameters are as follows: ball diameter 0.5 cm, grinding time: 6 h, rotation frequency: 20 Hz; after grinding, discharge the material and pass it through a 150-mesh stainless steel sieve to obtain a ferrous succinate composition.

[0051] Example 4

[0052] Ferrous succinate composition D

[0053] Weigh 100 g of ferrous succinate and 100 g of carrageenan (the mass ratio of ferrous succinate to carrageenan is 1:1) respectively, mix them, and place them in a ball mill for co-grinding. The ball mill parameters are as follows: ball diameter 0.5 cm, grinding time: 6 h, rotation frequency: 20 Hz; after the grinding, discharge the material and pass it through a 150-mesh stainless steel sieve to obtain a ferrous succinate composition.

[0054] Example 5

[0055] Ferrous succinate composition E

[0056] Weigh 100 g of ferrous succinate and 125 g of carrageenan (the mass ratio of ferrous succinate to carrageenan is 1:1.25) respectively, mix them, and place them in a ball mill for co-grinding. The ball mill parameters are as follows: ball diameter 0.5 cm, grinding time: 6 h, rotation frequency: 20 Hz; after grinding, discharge the material and pass it through a 150-mesh stainless steel sieve to obtain a ferrous succinate composition.

[0057] Example 6

[0058] Ferrous Succinate Composition F

[0059] Weigh 100 g of ferrous succinate and 200 g of carrageenan (the mass ratio of ferrous succinate to carrageenan is 1:2) respectively, mix them, and place them in a ball mill for co-grinding. The ball mill parameters are as follows: ball diameter 0.5 cm, grinding time: 6 h, rotation frequency: 20 Hz; after grinding, discharge the material and pass it through a 150-mesh stainless steel sieve to obtain a ferrous succinate composition.

[0060] Comparative Example 1

[0061] Ferrous succinate physical mixture a

[0062] Weigh 100 g of pre-crushed ferrous succinate (D90=72.1 μm) and 40 g of carrageenan respectively, mix well, and obtain the product.

[0063] Comparative Example 2

[0064] Ferrous succinate physical mixture b

[0065] Weigh 100 g of pre-crushed ferrous succinate (D90=72.1 μm) and 100 g of carrageenan respectively, mix well, and obtain the product.

[0066] Example 7

[0067] Ferrous succinate composition G

[0068] 100 g of ferrous succinate and 40 g of carrageenan (the mass ratio of ferrous succinate to carrageenan is 2.5:1) were weighed respectively, mixed, and placed in a ball mill for co-grinding. The ball mill parameters were: ball diameter 1 cm, grinding time: 6 h, rotation frequency: 20 Hz; after the grinding, the material was discharged and passed through a 150-mesh stainless steel sieve to obtain ferrous succinate composition G.

[0069] Example 8

[0070] Ferrous succinate composition H

[0071] 100 g of ferrous succinate and 40 g of carrageenan (the mass ratio of ferrous succinate to carrageenan is 2.5:1) were weighed respectively, mixed, and placed in a ball mill for co-grinding. The ball mill parameters were as follows: ball diameter 1.5 cm, grinding time: 6 h, rotation frequency: 20 Hz; after grinding, the material was discharged and passed through a 150-mesh stainless steel sieve to obtain a ferrous succinate composition H.

[0072] Example 9

[0073] Ferrous succinate composition I

[0074] 100 g of ferrous succinate and 40 g of carrageenan (the mass ratio of ferrous succinate to carrageenan is 2.5:1) were weighed respectively, mixed, and placed in a ball mill for co-grinding. The ball mill parameters were as follows: ball diameter 0.5 cm, grinding time: 2 h, rotation speed frequency: 20 Hz; after the grinding, the material was discharged and passed through a 150-mesh stainless steel sieve to obtain a ferrous succinate composition I.

[0075] Example 10

[0076] Ferrous succinate composition J

[0077] 100 g of ferrous succinate and 40 g of carrageenan (the mass ratio of ferrous succinate to carrageenan is 2.5:1) were weighed respectively, mixed, and placed in a ball mill for co-grinding. The ball mill parameters were as follows: ball diameter 0.5 cm, grinding time: 4 h, rotation frequency: 20 Hz; after grinding, the material was discharged and passed through a 150-mesh stainless steel sieve to obtain ferrous succinate composition J.

[0078] Embodiment 11

[0079] Ferrous succinate composition K

[0080] 100 g of ferrous succinate and 40 g of carrageenan (the mass ratio of ferrous succinate to carrageenan is 2.5:1) were weighed respectively, mixed, and placed in a ball mill for co-grinding. The ball mill parameters were as follows: ball diameter 0.5 cm, grinding time: 8 h, rotation frequency: 20 Hz. After the grinding, the material was discharged and passed through a 150-mesh stainless steel sieve to obtain a ferrous succinate composition K.

[0081] Example 12

[0082] Ferrous succinate composition L

[0083] 100 g of ferrous succinate and 40 g of carrageenan (the mass ratio of ferrous succinate to carrageenan is 2.5:1) were weighed respectively, mixed, and placed in a ball mill for co-grinding. The ball mill parameters were as follows: ball diameter 0.5 cm, grinding time: 6 h, rotation frequency: 15 Hz; after the grinding, the material was discharged and passed through a 150-mesh stainless steel sieve to obtain a ferrous succinate composition L.

[0084] Embodiment 13

[0085] Ferrous succinate composition M

[0086] 100 g of ferrous succinate and 40 g of carrageenan (the mass ratio of ferrous succinate to carrageenan is 2.5:1) are weighed respectively, mixed, and placed in a ball mill for co-grinding. The ball mill parameters are as follows: ball diameter 0.5 cm, grinding time: 6 h, rotation frequency: 25 Hz; after the grinding, the material is discharged and passed through a 150-mesh stainless steel sieve to obtain a ferrous succinate composition M.

[0087] Embodiment 14

[0088] Table 1. Ferrous succinate dry suspension formulation

[0089] materials Dosage(g) Ferrous succinate composition B 14 Mannitol (Pearlitol 200SD) 74 Succinic acid 10 Saccharin Sodium 2

[0090] The preparation process of ferrous succinate dry suspension comprises the following steps:

[0091] Step (1), pretreatment: weigh the raw and auxiliary materials in proportion and pass them through an 80-mesh sieve respectively;

[0092] Step (2), premixing: taking a prescribed amount of ferrous succinate composition B and an equal amount of mannitol 200SD, mixing them uniformly to obtain a premixed material;

[0093] Step (3), total mixing: adding the remaining amount of mannitol, succinic acid and saccharin sodium to the premixed material obtained in step (2), and mixing evenly;

[0094] Step (4), filling: the powder obtained in step (3) is filled into bags, each bag containing 1 g (containing 100 mg of ferrous succinate).

[0095] Embodiment 15

[0096] Comparison of sedimentation volume ratios of ferrous succinate compositions

[0097] The ferrous succinate compositions prepared in Examples 1 to 13 and the ferrous succinate physical mixtures prepared in Comparative Examples 1 and 2 were taken, and the sedimentation volume ratio was determined with reference to the Chinese Pharmacopoeia.

[0098] The determination method is as follows: take an appropriate amount of ferrous succinate composition or ferrous succinate physical mixture (containing about 100 mg of ferrous succinate), evenly disperse it in 50 mL of water, use a stoppered measuring cylinder to measure 50 mL of the test sample, stopper it, shake it vigorously for 1 minute, record the initial height H0 of the suspension, let it stand for 3 hours, record the final height H of the suspension, and calculate the sedimentation volume ratio according to the following formula.

[0099] Sedimentation volume ratio = H / H0

[0100] Table 2. Comparison of sedimentation volume ratios of ferrous succinate compositions

[0101] Serial number sample Sedimentation volume ratio 1 Ferrous succinate composition A 0.91 2 Ferrous succinate composition B 0.94 3 Ferrous Succinate Composition C 0.96 4 Ferrous succinate composition D 0.99 5 Ferrous succinate composition E 0.98 6 Ferrous Succinate Composition F 0.99 7 Ferrous succinate composition G 0.93 8 Ferrous succinate composition H 0.91 9 Ferrous succinate composition I 0.90 10 Ferrous succinate composition J 0.94 11 Ferrous succinate composition K 0.95 12 Ferrous succinate composition L 0.94 13 Ferrous succinate composition M 0.95 14 Ferrous succinate physical mixture a 0.08 15 Ferrous succinate physical mixture b 0.13

[0102] The results are shown in Table 2, which show that the sedimentation volume ratio of the ferrous succinate composition prepared by co-grinding is significantly better than that of the physical mixture, indicating that the dry suspension prepared by the ferrous succinate composition has better physical stability.

[0103] Example 16

[0104] Comparison of the stability of ferrous succinate compositions

[0105] The ferrous succinate compositions prepared in Examples 1 to 13 and the ferrous succinate physical mixtures prepared in Comparative Examples 1 to 2 were placed under high humidity (95% RH) and accelerated conditions (40°C, 75% RH), respectively, and the changes in high iron content were examined on the 15th and 30th days.

[0106] The method for determining high iron is as follows: take an appropriate amount of ferrous succinate composition or physical mixture (containing about 3g of ferrous succinate), accurately weigh it, place it in a 250mL iodine bottle, add 100mL of freshly boiled cold water and 10mL of hydrochloric acid to dissolve it, add 3g of potassium iodide, immediately seal it, shake it gently, place it in a dark place for 5 minutes, titrate it with sodium thiosulfate titration solution (0.1mol / L), add 2mL of starch indicator solution when it is close to the end point, continue titrating until the blue color disappears, and correct the titration result with a blank test. Each 1mL of sodium thiosulfate titration solution (0.1mol / L) is equivalent to 5.585mg Fe 3+ .

[0107] Table 3. Comparison results of the stability of ferrous succinate compositions

[0108]

[0109] The results are shown in Table 3, which show that the stability of the ferrous succinate composition obtained by co-grinding is significantly better than that of the physical mixture, and the growth of high-iron impurities is relatively slow under high humidity and accelerated conditions, indicating that after co-grinding, carrageenan can better protect ferrous iron from being oxidized to high-iron.

[0110] Embodiment 17

[0111] Particle size determination of ferrous succinate composition

[0112] Take about 1 g of the ferrous succinate composition obtained in Examples 1 to 13, use a Mastersizer 3000 particle size analyzer (equipped with an Aero S dry disperser and a high-energy venturi tube), and measure according to the parameters in Table 4 to obtain D 90 .

[0113] Table 4. Ferrous succinate composition particle size determination parameters

[0114] Particle Type Aspherical Refractive Index 1.52 Absorption rate 0.1 Slit width 1mm Injection speed 50％ Distribute pressure 2bar Background measurement time (s) 5s Sample measurement time (S) 15s Shading degree (%) 0.5-6 Number of measurements 1

[0115] Table 5. Ferrous succinate composition particle size measurement results

[0116] Serial number sample <![CDATA[D 90 ]]> 1 Ferrous succinate composition A 43.6 2 Ferrous succinate composition B 40.1 3 Ferrous Succinate Composition C 42.9 4 Ferrous succinate composition D 38.9 5 Ferrous succinate composition E 41.6 6 Ferrous Succinate Composition F 48.5 7 Ferrous succinate composition G 62.4 8 Ferrous succinate composition H 73.7 9 Ferrous succinate composition I 55.8 10 Ferrous succinate composition J 46.6 11 Ferrous succinate composition K 38.9 12 Ferrous succinate composition L 49.5 13 Ferrous succinate composition M 44.1

[0117] The results are shown in Table 5, which show that the particle size of the ferrous succinate composition obtained by co-grinding can reach less than 80 μm, and most of the particle sizes are less than 50 μm. Smaller particle sizes are helpful to improve the physical stability of the suspension.

[0118] Embodiment 19

[0119] Comparison of sedimentation volume ratios of ferrous succinate dry suspensions

[0120] The ferrous succinate dry suspension prepared in Example 14 and the reference preparation (Inofer, batch number M002) were taken, and the sedimentation volume ratio of the dry suspension was compared according to the sedimentation volume ratio determination method described in Example 15.

[0121] Table 6. Sedimentation volume ratio of ferrous succinate dry suspension

[0122] Serial number sample Sedimentation volume ratio 1 Ferrous succinate dry suspension 0.95 2 Inofer 0.14

[0123] The results are shown in Table 6, which show that compared with the reference preparation, the ferrous succinate dry suspension prepared by the co-grinding ferrous succinate composition of the present invention has better suspension stability, and its sedimentation volume ratio meets the requirements of the "Chinese Pharmacopoeia".

[0124] Embodiment 20

[0125] Comparison of polarizing microscope photos of ferrous succinate compositions

[0126] Take appropriate amounts of the ferrous succinate composition B prepared in Example 2 and the ferrous succinate physical mixture a prepared in Comparative Example 1, add them to appropriate amounts of edible oil, suspend them evenly, prepare a suspension with a concentration of about 10 mg / mL, prepare slices, and observe the polarization state of the particles in the suspension under a polarizing microscope (BM2100POL).

[0127] Results Figure 1 , showing that: compared with the physical mixture, the co-grinding material has significantly fewer ferrous succinate particles with polarized properties, indicating that ferrous succinate is adsorbed or wrapped by carrageenan during the co-grinding process, thereby masking its polarized properties.

Claims

1. A ferrous succinate composition, characterized in that: The ferrous succinate composition comprises ferrous succinate and carrageenan, and is prepared by co-grinding the ferrous succinate and carrageenan.

2. The ferrous succinate composition according to claim 1, characterized in that: The mass ratio of ferrous succinate to carrageenan is 5:1 to 1:2; preferably, the mass ratio of ferrous succinate to carrageenan is 2.5:1 to 1:

1.

3. The ferrous succinate composition according to claim 1, characterized in that: The particle size of the ferrous succinate composition is not greater than 80 μm; preferably, the particle size of the ferrous succinate composition is 20 to 80 μm; more preferably, the particle size of the ferrous succinate composition is 20 to 50 μm.

4. A method for preparing the ferrous succinate composition according to claim 1, characterized in that: The following steps are involved: Step (1), weighing ferrous succinate and carrageenan respectively; Step (2), adding ferrous succinate and carrageenan into a grinding device for co-grinding; Step (3), discharging the material, and sieving to obtain a ferrous succinate composition.

5. The preparation method of the ferrous succinate composition according to claim 4, wherein: In step (2), the grinding equipment is a device with grinding and crushing functions, selected from a drum grinder, a jet grinder, a multi-impact column grinder, a ball mill, a vibration mill or a hammer mill.

6. The method for preparing the ferrous succinate composition according to claim 4 or 5, wherein: In step (2), when the grinding equipment is a ball mill, the diameter of the grinding balls is 0.25 to 2 cm, preferably 0.5 to 1 cm; the total grinding time is not less than 2 hours, preferably 4 to 8 hours; the rotation speed frequency during grinding is 10 to 30 Hz, preferably 15 to 25 Hz.

7. A ferrous succinate dry suspension, characterized in that: The dry suspension comprises the ferrous succinate composition according to claim 1 and conventional pharmaceutical excipients.

8. The ferrous succinate dry suspension according to claim 8, characterized in that: The pharmaceutical excipients are one or more combinations of diluents, flavoring agents, and pH regulators; the diluents are one or more combinations of mannitol, microcrystalline cellulose, lactose, calcium hydrogen phosphate, talcum powder, starch, and sucrose; the flavoring agents are one or more combinations of saccharin sodium, steviol glycosides, xylitol, erythritol, sucrose, aspartame, and fruit flavors; and the pH regulator is succinic acid or citric acid.

9. A ferrous succinate dry suspension, characterized in that: The dry suspension is made of the following components in parts by mass: 6 to 60 parts of the ferrous succinate composition according to claim 1, 78 to 16 parts of a diluent, 5 to 20 parts of a pH regulator, and 1 to 4 parts of a flavoring agent; preferably, it is made of the following components in parts by mass: 14 parts of the ferrous succinate composition, 74 parts of a diluent, 10 parts of a pH regulator, and 2 parts of a flavoring agent.

10. A process for preparing the ferrous succinate dry suspension according to claim 9, characterized in that: The following steps are involved: Step (1), pretreatment: weigh the raw and auxiliary materials in proportion and sieve them respectively; Step (2), premixing: uniformly mixing the ferrous succinate composition and an equal mass of a diluent to obtain a premixed material; Step (3), total mixing: adding the remaining amount of diluent, pH adjuster and flavoring agent to the premixed material obtained in step (2), and mixing evenly; Step (4), filling: filling the powder obtained in step (3) into bags.

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