Ferrous lactate composition as well as preparation method and application thereof

Abstract

The invention relates to a ferrous lactate composition which comprises the following components in percentage by weight: 55-70% of ferrous lactate, 20-40% of corn starch, 1-15% of vitamin C and 0.5-1.5 billion CFU / g of bacillus coagulans. The components (ferrous lactate, vitamin C, bacillus coagulans and the like) in the composition are scientifically matched and proportioned, so that the immune function of the digestive tract is improved, the absorption and utilization of an iron agent and nutrient substances are promoted, and gastrointestinal motility and constipation symptoms are improved; the preparation can effectively prevent and treat gastritis, peptic ulcer, atrophic gastritis, gastric precancerous lesions, lymphoproliferative gastric lymphoma and other lesions caused by helicobacter pylori infection, and the bioavailability, stability, safety and effectiveness of the preparation are remarkably improved.

Description

Technical Field

[0001] The present invention belongs to the technical field of medicine, and particularly relates to a ferrous lactate composition, a preparation method thereof and an application thereof. Background Art

[0002] Iron is an essential trace element for the human body and is a main component of hemoglobin (the main oxygen-carrying component in red blood cells) and myoglobin (the site for storing oxygen in muscle cells, supplying oxygen during muscle movement). Insufficient addition of complementary foods for infants and young children, partial eating habits of teenagers, excessive menstrual flow / multiple pregnancies / lactation in women, certain pathological factors (such as subtotal gastrectomy, chronic blood loss, chronic diarrhea, atrophic gastritis, and hookworm infection, etc.), physiological factors, low iron absorption rate, poor eating habits, insufficient iron intake in food, etc. can all cause iron deficiency in the human body, insufficient iron reserves in the body, and a decrease in hemoglobin content. In populations with increased iron requirements such as pregnant women, teenagers, infants and young children, if iron supplementation is insufficient, iron deficiency anemia is extremely likely to occur. When the body's demand for iron is out of balance with the supply, resulting in the depletion of stored iron in the body (ID), followed by iron deficiency in red blood cells (IDE), and ultimately causing iron deficiency anemia (IDA). Iron deficiency anemia is very harmful to patients. Common symptoms of severe iron deficiency anemia in infants and young children include pallor, irritability, fatigue, delayed motor development, obesity and weakness, and low muscle tone. The signs of iron deficiency anemia include pallor, and usually combined with a history of weakness, dizziness, easy fatigue, irritability, anorexia, pica, etc. Severe iron deficiency anemia may present excessive sweating, dyspnea, tachycardia, a soft systolic murmur in the heart, and cardiac enlargement, etc.

[0003] Iron deficiency can lead to a decrease in the activity of various iron-containing enzymes, especially the activity of hemoglobin, hinder the transportation of oxygen, induce a decrease in the cellular oxygen metabolism level and the body's immunity, and be accompanied by symptoms such as fatigue, irritability, restlessness, inattention, memory loss, and cracked tongue. According to reports by the WHO, the incidence rate of iron deficiency anemia is 17%, the incidence rate of iron deficiency anemia (IDA) in men is 10%, the incidence rate of iron deficiency anemia (IDA) in women is 20% - 35.6%, the incidence rate of iron deficiency anemia (IDA) in pregnant women is 40% - 66.7%, and the incidence rate of iron deficiency anemia (IDA) in children is 52% - 82.5%.

[0004] After the ferrous ion of ferrous lactate is oxidized to ferric ion by ceruloplasmin in the blood, it binds to transferrin in the plasma and is transported to various tissues in the body. It enters the cells in the form of endocytosis through the transferrin receptor, and binds to protoporphyrin and globin on the mitochondria to form hemoglobin. The pathogenesis of iron deficiency anemia mainly includes excessive iron loss, iron absorption disorder, and insufficient iron intake, etc.

[0005] Studies have shown that iron-deficiency anemia may also occur when complementary foods are given to infants at inappropriate times and when breastfed infants are over 6 months old. After children are infected with Helicobacter pylori, it may cause iron absorption disorders, greatly increasing the likelihood of iron-deficiency anemia. Malabsorption caused by various reasons may also lead to iron-deficiency anemia. After iron supplements are given to iron-deficient patients, it can enhance the synthesis of hemoglobin and relieve anemia symptoms. However, existing iron supplements have poor stability, low absorption efficiency, and cause adverse reactions such as transient tooth discoloration, nausea, constipation, diarrhea, and abdominal pain. Therefore, there is an urgent need to develop safe and effective iron supplements to meet clinical needs. Summary of the Invention

[0006] The purpose of the present invention is to provide a ferrous lactate composition. By weight percentage, the composition consists of 55-70% ferrous lactate, 20-40% corn starch, 1-15% vitamin C, and Bacillus coagulans 0.5-150 million CFU / g.

[0007] In a preferred technical solution of the present invention, by weight percentage, the composition consists of 60-65% ferrous lactate, 25-35% corn starch, 5-10% vitamin C, and Bacillus coagulans 0.5-100 million CFU / g.

[0008] In a preferred technical solution of the present invention, the weight percentage ratio of ferrous lactate to corn starch in the composition is 1.5-3.0:1, preferably 1.8-2.5:1, and more preferably 2.0-2.2:1.

[0009] In a preferred technical solution of the present invention, by weight percentage, the ferrous lactate contained in the composition is 55-70%, preferably 60-65%.

[0010] In a preferred technical solution of the present invention, by weight percentage, the content of corn starch contained in the composition is 20-40%, preferably 25-35%.

[0011] In a preferred technical solution of the present invention, by weight percentage, the vitamin C contained in the composition is 1-15%, preferably 5-10%.

[0012] In a preferred technical solution of the present invention, the Bacillus coagulans contained in the composition is 0.5-150 million CFU / g, preferably 0.5-100 million CFU / g.

[0013] In a preferred technical solution of the present invention, by weight percentage, the composition consists of 60% ferrous lactate, 30% corn starch, 10% vitamin C, and Bacillus coagulans 0.5-100 million CFU / g.

[0014] In a preferred technical solution of the present invention, the composition is a capsule.

[0015] In the preferred technical solution of the present invention, ferrous lactate, corn starch and vitamin C are crushed to 40-50 mesh, and then uniformly mixed with the required amount of Bacillus coagulans, and filled into hollow capsules to obtain ferrous lactate capsules.

[0016] In the preferred technical solution of the present invention, the content of high-iron salt in the composition is ≤1.5%, preferably ≤1.0%, more preferably ≤0.5%, and still more preferably ≤0.2%.

[0017] The object of the present invention is to provide a preparation method of a ferrous lactate composition. By weight percentage, the composition consists of 55-70% ferrous lactate, 20-40% corn starch, 1-15% vitamin C and 0.5-1.5×10⁸ CFU / g of Bacillus coagulans. The preparation of the composition includes the following steps: crushing ferrous lactate, corn starch and vitamin C to 40-50 mesh, and then uniformly mixing them with the required amount of Bacillus coagulans to obtain the product.

[0018] In the preferred technical solution of the present invention, by weight percentage, the composition consists of 60-65% ferrous lactate, 25-35% corn starch, 5-10% vitamin C and 0.5-1.0×10⁸ CFU / g of Bacillus coagulans.

[0019] In the preferred technical solution of the present invention, the weight percentage of ferrous lactate to corn starch in the composition is 1.5-3.0:1, preferably 1.8-2.5:1, and more preferably 2.0-2.2:1.

[0020] In the preferred technical solution of the present invention, by weight percentage, the ferrous lactate contained in the composition is 55-70%, preferably 60-65%.

[0021] In the preferred technical solution of the present invention, by weight percentage, the content of corn starch contained in the composition is 20-40%, preferably 25-35%.

[0022] In the preferred technical solution of the present invention, by weight percentage, the vitamin C contained in the composition is 1-15%, preferably 5-10%.

[0023] In the preferred technical solution of the present invention, the Bacillus coagulans contained in the composition is 0.5-1.5×10⁸ CFU / g, preferably 0.5-1.0×10⁸ CFU / g.

[0024] In the preferred technical solution of the present invention, by weight percentage, the composition consists of 60% ferrous lactate, 30% corn starch, 10% vitamin C and 0.5-1.0×10⁸ CFU / g of Bacillus coagulans.

[0025] In a preferred technical solution of the present invention, the composition is filled into a hollow capsule to obtain ferrous lactate capsules.

[0026] In a preferred technical solution of the present invention, the content of high-iron salt in the composition is ≤1.5%, preferably ≤1.0%, more preferably ≤0.5%, and still more preferably ≤0.2%.

[0027] The object of the present invention is to provide a ferrous lactate composition, which is made of ferrous lactate and corn starch in a weight ratio of 1.5-3.0:1.

[0028] In a preferred technical solution of the present invention, the weight percentage of ferrous lactate to corn starch in the composition is 1.8-2.5:1, preferably 2.0-2.2:1.

[0029] In a preferred technical solution of the present invention, calculated by weight percentage, the ferrous lactate contained in the composition is 55-70%, preferably 60-65%.

[0030] In a preferred technical solution of the present invention, calculated by weight percentage, the content of corn starch contained in the composition is 20-40%, preferably 25-35%.

[0031] In a preferred technical solution of the present invention, the composition optionally contains any one or a combination of vitamin C and Bacillus coagulans.

[0032] In a preferred technical solution of the present invention, calculated by weight percentage, the vitamin C contained in the composition is 1-15%, preferably 5-10%.

[0033] In a preferred technical solution of the present invention, the content of Bacillus coagulans contained in the composition is 0.5-1.5×10⁸ CFU / g, preferably 0.5-1.0×10⁸ CFU / g.

[0034] In a preferred technical solution of the present invention, the composition is filled into a hollow capsule to obtain ferrous lactate capsules.

[0035] In a preferred technical solution of the present invention, the content of high-iron salt in the composition is ≤1.5%, preferably ≤1.0%, more preferably ≤0.5%, and still more preferably ≤0.2%.

[0036] The object of the present invention is to provide a preparation method of a ferrous lactate composition, which is made of ferrous lactate and corn starch in a weight ratio of 2:1. The preparation of the composition includes the following steps: ferrous lactate and corn starch are pulverized to 40-50 mesh and uniformly mixed to obtain the composition.

[0037] In a preferred technical solution of the present invention, the weight percentage of ferrous lactate to corn starch in the composition is 1.8-2.5:1, preferably 2.0-2.2:1.

[0038] In a preferred technical solution of the present invention, calculated by weight percentage, the ferrous lactate contained in the composition is 55-70%, preferably 60-65%.

[0039] In a preferred technical solution of the present invention, calculated by weight percentage, the content of corn starch in the composition is 20-40%, preferably 25-35%.

[0040] In a preferred technical solution of the present invention, the composition optionally contains any one or a combination of vitamin C and Bacillus coagulans.

[0041] In a preferred technical solution of the present invention, calculated by weight percentage, the vitamin C contained in the composition is 1-15%, preferably 5-10%.

[0042] In a preferred technical solution of the present invention, when the composition contains vitamin C, ferrous lactate, corn starch and vitamin C are pulverized to 40-50 mesh and uniformly mixed to obtain the product.

[0043] In a preferred technical solution of the present invention, the Bacillus coagulans contained in the composition is 0.5-150 million CFU / g, preferably 0.5-100 million CFU / g.

[0044] In a preferred technical solution of the present invention, the composition is filled into hollow capsules to prepare ferrous lactate capsules.

[0045] In a preferred technical solution of the present invention, the content of high-iron salt in the composition is ≤1.5%, preferably ≤1.0%, more preferably ≤0.5%, and still more preferably ≤0.2%.

[0046] Another object of the present invention is to provide the use of a pharmaceutical composition in the preparation of a drug for treating iron deficiency anemia.

[0047] Unless otherwise specified, when the present invention relates to the percentage between liquids, the percentage is volume / volume percentage; when the present invention relates to the percentage between a liquid and a solid, the percentage is volume / weight percentage; when the present invention relates to the percentage between a solid and a liquid, the percentage is weight / volume percentage; and the rest are weight / weight percentages.

[0048] Compared with the prior art, the present invention has the following beneficial effects:

[0049] 1. The components (ferrous lactate, vitamin C, Bacillus coagulans, etc.) and their ratios in the scientific composition of the present invention are as follows: First, vitamin C is used to effectively prevent the conversion of divalent iron into trivalent iron, improve the product stability, and promote iron absorption. Second, Bacillus coagulans is used to secrete a large amount of L-lactic acid to lower the gastrointestinal pH and inhibit pathogenic bacteria. Third, Bacillus coagulans and its large-scale reproduction in the intestine are used to improve the intestinal flora, competitively affect the colonization of Helicobacter pylori (Hp) in the gastric mucosa, produce a large amount of probiotic factors, absorb harmful substances such as ammonia and hydrogen sulfide produced by Hp, maintain the microecological balance of the digestive tract, improve the digestive tract immune function, promote the absorption and utilization of iron agents and nutrients, improve gastrointestinal motility and constipation symptoms, enhance non-specific and specific immunity, and inhibit Hp infection, etc., effectively preventing and treating lesions such as gastritis, peptic ulcer, atrophic gastritis, precancerous lesions of gastric cancer, and lymphoproliferative gastric lymphoma caused by Hp infection, significantly improving the bioavailability, stability, safety and effectiveness of the preparation. Fourth, the preparation method is improved to significantly improve the stability of the preparation.

[0050] 2. The preparation method of the present invention has the advantages of simple operation, good process stability, good stability of the obtained product, no special equipment requirements, and being suitable for industrial production. BRIEF DESCRIPTION OF THE DRAWINGS

[0051] Figure 1 Long-term stability study of the ferrous lactate capsules of the present invention, Figure 1a Content of high-iron salt, Figure 1b Content of ferrous lactate;

[0052] Figure 2 Dissolution study of the ferrous lactate capsules of the present invention;

[0053] Figure 3 Study on the effect of the ferrous lactate capsules of the present invention in improving anemia, Figure 3a Peripheral red blood cells (RBC), Figure 3b White blood cells (WBC), # indicates significant difference from the blank group (P < 0.05), * indicates significant difference from the model group (P < 0.05), ** indicates significant difference from the model group (P < 0.01);

[0054] Figure 4 Study on the effect of the ferrous lactate capsules of the present invention in improving gastrointestinal motility, ## indicates significant difference from the blank group (P < 0.01), ** indicates significant difference from the model group (P < 0.01). DETAILED DESCRIPTION OF THE INVENTION

[0055] The following illustrates the present invention with reference to the examples, but the present invention is not limited to the examples. The Bacillus coagulans used in the detailed description is commercially available, and the viable count is 1000 billion CFU / g.

[0056] Example 1 Preparation of Ferrous Lactate Capsules

[0057] Composition of Ferrous Lactate Capsules (10,000 capsules):

[0058] Component Dosage (Kg) Ferrous lactate 1.5 Corn starch 0.75

[0059] The preparation of ferrous lactate capsules comprises the following steps:

[0060] (1) Weigh the required amounts of ferrous lactate and corn starch, crush them to 40 mesh, then place them in a three-dimensional motion mixer and mix (750 revolutions / h * 30 min), and measure their angle of repose ( o ) is 33.5;

[0061] (2) Fill them into empty capsules to obtain ferrous lactate capsules.

[0062] Example 2 Preparation of Ferrous Lactate Capsules

[0063] Composition of Ferrous Lactate Capsules (10,000 capsules):

[0064] Component Dosage (Kg) Ferrous lactate 1.5 Corn starch 0.75 Vitamin C 0.15 Bacillus coagulans 0.0015

[0065] The preparation of ferrous lactate capsules comprises the following steps:

[0066] (1) Weigh the required amounts of ferrous lactate, corn starch and vitamin C, crush them to 40 mesh, then place them in a three-dimensional motion mixer and mix (750 revolutions / h * 30 min) until uniform, then add Bacillus coagulans and mix uniformly (about 10 min), and measure their angle of repose (o) as 36.8;

[0067] (2) Fill them into empty capsules to obtain ferrous lactate capsules.

[0068] Example 3 Preparation of Ferrous Lactate Capsules

[0069] Composition of Ferrous Lactate Capsules (10,000 capsules):

[0070] Component Dosage (Kg) Ferrous lactate 1.5 Corn starch 0.75 Vitamin C 0.25 Bacillus coagulans 0.0025

[0071] The preparation of ferrous lactate capsules comprises the following steps:

[0072] (1) Weigh the required amounts of ferrous lactate, corn starch and vitamin C, crush them to 40 mesh, then place them in a three-dimensional motion mixer and mix (700 revolutions / h * 30 min), then add Bacillus coagulans and mix uniformly (about 10 min), and measure their angle of repose ( o) is 38.8;

[0073] (2) Fill it into the hollow capsules to obtain ferrous lactate capsules.

[0074] Example 4 Preparation of Ferrous Lactate Capsules

[0075] Composition of ferrous lactate capsules (1000 capsules):

[0076] Component Dosage (g) Ferrous lactate 150 Corn starch 75 Vitamin C 50 Bacillus coagulans 0.25

[0077] The preparation of ferrous lactate capsules includes the following steps:

[0078] (1) Weigh the required amounts of ferrous lactate, corn starch, and vitamin C, crush them to 40 mesh, then place them in a three-dimensional motion mixer, mix (750 revolutions / h * 25 min), then add Bacillus coagulans, and after uniform mixing (about 10 min), measure its angle of repose ( o ) is 43.0;

[0079] (2) Fill it into the hollow capsules to obtain ferrous lactate capsules.

[0080] Example 5 Preparation of Ferrous Lactate Capsules

[0081] Composition of ferrous lactate capsules (1000 capsules):

[0082]

[0083]

[0084] The preparation of ferrous lactate capsules includes the following steps:

[0085] (1) Weigh the required amounts of ferrous lactate, corn starch, and vitamin C, crush them to 40 mesh, then place them in a three-dimensional motion mixer, mix (650 revolutions / h * 30 min), then add Bacillus coagulans, and after uniform mixing (about 10 min), measure its angle of repose ( o ) is 47.5;

[0086] (2) Fill it into the hollow capsules to obtain ferrous lactate capsules.

[0087] Example 6 Preparation of Ferrous Lactate Capsules

[0088] Composition of ferrous lactate capsules (1000 capsules):

[0089] Component Dosage (g) Ferrous lactate 150 Corn starch 75 Vitamin C 25 Bacillus coagulans 0.1

[0090] The preparation of ferrous lactate capsules comprises the following steps:

[0091] (1) Weigh the required amounts of ferrous lactate, corn starch, and vitamin C, crush them to 40 mesh, then place them in a three-dimensional motion mixer and mix (700 revolutions / h * 30 min), and then add Bacillus coagulans and mix evenly (about 10 min);

[0092] (2) Fill them into hollow capsules to obtain ferrous lactate capsules.

[0093] Comparative Example 1 The preparation of ferrous lactate capsules

[0094] Composition of ferrous lactate capsules (1000 capsules):

[0095] Component Dosage (g) Ferrous lactate 150 Corn starch 75

[0096] The preparation of ferrous lactate capsules comprises the following steps:

[0097] (1) Weigh the required amounts of ferrous lactate and corn starch, crush them to 40 mesh, granulate them by wet granulation with an appropriate amount of 10% PVP solution, and dry them to obtain granules with a particle size of 30 mesh;

[0098] (2) Fill them into hollow capsules to obtain 1000 ferrous lactate capsules.

[0099] Comparative Example 2 The preparation of ferrous lactate capsules

[0100] Composition of ferrous lactate capsules (1000 capsules):

[0101] Component Dosage (g) Ferrous lactate 150 Corn starch 75 Vitamin C 2

[0102] The preparation of ferrous lactate capsules comprises the following steps:

[0103] (1) Weigh the required amounts of ferrous lactate, corn starch, and vitamin C, crush them to 40 mesh, granulate them by wet granulation with an appropriate amount of 10% PVP solution, and dry them to obtain granules with a particle size of 30 mesh;

[0104] (2) Fill them into hollow capsules to obtain 1000 ferrous lactate capsules.

[0105] Test Example 1 Long-term stability study of the ferrous lactate capsules of the present invention

[0106] After the ferrous lactate capsules prepared in Examples 1-3 and Comparative Examples 1-2 were packaged in aluminum-plastic, they were placed under the conditions of 25°C ± 2°C and relative humidity of 60% ± 10% for 24 months, and the content of high-iron salts in them was examined (Figure 1a ) and the change in ferrous lactate content Figure 1b ). The ferrous lactate capsules of the present invention have good long-term stability.

[0107] Test Example 2 Dissolution test of the ferrous lactate capsules of the present invention

[0108] Select the ferrous lactate capsules prepared in Examples 1-3, and detect their dissolution according to the dissolution and release determination method (General Principles 0401, Volume IV, Chinese Pharmacopoeia 2015 Edition).

[0109] Using water as the dissolution medium and a rotation speed of 50 r / min, operate according to the law. At 5 min, 10 min, 15 min, 30 min, 45 min, and 60 min respectively, take 10 ml of the solution, filter it, and replenish 10 ml of the solution at the same time. Accurately measure 2 ml of the continuous filtrate and 1 ml of the ferrous ammonium lactate reference solution (accurately weigh about 25 mg of ferrous ammonium lactate, place it in a 50 ml volumetric flask, dissolve it with 5 ml of dilute hydrochloric acid, and dilute it to the scale with water), and place them in 25 ml volumetric flasks respectively. Add 2 ml of o-phenanthroline solution (0.12 g → 100 ml), 10 ml of 2 mol / L sodium acetate solution, dilute it to the scale with water, shake well, and let it stand for 15 min. Then, according to the ultraviolet-visible spectrophotometry (General Principles 0401, Volume IV, Chinese Pharmacopoeia 2015 Edition), measure the absorbance at a wavelength of 510 nm. Calculate the dissolution amount of each capsule by multiplying the absorbance ratio of the two by the coefficient 0.7346. The results are shown in Figure 2 .

[0110] Test Example 3 Study on the effect of the ferrous lactate capsules of the present invention in improving anemia

[0111] Select 60 SPF-grade female Kunming mice with a body weight of 18-22 g. Randomly divide them into six groups (blank group, model group, and experimental groups 1-4), with 10 mice in each group. During the experiment, the experimental animals were allowed to freely eat and drink deionized water, and were raised in an environment with a room temperature of 20°C-24°C and a relative humidity of 55%-68%.

[0112] Except for the blank group, the mice in the other groups were bled from the tail continuously for 3 days, once a day, and 0.5 ml of blood was collected each time. After the model was prepared, the mice in each group were gavaged with a sample at a dose of 0.2 ml / 10 g for 7 consecutive days. The blank group and the model group were given an equal volume of distilled water. Experimental groups 1-4 were respectively gavaged with the ferrous lactate capsule granules of Examples 1, 2, 3, and 6, which were made into a suspension with 5% sodium carboxymethylcellulose solution, and the gavage dose was 0.06 g / (Kg·d).

[0113] Before modeling, before dosing, and 7 days after dosing, blood was collected from the orbital venous plexus of the experimental animals to detect peripheral red blood cells (RBC) and white blood cells (WBC), and inter-group comparisons were made. The results are shown in Figure 3a and Figure 3b .

[0114] Test Example 4 Study on the Effect of Ferrous Lactate Capsules of the Invention on Improving Gastrointestinal Motility

[0115] Forty SPF-grade female Kunming mice weighing 18 - 22 g were selected. They were randomly divided into four groups (blank group, model group, and experimental groups 1 - 2), with 10 mice in each group. During the experiment, the experimental animals were allowed to freely eat and drink deionized water, and were raised in an environment with a room temperature of 20℃ - 24℃ and a relative humidity of 55% - 68%.

[0116] The blank group (0 mg / kg.bw) and the model group (0 mg / kg.bw) were given an equal volume of 5% sodium carboxymethylcellulose solution. Experimental groups 1 and 2 were respectively intragastrically administered the ferrous lactate capsule granules of Example 1 and Example 3, which were made into a suspension with 5% sodium carboxymethylcellulose solution, and the intragastric administration dose was 0.06 g / (Kg·d). Each group of mice was given maintenance feed and intragastrically administered once a day, at a dose of 0.2 ml / 10 g. After the experimental animals were continuously given the test substance for 14 days, the mice in each group were fasted but allowed to drink water for 16 h. Experimental groups 1 - 2 and the model group were respectively intragastrically administered loperamide hydrochloride (4.0 mg / Kg.BW), and the blank group was given the corresponding volume of distilled water. 30 minutes after the experimental animals were intragastrically administered loperamide hydrochloride, experimental groups 1 - 2 were intragastrically administered ink containing the test substance (containing 5% activated carbon and 10% gum arabic), and the blank group and the model group were given the corresponding volume of ink (containing 5% activated carbon and 10% gum arabic). The volume of ink intragastrically administered to the experimental animals was 10 mL / Kg.BW. 30 minutes after intragastric administration of ink, the experimental animals were immediately sacrificed by cervical dislocation, the abdominal cavity was opened to separate the mesentery, and the intestinal tube from the upper end at the pylorus to the lower end at the ileocecal junction was cut. The length of the intestinal tube was measured as the "total small intestine length", and the distance from the pylorus to the advancing front of the ink was measured as the "ink advancing length". The ink advancing rate was calculated according to the following formula.

[0117] Ink advancing rate (%) = Ink advancing length (cm) / Total small intestine length (cm) × 100%.

[0118] The results are shown in Figure 4 . Compared with the ink advancing rate of the blank group, there was a significant difference in the ink advancing rate of the model group (P < 0.01); compared with the ink advancing rate of the model group, there was a significant difference in the ink advancing rate of experimental group 2 (P < 0.01). The ferrous lactate capsules of the present invention significantly improved gastrointestinal motility.

[0119] The above description of the specific embodiments of the present invention does not limit the present invention. Those skilled in the art can make various changes or deformations according to the present invention, as long as they do not depart from the spirit of the present invention, they shall fall within the scope of protection of the claims of the present invention.

Claims

1. A ferrous lactate composition, which consists of 55-70% ferrous lactate, 20-40% corn starch, 1-15% vitamin C and 50-150 million CFU / g of Bacillus coagulans, by weight percentage.

2. The composition as claimed in claim 1, wherein the composition consists of 60-65% ferrous lactate, 25-35% corn starch, 5-10% vitamin C and 50-100 million CFU / g of Bacillus coagulans in terms of weight percentage.

3. A composition as described in any one of claims 1-2, wherein the weight percentage of ferrous lactate in the composition: corn starch is 1.5-3.0:1, preferably 1.8-2.5:1, and more preferably 2.0-2.2:

1.

4. The composition according to any one of claims 1 to 3, wherein the composition consists of 60% ferrous lactate, 30% corn starch, 10% vitamin C and 50-100 million CFU / g of Bacillus coagulans, in terms of weight percentage.

5. The composition according to any one of claims 1 to 4, which is a capsule.

6. The composition according to any one of claims 1 to 5, wherein ferrous lactate, corn starch and vitamin C are crushed into 40-50 meshes, uniformly mixed with a required amount of Bacillus coagulans, and filled into hollow capsules to prepare ferrous lactate capsules.

7. The composition according to any one of claims 1 to 6, wherein the ferric salt content in the composition is ≤1.5%, preferably ≤1.0%, more preferably ≤0.5%, and even more preferably ≤0.2%.

8. A method for preparing a ferrous lactate composition according to any one of claims 1 to 7, wherein the composition consists of 55-70% ferrous lactate, 20-40% corn starch, 1-15% vitamin C and 50-150 million CFU / g of Bacillus coagulans by weight, and the preparation of the composition comprises the following steps: crushing the ferrous lactate, corn starch and vitamin C into 40-50 meshes, and then uniformly mixing them with a required amount of Bacillus coagulans to obtain the composition.

9. The method according to claim 8, wherein the composition consists of 60-65% ferrous lactate, 25-35% corn starch, 5-10% vitamin C and 50-100 million CFU / g of Bacillus coagulans in terms of weight percentage.

10. Use of the pharmaceutical composition according to any one of claims 1 to 7 for preparing a medicament for treating iron deficiency anemia.

Images