Compound donkey-hide gelatin, ginseng and astragalus tablet for improving iron-deficiency anemia

Abstract

Ferrous fumarate, gellan gum and dextran sulfate are prepared into an ion-sensitive tablet, and the surface of the ion-sensitive tablet is subjected to enteric coating, so that the ion-sensitive tablet basically does not release iron elements in the stomach, and the ion-sensitive tablet is quickly converted into iron-containing gel when entering the intestinal tract, so that the iron-containing gel can be quickly dissolved in the intestinal tract. Further, slow and uniform release in intestinal tracts is realized, and stimulation of high-dose iron to gastrointestinal tracts is reduced; in addition, ferrous fumarate and Chinese herbal medicines are combined to form beneficial complementation, so that the dual purposes of supplementing iron and tonifying qi and blood are achieved, and the iron-deficiency anemia is effectively improved.

Description

Technical Field

[0001] The present invention relates to a preparation for improving iron deficiency anemia, in particular to a compound donkey-hide gelatin and ginseng astragalus tablet for improving iron deficiency anemia. Background Art

[0002] According to traditional Chinese medicine, anemia falls into the categories of "blood deficiency", "blood loss", "blood yellowness", etc. Currently, iron deficiency anemia is mostly improved by using donkey-hide gelatin or other iron supplements. The raw material composition is relatively simple, and divalent iron is not easy to preserve and be absorbed by the human body.

[0003] Currently, there are many types of health foods for treating iron deficiency anemia. For example, patent CN200510101178.6 discloses a pharmaceutical preparation made from Chinese herbal medicine as the main raw material. Although Chinese herbal medicine can form a beneficial complement with iron, it is slow to take effect. For example, patent CN101322778A discloses a double-layer sustained-release iron-supplementing tablet. The sustained-release layer is an iron-containing compound, and the immediate-release layer is a Chinese herbal extract. This allows for a slow and even release of the iron element, preventing gastrointestinal reactions caused by high iron levels. However, this gel matrix carrying the iron-containing compound rapidly absorbs water and swells in the stomach, and is rapidly released under the action of gastric acid. The rapid release amount can reach 30%, causing irritation to the gastric mucosa.

[0004] At present, Qi-tonifying and blood-invigorating products have been gaining great attention from consumers and have broad market prospects. There are three main categories of Qi-tonifying and blood-invigorating products on the market:

[0005] (1) Some precious Chinese medicinal ingredients such as ginseng, codonopsis, American ginseng, rehmannia root, angelica, astragalus, polygonum multiflorum and deer antler have strong qi-tonifying effects but insufficient blood-tonifying effects;

[0006] (2) Some medicinal and edible ingredients such as donkey-hide gelatin, wolfberry, red dates, longan, tangerine peel, white fungus, and honey have good blood-tonifying effects, but the effects take a long time to appear and require long-term use;

[0007] (3) Some inorganic or organic iron supplements such as ferrous sulfate, ferrous lactate, ferrous citrate and ferrous gluconate. The utilization rate of these iron supplements is low, and because high doses of iron can irritate the gastrointestinal tract, some people experience side effects such as nausea, bloating and constipation after taking them.

[0008] Therefore, it is very necessary to develop a product that is suitable for replenishing qi and producing blood, which has good taste, fast efficacy, small side effects, and is safe and peaceful. Summary of the Invention

[0009] In order to solve the technical problems existing in the background technology, the present invention proposes a compound donkey-hide gelatin and ginseng tablet for improving iron deficiency anemia. The compound donkey-hide gelatin and ginseng tablet comprises dextran sulfate, gellan gum, ferrous fumarate and traditional Chinese medicine extract powder.

[0010] The ferrous fumarate, dextran sulfate and gellan gum in the present invention form a semi-solid gel under the action of cations in the intestine, thereby controlling the slow release of iron and reducing the stimulation of the intestine caused by high-dose iron in a short period of time.

[0011] The traditional Chinese medicine extract powder comprises astragalus extract, codonopsis pilosula extract and donkey-hide gelatin.

[0012] The mass ratio of the dextran sulfate, gellan gum, ferrous fumarate and traditional Chinese medicine extract powder is 5:1:1.5-2:10-15.

[0013] In the traditional Chinese medicine extract powder, the mass ratio of astragalus extract: codonopsis extract: donkey-hide gelatin is 10:3-5:1-4.

[0014] Ferrous fumarate is a new type of soluble iron supplement with an iron content of 32%. It is stable and not easily oxidized. The intestinal absorption rate of ferrous fumarate is 4-5 times that of ferrous sulfate. Ferrous fumarate is a Western medicine ingredient that can provide the human body with hematopoietic raw materials. Chinese herbal medicines that replenish blood and qi synergistically improve the blood-tonifying effect and enhance human immunity.

[0015] The compound donkey-hide gelatin and ginseng astragalus tablets also include auxiliary materials;

[0016] Preferably, the excipients are silicon dioxide and magnesium stearate.

[0017] The compound donkey-hide gelatin and ginseng and astragalus tablets also include an enteric coating.

[0018] Enteric coating ensures that the tablets will not release a large amount of iron in the stomach, but will release it slowly in the intestines for about 12 hours.

[0019] The present invention also provides a method for preparing the compound donkey-hide gelatin and ginseng-qi tablets for improving iron deficiency anemia, comprising the following steps:

[0020] Mixed granules are obtained from Chinese herbal medicine extract powder, dextran sulfate, gellan gum, organic divalent iron, sodium carboxymethyl starch slurry and auxiliary materials, and the mixed granules are compressed to obtain tablets, which are finally enteric-coated.

[0021] The mixed granules are prepared by first mixing Chinese herbal medicine extract powder, dextran sulfate, gellan gum, organic divalent iron and sodium carboxymethyl starch slurry to form soft material granules, and then mixing the soft material granules with auxiliary materials to obtain mixed granules;

[0022] Preferably, the organic divalent iron is ferrous fumarate.

[0023] The coating liquid used for the enteric coating comprises 10-30 wt% of acrylic resin, 1-5 wt% of cross-linked sodium carboxymethyl cellulose, 2-5 wt% of hydroxypropyl methylcellulose, and 60-87 wt% of ethanol.

[0024] Beneficial effects of the present invention: The present invention compounds donkey-hide gelatin, astragalus, codonopsis and organic iron ferrous fumarate. The composite reagent can achieve the effect of quickly replenishing qi and producing blood, and has the advantages of little gastrointestinal irritation, little side effects, and slow and uniform release of iron. DETAILED DESCRIPTION

[0025] To facilitate understanding of the present invention, the present invention will be described more fully below in conjunction with specific embodiments. However, the present invention can be implemented in many different forms and is not limited to the embodiments described herein. On the contrary, the purpose of providing these embodiments is to provide a more thorough and comprehensive understanding of the disclosure of the present invention.

[0026] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those skilled in the art of the present invention. The terms used in the specification of the present invention herein are only for the purpose of describing specific embodiments and are not intended to limit the present invention.

[0027] The technical solution of the present invention is described more clearly and completely below with reference to specific embodiments and comparative examples.

[0028] Example 1

[0029] This embodiment provides a compound donkey-hide gelatin and ginseng tablet for improving iron deficiency anemia, and its preparation method is as follows:

[0030] (1) Preparation of Chinese herbal medicine extract powder

[0031] Take Astragalus membranaceus and extract it three times with distilled water, adding 10 times the weight of Astragalus membranaceus each time. Heat it to 80°C during extraction for 2 hours. Concentrate, dry and grind the Astragalus membranaceus extract to obtain Astragalus membranaceus extract powder.

[0032] Take Codonopsis pilosula and extract it twice with distilled water, each time adding 8 times the weight of Codonopsis pilosula. Heat it to 90°C during extraction and extract for 1.5 hours. Concentrate, dry and crush the Codonopsis pilosula extract to obtain Codonopsis pilosula extract powder.

[0033] Grind the donkey-hide gelatin and pass it through a 50-mesh sieve to obtain donkey-hide gelatin powder;

[0034] According to the mass ratio of astragalus extract powder: codonopsis extract powder: donkey-hide gelatin powder of 10:3:2, the Chinese herbal medicine extract powder was obtained by mixing evenly;

[0035] (2) Preparation of mixed particles

[0036] Dextran sulfate, gellan gum, ferrous fumarate and traditional Chinese medicine extract powder were weighed in a mass ratio of 5:1:2:15, and the raw materials were placed in a mixer and mixed for 20 minutes, and then 10wt% of sodium carboxymethyl starch slurry was added to prepare a soft material. After passing through a 16-mesh sieve, soft material particles of uniform size were obtained and dried. The dried soft material particles were mixed with excipients (silicon dioxide and magnesium stearate) in a mixer, and after passing through a 16-mesh sieve, mixed particles of uniform size were obtained, wherein the mass ratio of soft material particles: silicon dioxide: magnesium stearate was 20:0.8:1.2;

[0037] (3) Enteric coating

[0038] The mixed granules in step (2) were compressed into 0.8 g tablets, and then a coating solution was prepared using 25 wt % acrylic resin, 5 wt % cross-linked carboxymethyl cellulose sodium, 3 wt % hydroxypropyl methylcellulose, and 77 wt % ethanol, and the tablets were spray-coated.

[0039] Example 2

[0040] This embodiment provides a compound donkey-hide gelatin and ginseng tablet for improving iron deficiency anemia, and its preparation method is as follows:

[0041] (1) Preparation of Chinese herbal medicine extract powder

[0042] Take Astragalus membranaceus and extract it three times with distilled water, adding 10 times the weight of Astragalus membranaceus each time. Heat it to 90°C during extraction and extract it for 1.5 hours. Concentrate, dry and grind the Astragalus membranaceus extract to obtain Astragalus membranaceus extract powder.

[0043] Take Codonopsis pilosula and extract it twice with distilled water, adding 8 times the weight of Codonopsis pilosula each time. Heat it to 95°C during extraction and extract for 1 hour. Concentrate, dry and crush the Codonopsis pilosula extract to obtain Codonopsis pilosula extract powder.

[0044] Grind the donkey-hide gelatin and pass it through a 40-mesh sieve to obtain donkey-hide gelatin powder;

[0045] According to the mass ratio of astragalus extract powder: codonopsis pilosula extract powder: donkey-hide gelatin powder of 10:5:2, the Chinese herbal medicine extract powder was obtained by mixing evenly;

[0046] (2) Production

[0047] Dextran sulfate, gellan gum, ferrous fumarate and traditional Chinese medicine extract powder were weighed in a mass ratio of 5:1:1.8:10, and the raw materials were placed in a mixer and mixed for 30 minutes, and then 9wt% of sodium carboxymethyl starch slurry was added to prepare a soft material. After passing through a 16-mesh sieve, soft material particles of uniform size were obtained and dried. The dried soft material particles were mixed with excipients (silicon dioxide and magnesium stearate) in a mixer, and after passing through a 16-mesh sieve, mixed particles of uniform size were obtained, wherein the mass ratio of soft material particles: silicon dioxide: magnesium stearate was 20:1:1.2;

[0048] (3) Enteric coating

[0049] A coating solution was prepared with 20 wt % acrylic resin, 3 wt % cross-linked carboxymethyl cellulose sodium, 5 wt % hydroxypropyl methylcellulose and 72 wt % ethanol, and the tablets were spray-coated.

[0050] Example 3

[0051] This embodiment provides a compound donkey-hide gelatin and ginseng tablet for improving iron deficiency anemia, and its preparation method is as follows:

[0052] (1) Preparation of Chinese herbal medicine extract powder

[0053] Take Astragalus membranaceus and extract it three times with distilled water, adding 10 times the weight of Astragalus membranaceus each time. Heat the mixture to 85°C for 2 hours. Concentrate, dry and grind the Astragalus membranaceus extract to obtain Astragalus membranaceus extract powder.

[0054] Take Codonopsis pilosula and extract it twice with distilled water, each time adding 8 times the weight of Codonopsis pilosula. Heat it to 95°C during extraction and extract for 1.5 hours. Concentrate, dry and grind the Codonopsis pilosula extract to obtain Codonopsis pilosula extract powder.

[0055] Grind the donkey-hide gelatin and pass it through a 50-mesh sieve to obtain donkey-hide gelatin powder;

[0056] According to the mass ratio of astragalus extract powder: codonopsis extract powder: donkey-hide gelatin powder of 10:4:3, the Chinese herbal medicine extract powder was obtained by mixing evenly;

[0057] (2) Preparation of mixed particles

[0058] Dextran sulfate, gellan gum, ferrous fumarate and traditional Chinese medicine extract powder were weighed in a mass ratio of 5:1:2:12, and the raw materials were placed in a mixer and mixed for 20 minutes, and then 8wt% of sodium carboxymethyl starch slurry was added to prepare a soft material. After passing through a 16-mesh sieve, soft material particles of uniform size were obtained and dried. The dried soft material particles were mixed with excipients (silicon dioxide and magnesium stearate) in a mixer, and after passing through a 16-mesh sieve, mixed particles of uniform size were obtained, wherein the mass ratio of soft material particles: silicon dioxide: magnesium stearate was 20:1:1.5;

[0059] (3) Enteric coating

[0060] The mixed granules in step (2) were compressed into 0.8 g tablets, and then a coating solution was prepared using 15 wt % acrylic resin, 2 wt % cross-linked carboxymethyl cellulose sodium, 3 wt % hydroxypropyl methylcellulose, and 80 wt % ethanol, and the tablets were spray-coated.

[0061] Comparative Example 1

[0062] This comparative example proposes a compound donkey-hide gelatin and ginseng tablet for improving iron deficiency anemia. The preparation method thereof is the same as that in the embodiment, except that the "dextran sulfate" in step (1) is replaced by "sodium alginate".

[0063] Comparative Example 2

[0064] This comparative example proposes a compound donkey-hide gelatin and ginseng tablet for improving iron deficiency anemia. The preparation method is the same as that of Example 1, except that the "dextrose sulfate" in step (1) is replaced by "methyl cellulose (4000 cPa.s)".

[0065] The above embodiments and comparative examples were subjected to sustained-release tests, and the specific operations were as follows:

[0066] Sustained release: The release was determined using the first apparatus of the dissolution method (Appendix XC, Method 1, Basket Method, Part II, 2010 Edition of the Chinese Pharmacopoeia) with 900 mL of 0.1 mol / L HCl and pH 6.8 phosphate buffer as the release media, respectively. The release was determined by changing the pH medium to simulate the human gastrointestinal tract. The sample was first placed in 0.1 mol / L HCl for 2 h at a speed of 100 rpm and a temperature of 37°C. The solution was then replaced with pH 6.8 phosphate buffer for 3, 6, and 9 h, with the medium change completed within 5 min. Samples were taken at 15-min intervals and an equal amount of isothermal medium was added. The sample was filtered through a 0.45 μm microporous membrane. An appropriate amount of the filtrate was diluted and the iron content was determined by EDTA titration. The release was calculated. The experimental results are shown in Table 1.

[0067] Table 1 Performance test results of various embodiments and comparative examples

[0068]

[0069] As shown in Table 1, the compound donkey-hide gelatin and ginseng tablets prepared by the present invention have good performance. The 2-hour release amount in a medium simulating the gastric environment is less than 3%, while the 3-hour iron release amount in a medium simulating the intestinal environment is 20-30%, which can achieve precise drug delivery and slow release.

[0070] The above description is only a preferred specific embodiment of the present invention, but the scope of protection of the present invention is not limited thereto. Any technician familiar with the technical field, within the technical scope disclosed by the present invention, who makes equivalent replacements or changes based on the technical solution and inventive concept of the present invention, should be covered by the scope of protection of the present invention.

Claims

1. A compound donkey-hide gelatin and ginseng-qi tablet for improving iron deficiency anemia, characterized in that: The compound donkey-hide gelatin and astragalus tablets comprise dextran sulfate, gellan gum, ferrous fumarate and traditional Chinese medicine extract powder.

2. The compound donkey-hide gelatin and ginseng tablet for improving iron deficiency anemia according to claim 1, characterized in that: The traditional Chinese medicine extract powder comprises astragalus extract, codonopsis pilosula extract and donkey-hide gelatin.

3. The compound donkey-hide gelatin and ginseng tablet for improving iron deficiency anemia according to claim 1 or 2, characterized in that: The mass ratio of the dextran sulfate, gellan gum, ferrous fumarate and traditional Chinese medicine extract powder is 5:1:1.5-2:10-15.

4. The compound donkey-hide gelatin and ginseng tablet for improving iron deficiency anemia according to any one of claims 1 to 3, characterized in that: In the traditional Chinese medicine extract powder, the mass ratio of astragalus extract: codonopsis extract: donkey-hide gelatin is 10:3-5:1-4.

5. The compound donkey-hide gelatin and ginseng tablet for improving iron deficiency anemia according to any one of claims 1 to 4, characterized in that: The compound donkey-hide gelatin and ginseng astragalus tablets also include auxiliary materials; Preferably, the excipients are silicon dioxide and magnesium stearate.

6. The compound donkey-hide gelatin and ginseng tablet for improving iron deficiency anemia according to any one of claims 1 to 5, characterized in that: The compound donkey-hide gelatin and ginseng and astragalus tablets also include an enteric coating.

7. A method for preparing the compound donkey-hide gelatin and ginseng astragalus tablets for improving iron deficiency anemia according to any one of claims 1 to 6.

8. The preparation method according to claim 7, characterized in that The steps include: Mixed granules are obtained from Chinese herbal medicine extract powder, dextran sulfate, gellan gum, organic divalent iron, sodium carboxymethyl starch slurry and auxiliary materials, and the mixed granules are compressed to obtain tablets, which are finally enteric-coated.

9. The preparation method according to claim 7 or 8, characterized in that The mixed granules are prepared by first mixing Chinese herbal medicine extract powder, dextran sulfate, gellan gum, organic divalent iron and sodium carboxymethyl starch slurry to form soft material granules, and then mixing the soft material granules with auxiliary materials to obtain mixed granules; Preferably, the organic divalent iron is ferrous fumarate.

10. The preparation method according to any one of claims 7 to 9, characterized in that: The coating liquid used for the enteric coating comprises 10-30 wt% of acrylic resin, 1-5 wt% of cross-linked sodium carboxymethyl cellulose, 2-5 wt% of hydroxypropyl methylcellulose, and 60-87 wt% of ethanol.

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