CN103655574A - Compound ferrous succinate and folic acid composition - Google Patents
Compound ferrous succinate and folic acid composition Download PDFInfo
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- CN103655574A CN103655574A CN201310705972.6A CN201310705972A CN103655574A CN 103655574 A CN103655574 A CN 103655574A CN 201310705972 A CN201310705972 A CN 201310705972A CN 103655574 A CN103655574 A CN 103655574A
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- folic acid
- ferrous succinate
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- pharmaceutical carrier
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Abstract
The invention provides a compound ferrous succinate and folic acid composition which comprises ingredients of ferrous succinate, folic acid and a drug carrier. The ingredients are further prepared into a solid preparation for oral administration. The composition is used for iron supplement and folic acid deficiency treatment.
Description
one, technical field
The present invention relates to medical technical field, especially a kind of compositions that contains ferrous succinate, folic acid and pharmaceutical carrier composition, is further prepared into mentioned component can supply oral solid preparation, for iron supplement and folic acid deficiency.
two, background technology
Ferrum element is one of requisite element forming human body, iron deficiency can have influence on the healthy of human body and grow, maximum impact is iron deficiency anemia, and the investigation of World Health Organization (WHO) shows, iron deficiency anemia can occur for nearly 50% young girl, 20% adult female, 40% anemia of pregnant woman.Iron supplement is that human body additionally supplements necessary, appropriate inorganic iron or organoiron compound by food or pharmaceutical methods, thereby supplements ferrum element to reach the process of building body, prevention or adjuvant treatment of diseases object.
Folic acid (Folic acid), is called again FA or Bc, is called the earliest vitamin(e) M, is the water-soluble form of FA.Folic acid is as an important carbon carrier, synthetic at nucleotide, all more important physiological metabolisms aspect such as methylate again of homocysteine plays an important role, folic acid works with the form of tetrahydrofolic acid in vivo, and tetrahydrofolic acid participates in vivo the synthetic of purine nucleic acid and pyrimidine nucleotide and transforms.Folic acid is played the part of important role on manufacture nucleic acid (ribonucleic acid, DNA (deoxyribonucleic acid)), so folic acid is having the effect being even more important in cell division and growth course (as infant development, pregnancy) fast.Folic acid can promote the juvenile cell in bone marrow to reach maturity and form the erythrocyte of normal morphology, thereby avoids anemia, is to manufacture the indispensable material of erythrocyte.Folic acid is also the necessary material of human body when utilizing sugar and aminoacid, is the necessary material of body cell Growth and reproduction.
Iron deficiency anemia and other iron-deficient illness that human body causes because of iron deficiency are worldwide commonly encountered diseases, especially the highest with infant sickness rate, developed country is about 24%, developing country is about 30-90%, 7 years old following child of China is up to 25-65%, and iron deficiency anemia becomes affects one of major issue of Juvenile development and people constitution.Oral Iron Preparations is for preventing or treat the iron deficiency that a variety of causes causes, for example because of child or infancy stage, to need ferrum amount to increase in food supply not enough, or ferrum malabsorption person, or the anemia of pregnant woman of pregnant middle and late stage and chronic blood loss patient etc.When human body iron deficiency, except hemoglobin is synthetic, reduce, oxygen carrying capacity reduces, also occur and the relevant symptom of organizing iron deficiency and iron enzyme activity decreased: as abnormal in growth retardation, action, be short of physical strength, mucosal tissue variation and skin, fingernail pathological changes etc.After supplementing chalybeate, above-mentioned symptom all can be corrected gradually.
At present, the most of product in market all adopts ferrous iron as iron supplement agent, ferric iron and Organic Iron are not easy to absorb at intestinal, after must being reduced into free ferrous ion, just can be absorbed, market iron supplement based food, health product, the main effective ingredient of medicine is: ferrous sulfate, ferrous lactate, ferrous fumarate, Ferrous gluconate, ferrous succinate etc., the ferrum agent that ferrous sulfate etc. exist with low molecularity, bioavailability is lower, human body is difficult to fully absorb, and there is strong pungent iron taste in the inorganic iron supplement agent such as ferrous sulfate product, large to the intestines and stomach zest, easily make user produce nauseating, the untoward reaction such as vomiting, during excessive use, ferrum easily causes the serious side effects such as poisoning at human body class savings.
Ferrous succinate was once loaded in version British Pharmacopoeia in 1973, and succinic acid is human body endogenous material, and ferrous succinate is relatively little to digestive tract stimulation in above-mentioned iron supplement medicine, the medicine that bioavailability is relatively high.Domestic ferrous succinate sheet was produced by state approval on May 20th, 1993, commodity " turn of speed is luxuriant and rich with fragrance " by name.The result in clinical application of ferrous succinate sheet (turn of speed luxuriant and rich with fragrance) listing over 11 years confirm, it is that a good absorbing, curative effect are high really, instant effect, the less iron supplement medicine of side effect.
Alone iron preparation has certain limitation, folic acid can promote the juvenile cell in bone marrow to reach maturity and form the erythrocyte of normal morphology, thereby avoid anemia, to manufacture the indispensable material of erythrocyte, iron supplement while trimester of pregnancy Supplement of folic acid, can also be for preventing the effects such as Fetal neurotubules malformation except being used for the treatment of megaloblastic anemia.Ferrous succinate and folic acid " twin " preparation, facilitates anemia of pregnant woman to use, and can prevent to give birth to defect, and while improving iron deficiency anemia simultaneously with folic acid deficiency, the curative effect of chalybeate, gets twice the result with half the effort.
A kind of compound recipe ferrous succinate folic acid compound composition provided by the invention, said composition contains ferrous succinate, two kinds of effective ingredient of folic acid, for iron supplement and folic acid deficiency.
Patent CN1059827C provides a kind of complex ferrous sulfate tablet, and this compound preparation is comprised of chalybeate, folic acid, yeast and Radix Angelicae Sinensis, can promote the recovery of hemorrhagic anemia, iron deficiency anemia, nutritional anemia, promotes the anabolic effect of medullary cell DNA and RNA.Can improve antibody titer, have promotion appetite. strengthen the effect of digesting and assimilating with strong body constitution.Can promote the absorption of exogenous ferrum, improve the content of blood plasma ferrum, alleviate the gastropore intestinal untoward reaction that ferrous sulfate causes.
Patent CN101244079A discloses a kind of pharmaceutical composition as iron supplement agent, wherein contain carbonyl iron and the natural anti-oxidation composition with pharmaceutically active, and can contain pharmaceutical carrier, above-mentioned composition preparation, and the preparation method of establishing compositions and preparation, and said composition is for preventing and the purposes for the treatment of asiderosis.Said composition can be improved iron deficiency anemia, suppresses the generation of people's interior free yl, maintains the balance of oxygen metabolism in human body, strengthens patient's body constitution, improves immunity of organisms.
Patent CN100364522C provides a kind of sustained releasing preparation of ferrosi succinas that can significantly improve GI irritation reaction and preparation method thereof, every gram of ferrous succinate with hypromellose and or ethyl cellulose 0.4-0.8 gram, binding agent is selected from the PVP ethanol of 75%-85% ethanol or 20%-35%, it is characterized in that taking after ferrous succinate, sustained-release matrix material and disintegrating agent mixing by proportioning, add binding agent, well-established law is granulated, and 50 ℃-65 ℃ dry; Add lubricant, tabletting or encapsulated.
Patent CN102309464B provides a kind of YESUAN PIAN and preparation method thereof, counts ratio be prepared from by following raw materials in parts by weight: 0.4 part, folic acid, starch 28-32 part, lactose 38-42 part, sucrose 28-32 part, magnesium stearate 0.25-0.35 part.
Patent CN200910068535.1 provides stable oral formulations of a kind of l-leucovorin and preparation method thereof.Oral formulations adds appropriate pharmaceutic adjuvant by active component sodium levofolinate and makes tablet, capsule, granule, powder or oral administration solution, and wherein the single dose content of principal agent sodium levofolinate (take l-leucovorin) is 1-200mg, preferably 1-75mg; The weight proportion of principal agent and adjuvant is 1:1-1:100, preferably 1:10-1:60.
Patent CN101103985A provides a kind of folic acid dropping pill and preparation method thereof, this dropping pill formulation is comprised of medicine and adjuvant, pharmaceutical pack is containing folic acid, and adjuvant is one or more mixture in Polyethylene Glycol, magnesium stearate, stearic acid, sodium stearate, poloxamer, polyoxyethylene sorbitan fatty acid ester, polyoxyethylene (40) monostearate (S-40), sucrose fatty acid ester and glycerin gelatine.
Patent CN103070831A provides a kind of preparation method of 10-90% folic acid granule, a, prepare maltodextrin 8-40 kilogram, powdery folic acid 4-72 kilogram, b, the maltodextrin measuring is configured to solution, c, the powdery folic acid measuring is dropped into granulator, start, control inlet temperature 60-75 ℃, leaving air temp 20-30 ℃, open gun controls maltodextrin flow 0.6-0.8 kg/minute, d, after maltodextrin has sprayed, air intake valve is turned down, when leaving air temp reaches 44-50 ℃, stopping heating carrying out cooling, e, when leaving air temp is down to 20-25 ℃, sampling and measuring moisture, control moisture and between 5%-8.5%, shut down discharging, make folic acid granule.
The inorganic iron absorption of human body such as ferrous sulfate are not good, ferrous succinate is high as endogenous organic acid chalybeate bioavailability, alone ferrous succinate has certain limitation, folic acid can promote the juvenile cell in bone marrow to reach maturity and form the erythrocyte of normal morphology, thereby avoiding anemia, is to manufacture the indispensable material of erythrocyte.Iron supplement simultaneously Supplement of folic acid, except being used for the treatment of megaloblastic anemia, can also, for preventing the effects such as Fetal neurotubules malformation, have better clinical application effect.
As everyone knows, Chinese medicine and western medicine combination compound recipe is possible owing to existing in storage use procedure
Know chemical risk, therefore, chalybeate, folic acid are mixed and have unknown application risk with indefinite compositions of chemical constitution such as Chinese herbal medicine and effective sites thereof, and that two kinds of compound compound recipe ferrous succinate and folic acid compound have amount processed is controlled, in body, absorb clear and definite advantage, above-mentioned patent does not all relate to this two kinds of compound compounds.Ferrous succinate and folate composition preparation contain ferrous succinate, folic acid and pharmaceutical carrier composition, described mentioned component are further prepared into and can supply oral solid preparation, for iron supplement and folic acid deficiency.
three, summary of the invention
A kind of compound recipe ferrous succinate folate composition provided by the invention, said composition contains ferrous succinate, folic acid and pharmaceutical carrier composition, described mentioned component is further prepared into and can supplies oral solid preparation, for iron supplement and folic acid deficiency.
The compound recipe ferrous succinate folate composition of preparing for the present invention has following basic feature:
1, wherein the content of each constituent by percentage to the quality, the content of ferrous succinate is 5-50%, the content of folic acid is 0-20%, the content of pharmaceutical carrier is 50-95%.
2, the composition of pharmaceutical carrier comprises one or more of filler for oral solid formulation molding, disintegrating agent, lubricant, adhesive, substrate, suspending agent.
3, the composition of pharmaceutical carrier also can comprise for improving the additives of solid preparation stability or raising bioavailability.
4, filler is one or more in lactose, mannitol, microcrystalline Cellulose, starch, starch, dextrin.
5, disintegrating agent is: one or more in low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium.
6, lubricant is: one or more in Pulvis Talci, silicon dioxide, magnesium stearate.
7, adhesive is: one or more in polyvidone, hydroxypropyl cellulose.
8, substrate is Polyethylene Glycol, sodium stearate, glycerin gelatine, stearic acid, monostearate
One or more in glyceride, hexadecanol, octadecanol, insect wax, hydrogenated vegetable oil.
9, suspending agent is one or more in hydroxypropyl methylcellulose, sodium carboxymethyl cellulose, methylcellulose, arabic gum, xanthan gum.
10, additives are one or more in lecithin, cholesterol, poloxamer, Polyethylene Glycol, beta-schardinger dextrin-, polyvinylpyrrolidone, glyceryl monostearate, ascorbic acid.
11, additives can directly add after being prepared into solid mixture in pharmaceutical carrier or with ferrous succinate, folic acid and add in pharmaceutical carrier.
12, above-mentioned composition is further prepared into and can supplies oral solid preparation, comprise tablet, capsule, granule, powder, drop pill, dry suspension etc., preferred tablet, capsule, granule, more preferably tablet or capsule.
four, the specific embodiment
Below set forth and describe the present invention and effect thereof in detail, but do not limit institute of the present invention practical range.
embodiment 1
1, prescription forms
Make altogether 1000
2, preparation method
(1) ferrous succinate is crossed to 100 mesh sieves, folic acid is crossed 180 mesh sieves, and it is standby that lactose, carboxymethyl starch sodium, microcrystalline Cellulose are crossed 80 mesh sieves;
(2) take recipe quantity ferrous succinate, folic acid, lactose, carboxymethyl starch sodium, microcrystalline Cellulose mix homogeneously;
(3) the PVP K30 aqueous solution of preparation 5% concentration is as adhesive.
(4) in above-mentioned powder, add adhesive to prepare soft material, cross 20 mesh sieves and granulate, 20 mesh sieve granulate.
(5) to the magnesium stearate that adds recipe quantity in dried particles, mix homogeneously.
(6) above-mentioned total mixed powder suppress in flakes on tablet machine, controlled pressure is 3-5kg, puts tablet and puts blister packaging machine employing aluminum aluminum and pack and get final product.
embodiment 2
1, prescription forms
Make altogether 1000
2, preparation method
(1) ferrous succinate is crossed to 100 mesh sieves, folic acid is crossed 180 mesh sieves, and it is standby that polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, lactose are crossed 80 mesh sieves; (2) take recipe quantity ferrous succinate, folic acid, polyvinylpolypyrrolidone, low-substituted hydroxypropyl cellulose, carboxymethyl starch sodium, lactose mix homogeneously;
(3) the PVP K30 aqueous solution of preparation 5% concentration is as adhesive.
(4) in above-mentioned powder, add adhesive to prepare soft material, cross 40 mesh sieves and granulate, 40 mesh sieve granulate.
(5) to the magnesium stearate that adds recipe quantity in dried particles, mix homogeneously.
(6) by above-mentioned total mixed powder filled capsules in capsule filling machine, put blister packaging machine and adopt aluminum aluminum to pack and get final product.
embodiment 3
1, prescription forms
Make altogether 1000
2, preparation method
(1) ferrous succinate is crossed to 100 mesh sieves, folic acid is crossed 180 mesh sieves, and it is standby that cross-linking sodium carboxymethyl cellulose, lactose, starch are crossed 80 mesh sieves;
(2) take 1.2 times of recipe quantity folic acid, beta-schardinger dextrin-s and put in appropriate ethanol and grind 15 minutes, 40 ℃ of oven dry, cross 100 mesh sieves standby;
(3) hydroxypropyl cellulose aqueous solution of preparation 2% concentration is as adhesive.
(4) ferrous succinate, the folic acid-beta-schardinger dextrin-that take recipe quantity grind thing, cross-linking sodium carboxymethyl cellulose, lactose, starch mix homogeneously altogether, in above-mentioned powder, add adhesive to prepare soft material, cross 20 mesh sieves and granulate, 18 mesh sieve granulate.
(5) to the magnesium stearate that adds recipe quantity in dried particles, mix homogeneously.
(6) by above-mentioned, always mix granule packaging and get final product.
Claims (9)
1. a compound recipe ferrous succinate folate composition, said composition contains ferrous succinate, folic acid and pharmaceutical carrier composition, described mentioned component is further prepared into and can supplies oral solid preparation, for iron supplement and folic acid deficiency.
2. the compositions described in claim 1, wherein by percentage to the quality, the content of ferrous succinate is 5-50% to the content of each constituent, and the content of folic acid is 0-20%, and the content of pharmaceutical carrier is 50-95%.
3. the composition of the pharmaceutical carrier described in claim 1 comprises one or more of filler for oral solid formulation molding, disintegrating agent, lubricant, adhesive, substrate, suspending agent.
4. the composition of the pharmaceutical carrier described in claim 1 also can comprise for improving the additives of solid preparation stability or raising bioavailability.
5. the filler described in claim 3 is one or more in lactose, mannitol, microcrystalline Cellulose, starch, starch, dextrin; Described disintegrating agent is: one or more in low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium; Described lubricant is: one or more in Pulvis Talci, silicon dioxide, magnesium stearate; Described adhesive is: one or more in polyvidone, hydroxypropyl cellulose; Described substrate is one or more in Polyethylene Glycol, sodium stearate, glycerin gelatine, stearic acid, glyceryl monostearate, hexadecanol, octadecanol, insect wax, hydrogenated vegetable oil, and described suspending agent is one or more in hydroxypropyl methylcellulose, sodium carboxymethyl cellulose, methylcellulose, arabic gum, xanthan gum.
6. the additives described in claim 4 are one or more in lecithin, cholesterol, poloxamer, Polyethylene Glycol, beta-schardinger dextrin-, polyvinylpyrrolidone, glyceryl monostearate, ascorbic acid.
7. the additives described in claim 6 can directly add after being prepared into solid mixture in the pharmaceutical carrier described in claim 3 or with ferrous succinate, folic acid and add in the pharmaceutical carrier described in claim 3 again.
In claim 1-7 the compositions described in any one for the preparation of the oral solid formulation for the treatment of iron deficiency and folic acid deficiency.
9. the solid preparation that the oral solid preparation described in claim 1 comprises the Orally-administrables such as tablet, capsule, granule, powder, drop pill, dry suspension, preferred tablet, capsule, granule, more preferably tablet or capsule.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201310705972.6A CN103655574A (en) | 2013-12-20 | 2013-12-20 | Compound ferrous succinate and folic acid composition |
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| Application Number | Priority Date | Filing Date | Title |
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| CN201310705972.6A CN103655574A (en) | 2013-12-20 | 2013-12-20 | Compound ferrous succinate and folic acid composition |
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| CN103655574A true CN103655574A (en) | 2014-03-26 |
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| CN201310705972.6A Pending CN103655574A (en) | 2013-12-20 | 2013-12-20 | Compound ferrous succinate and folic acid composition |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107348514A (en) * | 2017-06-29 | 2017-11-17 | 安徽康博特保健食品有限公司 | A kind of preparation method of low-sugar type iron Couteat of Folic Acid |
| CN109701027A (en) * | 2019-01-24 | 2019-05-03 | 北京斯利安药业有限公司 | A kind of folic acid pharmaceutical composition and folic acid pharmaceutical preparation of novel enhancing folic acid antioxidant |
| CN113350375A (en) * | 2021-05-24 | 2021-09-07 | 北京斯利安药业有限公司 | Medicinal composition and application thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1190589A (en) * | 1998-02-17 | 1998-08-19 | 关天颖 | Complex ferrous sulfate tablet |
| CN102006868A (en) * | 2008-04-18 | 2011-04-06 | 博科药物化学有限公司 | Iron and zinc based pharmaceutical formulation for iron deficiency treatment |
| CN102872186A (en) * | 2012-10-31 | 2013-01-16 | 吉林省西点药业科技发展股份有限公司 | Production method of compound ferrous sulfate and folic acid tablets |
-
2013
- 2013-12-20 CN CN201310705972.6A patent/CN103655574A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1190589A (en) * | 1998-02-17 | 1998-08-19 | 关天颖 | Complex ferrous sulfate tablet |
| CN102006868A (en) * | 2008-04-18 | 2011-04-06 | 博科药物化学有限公司 | Iron and zinc based pharmaceutical formulation for iron deficiency treatment |
| CN102872186A (en) * | 2012-10-31 | 2013-01-16 | 吉林省西点药业科技发展股份有限公司 | Production method of compound ferrous sulfate and folic acid tablets |
Non-Patent Citations (1)
| Title |
|---|
| 杨六计 等: "琥珀酸亚铁叶酸片对孕晚期贫血孕妇妊娠不良结局的影响", 《河北医药》, vol. 35, no. 18, 30 September 2013 (2013-09-30), pages 2756 - 2757 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107348514A (en) * | 2017-06-29 | 2017-11-17 | 安徽康博特保健食品有限公司 | A kind of preparation method of low-sugar type iron Couteat of Folic Acid |
| CN109701027A (en) * | 2019-01-24 | 2019-05-03 | 北京斯利安药业有限公司 | A kind of folic acid pharmaceutical composition and folic acid pharmaceutical preparation of novel enhancing folic acid antioxidant |
| CN113350375A (en) * | 2021-05-24 | 2021-09-07 | 北京斯利安药业有限公司 | Medicinal composition and application thereof |
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Application publication date: 20140326 |