CN101278922A - Medicament composition capsule and method of preparing the same - Google Patents
Medicament composition capsule and method of preparing the same Download PDFInfo
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- CN101278922A CN101278922A CNA2008101145619A CN200810114561A CN101278922A CN 101278922 A CN101278922 A CN 101278922A CN A2008101145619 A CNA2008101145619 A CN A2008101145619A CN 200810114561 A CN200810114561 A CN 200810114561A CN 101278922 A CN101278922 A CN 101278922A
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- medicament composition
- composition capsule
- folic acid
- ferrous fumarate
- capsule
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Abstract
The invention relates to a medicinal composition capsule containing ferrous fumarate and folic acid and a preparation method thereof; active component is the medicinal composition capsule containing the ferrous fumarate and the folic acid, and also contains diluting agent, lubricant and binder as carrier for preparing capsule.
Description
Technical field
The present invention relates to a kind of Fu Maya of containing acid ferrum and the pharmaceutical composition of folic acid and the preparation method of preparation thereof, belong to medical technical field.
Background technology
Ferrum is the component of hemoglobin in the erythrocyte, during iron deficiency, erythrocyte synthetic hemoglobin amount reduces, cause erythrocyte volume to diminish, oxygen carrying capacity descends, and forms iron deficiency anemia, ferrous fumarate is a kind of safety, organic nutrition iron supplement agent efficiently, organic ferrous iron content height (Fe2+ 〉=30%) of ferrous fumarate, ferrous fumarate are absorbed back Fe2+ and more easily decompose, and enter erythrocyte and do not need additional energy, this product effect is identical with ferrous sulfate, characteristics are the iron-holder height, are slightly soluble in water, and are more stable, almost tasteless, zest is little, and it is very fast to prove effective, and feels sick, vomiting, side effect such as constipation are less.
Ferrous fumarate is orange red color or brown ceramic powder, is slightly soluble in water, promptly is slightly soluble in ethanol, and molecular formula is C4H2FeO4, and ferrous fumarate is to absorb at duodenum and barnyard epimere with the ferrous ion form in animal body.The ferrum that absorbs, major part participate in the synthetic of hemoglobin in bone marrow, remainder is stored in the netted chrotoplast of bone marrow, liver and spleen with ferritin and the xanchromatic form of iron content blood, and some is present in the intestinal mucosa cells in addition.The excretion pathway of ferrum mainly is intestinal and skin, in urine and the sweat gland a small amount of discharge is arranged also.It is recycling when most of ferrum discharge after haemoglobin molecule is destroyed.
Folic acid is a kind of b vitamin that extensively is present in the green vegetables, owing to it extracts from plant leaf the earliest and gets, so called after " folic acid ".The chemistry of folic acid is called " pteroylglutamic acid ", is by pteridine acid, para-amino benzoic acid and glutamic acid be combined into.Human (or other animals) are obstructed as lacking some amino acid whose change of folic acid, make the nucleic acid dyssynthesis in the erythrocyte forming process, and erythrocytic growth and anacmesis can cause megaloblastic anemia and leukopenia.Folic acid is even more important to the anemia of pregnant woman, as lacking folic acid in 3 months at conceived, can cause the fetal neural tube developmental defect, split animal brains thereby increase, the incidence rate of anencephaly, secondly, the frequent Supplement of folic acid of anemia of pregnant woman can prevent that neonatal weight from kicking the beam, premature labor and baby's cleft palate congenital malformatioies such as (cleftlips).Research is also found: 1, antitumor action, and 2, the neurocyte and the brain cell development of infant had facilitation, 3, folic acid can be used as schizophrenia patient's auxiliary therapeutical agent, it has significant mitigation to this disease.In addition, folic acid also can be used for treating chronic atrophic gastritis, suppresses the bronchus squamous transforms and control causes because of hyperhomocysteinemiainjury coronary sclerosis, myocardial damage and myocardial infarction etc.
The present invention forms compound preparation with ferrous fumarate and folic acid, is mainly used in iron supplement and folic acid, prevents anemia.
Summary of the invention
The object of the invention provides the capsule of the compound preparation that a kind of ferrous fumarate and folic acid and suitable adjuvant form, prevent and treat the human body anemia of folic acid and ferrum for want of, the present invention has guaranteed the folic acid of therapeutic dose, homogeneity and the stability of ferrous fumarate in compound preparation, make effective ingredient even, content uniformity is more easy to control, and cover the bad mouthfeel of its active ingredient ferrous fumarate, having overcome it takes to the patient and causes nauseating sensation, the more important thing is that the active ingredient stripping quantity is big, absorb in animal body steadily and to reach the peak fast, improved bioavailability, determined curative effect.
Another object of the present invention provides a kind of preparation method of capsule that active ingredient is the compound preparation of ferrous fumarate and folic acid for preparing.
A kind of medicament composition capsule of the present invention is characterized in that containing active ingredient ferrous fumarate and folic acid, also contains the capsule acceptable carrier.
Described a kind of medicament composition capsule is characterized in that active component ferrous fumarate content is 15mg-650mg.
Described a kind of medicament composition capsule is characterized in that the active component folate content is 0.1mg-30mg.
Described a kind of medicament composition capsule is characterized in that wherein said carrier comprises diluent, lubricant, binding agent.
Described a kind of medicament composition capsule is characterized in that diluent comprises starch, dextrin, microcrystalline Cellulose, sucrose, carboxymethyl starch sodium, hydroxypropyl starch.
Described a kind of medicament composition capsule is characterized in that lubricant comprises magnesium stearate, micropowder silica gel, Pulvis Talci.
Described a kind of medicament composition capsule, it is characterized in that binding agent comprises 50%--80% ethanol, 2%--5% ketopyrrolidine k30 solution, 1%--2% hydroxypropyl methylcellulose solution, 0.5%--2% carboxymethylcellulose sodium solution, 40%-70% sucrose solution.
The preparation method of described a kind of medicament composition capsule is characterized in that active component ferrous fumarate and folic acid are joined the mix homogeneously that sieves in the diluent, granulates with binding agent, and drying, granulate, the adding mix lubricant is even, encapsulated.
The obtained capsule of the inventive method has carried out the experimental study confirmation of external stripping with active ingredient folic acid as detecting index, and dissolution time is short, and stripping quantity is big, can replenish the human body folate level fully fast; Carried out the distribution research of the oral back of animal blood drug level with the active component ferrous fumarate as detecting index, test data shows that peak time is fast in the obtained capsule body of the inventive method, reach the peak concentration height, can effectively improve the iron deficiency symptom fast, play therapeutical effect.
(numbering: JN) (numbering: PJ) carry out dissolution in vitro relatively with the simulation simulated gastric fluid as dissolution medium, the stripping comparative test result sees Table 1, and curve chart is seen accompanying drawing 1 with marketed tablet to prepare capsule according to embodiment 3 preparation methoies.
Table 1:
| 0min | 5min | 15min | 30min | 45min | |
| JN(％) | 0 | 77.89 | 91.18 | 86.35 | 83.43 |
| PJ(％) | 0 | 43.70 | 74.81 | 76.72 | 79.51 |
By stripping result and curve chart as can be known, the inventive method prepares capsule and marketed tablet relatively, and dissolution time is short and stripping quantity is big.
Prepare capsule (numbering: according to embodiment 3 preparation methoies JN) with marketed tablet (numbering: PJ) carry out behind 1/time dog gastric infusion determination of plasma concentration when 0h, 0.5h, 1h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, 5h, 5.5h, 6h, 6.5h, 7h, 8h, the 10h, laboratory animal: 8 of hybrid domesticated dogs, ♀ ♂ dual-purpose, body weight 15 ± 1kg.Determination of plasma concentration the results are shown in Table 2, and blood drug level figure sees accompanying drawing 2
Table 2:
| 0h | 0.5h | 1h | 2h | 2.5h | 3h | 3.5h | 4h | 4.5h | 5h | 5.5h | 6h | 6.5h | 7h | 8h | 10h | |
| JN mg/ |
0 | 0.06 | 0.11 | 0.38 | 0.62 | 0.86 | 1.33 | 1.97 | 1.88 | 1.60 | 1.09 | 0.68 | 0.37 | 0.24 | 0.08 | 0.03 |
| PJ mg/ |
0 | 0.04 | 0.09 | 0.34 | 0.6 | 0.72 | 1.06 | 1.55 | 1.81 | 1.57 | 0.87 | 0.56 | 0.31 | 0.2 | 0.07 | 0.03 |
By determination of plasma concentration result and blood drug level figure as can be known, the inventive method prepares capsule and marketed tablet relatively, and peak time is obviously fast in the animal body, reaches the peak concentration height.
Description of drawings:
Fig. 1 is a stripping contrast test curve chart.
Fig. 2 is the blood drug level figure of Canis familiaris L..
The specific embodiment:
The embodiment that enumerates several active ingredients of the present invention and be the medicament composition capsule of Fu Maya acid ferrum and folic acid is used to further specify the present invention, but the present invention does not mean and only is confined to following examples.
Embodiment 1
Ferrous fumarate 15g
Folic acid 0.1g
Starch 200g
Magnesium stearate 2g
80% ethanol is an amount of
1000
Method for making: folic acid is joined mix homogeneously in the starch, add the mix homogeneously that sieves after ferrous fumarate mixes, add an amount of 80% ethanol and make soft material, granulate, dry below 40 ℃, granulate adds recipe quantity magnesium stearate mix homogeneously, and is encapsulated, gets final product.
Ferrous fumarate 650g
Folic acid 15g
Sucrose 200g
Pulvis Talci 2g
2% hydroxypropyl methylcellulose solution is an amount of
1000
Method for making: folic acid is joined mix homogeneously in the sucrose, add the mix homogeneously that sieves after ferrous fumarate mixes, add an amount of 2% hydroxypropyl methylcellulose solution and make soft material, granulate, dry below 40 ℃, granulate, add recipe quantity Pulvis Talci mix homogeneously, encapsulated, get final product.
Embodiment 3
Ferrous fumarate 325g
Folic acid 0.35g
Starch 100g
Magnesium stearate 4g
5% ketopyrrolidine k30 solution is an amount of
1000
Method for making: folic acid is joined mix homogeneously in the starch, add the mix homogeneously that sieves after ferrous fumarate mixes, add an amount of 5% pyrrole sieve alkane ketone k30 solution and make soft material, granulate, dry below 40 ℃, granulate, add recipe quantity magnesium stearate mix homogeneously, encapsulated, get final product.
Ferrous fumarate 350g
Folic acid 30g
Carboxymethyl starch sodium 100g
Micropowder silica gel 2g
70% ethanol is an amount of
1000
Method for making: folic acid is joined mix homogeneously in the carboxymethyl starch sodium, add the mix homogeneously that sieves after ferrous fumarate mixes, add an amount of 70% alcoholic solution and make soft material, granulate, dry below 40 ℃, granulate, add recipe quantity micropowder silica gel mix homogeneously, encapsulated, get final product.
Embodiment 5
Ferrous fumarate 180g
Folic acid 0.2g
Microcrystalline Cellulose 150g
Pulvis Talci 3g
40% sucrose solution is an amount of
1000
Method for making: folic acid is joined mix homogeneously in the microcrystalline Cellulose, add the mix homogeneously that sieves after ferrous fumarate mixes, add an amount of 40% sucrose solution and make soft material, granulate, dry below 40 ℃, granulate, add recipe quantity Pulvis Talci mix homogeneously, encapsulated, get final product.
Ferrous fumarate 450g
Folic acid 1g
Dextrin 100g
Magnesium stearate 3g
2% ketopyrrolidine k30 solution is an amount of
1000
Method for making: folic acid is joined mix homogeneously in the dextrin, add the mix homogeneously that sieves after ferrous fumarate mixes, add an amount of 2% ketopyrrolidine k30 solution and make soft material, granulate, dry below 40 ℃, granulate, add recipe quantity magnesium stearate mix homogeneously, encapsulated, get final product.
Embodiment 7
Sample according to above embodiment preparation is that index is investigated its stability through accelerated test with folic acid and ferrous fumarate, and the result shows: each sample has good stability.The accelerated tests condition: 40 ± 2 ℃, 75 ± 5%, sample number is with embodiment number ordering, and result of the test sees Table 3:
Table 3
Claims (8)
1, a kind of medicament composition capsule is characterized in that containing active component ferrous fumarate and folic acid, also contains the capsule acceptable carrier.
2, the described a kind of medicament composition capsule of claim 1 is characterized in that active ingredient ferrous fumarate content is 15mg-650mg.
3, the described a kind of medicament composition capsule of claim 1 is characterized in that the active ingredient folate content is 0.1mg-30mg.
4, the described a kind of medicament composition capsule of claim 1 is characterized in that wherein said carrier comprises diluent, lubricant, binding agent.
5, the described a kind of medicament composition capsule of claim 4 is characterized in that diluent comprises starch, dextrin, microcrystalline Cellulose, sucrose, carboxymethyl starch sodium, hydroxypropyl starch.
6, the described a kind of medicament composition capsule of claim 4 is characterized in that lubricant comprises magnesium stearate, micropowder silica gel, Pulvis Talci.
7, the described a kind of medicament composition capsule of claim 4, it is characterized in that binding agent comprises 50%--80% ethanol, 2%--5% ketopyrrolidine k30 solution, 1%--2% hydroxypropyl methylcellulose solution, 0.5%--2% carboxymethylcellulose sodium solution, 40%-70% sucrose solution.
8, the preparation method of the described a kind of medicament composition capsule of claim 1 is characterized in that active ingredient ferrous fumarate and folic acid are joined the mix homogeneously that sieves in the diluent, granulates with binding agent, and drying, granulate, the adding mix lubricant is even, encapsulated.
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| Application Number | Priority Date | Filing Date | Title |
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| CNA2008101145619A CN101278922A (en) | 2008-06-04 | 2008-06-04 | Medicament composition capsule and method of preparing the same |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNA2008101145619A CN101278922A (en) | 2008-06-04 | 2008-06-04 | Medicament composition capsule and method of preparing the same |
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| CN101278922A true CN101278922A (en) | 2008-10-08 |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8835068B2 (en) | 2009-08-07 | 2014-09-16 | Murata Manufacturing Co., Ltd. | Fuel cell |
| CN104224831A (en) * | 2014-09-18 | 2014-12-24 | 哈药集团三精制药股份有限公司 | Preparation method of folic acid class nutrient supplement |
| CN104906067A (en) * | 2014-03-10 | 2015-09-16 | 昆明制药集团股份有限公司 | Stable folic acid clathrate ferrous composition, preparation method and preparation thereof |
| CN105147658A (en) * | 2015-07-20 | 2015-12-16 | 北京邦尼康达医药科技有限公司 | Ferrous fumarate docusate sodium capsule |
| CN105796565A (en) * | 2014-12-30 | 2016-07-27 | 北京斯利安药业有限公司 | Ferrous fumarate folic acid solid preparation and preparation method thereof |
-
2008
- 2008-06-04 CN CNA2008101145619A patent/CN101278922A/en active Pending
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8835068B2 (en) | 2009-08-07 | 2014-09-16 | Murata Manufacturing Co., Ltd. | Fuel cell |
| CN104906067A (en) * | 2014-03-10 | 2015-09-16 | 昆明制药集团股份有限公司 | Stable folic acid clathrate ferrous composition, preparation method and preparation thereof |
| CN104906067B (en) * | 2014-03-10 | 2017-11-10 | 昆药集团股份有限公司 | Ferrous composition of folic acid inclusion compound of a kind of stabilization and preparation method thereof and preparation |
| CN104224831A (en) * | 2014-09-18 | 2014-12-24 | 哈药集团三精制药股份有限公司 | Preparation method of folic acid class nutrient supplement |
| CN105796565A (en) * | 2014-12-30 | 2016-07-27 | 北京斯利安药业有限公司 | Ferrous fumarate folic acid solid preparation and preparation method thereof |
| CN105796565B (en) * | 2014-12-30 | 2019-05-28 | 北京斯利安药业有限公司 | A kind of ferrous fumarate and folic acid solid pharmaceutical preparation and preparation method thereof |
| CN105147658A (en) * | 2015-07-20 | 2015-12-16 | 北京邦尼康达医药科技有限公司 | Ferrous fumarate docusate sodium capsule |
| CN105147658B (en) * | 2015-07-20 | 2018-04-10 | 哈尔滨瀚钧药业有限公司 | A kind of ferrous fumarate docusate sodium capsule |
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Open date: 20081008 |