CN101322778B - Double-layer sustained release tablets for compensating iron and preparation thereof - Google Patents
Double-layer sustained release tablets for compensating iron and preparation thereof Download PDFInfo
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Abstract
The invention relates to a double-layer sustained release tablet for supplementing iron, the double-layer sustained release tablet consists of a sustained release layer and a quick release layer laminated with each other by the weight ratio of 1:0.25-1:4; the sustained release layer consists of an iron-containing compound, a sustained release framework, an adhesive, a lubricant and a filler; the quick release layer consists of a traditional Chinese medicine for enriching the blood and/or invigorating vital energy, a filler, a disintegrating agent, an adhesive and a lubricant; the quick release layer can also be added with vitamins. In the double-layer sustained release tablet, the iron-containing compound is arranged in the sustained release layer and the traditional Chinese medicine is arranged in the quick release layer, thus the iron element is released slowly and uniformly, which increases the absorption rate, avoids gastrointestinal reaction caused by high-content iron; meanwhile the double-layer sustained release tablet supplements iron element and the traditional Chinese medicine which has the functions of enriching the blood and invigorating vital energy, thus fully improving the nutritional status caused by iron deficiency anemia and improving iron supplementing effect.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, particularly, relate to a kind of double-layer sustained release tablets for compensating iron and preparation method thereof.
Background technology
Iron deficiency anemia is a modal malnutrition in the world today, and is also very serious in China.National nutritional surveillance result showed in 2000, and the anemia rate of city and rural children is respectively 12.3% and 26.7%, and anemia of pregnant woman's anemia rate is then up to 35%." the Chinese residents nutrition and the Health Situation " of carrying out in 2002 investigation shows, though China resident anemia prevalence descends to some extent, but still ubiquity lacks micronutrients such as ferrum, vitamin A.China resident anemia prevalence average out to 15.2%, wherein the city male is 10.6%, the women is 17.0%; The rural area male is 12.9%, the women be 18.8%, two years old with interior infant, old man, women of child-bearing age's anemia prevalence are respectively 24.2%, 21.5% and 20.6% more than 60 years old.
Ferrum is a kind of micronutrient element of needed by human, is the essential constituent of hemoglobin and Myoglobin, and the ferrum Deficiency of Intake is the main cause that causes nutritional anemia.Iron deficiency anemia is very big to health hazard, during iron deficiency, human body can't fully arrive brain and whole body with oxygen delivery, causes memory, immunocompetence to descend, occur easily that fatigue and weak, shallow complexion, lip and nail are pale, dizzy, dim eyesight, symptom such as out of breath, also can cause various diseases to grow.
The health food that improves nutritional anemia of Yan Zhikaifaing is of a great variety in recent years, patent application discloses the agent of a kind of amino acid-ferrous compound iron supplement, its good water solubility, not stimulating gastrointestinal as CN03125317.2, can replenish ferrum and aminoacid simultaneously, but complicated process of preparation; The CN03142144.X patent application has reported with the chlorhematin to be the iron-supplementing preparation of main component, and chlorhematin is the higher a kind of biological source of iron of absorbance, no iron taste, and stimulating gastrointestinal not, but its preparation technology is required very high, and expensive.
Also having plant or its extract with medicine-food two-purpose is effective ingredient, as Radix Ginseng, Radix Notoginseng, Radix Angelicae Sinensis, the Radix Astragali, Fructus Lycii, Fructus Jujubae, Radix Codonopsis, Colla Corii Asini etc., add the iron supplement agent of iron containing compounds simultaneously, wherein iron containing compounds comprises the inorganic compound and organic compound two classes of ferrum, as the CN200510101178.6 patent disclosure a kind of be the pharmaceutical preparation that primary raw material is prepared from the Chinese herbal medicine.
But after taking existing product, on the one hand, because the ferrum of high level enters digestive tract, the intestines and stomach can only absorb limited ferrum, and unnecessary ferrum will excrete, and utilization rate is very low; On the other hand, too much to make body ferrum store system saturated for iron load in the body, can cause damage to human body, once there are some researches show, ferrum accumulate the state of an illness that can increase the weight of degenerative brain disorder.In addition, add and to enrich blood and/or the purpose of the Chinese medicine of QI invigorating is to form useful complementation with ferrum, make iron supplement and enrich blood, QI invigorating carries out simultaneously, but because there is the slow shortcoming of onset in Chinese medicine, the two is not absorbed by human body simultaneously.So, still need to research and develop fill a prescription reasonable more, the simple iron-supplementing preparation of production technology.
Summary of the invention
The object of the present invention is to provide a kind of preparation method simple, can bring into play synergistic double-layer sustained release tablets for compensating iron with contained Chinese medicine and vitamin better.
Iron supplement slow releasing tablet of the present invention is by slow release layer and release layer two-layer superimposed composition, and slow release layer is made up of iron containing compounds, sustained-release matrix, binding agent, lubricant and filler; Release layer also can be added vitamin by enriching blood and/or Chinese medicine, filler, disintegrating agent, binding agent and the lubricant of QI invigorating are formed in the release layer.Iron containing compounds is placed slow release layer, to enrich blood or the Chinese medicine of QI invigorating places release layer, ferrum element is discharged slowly, equably, improve absorbance, avoid because the gastrointestinal reaction that the ferrum of high level causes, simultaneously, with Chinese medicine (and vitamin) combined effect in the release layer, improve the iron supplement effect.
The slow release layer of iron supplement slow releasing tablet of the present invention and the weight ratio of release layer are 1: 0.25-1: 4, and the percentage ratio of each layer constituent (accounting for the percentage ratio of this layer weight) is respectively:
Slow release layer: iron containing compounds 20-70, sustained-release matrix 10-50, filler 0-50, binding agent 0-20, lubricant 0.2-2;
Release layer: Chinese medicine 15-60, vitamin 0-10, filler 0-50, disintegrating agent 5-15, binding agent 10-20, lubricant 0.2-2.
The iron compound that adds in the slow release layer can be an inorganic iron, as ferrous sulfate, iron chloride, ferrous carbonate, also can be organic ferrum, as sodium iron ethylenediaminetetraacetate, ferrous lactate, ferrous fumarate, ferrous citrate, Ferrous gluconate etc., can also be protein, iron-amino acid chelate, as methionine chelate ferrum, threonine chelated ferrum, ferrum glycinate, heme iron etc.Wherein, the iron content of inorganic iron is higher, but absorbance is relatively poor, the gastrointestinal reaction that causes is also relatively more serious, therefore, and preferred organic ferrum, especially iron-amino acid chelate, as third generation iron preparations such as methionine chelate ferrum, threonine chelated ferrum, ferrum glycinate, heme irons, it is stimulating gastrointestinal not, and absorbance is higher.
For making batch mixing even, action effect is better, and the Chinese medicine in the release layer preferably uses Powdered Chinese medicine batching.Add in the release layer enrich blood and/or the Chinese medicine of QI invigorating mainly comprises in Radix Notoginseng, Radix Ginseng, Radix Angelicae Sinensis, the Radix Astragali, Fructus Lycii, Fructus Jujubae, Radix Codonopsis, the Colla Corii Asini one or more, point out " ginseng qi-tonifying first; Radix Notoginseng enriches blood first " in supplementary Amplifications of the Compendium of Materia Medica one book, wherein Radix Ginseng has that strongly invigorating primordial QI, peaceful body Fructus Alpiniae Oxyphyllae, supplementing QI for promoting the production of body fluid, tonify deficiency are set upright, the effect of life lengthening, and Radix Notoginseng plays blood tonification effect by " promoting tissue regeneration by removing blood stasis ", can significantly promote erythrocyte, reticulocyte and hemoglobin production.Radix Angelicae Sinensis have enrich blood, invigorate blood circulation, the effect of menstruction regulating and pain relieving, the Radix Astragali has the effect of invigorating QI to consolidate the body surface resistance, tonifying Qi and lifting yang, with the Radix Angelicae Sinensis compatibility, often is used for the treatment of deficiency of qi and blood.Fructus Lycii has the effect of " gas can fill, blood can benefit, Yang Kesheng, the moon can grow, wet can going ", can be used to treat deficiency of kidney-YIN, deficiency of liver-blood.Contain rich saccharide, vitamin A, B in the Fructus Jujubae
1, B
2, C, P and alkaloid, Flavonoid substances, also contain trace element and tens seed amino acids such as calcium, ferrum, selenium, manganese, major function is invigorating the spleen and replenishing QI, nourishing blood to tranquillize the mind.Radix Codonopsis contains various saccharides and 17 seed amino acids, also contains Saponin, volatile oil and several kinds of mineral elements, with the Radix Ginseng function class seemingly, have the effect that invigorating the spleen and replenishing QI, stomach function regulating are nourished blood.The Colla Corii Asini nature and flavor are sweet, flat, nourishing YIN and supplementing blood, antiabortive effect are arranged, can improve the blood calcium balance, promote erythrocytic generation.In a word, the material of above-mentioned several integration of edible and medicinal herbs is by QI invigorating or enrich blood, and forms useful complementation with iron preparation, improves the effect of anemia with enhancing.
Can also add an amount of vitamin in the release layer,, have antioxidation as vitamin C; can play the protection erythrocyte membrane, prevent the effect of erythrocyte damage, simultaneously; ascorbic reproducibility helps ferrum element to exist with ferrous form, is more conducive to absorb.Vitamin B
6Can promote protein metabolism, it is synthetic to help hemoglobin.Vitamin B
12Participate in synthetic DNA with folic acid, have important function in the red blood cell development process, especially children the two Deficiency of Intake often occurs and cause the situation of anemia.
Sustained-release matrix in the slow release layer can be by one or more formations in hypromellose (HPMC), methylcellulose, hydroxyethyl-cellulose, hydroxy methocel, the sodium alginate etc.
Disintegrating agent in the release layer can be one or more in cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, microcrystalline Cellulose, polyvinylpolypyrrolidone, the low-substituted hydroxypropyl cellulose.
Used lubricant comprises one or more in magnesium stearate, micropowder silica gel, Pulvis Talci, the stearic acid.
Used filler can be one or more in starch, dextrin, microcrystalline Cellulose, lactose, the sucrose.
Used binding agent can be one or more in low viscosity hypromellose, polyvidone, starch, the dextrin.
Another object of the present invention provides a kind of method for preparing the iron supplement slow releasing tablet, and it comprises:
(1) required supplementary material is pulverized, crossed 80 mesh sieves, standby;
(2) mix powder:
Slow release layer batching: get iron containing compounds, sustained-release matrix, filler, mixed 60 mesh sieves, must mix powder A;
Release layer batching: get Chinese medicine, filler, disintegrating agent, vitamin (except the vitamin C, needing to add behind the granulate), mixed 60 mesh sieves, must mix powder B;
(3) preparation of soft material and wet granular: binding agent is dissolved in an amount of 20% Diluted Alcohol solution, adds respectively and mix powder A and B kneading system soft material, cross 20 mesh sieves and make slow release layer, the wet grain of release layer respectively;
(4) drying and tabletting: the grain that will wet placed 50-60 ℃ of oven drying 3-4 hour, after crossing 18 mesh sieve granulate, must do granule, after weighing respectively, add the moderate lubrication agent, mixing places the granule of slow release layer, release layer respectively two hoppers of bi-layer tablet press, compacting makes the iron supplement slow releasing tablet in flakes on bi-layer tablet press.
The preparation method of this iron supplement slow releasing tablet can also comprise:
(5) coating: adopt conventional coating material that the iron supplement slow releasing tablet is carried out coating, make coated tablet.
The preparation method of iron supplement slow releasing tablet provided by the invention is simple, and the iron supplement slow releasing tablet that obtains has the following advantages:
(1) iron containing compounds is placed slow release layer, ferrum element is discharged slowly, equably, improved absorbance, avoid causing gastrointestinal reaction;
(2) onset is slow Chinese medicine places release layer, make it with slow release layer in iron preparation bring into play synergism better;
(3) replenish ferrum element and Chinese medicine simultaneously, improve the nutriture of iron deficiency anemia, better effects if comprehensively with blood-enriching qi-invigorating function.
The specific embodiment
Following examples are used to illustrate the present invention, but are not used for limiting the scope of the invention.
Embodiment 1
Prepare the iron supplement slow releasing tablet with following step:
(1) required supplementary material is pulverized, crossed 80 mesh sieves, standby;
(2) slow release layer is got the raw materials ready: take by weighing ferrum glycinate 800g, Ferrous gluconate 320g, hypromellose (K15M) 272g, lactose 200g, mix homogeneously is crossed 60 mesh sieves, adds an amount of 20% Diluted Alcohol solution, mediate the system soft material, cross 20 mesh sieves and make wet grain, placed 50-60 ℃ of oven drying 3-4 hour, cross 18 mesh sieve granulate, weigh, get the slow release layer particulate material;
Release layer is got the raw materials ready: take by weighing Radix Angelicae Sinensis powder 300g, astragalus membranaceus powder 200g, vitamin B
61g, filler: white sand Icing Sugar 500g, disintegrating agent: carboxymethyl starch sodium 240g, with binding agent: low viscosity hypromellose 240g is dissolved in an amount of 20% Diluted Alcohol solution, adds in the powder, mediate the system soft material, cross 20 mesh sieves and make wet grain, placed 50-60 ℃ of oven drying 3-4 hour, cross 18 mesh sieve granulate, sneak into vitamin C 80g, get the release layer particulate material;
(3) tabletting: add 10g and 32g magnesium stearate in slow release layer, release layer particulate material respectively, mixing places two hoppers of bi-layer tablet press respectively, on bi-layer tablet press compacting in flakes, the heavy 400mg of slow release layer in the every slow releasing tablet, the heavy 400mg of release layer;
(4) coating makes slow release iron supplement sheet.
Every iron content 33.6mg of gained slow release iron supplement sheet (method of pressing the GB/T5009.90 regulation is measured), vitamin C 20mg (method of pressing the GB/T5009.159 regulation is measured), vitamin B
6(0.25mg the method for pressing the GB/T5009.154 regulation is measured).
Drug release determination
Assay method: drug release determination is with reference to 2000 editions second appendix X D of pharmacopeia, first method, get 6 in the tablet that embodiment 1 obtains, add 1000ml 0.1mol/L hydrochloric acid solution respectively, centrifugal, rotating speed is that per minute 100 changes, take out solution 10ml at 1 hour, 4 hours, 8 hours respectively, filter, and in time in process container, replenish 0.1mol/L hydrochloric acid solution 10ml.Get filtrate and measure iron content, calculate the percentage ratio that stripping ferrum accounts for labelled amount (33.6mg/ sheet) by the method for GB/T5009.90-2003 regulation.The results are shown in Table 1.
Table 1
Embodiment 2
Prepare the iron supplement slow releasing tablet with following step:
(1) required supplementary material is pulverized, crossed 80 mesh sieves, standby;
(2) slow release layer is got the raw materials ready: take by weighing heme iron 800g, methylcellulose (4000cPa.s) 1200g, Saccharum Sinensis Roxb. powder 160g, mix homogeneously, cross 60 mesh sieves, 200g is dissolved in an amount of 20% Diluted Alcohol solution with binding agent (low viscosity hypromellose), adds in the powder, mediate the system soft material, cross 20 mesh sieves and make wet grain, placed 50-60 ℃ of oven drying 3-4 hour, cross 18 mesh sieve granulate, weigh, get the slow release layer particulate material;
Release layer is got the raw materials ready: take by weighing Radix Notoginseng powder 200g, Radix Codonopsis powder 160g, filler (white sand Icing Sugar 132g), disintegrating agent (carboxymethyl starch sodium 30g), (low viscosity hypromellose 72g) is dissolved in an amount of 20% Diluted Alcohol solution with binding agent, add in the powder, mediate the system soft material, cross 20 mesh sieves and make wet grain, placed 50-60 ℃ of oven drying 3-4 hour, cross 18 mesh sieve granulate, get the release layer particulate material;
(3) tabletting: add 50g and 6g magnesium stearate in slow release layer, release layer particulate material respectively, mixing places two hoppers of bi-layer tablet press respectively, on bi-layer tablet press compacting in flakes, the heavy 640mg of slow release layer in the every slow releasing tablet, the heavy 160mg of release layer.
The gained iron-supplementing preparation, every iron content 25.6mg (method of pressing the GB/T5009.90 regulation is measured).
Drug release determination
Method the results are shown in Table 2 with identical described in the embodiment 1:
Table 2
Embodiment 3
Prepare the iron supplement slow releasing tablet with following step:
(1) required supplementary material is pulverized, crossed 80 mesh sieves, standby;
(2) slow release layer is got the raw materials ready: take by weighing sodium iron ethylenediaminetetraacetate 120g, methylcellulose (4000cPa.s) 60g, starch 300g, mix homogeneously, cross 60 mesh sieves, 120g is dissolved in an amount of 20% Diluted Alcohol solution with binding agent (dextrin), adds in the powder, mediate the system soft material, cross 20 mesh sieves and make wet grain, placed 50-60 ℃ of oven drying 3-4 hour, cross 18 mesh sieve granulate, weigh, get the slow release layer particulate material;
Release layer is got the raw materials ready: take by weighing red date powder 720g, Fructus Lycii powder 720g, vitamin B
610g, folic acid 2g, disintegrating agent (microcrystalline Cellulose) 360g, 480g is dissolved in an amount of 20% Diluted Alcohol solution with binding agent (starch), add in the powder, mediate the system soft material, cross 20 mesh sieves and make wet grain, placed 50-60 ℃ of oven drying 3-4 hour, cross 18 mesh sieve granulate, add vitamin C 60g, mixing gets the release layer particulate material;
(3) tabletting: add 1.2g and 48g micropowder silica gel in slow release layer, release layer particulate material respectively, mixing places two hoppers of bi-layer tablet press respectively, on bi-layer tablet press compacting in flakes, the heavy 160mg of slow release layer in the every slow releasing tablet, the heavy 640mg of release layer.
The gained iron-supplementing preparation, every iron content 4.2mg (method of pressing the GB/T5009.90 regulation is measured), vitamin C 16mg (method of pressing the GB/T5009.159 regulation is measured), vitamin B6 2.6mg (method of pressing the GB/T5009.154 regulation is measured), folic acid 0.53mg (method of pressing the GB/T5413.16 regulation is measured).
Drug release determination
Method the results are shown in Table 3 with identical described in the embodiment 1:
Table 3
Embodiment 4
Prepare the iron supplement slow releasing tablet with following step:
(1) required supplementary material is pulverized, crossed 80 mesh sieves, standby;
(2) slow release layer is got the raw materials ready: take by weighing heme iron 640g, hypromellose (K4M) 640g, mix homogeneously is crossed 60 mesh sieves, 288g is dissolved in an amount of 20% Diluted Alcohol solution with binding agent (polyvidone), add in the powder, mediate the system soft material, cross 20 mesh sieves and make wet grain, placed 50-60 ℃ of oven drying 3-4 hour, cross 18 mesh sieve granulate, weigh, get the slow release layer particulate material;
Release layer is got the raw materials ready: take by weighing Radix Ginseng powder 240g, vitamin B
610g, vitamin B
120.05g, lactose 800g, carboxymethyl starch sodium 240g, (low viscosity hypromellose 160g) is dissolved in an amount of 20% Diluted Alcohol solution with binding agent, add in the powder, mediate the system soft material, cross 20 mesh sieves and make wet grain, placed 50-60 ℃ of oven drying 3-4 hour, cross 18 mesh sieve granulate, add vitamin C 150g, mixing gets the release layer particulate material;
(3) tabletting: add 32g and 3.2g micropowder silica gel in slow release layer, release layer particulate material respectively, mixing places two hoppers of bi-layer tablet press respectively, on bi-layer tablet press compacting in flakes, the heavy 400mg of slow release layer in the every slow releasing tablet, the heavy 400mg of release layer.
The gained iron-supplementing preparation, every iron content 19.0mg (method of pressing the GB/T5009.90 regulation is measured), vitamin C 38mg (method of pressing the GB/T5009.159 regulation is measured), vitamin B6 2.4mg (method of pressing the GB/T5009.154 regulation is measured), vitamin B12 12 μ g (method of pressing the GB/T5413.14 regulation is measured).
Drug release determination
Method the results are shown in Table 4 with identical described in the embodiment 1:
Table 4
The experiment of experimental example 1 product stability
According to " health food evaluation technical regulation ", the slow release iron supplement sheet of embodiment 1-4 gained is placed 37-40 ℃, humidity is under 75% the condition, indexs such as the total plate count of selection energy representative products inherent quality, yeast, mycete, every month sampling determination once, continuous three months, it was stable to record index, is equivalent to store 2 years.
Experimental example 2 double-layer sustained release tablets for compensating iron are to anemia crowd's effect
1 experimental subject and method
1.1 laboratory sample
The iron-supplementing preparation of getting embodiment 1 gained is a test sample, reference substance is ferrous sulfate tablet (iron content is identical with test sample), be red coated tablet, both outward appearance tastes are basic identical, provided by Beijing Competitor Sports Technology Co., Ltd., compiling respectively under the condition of double blinding is I tablet and II tablet.
1.2 experimental subject
Adult's 60 examples of iron deficiency or malnutritional anemia are divided into experimental group 30 example and matched group 30 examples at random.Experimental group male 14 examples, women's 16 examples, 19～60 years old age, The median age 30 years old; Matched group male 12 examples, women's 18 examples, age 18-65 year, The median age 29 years old.
1.2.1 include experimenter's standard in:
Meet iron deficiency and malnutritional anemia diagnostic criteria, the age is more than 18 years old.The anemia diagnostic criteria: male's hemoglobin is less than 120g/L; Women's hemoglobin is less than 110g/L.
1.2.2 get rid of experimenter's standard:
(1) intentionally, important organ complication such as liver, kidney;
(2) merge other serious primary disease person;
(3) data is not accurately judged curative effect person completely without method;
(4) noncooperationist.
1.3 eating method
Experimental group and matched group are according to the principle of double blinding, and edible respectively I tablet and II tablet were taken 30 days 1 of every day, other hematinic of stopping using, but do not change original dietetic life custom.
1.4 key instrument and reagent
CELL-DYN3000 five classification blood counting instruments (U.S.), urinate ten analysers (Japan), F-4010 type spectrofluorophotometer (Japan), XH-6020 γ-calculating instrument (homemade), 721 types-spectrophotometer (homemade), agents useful for same is purchased in Huamei Bio-Engrg Co..
2 test items and index
Each surveys once every index when on-test and end.
2.1 effect observation
Blood testing index: hemoglobin; Free protoporphyrin in the erythrocyte; Packed cell volume; Red blood cell count(RBC).
2.2 safety is observed
2.2.1 toxic and side effects is observed: have or not allergy, poisoning, have or not performances such as nausea and vomiting, gastrointestinal reaction occur after eating.
2.2.2 routine urianlysis: urinalysis.
3 results
3.1 improve the anemia effect
3.1.1 the variation of hemoglobin before and after the test
The average hemoglobin rising of experimental group 12.6 ± 4.7g/L, the average hemoglobin rising of matched group 4.5 ± 3.8g/L, two group differences have utmost point significance (P＜0.01), see Table 5.
The variation of hemoglobin before and after the table 5 liang group test
△ compares for self; # compares between group
3.1.2 the variation of free protoporphyrin in the erythrocyte before and after the test:
Interior free protoporphyrin decline 0.45 ± 0.24 μ mol/L of experimental group mean corpuscular, free protoporphyrin decline 0.22 ± 0.26 μ mol/L in the matched group mean corpuscular, two group differences have utmost point significance (P＜0.01), see Table 6.
The variation of free protoporphyrin in the erythrocyte before and after the table 6 liang group test
△ compares for self; # compares between group
3.1.3 the variation of erythrocyte hematocrit before and after the test
The average erythrocyte hematocrit rising of experimental group (4.5 ± 3.1) %, matched group mean corpuscular hematocrit rising (2.8 ± 3.0) %, two group differences have utmost point significance (P＜0.01), see Table 7.
The variation of erythrocyte hematocrit before and after the table 7 liang group test
△ compares for self; # compares between group
3.1.4 the variation of red blood cell count(RBC) before and after the test
Experimental group mean corpuscular counting rising (0.7 ± 0.5) * 10
12/ L, matched group mean corpuscular counting rising (0.4 ± 0.6) * 10
12/ L, two group differences have utmost point significance (P＜0.01), see Table 8.
The variation of red blood cell count(RBC) before and after the table 8 liang group test
△ compares for self; # compares between group
3.2 untoward reaction is observed:
All find allergy for two groups in the test-meal process of the test, serious adverse reactions such as poisoning, routine urianlysis is no abnormal.After the test-meal experimental group all do not occur anyly feeling sick, vomiting and gastrointestinal reaction, 4 routine gastrointestinal upset situations appear in matched group.
4 conclusions
According to above result, illustrate that iron-supplementing preparation of the present invention has the effect of improving iron deficiency anemia, effect obviously is better than the agent of ferrous sulfate iron supplement, and the gastrointestinal reaction that causes is also less than the Feosol of not handling through slow release.
Claims (2)
1. double-layer sustained release tablets for compensating iron by slow release layer and release layer two-layer superimposed composition, is characterized in that the percentage ratio of the constituent of described slow release layer and release layer is respectively:
Slow release layer: iron containing compounds 20-70, sustained-release matrix 10-50, filler 0-50, binding agent 0-20, lubricant 0.2-2;
Release layer: Chinese medicine 15-60, vitamin 0-10, filler 0-50, disintegrating agent 5-15, binding agent 10-20, lubricant 0.2-2;
Wherein, described percentage ratio is the percentage ratio that accounts for this layer weight;
The weight ratio of described slow release layer and release layer is 1: 0.25-1: 4;
Described iron containing compounds is one or more in sodium iron ethylenediaminetetraacetate, ferrous lactate, ferrous fumarate, ferrous citrate, Ferrous gluconate, methionine chelate ferrum, threonine chelated ferrum, ferrum glycinate and the heme iron; Described Chinese medicine is one or more in Radix Ginseng, Radix Notoginseng, Radix Angelicae Sinensis, the Radix Astragali, Fructus Lycii, Fructus Jujubae, Radix Codonopsis and the Colla Corii Asini; Described vitamin is vitamin C, vitamin B
6, vitamin B
12, in the folic acid one or more; Described sustained-release matrix is made of in hypromellose, methylcellulose, hydroxyethyl-cellulose, hydroxy methocel, the sodium alginate one or more; Described lubricant is one or more in magnesium stearate, micropowder silica gel, Pulvis Talci, the stearic acid; Described filler is one or more in starch, dextrin, microcrystalline Cellulose, lactose, the sucrose; Described binding agent is one or more in low viscosity hypromellose, polyvidone, starch, the dextrin, and described disintegrating agent is one or more in cross-linking sodium carboxymethyl cellulose, carboxymethyl starch sodium, microcrystalline Cellulose, polyvinylpolypyrrolidone, the low-substituted hydroxypropyl cellulose.
2. the preparation method of the described double-layer sustained release tablets for compensating iron of claim 1 comprises step:
(1) required supplementary material is pulverized, crossed 80 mesh sieves, standby;
(2) mix powder;
Slow release layer batching: get iron containing compounds, sustained-release matrix, filler, mixed 60 mesh sieves, must mix powder A;
Release layer batching: get Chinese medicine, filler, disintegrating agent, vitamin, mixed 60 mesh sieves, must mix powder B,, then need behind described granulate of (4) step, to add if described vitamin is a vitamin C;
(3) preparation of soft material and wet granular
Binding agent is dissolved in an amount of 20% Diluted Alcohol solution, adds respectively and mix powder A and B kneading system soft material, cross 20 mesh sieves and make slow release layer, the wet grain of release layer respectively;
(4) drying and tabletting
The grain that will wet placed 50-60 ℃ of oven drying 3-4 hour, after crossing 18 mesh sieve granulate, must do granule, after weighing respectively, add the moderate lubrication agent, mixing places the granule of slow release layer, release layer respectively two hoppers of bi-layer tablet press, compacting makes the iron supplement slow releasing tablet in flakes on bi-layer tablet press.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE102011122250A1 (en) * | 2011-10-24 | 2013-04-25 | Maria Clementine Martin Klosterfrau Vertriebsgesellschaft Mbh | Multiphase system, useful e.g. to treat vitamin deficiency, comprises two different phases/layers comprising first phase/layer of active component comprising iron(II) compound, and second phase/layer of active component comprising vitamin |
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Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1209296A (en) * | 1997-08-25 | 1999-03-03 | 黄承耀 | Slice made mainly from sesame having blood-supplementing and spleen-tonifying functions |
-
2008
- 2008-07-22 CN CN2008101170216A patent/CN101322778B/en active Active
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1209296A (en) * | 1997-08-25 | 1999-03-03 | 黄承耀 | Slice made mainly from sesame having blood-supplementing and spleen-tonifying functions |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE102011122250A1 (en) * | 2011-10-24 | 2013-04-25 | Maria Clementine Martin Klosterfrau Vertriebsgesellschaft Mbh | Multiphase system, useful e.g. to treat vitamin deficiency, comprises two different phases/layers comprising first phase/layer of active component comprising iron(II) compound, and second phase/layer of active component comprising vitamin |
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| CN101322778A (en) | 2008-12-17 |
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