CN100453083C - Dextran iron dispersing agent and its prepn. method - Google Patents
Dextran iron dispersing agent and its prepn. method Download PDFInfo
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- CN100453083C CN100453083C CNB2005100198437A CN200510019843A CN100453083C CN 100453083 C CN100453083 C CN 100453083C CN B2005100198437 A CNB2005100198437 A CN B2005100198437A CN 200510019843 A CN200510019843 A CN 200510019843A CN 100453083 C CN100453083 C CN 100453083C
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Abstract
The present invention relates to an iron dextran dispersing tablet and a preparation process thereof. The ingredients of the dispersing tablet is prepared from the following raw materials with the proportion by weight: 5 to 40 parts of iron dextran and a plurality of auxiliary materials, wherein the auxiliary materials comprise 20 to 60 parts of disintegrating agent, 100 to 300 parts of filling agent, 0 to 50 parts of adhesive, 0 to 15 parts of lubricating agent, 0 to 5 parts of corrigent and 0 to 10 parts of coating material. The iron dextran dispersing tablet provided by the present invention is convenient to take to favourably meet the requirements of medical treatment. Good coating materials and technologies are selected from the preferable scheme to obtain specious dispersing tablets which has high commercial value. The present invention preferably selects auxiliary materials with high efficiency to be combined to realize that the dispersing tablet is quickly disintegrated, and obtain high dissolution rate, so good medicine biological availability is obtained. The dispersing tablet is a good iron-supplementing preparation.
Description
Technical field
The present invention relates to the dispersible tablet technical field, relate in particular to a kind of dispersible tablet and preparation technology thereof who contains iron dextran.
Background technology
Ferrum is the maximum trace element of people's in-vivo content, and iron deficiency is common nutritional disease, can influence a lot of metabolic processes of body and cause anemia.The ferrum food deficiency disease can divide for three phases: the first phase has only storage iron to reduce; The second phase can have multinomial ferrum indexs such as serum levels of iron unusual; The third phase is iron deficiency anemia (IDA).Iron deficiency is not only one of modal child nutrition deficiency disease of developing country and China, and each developed country's sickness rate is also higher.The iron deficiency affected individual is hundreds of millions of in the whole world, and China generaI investigation hemoglobin＜110gL-1 child accounts for 37.9%, and is most relevant with iron deficiency.National Iron deficiency anemia in children sickness rate such as Chile, Indonesia, Thailand are up to 30-90%, and the ferrum negative balance takes place the people of the about 20-40% of the U.S. particularly baby and anemia of pregnant woman.Huaxi Medical Univ's department of pediatrics finds that by to researchs such as TfRs anemia of pregnant woman's moderate IDA person also influences baby's ferrum situation, gives anemia of pregnant woman's iron supplement all beneficial to the mother and baby.Menstrual phase women's iron deficiency person is estimated as 10-20%, and adult man and menopausal women are lower than 5%.In a word, iron deficiency is very common nutritional disease, and is very harmful to population health.
Treatment ferrum food deficiency disease efficient ways is exactly to replenish chalybeate, and the iron supplement approach comprises oral, intramuscular injection and intravenous injection at present.Oral chalybeate is easy to use, and cheap, but its gastrointestinal side effect is common, and patient's compliance is relatively poor.China's oral chalybeate commonly used clinically has ferrous sulfate, ferrous fumarate, Ferrous gluconate, ferrous succinate and Chinese medicine preparation etc.Previously generally believe and have only free ferrous (ferrous iron) could be by gastrointestinal absorption, therefore ferrous sulfate is widely used in treating iron deficiency anemia clinically, but because this medicine is bigger to the upper digestive tract stimulation, cause some patient can not adhere to treatment, incured loss through delay the state of an illness because of the upper digestive tract reaction.Oral in recent years iron dextran, is obtained than satisfactory effect obtaining promoting aspect the treatment iron deficiency anemia with advantages such as its good effect, rapid-action, few side effects.
Iron dextran is the complex of hydrated ferric oxide. and 5000-7000 dalton unit's dextran, makes the intramuscular dose that every ml contains 50mg ferrum by Fletchr in 1954, and is used for clinical first.At present, DexFerrum has for two kinds of intramuscular injection and intravenous injections, and it is a kind of that Chinese Pharmacopoeia only records intramuscular dose.Though the injection chalybeate can replenish intravital ferrum rapidly and store, side effect is more, has limited its clinical practice.Studies show that organic high price ferrum (ferric iron) complex equally can be by intestinal absorption, its bioavailability is not less than ferrous sulfate, and clinical treatment is the result further show: organic high price chalybeate treatment iron deficiency anemia good effect, side effect is rare.
The oral iron dextran of application such as hematopathy hospital of Chinese Academy of Medical Sciences storage Yulin are treated 169 routine IDA patients, and with the same period with 58 routine IDA patients of ferrous sulfate treatment in contrast, after treating for 2 weeks, iron dextran treatment group effective percentage reaches 39.1%, reach 89.4% during 8 weeks, all be higher than the effective percentage (19% and 87.9%) of the ferrous sulfate matched group same period.Simultaneously, ferrous sulfate matched group side effect incidence rate is significantly higher than iron dextran treatment group, illustrates that iron dextran is rapid-action, good effect, few side effects.Three kinds of new oral chalybeates have also been compared in storage Yulin etc.: the curative effect of dextran iron plate, ferrous sulfate slow releasing capsule (Feospan) and ferrous sulfate slow releasing tablet (slow-Fe) and ferrous sulfate tablet treatment IDA, cure rate and the total effective rate ferrous sulfate matched group that all be higher than the same period of each treatment group after 2,4,6,8 weeks as a result.Iron dextran and Folw-Fe side effect are slight, and 2 examples (1.2%) and 1 example (7.6%) are arranged respectively; The Feospan side effect is also slighter, the slight epigastric discomfort sense of 15 examples (13.2%) patient, feel sick, inappetence etc.; The ferrous sulfate tablet side effect is more common, and more serious, wherein 55 examples (38.7%) patient epigastric discomfort occurs, feel sick, inappetence, diarrhoea, headache etc., apparently higher than the treatment group.
Hunan, Hunan Province Tan Shi one Xiao Hong of hospital etc. organize in contrast with 36 routine IDA patients of ferrous sulfate treatment, observe the effect of dextran iron plate treatment IDA, and after the result treated for 2 weeks, treatment group effective percentage (45.2%) was significantly higher than matched group (22.2%).The time that reaches healing is respectively: treatment group (26.32 ± 6.48) d, and matched group (32.58 ± 7.21) d, two groups relatively have significant difference.Its result of study also shows, treatment back iron dextran group serum levels of iron is apparently higher than the ferrous sulfate group, bone marrow can dye ferrum and recover also significantly better than the ferrous sulfate group, and bone marrow iron stain can be used as the goldstandard of judging iron deficiency anemia, this explanation iron dextran is not only than ferrous sulfate good effect, rapid-action, and iron dextran can recover intravital ferrum storage capacity better than ferrous sulfate, the recurrence of minimizing anemia.Simultaneously, researcher is also observed the Patients with iron deficiency anemia that some gastritis, digestive tract ulcer cause, in the time of can not tolerating with ferrous sulfate, uses iron dextran instead and often can tolerate, the gastrointestinal reaction that iron dextran is described is few, is particularly useful for the iron deficiency anemia due to the digestive tract disease.
The effect of ferrous sulfate, dextran iron plate and three kinds of oral chalybeates correction Iron deficiency anemia in children of heart K blood-forming agent has been compared in the bad four seas, the People's Hospital, Baoan District, Shenzhen etc., gastrointestinal symptoms such as ferrous sulfate group period in a medicine 25 examples (41.66%) appearance is as a result felt sick in various degree, abdominal discomfort, dry stool, wherein 2 examples withdraw from observation because of reaction is heavier, and dextran iron plate group and heart K blood-forming agent group are all right.The cure rate of iron dextran is 81.67%, and total effective rate is 96.67%, apparently higher than ferrous sulfate group (61.29%, 79.03%), also is higher than heart K blood-forming agent group (79.03%, 93.55%).After each 2,4,6,8 week of group treatment, cure rate and total effective rate relatively, the ferrous sulfate group is starkly lower than dextran iron plate group and the heart K blood-forming agent group same period, shows the two groups of rapid-action characteristics in back.Simultaneously, after research found that also 3 group Iron deficiency anemia in children are corrected, its nerves reaction ability obviously improved, and latter two group is better than the ferrous sulfate group.
Soup Yongxin of Jiangsu Province Nantong City No.2 People's Hospital uses the dextran iron plate and treats 72 routine IDA patients, and compares with the 72 routine IDA patients that treat with ferrous sulfate tablet the same period, and the result is for severe and moderate IDA patient, and treatment group effective percentage is higher than matched group; For the anemia patient, two groups of curative effects are similar.The side effect of treatment group in addition, is significantly less than matched group (P＜0.01).
Attached two, the three pediatric hospital blood group clocks of China medical university are given birth precious by the dextran iron plate being treated 100 routine IDA patients' clinical observation on the therapeutic effect, the result shows, 21-25 day after administration, hemoglobin has reached the above person of 12g and has accounted for 89%, and the beginning produce effects is 4-5 days after taking medicine then.
The Pediatrics Department Dong of the People's Hospital, Juxian County keeps report such as prunus mume (sieb.) sieb.et zucc. dextran iron plate treatment IDA pediatric patient 80 examples, cure rate 85.0%, and total effective rate 97.5% is all apparently higher than the cure rate (44.0%) and the total effective rate (86.0%) of ferrous sulfate matched group.
In sum, iron dextran is a kind of comparatively ideal oral chalybeate, transforms the form that existing iron dextran kind makes it to become dispersible tablet, can improve its bioavailability on the one hand, on the other hand the patient take also more convenient, but can swallow, take after mixing it with water, also buccal.
Summary of the invention
One of purpose of the present invention provides a kind of dextran iron dispersing agent, conveniently takes to better meet needs of medical treatment.
Two of purpose of the present invention provides a kind of dextran iron dispersing agent, carries out coating, obtains specious dispersible tablet.
Because iron dextran mainly is the iron supplement that is used for the child, fine outward appearance has special significance to attracting the child.And iron dextran is sepia or brownish black crystalline powder, odorless; Molten in the hot water part omitted, insoluble in ethanol.According to the trial test result, the prepared tablet outward appearance of tabletting piebaldism phenomenon is more serious behind the employing wet granulation, though the tablet upper and lower surface outward appearance of direct powder compression is better, the periphery of tablet influences attractive in appearance because of friction produces rust staining sample vestige.
Therefore coating material that chooses in preferred version or technology obtain specious dispersible tablet commercial value preferably.
Three of purpose of the present invention provides a kind of dextran iron dispersing agent, and the adjuvant combination that efficiency of selection is higher is according to qualifications finished disintegrate faster and obtained good dissolution, so that obtain the better medicament bioavailability.
Four of purpose of the present invention provides a kind of preparation technology of dextran iron dispersing agent.
Technical scheme of the present invention has following:
Dextran iron dispersing agent, the composition of this dispersible tablet comprise that the following weight proportion raw material makes: iron dextran 5-40 part, adjuvant are some; Adjuvant comprises disintegrating agent 20-60 part, filler 100-300 part, binding agent 0-50 part, lubricant 0-15 part, correctives 0-5 part, coating material 0-10 part.This scheme can realize one of purpose of inventing.
Dextran iron dispersing agent, disintegrating agent are any one or a few in carboxymethyl starch sodium, low-substituted hydroxypropyl cellulose, crospolyvinylpyrrolidone, cross-linking sodium carboxymethyl cellulose, the sodium carboxymethyl cellulose; Filler be in microcrystalline Cellulose, the lactose any one or a few; Binding agent comprises in polyvinylpyrrolidone, polyethylene glycol 6000, the Macrogol 4000 any one or a few; Lubricant be in magnesium stearate, micropowder silica gel, calcium stearate, Pulvis Talci, Stepanol MG, the silicon dioxide any one or a few; Correctives be in aspartame, glycyrrhizin, citric acid, the vanillin any one or a few.This scheme can realize one of purpose of inventing.
Filler is in order to increase the weight and volume of dispersible tablet, to be beneficial to molding and divided dose.Lubricant is for feeding in raw material smoothly and slice, making the pharmaceutic adjuvant of tablet smooth and beautiful appearance.Binding agent is to be convenient to wet granulation and the adherent pharmaceutic adjuvant of tabletting.
Dextran iron dispersing agent also comprises coating material 1-10 part.This scheme can realize two of the purpose of inventing.
Dextran iron dispersing agent, disintegrating agent are that crospolyvinylpyrrolidone, filler are that microcrystalline Cellulose, binding agent are that polyvinylpyrrolidone, lubricant are that micropowder silica gel, correctives are that aspartame, coating material are Opadry.This scheme can realize three of the purpose of inventing.
Dextran iron dispersing agent, each constituent weight proportion is: 25 parts of iron dextran, crospolyvinylpyrrolidone 10-50 part, microcrystalline Cellulose 100-300 part, polyvinylpyrrolidone 0-50 part, micropowder silica gel 0-15 part, aspartame 0-5 part.This scheme can realize three of the purpose of inventing.
Dextran iron dispersing agent, each constituent weight proportion is: 25 parts of iron dextran, 40 parts of crospolyvinylpyrrolidone, 244 parts of microcrystalline Cellulose, 20 parts of polyvinylpyrrolidones, 8 parts of micropowder silica gels, 2 parts of aspartames, 8 parts in Opadry coating material.This scheme can realize two, three of the purpose of inventing.
The preparation technology of dextran iron dispersing agent follows these steps to preparation: batching: iron dextran 25 grams, crospolyvinylpyrrolidone 40 grams, microcrystalline Cellulose 244 grams, polyvinylpyrrolidone 20 grams, micropowder silica gel 8 grams, aspartame 2 grams, Opadry coating material 8 grams; Step: with the iron dextran raw material pulverizing, cross 120 mesh sieves, add microcrystalline Cellulose, crospolyvinylpyrrolidone, polyvinylpyrrolidone, micropowder silica gel and aspartame in the prescription ratio, mix homogeneously, cross 80 mesh sieves 3 times after, direct powder compression, check promptly gets label; Opadry coating material is dissolved in the ethanol, stirs, with common transformation sweet tablet pan coating, inlet temperature 85-88 ℃, 40-42 ℃ of sheet bed tempertaure, atomizing pressure 2bar, coating pan rotating speed 6-10rpm, spraying makes weightening finish 2% continuously, cooling, slice, check, packing, promptly.This scheme can realize two, three, four of the purpose of inventing.
The preparation technology of traditional dispersible tablet need be prepared into soft material, complex process production cost height, and technology direct compression of the present invention obtains dispersible tablet, does not need to be prepared into soft material, technology is simple.
Disintegrating agent add, add in can adopting or in add and add combination.
Instructions of taking of the present invention is: each 2-4 sheet, every day 2-3 time.
Quality standard research of the present invention:
Differentiate:
Respectively dextran and ferrum element in the dextran iron construction have been carried out discrimination test, the method that studies show that is exclusive, and the adjuvant blank is noiseless.
Dissolution:
Dissolution determination has carried out the selection, choice of Solvent, the selection of rotating speed, a series of researchs such as mensuration, stripping uniformity test and sample dissolution determination of stripping curve of algoscopy, determined that at last with slurry method (two appendix XC second methods of Chinese Pharmacopoeia version in 2000) be algoscopy, 900ml is a solvent with hydrochloric acid solution (9 → 1000), rotating speed is that per minute 75 changes, and be 30 minutes sample time.This product 3 batch samples are carried out the stripping uniformity test, and RSD is respectively 1.77%, 2.57%, 2.04% (n=6) as a result.
Preparation stability is investigated
Accelerated test
6 months accelerated tests of this product detect by projects such as the listed character of quality standard draft, dissolution, free iron, assays, and the result shows that this product is stable, and every index has no significant change.
Long term test
24 months long term tests of this product detect by projects such as the listed character of quality standard draft, dissolution, free iron, assays, and the result shows that this product is stable, and every index has no significant change.
With this dextran iron dispersing agent of developing (lot number: 020716,020717,020718) simulation listing packing, put (40 ℃ of constant temperature and humidity incubators, RH75%) in, respectively at 0,1,2,3, the sampling in June, by dextran iron dispersing agent quality standard draft Listed Items its outward appearance, dissolution, free iron, content etc. are detected, to investigate the stability of this product.The results are shown in Table 1.
Table 1 dextran iron dispersing agent accelerated stability test result
Above result shows dissolution respond well of dextran iron dispersing agent of the present invention.
The key of dispersible tablet is its disintegration rate and dissolution in water, so the selection of the disintegrate system in the tablet is extremely important, the disintegrating agent that the present invention preferentially chooses even can finish clock time left and right sides disintegrate in 1 fen, the standard that disintegrate finishes in desired 3 minutes clock times of dispersible tablet.
Fast the disintegrate dissolution of becoming reconciled is the present invention's obvious results basic guarantee of enriching blood.
The different disintegrating agent comparative test designs of table 2
The different disintegrating agent comparative test of table 3 result
By above result as seen, the fastest with crospolyvinylpyrrolidone as the disintegration of tablet that disintegrating agent makes, so disintegrating agent is selected crospolyvinylpyrrolidone (PVPP
XL).30 POVIDONE K 30 BP/USP
30Be crospolyvinylpyrrolidone (PVPP
XL) in a kind of model.
In sum: the dextran iron dispersing agent that advantage of the present invention provides, can conveniently take to better meet needs of medical treatment.Coating material that chooses in preferred version and technology obtain specious dispersible tablet, rich commercial value preferably.The present invention's higher adjuvant of efficiency of selection combination of selecting the superior is finished disintegrate faster and is obtained good dissolution, and obtains the better medicament bioavailability.It is a kind of iron-supplementing preparation preferably.
The specific embodiment:
Embodiment 1:
The preparation technology of dextran iron dispersing agent follows these steps to preparation: batching: iron dextran 25 grams, crospolyvinylpyrrolidone 40 grams, microcrystalline Cellulose 244 grams, polyvinylpyrrolidone 20 grams, micropowder silica gel 8 grams, aspartame 2 grams, Opadry coating material 8 grams; Step: with the iron dextran raw material pulverizing, cross 120 mesh sieves, add microcrystalline Cellulose, crospolyvinylpyrrolidone, polyvinylpyrrolidone, micropowder silica gel and aspartame in the prescription ratio, mix homogeneously, cross 80 mesh sieves 3 times after, direct powder compression, check promptly gets label; Opadry coating material is dissolved in the ethanol, stirs, with common transformation sweet tablet pan coating, inlet temperature 85-88 ℃, 40-42 ℃ of sheet bed tempertaure, atomizing pressure 2bar, coating pan rotating speed 6-10rpm, spraying makes weightening finish 2% continuously, cooling, slice, check, packing, promptly.
Embodiment 2:
Dextran iron dispersing agent, each constituent weight proportion is: 25 parts of iron dextran, 50 parts of crospolyvinylpyrrolidone, 300 parts of microcrystalline Cellulose, 50 parts of polyvinylpyrrolidones, 15 parts of micropowder silica gels, 5 parts of aspartames.All the other are with embodiment 1.
Embodiment 3:
Dextran iron dispersing agent, each constituent weight proportion is: 25 parts of iron dextran, 10 parts of crospolyvinylpyrrolidone, 100 parts of microcrystalline Cellulose.All the other are with embodiment 1.
Embodiment 4:
Dextran iron dispersing agent, the composition of this dispersible tablet comprise that the following weight proportion raw material makes: 5 parts of iron dextran, adjuvant are some; Adjuvant comprises 20 parts of disintegrating agents, 100 parts of filleies.All the other are with embodiment 1.
Embodiment 5:
Dextran iron dispersing agent, the composition of this dispersible tablet comprise that the following weight proportion raw material makes: 40 parts of iron dextran, adjuvant are some; Adjuvant comprises 60 parts of disintegrating agents, 300 parts of filleies, 50 parts of binding agents, 15 parts of lubricants, 5 parts of correctivess, 10 parts in coating material.All the other are with embodiment 1.
Embodiment 6:
Dextran iron dispersing agent, the composition of this dispersible tablet comprise that the following weight proportion raw material makes: 15 parts of iron dextran, adjuvant are some; Adjuvant comprises 30 parts of disintegrating agents, 150 parts of filleies, 20 parts of binding agents, 5 parts of lubricants, 3 parts of correctivess, 5 parts in coating material.All the other are with embodiment 1.
Embodiment 7:
Dextran iron dispersing agent, the composition of this dispersible tablet comprise that the following weight proportion raw material makes: iron dextran 25 grams, pregelatinized Starch 15 grams, low-substituted hydroxypropyl cellulose 5 grams, crospolyvinylpyrrolidone 12 grams, microcrystalline Cellulose 200 grams, lactose 30 grams, polyvinylpyrrolidone 20 grams, micropowder silica gel 2 grams, aspartame 2 grams, Opadry coating material 6 grams.All the other are with embodiment 1.
Embodiment 8:
Dextran iron dispersing agent, the composition of this dispersible tablet comprise that the following weight proportion raw material makes: iron dextran 15 grams, sodium carboxymethyl cellulose 21 grams, crospolyvinylpyrrolidone 20 grams, microcrystalline Cellulose 125 grams, polyvinylpyrrolidone 5 grams, lactose 15 grams, polyvinylpyrrolidone 4 grams, micropowder silica gel 2 grams, Stepanol MG 3 grams.All the other are with embodiment 1.
Embodiment 9:
Dextran iron dispersing agent, the composition of this dispersible tablet comprise that the following weight proportion raw material makes: iron dextran 15 grams, carboxymethyl starch sodium 10 grams, cross-linking sodium carboxymethyl cellulose 15 grams, low-substituted hydroxypropyl cellulose 5 grams, crospolyvinylpyrrolidone 15 grams, polyvinylpyrrolidone 7 grams, Opadry coating material 6 grams.All the other are with embodiment 1.
Embodiment 10:
Dextran iron dispersing agent, disintegrating agent are that low-substituted hydroxypropyl cellulose 15 restrains, cross-linking sodium carboxymethyl cellulose 15 restrains, filler is lactose 10 grams, binding agent is polyethylene glycol 6000 2 grams, lubricant is calcium stearate 2 grams, silicon dioxide 2 restrains, correctives is that glycyrrhizin 2 restrains.All the other are with embodiment 1.
Embodiment 11:
Dextran iron dispersing agent, disintegrating agent are that low-substituted hydroxypropyl cellulose 10 grams, cross-linking sodium carboxymethyl cellulose 5 restrain, lubricant is magnesium stearate 2 grams, Stepanol MG 1 restrains, correctives is aspartame 2 grams.All the other are with embodiment 1.
Embodiment 12:
Dextran iron dispersing agent, disintegrating agent are 7 parts of low-substituted hydroxypropyl celluloses, 102 parts of microcrystalline Cellulose, 18 parts of crospolyvinylpyrrolidone, 2 parts of acesulfame potassiums, 0.8 part of magnesium stearate.All the other are with embodiment 1.
Claims (1)
1, dextran iron dispersing agent is characterized in that its prescription is: iron dextran, and by ferrum 2.5 grams, microcrystalline Cellulose 4 grams, starch 16.4 grams, micropowder silica gel 0.4 gram, 30 POVIDONE K 30 BP/USP
304 gram and PVPP
XL8 grams.
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| DE102007025908A1 (en) * | 2007-06-01 | 2008-12-04 | Bayer Healthcare Ag | Formulations containing triazinones and iron |
| CN104095818B (en) * | 2013-04-08 | 2017-02-08 | 天津怀仁制药有限公司 | Iron-dextrin particles and preparation process thereof |
| CN108635370A (en) * | 2018-07-13 | 2018-10-12 | 山东达因海洋生物制药股份有限公司 | A kind of composite preparation and preparation method thereof containing iron-dextrin |
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| US20030190355A1 (en) * | 2002-04-05 | 2003-10-09 | Hermelin Marc S. | Modified release minerals |
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| US20030190355A1 (en) * | 2002-04-05 | 2003-10-09 | Hermelin Marc S. | Modified release minerals |
| CN1408352A (en) * | 2002-09-20 | 2003-04-09 | 单玉华 | Formula of iron-compensating agent chewing tablet |
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