CN101756916A - Compound vitamin B6 sustained release tablets and preparation process thereof - Google Patents
Compound vitamin B6 sustained release tablets and preparation process thereof Download PDFInfo
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- CN101756916A CN101756916A CN200810181038A CN200810181038A CN101756916A CN 101756916 A CN101756916 A CN 101756916A CN 200810181038 A CN200810181038 A CN 200810181038A CN 200810181038 A CN200810181038 A CN 200810181038A CN 101756916 A CN101756916 A CN 101756916A
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Abstract
The invention provides a preparation method of double-layer sustained release tablets containing folic acid, calcium carbonate, vitamin B12 and vitamin B6, and the combination is a double-layered tablet, wherein, vitamin B6 is a slow release layer and the folic acid is a quick release layer. In the method, vitamin B6 is prepared into the slow release layer and the folic acid and the like are prepared into the quick release layer, and then the two layers are pressed into the double-layered tablets. The method solves the common problem of splinters owing to long-time placement of the double-layered tablets; and the prepared compound vitamin B6 sustained release tablets has good appearance, tight combination between an upper layer and a lower layer, wherein, the swelling rate and the swelling degree of the two layers are consistent under the influence of the external humiture, which can always maintain good appearance and release speed. The compound vitamin B6 sustained release tablets have simple preparation method, available raw materials, applicability to large-scale industrial production and good application prospect.
Description
Technical field
The invention provides a kind of preparation method that contains the double-layer sustained release tablets of folic acid etc. and vitamin B6, this is combined as double-layer tablet, and wherein the vitamin B6 layer is a slow release layer, and the folic acid layer is a release layer.
Background technology
The anemia of pregnant woman occurs selecting food, inappetence, mild nausea and vomiting etc. during early pregnancy, is common gestation reaction.The gestation nausea and vomiting is a kind of common phenomena, betides 70%～85% pregnant mother.Nausea and vomiting may appear in 50% anemia of pregnant woman simultaneously, and 25% anemia of pregnant woman only has nauseating symptom, and other 25% anemia of pregnant woman can be without any symptom.Yet, there is minority anemia of pregnant woman gestation reaction serious, nausea and vomiting is frequent, can not take food, and the patient often has dehydration, ketoacidosis, electrolyte and acid base imbalance etc., and it is healthy down to influencing, and life-threatening is called the hyperemesis gravidarum.Hyperemesis gravidarum's sickness rate is 0.5～2%.There are some researches show that 35% women's federation can't work because of morning sickness, the 62h that on average delays work, and 26% anemia of pregnant woman can influence housework work because of morning sickness.Therefore should actively treat.In order to avoid influence anemia of pregnant woman and baby's health.
Hyperemesis gravidarum's routine medication mainly comprises at present: vein fluid infusion, correction water, electrolyte balance disorder, vitimin supplement, emesis and hormone therapy.After above-mentioned treatment, patient's symptom does not still have and takes a turn for the better or after patient's body fluid balance disorder is repaired, be in stable phase, should in time give as early as possible and nutritional support treatment.Compound vitamin B 6 sustained release tablets is first alleviates the medicine of anemia of pregnant woman's morning vomiting symptom by vitamin/mineral being used to of forming.This medicine has several big advantages aspect curative effect and the safety:
1. can alleviate the morning vomiting symptom, thereby guarantee the absorption of nutrition.Said preparation contains vitamin B6, and clinical data shows that vitamin B6 can obviously alleviate anemia of pregnant woman's morning vomiting symptom, and safety is good, is a line medication case of recommending in the vomiting during pregnancy treatment guide, and the recommendation rank is A.Contained vitamin B6 measurer has theoretical basis.
2. contain folic acid, can reduce the danger of fetal nerve defective tube, be used to protect fetus and anemia of pregnant woman's health.
3. replenish calcium carbonate, can alleviate indigestion symptom, as the gastric acid buffer agent.Calcium can be kept the bone density of anemia of pregnant woman's phenolics, replenishes the needed calcium of infant development.
4. the synergism between folic acid and vitamin B6, the vitamin B12 can prevent neural tube defects.Take the generation that the compound vitamin supplement can significantly reduce neonate neural tube defects, heart, urinary system, extremity and gastrointestinal system congenital diseases from preparing pregnancy until the whole pregnancy period.Can also alleviate simultaneously the anemia of pregnant woman pregnancy early stage feel sick, vomiting and gestation reaction such as dizzy.
5. compare with other Western medicine of treatment hyperemesis gravidarum, safe.The patient takes more relieved.
6. when conduct alleviates the medicinal application of vomiting, can take the medicine of other additional microorganisms and mineral simultaneously.Do not influence replenishing of maternal nutritional.
7. employing slow release method was taken once and can be kept drug effect in whole day in one day, and is easy to use.
The compound vitamin B 6 sustained release tablets of our development, it is the double-layer tablet that is pressed into jointly by layers such as vitamin B 6 sustained release layer and folic acid, by prescription and technology controlling and process, the ubiquitous postpone of a specified duration of double-layer tablet that has solved different rate of releasing drug produces the problem of sliver, the compound vitamin B 6 sustained release tablets that makes not only outward appearance is good, and two-layer up and down combination is tight, under the influence of extraneous humiture, two-layer expansion rate is consistent with degrees of expansion, can remain good surface appearance and rate of releasing drug.This product preparation method is simple, and used supplementary material is easy to get, and is suitable for the big production of industry, has good application prospects.
Summary of the invention
The invention provides reliable and stable being used for of a kind of preparation technology's simple possible, curative effect and replenish pregnancy period vitamin and mineral, also can be used as the preparation method of the medicine that alleviates the pregnancy period nausea and vomiting simultaneously.Double-layer tablet of the present invention is made up of two-layer, and wherein one deck is the slow release layer that vitamin B6 is made, and one deck is the release layer that folic acid, calcium carbonate, vitamin B12 are made in addition.
In the present invention, the vitamin B6 layer is made slow release layer.Form by vitamin B6, a certain amount of sustained-release matrix material, binding agent, lubricant.Wherein, the vitamin B6 consumption is 40mg-100mg; The sustained-release matrix material is hypromellose, sodium carboxymethyl cellulose, carbomer, alginate, wherein preferred hypromellose K100M, and consumption is 10-80%, preferred 30-60%; Binding agent is polyvidone (K30) alcoholic solution, Polyethylene Glycol alcoholic solution, ethyl cellulose alcoholic solution, preferred polyvidone (K30) alcoholic solution, and binder concn is 2-20%, preferred 5-10%; Lubricant is magnesium stearate, Polyethylene Glycol, Pulvis Talci, preferred magnesium stearate, and consumption is 0.001-1%.It is theoretical nearly 50% that stearic acid dosage in the prescription reaches, and do not know it is conduct
The folic acid layer is a release layer.Form by folic acid, vitamin B12, calcium carbonate, a certain amount of diluent, disintegrating agent, binding agent, lubricant.Wherein, the folic acid consumption is 0.4mg～1mg, and the vitamin B12 consumption is 1 μ g～12 μ g, and diluent is starch, lactose, microcrystalline Cellulose, mannitol, calcium phosphate or calcium sulfate, and wherein preferred lactose is a diluent, and consumption is 5-90%; Disintegrating agent is dried starch, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, low-substituted hydroxypropyl methylcellulose, preferred cross-linking sodium carboxymethyl cellulose, and consumption is 0.2-20%, preferable amount is 1-10%; Binding agent is polyvidone (K30) alcoholic solution, Polyethylene Glycol alcoholic solution, ethyl cellulose alcoholic solution, hypromellose alcoholic solution, preferred hypromellose alcoholic solution, and binder concn is 1-20%, preferred 2-10%.
The present invention is that to have the vitamin B 6 sustained release preparation of folic acid of rapid release dosage etc. and sustained-release dosage be the slow releasing tablet of making by double-layer tablet preparation technology, two-layer up and down under the influence of extraneous humiture environment, expansion rate and degrees of expansion basically identical, its preparation method is a conventional method, can be according to conventional formulation technology preparation on the galenic pharmacy.
Concrete technical scheme is as follows:
Vitamin B6, calcium carbonate, folic acid were pulverized 100 mesh sieves, and lactose, cross-linking sodium carboxymethyl cellulose, polyvinylpyrrolidone K30, hypromellose, microcrystalline Cellulose are crossed 60 mesh sieves.Store standby after supplementary material sieves respectively.
Take by weighing lactose, the 1/2 cross-linking sodium carboxymethyl cellulose mix homogeneously of recipe quantity, with powder and the principal agent calcium carbonate that has mixed, folic acid is with the equivalent method mix homogeneously that progressively increases.Binding agent 50% hypromellose alcoholic solution and the vitamin B12 solution 10ml mix homogeneously that configures join above-mentioned mixed-powder, stir, and with binding agent mixing wet granulation, granule are 60 ℃ of dryings.The dried granule of gained is crossed 20 mesh sieve granulate.With the magnesium stearate of recipe quantity, 1/2 cross-linking sodium carboxymethyl cellulose adds in the dried granule, and mix homogeneously gets immediate-release granules.
Other gets vitamin B6, polyvinylpyrrolidone K30, hypromellose, the microcrystalline Cellulose mix homogeneously that takes by weighing recipe quantity, mixed-powder is added in the stearic acid of heating and melting mix homogeneously.To go up mixture and push 20 mesh sieves while hot, make granule, with granule 40 ℃ of dryings.The dried granule of gained is crossed 20 mesh sieve granulate.The magnesium stearate of recipe quantity is added in the dried granule, and mix homogeneously gets slow-releasing granules, and is standby.
Two-layer granule is pressed into double-layer tablet, the bag film-coat.
Preparation of the present invention has the active component good absorbing, and product is stable, free from extraneous odour, taking convenience, effect steadily, determined curative effect, quality controllable and side effect is little.
The specific embodiment
Embodiment 1:
Vitamin B 6 sustained release layer prescription
Vitamin B6 50g
Hypromellose 8g
30 POVIDONE K 30 BP/USP 30 4g
Stearic acid 200g
Magnesium stearate 2g
Microcrystalline Cellulose 111g
The folic acid release layer
Calcium carbonate 500g
Folic acid 1g
Vitamin B12 0.012g
Lactose 161g
Cross-linking sodium carboxymethyl cellulose 35g
2% hypromellose, 50% alcoholic solution is an amount of
Embodiment 2:
Vitamin B 6 sustained release layer prescription
Vitamin B6 70g
Hypromellose 8.5g
30 POVIDONE K 30 BP/USP 30 4.5g
Stearic acid 205g
Magnesium stearate 2g
Microcrystalline Cellulose 111g
The folic acid release layer
Calcium carbonate 500g
Folic acid 1g
Vitamin B12 0.012g
Lactose 161g
Cross-linking sodium carboxymethyl cellulose 35g
2% hypromellose, 50% alcoholic solution is an amount of
Embodiment 3:
Vitamin B 6 sustained release layer prescription
Vitamin B6 100g
Hypromellose 8g
30 POVIDONE K 30 BP/USP 30 5g
Stearic acid 198g
Magnesium stearate 2g
Microcrystalline Cellulose 120g
The folic acid release layer
Calcium carbonate 500g
Folic acid 1g
Vitamin B12 0.012g
Lactose 161g
Cross-linking sodium carboxymethyl cellulose 35g
2% hypromellose, 50% alcoholic solution is an amount of.
Claims (6)
- One kind have rapid release and a slow-released part be used for replenishing pregnancy period vitamin and mineral, also can be used as the pharmaceutical composition that alleviates the pregnancy period nausea and vomiting simultaneously, exist with the double-layer tablet form.
- 2. the drug regimen of claim 1, double-layer tablet wherein are by the double-layer tablet that substep is granulated, mixed pressuring plate is made, the bag film-coat.
- 3. the drug regimen of claim 1, one deck is the slow release layer of being made by vitamin B6, one deck is the release layer of being made by calcium carbonate, vitamin B12, folic acid.
- 4. the drug regimen of claim 1, the content range that it is characterized in that vitamin B6 is 40mg～100mg, and the content range of folic acid is 0.4mg～1mg, and the content range of vitamin B12 is 1 μ g～12 μ g.
- 5. the double-layer tablet in the claim 1, the vitamin B6 layer is made slow release layer; Form by vitamin B6, a certain amount of sustained-release matrix material, binding agent, lubricant; Wherein, the vitamin B6 consumption is 40mg～100mg; The sustained-release matrix material is hypromellose, sodium carboxymethyl cellulose, carbomer, alginate, wherein preferred hypromellose K100M, and consumption is 10-80%, preferred 30-60%; Binding agent is polyvidone (K30) alcoholic solution, Polyethylene Glycol alcoholic solution, ethyl cellulose alcoholic solution, preferred polyvidone (K30) alcoholic solution, and binder concn is 2-20%, preferred 5-10%; Lubricant is magnesium stearate, Polyethylene Glycol, Pulvis Talci, preferred, magnesium stearate, and consumption is 0.001-1%;The folic acid layer is a release layer; Form by folic acid, vitamin B12, calcium carbonate, a certain amount of diluent, disintegrating agent, binding agent, lubricant; Wherein, the folic acid consumption is 0.4mg～1mg, and the vitamin B12 consumption is 1 μ g～12 μ g, and diluent is starch, lactose, microcrystalline Cellulose, mannitol, calcium phosphate or calcium sulfate, and wherein preferred lactose is a diluent, and consumption is 5-90%; Disintegrating agent is dried starch, carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone, low-substituted hydroxypropyl methylcellulose, preferred cross-linking sodium carboxymethyl cellulose, and consumption is 0.2-20%, preferable amount is 1-10%; Binding agent is polyvidone (K30) alcoholic solution, Polyethylene Glycol alcoholic solution, ethyl cellulose alcoholic solution, hypromellose alcoholic solution, preferred hypromellose alcoholic solution, and binder concn is 1-20%, preferred 2-10%.
- 6. the preparation method of the slow releasing tablet of claim 1, its technology is:Vitamin B6, calcium carbonate, folic acid were pulverized 100 mesh sieves, and lactose, cross-linking sodium carboxymethyl cellulose, polyvinylpyrrolidone K30, hypromellose, microcrystalline Cellulose are crossed 60 mesh sieves.Store standby after supplementary material sieves respectively;Take by weighing lactose, the 1/2 cross-linking sodium carboxymethyl cellulose mix homogeneously of recipe quantity, with powder and the principal agent calcium carbonate that has mixed, the vitamin B12 solution 10ml mix homogeneously that folic acid progressively increases method mix homogeneously binding agent 50% hypromellose alcoholic solution and configures with equivalent, join above-mentioned mixed-powder, stir, and with binding agent mixing wet granulation, granule is 60 ℃ of dryings.The dried granule of gained is crossed 20 mesh sieve granulate; With the magnesium stearate of recipe quantity, 1/2 cross-linking sodium carboxymethyl cellulose adds in the dried granule, and mix homogeneously gets immediate-release granules;Other gets vitamin B6, polyvinylpyrrolidone K30, hypromellose, the microcrystalline Cellulose mix homogeneously that takes by weighing recipe quantity, mixed-powder is added in the stearic acid of heating and melting mix homogeneously.To go up mixture and push 20 mesh sieves while hot, make granule, with granule 40 ℃ of dryings.The dried granule of gained is crossed 20 mesh sieve granulate; The magnesium stearate of recipe quantity is added in the dried granule, and mix homogeneously gets slow-releasing granules, and is standby;Two-layer granule is pressed into double-layer tablet, the bag film-coat.
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| CN200810181038A CN101756916A (en) | 2008-11-21 | 2008-11-21 | Compound vitamin B6 sustained release tablets and preparation process thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN200810181038A CN101756916A (en) | 2008-11-21 | 2008-11-21 | Compound vitamin B6 sustained release tablets and preparation process thereof |
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| CN101756916A true CN101756916A (en) | 2010-06-30 |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103463120A (en) * | 2013-09-03 | 2013-12-25 | 福州闽海药业有限公司 | Stable-type composite vitamin B tablet and preparation method thereof |
| CN106491565A (en) * | 2016-12-16 | 2017-03-15 | 江苏艾兰得营养品有限公司 | A kind of vitamin C zincification sustained-release pellet preparation and preparation method thereof |
| CN106924203A (en) * | 2015-12-31 | 2017-07-07 | 深圳翰宇药业股份有限公司 | A kind of Eptifibatide sublingual administration composition |
| CN112006998A (en) * | 2020-09-03 | 2020-12-01 | 北京东方天合生物技术有限责任公司 | Novel rumen bypass vitamin B6Preparation method and application thereof |
| CN116509893A (en) * | 2023-06-07 | 2023-08-01 | 安徽省慧灵生物科技有限公司 | Compound mineral vitamin slow-release preparation |
-
2008
- 2008-11-21 CN CN200810181038A patent/CN101756916A/en active Pending
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103463120A (en) * | 2013-09-03 | 2013-12-25 | 福州闽海药业有限公司 | Stable-type composite vitamin B tablet and preparation method thereof |
| CN103463120B (en) * | 2013-09-03 | 2015-10-28 | 福州闽海药业有限公司 | A kind of stable type compound vitamin B tablet and preparation method thereof |
| CN106924203A (en) * | 2015-12-31 | 2017-07-07 | 深圳翰宇药业股份有限公司 | A kind of Eptifibatide sublingual administration composition |
| CN106491565A (en) * | 2016-12-16 | 2017-03-15 | 江苏艾兰得营养品有限公司 | A kind of vitamin C zincification sustained-release pellet preparation and preparation method thereof |
| CN106491565B (en) * | 2016-12-16 | 2019-01-22 | 江苏艾兰得营养品有限公司 | A kind of vitamin C zincification sustained-release pellet preparation and preparation method thereof |
| CN112006998A (en) * | 2020-09-03 | 2020-12-01 | 北京东方天合生物技术有限责任公司 | Novel rumen bypass vitamin B6Preparation method and application thereof |
| CN112006998B (en) * | 2020-09-03 | 2022-07-26 | 北京东方天合生物技术有限责任公司 | Rumen bypass vitamin B 6 Preparation method and application thereof |
| CN116509893A (en) * | 2023-06-07 | 2023-08-01 | 安徽省慧灵生物科技有限公司 | Compound mineral vitamin slow-release preparation |
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Open date: 20100630 |