CN101716180B - Combined medicament for supplementing zinc and calcium and preparation method thereof - Google Patents
Combined medicament for supplementing zinc and calcium and preparation method thereof Download PDFInfo
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- CN101716180B CN101716180B CN 200910114536 CN200910114536A CN101716180B CN 101716180 B CN101716180 B CN 101716180B CN 200910114536 CN200910114536 CN 200910114536 CN 200910114536 A CN200910114536 A CN 200910114536A CN 101716180 B CN101716180 B CN 101716180B
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Abstract
The invention relates to a combined medicament for supplementing zinc and calcium and a preparation method thereof. Medicament components are released at a fixed part. The preparation method comprises the following steps of: taking zinc gluconate and vitamin D, adding medicinal starch and microcrystalline cellulose and mixing, adding crushed superfine silica gel powder and evenly mixing and sub-packaging into enteric capsules; and mixing water-soluble calcium acetate, the medicinal starch and the microcrystalline cellulose, adding the crushed superfine silica gel powder and evenly mixing and sub-packaging into Muslim capsules. The medicament and the preparation method thereof ensure that the vitamin D cannot be damaged in an acid environment, avoid the direct stimulation of the zinc gluconate to the stomach and block off the direct contact of vitamin E and oxygen. After patients take two kinds of capsules, effective components of the vitamin E and the calcium acetate are rapidly disintegrated and absorbed in the stomach; the vitamin D and the zinc gluconate are disintegrated and absorbed in the intestine; and the invention has the characteristics of taking effect of medicament, high bioavailability, small side effect and the like, and is specially suitable for children, pregnant women, adults and old people for supplement and administration for a long term.
Description
Technical field:
The present invention relates to a kind of medicine and preparation method thereof, particularly a kind of combination replenishes zinc, calcium medicine and preparation method thereof.
Background technology:
At present, the national calcium of China is taken in and is had two aspect problems.The one, over all, national calcium intake is really on the low side.It is 800 milligrams that calcium every day that Chinese Soclety of Nutrition announces is taken in recommended amounts, and it is the 1200-1500 milligram that teenager and anemia of pregnant woman's calcium are taken in recommended amounts, but its people's calcium intake every day is about 400 milligrams at present.The 2nd, national calcium intake is because of interlocal widely different, is not everybody calcium deficiency.Pastoral area crowd and the higher regional crowd's of bean product intake calcium is taken in sufficient, it is also relatively more sufficient that egg milk is taken in the more crowd's calcium intake of more city crowd and coastal edible fishes, and especially the crowd calcium intake of northern country take the rice and flour dish as staple food is on the low side some areas, interior ground.
In common people's diet, be easy to zinc deficiency, on average between the 8-12 milligram, the male is slightly higher than the women for the zinc intake of every day.The zinc intake of every day merges food and supplement, preferably can be between the 15-25 milligram.If the zinc in the worry food contains quantity not sufficient, if every day required picked-up zinc supplement have the 10-15 milligram just much of that.Zinc is present in numerous enzyme systems, such as carbonic anhydrase, and respiratory enzyme, lactic acid dehydrogenase, superoxide dismutase.Alkali phosphatase, DNA (deoxyribonucleic acid) and ribonucleic acid polymerase etc. are nucleic acid, protein, the utilization institute of the synthetic and vitamin A of carbohydrate is essential.Zinc has enhancing development, improves the effect of the sense of taste.Occur the sense of taste during zinc deficiency, olfactory sensation is poor, anorexia, and growth is lower than normally with intelligence development.
Present stage Zinc and calcium supplement medicine, various in style, effect is different, existing biologically active agents, inorganic calcium zinc salt etc. is also arranged, but the toxic and side effects that existing medicine has is large, what have can not be absorbed by health, be not suitable for life-time service, even some inorganic salts in vivo can't metabolism, is detained in the body, causes some diseases, these all do not meet the characteristics of Zinc and calcium supplement medication, fail to make drug effect to give full play of.
Summary of the invention:
The combination that the objective of the invention is to invent a kind of suitable life-time service, can be absorbed by health, can make drug effect to give full play to replenishes zinc, calcium medicine and preparation method thereof.
The present invention makes up additional zinc, calcium medicine, it is characterized in that position, ingredient bonding part discharges.
The present invention makes up the preparation method of additional zinc, calcium medicine, and its key step is:
(1) get zinc gluconate, vitamin D adds medical starch, microcrystalline Cellulose, mixes, and makes soft material, and the 16-20 mesh sieve is granulated, and dry below 50 ℃, with micropowder silica gel and above-mentioned granule mix homogeneously, is distributed into enteric coated capsule;
(2) water solublity calcium acetate micronizing is for subsequent use;
(3) with medical starch, microcrystalline Cellulose, mixing for standby use;
(4) fine powder with (2) and (3) mixes, and makes soft material, and the 16-20 mesh sieve is granulated, and is dry at low temperatures, adds the micropowder silica gel mix homogeneously, is distributed into the Islamic capsule.
Before packing Islamic capsule, can also add vitamin E.The steps include: vitamin E is joined in the beta cyclodextrin, biphase prescription mol ratio is 0.5-1.5: 0.75-1.25, the enclose time is 10-40min, and solvent is 45-75% ethanol, and fine powder is made in the clathrate cold drying, mix with the fine powder of above-mentioned (2) and (3), make soft material, the 16-20 mesh sieve is granulated, and is dry at low temperatures, add the micropowder silica gel mix homogeneously, be distributed into the Islamic capsule.
Usually make 2000 enteric coated capsulees, be by Zn
2+The 8-15g meter takes by weighing solid glucose acid zinc; take by weighing the solid vitamin D by D360000-400000IU; add medical starch, microcrystalline Cellulose, carboxymethyl starch sodium or other proper auxiliary materials; mix; make soft material; the granulation of sieving dry below 50 ℃, adds lubricant with dry good granule mix homogeneously packing.
Usually make 4000 Islamic capsules, be by Ca
2+The 150-1000g meter takes by weighing the water solublity calcium acetate, and adding medical starch, microcrystalline Cellulose, carboxymethyl starch sodium, micropowder silica gel are made.To amount to the solid vitamin E by vitamin e1 00% 75g when adding vitamin E.
According to the physicochemical property difference of each composition in the prescription and the characteristics of drug absorption, to vitamin D and zinc gluconate mixing granulation, the enteric coated capsule of packing into guarantees that vitamin D can be not destroyed under sour environment; Zinc gluconate to stomach direct stimulation also can avoid.Vitamin E and the preparation of beta cyclodextrin packing technology have been blocked vitamin E and have been contacted with the direct of oxygen, and absorbed in the gastric disintegrate, have further improved the bioavailability of this product.
Made medicine adopts different prescriptions according to different crowd, the first, the child vitaminize D that replenishes the calcium can increase the absorption of organic calcium, reduce the dose of organic calcium, it is residual to reduce calcareous non-pharmacology in vivo, increase an amount of zinc in the prescription and improve child's taste and smell, increase appetite, promote physical growth and intelligence development.The second, anemia of pregnant woman's relatively larger and auxiliary vitamin D of content of other crowd's calcium constituent of replenishing the calcium, can increase calcareous absorption, the detection of raw material heavy metal and harmful substance is used in strict control, preparation process requires zinc and vitamin D fixed position to discharge, rationally avoided the untoward reaction of medicine, be conducive to absorb in vivo, increased an amount of zinc in the prescription and improve anemia of pregnant woman's taste and smell, increase appetite, promote pregnant youngster's physical growth and intelligence development.Three, according to the characteristics of adult in period of duration and calcareous a large amount of losses after 40 years old, especially Female Sexual Hormones obvious characteristics that descend simultaneously, calcareous vitaminize D can increase the absorption of organic calcium, promote New bone formation, keep nerve conduction, muscle contraction, the normal osmotic pressure of blood capillary, keep blood acid-base balance, participate in Enzyme Production and metabolism.Replenish an amount of vitamin E and increase zinc content and can improve the crowd's of taking hormonal readiness, increase appetite, reduce or eliminate because calcium loss and hormonal readiness reduce the ill symptoms that occurs, reduce cell senescence, increase skin elasticity.Keep erythrocytic integrity, promote cell synthetic, antipollution promotes the body metabolism.
According to clinical actual demand and the support of new technique, can allocate arbitrarily kind and the consumption of adjuvant, also can inquire into the said goods is made other suitable dosage forms, such as tablet, pill, granule etc.On demand two kinds of finished capsule products are formed companion's minute packing by taking dose and namely get the listing product.
Quality investigation of the present invention
1, outward appearance: Islamic capsule and enteric coated capsule outward appearance are clean and tidy, without phenomenons such as boning, be out of shape or break, without foreign odor.The content of two kinds of capsules is dry, appropriate, the mix homogeneously of degree of tightness, and is all up to specification on inspection.
2, moisture: the moisture of two kinds of capsule contents, except as otherwise herein provided, must not surpass 9.0%, all up to specification on inspection.
3, content uniformity: get each 20 of Islamic capsule and enteric coated capsulees, the accurately weighed weight of difference, incline and content (must not lose softgel shell), the hard capsule softgel shell is wiped away only with little brush or other suitable apparatus, distinguish again accurately weighed softgel shell weight, obtain the loading amount of every capsules content and 20 average loading amount.Every loading amount is compared with average loading amount, and what exceed the content uniformity limit must not be more than 2, and one times of an overrun must not be arranged, all up to specification on inspection.
4, disintegration and dissolution: the Islamic capsule, get 6 inspections of test sample.Hard capsule should whole disintegrates the results are shown in Table 1 also by screen cloth (except the softgel shell fragment) in 30 minutes.Enteric coated capsule is got 6 inspections of test sample.Check 2 hours first in hydrochloric acid solution (9 → 1000), every softgel shell all must not have crack or disintegration phenomenon; Check in phosphate buffer (pH6.8) that the whole disintegrates of planted agent in 1 hour are also passed through screen cloth (except the softgel shell fragment), the results are shown in Table 1.
| 1 | 2 | 3 | 4 | 5 | 6 | Meansigma methods | |
| Islamic capsule (dividing) | 22 | 25 | 23 | 21 | 25 | 28 | 24 |
| Enteric coated capsule (dividing) | 45 | 48 | 46 | 44 | 48 | 51 | 47 |
5, examine stability: the technique definite according to experiment, prepare 3 batches of products (10,000 every batch), adopt aluminium-plastic bubble plate packing, place under the room temperature condition, respectively at the 0th, 1,3,6, the December detection of regularly taking a sample, through many-side examination, in probation, adopt the finished product of this explained hereafter all meet quality standard requirement, prove this practical process.
Discuss
(1) vitamin D and zinc gluconate mixing granulation are because effective ingredient is not water funk and mixed stability, so make enteric coated capsule.
(2) physicochemical property of vitamin D is neutral and alkaline, and is heat-resisting in solution, is difficult for oxidized; But under sour environment, can destroy gradually; Consider that gastric juice to its direct destruction, makes effective absorption and utilization that enteric coated capsule has solved former medicine.
(3) zinc gluconate directly stimulates stomach, produces easily the digestive tract irritations such as stomach discomfort, n or V, and physicochemical property own is more stable, so be mixed and made into enteric coated capsule with vitamin D.
(4) vitamin E is stable to heat and acid, and is unstable to alkali, very responsive to oxygen, so vitamin E prepares with the beta cyclodextrin packing technology, blocked vitamin E and contacted with the direct of oxygen, and absorbed in the gastric disintegrate, further improved the bioavailability of this product.
Advantage of the present invention is:
The present invention makes up additional zinc, calcium medicine and formulates different formula for a product according to different crowd's medication characteristics: replenish the calcium vitaminize D and zinc element of child meets physical growth and intelligence development; The anemia of pregnant woman replenishes the calcium and the zinc amount is assisted vitamin D greatly and simultaneously, and the detection of the heavy metal of keeping under strict control and harmful substance under the prerequisite that guarantees patient's drug safety, improves constantly the bioavailability of medicine, thereby reduced the consumption of raw material, has alleviated the burden of liver; Characteristics according to adult's calcareous a large amount of losses after 40 years old, especially the Female Sexual Hormones obvious phenomenon that descends simultaneously, replenish an amount of vitamin E and increase zinc content and can improve the crowd's of taking hormonal readiness, increase appetite, reduce or eliminate because calcium loss and hormonal readiness reduce the ill symptoms that occurs, reduce cell senescence, promote cell synthetic, keep erythrocytic integrity, increase skin elasticity.Medicine of the present invention is applicable to treat osteoporosis, hyperosteogeny, osteodynia, the muscle spasm that child, anemia of pregnant woman, adult or old people's calcium deficiency zinc deficiency and hormone secretion deficiency cause, climacteric syndrome, children's's rickets, growth retardation, malnutrition, apositia, recurrent oral ulceration, the diseases such as skin acne.
Method of the present invention guarantees that vitamin D is not destroyed under sour environment; Avoided the direct stimulation of zinc gluconate to stomach; Having blocked vitamin E contacts with the direct of oxygen.Rely on strong longevity Pharma Inc.'s new drug scientific research strength production equipment advanced with meeting the GMP requirement, when guaranteeing that former pharmaceutically active ingredient is constant, rationally make enteric coated capsule and Islamic capsule, after the patient took simultaneously, the effective ingredient of vitamin E and calcium acetate can be in the rapid disintegrate of gastric, absorption; Vitamin D and zinc gluconate can be in enteral disintegrate, absorptions, have the characteristics such as drug effect, bioavailability is high, side effect is little, are specially adapted to child, anemia of pregnant woman, grow up and the old people replenishes zinc for a long time, calcium is taken.
The specific embodiment:
Embodiment 1
The fill a prescription key step of preparation method of medicine child of the present invention is:
(1) presses Zn
2+Meter 10g takes by weighing solid glucose acid zinc and takes by weighing 200000IU solid vitamin D by D3, medical starch 365g, microcrystalline Cellulose 10g, micropowder silica gel 10g.First zinc gluconate and vitamin D are mixed to get mixed powder No. 1, again medical starch, microcrystalline Cellulose are mixed, get mixed powder No. 2, then No. 1 No. 2 mixed powders are mixed by the equivalent incremental method, add 10g micropowder silica gel mix homogeneously, be distributed into 2000 with enteric coated capsule;
(2) press Ca
2+It is for subsequent use that meter 200g takes by weighing the good water solublity calcium acetate of micronizing;
(3) with medical starch 50g, microcrystalline Cellulose 10g, mixing, for subsequent use;
(4) (2) and (3) are mixed, add micropowder silica gel 20g mix homogeneously, become 4000 with the Islamic capsule subpackage;
(5) with enteric coated capsule, Islamic capsule by arrange in pairs or groups packing and get final product of companion.
Embodiment 2
The fill a prescription key step of preparation method of medicine anemia of pregnant woman of the present invention is:
(1) presses Zn
2+Meter 15g takes by weighing solid glucose acid zinc and takes by weighing 400000IU solid vitamin D by D3, medical starch 330g, microcrystalline Cellulose 10g, micropowder silica gel 10g.First zinc gluconate and vitamin D mix homogeneously are got mixed powder No. 1, again medical starch and microcrystalline cellulose mix homogeneously are got powder No. 2, then No. 1 No. 2 mixed powders are mixed by the equivalent incremental method, add micropowder silica gel 10g mix homogeneously, be distributed into 2000 with enteric coated capsule;
(2) press Ca
2+It is for subsequent use that meter 300g takes by weighing the water solublity calcium acetate of micronizing;
(3) medical starch 55g, microcrystalline Cellulose 15g, co-grinding is for subsequent use;
(4) (2) and (3) are mixed, add micropowder silica gel 20g mix homogeneously, become 4000 with the Islamic capsule subpackage;
(5) with enteric coated capsule, Islamic capsule by arrange in pairs or groups packing and get final product of companion.
Embodiment 3
The key step of medicine adult prescription preparation method of the present invention is:
(1) presses Zn
2+Meter 10g takes by weighing solid glucose acid zinc and takes by weighing 200000IU solid vitamin D by D3, medical starch 365g, microcrystalline Cellulose 10g, micropowder silica gel 10g.First zinc gluconate and vitamin D are mixed to get mixed powder No. 1, again medical starch, microcrystalline cellulose are mixed up, get mixed powder No. 2, then No. 1 No. 2 mixed powders are mixed by the equivalent incremental method, add 10g micropowder silica gel mix homogeneously, be distributed into 2000 with enteric coated capsule;
(2) press Ca
2+It is for subsequent use that meter 150g takes by weighing the water solublity calcium acetate of micronizing;
(3) amount to the solid vitamin E by vitamin e1 00% 75g and join in the beta cyclodextrin, biphase prescription mol ratio is 1: 1, and the enclose time is 25min, and solvent is 60% ethanol, and the clathrate cold drying is for subsequent use;
(4) with medical starch 40g, microcrystalline Cellulose 10g, mixing for standby use;
(5) (2), (3), (4) are mixed, add micropowder silica gel 20g mix homogeneously, become 4000 with the Islamic capsule subpackage;
(6) with enteric coated capsule, Islamic capsule by arrange in pairs or groups packing and get final product of companion.
Claims (3)
1. one kind is made up the medicine that replenishes zinc, calcium, it is characterized in that position, ingredient bonding part discharges, and this medicine is obtained by following steps:
(1) presses Zn
2+Meter 10g takes by weighing solid glucose acid zinc and takes by weighing 200000IU solid vitamin D by D3, medical starch 365g, microcrystalline Cellulose 10g, micropowder silica gel 10g, first zinc gluconate and vitamin D are mixed to get mixed powder No. 1, again medical starch, microcrystalline Cellulose are mixed, get mixed powder No. 2, then No. 1 No. 2 mixed powders are mixed by the equivalent incremental method, add 10g micropowder silica gel mix homogeneously, be distributed into 2000 enteric coated capsulees;
(2) press Ca
2+It is for subsequent use that meter 200g takes by weighing the good water solublity calcium acetate of micronizing;
(3) with medical starch 50g, microcrystalline Cellulose 10g, mixing for standby use;
(4) (2) and (3) are mixed, add micropowder silica gel 20g mix homogeneously, be distributed into 4000 Islamic capsules;
(5) with enteric coated capsule, Islamic capsule by arrange in pairs or groups packing and get final product of companion.
2. one kind is made up the medicine that replenishes zinc, calcium, it is characterized in that position, ingredient bonding part discharges, and this medicine is obtained by following steps:
(1) presses Zn
2+Meter 15g takes by weighing solid glucose acid zinc and takes by weighing 400000IU solid vitamin D by D3, medical starch 330g, microcrystalline Cellulose 10g, micropowder silica gel 10g, first zinc gluconate and vitamin D are mixed to get mixed powder No. 1, again medical starch, microcrystalline Cellulose are mixed, get mixed powder No. 2, then No. 1 No. 2 mixed powders are mixed by the equivalent incremental method, add 10g micropowder silica gel mix homogeneously, be distributed into 2000 enteric coated capsulees;
(2) press Ca
2+It is for subsequent use that meter 300g takes by weighing the good water solublity calcium acetate of micronizing;
(3) medical starch 55g, microcrystalline Cellulose 15g, co-grinding is for subsequent use;
(4) (2) and (3) are mixed, add micropowder silica gel 20g mix homogeneously, be distributed into 4000 Islamic capsules;
(5) with enteric coated capsule, Islamic capsule by arrange in pairs or groups packing and get final product of companion.
3. one kind is made up the medicine that replenishes zinc, calcium, it is characterized in that position, ingredient bonding part discharges, and this medicine is obtained by following steps:
(1) presses Zn
2+Meter 10g takes by weighing solid glucose acid zinc and takes by weighing 200000IU solid vitamin D by D3, medical starch 365g, microcrystalline Cellulose 10g, micropowder silica gel 10g, first zinc gluconate and vitamin D are mixed to get mixed powder No. 1, again medical starch, microcrystalline Cellulose are mixed, get mixed powder No. 2, then No. 1 No. 2 mixed powders are mixed by the equivalent incremental method, add 10g micropowder silica gel mix homogeneously, be distributed into 2000 enteric coated capsulees;
(2) press Ca
2+It is for subsequent use that meter 150g takes by weighing the good water solublity calcium acetate of micronizing;
(3) amount to the solid vitamin E by vitamin e1 00% 75g and join in the beta cyclodextrin, biphase prescription mol ratio is 1: 1, and the enclose time is 25min, and solvent is 60% ethanol, and the clathrate cold drying is for subsequent use;
(4) with medical starch 40g, microcrystalline Cellulose 10g, mixing for standby use;
(5) (2), (3), (4) are mixed, add micropowder silica gel 20g mix homogeneously, be distributed into 4000 Islamic capsules;
(6) with enteric coated capsule, Islamic capsule by arrange in pairs or groups packing and get final product of companion.
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| CN 200910114536 CN101716180B (en) | 2009-11-06 | 2009-11-06 | Combined medicament for supplementing zinc and calcium and preparation method thereof |
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| CN 200910114536 CN101716180B (en) | 2009-11-06 | 2009-11-06 | Combined medicament for supplementing zinc and calcium and preparation method thereof |
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| CN101716180B true CN101716180B (en) | 2013-04-24 |
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Families Citing this family (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101885780B (en) * | 2010-06-21 | 2012-05-09 | 华南理工大学 | Preparation method of starch based zinc-supplementing nutrient reinforcer |
| CN102241733A (en) * | 2011-05-18 | 2011-11-16 | 吉林大学 | Deer ossein polypeptide chelated calcium and enteric capsule and preparation method of enteric capsule |
| CN103083358B (en) * | 2011-10-27 | 2014-07-16 | 上海诺成药业股份有限公司 | Vitamin D-containing calcium preparation and preparation method thereof |
| SG10201609131YA (en) | 2016-11-01 | 2018-06-28 | Xylonix Ip Holdings Pte Ltd | Zinc-pga compositions and methods for treating cancer |
| SG10201609137PA (en) * | 2016-11-01 | 2018-06-28 | Xylonix Ip Holdings Pte Ltd | Gamma-polyglutamic acid and zinc compositions |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1762236A (en) * | 2005-11-02 | 2006-04-26 | 江中药业股份有限公司 | Health-caring product capable of increasing human immunity and its preparation method |
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Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1762236A (en) * | 2005-11-02 | 2006-04-26 | 江中药业股份有限公司 | Health-caring product capable of increasing human immunity and its preparation method |
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