CN104127370A - Oral folic acid instantly-dissolved membrane and preparation method thereof - Google Patents
Oral folic acid instantly-dissolved membrane and preparation method thereof Download PDFInfo
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- CN104127370A CN104127370A CN201410378739.6A CN201410378739A CN104127370A CN 104127370 A CN104127370 A CN 104127370A CN 201410378739 A CN201410378739 A CN 201410378739A CN 104127370 A CN104127370 A CN 104127370A
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- folic acid
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- oral instant
- instant membrane
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- OVBPIULPVIDEAO-LBPRGKRZSA-N folic acid Chemical compound C=1N=C2NC(N)=NC(=O)C2=NC=1CNC1=CC=C(C(=O)N[C@@H](CCC(O)=O)C(O)=O)C=C1 OVBPIULPVIDEAO-LBPRGKRZSA-N 0.000 title claims abstract description 129
- 239000011724 folic acid Substances 0.000 title claims abstract description 65
- 235000019152 folic acid Nutrition 0.000 title claims abstract description 65
- OVBPIULPVIDEAO-UHFFFAOYSA-N N-Pteroyl-L-glutaminsaeure Natural products C=1N=C2NC(N)=NC(=O)C2=NC=1CNC1=CC=C(C(=O)NC(CCC(O)=O)C(O)=O)C=C1 OVBPIULPVIDEAO-UHFFFAOYSA-N 0.000 title claims abstract description 64
- 229960000304 folic acid Drugs 0.000 title claims abstract description 64
- 239000012528 membrane Substances 0.000 title claims abstract description 39
- 238000002360 preparation method Methods 0.000 title claims abstract description 24
- 239000003795 chemical substances by application Substances 0.000 claims abstract description 19
- 230000008961 swelling Effects 0.000 claims abstract description 15
- 238000003756 stirring Methods 0.000 claims abstract description 13
- 239000000945 filler Substances 0.000 claims abstract description 10
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 9
- 238000000034 method Methods 0.000 claims abstract description 8
- 239000004014 plasticizer Substances 0.000 claims abstract description 8
- 239000008213 purified water Substances 0.000 claims abstract description 8
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 claims description 24
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 14
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 14
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 14
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims description 14
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims description 12
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 10
- 229930195725 Mannitol Natural products 0.000 claims description 10
- 239000000594 mannitol Substances 0.000 claims description 10
- 235000010355 mannitol Nutrition 0.000 claims description 10
- 239000004376 Sucralose Substances 0.000 claims description 8
- 235000011187 glycerol Nutrition 0.000 claims description 8
- 235000019408 sucralose Nutrition 0.000 claims description 8
- BAQAVOSOZGMPRM-QBMZZYIRSA-N sucralose Chemical compound O[C@@H]1[C@@H](O)[C@@H](Cl)[C@@H](CO)O[C@@H]1O[C@@]1(CCl)[C@@H](O)[C@H](O)[C@@H](CCl)O1 BAQAVOSOZGMPRM-QBMZZYIRSA-N 0.000 claims description 8
- IFNWPVOGRPXDCH-UHFFFAOYSA-N (3,5-dichloro-2,4-difluorophenyl)urea Chemical compound NC(=O)NC1=CC(Cl)=C(F)C(Cl)=C1F IFNWPVOGRPXDCH-UHFFFAOYSA-N 0.000 claims description 6
- 239000004375 Dextrin Substances 0.000 claims description 6
- 229920001353 Dextrin Polymers 0.000 claims description 6
- 229920000881 Modified starch Polymers 0.000 claims description 6
- 235000019425 dextrin Nutrition 0.000 claims description 6
- 108010011485 Aspartame Proteins 0.000 claims description 4
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 4
- 229920002565 Polyethylene Glycol 400 Polymers 0.000 claims description 4
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 4
- 229930006000 Sucrose Natural products 0.000 claims description 4
- DPXJVFZANSGRMM-UHFFFAOYSA-N acetic acid;2,3,4,5,6-pentahydroxyhexanal;sodium Chemical compound [Na].CC(O)=O.OCC(O)C(O)C(O)C(O)C=O DPXJVFZANSGRMM-UHFFFAOYSA-N 0.000 claims description 4
- IAOZJIPTCAWIRG-QWRGUYRKSA-N aspartame Chemical compound OC(=O)C[C@H](N)C(=O)N[C@H](C(=O)OC)CC1=CC=CC=C1 IAOZJIPTCAWIRG-QWRGUYRKSA-N 0.000 claims description 4
- 239000000605 aspartame Substances 0.000 claims description 4
- 235000010357 aspartame Nutrition 0.000 claims description 4
- 229960003438 aspartame Drugs 0.000 claims description 4
- 239000001768 carboxy methyl cellulose Substances 0.000 claims description 4
- 229940031703 low substituted hydroxypropyl cellulose Drugs 0.000 claims description 4
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 4
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 4
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 4
- JLFNLZLINWHATN-UHFFFAOYSA-N pentaethylene glycol Chemical compound OCCOCCOCCOCCOCCO JLFNLZLINWHATN-UHFFFAOYSA-N 0.000 claims description 4
- 239000001253 polyvinylpolypyrrolidone Substances 0.000 claims description 4
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims description 4
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims description 4
- 235000019812 sodium carboxymethyl cellulose Nutrition 0.000 claims description 4
- 229920001027 sodium carboxymethylcellulose Polymers 0.000 claims description 4
- 239000005720 sucrose Substances 0.000 claims description 4
- 210000000214 mouth Anatomy 0.000 abstract description 7
- 239000003814 drug Substances 0.000 abstract description 4
- 235000019640 taste Nutrition 0.000 abstract description 4
- 239000003651 drinking water Substances 0.000 abstract description 3
- 235000020188 drinking water Nutrition 0.000 abstract description 3
- 238000010579 first pass effect Methods 0.000 abstract description 2
- 239000002994 raw material Substances 0.000 abstract description 2
- 239000000463 material Substances 0.000 abstract 3
- 235000003599 food sweetener Nutrition 0.000 abstract 2
- 239000003765 sweetening agent Substances 0.000 abstract 2
- 239000011248 coating agent Substances 0.000 abstract 1
- 238000000576 coating method Methods 0.000 abstract 1
- 238000007872 degassing Methods 0.000 abstract 1
- 229940079593 drug Drugs 0.000 abstract 1
- 238000001035 drying Methods 0.000 abstract 1
- 239000000796 flavoring agent Substances 0.000 abstract 1
- 235000013355 food flavoring agent Nutrition 0.000 abstract 1
- 238000002156 mixing Methods 0.000 abstract 1
- 238000005303 weighing Methods 0.000 abstract 1
- 239000000203 mixture Substances 0.000 description 7
- 206010016880 Folate deficiency Diseases 0.000 description 5
- 208000010188 Folic Acid Deficiency Diseases 0.000 description 5
- 208000007502 anemia Diseases 0.000 description 4
- 210000003754 fetus Anatomy 0.000 description 4
- 229940083626 folic acid 0.4 mg Drugs 0.000 description 4
- 238000003556 assay Methods 0.000 description 3
- 235000019658 bitter taste Nutrition 0.000 description 3
- 229940019142 folic acid 5 mg Drugs 0.000 description 3
- 206010002065 Anaemia megaloblastic Diseases 0.000 description 2
- 208000000682 Megaloblastic Anemia Diseases 0.000 description 2
- 238000002347 injection Methods 0.000 description 2
- 239000007924 injection Substances 0.000 description 2
- 231100001016 megaloblastic anemia Toxicity 0.000 description 2
- 239000013589 supplement Substances 0.000 description 2
- 239000003826 tablet Substances 0.000 description 2
- 208000009206 Abruptio Placentae Diseases 0.000 description 1
- 241000459479 Capsula Species 0.000 description 1
- 208000032170 Congenital Abnormalities Diseases 0.000 description 1
- 206010010356 Congenital anomaly Diseases 0.000 description 1
- 208000019505 Deglutition disease Diseases 0.000 description 1
- 208000001362 Fetal Growth Retardation Diseases 0.000 description 1
- 206010070531 Foetal growth restriction Diseases 0.000 description 1
- 206010070538 Gestational hypertension Diseases 0.000 description 1
- 201000005624 HELLP Syndrome Diseases 0.000 description 1
- 241000282414 Homo sapiens Species 0.000 description 1
- 208000005347 Pregnancy-Induced Hypertension Diseases 0.000 description 1
- 208000006399 Premature Obstetric Labor Diseases 0.000 description 1
- 206010036600 Premature labour Diseases 0.000 description 1
- 201000010829 Spina bifida Diseases 0.000 description 1
- 208000006097 Spinal Dysraphism Diseases 0.000 description 1
- 229930003270 Vitamin B Natural products 0.000 description 1
- 238000002835 absorbance Methods 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 235000001014 amino acid Nutrition 0.000 description 1
- 150000001413 amino acids Chemical class 0.000 description 1
- 206010002320 anencephaly Diseases 0.000 description 1
- 230000007698 birth defect Effects 0.000 description 1
- 239000002775 capsule Substances 0.000 description 1
- 230000001684 chronic effect Effects 0.000 description 1
- 206010009259 cleft lip Diseases 0.000 description 1
- 208000028831 congenital heart disease Diseases 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 230000018109 developmental process Effects 0.000 description 1
- 230000004069 differentiation Effects 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 239000002552 dosage form Substances 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 230000003203 everyday effect Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000004744 fabric Substances 0.000 description 1
- 230000001605 fetal effect Effects 0.000 description 1
- 208000030941 fetal growth restriction Diseases 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 229960005150 glycerol Drugs 0.000 description 1
- 208000007475 hemolytic anemia Diseases 0.000 description 1
- 230000036244 malformation Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 201000010193 neural tube defect Diseases 0.000 description 1
- 150000007523 nucleic acids Chemical class 0.000 description 1
- 102000039446 nucleic acids Human genes 0.000 description 1
- 108020004707 nucleic acids Proteins 0.000 description 1
- 235000015097 nutrients Nutrition 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 230000028742 placenta development Effects 0.000 description 1
- 201000008532 placental abruption Diseases 0.000 description 1
- 208000036335 preeclampsia/eclampsia 1 Diseases 0.000 description 1
- 208000026440 premature labor Diseases 0.000 description 1
- 239000000047 product Substances 0.000 description 1
- 235000013772 propylene glycol Nutrition 0.000 description 1
- 230000003161 proteinsynthetic effect Effects 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 208000035581 susceptibility to neural tube defects Diseases 0.000 description 1
- 208000011580 syndromic disease Diseases 0.000 description 1
- 238000012360 testing method Methods 0.000 description 1
- 235000019156 vitamin B Nutrition 0.000 description 1
- 239000011720 vitamin B Substances 0.000 description 1
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- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention discloses a preparation method of an oral folic acid instantly-dissolved membrane, and the method comprises the following steps: (1) weighing raw materials and auxiliary materials comprising a film-forming material, a filler, a sweetening agent, a plasticizer, a disintegrating agent and folic acid; (2) evenly mixing the folic acid, the sweetening agent, the disintegrating agent, the filler and the film-forming material, adding purified water, stirring evenly; after full swelling, adding the plasticizer, placing for completely swelling, degassing, and coating; and (3) drying, demoulding, cutting to obtain the oral folic acid instantly-dissolved membrane. The oral folic acid instantly-dissolved membrane tastes good, the oral folic acid instantly-dissolved membrane can be taken without drinking water, and can be instantly dissolved in the oral cavity without first pass effect, medication compliance of patients is high, and the need of the use of special flavoring agent is eliminated. The preparation method is simple, short in time and low in cost.
Description
Technical field
The invention belongs to field of pharmaceutical preparations, relate to a kind of folic acid oral instant membrane and preparation method thereof.
Background technology
China is one of baby due defect country occurred frequently in the world, and expert points out that such birth defect is avoidable both at home and abroad, as long as the women of child-bearing age supplement appropriate folic acid every day, just can prevent the generation of most baby's neural tube defects.
Folic acid is a kind of water solublity vitamin B group, and the merisis of cell, nucleic acid, aminoacid, protein synthetic had to extremely important effect, is the indispensable nutrient of fetus, anemia of pregnant woman.Pregnant is the critical period of the differentiation of fetus tract, placentation in early days, and now folic acid deficiency can cause Fetal neurotubules malformation, and very person can cause spina bifida or congenital anencephaly.Pregnant middle and advanced stage folic acid deficiency, anemia of pregnant woman Yi Fasheng placental abruption, pregnancy induced hypertension syndrome, megaloblastic anemia etc.; And intrauterine growth retardation, premature labor and LBW, harelip, heart defect easily occur fetus, affect the intelligent development of fetus.Yet the natural folic acid absorbance in food is lower, anemia of pregnant woman is higher 4 times than normal person to the demand of folic acid simultaneously, therefore needs timely Supplement of folic acid.Except anemia of pregnant woman needs, the folic acid deficiency causing due to a variety of causes and the megaloblastic anemia due to folic acid deficiency, the folic acid deficiency due to chronic hemolytic anemia also should be taken in time folic acid and treat.
The foliamin that China has developed at present comprises following dosage form: tablet, capsule and injection etc.Tablet and Capsula agent absorption difference, bioavailability is low.Child, old people, bed patient and dysphagia patients are taken inconvenience.And injection cost is high, use inconvenience, to patient, bring misery.
Chinese patent CN 102309464 A disclose a kind of YESUAN PIAN and preparation method thereof, and this complicated process of preparation is sieved and increased the possibility of pollution of preparation process through twice, and whole preparation technology length consuming time, has reduced efficiency.
Summary of the invention
The object of the invention is to overcome the deficiencies in the prior art, provide a kind of preparation technology simple, consuming time short, the preparation method of a kind of folic acid oral instant membrane of lower cost.
Second object of the present invention is to provide a kind of folic acid oral instant membrane.
Technical scheme of the present invention is summarized as follows:
A preparation method for folic acid oral instant membrane, comprises the steps:
(1) by mass fraction, take raw material: filmogen 6-15 part; Filler 2-7 part; Sweeting agent 1-3 part; Plasticizer 2-3 part; Disintegrating agent 2-6 part; Folic acid 0.4-5 part;
(2) by after folic acid, sweeting agent, disintegrating agent, filler, filmogen mix homogeneously, add and be equivalent to folic acid, sweeting agent, disintegrating agent, filler and filmogen gross mass 1.2-1.7 purified water doubly, stir evenly evenly; Fully swelling completely after, add plasticizer, place 10～50min, make its complete swelling, degassed, film;
(3) at 50～70 ℃, dry 10～50min, demoulding, cuts, and obtains folic acid oral instant membrane.
Filmogen is selected from least one in hydroxypropyl methylcellulose E-5, hydroxypropyl methylcellulose E-15 and sodium carboxymethyl cellulose.
Filler is selected from least one in dextrin, mannitol.
Sweeting agent is selected from least one in sucralose, aspartame, sucrose.
Plasticizer is selected from least one in glycerol, propylene glycol, PEG400.
Disintegrating agent is selected from least one in low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, microcrystalline Cellulose and pregelatinized Starch.
Folic acid oral instant membrane prepared by said method.
Advantage of the present invention:
A kind of folic acid oral instant membrane taste of the present invention is good, and while taking medicine, without drinking-water, patient's compliance is high, dissolves fast, without first pass effect in oral cavity; Without using special correctives.Preparation method of the present invention is simple, consuming time short, lower cost.
The specific embodiment
The present invention is further elaborated by following examples, but scope of the present invention is not limited to these embodiment.So, under method prerequisite of the present invention, simple modifications of the present invention is all belonged to the scope of protection of present invention.
Embodiment in table 1 is composition and the quality of 1000 folic acid oral instant membranes
Make every and contain folic acid 0.4mg or 5mg.
Embodiment 6
Every contains folic acid 0.4mg, and the preparation method of every 1000 folic acid oral instant membranes, comprises the steps:
(1) by the embodiment of table 11, take hydroxypropyl methylcellulose E-5, dextrin, sucralose, glycerol, low-substituted hydroxypropyl cellulose, folic acid;
(2) by folic acid, sucralose, dextrin, hydroxypropyl methylcellulose E-5, low-substituted hydroxypropyl cellulose, after mix homogeneously, add 28.08g purified water, stir, swelling approximately 30 minutes, adds glycerol to stir, and places 30min, make its complete swelling, degassed, film;
(3) at 60 ℃, dry 30min, demoulding, by specification cutting, obtaining specification is the folic acid oral instant membrane of 0.4mg.
Evaluate: the light yellow even diaphragm of outward appearance; Good film-forming property, toughness is general; Dissolve soon mouthfeel free from extraneous odour.
Embodiment 7
Every contains folic acid 0.4mg, and the preparation method of every 1000 folic acid oral instant membranes, comprises the steps:
(1) by the embodiment of table 12, take hydroxypropyl methylcellulose E-15, mannitol, sucralose, PEG400, pregelatinized Starch, folic acid;
(2) by folic acid, sucralose, mannitol, hydroxypropyl methylcellulose E-15, pregelatinized Starch, after mix homogeneously, add 27.82g purified water, stir, swelling 30 minutes, adds PEG400 to stir, and places 10min, make its complete swelling, degassed, film;
(3) at 50 ℃, dry 50min, demoulding, by specification cutting, obtaining specification is the folic acid oral instant membrane folic acid oral instant membrane of 0.4mg.
Evaluate: outward appearance is compared with the yellow diaphragm of uniform shallow; Good demoulding, good toughness; Dissolve soon free from extraneous odour.
Embodiment 8
Every contains folic acid 0.4mg, and the preparation method of every 1000 folic acid oral instant membranes, comprises the steps:
(1) by the embodiment of table 13, take hydroxypropyl methylcellulose E-5, sodium carboxymethyl cellulose, mannitol, sucrose, microcrystalline Cellulose, glycerol, folic acid;
(2) by after folic acid, sucrose, mannitol, hydroxypropyl methylcellulose E-5, sodium carboxymethyl cellulose, microcrystalline Cellulose mix homogeneously, add 31.04g purified water, stir, swelling 60 minutes, adds glycerol to stir, and places 50min, make its complete swelling, degassed, film;
(3) at 70 ℃, dry 10min, demoulding, by specification cutting, obtaining specification is the folic acid oral instant membrane folic acid oral instant membrane of 0.4mg.
Evaluate: outward appearance is even; The good demoulding, good toughness; Dissolve slowly, almost free from extraneous odour.
Embodiment 9
Every contains folic acid 5mg, and the preparation method of every 1000 folic acid oral instant membranes, comprises the steps:
(1) by the embodiment of table 14, take hydroxypropyl methylcellulose E-15, dextrin, mannitol, sucralose, propylene glycol, polyvinylpolypyrrolidone, folic acid;
(2) by after hydroxypropyl methylcellulose E-15, dextrin, mannitol, sucralose, polyvinylpolypyrrolidone, folic acid mix homogeneously, add 49.3g purified water, stir, swelling 60 minutes, adds propylene glycol to stir, and places 30min, make its complete swelling, degassed, film;
(3) at 50 ℃, dry 50min, demoulding, by specification cutting, obtaining specification is the folic acid oral instant membrane folic acid oral instant membrane of 5mg.
Evaluate: outward appearance is even; The good demoulding, good toughness; Dissolve soon free from extraneous odour.
Embodiment 10
Every contains folic acid 5mg, and the preparation method of every 1000 folic acid oral instant membranes, comprises the steps:
(1) by the embodiment of table 15, take hydroxypropyl methylcellulose E-5, mannitol, aspartame, glycerol, pregelatinized Starch, folic acid;
(2) by after hydroxypropyl methylcellulose E-5, mannitol, aspartame, pregelatinized Starch, folic acid mix homogeneously, add 45g purified water, stir, swelling 60 minutes, adds glycerol to stir, and places 30min, makes its complete swelling, degassed, films;
(3) at 70 ℃, dry 10min, demoulding, by specification cutting, obtaining specification is the folic acid oral instant membrane folic acid oral instant membrane of 5mg.
Evaluate: outward appearance is even, the good demoulding, dissolves soon features good taste.
With reference to second YESUAN PIAN touchstone of recording of 2010 editions < < Chinese Pharmacopoeia > >, to character in embodiment better, dissolve folic acid oral instant membrane faster and carried out the check of content, uniformity of dosage units and dissolution, assay sees the following form 2.
The assay of table 2 folic acid oral instant membrane
Product dissolves the assay method in time limit: get respectively 6 medicine films of test sample prepared by embodiment 6-10, adopt respectively disintegration time mensuration method (two appendix XA of Chinese Pharmacopoeia version in 2010) to measure, each sheet medicine film all should all dissolve and pass through screen cloth in 3 minutes.
The method of test-meal experiment: by 5 healthy volunteer's test-meal folic acid dissolving films, everyone takes a slice, in the situation that not drinking water, the solution time behind oral cavity put in record, and mouthfeel is evaluated, and standards of grading are: 0 minute: without bitterness, mouthfeel is good, 1 minute: have slight taste, good mouthfeel, 2 minutes: bitterness is more obvious, mouthfeel is general, 3 minutes: have strong bitterness, mouthfeel is poor, concrete result (meansigma methods) referred to table 3.
Time limit result is dissolved in mouth feel score and the oral cavity of table 3 folic acid oral instant membrane
| Embodiment numbering | 6 | 7 | 8 | 9 | 10 |
| Mouth feel score (dividing) | 0 | 0 | 0 | 0 | 0 |
| (second) dissolved the time limit in oral cavity | 32 | 31 | 33 | 32 | 22 |
Claims (7)
1. a preparation method for folic acid oral instant membrane, is characterized in that comprising the steps:
(1) by mass fraction, take supplementary material: filmogen 6-15 part; Filler 2-7 part; Sweeting agent 1-3 part; Plasticizer 2-3 part; Disintegrating agent 2-6 part; Folic acid 0.4-5 part;
(2) by after folic acid, sweeting agent, disintegrating agent, filler, filmogen mix homogeneously, add and be equivalent to folic acid, sweeting agent, disintegrating agent, filler and filmogen gross mass 1.2-1.7 purified water doubly, stir evenly evenly; Fully swelling, adds plasticizer, places 10～50min, degassed, film;
(3) at 50～70 ℃, dry 10～50min, demoulding, cuts, and obtains folic acid oral instant membrane.
2. the preparation method of a kind of folic acid oral instant membrane according to claim 1, is characterized in that described filmogen is selected from least one in hydroxypropyl methylcellulose E-5, hydroxypropyl methylcellulose E-15 and sodium carboxymethyl cellulose.
3. the preparation method of a kind of folic acid oral instant membrane according to claim 4, is characterized in that described filler is selected from dextrin, mannitol.
4. the preparation method of a kind of folic acid oral instant membrane according to claim 1, is characterized in that described sweeting agent is selected from least one in sucralose, aspartame, sucrose.
5. the preparation method of a kind of folic acid oral instant membrane according to claim 1, is characterized in that described plasticizer is selected from least one in glycerol, propylene glycol, PEG400.
6. the preparation method of a kind of folic acid oral instant membrane according to claim 1, is characterized in that described disintegrating agent is selected from least one in low-substituted hydroxypropyl cellulose, polyvinylpolypyrrolidone, microcrystalline Cellulose and pregelatinized Starch.
7. the folic acid oral instant membrane that prepared by the method for one of claim 1-6.
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105982070A (en) * | 2015-02-10 | 2016-10-05 | 苏州百益倍肯新材料科技有限公司 | Melatonin oral cavity instant films and preparation method thereof |
| CN105982072A (en) * | 2015-02-10 | 2016-10-05 | 苏州百益倍肯新材料科技有限公司 | Vitamin D3 calcium carbonate oral cavity instant films and preparation method thereof |
| CN105982063A (en) * | 2015-02-10 | 2016-10-05 | 苏州百益倍肯新材料科技有限公司 | Mint flavored oral cavity instant films and preparation method thereof |
| CN105997949A (en) * | 2016-06-02 | 2016-10-12 | 云南省药物研究所 | Oral dissolving film preparation containing bulleyaconitine A and preparation technology of oral dissolving film preparation |
| CN108813630A (en) * | 2018-07-04 | 2018-11-16 | 上海海洋大学 | It is a kind of directly to take orally and instant self-emulsifying film and preparation method thereof |
| CN113440499A (en) * | 2021-06-18 | 2021-09-28 | 北京斯利安药业有限公司 | Folic acid oral dissolving film agent and preparation method thereof |
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| CN105982070A (en) * | 2015-02-10 | 2016-10-05 | 苏州百益倍肯新材料科技有限公司 | Melatonin oral cavity instant films and preparation method thereof |
| CN105982072A (en) * | 2015-02-10 | 2016-10-05 | 苏州百益倍肯新材料科技有限公司 | Vitamin D3 calcium carbonate oral cavity instant films and preparation method thereof |
| CN105982063A (en) * | 2015-02-10 | 2016-10-05 | 苏州百益倍肯新材料科技有限公司 | Mint flavored oral cavity instant films and preparation method thereof |
| CN105997949A (en) * | 2016-06-02 | 2016-10-12 | 云南省药物研究所 | Oral dissolving film preparation containing bulleyaconitine A and preparation technology of oral dissolving film preparation |
| CN108813630A (en) * | 2018-07-04 | 2018-11-16 | 上海海洋大学 | It is a kind of directly to take orally and instant self-emulsifying film and preparation method thereof |
| CN108813630B (en) * | 2018-07-04 | 2021-09-17 | 上海海洋大学 | Self-emulsifying film agent capable of being directly taken orally and rapidly dissolved and preparation method thereof |
| CN113440499A (en) * | 2021-06-18 | 2021-09-28 | 北京斯利安药业有限公司 | Folic acid oral dissolving film agent and preparation method thereof |
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