CN111000819A - Fukean film-coated tablet and preparation process thereof - Google Patents
Fukean film-coated tablet and preparation process thereof Download PDFInfo
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- CN111000819A CN111000819A CN202010011196.XA CN202010011196A CN111000819A CN 111000819 A CN111000819 A CN 111000819A CN 202010011196 A CN202010011196 A CN 202010011196A CN 111000819 A CN111000819 A CN 111000819A
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- tablet
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- fukean
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- 239000007941 film coated tablet Substances 0.000 title claims abstract description 27
- 238000002360 preparation method Methods 0.000 title claims abstract description 23
- 239000003826 tablet Substances 0.000 claims abstract description 42
- 239000011248 coating agent Substances 0.000 claims abstract description 35
- 238000000576 coating method Methods 0.000 claims abstract description 35
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 claims abstract description 27
- 239000007888 film coating Substances 0.000 claims abstract description 26
- 238000009501 film coating Methods 0.000 claims abstract description 26
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 23
- 239000003814 drug Substances 0.000 claims abstract description 21
- GWEVSGVZZGPLCZ-UHFFFAOYSA-N Titan oxide Chemical compound O=[Ti]=O GWEVSGVZZGPLCZ-UHFFFAOYSA-N 0.000 claims abstract description 18
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 16
- 238000004519 manufacturing process Methods 0.000 claims abstract description 12
- 239000000843 powder Substances 0.000 claims abstract description 12
- 108010068370 Glutens Proteins 0.000 claims abstract description 11
- 235000021312 gluten Nutrition 0.000 claims abstract description 11
- 239000002994 raw material Substances 0.000 claims abstract description 11
- WEAPVABOECTMGR-UHFFFAOYSA-N triethyl 2-acetyloxypropane-1,2,3-tricarboxylate Chemical compound CCOC(=O)CC(C(=O)OCC)(OC(C)=O)CC(=O)OCC WEAPVABOECTMGR-UHFFFAOYSA-N 0.000 claims abstract description 11
- 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 abstract description 9
- 229930195725 Mannitol Natural products 0.000 claims abstract description 9
- 241000209140 Triticum Species 0.000 claims abstract description 9
- 235000021307 Triticum Nutrition 0.000 claims abstract description 9
- 239000000594 mannitol Substances 0.000 claims abstract description 9
- 235000010355 mannitol Nutrition 0.000 claims abstract description 9
- 239000004408 titanium dioxide Substances 0.000 claims abstract description 9
- 229920002261 Corn starch Polymers 0.000 claims abstract description 8
- 239000008120 corn starch Substances 0.000 claims abstract description 8
- 239000010410 layer Substances 0.000 claims abstract description 8
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 8
- 241000207840 Jasminum Species 0.000 claims abstract description 6
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims abstract description 5
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims abstract description 5
- 229920000053 polysorbate 80 Polymers 0.000 claims abstract description 5
- 229940068968 polysorbate 80 Drugs 0.000 claims abstract description 5
- 239000007788 liquid Substances 0.000 claims description 30
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 24
- 238000003756 stirring Methods 0.000 claims description 18
- 238000001914 filtration Methods 0.000 claims description 12
- 238000005086 pumping Methods 0.000 claims description 12
- 239000000047 product Substances 0.000 claims description 10
- QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Chemical compound CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims description 9
- 238000001035 drying Methods 0.000 claims description 9
- 238000002156 mixing Methods 0.000 claims description 9
- 238000010438 heat treatment Methods 0.000 claims description 7
- 238000003860 storage Methods 0.000 claims description 7
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims description 6
- 238000007664 blowing Methods 0.000 claims description 6
- 239000003651 drinking water Substances 0.000 claims description 6
- 235000020188 drinking water Nutrition 0.000 claims description 6
- 230000005484 gravity Effects 0.000 claims description 6
- 239000000463 material Substances 0.000 claims description 6
- 239000008213 purified water Substances 0.000 claims description 6
- 239000007787 solid Substances 0.000 claims description 6
- 239000006228 supernatant Substances 0.000 claims description 6
- 238000005303 weighing Methods 0.000 claims description 6
- 238000000034 method Methods 0.000 claims description 5
- 239000000203 mixture Substances 0.000 claims description 5
- 230000008569 process Effects 0.000 claims description 5
- 241000209035 Ilex Species 0.000 claims description 4
- 235000003332 Ilex aquifolium Nutrition 0.000 claims description 4
- 235000002296 Ilex sandwicensis Nutrition 0.000 claims description 4
- 235000002294 Ilex volkensiana Nutrition 0.000 claims description 4
- 235000003805 Musa ABB Group Nutrition 0.000 claims description 4
- 240000008790 Musa x paradisiaca Species 0.000 claims description 4
- 240000003109 Persicaria chinensis Species 0.000 claims description 4
- 235000015266 Plantago major Nutrition 0.000 claims description 4
- 244000294611 Punica granatum Species 0.000 claims description 4
- 235000014360 Punica granatum Nutrition 0.000 claims description 4
- 238000006243 chemical reaction Methods 0.000 claims description 4
- 108090000526 Papain Proteins 0.000 claims description 3
- 239000004365 Protease Substances 0.000 claims description 3
- 239000000084 colloidal system Substances 0.000 claims description 3
- 238000001816 cooling Methods 0.000 claims description 3
- 238000011049 filling Methods 0.000 claims description 3
- 239000000706 filtrate Substances 0.000 claims description 3
- 238000004108 freeze drying Methods 0.000 claims description 3
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 3
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 3
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 3
- 238000003801 milling Methods 0.000 claims description 3
- 229910052757 nitrogen Inorganic materials 0.000 claims description 3
- 229940055729 papain Drugs 0.000 claims description 3
- 235000019834 papain Nutrition 0.000 claims description 3
- 239000002244 precipitate Substances 0.000 claims description 3
- 238000007873 sieving Methods 0.000 claims description 3
- 239000002002 slurry Substances 0.000 claims description 3
- 229910001220 stainless steel Inorganic materials 0.000 claims description 3
- 239000010935 stainless steel Substances 0.000 claims description 3
- 238000005406 washing Methods 0.000 claims description 3
- 229940079593 drug Drugs 0.000 claims description 2
- 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 2
- 229920000136 polysorbate Polymers 0.000 claims description 2
- 229950008882 polysorbate Drugs 0.000 claims description 2
- 238000010521 absorption reaction Methods 0.000 abstract description 11
- 235000013772 propylene glycol Nutrition 0.000 abstract 1
- 235000010215 titanium dioxide Nutrition 0.000 abstract 1
- 230000000052 comparative effect Effects 0.000 description 8
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- 239000008298 dragée Substances 0.000 description 3
- 238000007689 inspection Methods 0.000 description 3
- 239000007940 sugar coated tablet Substances 0.000 description 3
- FLKPEMZONWLCSK-UHFFFAOYSA-N diethyl phthalate Chemical compound CCOC(=O)C1=CC=CC=C1C(=O)OCC FLKPEMZONWLCSK-UHFFFAOYSA-N 0.000 description 2
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 description 2
- 238000009472 formulation Methods 0.000 description 2
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- 235000018102 proteins Nutrition 0.000 description 2
- 108090000623 proteins and genes Proteins 0.000 description 2
- 102000004169 proteins and genes Human genes 0.000 description 2
- 208000004998 Abdominal Pain Diseases 0.000 description 1
- JMGZEFIQIZZSBH-UHFFFAOYSA-N Bioquercetin Natural products CC1OC(OCC(O)C2OC(OC3=C(Oc4cc(O)cc(O)c4C3=O)c5ccc(O)c(O)c5)C(O)C2O)C(O)C(O)C1O JMGZEFIQIZZSBH-UHFFFAOYSA-N 0.000 description 1
- 206010012735 Diarrhoea Diseases 0.000 description 1
- 208000005577 Gastroenteritis Diseases 0.000 description 1
- 208000002193 Pain Diseases 0.000 description 1
- 208000004880 Polyuria Diseases 0.000 description 1
- GAMYVSCDDLXAQW-AOIWZFSPSA-N Thermopsosid Natural products O(C)c1c(O)ccc(C=2Oc3c(c(O)cc(O[C@H]4[C@H](O)[C@@H](O)[C@H](O)[C@H](CO)O4)c3)C(=O)C=2)c1 GAMYVSCDDLXAQW-AOIWZFSPSA-N 0.000 description 1
- 206010047700 Vomiting Diseases 0.000 description 1
- 229920002494 Zein Polymers 0.000 description 1
- 208000012873 acute gastroenteritis Diseases 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 230000008901 benefit Effects 0.000 description 1
- 238000004140 cleaning Methods 0.000 description 1
- 239000011247 coating layer Substances 0.000 description 1
- 238000005336 cracking Methods 0.000 description 1
- 206010012601 diabetes mellitus Diseases 0.000 description 1
- 230000035619 diuresis Effects 0.000 description 1
- 201000006549 dyspepsia Diseases 0.000 description 1
- 230000000694 effects Effects 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- IVTMALDHFAHOGL-UHFFFAOYSA-N eriodictyol 7-O-rutinoside Natural products OC1C(O)C(O)C(C)OC1OCC1C(O)C(O)C(O)C(OC=2C=C3C(C(C(O)=C(O3)C=3C=C(O)C(O)=CC=3)=O)=C(O)C=2)O1 IVTMALDHFAHOGL-UHFFFAOYSA-N 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 238000005562 fading Methods 0.000 description 1
- 229930003944 flavone Natural products 0.000 description 1
- 150000002212 flavone derivatives Chemical class 0.000 description 1
- 235000011949 flavones Nutrition 0.000 description 1
- 238000000227 grinding Methods 0.000 description 1
- 230000002209 hydrophobic effect Effects 0.000 description 1
- 125000001165 hydrophobic group Chemical group 0.000 description 1
- 229960003943 hypromellose Drugs 0.000 description 1
- 238000011031 large-scale manufacturing process Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 239000012466 permeate Substances 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- FDRQPMVGJOQVTL-UHFFFAOYSA-N quercetin rutinoside Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC=2C(C3=C(O)C=C(O)C=C3OC=2C=2C=C(O)C(O)=CC=2)=O)O1 FDRQPMVGJOQVTL-UHFFFAOYSA-N 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 238000012827 research and development Methods 0.000 description 1
- IKGXIBQEEMLURG-BKUODXTLSA-N rutin Chemical compound O[C@H]1[C@H](O)[C@@H](O)[C@H](C)O[C@@H]1OC[C@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](OC=2C(C3=C(O)C=C(O)C=C3OC=2C=2C=C(O)C(O)=CC=2)=O)O1 IKGXIBQEEMLURG-BKUODXTLSA-N 0.000 description 1
- ALABRVAAKCSLSC-UHFFFAOYSA-N rutin Natural products CC1OC(OCC2OC(O)C(O)C(O)C2O)C(O)C(O)C1OC3=C(Oc4cc(O)cc(O)c4C3=O)c5ccc(O)c(O)c5 ALABRVAAKCSLSC-UHFFFAOYSA-N 0.000 description 1
- 235000005493 rutin Nutrition 0.000 description 1
- 229960004555 rutoside Drugs 0.000 description 1
- 239000006188 syrup Substances 0.000 description 1
- 235000020357 syrup Nutrition 0.000 description 1
- 125000003396 thiol group Chemical group [H]S* 0.000 description 1
- VHBFFQKBGNRLFZ-UHFFFAOYSA-N vitamin p Natural products O1C2=CC=CC=C2C(=O)C=C1C1=CC=CC=C1 VHBFFQKBGNRLFZ-UHFFFAOYSA-N 0.000 description 1
- 239000005019 zein Substances 0.000 description 1
- 229940093612 zein Drugs 0.000 description 1
Classifications
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/282—Organic compounds, e.g. fats
- A61K9/2826—Sugars or sugar alcohols, e.g. sucrose; Derivatives thereof
-
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
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- A61K36/18—Magnoliophyta (angiosperms)
- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/63—Oleaceae (Olive family), e.g. jasmine, lilac or ash tree
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- A61K36/18—Magnoliophyta (angiosperms)
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- A61K36/68—Plantaginaceae (Plantain Family)
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- A61K36/185—Magnoliopsida (dicotyledons)
- A61K36/70—Polygonaceae (Buckwheat family), e.g. spineflower or dock
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- A—HUMAN NECESSITIES
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2806—Coating materials
- A61K9/2813—Inorganic compounds
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- A61K9/2806—Coating materials
- A61K9/2833—Organic macromolecular compounds
- A61K9/286—Polysaccharides, e.g. gums; Cyclodextrin
- A61K9/2866—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
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- A61K9/2873—Proteins, e.g. gelatin
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
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- A61K2236/30—Extraction of the material
- A61K2236/33—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
- A61K2236/331—Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones using water, e.g. cold water, infusion, tea, steam distillation or decoction
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
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- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Natural Medicines & Medicinal Plants (AREA)
- Engineering & Computer Science (AREA)
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- Bioinformatics & Cheminformatics (AREA)
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- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Microbiology (AREA)
- Alternative & Traditional Medicine (AREA)
- Biotechnology (AREA)
- Botany (AREA)
- Medical Informatics (AREA)
- Mycology (AREA)
- Nutrition Science (AREA)
- Inorganic Chemistry (AREA)
- Hospice & Palliative Care (AREA)
- Otolaryngology (AREA)
- Pain & Pain Management (AREA)
- Rheumatology (AREA)
- Medicinal Preparation (AREA)
Abstract
The invention belongs to the technical field of medicine coating, and particularly relates to a Fukean film-coated tablet and a preparation process thereof, wherein the Fukean film-coated tablet consists of a tablet core and a film coating layer, and the tablet core comprises the following preparation raw materials: jasminum Amplexicaule, herb Polygoni chinensis, cortex Ilicis Rotundae, herba plantaginis, pericarpium Granati, corn starch, sugar powder and magnesium stearate; the film coating layer comprises the following preparation raw materials: mannitol, acetyl triethyl citrate, titanium dioxide, wheat gluten, polysorbate-80 and propylene glycol. The Fukean film-coated tablet has the characteristics of high yield, good stability and low water absorption rate, and is suitable for industrial mass production.
Description
Technical Field
The invention belongs to the technical field of medicine coating, and particularly relates to a Fukean film-coated tablet and a preparation process thereof.
Background
Fukean tablet has effects of clearing heat, promoting diuresis, astringing and relieving pain, and can be used for treating acute gastroenteritis, and abdominal pain, diarrhea and emesis caused by dyspepsia. The traditional Fukean sugar-coated tablet has long coating operation time, considerable water in syrup permeates a tablet core to influence the quality of the medicine, a large amount of talcum powder is used during coating of the Fukean sugar-coated tablet to cause the defects of powder flying, poor operation environment and the like, and the defects can be overcome by using a film coating.
The traditional Chinese patent medicine tablets are coated by sugar coating, not only have the defects of easy moisture absorption, fading, cracking and the like, but also have the weight increased by 70 percent and high water absorption rate after the sugar coating is carried out on one tablet. In addition, the sugar powder and talcum powder contained in the sugar coating are not beneficial to the middle-aged and the elderly and diabetes. Meanwhile, the results of experimental production of film coating are greatly different from those of actual production because the specifications of experimental production are mostly thousands or tens of thousands of tablets, and the specifications of actual production are over a million tablets, the increase of production capacity causes that equipment needs higher pressure, concentration needs more cycle times or more production time to achieve the results of experimental production, and the increase of the conditions causes the cost increase and the production efficiency reduction of enterprises, thereby causing the burden of the enterprises. Therefore, on the basis of the prior art, the research and development of the high-efficiency and low-water absorption scale-available Fukean film-coated tablet has important significance.
Disclosure of Invention
The invention discloses a Fukean film-coated tablet, which not only has the performance of the conventional film-coated tablet, but also has the characteristics of high yield, good stability and low water absorption rate, and is also suitable for industrial mass production.
In order to achieve the purpose, the invention adopts the following technical scheme:
a Fukean film-coated tablet consists of a tablet core and a film coating layer, wherein the tablet core comprises the following preparation raw materials in parts by weight: 1000-3000 parts of Jasminum Amplexicaule, 1000-3000 parts of Chinese knotweed herb, 670-800 parts of ovate leaf holly bark, 330-600 parts of plantain herb, 330-600 parts of pomegranate bark, 28.7-50.3 parts of corn starch, 61-125 parts of powdered sugar and 3.3-6.5 parts of magnesium stearate; the film coating layer comprises the following preparation raw materials in parts by weight: 6.45-12.9 parts of mannitol, 1.93-5.03 parts of acetyl triethyl citrate, 2.55-5.10 parts of titanium dioxide, 0.77-1.54 parts of wheat gluten, 0.51-1.03 parts of polysorbate-800.51 and 0.51-1.03 parts of propylene glycol.
Preferably, the tablet core comprises the following preparation raw materials in parts by weight: 1000 parts of Jasminum Amplexicaule, 1000 parts of Chinese knotweed herb, 670 parts of ovate leaf holly bark, 330 parts of plantain herb and 330 parts of pomegranate bark; 28.7 parts of corn starch, 61 parts of powdered sugar and 3.3 parts of magnesium stearate; the film coating layer comprises the following preparation raw materials in parts by weight: 6.45 parts of hydroxypropyl methylcellulose, 1.93 parts of acetyl triethyl citrate, 2.55 parts of titanium dioxide, 0.77 part of wheat gluten, 800.51 parts of polysorbate and 0.51 part of propylene glycol.
Preferably, the preparation process of the tablet core comprises the following steps:
(1) weighing the medicinal materials, adding water for decocting, adding 6 times of drinking water, decocting for 2 hours, filtering to collect supernatant, adding 4 times of drinking water into filter residue, decocting for 2 hours for the second time, filtering the 2 times of extractive liquid medicines respectively through 80 mesh sieves, pumping into a liquid medicine temporary storage tank, mixing to obtain liquid medicine A, and standing at room temperature;
(2) pumping the liquid medicine A in the liquid medicine tank into a double-effect vacuum concentrator, heating and concentrating, measuring the specific gravity by a specific gravity meter at any time, concentrating to obtain clear paste with the relative density of 1.18-1.20, and collecting the paste;
(3) adding high-concentration ethanol into the clear paste, stirring for 15min to enable the ethanol content to reach 65%, standing for 24 hours, pumping supernatant into a liquid medicine storage tank, washing residues with 65% ethanol for one time, standing for 12 hours, filtering, combining secondary filtrate, recovering ethanol, pumping into a spherical concentration tank for concentration, concentrating into thick paste with the relative density of 1.30-1.40, drying at low temperature, and crushing;
(4) adding corn starch and sugar powder, granulating, drying, grading, adding magnesium stearate, mixing, and tabletting to obtain tablet core.
Further, the invention provides a preparation process of the Fukean film-coated tablet, which comprises the following steps:
s1 pretreatment of materials: weighing required film coating solid powder, sieving, adding water to dissolve wheat gluten, adding papain, adjusting the pH to 4.5 by using acetic acid, placing the mixture into a 50 ℃ reaction tank, filling nitrogen for reacting for 8 hours, heating the reacted product to 95 ℃ for 10min, cooling the temperature to 4 ℃, freeze-drying the freeze-dried product, putting the frozen product, mannitol, triethyl acetylcitrate, titanium dioxide, polysorbate-80 and propylene glycol into a full-automatic colloid mill, and pre-milling to 0.05-0.015 mm;
s2 mixing: adding a required amount of purified water into a stirring cylinder, starting stirring slurry to enable the purified water to form a vortex, uniformly adding the film-coated solid powder obtained in the step S1 into the vortex, and uniformly stirring; reducing stirring speed to eliminate vortex, stirring for 45min, filtering with 100 mesh stainless steel sieve, and checking the coating liquid to be uniform, free of precipitate and bubble to obtain film coating liquid;
s3 preheating of tablet cores: putting the tablet core into a high-efficiency coating cylinder, inching a high-efficiency coating machine, rotating for half a circle at an interval of 2min, blowing hot air and simultaneously exhausting air, and preheating the tablet core;
s4 coating: adding the film coating liquid prepared in advance in the step S1 into a high-efficiency coating cylinder, adjusting the rotating speed of a nozzle and a coating machine, coating until the coating liquid is coated, blowing hot air for drying, and stopping the machine to obtain the Fukean film coated tablet.
Preferably, the temperature of the hot air in the step S3 is 65-70 ℃, and the temperature of the air exhaust is 40-45 ℃.
Preferably, the temperature for preheating the tablet core in the step S3 is 55 +/-2 ℃.
Preferably, the coating rotation speed in the step S4 is 5 revolutions per minute for the first 5 minutes, and then the rotation speed is adjusted to 8 revolutions per minute, and the distance between the nozzle and the tablet surface is 25-30 cm.
The invention provides a Fukean film-coated tablet and a preparation process thereof, which improves a coating layer in the technical process of film coating, and gluten is modified and added with mannitol, triethyl acetyl citrate, titanium dioxide, polysorbate-80 and propylene glycol for pre-grinding, so that the film coating has strong binding power, high toughness and bright color. After the wheat gluten is subjected to enzymolysis, hydrophobic groups and sulfhydryl groups in molecules are exposed, hydrophobic bonds in protein molecules can be combined with disulfide bonds to form a new three-dimensional network structure, and the protein molecules are combined with mannitol and acetyl triethyl citrate, so that the coating liquid has good hydrophobicity and film-forming property, raw materials are easy to obtain, the price is low, and the product quality is improved.
Aiming at the research of improving the stability, water absorption and industrial yield of the prior film technology, the invention improves the coating premix liquid in the film coating technical process, reduces the cost, improves the economic benefit and is suitable for industrial large-scale production.
Detailed Description
The present invention will be described in further detail with reference to the following examples. It should not be understood that the scope of the above-described subject matter of the present invention is limited to the following examples.
EXAMPLES 1-3 preparation of samples
Examples 1-3 provide the tablet core formulations shown in table 1.
The preparation process of the tablet core comprises the following steps:
(1) weighing and cleaning Jasminum Amplexicaule, herba plantaginis, pericarpium Granati, herb Polygoni chinensis and cortex Ilicis Rotundae, decocting with water, adding 6 times of drinking water, decocting for 2 hr, filtering to obtain supernatant, adding 4 times of drinking water into the residue, decocting for 2 hr for the second time, filtering the 2 extractive liquids with 80 mesh sieve, pumping into a liquid medicine temporary storage tank, mixing to obtain liquid medicine A, and standing at room temperature;
(2) pumping the liquid medicine A in the liquid medicine tank into a double-effect vacuum concentrator, heating and concentrating, measuring the specific gravity by a specific gravity meter at any time, concentrating to obtain clear paste with the relative density of 1.18-1.20, and collecting the paste;
(3) adding high-concentration ethanol into the clear paste, stirring for 15min to enable the ethanol content to reach 65%, standing for 24 hours, pumping supernatant into a liquid medicine storage tank, washing residues with 65% ethanol for one time, standing for 12 hours, filtering, combining secondary filtrate, recovering ethanol, pumping into a spherical concentration tank for concentration, concentrating into thick paste with the relative density of 1.30-1.40, drying at low temperature, and crushing;
(4) adding corn starch and sugar powder, granulating, drying, grading, adding magnesium stearate, mixing, and tabletting to obtain 20000 tablet core.
The tablet cores of examples 1-3 were subjected to film coating experiments, and the tablet core film coating formulations are given in table 2.
TABLE 2 tablet core film coating recipe
The preparation process of the Fukean film-coated tablet comprises the following steps:
s1 pretreatment of materials: weighing required film coating solid powder, sieving, adding water to dissolve wheat gluten, adding papain, adjusting the pH to 4.5 by using acetic acid, placing the mixture into a 50 ℃ reaction tank, filling nitrogen for reacting for 8 hours, heating the reacted product to 95 ℃ for 10min, cooling the temperature to 4 ℃, freeze-drying the freeze-dried product, putting the frozen product, mannitol, triethyl acetylcitrate, titanium dioxide, polysorbate-80 and propylene glycol into a full-automatic colloid mill, and pre-milling to 0.05-0.015 mm;
s2 mixing: adding a required amount of purified water into a stirring cylinder, starting stirring slurry to enable the purified water to form a vortex, uniformly adding the film-coated solid powder obtained in the step S1 into the vortex, and uniformly stirring; reducing stirring speed to eliminate vortex, stirring for 45min, filtering with 100 mesh stainless steel sieve, and checking the coating liquid to be uniform, free of precipitate and bubble to obtain film coating liquid;
s3 preheating of tablet cores: putting the core tablet obtained in claim 3 into a high-efficiency coating cylinder, inching a high-efficiency coating machine, rotating for half a circle at an interval of 2min, blowing hot air and simultaneously exhausting air, and preheating the core tablet;
s4 coating: adding the film coating solution prepared in advance in the step S1 into a high-efficiency coating cylinder, adjusting the rotating speed of a nozzle and a coating machine, coating until the coating solution is coated, blowing hot air for drying for 15min, and stopping the machine to obtain the Fukean film coated tablet.
Comparative example 1
Similar to example 2, except that: other parameters for the conversion of mannitol to hypromellose were the same as in example 2.
Comparative example 2
Similar to example 2, except that: the acetyl triethyl citrate was exchanged for diethyl phthalate with the same other parameters as in example 2.
Comparative example 3
Similar to example 2, except that: gluten was changed to zein, and the other parameters were the same as in example 2.
Comparative example 4
The tablet core is the same as example 2, except that: the film coating excipients were replaced with commercially available sugar coating excipients, and the other parameters were the same as in example 2.
Test example 1 test results of film-coated tablets
Test samples: coated tablets prepared according to examples 1 to 3 and comparative examples 1 to 4
Observing the above samples, and performing identification, examination, tablet weight gain rate measurement and content measurement (based on the total flavone and rutin (C)27H30O16) Meter), the coating time was recorded and the results are shown in table 3.
The inspection results of the film-coated tablets show that all the inspection items in the examples 1 to 3 meet the standard specification, the yield can reach more than 97%, the weight gain of the film-coated tablets is only about 3.47% of that of the tablet cores, the weight gain of the sugar-coated tablets in the comparative example 4 is about 85.9% of that of the tablet cores, the coating weight gains of the comparative examples 1 to 3 are heavier, the coating time is longer, and the equipment cost and the auxiliary material consumption are higher.
Table 3 inspection results of film coated tablets
Test example 2 high temperature and high humidity accelerated test
Taking 20 tablets respectively, placing at 60 deg.C and relative humidity of 75% and 92.5%, examining water absorption rate, standing for 10 days and 30 days, comparing water absorption, and performing friability measurement and content measurement.
TABLE 4 Water absorption results of high temperature and high humidity accelerated test
TABLE 5 determination of contents and variation of friability
The results in the above table show that under the same storage conditions, examples 1 to 3 are superior to comparative examples 1 to 4 in water absorption, content change and coarse degree, wherein example 2 has the lowest water absorption and small content change under the relative humidity of 92.5%.
The foregoing embodiments are merely illustrative of the principles and utilities of the present invention and are not intended to limit the invention. Any person skilled in the art can modify or change the above-mentioned embodiments without departing from the spirit and scope of the present invention. Accordingly, it is intended that all equivalent modifications or changes which can be made by those skilled in the art without departing from the spirit and technical spirit of the present invention be covered by the claims of the present invention.
Claims (7)
1. The Fukean film-coated tablet consists of a tablet core and a film coating layer, and is characterized in that the tablet core comprises the following preparation raw materials in parts by weight: 1000-3000 parts of Jasminum Amplexicaule, 1000-3000 parts of Chinese knotweed herb, 670-800 parts of ovate leaf holly bark, 330-600 parts of plantain herb, 330-600 parts of pomegranate bark, 28.7-50.3 parts of corn starch, 61-125 parts of powdered sugar and 3.3-6.5 parts of magnesium stearate; the film coating layer comprises the following preparation raw materials in parts by weight: 6.45-12.9 parts of mannitol, 1.93-5.03 parts of acetyl triethyl citrate, 2.55-5.10 parts of titanium dioxide, 0.77-1.54 parts of wheat gluten, 0.51-1.03 parts of polysorbate-800.51 and 0.51-1.03 parts of propylene glycol.
2. The abdomen-cotine film coated tablet according to claim 1, wherein the tablet core comprises the following preparation raw materials in parts by weight: 1000 parts of Jasminum Amplexicaule, 1000 parts of Chinese knotweed herb, 670 parts of ovate leaf holly bark, 330 parts of plantain herb and 330 parts of pomegranate bark; 28.7 parts of corn starch, 61 parts of powdered sugar and 3.3 parts of magnesium stearate; the film coating layer comprises the following preparation raw materials in parts by weight: 6.45 parts of hydroxypropyl methylcellulose, 1.93 parts of acetyl triethyl citrate, 2.55 parts of titanium dioxide, 0.77 part of wheat gluten, 800.51 parts of polysorbate and 0.51 part of propylene glycol.
3. The abdomen-attachable film coated tablet according to claim 1 or 2, wherein the process for preparing the tablet core comprises the steps of:
(1) weighing the medicinal materials, adding water for decocting, adding 6 times of drinking water, decocting for 2 hours, filtering to collect supernatant, adding 4 times of drinking water into filter residue, decocting for 2 hours for the second time, filtering the 2 times of extractive liquid medicines respectively through 80 mesh sieves, pumping into a liquid medicine temporary storage tank, mixing to obtain liquid medicine A, and standing at room temperature;
(2) pumping the liquid medicine A in the liquid medicine tank into a double-effect vacuum concentrator, heating and concentrating, measuring the specific gravity by a specific gravity meter at any time, concentrating to obtain clear paste with the relative density of 1.18-1.20, and collecting the paste;
(3) adding high-concentration ethanol into the clear paste, stirring for 15min to enable the ethanol content to reach 65%, standing for 24 hours, pumping supernatant into a liquid medicine storage tank, washing residues with 65% ethanol for one time, standing for 12 hours, filtering, combining secondary filtrate, recovering ethanol, pumping into a spherical concentration tank for concentration, concentrating into thick paste with the relative density of 1.30-1.40, drying at low temperature, and crushing;
(4) adding corn starch and sugar powder, granulating, drying, grading, adding magnesium stearate, mixing, and tabletting to obtain tablet core.
4. A process for the preparation of a film coated tablet according to claim 1 or 2, comprising the steps of:
s1 pretreatment of materials: weighing required film coating solid powder, sieving, adding water to dissolve wheat gluten, adding papain, adjusting the pH to 4.5 by using acetic acid, placing the mixture into a 50 ℃ reaction tank, filling nitrogen for reacting for 8 hours, heating the reacted product to 95 ℃ for 10min, cooling the temperature to 4 ℃, freeze-drying the freeze-dried product, putting the frozen product, mannitol, triethyl acetylcitrate, titanium dioxide, polysorbate-80 and propylene glycol into a full-automatic colloid mill, and pre-milling to 0.05-0.015 mm;
s2 mixing: adding a required amount of purified water into a stirring cylinder, starting stirring slurry to enable the purified water to form a vortex, uniformly adding the film-coated solid powder obtained in the step S1 into the vortex, and uniformly stirring; reducing stirring speed to eliminate vortex, stirring for 45min, filtering with 100 mesh stainless steel sieve, and checking the coating liquid to be uniform, free of precipitate and bubble to obtain film coating liquid;
s3 preheating of tablet cores: putting the core tablet obtained in claim 3 into a high-efficiency coating cylinder, inching a high-efficiency coating machine, rotating for half a circle at an interval of 2min, blowing hot air and simultaneously exhausting air, and preheating the core tablet;
s4 coating: adding the film coating liquid prepared in advance in the step S1 into a high-efficiency coating cylinder, adjusting the rotating speed of a nozzle and a coating machine, coating until the coating liquid is coated, blowing hot air for drying, and stopping the machine to obtain the Fukean film coated tablet.
5. Process for the preparation of a Fukean film coated tablet according to claim 4, characterized in that said step
The temperature of the hot air in the S3 is 65-70 ℃, and the temperature of the exhaust air is 40-45 ℃.
6. Process for the preparation of a Fukean film coated tablet according to claim 4, characterized in that said step
The pre-heating temperature of the core in S3 was 55 ± 2 ℃.
7. The process for preparing a belly-mountable film-coated tablet according to claim 4, wherein the coating speed in the step S4 is 5 rpm for the first 5min, and is adjusted to 8 rpm with the nozzle being 25 to 30cm from the tablet surface.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN114984126A (en) * | 2022-07-15 | 2022-09-02 | 深圳德荫堂生物科技有限公司 | Biological agent suitable for supplementing hormone for female and production method thereof |
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| CN114984126A (en) * | 2022-07-15 | 2022-09-02 | 深圳德荫堂生物科技有限公司 | Biological agent suitable for supplementing hormone for female and production method thereof |
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