CN110327368B - Tabletting preparation for supplementing selenium for adults and preparation method thereof - Google Patents
Tabletting preparation for supplementing selenium for adults and preparation method thereof Download PDFInfo
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- CN110327368B CN110327368B CN201910574420.3A CN201910574420A CN110327368B CN 110327368 B CN110327368 B CN 110327368B CN 201910574420 A CN201910574420 A CN 201910574420A CN 110327368 B CN110327368 B CN 110327368B
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- BUGBHKTXTAQXES-UHFFFAOYSA-N Selenium Chemical compound [Se] BUGBHKTXTAQXES-UHFFFAOYSA-N 0.000 title claims abstract description 108
- 239000011669 selenium Substances 0.000 title claims abstract description 108
- 229910052711 selenium Inorganic materials 0.000 title claims abstract description 107
- 238000002360 preparation method Methods 0.000 title claims abstract description 66
- 230000001502 supplementing effect Effects 0.000 title claims abstract description 61
- 229920000881 Modified starch Polymers 0.000 claims abstract description 52
- 239000012752 auxiliary agent Substances 0.000 claims abstract description 28
- 229920002774 Maltodextrin Polymers 0.000 claims abstract description 19
- 239000005913 Maltodextrin Substances 0.000 claims abstract description 18
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract description 18
- 240000004808 Saccharomyces cerevisiae Species 0.000 claims abstract description 18
- 229940035034 maltodextrin Drugs 0.000 claims abstract description 18
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims abstract description 18
- 239000008108 microcrystalline cellulose Substances 0.000 claims abstract description 18
- 229940016286 microcrystalline cellulose Drugs 0.000 claims abstract description 18
- 239000000203 mixture Substances 0.000 claims description 53
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims description 28
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 26
- 238000003756 stirring Methods 0.000 claims description 25
- MCMNRKCIXSYSNV-UHFFFAOYSA-N Zirconium dioxide Chemical compound O=[Zr]=O MCMNRKCIXSYSNV-UHFFFAOYSA-N 0.000 claims description 20
- 239000003607 modifier Substances 0.000 claims description 18
- 239000003826 tablet Substances 0.000 claims description 16
- 238000000034 method Methods 0.000 claims description 15
- 238000002156 mixing Methods 0.000 claims description 15
- 239000004372 Polyvinyl alcohol Substances 0.000 claims description 14
- 229920002451 polyvinyl alcohol Polymers 0.000 claims description 14
- 239000000377 silicon dioxide Substances 0.000 claims description 14
- 229920002472 Starch Polymers 0.000 claims description 13
- 239000007891 compressed tablet Substances 0.000 claims description 13
- 235000019359 magnesium stearate Nutrition 0.000 claims description 13
- 235000012239 silicon dioxide Nutrition 0.000 claims description 13
- 235000019698 starch Nutrition 0.000 claims description 13
- 239000008107 starch Substances 0.000 claims description 13
- 229940032147 starch Drugs 0.000 claims description 13
- 240000003183 Manihot esculenta Species 0.000 claims description 12
- 235000016735 Manihot esculenta subsp esculenta Nutrition 0.000 claims description 12
- -1 alkyl glycoside Chemical class 0.000 claims description 12
- 229930182470 glycoside Natural products 0.000 claims description 12
- 235000021355 Stearic acid Nutrition 0.000 claims description 11
- QIQXTHQIDYTFRH-UHFFFAOYSA-N octadecanoic acid Chemical compound CCCCCCCCCCCCCCCCCC(O)=O QIQXTHQIDYTFRH-UHFFFAOYSA-N 0.000 claims description 11
- OQCDKBAXFALNLD-UHFFFAOYSA-N octadecanoic acid Natural products CCCCCCCC(C)CCCCCCCCC(O)=O OQCDKBAXFALNLD-UHFFFAOYSA-N 0.000 claims description 11
- 239000008117 stearic acid Substances 0.000 claims description 11
- 238000009472 formulation Methods 0.000 claims description 10
- 230000004048 modification Effects 0.000 claims description 9
- 238000012986 modification Methods 0.000 claims description 9
- 239000002131 composite material Substances 0.000 claims description 4
- 239000002671 adjuvant Substances 0.000 claims 1
- 230000036541 health Effects 0.000 abstract description 10
- 230000009286 beneficial effect Effects 0.000 abstract description 4
- 229940091258 selenium supplement Drugs 0.000 description 102
- 238000012360 testing method Methods 0.000 description 29
- 239000000463 material Substances 0.000 description 17
- 230000000052 comparative effect Effects 0.000 description 16
- 241000700159 Rattus Species 0.000 description 14
- 239000000047 product Substances 0.000 description 14
- 235000012907 honey Nutrition 0.000 description 6
- 230000000694 effects Effects 0.000 description 5
- 239000008280 blood Substances 0.000 description 4
- 210000004369 blood Anatomy 0.000 description 4
- 238000010521 absorption reaction Methods 0.000 description 3
- 238000004519 manufacturing process Methods 0.000 description 3
- 239000013642 negative control Substances 0.000 description 3
- 239000013641 positive control Substances 0.000 description 3
- 238000010998 test method Methods 0.000 description 3
- 230000036039 immunity Effects 0.000 description 2
- 235000015097 nutrients Nutrition 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 230000001953 sensory effect Effects 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 239000013589 supplement Substances 0.000 description 2
- RTIXKCRFFJGDFG-UHFFFAOYSA-N Chrysin Natural products C=1C(O)=CC(O)=C(C(C=2)=O)C=1OC=2C1=CC=CC=C1 RTIXKCRFFJGDFG-UHFFFAOYSA-N 0.000 description 1
- 102000004190 Enzymes Human genes 0.000 description 1
- 108090000790 Enzymes Proteins 0.000 description 1
- 241000588724 Escherichia coli Species 0.000 description 1
- 208000019926 Keshan disease Diseases 0.000 description 1
- 241001465754 Metazoa Species 0.000 description 1
- FGUBFGWYEYFGRK-HNNXBMFYSA-N Pinocembrin Natural products Cc1cc(C)c2C(=O)C[C@H](Oc2c1)c3ccccc3 FGUBFGWYEYFGRK-HNNXBMFYSA-N 0.000 description 1
- 241000607142 Salmonella Species 0.000 description 1
- 206010039921 Selenium deficiency Diseases 0.000 description 1
- 241000191967 Staphylococcus aureus Species 0.000 description 1
- 206010070863 Toxicity to various agents Diseases 0.000 description 1
- 230000009471 action Effects 0.000 description 1
- 239000000654 additive Substances 0.000 description 1
- 230000000996 additive effect Effects 0.000 description 1
- 230000008485 antagonism Effects 0.000 description 1
- 230000003064 anti-oxidating effect Effects 0.000 description 1
- 239000003963 antioxidant agent Substances 0.000 description 1
- 230000003078 antioxidant effect Effects 0.000 description 1
- 229910052785 arsenic Inorganic materials 0.000 description 1
- RQNWIZPPADIBDY-UHFFFAOYSA-N arsenic atom Chemical compound [As] RQNWIZPPADIBDY-UHFFFAOYSA-N 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 238000000354 decomposition reaction Methods 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 238000001784 detoxification Methods 0.000 description 1
- 238000011161 development Methods 0.000 description 1
- 235000005911 diet Nutrition 0.000 description 1
- 230000000378 dietary effect Effects 0.000 description 1
- KCFYHBSOLOXZIF-UHFFFAOYSA-N dihydrochrysin Natural products COC1=C(O)C(OC)=CC(C2OC3=CC(O)=CC(O)=C3C(=O)C2)=C1 KCFYHBSOLOXZIF-UHFFFAOYSA-N 0.000 description 1
- 238000007907 direct compression Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- BVTBRVFYZUCAKH-UHFFFAOYSA-L disodium selenite Chemical compound [Na+].[Na+].[O-][Se]([O-])=O BVTBRVFYZUCAKH-UHFFFAOYSA-L 0.000 description 1
- 238000004090 dissolution Methods 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 230000002526 effect on cardiovascular system Effects 0.000 description 1
- 230000032050 esterification Effects 0.000 description 1
- 238000005886 esterification reaction Methods 0.000 description 1
- 238000011156 evaluation Methods 0.000 description 1
- 238000007710 freezing Methods 0.000 description 1
- 230000008014 freezing Effects 0.000 description 1
- 238000005469 granulation Methods 0.000 description 1
- 230000003179 granulation Effects 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 238000007689 inspection Methods 0.000 description 1
- QSHDDOUJBYECFT-UHFFFAOYSA-N mercury Chemical compound [Hg] QSHDDOUJBYECFT-UHFFFAOYSA-N 0.000 description 1
- 229910052753 mercury Inorganic materials 0.000 description 1
- 230000000474 nursing effect Effects 0.000 description 1
- 235000006286 nutrient intake Nutrition 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 201000008482 osteoarthritis Diseases 0.000 description 1
- 235000011837 pasties Nutrition 0.000 description 1
- 125000002081 peroxide group Chemical group 0.000 description 1
- 230000035790 physiological processes and functions Effects 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- URFCJEUYXNAHFI-ZDUSSCGKSA-N pinocembrin Chemical compound C1([C@@H]2CC(=O)C3=C(O)C=C(C=C3O2)O)=CC=CC=C1 URFCJEUYXNAHFI-ZDUSSCGKSA-N 0.000 description 1
- 238000004321 preservation Methods 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 230000002000 scavenging effect Effects 0.000 description 1
- 229960001471 sodium selenite Drugs 0.000 description 1
- 239000011781 sodium selenite Substances 0.000 description 1
- 235000015921 sodium selenite Nutrition 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 230000002195 synergetic effect Effects 0.000 description 1
- 231100000701 toxic element Toxicity 0.000 description 1
- 239000011573 trace mineral Substances 0.000 description 1
- 235000013619 trace mineral Nutrition 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 238000005303 weighing Methods 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K33/00—Medicinal preparations containing inorganic active ingredients
- A61K33/04—Sulfur, selenium or tellurium; Compounds thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K36/00—Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
- A61K36/06—Fungi, e.g. yeasts
- A61K36/062—Ascomycota
- A61K36/064—Saccharomycetales, e.g. baker's yeast
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- 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
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/02—Nutrients, e.g. vitamins, minerals
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
- C08B31/00—Preparation of derivatives of starch
- C08B31/02—Esters
- C08B31/04—Esters of organic acids, e.g. alkenyl-succinated starch
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Mycology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Natural Medicines & Medicinal Plants (AREA)
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- Diabetes (AREA)
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Abstract
The invention belongs to the technical field of health care products, and particularly relates to a tabletting preparation for supplementing selenium for adults and a preparation method thereof. The invention provides a tabletting preparation for supplementing selenium for adults, which comprises the following components in parts by weight: 10 to 26 parts of selenium-enriched yeast, 25 to 38 parts of pregelatinized starch, 25 to 38 parts of maltodextrin, 5 to 18 parts of microcrystalline cellulose and 1.5 to 3.75 parts of functional auxiliary agent. The tabletting preparation for supplementing selenium for adults provided by the invention is convenient to eat and easy to carry, and has a good selenium supplementing effect. The tabletting preparation for supplementing selenium for adults, which is provided by the invention, is suitable for adults, pregnant women and lactating mothers and is beneficial to supplementing the daily selenium requirement.
Description
Technical Field
The invention belongs to the technical field of health care products, and particularly relates to a tabletting preparation for supplementing selenium for adults and a preparation method thereof.
Background
Selenium is a trace element necessary for animals, and plays an important role in decomposition of peroxide, scavenging of free radicals, regulation of body immunity, antagonism of toxic elements and the like. The selenium-enriched yeast becomes the preferred selenium supplement additive due to the advantages of strong edible safety, high bioavailability and the like. Selenium has many important physiological functions, including antioxidation, cardiovascular preservation, detoxification, growth promotion, visual organ protection, and immunity enhancement. A large number of research reports show that the selenium deficiency of the body can cause a series of diseases, such as keshan disease, Kaschin-Beck disease and the like. On the other hand, excessive intake of selenium by the body also produces toxic symptoms. According to the reference dietary nutrient intake scale (DRIs 2013) of Chinese residents, the recommended daily intake of selenium for adults is 60 mug/d, 65 mug/d for pregnant women and 78 mug/d for nursing mothers.
Chinese patent application CN107440037A discloses a high-efficiency selenium supplement health care product and a preparation method thereof, wherein the high-efficiency selenium supplement health care product comprises 60-120 parts by weight of VE, 40-50 parts by weight of organic selenium and 1800-2100 parts by weight of honey; the preparation method of the health product comprises the steps of weighing VE, organic selenium and honey, uniformly mixing, and refrigerating in a refrigerator until the mixture is pasty and does not have layering. The selenium supplement health care product is a ternary composition, and VE is added while selenium supplement, so that the selenium supplement health care product can promote the body to absorb selenium, reduce the loss of the selenium in the body and improve the utilization rate of the selenium; meanwhile, selenium can promote the absorption of VE, reduce the loss of VE in vivo and also improve the utilization rate of VE; secondly, the honey is matched to form selenium-VE-honey, the taste is improved, and more importantly, the unique antioxidant components of pinocembrin and selenium in the honey have an effect synergistic effect; meanwhile, the honey also contains various vitamins, biological enzymes and the like, has the effect of complementing selenium, and the selenium, VE and honey are mutually promoted to play a health-care role of 1+1+1> 3. However, the high-efficiency selenium supplement health care product is paste, needs to be preserved in a freezing way, is inconvenient to eat and is not easy to carry.
At present, the existing selenium supplement health care products have the problems of inconvenient eating, difficult carrying, unsatisfactory selenium supplement effect and the like.
Disclosure of Invention
Aiming at the defects of the prior art, the invention aims to provide a tabletting preparation for supplementing selenium for adults and a preparation method thereof. The tabletting preparation for supplementing selenium for adults provided by the invention is convenient to eat and easy to carry, and has a good selenium supplementing effect. The tabletting preparation for supplementing selenium for adults, which is provided by the invention, is suitable for adults, pregnant women and lactating mothers and is beneficial to supplementing the daily selenium requirement.
The technical scheme of the invention is as follows:
a tabletting preparation for supplementing selenium for adults comprises the following components in parts by weight: 10 to 26 parts of selenium-enriched yeast, 25 to 38 parts of pregelatinized starch, 25 to 38 parts of maltodextrin, 5 to 18 parts of microcrystalline cellulose and 1.5 to 3.75 parts of functional auxiliary agent.
Further, the tabletting preparation for supplementing the selenium element for the adult comprises the following components in parts by mass: 14.5 parts of selenium-enriched yeast, 35 parts of pregelatinized starch, 32.5 parts of maltodextrin, 15 parts of microcrystalline cellulose and 3 parts of functional auxiliary agent.
Further, the functional auxiliary agent is prepared from silicon dioxide and magnesium stearate in a mass ratio of 1-2.5: 0.5 to 1.25.
Furthermore, the functional auxiliary agent is prepared from silicon dioxide and magnesium stearate according to a mass ratio of 2: 1.
Further, the pregelatinized starch is a pregelatinized starch modifier.
Further, the preparation method of the pregelatinized starch modifier comprises the following steps:
s1, taking cassava starch and stearic acid, wherein the stearic acid accounts for 1/60 of the cassava starch in mass, mixing and stirring at a stirring speed of 600-800 r/min for 25min to obtain a mixture A;
s2, placing the mixture A obtained in the step S1 and zirconia balls into a ball mill, and controlling the bulk volume ratio of the mixture A to the zirconia balls to be 100 g: 400-500 mL, and reacting for 15-25 min under the condition that the stirring speed is 300-500 r/min to obtain a mixture B;
s3, mixing the mixture B obtained in the step S2 with alkyl glycoside and polyvinyl alcohol, wherein the amount of the alkyl glycoside is 1/100 of the mass of the mixture B, and the amount of the polyvinyl alcohol is 3/80 of the mass of the mixture B, and stirring for 20min at a stirring speed of 400-600 r/min to obtain the composite material.
Further, the average molecular weight of the polyvinyl alcohol in step S3 of the preparation method of the pregelatinized starch modified product is 16000.
In addition, the invention also provides a preparation method of the tabletting preparation for supplementing selenium for adults, which comprises the following steps: adding selenium-enriched yeast into a mixer, sequentially adding pregelatinized starch, microcrystalline cellulose and maltodextrin, adding functional auxiliary agent, mixing for 10min, and tabletting in a tabletting machine to obtain tablet with weight of 0.5g per tablet.
The tabletting preparation for supplementing selenium for adults provided by the invention selects the pregelatinized starch, the maltodextrin and the microcrystalline cellulose to be matched, so that the tabletting preparation has good performances in aspects of tabletting hardness, demoulding and the like.
In the tabletting preparation for supplementing selenium for adults, the ratio of silicon dioxide to magnesium stearate used in the functional auxiliary agent is 2:1, so that on one hand, materials have good fluidity and demolding capacity during tabletting, and simultaneously, the tablets can be rapidly disintegrated according to requirements on hardness and are easy to absorb.
According to the invention, cassava starch and stearic acid are mixed to obtain a mixture A, then pregelatinization and esterification composite modification are carried out, and finally alkyl glycoside and polyvinyl alcohol are added for modification, so that the prepared pregelatinization starch modifier has good fluidity, stability and viscosity, can improve the disintegration effect, improve the dissolution rate of tablets, promote the absorption of human bodies to selenium, enhance the stability of products and prolong the quality guarantee period of the tablets. In addition, the pregelatinized starch modifier provided by the invention and the functional auxiliary agent have the combined action, the physical and mechanical properties of the pregelatinized starch modifier are improved, the compressibility and the binding force are good, the pregelatinized starch modifier is suitable for a direct tabletting process, the weight difference of the obtained tablets is small, and the hardness of the pressed tablets is high.
The tabletting preparation for supplementing selenium for adults provided by the invention adopts the production process of direct mixing and tabletting, is simple and convenient to operate, and avoids nutrient degradation caused by granulation and drying.
Compared with the prior art, the invention has the following advantages:
(1) the tabletting preparation for supplementing selenium for adults, provided by the invention, is suitable for adults, pregnant women and lactating mothers, each tablet contains 35-90 mu g of selenium, can meet daily requirements of suitable people, is helpful for maintaining the level of selenium in organisms and promotes the healthy development of the bodies.
(2) The tabletting preparation for supplementing selenium for adults provided by the invention has scientific formula collocation, is designed into 0.5 g/tablet, is easy to eat and carry, is beneficial to supplementing selenium for consumers at any time and any place, is quickly disintegrated, and is beneficial to being quickly absorbed by organisms.
(3) The tabletting preparation for supplementing selenium for adults provided by the invention adopts a direct compression process, effectively keeps the content of selenium in tablets stable, ensures the product quality, and simultaneously can improve the production efficiency and reduce the loss in the production process.
(4) The tabletting preparation for supplementing selenium for adults provided by the invention has the advantages of small weight difference, short disintegration time and good selenium supplementing effect.
Detailed Description
The present invention is further described in the following description of the specific embodiments, which is not intended to limit the invention, but various modifications and improvements can be made by those skilled in the art according to the basic idea of the invention, within the scope of the invention, as long as they do not depart from the basic idea of the invention.
In the present invention, microcrystalline cellulose is available from Huayue chemical products, Inc., Cat. No.: HNHUAYUE 1603; selenium-enriched yeast can be purchased from Guangzhou Jingfu bioengineering, Inc., Cat No.: 101, a first electrode and a second electrode; pregelatinized starch is available from Guangzhou Zengzhao Biotech, Inc., cat #: 569; maltodextrins are available from guangzhou chenxin chemical ltd, cat #: CX 1688; silica is available from guangzhou huijian biotechnology limited, cat #: SP 213456; alkyl glycosides are available from guangzhou, chang-macrochemical, ltd, cat #: APG 1214; the cassava starch is available from Baoder Biotech limited, Guangzhou, cat #: bd 38.
Example 1A tabletted preparation for adult human to supplement selenium
The tabletting preparation for supplementing selenium for adults comprises the following components in parts by weight: 10 parts of selenium-enriched yeast, 38 parts of pregelatinized starch, 38 parts of maltodextrin, 18 parts of microcrystalline cellulose and 3.75 parts of functional auxiliary agent; the functional auxiliary agent is prepared from silicon dioxide and magnesium stearate in a mass ratio of 1: 1.25; the pregelatinized starch is a pregelatinized starch modifier.
The preparation method of the pregelatinized starch modifier comprises the following steps:
s1, taking cassava starch and stearic acid, wherein the stearic acid accounts for 1/60 of the cassava starch in mass, mixing and stirring at a stirring speed of 600r/min for 25min to obtain a mixture A;
s2, placing the mixture A obtained in the step S1 and zirconia balls into a ball mill, and controlling the bulk volume ratio of the mixture A to the zirconia balls to be 100 g: 400mL, and reacting for 15min under the condition that the stirring speed is 300r/min to obtain a mixture B;
s3, mixing the mixture B obtained in the step S2 with alkyl glycoside and polyvinyl alcohol with the average molecular weight of 16000, wherein the amount of the alkyl glycoside is 1/100 of the mass of the mixture B, and the amount of the polyvinyl alcohol is 3/80 of the mass of the mixture B, and stirring for 20min at the stirring speed of 400r/min to obtain the product.
The preparation method of the tabletting preparation for supplementing selenium for adults comprises the following steps:
adding selenium-enriched yeast into a mixer, sequentially adding pregelatinized starch, microcrystalline cellulose and maltodextrin, adding functional auxiliary agent, mixing for 10min, and tabletting in a tabletting machine to obtain tablet with weight of 0.5g per tablet.
Example 2 an adult tableting formulation for supplementing selenium
The tabletting preparation for supplementing selenium for adults comprises the following components in parts by weight: 26 parts of selenium-enriched yeast, 25 parts of pregelatinized starch, 25 parts of maltodextrin, 5 parts of microcrystalline cellulose and 1.5 parts of functional auxiliary agent; the functional auxiliary agent is prepared from silicon dioxide and magnesium stearate according to a mass ratio of 2.5: 0.5; the pregelatinized starch is a pregelatinized starch modifier.
The preparation method of the pregelatinized starch modifier comprises the following steps:
s1, taking cassava starch and stearic acid, wherein the stearic acid accounts for 1/60 of the cassava starch in mass, mixing and stirring at the stirring speed of 800r/min for 25min to obtain a mixture A;
s2, placing the mixture A obtained in the step S1 and zirconia balls into a ball mill, and controlling the bulk volume ratio of the mixture A to the zirconia balls to be 100 g: 500mL, and reacting for 25min under the condition that the stirring speed is 500r/min to obtain a mixture B;
s3, mixing the mixture B obtained in the step S2 with alkyl glycoside and polyvinyl alcohol with the average molecular weight of 16000, wherein the amount of the alkyl glycoside is 1/100 of the mass of the mixture B, and the amount of the polyvinyl alcohol is 3/80 of the mass of the mixture B, and stirring for 20min at the stirring speed of 600r/min to obtain the product.
The adult human compressed tablet formulation for supplementing selenium was prepared in a similar manner to example 1.
Example 3A tabletted preparation for adult human to supplement selenium
The tabletting preparation for supplementing selenium for adults comprises the following components in parts by weight: 14.5 parts of selenium-enriched yeast, 35 parts of pregelatinized starch, 32.5 parts of maltodextrin, 15 parts of microcrystalline cellulose and 3 parts of functional auxiliary agent; the functional auxiliary agent is prepared from silicon dioxide and magnesium stearate in a mass ratio of 2:1, preparing a composition; the pregelatinized starch is a pregelatinized starch modifier.
The preparation method of the pregelatinized starch modifier comprises the following steps:
s1, taking cassava starch and stearic acid, wherein the stearic acid accounts for 1/60 of the cassava starch in mass, mixing and stirring at a stirring speed of 700r/min for 25min to obtain a mixture A;
s2, placing the mixture A obtained in the step S1 and zirconia balls into a ball mill, and controlling the bulk volume ratio of the mixture A to the zirconia balls to be 100 g: 450mL, reacting for 18min under the condition that the stirring speed is 400r/min to obtain a mixture B;
s3, mixing the mixture B obtained in the step S2 with alkyl glycoside and polyvinyl alcohol with the average molecular weight of 16000, wherein the amount of the alkyl glycoside is 1/100 of the mass of the mixture B, and the amount of the polyvinyl alcohol is 3/80 of the mass of the mixture B, and stirring for 20min at the stirring speed of 500r/min to obtain the composite material.
The adult human compressed tablet formulation for supplementing selenium was prepared in a similar manner to example 1.
Comparative example 1 a tabletted preparation for supplementing selenium for adults
The tabletting preparation for supplementing selenium for adults comprises the following components in parts by weight: 14.5 parts of selenium-enriched yeast, 35 parts of pregelatinized starch, 32.5 parts of maltodextrin, 15 parts of microcrystalline cellulose and 3 parts of functional auxiliary agent; the functional auxiliary agent is prepared from silicon dioxide and magnesium stearate in a mass ratio of 1: 2, preparing a composition; the pregelatinized starch is a pregelatinized starch modifier.
The pregelatinized starch modification was prepared in a manner similar to that described in example 3.
The adult human compressed tablet formulation for supplementing selenium was prepared in a similar manner to example 1.
The difference from example 3 is that the functional auxiliary agent is prepared from silicon dioxide and magnesium stearate according to a mass ratio of 1: 2.
Comparative example 2, a tabletted preparation for supplementing selenium for adults
The tabletting preparation for supplementing selenium for adults comprises the following components in parts by weight: 14.5 parts of selenium-enriched yeast, 27.5 parts of pregelatinized starch, 27.5 parts of maltodextrin, 27.5 parts of microcrystalline cellulose and 3 parts of functional auxiliary agent; the functional auxiliary agent is prepared from silicon dioxide and magnesium stearate in a mass ratio of 2:1, preparing a composition; the pregelatinized starch is a pregelatinized starch modifier.
The pregelatinized starch modification was prepared in a manner similar to that described in example 3.
The adult human compressed tablet formulation for supplementing selenium was prepared in a similar manner to example 1.
The difference from example 3 is that the mass part of pregelatinized starch was changed from 35 parts to 27.5 parts, the mass part of maltodextrin was changed from 32.5 parts to 27.5 parts, and the mass part of microcrystalline cellulose was changed from 15 parts to 27.5 parts.
Comparative example 3 a tabletted preparation for supplementing selenium for adults
The tabletting preparation for supplementing selenium for adults comprises the following components in parts by weight: 14.5 parts of selenium-enriched yeast, 41.25 parts of pregelatinized starch, 41.25 parts of maltodextrin and 3 parts of functional auxiliary agent; the functional auxiliary agent is prepared from silicon dioxide and magnesium stearate in a mass ratio of 2:1, preparing a composition; the pregelatinized starch is a pregelatinized starch modifier.
The pregelatinized starch modification was prepared in a manner similar to that described in example 3.
The adult human compressed tablet formulation for supplementing selenium was prepared in a similar manner to example 1.
The difference from example 3 is that the mass part of pregelatinized starch was changed from 35 parts to 41.25 parts, the mass part of maltodextrin was changed from 32.5 parts to 41.25 parts, and the mass part of microcrystalline cellulose was changed from 15 parts to 0 part.
Comparative example 4 a tabletted preparation for supplementing selenium for adults
The tabletting preparation for supplementing selenium for adults comprises the following components in parts by weight: 14.5 parts of selenium-enriched yeast, 35 parts of pregelatinized starch, 32.5 parts of maltodextrin, 15 parts of microcrystalline cellulose and 3 parts of functional auxiliary agent; the functional auxiliary agent is prepared from silicon dioxide and magnesium stearate in a mass ratio of 2:1, preparing a composition; the pregelatinized starch is a pregelatinized starch modifier.
The pregelatinized starch modification was prepared in a manner similar to that described in example 3.
The adult human compressed tablet formulation for supplementing selenium was prepared in a similar manner to example 1.
The difference from example 3 is that no polyvinyl alcohol is added in step S3 of the preparation method of the pregelatinized starch modification.
Test example I test of the sanitary, organoleptic and physicochemical index Properties of a selenium-supplemented tabletted preparation for adults
1. Test materials: the compressed tablets for adults, prepared in example 1, example 2, example 3 and comparative examples 1 to 4, are supplemented with selenium.
2. The test method comprises the following steps: measuring the moisture of the test material with reference to a first method of GB5009.3-2016, measuring the ash of the test material with reference to a first method of GB5009.4-2016, measuring the lead (in Pb) of the test material with reference to a first method of GB5009.12-2017, measuring the total arsenic (in As) of the test material with reference to a first method of GB 5009.11-2014/a first method of second, measuring the total mercury (in Hg) of the test material with reference to GB 5009.17-2014/a first method of second, measuring the total number of colonies of the test material with reference to GB4789.2-2016, measuring the Escherichia coli of the test material with reference to a first method of GB4789.3-2016 MPN counting, measuring the mold and yeast of the test material with reference to a first method of GB4789.15-2016, measuring the Staphylococcus aureus of the test material with reference to a first method of GB4789.10-2016, measuring the Salmonella of the test material with reference to GB4789.4-2016, the selenium (in Se) of the test material was determined with reference to GB 5009.93-2017/first method.
3. And (3) test results:
the test results are shown in tables 1 and 2.
Table 1: test result of sensory and physicochemical indexes of tabletting preparation for supplementing selenium for adults
As can be seen from Table 1, the test results of the sensory and physicochemical indexes of the tabletted preparations for adult use in supplementing selenium prepared in examples 1-3 and comparative examples 1-4 of the present invention all meet the relevant standards.
Table 2: adult uses tablet preparation health index test result of supplementing selenium element
As is clear from Table 2, the examination results of the hygiene index of the tabletted preparations for adult human use supplemented with selenium prepared in examples 1 to 3 of the present invention and comparative examples 1 to 4 were all acceptable.
Test example II examination of Performance index of selenium-supplemented tableting preparation for adults
1. Test materials: the tabletting preparations for adults, which are obtained by the examples 1-3, the comparative example 1, the comparative example 2, the comparative example 3 and the comparative example 4, are supplemented with selenium element.
2. The test method comprises the following steps:
the disintegration time was measured for the test material according to the method for detecting disintegration time of 0921 in accordance with the general rule of the fourth part of the year 2015, and the weight difference was measured for the test material according to 0101 tablet in accordance with the general rule of the fourth part of the year 2015, in accordance with the chinese pharmacopoeia.
3. And (3) test results: the test results are shown in table 3.
Table 3: performance index inspection result of tabletting preparation for supplementing selenium for adults
As can be seen from table 3, the weight difference of the compressed tablets for supplementing selenium for adults prepared by the present invention is small, and the disintegration time is short, wherein the compressed tablets for supplementing selenium for adults prepared in example 3 have the best performance, and therefore, example 3 is the best example of the present invention; compared with comparative examples 1, 2, 3 and 4, the tabletting preparation for supplementing selenium for adults prepared in example 3 has better performances and meets the requirements.
Third test example evaluation of selenium supplement Effect
1. Test materials: the tabletting preparations for adults, which are obtained in examples 1-3, comparative example 1 and comparative example 4, are supplemented with selenium element.
2. Test subjects: clean grade rats 70, male and female halves.
3. The test method comprises the following steps:
70 clean-grade rats are randomly divided into 7 groups, 10 rats are divided into 10 rats each group, the male rat and the female rat are divided into 10 rats, the rats are respectively a group of example 1, a group of example 2, a group of example 3, a group of comparative example 1, a group of comparative example 4, a positive control group and a negative control group, the feed for each group is the same, the positive control group is added with a sodium selenite solution with the selenium content of 6mg/100g, the negative control group is added with physiological saline, the adding amount of each group is 10% of the feed weight according to the feed weight, the rats are continuously fed for 14 days, and the selenium content in the rats of each group is detected.
4. The test results are shown in table 4.
Table 4: selenium supplementing effect of tabletting preparation for supplementing selenium for adults
As can be seen from table 4, compared with the negative control group, the blood selenium content of rats in the example group using the tabletting preparation for supplementing selenium for adults prepared by the present invention is significantly improved, and is significantly higher than that of the positive control group, wherein the rats in the example 3 group have the highest blood selenium content, and are the best examples of the present invention; the rats of the group of example 3 had higher blood selenium levels than the control group. Therefore, the tabletting preparation for supplementing the selenium element for the adult can promote the absorption of the nutrient components of the rat and improve the selenium content in the blood of the body.
Claims (5)
1. The tabletting preparation for supplementing selenium for adults is characterized by comprising the following components in parts by mass: 10 to 26 parts of selenium-enriched yeast, 25 to 38 parts of pregelatinized starch, 25 to 38 parts of maltodextrin, 5 to 18 parts of microcrystalline cellulose and 1.5 to 3.75 parts of functional auxiliary agent;
the functional auxiliary agent is prepared from silicon dioxide and magnesium stearate in a mass ratio of 1-2.5: 0.5 to 1.25;
the pregelatinized starch is a pregelatinized starch modifier;
the preparation method of the pregelatinized starch modifier comprises the following steps:
s1, taking cassava starch and stearic acid, wherein the stearic acid accounts for 1/60 of the cassava starch in mass, mixing and stirring at a stirring speed of 600-800 r/min for 25min to obtain a mixture A;
s2, placing the mixture A obtained in the step S1 and zirconia balls into a ball mill, and controlling the bulk volume ratio of the mixture A to the zirconia balls to be 100 g: 400-500 mL, and reacting for 15-25 min under the condition that the stirring speed is 300-500 r/min to obtain a mixture B;
s3, mixing the mixture B obtained in the step S2 with alkyl glycoside and polyvinyl alcohol, wherein the amount of the alkyl glycoside is 1/100 of the mass of the mixture B, and the amount of the polyvinyl alcohol is 3/80 of the mass of the mixture B, and stirring for 20min at a stirring speed of 400-600 r/min to obtain the composite material.
2. The compressed tablet preparation for supplementing selenium for adults as claimed in claim 1, which comprises the following components in parts by weight: 14.5 parts of selenium-enriched yeast, 35 parts of pregelatinized starch, 32.5 parts of maltodextrin, 15 parts of microcrystalline cellulose and 3 parts of functional auxiliary agent.
3. The compressed tablet formulation for supplementing selenium for adults as claimed in claim 1, wherein the functional adjuvant is prepared from silicon dioxide and magnesium stearate in a mass ratio of 2: 1.
4. The compressed tablet formulation for supplementing selenium for adults as claimed in claim 1, wherein the average molecular weight of polyvinyl alcohol in step S3 of the method for preparing the pregelatinized starch modification is 16000.
5. The method for preparing a compressed tablet formulation for supplementing elemental selenium for adults as claimed in any of claims 1 to 4, comprising the steps of:
adding selenium-enriched yeast into a mixer, sequentially adding pregelatinized starch, microcrystalline cellulose and maltodextrin, adding functional auxiliary agent, mixing for 10min, and tabletting in a tabletting machine to obtain tablet with weight of 0.5g per tablet.
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Denomination of invention: Tablet preparation of selenium supplement for adults and its preparation method Effective date of registration: 20220927 Granted publication date: 20210914 Pledgee: Development Zone sub branch of Bank of Guangzhou Co.,Ltd. Pledgor: GUANGZHOU FUNUO NUTRITION TECHNOLOGY Co.,Ltd. Registration number: Y2022980016324 |
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Granted publication date: 20210914 Pledgee: Development Zone sub branch of Bank of Guangzhou Co.,Ltd. Pledgor: GUANGZHOU FUNUO NUTRITION TECHNOLOGY Co.,Ltd. Registration number: Y2022980016324 |