CN113876725A - Vitamin B6 tablet and preparation method thereof - Google Patents
Vitamin B6 tablet and preparation method thereof Download PDFInfo
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- CN113876725A CN113876725A CN202011085463.4A CN202011085463A CN113876725A CN 113876725 A CN113876725 A CN 113876725A CN 202011085463 A CN202011085463 A CN 202011085463A CN 113876725 A CN113876725 A CN 113876725A
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- LXNHXLLTXMVWPM-UHFFFAOYSA-N pyridoxine Chemical compound CC1=NC=C(CO)C(CO)=C1O LXNHXLLTXMVWPM-UHFFFAOYSA-N 0.000 title claims abstract description 142
- RADKZDMFGJYCBB-UHFFFAOYSA-N pyridoxal hydrochloride Natural products CC1=NC=C(CO)C(C=O)=C1O RADKZDMFGJYCBB-UHFFFAOYSA-N 0.000 title claims abstract description 72
- 229940011671 vitamin b6 Drugs 0.000 title claims abstract description 71
- 239000011726 vitamin B6 Substances 0.000 title claims abstract description 68
- 235000019158 vitamin B6 Nutrition 0.000 title claims abstract description 68
- 238000002360 preparation method Methods 0.000 title claims description 11
- 229920002261 Corn starch Polymers 0.000 claims abstract description 28
- 229920002472 Starch Polymers 0.000 claims abstract description 28
- 239000008120 corn starch Substances 0.000 claims abstract description 28
- 239000008107 starch Substances 0.000 claims abstract description 27
- 235000019698 starch Nutrition 0.000 claims abstract description 27
- VYPSYNLAJGMNEJ-UHFFFAOYSA-N Silicium dioxide Chemical compound O=[Si]=O VYPSYNLAJGMNEJ-UHFFFAOYSA-N 0.000 claims abstract description 26
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 26
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims abstract description 23
- 239000008101 lactose Substances 0.000 claims abstract description 23
- 239000002002 slurry Substances 0.000 claims abstract description 23
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 16
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 13
- 235000012239 silicon dioxide Nutrition 0.000 claims abstract description 13
- 239000000377 silicon dioxide Substances 0.000 claims abstract description 13
- 239000002994 raw material Substances 0.000 claims abstract description 7
- 229940088594 vitamin Drugs 0.000 claims abstract description 6
- 229930003231 vitamin Natural products 0.000 claims abstract description 6
- 235000013343 vitamin Nutrition 0.000 claims abstract description 6
- 239000011782 vitamin Substances 0.000 claims abstract description 6
- 150000003722 vitamin derivatives Chemical class 0.000 claims abstract description 6
- 238000002156 mixing Methods 0.000 claims description 29
- 239000000463 material Substances 0.000 claims description 28
- 239000008187 granular material Substances 0.000 claims description 21
- 238000001035 drying Methods 0.000 claims description 18
- 238000003756 stirring Methods 0.000 claims description 15
- 238000005520 cutting process Methods 0.000 claims description 10
- 238000007873 sieving Methods 0.000 claims description 9
- 238000000034 method Methods 0.000 claims description 7
- 238000005469 granulation Methods 0.000 claims description 6
- 230000003179 granulation Effects 0.000 claims description 6
- 238000005550 wet granulation Methods 0.000 claims description 6
- 238000007908 dry granulation Methods 0.000 claims description 5
- 238000004806 packaging method and process Methods 0.000 claims description 5
- 238000005303 weighing Methods 0.000 claims description 5
- 229930003270 Vitamin B Natural products 0.000 claims description 3
- 238000009835 boiling Methods 0.000 claims description 3
- 239000002245 particle Substances 0.000 claims description 3
- 235000019156 vitamin B Nutrition 0.000 claims description 3
- 239000011720 vitamin B Substances 0.000 claims description 3
- 238000003860 storage Methods 0.000 abstract description 3
- 230000009286 beneficial effect Effects 0.000 description 7
- 239000003814 drug Substances 0.000 description 6
- 238000001514 detection method Methods 0.000 description 4
- NHZMQXZHNVQTQA-UHFFFAOYSA-N pyridoxamine Chemical compound CC1=NC=C(CO)C(CN)=C1O NHZMQXZHNVQTQA-UHFFFAOYSA-N 0.000 description 4
- 235000013339 cereals Nutrition 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000004080 punching Methods 0.000 description 3
- 235000008160 pyridoxine Nutrition 0.000 description 3
- 239000011677 pyridoxine Substances 0.000 description 3
- 238000013112 stability test Methods 0.000 description 3
- 238000012360 testing method Methods 0.000 description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- 206010047700 Vomiting Diseases 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 235000008164 pyridoxal Nutrition 0.000 description 2
- 239000011674 pyridoxal Substances 0.000 description 2
- 229960003581 pyridoxal Drugs 0.000 description 2
- 235000008151 pyridoxamine Nutrition 0.000 description 2
- 239000011699 pyridoxamine Substances 0.000 description 2
- 239000000243 solution Substances 0.000 description 2
- 230000008673 vomiting Effects 0.000 description 2
- 241000251468 Actinopterygii Species 0.000 description 1
- 235000017060 Arachis glabrata Nutrition 0.000 description 1
- 244000105624 Arachis hypogaea Species 0.000 description 1
- 235000010777 Arachis hypogaea Nutrition 0.000 description 1
- 235000018262 Arachis monticola Nutrition 0.000 description 1
- 240000003183 Manihot esculenta Species 0.000 description 1
- 235000016735 Manihot esculenta subsp esculenta Nutrition 0.000 description 1
- 229910019142 PO4 Inorganic materials 0.000 description 1
- 244000046052 Phaseolus vulgaris Species 0.000 description 1
- 235000010627 Phaseolus vulgaris Nutrition 0.000 description 1
- 240000004808 Saccharomyces cerevisiae Species 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 239000003513 alkali Substances 0.000 description 1
- 239000012670 alkaline solution Substances 0.000 description 1
- 230000037354 amino acid metabolism Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 239000005515 coenzyme Substances 0.000 description 1
- 230000000052 comparative effect Effects 0.000 description 1
- 239000013078 crystal Substances 0.000 description 1
- 230000003247 decreasing effect Effects 0.000 description 1
- 239000007884 disintegrant Substances 0.000 description 1
- 235000013601 eggs Nutrition 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 239000000945 filler Substances 0.000 description 1
- 235000019688 fish Nutrition 0.000 description 1
- 239000000796 flavoring agent Substances 0.000 description 1
- 235000013355 food flavoring agent Nutrition 0.000 description 1
- 239000012535 impurity Substances 0.000 description 1
- 238000001727 in vivo Methods 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 206010025482 malaise Diseases 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 235000013372 meat Nutrition 0.000 description 1
- 238000006241 metabolic reaction Methods 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 235000020232 peanut Nutrition 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- NBIIXXVUZAFLBC-UHFFFAOYSA-K phosphate Chemical compound [O-]P([O-])([O-])=O NBIIXXVUZAFLBC-UHFFFAOYSA-K 0.000 description 1
- 239000010452 phosphate Substances 0.000 description 1
- 230000035935 pregnancy Effects 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 231100000331 toxic Toxicity 0.000 description 1
- 230000002588 toxic effect Effects 0.000 description 1
- 229940100445 wheat starch Drugs 0.000 description 1
Classifications
-
- 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
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/44—Non condensed pyridines; Hydrogenated derivatives thereof
- A61K31/4415—Pyridoxine, i.e. Vitamin B6
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
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- Health & Medical Sciences (AREA)
- Public Health (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Otolaryngology (AREA)
- Hospice & Palliative Care (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicinal Preparation (AREA)
- Organic Chemistry (AREA)
Abstract
The invention discloses a vitamin B6 tablet which is prepared from the following raw materials in parts by weight: vitamin B65-14 parts, corn starch 25-35 parts, lactose 25-35 parts, starch slurry 0.8-2 parts, silicon dioxide 0.2-0.5 part, magnesium stearate 0.2-0.5 part, and water 8-15 parts. The invention can improve the binding and disintegrating action of the corn starch in the tablet, improve the formability of the tablet, shorten the disintegrating time of the tablet, improve the bioavailability of the tablet, improve the stability of the product and prolong the storage period.
Description
Technical Field
The invention belongs to the technical field of pharmaceutical preparations, and particularly relates to a vitamin B6 tablet and a preparation method thereof.
Background
Vitamin B6 is also called pyridoxine, which includes pyridoxine, pyridoxal and pyridoxamine, exists in vivo in the form of phosphate, is a water-soluble vitamin, is easily destroyed by light or alkali, and is not resistant to high temperature. Named vitamin B6 in 1936. Vitamin B6 is colorless crystal, is easily soluble in water and ethanol, is stable in acid solution, is easily destroyed in alkaline solution, and has heat resistance to pyridoxine, pyridoxal and pyridoxamine. Vitamin B6 is rich in yeast, liver, grain, meat, fish, egg, bean and peanut. Vitamin B6 is a component of some coenzymes in human body, participates in various metabolic reactions, and especially has close relation with amino acid metabolism. The vitamin B6 preparation is clinically applied to prevent and treat vomiting of pregnancy and vomiting of radiation sickness.
At present, the existing vitamin B6 tablets contain more types and quantities of auxiliary materials, generally use fillers, lubricants, disintegrants, adhesives, flavoring agents and the like, and have long disintegration time, lower bioavailability and low stability. And more researches show that the toxic and side effects of the auxiliary materials, the incompatibility of the auxiliary materials and the main medicine, impurities in the auxiliary materials and the like all affect the safety of the medicine.
Therefore, the formula and the preparation method for reducing the types and the dosage of the auxiliary materials in the vitamin B6 tablets and improving the bioavailability of the vitamin B6 tablets are provided by selecting proper auxiliary materials and processes, and the problems to be solved by the technical personnel in the field are urgently needed.
Disclosure of Invention
In view of the above, the present invention provides a vitamin B6 tablet and a preparation method thereof.
In order to achieve the purpose, the invention adopts the following technical scheme:
a vitamin B6 tablet is prepared from the following raw materials in parts by weight: vitamin B65-14 parts, corn starch 25-35 parts, lactose 25-35 parts, starch slurry 0.8-2 parts, silicon dioxide 0.2-0.5 part, magnesium stearate 0.2-0.5 part, and water 8-15 parts.
The invention has the beneficial effects that: the invention can improve the binding and disintegrating action of starch in the tablet, improve the formability of the tablet, shorten the disintegrating time of the tablet, improve the bioavailability of the tablet, improve the stability of the product and prolong the storage period.
Further, the vitamin B6 tablet is prepared from the following raw materials in parts by weight: 610 parts of vitamin B, 30 parts of corn starch, 28 parts of lactose, 1.2 parts of starch slurry, 0.3 part of silicon dioxide, 0.3 part of magnesium stearate and 10.8 parts of water.
Further, the starch slurry is prepared by mixing starch and water, wherein the mass percentage concentration of the starch is 8-12%.
Further, the starch is any one of wheat starch slurry, tapioca starch slurry and corn starch slurry.
Adopt above-mentioned further beneficial effect: starch slurry with a certain concentration is added, so that the viscosity of the material is increased, and the stability of the product is improved.
Furthermore, the grain sizes of the corn starch and the lactose are both 70-90 meshes.
The invention also provides a preparation method of the vitamin B6 tablet, which comprises the following steps:
1) weighing the raw materials according to the vitamin B6 tablet;
2) mixing and granulating: firstly, averagely dividing vitamin B6 into two parts, then mixing each part of vitamin B6 with corn starch and lactose according to the weight ratio of 1:1:1, sieving, adding the two parts of sieved materials and the rest of corn starch and lactose into a wet granulator, stirring and cutting, adding starch slurry, and granulating to obtain wet materials;
3) wet granulation: placing the obtained wet material in a swinging granulator, and preparing wet granules by using a screen mesh;
4) and (3) drying: drying the obtained wet granules in a boiling dryer;
5) dry granulation: placing the dried granules in a swinging granulator, and granulating by using a screen;
6) total mixing: putting the dried and granulated granules into a mixer, adding silicon dioxide and magnesium stearate, and mixing;
7) tabletting and packaging.
The invention has the beneficial effects that: the production process is mature and simple, the production efficiency is high, the equipment investment is low, and the product cost is low.
Further, the sieving in the step 2) is 50-70 mesh sieving, the stirring speed is 230r/min and the stirring time is 8-12min, the cutting speed is 2100r/min and the granulation time is 4-6 min.
Adopt above-mentioned further beneficial effect: the materials are mixed more uniformly, and the formability of the tablet is improved.
Further, the wet granules prepared in the step 3) are prepared by using a 17-19 mesh screen.
Further, in the step 4), the air inlet temperature of the boiling dryer is 90-110 ℃, the air outlet temperature is 30-50 ℃, the drying time is 10-15min, and the drying is carried out until the water content is 3% -5%.
Adopt above-mentioned further beneficial effect: drying to a certain extent can improve the stability of the product and prolong the storage life.
Further, step 5) the above granulation is granulation with 17-19 mesh screen.
Further, the mixing time in the step 6) is 22-28min, and the mixing rotating speed is 10-13 r/min.
Adopt above-mentioned further beneficial effect: the materials are mixed more uniformly, and the formability of the tablet is improved.
Further, step 7) calculating the tablet weight according to the detection result of the total mixed materials by the tabletting:
standard tablet weight of 0.01g × 100.0%/main medicine content
The 5.5mm flat punch is adopted, the tabletting speed is controlled within 20-25rpm/min, the weight range of the tablet is controlled within +/-5 percent, and the hardness control range is 2kg-5 kg.
Adopt above-mentioned further beneficial effect: the vitamin B6 tablet has no obvious difference with the common tablet in friability and hardness, and meets the requirements of Chinese pharmacopoeia on tablets in 2010 edition.
Detailed Description
The technical solutions in the embodiments of the present invention will be clearly and completely described below, and it is obvious that the described embodiments are only a part of the embodiments of the present invention, and not all embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.
Example 1
A preparation method of vitamin B6 tablets comprises the following steps:
1) weighing vitamin B65kg, 25kg of corn starch, 25kg of lactose, 0.8kg of starch slurry, 0.2kg of silicon dioxide, 0.2kg of magnesium stearate and 8kg of water, wherein the mass percentage concentration of the corn starch in the starch slurry is 8 percent, and the grain sizes of the corn starch and the lactose are both 70 meshes;
2) mixing and granulating: firstly, averagely dividing vitamin B6 into two parts, then mixing each part of vitamin B6 with corn starch and lactose according to the weight ratio of 1:1:1, sieving by a 50-mesh sieve, adding the two parts of sieved materials and the rest of corn starch and lactose into a wet granulator, starting stirring and cutting, wherein the stirring rotating speed is 210r/min, the stirring time is 8min, the cutting rotating speed is 1900r/min, starch slurry is added at 210r/min, and granulation is carried out for 4min to obtain wet materials;
3) wet granulation: placing the obtained wet material in a swinging granulator, and preparing wet granules by using a 17-mesh screen;
4) and (3) drying: drying the obtained wet granules in a fluidized bed dryer at air inlet temperature of 90 deg.C and air outlet temperature of 30 deg.C for 10min until the water content is 3%;
5) dry granulation: placing the dried granules in a swinging granulator, and granulating by using a 17-mesh screen;
6) total mixing: putting the dry and granulated granules into a mixer, adding silicon dioxide and magnesium stearate, and mixing for 22min at a mixing speed of 10 r/min;
7) tabletting, packaging, and calculating the tablet weight according to the detection result of the total mixed material by tabletting:
standard tablet weight of 0.01g × 100.0%/main medicine content
5.5mm flat punching is adopted, the tabletting speed is controlled at 20rpm/min, the weight range of the tablet is controlled within +/-5 percent, and the hardness control range is 2 kg.
Example 2
A preparation method of vitamin B6 tablets comprises the following steps:
1) weighing 610kg vitamin B, 30kg corn starch, 28kg lactose, 1.2kg starch slurry, 0.3kg silicon dioxide, 0.3kg magnesium stearate and 10.8kg water, wherein the mass percentage concentration of the corn starch in the starch slurry is 10%, and the particle sizes of the corn starch and the lactose are both 80 meshes;
2) mixing and granulating: firstly, averagely dividing vitamin B6 into two parts, then mixing each part of vitamin B6 with corn starch and lactose according to the weight ratio of 1:1:1, sieving by a 60-mesh sieve, adding the two parts of sieved materials and the rest of corn starch and lactose into a wet granulator, starting stirring and cutting, wherein the stirring rotating speed is 2120r/min, the stirring time is 10min, the cutting rotating speed is 2000r/min, adding starch slurry at 220r/min, granulating, and granulating for 5min to obtain wet materials;
3) wet granulation: placing the obtained wet material in a swing granulator, and preparing wet granules by using a 18-mesh screen;
4) and (3) drying: drying the obtained wet granules in a fluidized bed dryer at air inlet temperature of 100 deg.C and air outlet temperature of 40 deg.C for 12min until the water content is 4%;
5) dry granulation: placing the dried granules in a swing granulator, and granulating with a 18-mesh screen;
6) total mixing: putting the dry and granulated granules into a mixer, adding silicon dioxide and magnesium stearate, and mixing for 25min at a mixing speed of 11 r/min;
7) tabletting, packaging, and calculating the tablet weight according to the detection result of the total mixed material by tabletting:
standard tablet weight of 0.01g × 100.0%/main medicine content
5.5mm flat punching is adopted, the tabletting speed is controlled at 22rpm/min, the weight range of the tablet is controlled within +/-5 percent, and the hardness control range is 4 kg.
Example 3
A preparation method of vitamin B6 tablets comprises the following steps:
1) weighing vitamin B614kg, 35kg of corn starch, 35kg of lactose, 2kg of starch slurry, 0.5kg of silicon dioxide, 0.5kg of magnesium stearate and 15kg of water, wherein the mass percentage concentration of the corn starch in the starch slurry is 12 percent, and the particle sizes of the corn starch and the lactose are both 90 meshes;
2) mixing and granulating: firstly, averagely dividing vitamin B6 into two parts, then mixing each part of vitamin B6 with corn starch and lactose according to the weight ratio of 1:1:1, sieving with a 70-mesh sieve, adding the two parts of sieved materials and the rest of corn starch and lactose into a wet granulator, starting stirring and cutting, wherein the stirring rotation speed is 230r/min, the stirring time is 12min, the cutting rotation speed is 2100r/min, starch slurry is added at 230r/min, and granulation is carried out for 6min to obtain wet materials;
3) wet granulation: placing the obtained wet material in a swing granulator, and using a 19-mesh screen to prepare wet granules;
4) and (3) drying: drying the obtained wet granules in a fluidized bed dryer, setting the air inlet temperature at 110 ℃, the air outlet temperature at 50 ℃ and the drying time at 15min, and drying until the water content is 5%;
5) dry granulation: placing the dried granules in a swing granulator, and granulating with a 19-mesh screen;
6) total mixing: putting the dry and granulated granules into a mixer, adding silicon dioxide and magnesium stearate, and mixing for 28min at a mixing speed of 13 r/min;
7) tabletting, packaging, and calculating the tablet weight according to the detection result of the total mixed material by tabletting:
standard tablet weight of 0.01g × 100.0%/main medicine content
5.5mm flat punching is adopted, the tabletting speed is controlled at 25rpm/min, the weight range of the tablet is controlled within +/-5 percent, and the hardness control range is 5 kg.
Effect experiment: the vitamin B6 tablets prepared in examples 1 to 3 above were subjected to the following quality study tests:
1. comparative test of disintegration time limit: the disintegration time of the vitamin B6 tablets and the vitamin B6 tablets prepared in examples 1 to 3 (commercially available) was checked according to the procedure of annex XA of the second part of the chinese pharmacopoeia (2010 version), and the results are shown in tables 1 and 2, wherein nos. 1 to 6 in table 1 are vitamin B6 tablets (commercially available), nos. 1 and 2 in table 2 are example 1 tablets, nos. 3 and 4 are example 2 tablets, and nos. 5 and 6 are example 3 tablets;
TABLE 1 disintegration of commercially available vitamin B6 tablets
TABLE 2 disintegration of vitamin B6 tablets of the invention
And (5) judging a result: according to the quality standard of vitamin B6 tablets in the second part of Chinese pharmacopoeia (2010 version) and the measurement standard of annex XA in the second part of Chinese pharmacopoeia (2010 version) on the disintegration time limit of the tablets, the disintegration time limit of the vitamin B6 tablets is qualified when not more than 15min and is actually measured to be 13min, while the disintegration time limit of the vitamin B6 tablets is 5 min. Therefore, the disintegration time of the vitamin B6 tablet is reduced by 8min compared with the disintegration time of the vitamin B6 tablet, so that the vitamin B6 tablet is absorbed by human bodies more quickly, the peak time of the blood concentration is shorter than that of a common vitamin B6 tablet (sold in the market), the bioavailability is higher, and the curative effect is better.
2. Stability test
Vitamin B6 general tablets (commercially available) No. 1 to No. 3 and vitamin B6 tablets No. 1 to No. 3 of the examples of the present invention were subjected to a three-month stability test, and the quality of vitamin B6 was examined. The ratio of the mass of vitamin B6 remaining after three months to the mass of vitamin B6 at 0 month was recorded in table 3 with the content of vitamin B6 at 0 month defined as 100%, and the test results are listed in table 3.
TABLE 3 stability test results of vitamin B6 tablets of the present invention
As can be seen from Table 3, the vitamin B6 content of the conventional vitamin B6 tablet (commercially available) decreased rapidly, whereas the vitamin B6 content of the vitamin B6 tablet sample of the present invention was maintained at a constant level.
The description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.
Claims (10)
1. The vitamin B6 tablet is characterized by being prepared from the following raw materials in parts by weight: vitamin B65-14 parts, corn starch 25-35 parts, lactose 25-35 parts, starch slurry 0.8-2 parts, silicon dioxide 0.2-0.5 part, magnesium stearate 0.2-0.5 part, and water 8-15 parts.
2. The vitamin B6 tablet according to claim 1, wherein the vitamin B6 tablet is prepared from the following raw materials in parts by weight: 610 parts of vitamin B, 30 parts of corn starch, 28 parts of lactose, 1.2 parts of starch slurry, 0.3 part of silicon dioxide, 0.3 part of magnesium stearate and 10.8 parts of water.
3. The vitamin B6 tablet of claim 2, wherein the starch slurry is prepared by mixing starch and water, and the starch concentration in the starch slurry is 8-12% by weight.
4. The vitamin B6 tablet according to claim 2, wherein the corn starch and the lactose each have a particle size of 70-90 mesh.
5. A preparation method of a vitamin B6 tablet is characterized by comprising the following steps:
1) weighing the raw materials according to the vitamin B6 tablet of any one of claims 1 to 4;
2) mixing and granulating: firstly, averagely dividing vitamin B6 into two parts, then mixing each part of vitamin B6 with corn starch and lactose according to the weight ratio of 1:1:1, sieving, adding the two parts of sieved materials and the rest of corn starch and lactose into a wet granulator, stirring and cutting, adding starch slurry, and granulating to obtain wet materials;
3) wet granulation: placing the obtained wet material in a swinging granulator, and preparing wet granules by using a screen mesh;
4) and (3) drying: drying the obtained wet granules in a boiling dryer;
5) dry granulation: placing the dried granules in a swinging granulator, and granulating by using a screen;
6) total mixing: putting the dried and granulated granules into a mixer, adding silicon dioxide and magnesium stearate, and mixing;
7) tabletting and packaging.
6. The method for preparing vitamin B6 tablets as claimed in claim 5, wherein the sieving in step 2) is 50-70 mesh sieving, the stirring speed is 230r/min, the stirring time is 8-12min, the cutting speed is 2100r/min, and the granulation time is 4-6 min.
7. The method for preparing vitamin B6 tablets, according to claim 5, wherein the wet granulation prepared in step 3) is prepared by using a 17-19 mesh sieve.
8. The method for preparing vitamin B6 tablets according to claim 5, wherein the air inlet temperature of the fluidized drying machine in step 4) is set to be 90-110 ℃, the air outlet temperature is set to be 30-50 ℃, the drying time is 10-15min, and the drying is carried out until the water content is 3% -5%.
9. The method for preparing vitamin B6 tablets, according to claim 5, wherein the granulating of step 5) is performed by using a 17-19 mesh screen.
10. The method for preparing vitamin B6 tablets, according to claim 5, wherein the mixing time of step 6) is 22-28min, and the mixing speed is 10-13 r/min.
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| Application Number | Priority Date | Filing Date | Title |
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| CN202011085463.4A CN113876725A (en) | 2020-10-12 | 2020-10-12 | Vitamin B6 tablet and preparation method thereof |
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| Application Number | Priority Date | Filing Date | Title |
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| CN202011085463.4A CN113876725A (en) | 2020-10-12 | 2020-10-12 | Vitamin B6 tablet and preparation method thereof |
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| US5501861A (en) * | 1992-01-29 | 1996-03-26 | Takeda Chemical Industries, Ltd. | Fast dissolving tablet and its production |
| CN102940610A (en) * | 2012-11-05 | 2013-02-27 | 海南卫康制药(潜山)有限公司 | Vitamin B6 composition freeze-drying orally disintegrating tablets and preparation method thereof |
| CN104523614A (en) * | 2014-12-05 | 2015-04-22 | 海南卫康制药(潜山)有限公司 | Vitamin B6 composition freeze-dried tablet and preparation method thereof |
| CN111110643A (en) * | 2020-01-09 | 2020-05-08 | 仁和堂药业有限公司 | Vitamin B6 tablet and quality detection method thereof |
| CN111419808A (en) * | 2020-04-23 | 2020-07-17 | 河南海汇药物研究有限公司 | Vitamin B6 full-powder tabletting process |
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| US5501861A (en) * | 1992-01-29 | 1996-03-26 | Takeda Chemical Industries, Ltd. | Fast dissolving tablet and its production |
| CN102940610A (en) * | 2012-11-05 | 2013-02-27 | 海南卫康制药(潜山)有限公司 | Vitamin B6 composition freeze-drying orally disintegrating tablets and preparation method thereof |
| CN104523614A (en) * | 2014-12-05 | 2015-04-22 | 海南卫康制药(潜山)有限公司 | Vitamin B6 composition freeze-dried tablet and preparation method thereof |
| CN111110643A (en) * | 2020-01-09 | 2020-05-08 | 仁和堂药业有限公司 | Vitamin B6 tablet and quality detection method thereof |
| CN111419808A (en) * | 2020-04-23 | 2020-07-17 | 河南海汇药物研究有限公司 | Vitamin B6 full-powder tabletting process |
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| 张汝华等主编, 中国医药科技出版社 * |
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