CN110664832A - Vitamin B6 vitamin B12 folic acid tablet and preparation method thereof - Google Patents

Vitamin B6 vitamin B12 folic acid tablet and preparation method thereof Download PDF

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Publication number
CN110664832A
CN110664832A CN201911126929.8A CN201911126929A CN110664832A CN 110664832 A CN110664832 A CN 110664832A CN 201911126929 A CN201911126929 A CN 201911126929A CN 110664832 A CN110664832 A CN 110664832A
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vitamin
coating
folic acid
tablet
tablet core
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陈斌
陈国靖
汪善文
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XUANCHENG BAIWEILI BIOLOGICAL ENGINEERING CO LTD
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435Heterocyclic 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
    • A61K31/44Non condensed pyridines; Hydrogenated derivatives thereof
    • A61K31/4415Pyridoxine, i.e. Vitamin B6
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7135Compounds containing heavy metals
    • A61K31/714Cobalamins, e.g. cyanocobalamin, i.e. vitamin B12
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2013Organic compounds, e.g. phospholipids, fats
    • A61K9/2018Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods
    • A61K9/2004Excipients; Inactive ingredients
    • A61K9/2022Organic macromolecular compounds
    • A61K9/205Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
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    • A61K9/2095Tabletting 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
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    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
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    • A61K9/28Dragees; Coated pills or tablets, e.g. with film or compression coating
    • AHUMAN NECESSITIES
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • AHUMAN NECESSITIES
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    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/02Nutrients, e.g. vitamins, minerals
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    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/04Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

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Abstract

The vitamin B6 vitamin B12 folic acid tablet comprises a tablet core and a coating, wherein the tablet core comprises folic acid, cyanocobalamine 1%, pyridoxine hydrochloride, microcrystalline cellulose PH102, lactose and magnesium stearate in parts by weight, and the coating mainly composed of coating powder is coated outside the tablet core. The invention has the beneficial effects that: the vitamin B6 vitamin B12 folic acid tablet can comprehensively supplement vitamin B6 vitamin B12 folic acid and prevent cerebrovascular diseases, is designed to be swallowed and is convenient to carry; the finished product prepared by the preparation method has high qualification rate, and the waste of raw materials is reduced.

Description

Vitamin B6 vitamin B12 folic acid tablet and preparation method thereof
Technical Field
The invention relates to the field of health-care food, in particular to a vitamin B6 vitamin B12 folic acid tablet and a preparation method thereof.
Background
Cerebrovascular diseases are brain diseases caused by various cerebrovascular diseases, and can be classified into ischemic brain, stroke and hemorrhagic stroke according to the pathological nature. At home and abroad, it is acknowledged that the deficiency of folic acid, vitamin B6 and vitamin B12 can cause homocysteinemia and increase the risk of cerebrovascular diseases, and the deficiency of folic acid, vitamin B6 and vitamin B12 is a risk factor for causing cerebrovascular diseases.
Folic acid, vitamin B6 and vitamin B12 are important coenzymes for metabolism of homocysteine in vivo, and in order to reduce serum homocysteine concentration, the vitamin B supplementing method can be adopted. The research on folic acid, vitamin B6, vitamin B12 and homocysteine can help to prevent and treat cerebrovascular diseases.
At present, most of products in the market, including pharmaceutical preparations, exist in a single mode, and no compound product which is mainly used for prevention is definitely appeared. Therefore, the emergence of vitamin B6 vitamin B12 folic acid tablets can certainly generate important clinical significance.
Disclosure of Invention
In order to solve the technical problems, the invention provides vitamin B6, vitamin B12 and folic acid tablets and a preparation method thereof, which can comprehensively supplement vitamin B6, vitamin B12 and folic acid and prevent cerebrovascular diseases. It is designed to be swallowed and is convenient to carry.
The invention relates to a vitamin B6 vitamin B12 folic acid tablet, which adopts the technical scheme that: the tablet core mainly comprises a tablet core and a coating, wherein the tablet core comprises folic acid, cyanocobalamine 1% (vitamin B12), pyridoxine hydrochloride (vitamin B6), microcrystalline cellulose PH102, lactose and magnesium stearate according to parts by weight, and the coating mainly comprises coating powder.
Further, the vitamin B6 vitamin B12 folic acid tablet is designed into a tablet shape, the tablet core of each tablet is 250mg, and the tablet comprises the following components: 0.48mg folic acid, 0.31mg cyanocobalamin 1%, 4.01mg pyridoxine hydrochloride, 144.5mg microcrystalline cellulose pH102, 98.2mg lactose and 2.5mg magnesium stearate.
Further, the coating outside each tablet core contains: 7.5mg coating powder.
A preparation method of vitamin B6 vitamin B12 folic acid tablets comprises the following steps:
1) mixing: mixing folic acid, 1% of cyanocobalamine and pyridoxine hydrochloride by hand for 3 minutes according to the formula amount, sieving with an 80-mesh sieve, and then gradually mixing with microcrystalline cellulose PH102 according to the equivalent amount for three times, and sieving with the 80-mesh sieve each time to obtain a first mixture;
2) total mixing: the first mixture was then sequentially fed into a mixer with the remaining microcrystalline cellulose PH102, lactose, set to: rotating at a speed of 10 r/min for 5min, stopping the machine, adding magnesium stearate in a prescribed amount, continuously mixing for 5min, stopping the machine after mixing, obtaining granules to be subjected to tabletting, and transferring the granules to a tabletting room or an intermediate station for tabletting and temporarily storing;
3) tabletting: putting the total mixed granules to be tabletted into a punch die of a high-speed tabletting machine for tabletting to obtain tablet cores;
4) sampling and detecting;
5) coating: placing 6.14kg of purified water in a slurry preparation container of a coating machine, starting stirring to keep the solution in a vortex shape, slowly adding 1kg of pink coating powder into the purified water, and continuously stirring for 45 minutes to obtain a coating solution;
putting the tablet core into a coating machine for coating, and drying the finished product for 5-10 minutes;
6) packaging: and packaging the finished product.
Further, in the step 3), the punch die is in a circular shallow arc shape, and the diameter of the punch die is 8 mm.
Further, in the step 3), the average tablet weight of the obtained tablet cores is checked every 15 min; checking the weight of each slice every 30min, and taking 10 slices each time; and simultaneously checking whether the appearance meets the requirement, wherein the difference of the tablet weight is 231mg-268mg (+ -7.5%), the hardness is 80-150N, the friability is less than 0.5%, the disintegration time is within 30min, and the tablet cores which do not meet the condition are scrapped according to unqualified products.
Further, in the step 5), the conditions of coating the tablet core by the coating machine are set as that the rotating speed of a coating pan is 2-5r/min, the preheating tablet bed is 35-45 ℃, the air inlet temperature is 60-70 ℃, the air outlet temperature is 30-40 ℃, the air return is negative pressure and atomization pressure which are used for keeping 0.02-0.10KPa in the coating machine: 0.40-0.60MPa, and the spraying speed of the spray gun of the coating machine is 5-15 HZ.
The invention has the beneficial effects that: the vitamin B6 vitamin B12 folic acid tablet can comprehensively supplement vitamin B6 vitamin B12 folic acid and prevent cerebrovascular diseases, is designed to be swallowed and is convenient to carry; the finished product prepared by the preparation method has high qualification rate, and the waste of raw materials is reduced.
Drawings
In order that the present invention may be more readily and clearly understood, a more particular description of the invention briefly described above will be rendered by reference to specific embodiments that are illustrated in the appended drawings.
FIG. 1 is a first batch test report of vitamin B6 vitamin B12 folic acid tablets according to the present invention.
Fig. 2 is a second batch test report sheet of vitamin B6, vitamin B12 folic acid tablets according to the present invention.
Fig. 3 is a third batch test report sheet of vitamin B6, vitamin B12 folic acid tablets according to the present invention.
Detailed Description
As shown in fig. 1-3, the vitamin B6 vitamin B12 folic acid tablet of the present invention comprises a tablet core and a coating, wherein each 250mg tablet core comprises: 0.48mg folic acid, 0.31mg cyanocobalamin 1%, 4.01mg pyridoxine hydrochloride, 144.5mg microcrystalline cellulose PH102, 98.2mg lactose and 2.5mg magnesium stearate, the core being coated with a coating consisting of 7.5mg coating powder.
A preparation method of vitamin B6 vitamin B12 folic acid tablets comprises the following steps:
1) mixing: mixing folic acid, 1% of cyanocobalamine and pyridoxine hydrochloride by hand for 3 minutes according to the formula amount, sieving with an 80-mesh sieve, and then gradually mixing with microcrystalline cellulose PH102 according to the equivalent amount for three times, and sieving with the 80-mesh sieve each time to obtain a first mixture;
because no mechanical equipment meeting the requirements can accurately finish the equivalent incremental mixing of trace elements at present, the equivalent incremental mixing of three elements of folic acid, cyanocobalamin 1 percent and pyridoxine hydrochloride is manually finished according to production batches in the step 1) according to the batches of each batch, so that the actual production operation is more convenient and accurate;
mixing the microcrystalline cellulose PH102 three times through a mixing device (model of a mixer: HDJ-15) according to the principle that the output of each batch is increased in equal quantity, mixing three trace elements in equal quantity to the three elements in equal quantity, mixing the mixed elements in equal quantity with the microcrystalline cellulose, and increasing the mixing quantity of each time step by step in equal ratio, so that the stability of functional components and the uniformity of particles of the product can be ensured, and the quality of the product is more stable;
2) total mixing: the first mixture was then sequentially fed into a mixer with the remaining microcrystalline cellulose PH102 and direct lactose press, set to: rotating at a speed of 10 r/min for 5min, stopping the machine, adding magnesium stearate in a prescribed amount, continuously mixing for 5min, stopping the machine for blanking after mixing is finished to obtain total mixed granules to be tabletted, packaging the granules by a double-layer PE bag, and then transferring the granules to a tabletting room or an intermediate station for tabletting and temporarily storing;
the mixer adopted in the embodiment is an HZD type mixer produced by Tianjin Hanlin aerospace science and technology development Limited;
3) tabletting: putting the total mixed granules to be tabletted into a punch die of a high-speed tabletting machine for tabletting to obtain a tablet core;
in the embodiment, a GZPS-51 full-automatic double-discharging high-speed tablet press is adopted, the model of the punch die is MG-001, the punch die is in a circular shallow arc shape, and the diameter of the punch die is 8 mm;
checking the average tablet weight of the obtained tablet core every 15 min; checking the weight of each slice every 30min, and taking 10 slices each time; checking whether the appearance meets the requirement, wherein the tablet weight is 250mg-268mg (preferably 250mg or above, ensuring that the net content meets the requirement), the hardness is 80-150N, the friability is less than 0.5%, the disintegration time is within 30min, and the thickness of the tablet core is 4 mm;
4) sampling and detecting;
5) coating: placing 6.14kg of purified water in a slurry preparation container of a coating machine, starting stirring to keep the solution in a vortex shape, slowly adding 1kg of pink coating powder into the purified water, and continuously stirring for 45 minutes to obtain a coating solution;
placing the tablet core into JBG-150C/JBG-350E high-efficiency sugar-coating film coating machine manufactured by Wenzhou Jianpai pharmaceutical machinery science and technology Limited company, wherein the rotating speed of a coating pan is 2-5r/min, the tablet bed is preheated by 35-45 ℃, the air inlet temperature is 60-70 ℃, the air outlet temperature is 30-40 ℃, the air return is the negative pressure and the atomization pressure which are used for keeping 0.02-0.10KPa in the coating machine: coating the tablet core under the conditions of 0.40-0.60MPa and the spraying speed of a spray gun of a coating machine of 5-15HZ, drying the finished product for 5-10 minutes after coating, and discharging;
6) packaging: and packaging the finished product.
The formula amount for producing 2 ten thousand vitamin B6 vitamin B12 folic acid tablets is shown in the following table 1:
Figure BDA0002277141950000041
the qualification rate of finished products for producing 2 ten thousand vitamin B6 vitamin B12 folic acid tablets is shown in the following table 2:
fig. 1-3 are 3 batch test reports of vitamin B6 vitamin B12 folic acid tablets according to the present invention.
From the above table and fig. 1-3, it can be known that the finished product prepared by the preparation method has high qualification rate, meets the requirements of related technical standards, effectively reduces the waste of raw materials, improves the stability of the product in shelf life, and better ensures the product quality.
The above description is only a preferred embodiment of the present invention, and is not intended to limit the present invention, and all equivalent variations made by using the contents of the present specification and the drawings are within the protection scope of the present invention.

Claims (7)

1. The vitamin B6 vitamin B12 folic acid tablet is characterized by comprising a tablet core and a coating, wherein the tablet core comprises folic acid, cyanocobalamine 1%, pyridoxine hydrochloride, microcrystalline cellulose PH102, lactose and magnesium stearate in parts by weight, and the coating mainly consisting of coating powder is coated outside the tablet core.
2. The vitamin B6 vitamin B12 folic acid tablet of claim 1, wherein each 250mg tablet core contains: 0.48mg folic acid, 0.31mg cyanocobalamin 1%, 4.01mg pyridoxine hydrochloride, 144.5mg microcrystalline cellulose pH102, 98.2mg lactose and 2.5mg magnesium stearate.
3. A vitamin B6 vitamin B12 folic acid tablet according to claim 2, characterized in that the coating outside each tablet core contains: 7.5mg coating powder.
4. The process for preparing vitamin B6 vitamin B12 folic acid tablets of claim 1, 2 or 3, comprising the steps of:
1) mixing: mixing folic acid, 1% of cyanocobalamine and pyridoxine hydrochloride by hand for 3 minutes according to the formula amount, sieving with an 80-mesh sieve, and then gradually mixing with microcrystalline cellulose PH102 according to the equivalent amount for three times, and sieving with the 80-mesh sieve each time to obtain a first mixture;
2) total mixing: the first mixture was then sequentially fed into a mixer with the remaining microcrystalline cellulose PH102, lactose, set to: rotating at a speed of 10 r/min for 5min, stopping the machine, adding magnesium stearate in a prescribed amount, continuously mixing for 5min, stopping the machine after mixing, obtaining granules to be subjected to tabletting, and transferring the granules to a tabletting room or an intermediate station for tabletting and temporarily storing;
3) tabletting: putting the total mixed granules to be tabletted into a punch die of a high-speed tabletting machine for tabletting to obtain tablet cores;
4) sampling and detecting;
5) coating: placing 6.14kg of purified water in a slurry preparation container of a coating machine, starting stirring to keep the solution in a vortex shape, slowly adding 1kg of pink coating powder into the purified water, and continuously stirring for 45 minutes to obtain a coating solution;
putting the tablet core into a coating machine for coating, closing a spray gun of the coating machine after coating is finished, reducing the rotating speed, drying the finished product for 5-10 minutes and discharging;
6) packaging: and packaging the finished product.
5. The method for preparing vitamin B6 vitamin B12 folic acid tablets according to claim 4, wherein in the step 3), the punch die is in a circular shallow arc shape with the diameter of 8 mm.
6. The method for preparing vitamin B6 vitamin B12 folic acid tablets according to the claim 4, characterized in that in the step 3), the average tablet weight of the obtained tablet cores is checked every 15 min; checking the weight of each slice every 30min, and taking 10 slices each time; and simultaneously checking whether the appearance meets the requirements, wherein the difference of the tablet weight is 231mg-268mg, the hardness is 80-150N, the friability is less than 0.5%, the disintegration time is within 30min, and the thickness of the tablet core is 4 mm.
7. The preparation method of the vitamin B6, vitamin B12 and folic acid tablet as claimed in claim 4, wherein in the step 5), the conditions of the coating machine for coating the tablet core are set as the following, namely the rotation speed of a coating pan is 2-5r/min, the preheating tablet bed is 35-45 ℃, the air inlet temperature is 60-70 ℃, the air outlet temperature is 30-40 ℃, the air return is a negative pressure and the atomization pressure for keeping 0.02-0.10KPa in the coating machine: 0.40-0.60MPa, and the spraying speed of the spray gun of the coating machine is 5-15 HZ.
CN201911126929.8A 2019-11-18 2019-11-18 Vitamin B6 vitamin B12 folic acid tablet and preparation method thereof Pending CN110664832A (en)

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101897706A (en) * 2009-05-27 2010-12-01 北京奥萨医药研究中心有限公司 Composition containing folic acid and B vitamins and applications thereof
CN105962379A (en) * 2016-05-03 2016-09-28 宣城柏维力生物工程有限公司 Vitamin B tablets and preparation method thereof
CN109498643A (en) * 2018-12-06 2019-03-22 北京斯利安药业有限公司 A kind of folate composition and its application in the old mistake intelligence drug of preparation improvement

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN101897706A (en) * 2009-05-27 2010-12-01 北京奥萨医药研究中心有限公司 Composition containing folic acid and B vitamins and applications thereof
CN105962379A (en) * 2016-05-03 2016-09-28 宣城柏维力生物工程有限公司 Vitamin B tablets and preparation method thereof
CN109498643A (en) * 2018-12-06 2019-03-22 北京斯利安药业有限公司 A kind of folate composition and its application in the old mistake intelligence drug of preparation improvement

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
关志宇主编: "微晶纤维素", 《药物制剂辅料与包装材料》 *
张双庆主编: "乳糖", 《特殊医学用途配方食品理论与实践》 *

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