CN108578378A - A kind of dramamine oral disnitegration tablet and preparation method thereof - Google Patents

A kind of dramamine oral disnitegration tablet and preparation method thereof Download PDF

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Publication number
CN108578378A
CN108578378A CN201810829717.5A CN201810829717A CN108578378A CN 108578378 A CN108578378 A CN 108578378A CN 201810829717 A CN201810829717 A CN 201810829717A CN 108578378 A CN108578378 A CN 108578378A
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weight
parts
dramamine
oral disnitegration
disnitegration tablet
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朱正标
张汉华
裴雪梅
范小雪
刘耀文
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HUANGHE PHARMACEUTICAL INDUSTRY Co Ltd JIANGSU
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HUANGHE PHARMACEUTICAL INDUSTRY Co Ltd JIANGSU
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    • 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
    • A61K9/2068Compounds of unknown constitution, e.g. material from plants or animals
    • 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
    • A61K31/52Purines, e.g. adenine
    • A61K31/522Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/006Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays
    • 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
    • A61K9/2031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
    • 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
    • A61K9/2059Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/08Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics

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  • Health & Medical Sciences (AREA)
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Abstract

The present invention relates to drug and its preparing technical field more particularly to a kind of dramamine oral disnitegration tablet and preparation method thereof, the dramamine oral disnitegration tablet is made of the substance of following parts by weight:1 ~ 5 parts by weight of dramamine, 0.05 ~ 2 parts by weight of mouth feel modifying agents, 1 ~ 5 parts by weight of pore-foaming agent, 30 ~ 80 parts by weight of filler, 1 ~ 5 parts by weight of lubricant, 3 ~ 8 parts by weight of adhesive, 3 ~ 12 parts by weight of disintegrant, 0.05 ~ 2 parts by weight of preservative, 0 ~ 0.5 parts by weight of colorant, 0.05 ~ 1 parts by weight of antioxidant, 0.05 ~ 2 parts by weight of plasticizer;Dramamine oral disnitegration tablet provided by the invention directly can steadily discharge drug in the oral cavity, can cover the numb taste of hardship and fater disintegration of drug so that motion sickness patient symptom is alleviated, and mouthfeel is good, is especially suitable for tourism traveler and children taking.

Description

A kind of dramamine oral disnitegration tablet and preparation method thereof
Technical field
The present invention relates to drug and its preparing technical field more particularly to a kind of dramamine oral disnitegration tablet and its preparations Method.
Background technology
Dramamine also known as dramamine, dimenhydrinate, chemical name are:[2- (two benzyloxies)-N, N- dimethyl second Amine]-teoclate.Dramamine is histamine H1 receptor blocker, has and inhibits blood vessel exudation, mitigates tissue edema, calmness And antiemetic effect.Suitable for the allergic reaction of skin, mucous membrane, such as nettle rash, allergic dermatitis, allergic rhinitis, vascular Oedema, pollinosis and cutaneous pruritus etc. can efficiently control symptom;For the anaphylaxis disease such as serum sickness, allergic conjunctivitis Disease, curative effect are taken second place;It can be used for prevention of motion sickness, often shared with hyoscine;Also it can be used for treating the vomiting of pregnancy and radioactivity vomitted It spits.And it can be used for preventing blood transfusion and the reaction of blood substitute.It may be made as emulsifiable paste, external curing insect bite, neurodermatitis, scabies Itch and a variety of Dermatosis of enzema and dermatitis etc..Parkinsonian symptoms and many drug-induced the extrapyramidal symptoms can be alleviated.
Dramamine oral preparation is mainly conventional tablet currently on the market, and dramamine bitter fiber crops itself are especially numb It stays sense stronger after taste, conventional tablet is swallowed for old man, child patient and dysphagia person, to ensure treatment effect Fruit.
Invention content
In view of the deficiencies of the prior art, the object of the present invention is to provide a kind of dramamine oral disnitegration tablet and its preparation sides Method, dramamine oral disnitegration tablet provided by the invention directly can steadily discharge drug, can cover drug in the oral cavity Bitter fiber crops taste, and energy fater disintegration so that motion sickness patient symptom is alleviated, and mouthfeel is good, is especially suitable for tourism traveler And children taking.
The present invention provides a kind of dramamine oral disnitegration tablets, are made of the substance of following parts by weight:Dramamine 1 ~ 5 Parts by weight, 0.05 ~ 2 parts by weight of mouth feel modifying agents, 1 ~ 5 parts by weight of pore-foaming agent, 30 ~ 80 parts by weight of filler, 1 ~ 5 weight of lubricant Part, 3 ~ 8 parts by weight of adhesive, 3 ~ 12 parts by weight of disintegrant, 0.05 ~ 2 parts by weight of preservative, 0 ~ 0.5 parts by weight of colorant, antioxygen 0.05 ~ 1 parts by weight of agent, 0.05 ~ 2 parts by weight of plasticizer.
Preferably, the dramamine oral disnitegration tablet, is made of the substance of following parts by weight:2 ~ 3 weight of dramamine Part, 0.08 ~ 0.12 parts by weight of mouth feel modifying agents, 1.5 ~ 4.2 parts by weight of pore-foaming agent, 40 ~ 60 parts by weight of filler, lubricant 1.5 ~ 4 parts by weight, 3.6 ~ 7.2 parts by weight of adhesive, 5 ~ 10 parts by weight of disintegrant, 0.05 ~ 1 parts by weight of preservative, colorant 0.1 ~ 0.4 Parts by weight, 0.05 ~ 0.08 parts by weight of antioxidant, 0.05 ~ 1 parts by weight of plasticizer.
Preferably, the dramamine oral disnitegration tablet, is made of the substance of following parts by weight:2.5 weight of dramamine Part, 0.1 parts by weight of mouth feel modifying agents, 2.6 parts by weight of pore-foaming agent, 50 parts by weight of filler, 3 parts by weight of lubricant, adhesive 4.6 Parts by weight, 6 parts by weight of disintegrant, 0.08 parts by weight of preservative, 0.06 parts by weight of antioxidant, 0.06 parts by weight of plasticizer.
For oral disnitegration tablet, the mouthfeel of drug is one of an important factor for influencing drug adaptability, in the present invention Oral disnitegration tablet in contain mouth feel modifying agents, the mouth feel modifying agents are milk powder, honey, fructose, sucrose, stevioside, Radix Glycyrrhizae At least one of glucin, aspartame, Sucralose, citric acid, citric acid or essence.
Preferably, the pore-foaming agent is selected from polyethylene glycol or polyvinylpyrrolidone.Have the characteristics that dissolubility is good, makes It can be dissolved rapidly after contacting body fluid, form the drug release duct of perforation in coatings.As a further preference, described Pore-foaming agent is selected from polyethylene glycol.
In order to improve the inoxidizability of dramamine oral disnitegration tablet, extend its storage time, it is preferred that described anti-oxidant Agent is butylated hydroxy anisole, dibutyl hydroxy toluene, propylgallate, tert-butylhydroquinone, tocopherol and Vitamin C At least one of acid.The preservative is benzoic acid and salt, potassium sorbate, dehydroactic acid sodium, propylparaben, third Sour calcium, sodium Diacetate, sodium lactate, streptococcus lactis, natamycin, hydrogen peroxide, sulfur dioxide, sulphite and nitrite At least one of Deng.
Preferably, the filler is in microcrystalline cellulose, lactose, starch, pre-paying starch, sucrose, dextrin One or more.As a further preference, the filler is one or more of in lactose, starch, microcrystalline cellulose. The disintegrant is at least one of crospovidone, sodium carboxymethyl starch and croscarmellose sodium;Lactose can It is dissolved in water, dramamine oral disnitegration tablet obtained can be made to have the effect of smooth and beautiful appearance, and has and utilizes raising dramamine The bioavilability of oral disnitegration tablet.
Preferably, the dramamine oral disnitegration tablet also includes adhesive.The adhesive selects this field Conventional adhesive can play the role of bonding, and heretofore described described adhesive is preferably edible glue, described edible Glue is Arabic gum, bassora gum, Karaya Gum, agar, alginate, carragheen, pectin, arabogalactan, gelatin, melon In your bean gum, locust bean gum, starch, microcrystalline cellulose, xanthans, pullulan, low methyl pectin and propylene glycol alginate At least one.
Colorant has strong color, can improve interest of the children to drug, to reduce the difficulty of children's medication Degree, it is preferred that the colorant is red amaranth, beet red, lac, red pigment of cowberry, capsanthin, red, carmine, the red moss of red rice At least one of red, newly red, lemon yellow, sunset yellow, indigo, brilliant blue.
Also include plasticizer in the oral disnitegration tablet, the plasticizer can improve the Orally disintegrating of the present invention The plasticity of piece makes to be not likely to produce crackle.As a further preference, the one kind of the plasticizer in glycerine, castor oil Or two kinds.
Lubricant can play the role of lubricating and help stream, the lubricant to be selected from magnesium stearate, talcum powder, micro mist silicon At least one of glue, sodium stearyl fumarate.
The present invention also provides a kind of preparation methods of dramamine oral disnitegration tablet, include the following steps:
(1)Dramamine is uniformly mixed in water, 0.2 ~ 0.3 μm of membrane filtration degerming is used in combination, obtains mixed solution;It connects It and mouth feel modifying agents, pore-foaming agent, filler, lubricant, disintegrant, preservative, antioxidant, plasticising is added in mixed solution Agent sterilizes after mixing and under the conditions of 121 ~ 125 DEG C 30 ~ 40 min, is subsequently added into adhesive under normal temperature condition, with 8 ~ 10min of rotating speed cutting of 1000 ~ 1750r/min is starched then with 4 ~ 5min of rotating speed cutting of 2000 ~ 2800r/min Material;
(3)Slurry is pressed into tablet with tablet press machine, then dry 5 at 40 ~ 60 DEG C ~ for 24 hours to get to dramamine Orally disintegrating Piece.
Compared with prior art, the present invention has the following technical effects:
The buccal convenience of dramamine oral disnitegration tablet of the present invention works rapidly, efficiently solves the problems, such as patient's blindness medication, together When the main absorbed through oral mucosa of the product, partly absorbed from alimentary canal, alleviate direct pressure of the drug to liver, biology profit Expenditure is high, Small side effects.And the oral disnitegration tablet of the present invention has unique in taste, masks the numb taste of hardship of dramamine, especially It is suitble to tourism traveler and children taking.
Specific implementation mode
In order to make the purpose , technical scheme and advantage of the present invention be clearer, with reference to embodiments, to the present invention It is further elaborated.It should be appreciated that the specific embodiments described herein are merely illustrative of the present invention, it is not used to Limit the present invention.
Embodiment 1
A kind of dramamine oral disnitegration tablet, is made of the substance of following parts by weight:2.5 parts by weight of dramamine, 0.1 weight of milk powder Measure part, 5 parts by weight of honey, 2.6 parts by weight of polyethylene glycol, 47 parts by weight of starch, 2.1 parts by weight of magnesium stearate, Arabic gum 4.6 Parts by weight, 6 parts by weight of crospovidone, 0.08 parts by weight of sodium benzoate, 0.06 parts by weight of butylated hydroxy anisole, castor oil 0.06 parts by weight, 3 parts by weight of beet red.
The preparation method of the dramamine oral disnitegration tablet, includes the following steps:
(1)2.5 parts by weight of dramamine are uniformly mixed in water, 0.3 μm of membrane filtration degerming is used in combination, obtains mixing molten Liquid;Then 0.1 parts by weight of milk powder, 5 parts by weight of honey, 2.6 parts by weight of polyethylene glycol, 47 weight of starch are added in mixed solution Part, 2.1 parts by weight of magnesium stearate, 6 parts by weight of crospovidone, 0.08 parts by weight of sodium benzoate, butylated hydroxy anisole 0.06 Parts by weight, 0.06 parts by weight of castor oil, 3 parts by weight of beet red sterilize 40 min after mixing and under the conditions of 125 DEG C, then 4.6 parts by weight of Arabic gum are added under normal temperature condition, with the rotating speed cutting 10min of 1750r/min, then with 2000r/min Rotating speed cutting 5min, obtain slurry;
(3)Slurry is pressed into tablet with tablet press machine, it is then dry for 24 hours to get to dramamine oral disnitegration tablet at 60 DEG C.
Embodiment 2
A kind of dramamine oral disnitegration tablet, is made of the substance of following parts by weight:3 parts by weight of dramamine, 0.12 weight of honey Measure part, 1.5 parts by weight of polyethylene glycol, 20 parts by weight of microcrystalline cellulose, 10 parts by weight of pre-paying starch, 20 parts by weight of sucrose, paste Smart 10 parts by weight, 1.5 parts by weight of magnesium stearate, low 7.2 parts by weight of methyl pectin, 5 parts by weight of crospovidone, natamycin 1 Parts by weight, 0.1 parts by weight of beet red, 0.08 parts by weight of butylated hydroxy anisole, 1 parts by weight of castor oil.
The preparation method of the dramamine oral disnitegration tablet, includes the following steps:
(1)3 parts by weight of dramamine are uniformly mixed in water, 0.3 μm of membrane filtration degerming is used in combination, obtains mixing molten Liquid;Then honey 0.12 parts by weight, 1.5 parts by weight of polyethylene glycol, 20 parts by weight of microcrystalline cellulose, pre- are added in mixed solution 10 parts by weight of friendshipization starch, 20 parts by weight of sucrose, 10 parts by weight of dextrin, 1.5 parts by weight of magnesium stearate, 5 weight of crospovidone Part, the mixing of 1 parts by weight of natamycin, 0.1 parts by weight of beet red, 0.08 parts by weight of butylated hydroxy anisole, 1 parts by weight of castor oil Sterilize 35 min after uniformly and under the conditions of 125 DEG C, is subsequently added into low 7.2 parts by weight of methyl pectin under normal temperature condition, with The rotating speed cutting 10min of 1750r/min obtains slurry then with the rotating speed cutting 5min of 2500r/min;
(3)Slurry is pressed into tablet with tablet press machine, it is then dry for 24 hours to get to dramamine oral disnitegration tablet at 60 DEG C.
Embodiment 3
A kind of dramamine oral disnitegration tablet, is made of the substance of following parts by weight:2 parts by weight of dramamine, 0.03 weight of fructose Measure part, 0.05 parts by weight of stevioside, 4.2 parts by weight of polyethylene glycol, 20 parts by weight of lactose, 20 parts by weight of starch, 4 weight of superfine silica gel powder Measure part, 3.6 parts by weight of locust bean gum, 10 parts by weight of crospovidone, 0.05 parts by weight of propylparaben, brilliant blue 0.4 Parts by weight, 0.05 parts by weight of butylated hydroxy anisole, 0.05 parts by weight of castor oil.
The preparation method of the dramamine oral disnitegration tablet, includes the following steps:
(1)2 parts by weight of dramamine are uniformly mixed in water, 0.2 μm of membrane filtration degerming is used in combination, obtains mixing molten Liquid;Then 0.03 parts by weight of fructose, 0.05 parts by weight of stevioside, 4.2 parts by weight of polyethylene glycol, lactose are added in mixed solution 20 parts by weight, 20 parts by weight of starch, 4 parts by weight of superfine silica gel powder, 10 parts by weight of crospovidone, propylparaben 0.05 Parts by weight, 0.4 parts by weight of brilliant blue, 0.05 parts by weight of butylated hydroxy anisole, 0.05 parts by weight of castor oil after mixing and Sterilize 40 min under the conditions of 121 DEG C, 3.6 parts by weight of locust bean gum is subsequently added under normal temperature condition, with the rotating speed of 1500r/min Shearing 9min obtains slurry then with the rotating speed cutting 5min of 2500r/min;
(3)Slurry is pressed into tablet with tablet press machine, then at 50 DEG C dry 12h to get to dramamine oral disnitegration tablet.
Embodiment 4
A kind of dramamine oral disnitegration tablet, is made of the substance of following parts by weight:5 parts by weight of dramamine, 0.5 weight of citric acid Measure part, 0.5 parts by weight of milk powder, 1 parts by weight of honey, 1 parts by weight of polyvinylpyrrolidone, 40 parts by weight of microcrystalline cellulose, lactose 15 parts by weight, 10 parts by weight of pre-paying starch, 15 parts by weight of dextrin, 1 parts by weight of superfine silica gel powder, 8 parts by weight of bassora gum, carboxymethyl 12 parts by weight of sodium starch, 0.05 parts by weight of streptococcus lactis, red 0.5 parts by weight of red rice, 1 parts by weight of tert-butylhydroquinone, castor 2 parts by weight of sesame oil.
The preparation method of the dramamine oral disnitegration tablet, includes the following steps:
(1)5 parts by weight of dramamine are uniformly mixed in water, 0.3 μm of membrane filtration degerming is used in combination, obtains mixing molten Liquid;Then 0.5 parts by weight of citric acid, 0.5 parts by weight of milk powder, 1 parts by weight of honey, polyvinylpyrrolidine are added in mixed solution It is 1 parts by weight of ketone, 40 parts by weight of microcrystalline cellulose, 15 parts by weight of lactose, 10 parts by weight of pre-paying starch, 15 parts by weight of dextrin, micro- 1 parts by weight of powder silica gel, 12 parts by weight of sodium carboxymethyl starch, 0.05 parts by weight of streptococcus lactis, red 0.5 parts by weight of red rice, special fourth 1 parts by weight of base hydroquinone, 2 parts by weight of castor oil sterilize 40 min after mixing and under the conditions of 125 DEG C, are subsequently added into Huang 8 parts by weight of alpine yarrow glue are under normal temperature condition, with the rotating speed cutting 10min of 1750r/min, then with the rotating speed cutting of 2000r/min 5min obtains slurry;
(3)Slurry is pressed into tablet with tablet press machine, then at 60 DEG C dry 5h to get to dramamine oral disnitegration tablet.
Embodiment 5
A kind of dramamine oral disnitegration tablet, is made of the substance of following parts by weight:1 parts by weight of dramamine, 0.02 weight of fructose Measure part, 0.03 parts by weight of stevioside, 5 parts by weight of polyvinylpyrrolidone, 10 parts by weight of lactose, 20 parts by weight of starch, stearic acid 5 parts by weight of fumaric acid sodium, 3 parts by weight of xanthans, 3 parts by weight of sodium carboxymethyl starch, 2 parts by weight of potassium sorbate, gallic acid third 0.05 parts by weight of ester, 0.05 parts by weight of glycerine.
The preparation method of the dramamine oral disnitegration tablet, includes the following steps:
(1)1 parts by weight of dramamine are uniformly mixed in water, 0.2 μm of membrane filtration degerming is used in combination, obtains mixing molten Liquid;Then be added in mixed solution fructose 0.02 parts by weight, 0.03 parts by weight of stevioside, 5 parts by weight of polyvinylpyrrolidone, 10 parts by weight of lactose, 20 parts by weight of starch, 5 parts by weight of sodium stearyl fumarate, 3 parts by weight of sodium carboxymethyl starch, potassium sorbate 2 Parts by weight, 0.05 parts by weight of propylgallate, 0.05 parts by weight of glycerine sterilize after mixing and under the conditions of 121 DEG C 30min is subsequently added into 3 parts by weight of xanthans under normal temperature condition, with the rotating speed cutting 8min of 1000r/min, then with The rotating speed cutting 4min of 2800r/min, obtains slurry;
(3)Slurry is pressed into tablet with tablet press machine, it is then dry for 24 hours to get to dramamine oral disnitegration tablet at 40 DEG C.
Foregoing description is only the description to section Example of the present invention, not to any restriction of the scope of the invention, one's own profession The those of ordinary skill of industry can make above-described embodiment according to the present invention and improve or modify, but belong to present invention protection model It encloses.

Claims (10)

1. a kind of dramamine oral disnitegration tablet, which is characterized in that be made of the substance of following parts by weight:1 ~ 5 weight of dramamine Measure part, 0.05 ~ 2 parts by weight of mouth feel modifying agents, 1 ~ 5 parts by weight of pore-foaming agent, 30 ~ 80 parts by weight of filler, 1 ~ 5 weight of lubricant Part, 3 ~ 8 parts by weight of adhesive, 3 ~ 12 parts by weight of disintegrant, 0.05 ~ 2 parts by weight of preservative, 0 ~ 0.5 parts by weight of colorant, antioxygen 0.05 ~ 1 parts by weight of agent, 0.05 ~ 2 parts by weight of plasticizer.
2. dramamine oral disnitegration tablet according to claim 1, which is characterized in that by the substance system of following parts by weight At:2 ~ 3 parts by weight of dramamine, 0.08 ~ 0.12 parts by weight of mouth feel modifying agents, 1.5 ~ 4.2 parts by weight of pore-foaming agent, filler 40 ~ 60 parts by weight, 1.5 ~ 4 parts by weight of lubricant, 3.6 ~ 7.2 parts by weight of adhesive, 5 ~ 10 parts by weight of disintegrant, preservative 0.05 ~ 1 Parts by weight, 0.1 ~ 0.4 parts by weight of colorant, 0.05 ~ 0.08 parts by weight of antioxidant, 0.05 ~ 1 parts by weight of plasticizer.
3. dramamine oral disnitegration tablet according to claim 2, which is characterized in that by the substance system of following parts by weight At:2.5 parts by weight of dramamine, 0.1 parts by weight of mouth feel modifying agents, 2.6 parts by weight of pore-foaming agent, 50 parts by weight of filler, lubrication 3 parts by weight of agent, 4.6 parts by weight of adhesive, 6 parts by weight of disintegrant, 0.08 parts by weight of preservative, 0.06 parts by weight of antioxidant, 0.06 parts by weight of plasticizer.
4. the dramamine oral disnitegration tablet according to claim 1 ~ 3 any one, which is characterized in that the mouthfeel is adjusted Agent is milk powder, honey, fructose, sucrose, stevioside, glycyrrhizin, aspartame, Sucralose, citric acid, citric acid or essence At least one of.
5. dramamine oral disnitegration tablet according to claim 4, which is characterized in that the pore-foaming agent is polyethylene glycol And/or polyvinylpyrrolidone.
6. dramamine oral disnitegration tablet according to claim 5, which is characterized in that the preservative be benzoic acid and Salt, dehydroactic acid sodium, propylparaben, calcium propionate, sodium Diacetate, sodium lactate, streptococcus lactis, is received potassium sorbate At least one of his mycin, hydrogen peroxide, sulfur dioxide, sulphite and nitrite etc..
7. the dramamine oral disnitegration tablet according to claim 1 ~ 3 any one, which is characterized in that the antioxidant For butylated hydroxy anisole, dibutyl hydroxy toluene, propylgallate, tert-butylhydroquinone, tocopherol and ascorbic acid At least one of.
8. dramamine oral disnitegration tablet according to claim 5, which is characterized in that the filler is selected from starch, breast Sugar, mannitol, dextrin, microcrystalline cellulose, sodium carboxymethylcellulose, low-substituted hydroxypropyl cellulose, crospovidone, crosslinking carboxylic first At least one of base sodium cellulosate.
9. dramamine oral disnitegration tablet according to claim 8, which is characterized in that described adhesive be Arabic gum, Bassora gum, Karaya Gum, agar, alginate, carragheen, pectin, arabogalactan, gelatin, guar gum, locust bean At least one of glue, starch, microcrystalline cellulose, xanthans, pullulan, low methyl pectin and propylene glycol alginate.
10. the preparation method of the dramamine oral disnitegration tablet according to claim 1 ~ 9 any one, which is characterized in that Include the following steps:
(1)Dramamine is uniformly mixed in water, 0.2 ~ 0.3 μm of membrane filtration degerming is used in combination, obtains mixed solution;It connects It and mouth feel modifying agents, pore-foaming agent, filler, lubricant, disintegrant, preservative, antioxidant, plasticising is added in mixed solution Agent sterilizes after mixing and under the conditions of 121 ~ 125 DEG C 30 ~ 40 min, is subsequently added into adhesive under normal temperature condition, with 8 ~ 10min of rotating speed cutting of 1000 ~ 1750r/min is starched then with 4 ~ 5min of rotating speed cutting of 2000 ~ 2800r/min Material;
(3)Slurry is pressed into tablet with tablet press machine, then dry 5 at 40 ~ 60 DEG C ~ for 24 hours to get to dramamine Orally disintegrating Piece.
CN201810829717.5A 2018-07-25 2018-07-25 A kind of dramamine oral disnitegration tablet and preparation method thereof Pending CN108578378A (en)

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Publication number Priority date Publication date Assignee Title
CN108969502A (en) * 2018-10-11 2018-12-11 田国荣 A kind of atenolol sustained-release piece and preparation method thereof
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CN108969502A (en) * 2018-10-11 2018-12-11 田国荣 A kind of atenolol sustained-release piece and preparation method thereof
CN109793759A (en) * 2019-03-06 2019-05-24 华中农业大学 A kind of compound pollen cream ball and preparation method thereof
CN109793759B (en) * 2019-03-06 2022-05-03 华中农业大学 Compound pollen paste pill and preparation method thereof

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Application publication date: 20180928