CN108904456A - A kind of dimenhydrinate tablets - Google Patents

A kind of dimenhydrinate tablets Download PDF

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Publication number
CN108904456A
CN108904456A CN201810829719.4A CN201810829719A CN108904456A CN 108904456 A CN108904456 A CN 108904456A CN 201810829719 A CN201810829719 A CN 201810829719A CN 108904456 A CN108904456 A CN 108904456A
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peppermint
dramamine
mass ratio
borneol
compound
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张汉华
朱正标
闫海粟
唐登高
曹群
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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
    • A61K9/2022Organic 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
    • 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
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • 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
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/08Antiallergic agents

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Abstract

The present invention relates to medicine and field of medicine production, and in particular to a kind of dimenhydrinate tablets, including dramamine compound, pharmaceutic adjuvant, starch, peppermint and borneol;Wherein the mass ratio of dramamine compound, pharmaceutic adjuvant, starch, peppermint and borneol is(1~12):(0.5~8):(3~30):(0.2~5):(0.1~3).Dimenhydrinate tablets disintegration of the invention leaches fastly, and dissolution rate is high, and quality is stablized, and quickly releases the drug, quick effective, can also be swallowed with sublingual administration, works faster, easy to carry and use.Invention formulation simple process, for workshop without dust, few using supplementary product kind, production process is short, at low cost.

Description

A kind of dimenhydrinate tablets
Technical field
The present invention relates to medicine and field of medicine production, and in particular to a kind of dimenhydrinate tablets for sucking anti-blooming.
Background technique
It is reported that about 80% people experienced motion sickness, have about people because motion sickness influence they by land, it is marine and empty In travelling.Motion sickness is stimulated and is caused by unfavorable movement environment since body is exposed in movement environment, clinical Symptom is tired, indifferent, drowsiness, powerless to occur in early days, occurs bottleneck throat discomfort, excessive saliva, nausea, dizziness, complexion therewith Pale, cold sweat is further aggravated with symptom and vomiting, headache, nervous uncomfortable in chest etc. occurs.Therefore, the person that is susceptible to suffer from motion sickness can be Before means of transportation, the drug of prevention and treatment motion sickness is taken, in advance to mitigate motion sickness.
Dramamine(Dimenhydrinate), molecular formula C24H28ClN5O3, entitled 1, the 3- dimethyl -8- of chemistry is chloro- 3,7- dihydro -1H- purine -2,6- diketone-N, N- dimethyl -2- (diphenylmethyl oxygroup) ethylamine salt.It is calculated by dry product, contains benzene Extra large Lamine(C17H21NO)53.0%~55.5%;Containing 8-Chlorotheophyline(C7H7ClN4O2)44.0%~47.0%;It is slightly soluble in water, is soluble in Ethyl alcohol.
Dramamine is antihistamine, by U.S. Xi Er(searle))Company develops, and lists in the U.S. within 1949, China Started to produce in 1963.Dramamine is histamine h1 receptor antagonist, can inhibit blood vessel exudation, mitigates tissue edema, can prevent Nausea and vomiting caused by controlling because of cinetosis, dizziness etc. can also be prevented and treated because of operation, drug-induced vomiting and the vomiting of pregnancy.Clinically It is most commonly used to anti-motion sickness, is choice drug, including prevention and treatment children's motion sickness because of its safety.It is also used for anaphylactia, such as Hay fever, nettle rash.
Dramamine oral preparation is mainly tablet currently on the market.As possessed by conventional tablet fabricating technology Feature works slow, bioavilability is lower, to influence giving full play to for drug effect so that this kind of oral preparation disintegration time is long. In addition, staying sense stronger after dramamine bitter fiber crops itself, especially fiber crops taste.Accordingly, it is desirable to provide a kind of dimenhydrinate tablets, it can Cover the numb taste of hardship of drug;Again can fater disintegration so that motion sickness patient symptom is alleviated, be especially suitable for tourism traveler and Children taking.
Summary of the invention
(One)The technical issues of solution
In view of the deficiencies of the prior art, the present invention provides a kind of dimenhydrinate tablets, so that the dimenhydrinate tablets disintegration time is short, Rapid-action, bioavilability is higher, promotes giving full play to for drug effect;And the numb taste of the hardship that drug can be covered.
(Two)Technical solution
In order to achieve the above object, the present invention is achieved by the following technical programs:
A kind of dimenhydrinate tablets, including dramamine compound, pharmaceutic adjuvant, starch, peppermint and borneol.
Preferably, the mass ratio of dramamine compound, pharmaceutic adjuvant, starch, peppermint and borneol is(1~12):(0.5 ~8):(3~30):(0.2~5):(0.1~3).
Preferably, pharmaceutic adjuvant includes disintegrating agent, corrigent, binder, lubricant, sorbefacient and surface-active Agent.
Preferably, the mass ratio of disintegrating agent, corrigent, binder, lubricant, sorbefacient and surfactant is(3 ~15):(2~12):(3~9):(1~10):(2~8):(1.5~4.5).
Preferably, disintegrating agent is the mixture of microcrystalline cellulose and low-substituted hydroxypropyl cellulose, and microcrystalline cellulose takes with low Mass ratio for hydroxypropylcellulose is(1~10):(0.2~5);Corrigent is starch sugar or stevioside or Radix Glycyrrhizae;Lubricant is Talcum powder or magnesium stearate or sodium stearyl fumarate;Surfactant is lecithin or fatty glyceride or fatty acid sorb It is smooth.
Preferably, the mass ratio of dramamine compound, pharmaceutic adjuvant, starch, peppermint and borneol is(2~10):(1~ 6):(5~23):(1~4):(0.5~2.5);Disintegrating agent, corrigent, binder, lubricant, sorbefacient and surface-active The mass ratio of agent is(4~12):(3~10):(4~8):(2~8):(3~7):(2~4).
Preferably, the mass ratio of dramamine compound, pharmaceutic adjuvant, starch, peppermint and borneol is(3~8):(2~ 5):(8~15):(1.8~3.2):(0.8~2);Disintegrating agent, corrigent, binder, lubricant, sorbefacient and surface are living The mass ratio of property agent is(5~10):(4~8):(5~7):(3~7):(3.8~6):(2.5~3.6).
Preferably, the mass ratio of dramamine compound, pharmaceutic adjuvant, starch, peppermint and borneol is(4~6):(3~ 4):(10~12):(2.1~3.7):(1~1.6);Disintegrating agent, corrigent, binder, lubricant, sorbefacient and surface The mass ratio of activating agent is(6~8):(5~7):(5.5~6.3):(4~5.5):(4.3~5.5):(3~3.3).
Preferably, the mass ratio of dramamine compound, pharmaceutic adjuvant, starch, peppermint and borneol is 5:3.5:11:3: 1.3;Disintegrating agent, corrigent, binder, lubricant, sorbefacient and surfactant mass ratio be 7:6:6:5:4.8: 3.2。
A kind of preparation method of dimenhydrinate tablets, includes the following steps:
1)Stock, peppermint is cleaned, is ground into coarse powder after drying;Peppermint and borneol are crushed with pulverizer respectively, reach 80 mesh It is required that;Dramamine compound, pharmaceutic adjuvant and starch reach 80 mesh;Weigh dramamine compound, medicine respectively in mass ratio It is spare with auxiliary material, starch, peppermint and borneol;
2)Mixing, by step 1)In dramamine compound, pharmaceutic adjuvant, starch, peppermint and borneol put into together to high speed In mixer-granulator, stirring is started, dry-mixed 10~30min obtains dry-mixed raw material;
3)Granulation, by step 2)In dry-mixed raw material 30 DEG C at a temperature of be dried, then carry out whole grain, continue after whole grain 40 DEG C at a temperature of dry, obtain dry feedstock;
4)Sterilizing, by step 3)In dry feedstock sterilized using flowing steam, wherein live steam temperature is 100 DEG C, Sterilization time is 30~60min, obtains sterilized mixture;
5)Tabletting:By rapid 4)In sterilized mixture punch die tabletting.
(Three)Beneficial effect
The present invention provides a kind of dimenhydrinate tablets, include the disintegrating agent of microcrystalline cellulose composition, microcrystalline cellulose is current A kind of most widely used auxiliary material, it has spongiform porous tubular structured, and when compression, the porous structure of microcrystalline cellulose is by miscellaneous Disorderly without Zhang Chengwei linear array, plastic deformation in addition, after so that microcrystalline cellulose is met water, hydrone enters inside tablet, destroys Hydrogen bond between crystallite, promotes tablet to be disintegrated rapidly.
For the present invention as lozenge, mouthfeel is a critically important index, with peppermint and borneol and corrigent, wherein peppermint It absorbs heat when orally-dissolvable with borneol, thus has cooling feeling, while having both certain sweet taste, without sand type in mouth;It can go Except bitter numb taste remaining in mouth.
Invention formulation simple process and low cost;Drug Fast Stripping, dissolution rate is high, rapid-action, and bioavilability is high, Small side effects can be swallowed, can also sublingual administration, such as using sublingual administration be administered, dissolved rapidly with after saliva contacts, by oral cavity Mucosal absorption is directly entered the circulatory system without gastrointestinal tract and liver, not only avoids liver sausage first-pass effect, and has reached Effect rapidly, improves bioavilability, reduces the purpose of side effect.
Specific embodiment
In order to make the object, technical scheme and advantages of the embodiment of the invention clearer, below in conjunction with the embodiment of the present invention, Technical scheme in the embodiment of the invention is clearly and completely described, it is clear that described embodiment is the present invention one Divide embodiment, instead of all the embodiments.Based on the embodiments of the present invention, those of ordinary skill in the art are not making Every other embodiment obtained, shall fall within the protection scope of the present invention under the premise of creative work.
Embodiment 1
A kind of dimenhydrinate tablets, including dramamine compound, pharmaceutic adjuvant, starch, peppermint and borneol, dramamine are compound Object, pharmaceutic adjuvant, starch, peppermint and borneol mass ratio be 1:1:5:1:0.5;
Pharmaceutic adjuvant includes that mass ratio is 3:3:4:2:3:2 disintegrating agent, corrigent, binder, lubricant, sorbefacient and Surfactant;Wherein, disintegrating agent is the mixture of microcrystalline cellulose and low-substituted hydroxypropyl cellulose, and microcrystalline cellulose takes with low Mass ratio for hydroxypropylcellulose is 5:1;Corrigent is starch sugar;Lubricant is talcum powder;Surfactant is lecithin.
A kind of preparation method of dimenhydrinate tablets, includes the following steps:
1)Stock, peppermint is cleaned, is ground into coarse powder after drying;Peppermint and borneol are crushed with pulverizer respectively, reach 80 mesh It is required that;Dramamine compound, pharmaceutic adjuvant and starch reach 80 mesh;Weigh dramamine compound, medicine respectively in mass ratio It is spare with auxiliary material, starch, peppermint and borneol;
2)Mixing, by step 1)In dramamine compound, pharmaceutic adjuvant, starch, peppermint and borneol put into together to high speed In mixer-granulator, stirring is started, dry-mixed 10min obtains dry-mixed raw material;
3)Granulation, by step 2)In dry-mixed raw material 30 DEG C at a temperature of be dried, then carry out whole grain, continue after whole grain 40 DEG C at a temperature of dry, obtain dry feedstock;
4)Sterilizing, by step 3)In dry feedstock sterilized using flowing steam, wherein live steam temperature is 100 DEG C, Sterilization time is 30min, obtains sterilized mixture;
5)Tabletting:By rapid 4)In sterilized mixture punch die tabletting.
Embodiment 2
A kind of dimenhydrinate tablets, including dramamine compound, pharmaceutic adjuvant, starch, peppermint and borneol, dramamine are compound Object, pharmaceutic adjuvant, starch, peppermint and borneol mass ratio be 1:3.5:11:3:1.3;
Pharmaceutic adjuvant includes that mass ratio is 3:6:7:5:5:3 disintegrating agent, corrigent, binder, lubricant, sorbefacient and Surfactant;Wherein, disintegrating agent is the mixture of microcrystalline cellulose and low-substituted hydroxypropyl cellulose, and microcrystalline cellulose takes with low Mass ratio for hydroxypropylcellulose is 5:1;Corrigent is starch sugar;Lubricant is talcum powder;Surfactant is lecithin.
A kind of preparation method of dimenhydrinate tablets, includes the following steps:
1)Stock, peppermint is cleaned, is ground into coarse powder after drying;Peppermint and borneol are crushed with pulverizer respectively, reach 80 mesh It is required that;Dramamine compound, pharmaceutic adjuvant and starch reach 80 mesh;Weigh dramamine compound, medicine respectively in mass ratio It is spare with auxiliary material, starch, peppermint and borneol;
2)Mixing, by step 1)In dramamine compound, pharmaceutic adjuvant, starch, peppermint and borneol put into together to high speed In mixer-granulator, stirring is started, dry-mixed 10min obtains dry-mixed raw material;
3)Granulation, by step 2)In dry-mixed raw material 30 DEG C at a temperature of be dried, then carry out whole grain, continue after whole grain 40 DEG C at a temperature of dry, obtain dry feedstock;
4)Sterilizing, by step 3)In dry feedstock sterilized using flowing steam, wherein live steam temperature is 100 DEG C, Sterilization time is 30min, obtains sterilized mixture;
5)Tabletting:By rapid 4)In sterilized mixture punch die tabletting.
Embodiment 3
A kind of dimenhydrinate tablets, including dramamine compound, pharmaceutic adjuvant, starch, peppermint and borneol, dramamine are compound Object, pharmaceutic adjuvant, starch, peppermint and borneol mass ratio be 1:7:26:5:2.6;
Pharmaceutic adjuvant includes that mass ratio is 3:10:9:8:7:4 disintegrating agent, corrigent, binder, lubricant, sorbefacient And surfactant, wherein disintegrating agent be microcrystalline cellulose and low-substituted hydroxypropyl cellulose mixture, microcrystalline cellulose with it is low The mass ratio for replacing hydroxypropylcellulose is 5:1;Corrigent is starch sugar;Lubricant is talcum powder;Surfactant is lecithin.
A kind of preparation method of dimenhydrinate tablets, includes the following steps:
1)Stock, peppermint is cleaned, is ground into coarse powder after drying;Peppermint and borneol are crushed with pulverizer respectively, reach 80 mesh It is required that;Dramamine compound, pharmaceutic adjuvant and starch reach 80 mesh;Weigh dramamine compound, medicine respectively in mass ratio It is spare with auxiliary material, starch, peppermint and borneol;
2)Mixing, by step 1)In dramamine compound, pharmaceutic adjuvant, starch, peppermint and borneol put into together to high speed In mixer-granulator, stirring is started, dry-mixed 10min obtains dry-mixed raw material;
3)Granulation, by step 2)In dry-mixed raw material 30 DEG C at a temperature of be dried, then carry out whole grain, continue after whole grain 40 DEG C at a temperature of dry, obtain dry feedstock;
4)Sterilizing, by step 3)In dry feedstock sterilized using flowing steam, wherein live steam temperature is 100 DEG C, Sterilization time is 30min, obtains sterilized mixture;
5)Tabletting:By rapid 4)In sterilized mixture punch die tabletting.
Embodiment 4
A kind of dimenhydrinate tablets, including dramamine compound, pharmaceutic adjuvant, starch, peppermint and borneol, dramamine are compound Object, pharmaceutic adjuvant, starch, peppermint and borneol mass ratio be 5:1:5:1:0.5;
Pharmaceutic adjuvant includes that mass ratio is 9:3:4:2:3:2 disintegrating agent, corrigent, binder, lubricant, sorbefacient and Surfactant;Wherein, disintegrating agent is the mixture of microcrystalline cellulose and low-substituted hydroxypropyl cellulose, and microcrystalline cellulose takes with low Mass ratio for hydroxypropylcellulose is 8:3;Corrigent is stevioside;Lubricant is magnesium stearate;Surfactant is fatty acid Glyceride.
A kind of preparation method of dimenhydrinate tablets, includes the following steps:
1)Stock, peppermint is cleaned, is ground into coarse powder after drying;Peppermint and borneol are crushed with pulverizer respectively, reach 80 mesh It is required that;Dramamine compound, pharmaceutic adjuvant and starch reach 80 mesh;Weigh dramamine compound, medicine respectively in mass ratio It is spare with auxiliary material, starch, peppermint and borneol;
2)Mixing, by step 1)In dramamine compound, pharmaceutic adjuvant, starch, peppermint and borneol put into together to high speed In mixer-granulator, stirring is started, dry-mixed 15min obtains dry-mixed raw material;
3)Granulation, by step 2)In dry-mixed raw material 30 DEG C at a temperature of be dried, then carry out whole grain, continue after whole grain 40 DEG C at a temperature of dry, obtain dry feedstock;
4)Sterilizing, by step 3)In dry feedstock sterilized using flowing steam, wherein live steam temperature is 100 DEG C, Sterilization time is 45min, obtains sterilized mixture;
5)Tabletting:By rapid 4)In sterilized mixture punch die tabletting.
Embodiment 5
A kind of dimenhydrinate tablets, including dramamine compound, pharmaceutic adjuvant, starch, peppermint and borneol, dramamine are compound Object, pharmaceutic adjuvant, starch, peppermint and borneol mass ratio be 5:3.5:11:3:1.3;
Pharmaceutic adjuvant includes that mass ratio is 9:6:7:5:5:3 disintegrating agent, corrigent, binder, lubricant, sorbefacient and Surfactant;Wherein, disintegrating agent is the mixture of microcrystalline cellulose and low-substituted hydroxypropyl cellulose, and microcrystalline cellulose takes with low Mass ratio for hydroxypropylcellulose is 8:3;Corrigent is stevioside;Lubricant is magnesium stearate;Surfactant is fatty acid Glyceride.
A kind of preparation method of dimenhydrinate tablets, includes the following steps:
1)Stock, peppermint is cleaned, is ground into coarse powder after drying;Peppermint and borneol are crushed with pulverizer respectively, reach 80 mesh It is required that;Dramamine compound, pharmaceutic adjuvant and starch reach 80 mesh;Weigh dramamine compound, medicine respectively in mass ratio It is spare with auxiliary material, starch, peppermint and borneol;
2)Mixing, by step 1)In dramamine compound, pharmaceutic adjuvant, starch, peppermint and borneol put into together to high speed In mixer-granulator, stirring is started, dry-mixed 15min obtains dry-mixed raw material;
3)Granulation, by step 2)In dry-mixed raw material 30 DEG C at a temperature of be dried, then carry out whole grain, continue after whole grain 40 DEG C at a temperature of dry, obtain dry feedstock;
4)Sterilizing, by step 3)In dry feedstock sterilized using flowing steam, wherein live steam temperature is 100 DEG C, Sterilization time is 45min, obtains sterilized mixture;
5)Tabletting:By rapid 4)In sterilized mixture punch die tabletting.
Embodiment 6
A kind of dimenhydrinate tablets, including dramamine compound, pharmaceutic adjuvant, starch, peppermint and borneol, dramamine are compound Object, pharmaceutic adjuvant, starch, peppermint and borneol mass ratio be 5:7:26:5:2.6;
Pharmaceutic adjuvant includes that mass ratio is 9:10:9:8:7:4 disintegrating agent, corrigent, binder, lubricant, sorbefacient And surfactant;Wherein, disintegrating agent be microcrystalline cellulose and low-substituted hydroxypropyl cellulose mixture, microcrystalline cellulose with it is low The mass ratio for replacing hydroxypropylcellulose is 8:3;Corrigent is stevioside;Lubricant is magnesium stearate;Surfactant is fat Acid glyceride.
A kind of preparation method of dimenhydrinate tablets, includes the following steps:
1)Stock, peppermint is cleaned, is ground into coarse powder after drying;Peppermint and borneol are crushed with pulverizer respectively, reach 80 mesh It is required that;Dramamine compound, pharmaceutic adjuvant and starch reach 80 mesh;Weigh dramamine compound, medicine respectively in mass ratio It is spare with auxiliary material, starch, peppermint and borneol;
2)Mixing, by step 1)In dramamine compound, pharmaceutic adjuvant, starch, peppermint and borneol put into together to high speed In mixer-granulator, stirring is started, dry-mixed 15min obtains dry-mixed raw material;
3)Granulation, by step 2)In dry-mixed raw material 30 DEG C at a temperature of be dried, then carry out whole grain, continue after whole grain 40 DEG C at a temperature of dry, obtain dry feedstock;
4)Sterilizing, by step 3)In dry feedstock sterilized using flowing steam, wherein live steam temperature is 100 DEG C, Sterilization time is 45min, obtains sterilized mixture;
5)Tabletting:By rapid 4)In sterilized mixture punch die tabletting.
Embodiment 7
A kind of dimenhydrinate tablets, including dramamine compound, pharmaceutic adjuvant, starch, peppermint and borneol, dramamine are compound Object, pharmaceutic adjuvant, starch, peppermint and borneol mass ratio be 10:3.5:11:3:1.3;
Pharmaceutic adjuvant includes that mass ratio is 7:6:6:5:4.8:3.2 disintegrating agent, corrigent, binder, lubricant, absorption enhancement Agent and surfactant;Wherein, disintegrating agent be microcrystalline cellulose and low-substituted hydroxypropyl cellulose mixture, microcrystalline cellulose with The mass ratio of low-substituted hydroxypropyl cellulose is 3:0.5;Corrigent is Radix Glycyrrhizae;Lubricant is sodium stearyl fumarate;Surface-active Agent is fatty acid sorbitan.
A kind of preparation method of dimenhydrinate tablets, includes the following steps:
1)Stock, peppermint is cleaned, is ground into coarse powder after drying;Peppermint and borneol are crushed with pulverizer respectively, reach 80 mesh It is required that;Dramamine compound, pharmaceutic adjuvant and starch reach 80 mesh;Weigh dramamine compound, medicine respectively in mass ratio It is spare with auxiliary material, starch, peppermint and borneol;
2)Mixing, by step 1)In dramamine compound, pharmaceutic adjuvant, starch, peppermint and borneol put into together to high speed In mixer-granulator, stirring is started, dry-mixed 30min obtains dry-mixed raw material;
3)Granulation, by step 2)In dry-mixed raw material 30 DEG C at a temperature of be dried, then carry out whole grain, continue after whole grain 40 DEG C at a temperature of dry, obtain dry feedstock;
4)Sterilizing, by step 3)In dry feedstock sterilized using flowing steam, wherein live steam temperature is 100 DEG C, Sterilization time is 60min, obtains sterilized mixture;
5)Tabletting:By rapid 4)In sterilized mixture punch die tabletting.
Embodiment 8
The mass ratio of a kind of dimenhydrinate tablets, including dramamine, starch, dramamine compound and starch is 10:11.
A kind of preparation method of dimenhydrinate tablets, includes the following steps:
1)Stock, peppermint is cleaned, is ground into coarse powder after drying;Peppermint and borneol are crushed with pulverizer respectively, reach 80 mesh It is required that;Dramamine compound, pharmaceutic adjuvant and starch reach 80 mesh;Weigh dramamine compound, medicine respectively in mass ratio It is spare with auxiliary material, starch, peppermint and borneol;
2)Mixing, by step 1)In dramamine compound, pharmaceutic adjuvant, starch, peppermint and borneol put into together to high speed In mixer-granulator, stirring is started, dry-mixed 30min obtains dry-mixed raw material;
3)Granulation, by step 2)In dry-mixed raw material 30 DEG C at a temperature of be dried, then carry out whole grain, continue after whole grain 40 DEG C at a temperature of dry, obtain dry feedstock;
4)Sterilizing, by step 3)In dry feedstock sterilized using flowing steam, wherein live steam temperature is 100 DEG C, Sterilization time is 60min, obtains sterilized mixture;
5)Tabletting:By rapid 4)In sterilized mixture punch die tabletting.
Dissolution comparison test
Above-described embodiment dimenhydrinate tablets are taken, press Chinese Pharmacopoeia respectively(2010 editions)Second dissolution test appendix XC second Method, using water 900mL as dissolution medium, revolving speed is 50 turns per minute, operates according to methods, operates according to methods, when taking 40min respectively, takes molten Liquid 10ml, filtration, precision measure subsequent filtrate 5ml and set 20ml measuring bottle(50mg specification)In, it is diluted with water to scale, is shaken up, according in State's pharmacopeia(2010 editions)Second appendix IVA uv-vis spectrophotometry;Every the amount of dissolution is calculated, it is as a result as follows:
The dissolution rate of 1 dimenhydrinate tablets of table
To sum up, the embodiment of the present invention has the advantages that:The dimenhydrinate tablets prepared using formula of the invention and technique, Drug Fast Stripping, dissolution rate is high, and bioavilability is higher, and curative effect is better.
It should be noted that, in this document, relational terms such as first and second and the like are used merely to a reality Body or operation are distinguished with another entity or operation, are deposited without necessarily requiring or implying between these entities or operation In any actual relationship or order or sequence.Moreover, the terms "include", "comprise" or its any other variant are intended to Non-exclusive inclusion, so that the process, method, article or equipment including a series of elements is not only wanted including those Element, but also including other elements that are not explicitly listed, or further include for this process, method, article or equipment Intrinsic element.In the absence of more restrictions, the element limited by sentence "including a ...", it is not excluded that There is also other identical elements in process, method, article or equipment including the element.
The above embodiments are merely illustrative of the technical solutions of the present invention, rather than its limitations;Although with reference to the foregoing embodiments Invention is explained in detail, those skilled in the art should understand that:It still can be to aforementioned each implementation Technical solution documented by example is modified or equivalent replacement of some of the technical features;And these modification or Replacement, the spirit and scope for technical solution of various embodiments of the present invention that it does not separate the essence of the corresponding technical solution.

Claims (10)

1. a kind of dimenhydrinate tablets, which is characterized in that including dramamine compound, pharmaceutic adjuvant, starch, peppermint and borneol.
2. dimenhydrinate tablets as described in claim 1, which is characterized in that the dramamine compound, pharmaceutic adjuvant, shallow lake The mass ratio of powder, peppermint and borneol is(1~12):(0.5~8):(3~30):(0.2~5):(0.1~3).
3. dimenhydrinate tablets as claimed in claim 2, which is characterized in that the pharmaceutic adjuvant includes disintegrating agent, corrigent, sticks Mixture, lubricant, sorbefacient and surfactant.
4. dimenhydrinate tablets as claimed in claim 3, which is characterized in that the disintegrating agent, corrigent, binder, lubricant, The mass ratio of sorbefacient and surfactant is(3~15):(2~12):(3~9):(1~10):(2~8):(1.5~ 4.5).
5. such as Claims 2 or 3 or the dimenhydrinate tablets, which is characterized in that the disintegrating agent be microcrystalline cellulose with it is low Replace the mixture of hydroxypropylcellulose, the mass ratio of the microcrystalline cellulose and low-substituted hydroxypropyl cellulose is(1~10):(0.2 ~5);The corrigent is starch sugar or stevioside or Radix Glycyrrhizae;The lubricant is that talcum powder or magnesium stearate or stearic acid are rich Horse acid sodium;The surfactant is lecithin or fatty glyceride or fatty acid sorbitan.
6. the dimenhydrinate tablets as described in claim 1-4 is any, which is characterized in that the dramamine compound, medicinal auxiliary Material, starch, peppermint and borneol mass ratio be(2~10):(1~6):(5~23):(1~4):(0.5~2.5);The disintegration Agent, corrigent, binder, lubricant, sorbefacient and surfactant mass ratio be(4~12):(3~10):(4~ 8):(2~8):(3~7):(2~4).
7. dimenhydrinate tablets as claimed in claim 6, which is characterized in that the dramamine compound, pharmaceutic adjuvant, shallow lake The mass ratio of powder, peppermint and borneol is(3~8):(2~5):(8~15):(1.8~3.2):(0.8~2);The disintegrating agent, Corrigent, binder, lubricant, sorbefacient and surfactant mass ratio be(5~10):(4~8):(5~7):(3 ~7):(3.8~6):(2.5~3.6).
8. dimenhydrinate tablets as claimed in claim 7, which is characterized in that the dramamine compound, pharmaceutic adjuvant, shallow lake The mass ratio of powder, peppermint and borneol is(4~6):(3~4):(10~12):(2.1~3.7):(1~1.6);The disintegrating agent, Corrigent, binder, lubricant, sorbefacient and surfactant mass ratio be(6~8):(5~7):(5.5~ 6.3):(4~5.5):(4.3~5.5):(3~3.3).
9. dimenhydrinate tablets as claimed in claim 8, which is characterized in that the dramamine compound, pharmaceutic adjuvant, shallow lake The mass ratio of powder, peppermint and borneol is 5:3.5:11:3:1.3;The disintegrating agent, binder, lubricant, absorbs rush at corrigent It is 7 into the mass ratio of agent and surfactant:6:6:5:4.8:3.2.
10. the preparation method of the dimenhydrinate tablets as described in claim 1-4 is any, which is characterized in that include the following steps:
1)Stock, peppermint is cleaned, is ground into coarse powder after drying;The peppermint and borneol are crushed with pulverizer respectively, reached The requirement of 80 mesh;Dramamine compound, pharmaceutic adjuvant and starch reach 80 mesh;It is compound to weigh dramamine respectively in mass ratio Object, pharmaceutic adjuvant, starch, peppermint and borneol, it is spare;
2)Mixing, by step 1)In dramamine compound, pharmaceutic adjuvant, starch, peppermint and borneol put into together to high speed In mixer-granulator, stirring is started, dry-mixed 10~30min obtains dry-mixed raw material;
3)Granulation, by step 2)In dry-mixed raw material 30 DEG C at a temperature of be dried, then carry out whole grain, continue after whole grain 40 DEG C at a temperature of dry, obtain dry feedstock;
4)Sterilizing, by step 3)In dry feedstock sterilized using flowing steam, wherein live steam temperature is 100 DEG C, Sterilization time is 30~60min, obtains sterilized mixture;
5)Tabletting:By rapid 4)In sterilized mixture punch die tabletting.
CN201810829719.4A 2018-07-25 2018-07-25 A kind of dimenhydrinate tablets Pending CN108904456A (en)

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1161201A (en) * 1997-02-21 1997-10-08 吴贤 Chewing gum for anti-carsickness and method for preparing same
CN101485635A (en) * 2008-01-17 2009-07-22 北京益民药业有限公司 Dramamine lozenge and preparation method thereof

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1161201A (en) * 1997-02-21 1997-10-08 吴贤 Chewing gum for anti-carsickness and method for preparing same
CN101485635A (en) * 2008-01-17 2009-07-22 北京益民药业有限公司 Dramamine lozenge and preparation method thereof

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
张鹏威,等: "茶苯海明口腔崩解片的研制", 《中国药学杂志》 *

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Application publication date: 20181130