CN105920043A - Compound paracetamol and amantadine hydrochloride tablet and preparation method thereof - Google Patents

Compound paracetamol and amantadine hydrochloride tablet and preparation method thereof Download PDF

Info

Publication number
CN105920043A
CN105920043A CN201610463756.9A CN201610463756A CN105920043A CN 105920043 A CN105920043 A CN 105920043A CN 201610463756 A CN201610463756 A CN 201610463756A CN 105920043 A CN105920043 A CN 105920043A
Authority
CN
China
Prior art keywords
paracetamol
compound sheet
amantadine
preparation
amantadine compound
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201610463756.9A
Other languages
Chinese (zh)
Inventor
邢福涛
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
JILIN WUTAI GANKANG PHARMACY CO Ltd
Original Assignee
JILIN WUTAI GANKANG PHARMACY CO Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by JILIN WUTAI GANKANG PHARMACY CO Ltd filed Critical JILIN WUTAI GANKANG PHARMACY CO Ltd
Priority to CN201610463756.9A priority Critical patent/CN105920043A/en
Publication of CN105920043A publication Critical patent/CN105920043A/en
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/16Amides, e.g. hydroxamic acids
    • A61K31/165Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
    • A61K31/167Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • 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
    • A61K31/435Heterocyclic 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
    • A61K31/4402Non condensed pyridines; Hydrogenated derivatives thereof only substituted in position 2, e.g. pheniramine, bisacodyl
    • 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
    • A61K35/00Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/37Digestive system
    • A61K35/413Gall bladder; Bile
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Nutrition Science (AREA)
  • Physiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Developmental Biology & Embryology (AREA)
  • Immunology (AREA)
  • Virology (AREA)
  • Zoology (AREA)
  • Pain & Pain Management (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)

Abstract

The invention relates to the technical field of pharmaceutical preparation, and particularly relates to a compound paracetamol and amantadine hydrochloride tablet and a preparation method thereof. The compound paracetamol and amantadine hydrochloride tablet is prepared from acetaminophen, mydantane, caffeine, chlorpheniramine maleate, artificial calculus bovis and a pharmaceutically acceptable auxiliary material, wherein the pharmaceutically acceptable auxiliary material is a mixture of two or more than two of starch, magnesium stearate, hydroxypropyl methylcellulose, sodium carboxymethyl starch and microcrystalline cellulose. According to the compound paracetamol and amantadine hydrochloride tablet and the preparation method thereof, through changing the variety and the proportion of an auxiliary material in an original prescription, the dissolution rate and the stability of the compound paracetamol and amantadine hydrochloride tablet are improved; the dissolution rate within 10 minutes can be as high as 95 percent or above; through a six-month acceleration and normal-temperature long-term stability test, the content is stabilized to be 95.0 percent or above, and is superior to that of the original prescription and other commercially sold products.

Description

A kind of Paracetamol and Amantadine Compound sheet and preparation method thereof
Technical field
The present invention relates to technical field of medicine, particularly to a kind of Paracetamol and Amantadine Compound sheet and preparation method thereof.
Background technology
The infection of the upper respiratory tract, also known as common cold, is commonly called as " cold ", is include nasal cavity, pharynx or acute throat inflammation total Claiming, be modal acute infections of respiratory tract disease, how in self limiting, but incidence is higher.Common cold is many by rhinovirus Cause, secondly cause for coronavirus, parainfluenza virus, Respiratory Syncytial Virus(RSV), echovirus, Coxsackie virus etc..It faces Bed shows themselves in that onset is relatively anxious, and incubation period 1~3 days, different with virus, enterovirus is shorter, and adenovirus, respiratory syncystial are sick Poison etc. are longer.Mainly show as sniffle, such as sneeze, have a stuffy nose, flow clear water sample nasal mucus, it is possible to show as cough, dry throat, pharynx are itched Or burning heat sensation, even Postnasal drip sense.Morbidity or can have sneeze simultaneously, have a stuffy nose, flows the symptoms such as clear water sample nasal mucus after a few hours.2 ~nasal mucus retrogradation after 3 days, often accompany pharyngalgia, shed tears, hypogeusia, unsmooth breath, trachyphonia etc..It is general without heating and constitutional symptom, Or only low-heat, discomfort, slight chilly, headache.Bronchia mucosal hyperemia, oedema seen from health check-up, there is secretion, pharyngeal slightly fill Blood.Adult is annual to be occurred 2~4 times, and children's incidence is higher, annual 6~8 times.The whole year all can fall ill, and winter-spring season is more.
Sense health (Paracetamol and Amantadine Compound sheet) is one of cold drug of extensively being favored by patient in existing market, according to state food medicine The investigational data of south medication economics research institute of product Surveillance Authority shows, sense health was in 2001,2002,2003,2004,2005 Within continuous 5 years, occupy cold drug and sell the umber one.Sense health is compound preparation, and its component is: every contains paracetamol 0.25g, salt Symmetrel 0.1g, caffeine 15mg, calculus bovis factitius 10mg, chlorphenamine maleate 2mg.Wherein, paracetamol tool Having antipyretic effect, its mechanism of action is to be synthesized by suppression hypothalamus heat-regulating centers prostaglandin (PGE2) and discharged And reduce inflammation, and have certain vasodilative effect, cause perspiration to reach refrigeration function, the work of bradykinin etc. can be suppressed simultaneously With, improve the threshold of pain and produce analgesic activity.Chlorphenamine maleate is antihistamine, competitive can block H1 acceptor and produce anti- Allergy effect, the most also can eliminate or alleviate nasal obstruction, sneeze, have a running nose and various allergic symptom, and have sedation. Amantadine has anti influenza A type virus function, and remaining composition has the effects such as antipyretic, analgesia, anti-inflammatory, antiallergy.Clinical treatment Effect display sense health can effectively alleviate common cold and influenza causes heating, headache, four limbs are touched a tender spot, sneeze, are flowed nose The symptoms such as tears, nasal obstruction, sore-throat.
At present, existing commercially available sense health product exists that dissolution rate is relatively low, the problem of less stable.Therefore it provides it is a kind of molten Out-degree is high, the Paracetamol and Amantadine Compound sheet of good stability and preparation method thereof has important practical significance.
Summary of the invention
In view of this, the invention provides a kind of Paracetamol and Amantadine Compound sheet and preparation method thereof.This Paracetamol and Amantadine Compound sheet There is higher dissolution rate and preferable stability.
In order to realize foregoing invention purpose, the present invention provides techniques below scheme:
The invention provides a kind of Paracetamol and Amantadine Compound sheet, including paracetamol, amantadine hydrochloride, caffeine, Chlorphenamine maleate, calculus bovis factitius and pharmaceutically acceptable auxiliary material;
Pharmaceutically acceptable auxiliary material is that starch, magnesium stearate, HPMC, sodium carboxymethyl starch or crystallite are fine Two or more mixture in dimension element.
As preferably, the quality of starch, magnesium stearate, HPMC, sodium carboxymethyl starch and microcrystalline cellulose Than being (10~30): (1~5): (1~6): (5~12): (5~12).
The present invention is by changing kind and the ratio of auxiliary material in original prescription, thus improves the molten of Paracetamol and Amantadine Compound sheet Out-degree and stability.
As preferably, pharmaceutically acceptable auxiliary material is starch, magnesium stearate, HPMC, CMS The mixture of at least 4 kinds in sodium or microcrystalline cellulose.
In some embodiments that the present invention provides, the formula of Paracetamol and Amantadine Compound sheet is as follows:
Its preparation method is: by formula ratio by paracetamol, amantadine hydrochloride, caffeine, chlorphenamine maleate Quick, calculus bovis factitius, starch mixing, obtains the first mixture;
The preparation HPMC aqueous solution, mixes with ethanol water, obtains the second mixture;
First mixture and the second mixture are mixed, through softwood processed, grain predrying, whole, after drying, with magnesium stearate and Sodium carboxymethyl starch mixes, compressing tablet, it is thus achieved that Paracetamol and Amantadine Compound sheet.
The mass percentage concentration of the HPMC aqueous solution is 1%~4%, the concentration expressed in percentage by volume of ethanol water It is 70%~95%.
In other embodiments that the present invention provides, the formula of Paracetamol and Amantadine Compound sheet is as follows:
Its preparation method is: by formula ratio by paracetamol, amantadine hydrochloride, caffeine, chlorphenamine maleate Quick, calculus bovis factitius, microcrystalline cellulose mixing, obtains the first mixture;Preparation amidin;
First mixture and amidin are mixed, through softwood processed, grain predrying, whole, after drying, with magnesium stearate and Sodium carboxymethyl starch mixes, compressing tablet, it is thus achieved that Paracetamol and Amantadine Compound sheet.
In other embodiments that the present invention provides, the formula of Paracetamol and Amantadine Compound sheet is as follows:
Its preparation method is: by formula ratio by paracetamol, amantadine hydrochloride, caffeine, chlorphenamine maleate Quick, calculus bovis factitius, starch, microcrystalline cellulose mixing, obtains the first mixture;
The preparation HPMC aqueous solution, mixes with ethanol water, obtains the second mixture;
First mixture and the second mixture are mixed, through softwood processed, grain predrying, whole, dried, mixed with magnesium stearate Close, compressing tablet, it is thus achieved that Paracetamol and Amantadine Compound sheet.
The mass percentage concentration of the HPMC aqueous solution is 1%~4%, the concentration expressed in percentage by volume of ethanol water It is 70%~95%.
As preferably, the formula of Paracetamol and Amantadine Compound sheet is as follows:
Its preparation method is: by formula ratio by paracetamol, amantadine hydrochloride, caffeine, chlorphenamine maleate Quick, calculus bovis factitius, starch, microcrystalline cellulose mixing, obtains the first mixture;
The preparation HPMC aqueous solution, mixes with ethanol water, obtains the second mixture;
First mixture and the second mixture are mixed, through softwood processed, grain predrying, whole, after drying, with magnesium stearate and Sodium carboxymethyl starch mixes, compressing tablet, it is thus achieved that Paracetamol and Amantadine Compound sheet.
The mass percentage concentration of the HPMC aqueous solution is 1%~4%, the concentration expressed in percentage by volume of ethanol water It is 70%~95%.
In the embodiment that the present invention provides, the formula of Paracetamol and Amantadine Compound sheet is as follows:
In another embodiment that the present invention provides, the formula of Paracetamol and Amantadine Compound sheet is as follows:
In another embodiment that the present invention provides, the formula of Paracetamol and Amantadine Compound sheet is as follows:
Present invention also offers the preparation method of this Paracetamol and Amantadine Compound sheet, including: by formula ratio by paracetamol, Pelletize after amantadine hydrochloride, caffeine, chlorphenamine maleate, calculus bovis factitius and the mixing of pharmaceutically acceptable auxiliary material, dry Dry, compressing tablet, it is thus achieved that Paracetamol and Amantadine Compound sheet.
In the embodiment that the present invention provides, the formula of Paracetamol and Amantadine Compound sheet is as follows:
Its preparation method is: by formula ratio by paracetamol, amantadine hydrochloride, caffeine, chlorphenamine maleate Quick, calculus bovis factitius, starch, microcrystalline cellulose mixing, obtains the first mixture;
The preparation HPMC aqueous solution, mixes with ethanol water, obtains the second mixture;
First mixture and the second mixture are mixed, through softwood processed, grain predrying, whole, after drying, with magnesium stearate and Sodium carboxymethyl starch mixes, compressing tablet, it is thus achieved that Paracetamol and Amantadine Compound sheet.
As preferably, the screen size of supplementary material used by Paracetamol and Amantadine Compound sheet is 100 mesh.
As preferably, the mass percentage concentration of the HPMC aqueous solution is 1%~4%, the body of ethanol water Long-pending percentage concentration is 70%~95%.
As preferably, the HPMC aqueous solution is 1:1 with the volume ratio of ethanol water.
The invention provides a kind of Paracetamol and Amantadine Compound sheet and preparation method thereof.This Paracetamol and Amantadine Compound sheet includes acetyl Amino phenols, amantadine hydrochloride, caffeine, chlorphenamine maleate, calculus bovis factitius and pharmaceutically acceptable auxiliary material;Pharmaceutically Acceptable auxiliary material is in starch, magnesium stearate, HPMC, sodium carboxymethyl starch or microcrystalline cellulose two kinds or two Plant above mixture.The device have the advantages that for:
The present invention is by changing kind and the ratio of auxiliary material in original prescription, thus improves the molten of Paracetamol and Amantadine Compound sheet Out-degree, the dissolution rate of 10 minutes may be up to more than 95%, is better than original prescription and other commercially available prod;
The present invention is by changing kind and the ratio of auxiliary material in original prescription, thus improves the steady of Paracetamol and Amantadine Compound sheet Qualitative, through the acceleration of 6 months, normal temperature long-term stable experiment, stable content, more than 95.0%, is better than original prescription.
Accompanying drawing explanation
The preparation technology flow chart of the Paracetamol and Amantadine Compound sheet that Fig. 1 provides for the embodiment of the present invention.
Detailed description of the invention
The invention discloses a kind of Paracetamol and Amantadine Compound sheet and preparation method thereof, those skilled in the art can use for reference herein Content, is suitably modified technological parameter and realizes.Special needs to be pointed out is, all similar replacements and change are to people in the art Being apparent from for Yuan, they are considered as being included in the present invention.The method of the present invention and application have been passed through the most real Executing example to be described, related personnel substantially can be to method described herein in without departing from present invention, spirit and scope It is modified with application or suitably changes and combine, realize and apply the technology of the present invention.
In Paracetamol and Amantadine Compound sheet and preparation method thereof that the present invention provides, raw materials used or auxiliary material all can be buied by market.
Below in conjunction with embodiment, the present invention it is expanded on further:
The preparation of embodiment 1 Paracetamol and Amantadine Compound sheet
In the present embodiment, the formula of Paracetamol and Amantadine Compound sheet is as follows:
Preparation technology: take the paracetamol of 250 weight portions, the amantadine hydrochloride of 100 weight portions, 15 weight portions Caffeine, the chlorphenamine maleate of 2 weight portions, 10 weight portions calculus bovis factitius through 100 mesh sieves, after mixing with pharmaceutic adjuvant make Grain, fluidized drying, compressing tablet, to obtain final product.
The preparation of embodiment 2 Paracetamol and Amantadine Compound sheet
In the present embodiment, the formula of Paracetamol and Amantadine Compound sheet is as follows:
Preparation technology: take the paracetamol of 250 weight portions, the amantadine hydrochloride of 100 weight portions, 15 weight portions Caffeine, the chlorphenamine maleate of 2 weight portions, 10 weight portions calculus bovis factitius through 100 mesh sieves, after mixing with pharmaceutic adjuvant make Grain, fluidized drying, compressing tablet, to obtain final product.
The preparation of embodiment 3 Paracetamol and Amantadine Compound sheet
In the present embodiment, the formula of Paracetamol and Amantadine Compound sheet is as follows:
Preparation technology: take the paracetamol of 250 weight portions, the amantadine hydrochloride of 100 weight portions, 15 weight portions Caffeine, the chlorphenamine maleate of 2 weight portions, 10 weight portions calculus bovis factitius through 100 mesh sieves, after mixing with pharmaceutic adjuvant make Grain, fluidized drying, compressing tablet, to obtain final product.
The preparation of embodiment 4 Paracetamol and Amantadine Compound sheet
In the present embodiment, the formula of Paracetamol and Amantadine Compound sheet is as follows:
Preparation technology: take the paracetamol of 250 weight portions, the amantadine hydrochloride of 100 weight portions, 15 weight portions Caffeine, the chlorphenamine maleate of 2 weight portions, 10 weight portions calculus bovis factitius through 100 mesh sieves, after mixing with pharmaceutic adjuvant make Grain, fluidized drying, compressing tablet, to obtain final product.Concrete technology flow process is shown in Fig. 1.The preparation of embodiment 5 Paracetamol and Amantadine Compound sheet
In the present embodiment, the formula of Paracetamol and Amantadine Compound sheet is as follows:
Preparation technology: take the paracetamol of 250 weight portions, the amantadine hydrochloride of 100 weight portions, 15 weight portions Caffeine, the chlorphenamine maleate of 2 weight portions, 10 weight portions calculus bovis factitius through 100 mesh sieves, after mixing with pharmaceutic adjuvant make Grain, fluidized drying, compressing tablet, to obtain final product.
The preparation of embodiment 6 Paracetamol and Amantadine Compound sheet
In the present embodiment, the formula of Paracetamol and Amantadine Compound sheet is as follows:
Preparation technology: take the paracetamol of 250 weight portions, the amantadine hydrochloride of 100 weight portions, 15 weight portions Caffeine, the chlorphenamine maleate of 2 weight portions, 10 weight portions calculus bovis factitius through 100 mesh sieves, after mixing with pharmaceutic adjuvant make Grain, fluidized drying, compressing tablet, to obtain final product.
Comparative example 1
The formula of original prescription Paracetamol and Amantadine Compound sheet (sense health sheet) is as follows:
Comparative example 2
Commercially available Paracetamol and Amantadine Compound sheet is purchased from A pharmaceutical Co. Ltd, fills a prescription as follows:
Comparative example 3
Commercially available Paracetamol and Amantadine Compound sheet is purchased from B pharmaceutical Co. Ltd, fills a prescription as follows:
Comparative example 4
Commercially available Paracetamol and Amantadine Compound sheet is purchased from C pharmaceutical Co. Ltd, fills a prescription as follows:
Embodiment 7 Dissolution Rate Testing
Embodiment 1-6 and comparative example 1-4 product are detected in accordance with the following methods its dissolution rate:
Take three batch samples, according to dissolution rate and drug release determination method (" Chinese Pharmacopoeia " version general rule 0,931 first method in 2015), Adding water to 1000ml as dissolution medium with hydrochloric acid 9ml, rotating speed is 100 turns per minute, operates in accordance with the law, through 10 minutes time, takes solution 5ml filters, and precision measures subsequent filtrate 1ml, puts in 50ml measuring bottle, adds 0.1mol/L NaOH to scale, divides according to ultraviolet-visible Light photometry (Chinese Pharmacopoeia " 2015 year version general rule 0401), measures absorbance, by paracetamol at the wavelength of 257nm (C8H9NO2) absorption coefficientIt it is the stripping quantity of 715 calculating every.Result sees table 1.
Table 1 embodiment and 10 minutes dissolution rate testing results of comparative example Paracetamol and Amantadine Compound sheet
As shown in Table 1, Paracetamol and Amantadine Compound sheet embodiment 1-6 made with preparation method of the present invention, the proterties of medicine, have Related substance, content all meet regulation, and in 10 minutes, drug dissolution substantially relatively comparative example 1,2,3,4 is high, and result of extraction is described It is better than other families commercially available and the effect of existing formula;As the embodiment 4 of preferred auxiliary material combination, for all embodiments and comparative example Middle Dissolution Value is the highest, and dissolution rate is more than 95%, and effect is best;After auxiliary material combines entirely, effect becomes apparent from, and surpasss the expectation.
Embodiment 8 stability test
Take three batch samples, according to material medicine and preparation stability test direction principle (" Chinese Pharmacopoeia " version general rule in 2015 9001), the Paracetamol and Amantadine Compound sheet to embodiment 1-6 and comparative example 1-4 be accelerated test (acceleration environment be temperature 40 DEG C ± 2 DEG C, relative humidity 75% ± 5%), result sees table 2.
Table 2 embodiment 1-6 and the accelerated test result (%) of comparative example 1-4 Paracetamol and Amantadine Compound sheet
Take three batch samples, according to material medicine and preparation stability test direction principle (" Chinese Pharmacopoeia " version general rule in 2015 9001), the Paracetamol and Amantadine Compound sheet to embodiment 1-6 and comparative example 1-4 carries out normal temperature long term test (long-term conditions is temperature 25 DEG C scholar 2 DEG C, relative humidity 60% scholar 10%), result sees table 3.
Table 3 inventive embodiments 1-6 and the normal temperature long-term test results (%) of comparative example 1-4 Paracetamol and Amantadine Compound sheet
From table 2,3, the stability data of Paracetamol and Amantadine Compound sheet embodiment 4 prepared by the present invention relatively other embodiments And comparative example is the best, stable content is more than 95%.
The above is only the preferred embodiment of the present invention, it is noted that for the ordinary skill people of the art For Yuan, under the premise without departing from the principles of the invention, it is also possible to make some improvements and modifications, these improvements and modifications also should It is considered as protection scope of the present invention.

Claims (10)

1. a Paracetamol and Amantadine Compound sheet, it is characterised in that include paracetamol, amantadine hydrochloride, caffeine, Malaysia Acid chlorphenamine, calculus bovis factitius and pharmaceutically acceptable auxiliary material;
Described pharmaceutically acceptable auxiliary material is that starch, magnesium stearate, HPMC, sodium carboxymethyl starch and crystallite are fine Two or more mixture in dimension element.
Paracetamol and Amantadine Compound sheet the most according to claim 1, it is characterised in that described starch, described magnesium stearate, described The mass ratio of HPMC, described sodium carboxymethyl starch and described microcrystalline cellulose is (10~30): (1~5): (1~ 6): (5~12): (5~12).
Paracetamol and Amantadine Compound sheet the most according to claim 1 and 2, it is characterised in that joining of described Paracetamol and Amantadine Compound sheet Side is as follows:
Paracetamol and Amantadine Compound sheet the most according to claim 1 and 2, it is characterised in that joining of described Paracetamol and Amantadine Compound sheet Side is as follows:
Paracetamol and Amantadine Compound sheet the most according to claim 1 and 2, it is characterised in that joining of described Paracetamol and Amantadine Compound sheet Side is as follows:
Paracetamol and Amantadine Compound sheet the most according to claim 1 and 2, it is characterised in that joining of described Paracetamol and Amantadine Compound sheet Side is as follows:
7. the preparation method of Paracetamol and Amantadine Compound sheet as according to any one of claim 1 to 6, it is characterised in that including: by joining Side's amount is by paracetamol, amantadine hydrochloride, caffeine, chlorphenamine maleate, calculus bovis factitius and pharmaceutically acceptable Auxiliary material mixing after pelletize, be dried, compressing tablet, it is thus achieved that Paracetamol and Amantadine Compound sheet.
Preparation method the most according to claim 7, it is characterised in that the formula of described Paracetamol and Amantadine Compound sheet is as follows:
Its preparation method is: by formula ratio by paracetamol, amantadine hydrochloride, caffeine, chlorphenamine maleate, people Work cow-bezoar, starch, microcrystalline cellulose mix, and obtain the first mixture;
The preparation HPMC aqueous solution, mixes with ethanol water, obtains the second mixture;
By described first mixture and described second mixture mixing, through softwood processed, grain predrying, whole, after drying, with stearic acid Magnesium and sodium carboxymethyl starch mixing, compressing tablet, it is thus achieved that Paracetamol and Amantadine Compound sheet.
9. according to the preparation method described in claim 7 or 8, it is characterised in that the matter of the described HPMC aqueous solution Amount percentage concentration is 1%~4%, and the concentration expressed in percentage by volume of described ethanol water is 70%~95%.
10. according to the preparation method according to any one of claim 7 to 9, it is characterised in that described HPMC water Solution is 1:1 with the volume ratio of described ethanol water.
CN201610463756.9A 2016-06-23 2016-06-23 Compound paracetamol and amantadine hydrochloride tablet and preparation method thereof Pending CN105920043A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201610463756.9A CN105920043A (en) 2016-06-23 2016-06-23 Compound paracetamol and amantadine hydrochloride tablet and preparation method thereof

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN201610463756.9A CN105920043A (en) 2016-06-23 2016-06-23 Compound paracetamol and amantadine hydrochloride tablet and preparation method thereof

Publications (1)

Publication Number Publication Date
CN105920043A true CN105920043A (en) 2016-09-07

Family

ID=56832026

Family Applications (1)

Application Number Title Priority Date Filing Date
CN201610463756.9A Pending CN105920043A (en) 2016-06-23 2016-06-23 Compound paracetamol and amantadine hydrochloride tablet and preparation method thereof

Country Status (1)

Country Link
CN (1) CN105920043A (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112716911A (en) * 2021-02-04 2021-04-30 吉林省吴太感康药业有限公司 Caffeine microcapsule, preparation method thereof and compound paracetamol and alkyl amine preparation

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104415054A (en) * 2013-08-20 2015-03-18 哈药集团三精制药股份有限公司 Preparation method of quickly-releasing compounded paracetamol and amantadine hydrochloride tablet

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN104415054A (en) * 2013-08-20 2015-03-18 哈药集团三精制药股份有限公司 Preparation method of quickly-releasing compounded paracetamol and amantadine hydrochloride tablet

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112716911A (en) * 2021-02-04 2021-04-30 吉林省吴太感康药业有限公司 Caffeine microcapsule, preparation method thereof and compound paracetamol and alkyl amine preparation

Similar Documents

Publication Publication Date Title
TW201922259A (en) Pharmaceutical preparation excellent in light stability and dissolution property
CN104622855A (en) Oral solution containing ambroxol hydrochloride and salbutamol sulfate
Khinchi et al. Studies on the disintegrant properties of seed powder, husk powder and mucilage of Plantago ovata by formulation of orally disintegrating tablet
TWI822498B (en) Solid dosage form having excellent stability
CN104622854A (en) Tablet containing ambroxol hydrochloride and salbutamol sulfate
CN105920043A (en) Compound paracetamol and amantadine hydrochloride tablet and preparation method thereof
WO2017047586A1 (en) Tablet
CN106361689A (en) Fudosteine oral solution and preparation method thereof
CN108888602A (en) A kind of montelukast preparation of sodium and preparation method thereof
US11744841B2 (en) Use of trezastilbenoside in manufacture of product for treating and/or preventing disease of respiratory system
JP6590436B1 (en) Solid formulation with excellent stability
AU2015261940B2 (en) Cough medicine containing ambroxol hydrochloride
CN114557981A (en) Montelukast oral cavity dissolving film agent and preparation process thereof
JP2018188377A (en) Pharmaceutical composition
CN112386578A (en) Montelukast sodium chewable tablet and preparation method thereof
CN103446070B (en) A kind of roflumilast solid immediate release preparation and preparation method thereof
CN107569504A (en) A kind of ambroxol hydrochloride dispersible tablet and preparation method
CN112089696A (en) Marbofloxacin flavor tablet and preparation method thereof
CN107049973B (en) Ambroxol hydrochloride orally disintegrating tablet and preparation method thereof
JP2010047566A (en) Pharmaceutical composition
JPWO2019230937A1 (en) Oral solid preparation with excellent dissolution
CN1742751A (en) Compound paracetamol and amantadine hydrochloride dripping pills and preparation method
CN107929744A (en) The application in respiratory drugs are prepared of Moringa and pidotimod composition, animal respiratory tract protective agents and preparation method thereof
JP2010047518A (en) Rhinostenosis inhibitor
CN109771477B (en) Chewable tablet containing honeysuckle flower and radix scutellariae and preparation method thereof

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
RJ01 Rejection of invention patent application after publication
RJ01 Rejection of invention patent application after publication

Application publication date: 20160907