CN108635334A - A kind of novel Dequalinium Chloride lozenge and preparation method thereof - Google Patents
A kind of novel Dequalinium Chloride lozenge and preparation method thereof Download PDFInfo
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- A61K9/0056—Mouth 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
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Abstract
The invention discloses a kind of novel Dequalinium Chloride lozenges and preparation method thereof, including：Dequalinium Chloride, mannitol, maltitol, acesulfame potassium, citric acid, liquid extract of liquorice, methyl p-hydroxybenzoate, menthol, lac, pigment, adhesive, antioxidant.Method：1）Mannitol, maltitol, acesulfame potassium and liquid extract of liquorice add water and mix to obtain solution A；2）Dequalinium Chloride, methyl p-hydroxybenzoate, menthol, pigment, adhesive and antioxidant mixing, obtain material B；3）By solution A and material B wet mixings, wet granular is made；4）Wet granular is dried；5）Tabletting；6）Make pure shellac solution；7）By pure shellac solution=be applied to step 5）Gained Dequalinium Chloride preform outer surface, it is dry.The present invention solves the disadvantage that the edible impression of Dequalinium Chloride lozenge in the prior art is poor, drug effect is difficult to give full play to, has stronger replicability well by relatively simple manufacture craft and lower cost of manufacture.
Description
Technical field
The present invention relates to pharmaceutical technology fields, and in particular to a kind of novel Dequalinium Chloride lozenge and preparation method thereof.
Background technology
Dequalinium Chloride is also known as Dequavet dequaline chloride, is cationic surfactant, has broad-spectrum antibacterial action, to oral cavity
It is effective with pharyngeal common pathogen and fungal infection, therefore be usually used in acute laryngopharyngitis, oral disinfecting etc..
Dequalinium Chloride lozenge is a kind of contained in oral cavity and the compressed tablets of slow mechanism dissolved, can to oral cavity and pharyngeal generation compared with
For lasting drug effect, it to be used for topical anti-inflammatory, disinfection etc..Dequalinium Chloride lozenge due to it is convenient to take, have preferable mouthfeel and by
To the welcome of many patients.Change due to slowly containing, so that the drug long period is rested on pharyngeal, persistently play drug effect.
But the melting time of Dequalinium Chloride lozenge in the prior art is shorter, therefore patient needs fairly frequently to take
Drug is simultaneously taken again, this not only bad for drug effect lasting performance, and high frequency time take medication object also brought not to patient
Just；In addition, after the Dequalinium Chloride lozenge sold at present takes entrance for a period of time, it will usually generate a kind of not satiny, puckery
Bad mouthfeel, give user poor mouthfeel, be easy to cause and take resentment, to be difficult to be accepted by patients, be unfavorable for
It promotes.
Chinese patent CN106632031A discloses the preparation method of a kind of Dequalinium Chloride crystal and its lozenge and lozenge, ground
Quinoline oronain lozenge is made of the following raw material medicine：Dequalinium Chloride crystal 0.01-0.03 parts by weight, mannitol 45-50 parts by weight, xylose
Alcohol 45-50 parts by weight, sodium carboxymethylcellulose 1.0-2.0 parts by weight, chlorophyll copper sodium 0.005-0.02 parts by weight, para hydroxybenzene
Methyl formate 0.002-0.006 parts by weight, liquid extract of liquorice 0.4-0.6 parts by weight, strawberry essence 0.2-0.5 parts by weight, peppermint
Brain 0.3-0.5 parts by weight, aspartame 0.3-0.5 parts by weight, silica 0.3-0.5 parts by weight, polyethylene glycol-6000 1.0-
2.0 parts by weight and magnesium stearate 0.3-0.5 parts by weight.The solution rate of other each ingredients of the Dequalinium Chloride lozenge is consistent, will not
Generate the feeling of " puckery "；The stability of the Dequalinium Chloride lozenge of the present invention is preferable, and storing active ingredient for a long time will not decline.
But the Dequalinium Chloride lozenge preparation condition is more harsh, preparation process is complex, and cost is higher.
Chinese patent CN106727369A discloses a kind of Dequalinium Chloride lozenge and preparation method thereof, Dequalinium Chloride lozenge by
Following ingredients form：Sucrose 80-95 parts by weight, mannitol 1.5-2.5 parts by weight, stearic acid 0.15-0.4 parts by weight, pigment
0.005-0.01 parts by weight, Dequalinium Chloride 0.01-0.025 parts by weight, liquid extract of liquorice 0.3-0.5 parts by weight, para hydroxybenzene first
Sour methyl esters 0.002-0.004 parts by weight, gelatin 1-3 parts by weight, menthol 0.1-0.3 parts by weight, essence 0.1-0.3 parts by weight,
Magnesium stearate 0.1-0.35 parts by weight, sodium carboxymethylcellulose 0.5-1.5 parts by weight.Dequalinium Chloride lozenge melting time length,
Lasting medicine.But patient often chews pharynx or swallows or directly during take because it needs to suck overlong time selection
Selecting, which is selected, to be abandoned, and causes the actual efficacy of drug that can not play.
Invention content
For problems of the prior art, the present invention provides a kind of novel Dequalinium Chloride lozenge and its preparation sides
Method, the present invention solve the disadvantage that the edible impression of Dequalinium Chloride lozenge in the prior art is poor, drug effect is difficult to give full play to.
In order to achieve the above object, the present invention is achieved through the following technical solutions：
A kind of novel Dequalinium Chloride lozenge, includes the raw material of following parts by weight meter：0.015-0.025 parts of Dequalinium Chloride, mannitol
10-13 parts, 5-12 parts of maltitol, 10-20 parts of acesulfame potassium, 2-5 parts of citric acid, 1-3 parts of liquid extract of liquorice, P-hydroxybenzoic acid
0.015-0.05 parts of methyl esters, 2-3 parts of menthol, 5-8 parts of lac, 0.5-1.2 parts of pigment, 0.5-0.8 parts of adhesive, antioxidant
1-3 parts.
Preferably, include the raw material of following parts by weight meter：0.015 part of Dequalinium Chloride, 10 parts of mannitol, 5 parts of maltitol,
10 parts of acesulfame potassium, 2 parts of citric acid, 1 part of liquid extract of liquorice, 0.015 part of methyl p-hydroxybenzoate, 2 parts of menthol, 5 parts of lac,
0.5 part of pigment, 0.5 part of adhesive, 1 part of antioxidant.
Preferably, include the raw material of following parts by weight meter：0.025 part of Dequalinium Chloride, 13 parts of mannitol, maltitol 12
Part, 20 parts of acesulfame potassium, 5 parts of citric acid, 3 parts of liquid extract of liquorice, 0.05 part of methyl p-hydroxybenzoate, 3 parts of menthol, lac 8
Part, 1.2 parts of pigment, 0.8 part of adhesive, 3 parts of antioxidant.
Preferably, include the raw material of following parts by weight meter：0.020 part of Dequalinium Chloride, 12 parts of mannitol, maltitol 10
Part, 15 parts of acesulfame potassium, 4 parts of citric acid, 2 parts of liquid extract of liquorice, 0.03 part of methyl p-hydroxybenzoate, 2.5 parts of menthol, lac
6 parts, 1 part of pigment, 0.6 part of adhesive, 2 parts of antioxidant.
Preferably, pigment is one or more in gardenia blue, alkermes, safflower yellow.
Preferably, adhesive is povidone k30, hydroxypropyl methylcellulose, microcrystalline cellulose with mass ratio are 1:1:1.5 it is mixed
Close object.
Preferably, it with mass ratio is 1 that antioxidant, which is D-araboascorbic acid, glutathione,:2 mixture.
The preparation method that novel Dequalinium Chloride lozenge is also disclosed in the present invention, includes the following steps：
1）Deionized water ultrasonication 5- is added in mannitol, maltitol, acesulfame potassium and the liquid extract of liquorice for weighing formula ratio
8min, and it is heated to 50-60 DEG C of heat preservation, uniformly mixed solution A is obtained, it is spare；
2）Dequalinium Chloride, methyl p-hydroxybenzoate, menthol, pigment, adhesive and the antioxidant of formula ratio is taken to pour into more
The mixed processing 5-10min into movement mixer obtains material B；
3）Solution A and material B are poured into wet mixing 10min in high-speed mixing granulating machine, suitable softwood is made after mixing；It will
The softwood made is added in oscillating granulator through sieve, and wet granular is made；
4）Wet granular is laid in baking material disk to be placed in heated-air circulation oven, is 2-3MPa in steam pressure, temperature is 70-80 DEG C
Under conditions of dry 5-6h；
5）Material oscillating granulator whole grain after drying, sieve mesh number are 10 mesh, and dry particl is made, is pressed using tablet press machine
Piece obtains Dequalinium Chloride preform；
6）The lac of parts by weight is taken to be dissolved with 50% ethyl alcohol, filtering removal insoluble matter takes filtrate, evaporative removal ethyl alcohol to obtain
Pure shellac solution；
7）By step 6）Obtained pure shellac solution is uniformly applied to step 5）The Dequalinium Chloride preform outer surface of gained, very
Novel Dequalinium Chloride lozenge is drying to obtain under Altitude.
Preferably, step 7）In pure shellac solution be applied to Dequalinium Chloride preform outer surface thickness be 0.03-
0.05mm。
Preferably, step 7）Novel Dequalinium Chloride lozenge obtained is packed using aluminum foil under vacuum.
The present invention has following advantageous effect：
1, novel Dequalinium Chloride lozenge disclosed by the invention is that primary sweetener assists addition sweet dew simultaneously by the way that acesulfame potassium is arranged
As sweetener, acesulfame potassium is a kind of food additives, soluble easily in water, can increase food for alcohol, maltitol and liquid extract of liquorice
Product sweet taste, nonnutritive, in good taste, empty calory, have be not metabolized, do not absorb in human body, be the middle-aged and the old, adiposis patient,
The ideal sweetener of diabetic；Acesulfame potassium and other sweeteners, which are used in mixed way, simultaneously can generate very strong synergistic effect, and one
As can increase sugariness 30% ~ 50% under concentration, largely improve Dequalinium Chloride lozenge, avoid people containing being generated after the long period
Undesirable experience, and then medication time is influenced, lead to the situation that drug effect is undesirable.
2, by the way that in the pure lac of Dequalinium Chloride lozenge outer surface even application, the stabilization of Dequalinium Chloride lozenge can be increased
Property, the preservation long period will not go bad after production, and then can produce in enormous quantities, improve production efficiency.
3, the Dequalinium Chloride lozenge after production is completed is packed using aluminum foil under vacuum, can further prevent air quinoline over the ground
The oxidation of oronain lozenge, the further pot-life for extending drug.
In conclusion a kind of novel Dequalinium Chloride lozenge disclosed by the invention and preparation method thereof, by relatively simple
Manufacture craft and lower cost of manufacture solve the poor, medicine of the edible impression of Dequalinium Chloride lozenge in the prior art well
The shortcomings that effect is difficult to give full play to has stronger replicability.
Specific implementation mode
The specific implementation mode of the present invention is further described with reference to embodiment, following embodiment is only used for more
Technical scheme of the present invention is clearly demonstrated, and not intended to limit the protection scope of the present invention.
Embodiment 1
A kind of novel Dequalinium Chloride lozenge, includes the raw material of following parts by weight meter：0.015 part of Dequalinium Chloride, 10 parts of mannitol, wheat
5 parts of bud sugar alcohol, 10 parts of acesulfame potassium, 2 parts of citric acid, 1 part of liquid extract of liquorice, 0.015 part of methyl p-hydroxybenzoate, menthol 2
Part, 5 parts of lac, 0.5 part of pigment, 0.5 part of adhesive, 1 part of antioxidant.
Wherein, pigment is gardenia blue, alkermes with the mixture of arbitrary proportion.
Wherein, adhesive is povidone k30, hydroxypropyl methylcellulose, microcrystalline cellulose with mass ratio are 1:1:1.5 mixing
Object.
Wherein, it with mass ratio is 1 that antioxidant, which is D-araboascorbic acid, glutathione,:2 mixture.
A kind of preparation method of novel Dequalinium Chloride lozenge, includes the following steps：
1）Deionized water ultrasonication is added in mannitol, maltitol, acesulfame potassium and the liquid extract of liquorice for weighing formula ratio
5min, and 50 DEG C of heat preservations are heated to, uniformly mixed solution A is obtained, it is spare；
2）Dequalinium Chloride, methyl p-hydroxybenzoate, menthol, pigment, adhesive and the antioxidant of formula ratio is taken to pour into more
The mixed processing 5min into movement mixer obtains material B；
3）Solution A and material B are poured into wet mixing 10min in high-speed mixing granulating machine, suitable softwood is made after mixing；It will
The softwood made is added in oscillating granulator through sieve, and wet granular is made；
4）Wet granular is laid in baking material disk to be placed in heated-air circulation oven, is 2MPa, the item that temperature is 70 DEG C in steam pressure
Dry 5h under part；
5）Material oscillating granulator whole grain after drying, sieve mesh number are 10 mesh, and dry particl is made, is pressed using tablet press machine
Piece obtains Dequalinium Chloride preform；
6）The lac of parts by weight is taken to be dissolved with 50% ethyl alcohol, filtering removal insoluble matter takes filtrate, evaporative removal ethyl alcohol to obtain
Pure shellac solution；
7）By step 6）Obtained pure shellac solution is uniformly applied to step 5）The Dequalinium Chloride preform outer surface of gained, very
Novel Dequalinium Chloride lozenge is drying to obtain under Altitude, the thickness of smearing is 0.03mm, and novel Dequalinium Chloride lozenge obtained is adopted
It is packed with aluminum foil under vacuum.
Embodiment 2
A kind of novel Dequalinium Chloride lozenge, includes the raw material of following parts by weight meter：0.025 part of Dequalinium Chloride, 13 parts of mannitol, wheat
12 parts of bud sugar alcohol, 20 parts of acesulfame potassium, 5 parts of citric acid, 3 parts of liquid extract of liquorice, 0.05 part of methyl p-hydroxybenzoate, menthol 3
Part, 8 parts of lac, 1.2 parts of pigment, 0.8 part of adhesive, 3 parts of antioxidant.
Wherein, pigment is gardenia blue.
Wherein, adhesive is povidone k30, hydroxypropyl methylcellulose, microcrystalline cellulose with mass ratio are 1:1:1.5 mixing
Object.
Wherein, it with mass ratio is 1 that antioxidant, which is D-araboascorbic acid, glutathione,:2 mixture.
A kind of preparation method of novel Dequalinium Chloride lozenge, includes the following steps：
1）Deionized water ultrasonication is added in mannitol, maltitol, acesulfame potassium and the liquid extract of liquorice for weighing formula ratio
8min, and 60 DEG C of heat preservations are heated to, uniformly mixed solution A is obtained, it is spare；
2）Dequalinium Chloride, methyl p-hydroxybenzoate, menthol, pigment, adhesive and the antioxidant of formula ratio is taken to pour into more
The mixed processing 10min into movement mixer obtains material B；
3）Solution A and material B are poured into wet mixing 10min in high-speed mixing granulating machine, suitable softwood is made after mixing；It will
The softwood made is added in oscillating granulator through sieve, and wet granular is made；
4）Wet granular is laid in baking material disk to be placed in heated-air circulation oven, is 3MPa, the item that temperature is 80 DEG C in steam pressure
Dry 6h under part；
5）Material oscillating granulator whole grain after drying, sieve mesh number are 10 mesh, and dry particl is made, is pressed using tablet press machine
Piece obtains Dequalinium Chloride preform；
6）The lac of parts by weight is taken to be dissolved with 50% ethyl alcohol, filtering removal insoluble matter takes filtrate, evaporative removal ethyl alcohol to obtain
Pure shellac solution；
7）By step 6）Obtained pure shellac solution is uniformly applied to step 5）The Dequalinium Chloride preform outer surface of gained, very
Novel Dequalinium Chloride lozenge is drying to obtain under Altitude, the thickness of smearing is 0.05mm, and novel Dequalinium Chloride lozenge obtained is adopted
It is packed with aluminum foil under vacuum.
Embodiment 3
A kind of novel Dequalinium Chloride lozenge, includes the raw material of following parts by weight meter：0.020 part of Dequalinium Chloride, 12 parts of mannitol, wheat
10 parts of bud sugar alcohol, 15 parts of acesulfame potassium, 4 parts of citric acid, 2 parts of liquid extract of liquorice, 0.03 part of methyl p-hydroxybenzoate, menthol
2.5 parts, 6 parts of lac, 1 part of pigment, 0.6 part of adhesive, 2 parts of antioxidant.
Wherein, pigment is safflower yellow.
Wherein, adhesive is povidone k30, hydroxypropyl methylcellulose, microcrystalline cellulose with mass ratio are 1:1:1.5 mixing
Object.
Wherein, it with mass ratio is 1 that antioxidant, which is D-araboascorbic acid, glutathione,:2 mixture.
A kind of preparation method of novel Dequalinium Chloride lozenge, includes the following steps：
1）Deionized water ultrasonication is added in mannitol, maltitol, acesulfame potassium and the liquid extract of liquorice for weighing formula ratio
7min, and 55 DEG C of heat preservations are heated to, uniformly mixed solution A is obtained, it is spare；
2）Dequalinium Chloride, methyl p-hydroxybenzoate, menthol, pigment, adhesive and the antioxidant of formula ratio is taken to pour into more
The mixed processing 8min into movement mixer obtains material B；
3）Solution A and material B are poured into wet mixing 10min in high-speed mixing granulating machine, suitable softwood is made after mixing；It will
The softwood made is added in oscillating granulator through sieve, and wet granular is made；
4）Wet granular is laid in baking material disk to be placed in heated-air circulation oven, is 3MPa, the item that temperature is 75 DEG C in steam pressure
Dry 6h under part；
5）Material oscillating granulator whole grain after drying, sieve mesh number are 10 mesh, and dry particl is made, is pressed using tablet press machine
Piece obtains Dequalinium Chloride preform；
6）The lac of parts by weight is taken to be dissolved with 50% ethyl alcohol, filtering removal insoluble matter takes filtrate, evaporative removal ethyl alcohol to obtain
Pure shellac solution；
7）By step 6）Obtained pure shellac solution is uniformly applied to step 5）The Dequalinium Chloride preform outer surface of gained, very
Novel Dequalinium Chloride lozenge is drying to obtain under Altitude, the thickness of smearing is 0.04mm, and novel Dequalinium Chloride lozenge obtained is adopted
It is packed with aluminum foil under vacuum.
The foregoing is only a preferred embodiment of the present invention, is not intended to restrict the invention, although with reference to aforementioned reality
Applying example, invention is explained in detail, for those skilled in the art, still can be to aforementioned each implementation
Technical solution recorded in example is modified or equivalent replacement of some of the technical features.All essences in the present invention
With within principle, any modification, equivalent replacement, improvement and so on should all be included in the protection scope of the present invention god.
Claims (10)
1. a kind of novel Dequalinium Chloride lozenge, which is characterized in that include the raw material of following parts by weight meter：Dequalinium Chloride 0.015-
0.025 part, 10-13 parts of mannitol, 5-12 parts of maltitol, 10-20 parts of acesulfame potassium, 2-5 parts of citric acid, liquid extract of liquorice 1-3
Part, 0.015-0.05 parts of methyl p-hydroxybenzoate, 2-3 parts of menthol, 5-8 parts of lac, 0.5-1.2 parts of pigment, adhesive
0.5-0.8 parts, 1-3 parts of antioxidant.
2. a kind of novel Dequalinium Chloride lozenge according to claim 1, it is characterised in that：Include the original of following parts by weight meter
Material：0.015 part of Dequalinium Chloride, 10 parts of mannitol, 5 parts of maltitol, 10 parts of acesulfame potassium, 2 parts of citric acid, 1 part of liquid extract of liquorice,
0.015 part of methyl p-hydroxybenzoate, 2 parts of menthol, 5 parts of lac, 0.5 part of pigment, 0.5 part of adhesive, 1 part of antioxidant.
3. a kind of novel Dequalinium Chloride lozenge according to claim 1, it is characterised in that：Include the original of following parts by weight meter
Material：0.025 part of Dequalinium Chloride, 13 parts of mannitol, 12 parts of maltitol, 20 parts of acesulfame potassium, 5 parts of citric acid, liquid extract of liquorice 3
Part, 0.05 part of methyl p-hydroxybenzoate, 3 parts of menthol, 8 parts of lac, 1.2 parts of pigment, 0.8 part of adhesive, antioxidant 3
Part.
4. a kind of novel Dequalinium Chloride lozenge according to claim 1, it is characterised in that：Include the original of following parts by weight meter
Material：0.020 part of Dequalinium Chloride, 12 parts of mannitol, 10 parts of maltitol, 15 parts of acesulfame potassium, 4 parts of citric acid, liquid extract of liquorice 2
Part, 0.03 part of methyl p-hydroxybenzoate, 2.5 parts of menthol, 6 parts of lac, 1 part of pigment, 0.6 part of adhesive, antioxidant 2
Part.
5. a kind of novel Dequalinium Chloride lozenge according to claim 1, it is characterised in that：The pigment is gardenia blue, rouge
It is one or more in fat dried female insect, safflower yellow.
6. a kind of novel Dequalinium Chloride lozenge according to claim 1, it is characterised in that：Described adhesive is povidone
K30, hydroxypropyl methylcellulose, microcrystalline cellulose are with mass ratio for 1:1:1.5 mixture.
7. a kind of novel Dequalinium Chloride lozenge according to claim 1, it is characterised in that：The antioxidant is D- different anti-
Bad hematic acid, glutathione are with mass ratio for 1:2 mixture.
8. a kind of preparation method of such as novel Dequalinium Chloride lozenge of claim 1-7 any one of them, which is characterized in that including
Following steps：
1）Deionized water ultrasonication 5- is added in mannitol, maltitol, acesulfame potassium and the liquid extract of liquorice for weighing formula ratio
8min, and it is heated to 50-60 DEG C of heat preservation, uniformly mixed solution A is obtained, it is spare；
2）Dequalinium Chloride, methyl p-hydroxybenzoate, menthol, pigment, adhesive and the antioxidant of formula ratio is taken to pour into more
The mixed processing 5-10min into movement mixer obtains material B；
3）Solution A and material B are poured into wet mixing 10min in high-speed mixing granulating machine, suitable softwood is made after mixing；It will
The softwood made is added in oscillating granulator through sieve, and wet granular is made；
4）Wet granular is laid in baking material disk to be placed in heated-air circulation oven, is 2-3MPa in steam pressure, temperature is 70-80 DEG C
Under conditions of dry 5-6h；
5）Material oscillating granulator whole grain after drying, sieve mesh number are 10 mesh, and dry particl is made, is pressed using tablet press machine
Piece obtains Dequalinium Chloride preform；
6）The lac of parts by weight is taken to be dissolved with 50% ethyl alcohol, filtering removal insoluble matter takes filtrate, evaporative removal ethyl alcohol to obtain
Pure shellac solution；
7）By step 6）Obtained pure shellac solution is uniformly applied to step 5）The Dequalinium Chloride preform outer surface of gained, very
Novel Dequalinium Chloride lozenge is drying to obtain under Altitude.
9. preparation method according to claim 8, it is characterised in that：The step 7）In pure shellac solution be applied to ground
The thickness of quinoline oronain preform outer surface is 0.03-0.05mm.
10. preparation method according to claim 8, it is characterised in that：The step 7）Novel Dequalinium Chloride obtained contains
Piece is packed using aluminum foil under vacuum.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110801437A (en) * | 2019-11-26 | 2020-02-18 | 安徽恒星制药有限公司 | Dequalinium chloride buccal tablet and preparation method thereof |
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