CN108451914A - A kind of vitamin C oral disintegration tablet - Google Patents
A kind of vitamin C oral disintegration tablet Download PDFInfo
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- CN108451914A CN108451914A CN201810547788.6A CN201810547788A CN108451914A CN 108451914 A CN108451914 A CN 108451914A CN 201810547788 A CN201810547788 A CN 201810547788A CN 108451914 A CN108451914 A CN 108451914A
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/365—Lactones
- A61K31/375—Ascorbic acid, i.e. vitamin C; Salts thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- 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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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/02—Nutrients, e.g. vitamins, minerals
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D307/00—Heterocyclic compounds containing five-membered rings having one oxygen atom as the only ring hetero atom
- C07D307/02—Heterocyclic compounds containing five-membered rings having one oxygen atom as the only ring hetero atom not condensed with other rings
- C07D307/34—Heterocyclic compounds containing five-membered rings having one oxygen atom as the only ring hetero atom not condensed with other rings having two or three double bonds between ring members or between ring members and non-ring members
- C07D307/56—Heterocyclic compounds containing five-membered rings having one oxygen atom as the only ring hetero atom not condensed with other rings having two or three double bonds between ring members or between ring members and non-ring members with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
- C07D307/62—Three oxygen atoms, e.g. ascorbic acid
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Abstract
The invention discloses a kind of vitamin C oral disintegration tablets, are mainly made of the component of following parts by weight：100 150 parts of L sodium ascorbates, 40 50 parts of L ascorbic acid, 360 400 parts of D-sorbite, 130 180 parts of microcrystalline cellulose, 10 20 parts of citric acid, 0 12 parts of silica 1,68 parts of magnesium stearate, 0.5 1 parts of steviol glycoside, 68 parts of orange flavor.The invention discloses one kind extracting ascorbic method from acerola concentrate, Sweet tea：, Microwave Extraction broken by low-temperature fine powder, reduced pressure, freeze-drying obtain.The vitamin C oral disintegration tablet that the present invention is prepared is safe and stable, effective, and good mouthfeel, non-stimulated to oral mucosa, and disintegrating property is good, and sliver is less prone in production.Preparation method provided by the invention is easy to operate, and production cost is low, and production efficiency is high, environmentally protective, is suitable for industrialized production.
Description
Technical field
The invention belongs to pharmaceutical technology fields, and in particular to a kind of vitamin C oral disintegration tablet.
Background technology
Vitamin C is called L-AA, is a kind of water soluble vitamin.Vitamin C in food is by human small intestine
Section absorbs.Once absorbing, just it is distributed in water-soluble structures all in vivo, the vitamin C metabolic activity in normal adult's body
There are about 1500mg vitamin Cs in pond, it is 3000mg vitamin Cs that highest, which stores peak value,.Vitamin C can prevent scurvy, also known as " anti-
Bad hematic acid ".The study found that vitamin C can reduce cholesterolemia content, strengthen immunity increases hair and blood tubular elastic, promotes wound
Mouth and operative incision healing, anti-to cure cold, enhancing development prevent the metallicity such as chronic mercury, lead and are poisoned, prevention aging, in advance
Preventing tumor etc..
Since vitamin C efficacy is extensive, it is more that ascorbic people is taken at present.Conventional tablet or capsule need to use water
It swallows, for children, old man, is unable to leave the bed and has for dysphagia or the inconvenient patient of water intaking with severe disability etc., it is difficult to take
With.And oral disnitegration tablet is not usually required to water or only need a small amount of water when taking, tablet is placed in lingual surface, without chewing, meets
Saliva is disintegrated rapidly.The dosage form to children, old man, be unable to leave the bed and severely-disabled patient's optimum.But currently available technology
Disclosed in easily there is sliver, technique more in vitamin C oral disintegration tablet and preparation method thereof there are disintegrating properties poor, production
Complicated, the defects of production cost is high.
Invention content
Goal of the invention：In order to solve the above-mentioned problems in the prior art, the present invention provides a kind of vitamin C orals
Disintegrated tablet.
It is a further object to provide the preparation methods of the vitamin C oral disintegration tablet.
Technical solution：Vitamin C oral disintegration tablet of the present invention is mainly made of the component of following parts by weight：
100-150 parts of L-AA sodium, 40-50 parts of L-AA, 360-400 parts of D-sorbite, microcrystalline cellulose
130-180 parts, 10-20 parts of citric acid, 0-12 parts of silica 1,6-8 parts of magnesium stearate, 0.5-1 parts of steviol glycoside, sweet orange it is fragrant
It is 6-8 parts smart.
Preferably, the vitamin C oral disintegration tablet is mainly made of the component of following parts by weight：
120-150 parts of L-AA sodium, 44-50 parts of L-AA, 380-390 parts of D-sorbite, microcrystalline cellulose
140-160 parts, 12-18 parts of citric acid, 0-12 parts of silica 1,6-8 parts of magnesium stearate, 0.5-1 parts of steviol glycoside, sweet orange it is fragrant
It is 6-8 parts smart.
Preferably, the vitamin C oral disintegration tablet is mainly made of the component of following parts by weight：
130-135 parts of L-AA sodium, 44-50 parts of L-AA, 380-386 parts of D-sorbite, microcrystalline cellulose
140-160 parts, 12-18 parts of citric acid, 0-12 parts of silica 1,6-8 parts of magnesium stearate, 0.5-1 parts of steviol glycoside, sweet orange it is fragrant
It is 6-8 parts smart.
It is highly preferred that the vitamin C oral disintegration tablet, is mainly made of the component of following parts by weight：
132 parts of L-AA sodium, 44 parts of L-AA, 382 parts of D-sorbite, 150 parts of microcrystalline cellulose, citric acid
15 parts, 1.25 parts of silica 1,7.5 parts of magnesium stearate, 0.75 part of steviol glycoside, 7.5 parts of orange flavor.
Preferably, the microcrystalline cellulose is from microcrystalline cellulose PH101, microcrystalline cellulose PH103 or microcrystalline cellulose
PH301。
Vitamin C oral disintegration tablet of the present invention, primary raw material L-AA preparation method are as follows：
(1) weigh 10~15g sweet tea powders cross 100~120 mesh sieve it is spare.
(2) 40~100g acerola concentrates are weighed, sweet tea powder is added, are crushed using vibration atomizer low temperature interval：Every time
It crushes 5~25 minutes, every minor tick 4~6 minutes recycles 4~6 times.
(3) step (2) crushed material is taken, is extracted with microwave negative pressure, 0.15~0.25MPa of pressure is extracted, temperature is 60~80
DEG C, 1~10min of extraction time at 100~500W continuously extracts 2~3 times, obtains extracting solution.
(4) extracting solution is subjected to ultrafiltration through hollow fiber filter membrane, obtains filtrate.
(5) it after filtrate obtained by step (4) being carried out 30~60 DEG C of low-temperature reduced-pressure concentrations, is freeze-dried through -20~-40 DEG C,
Up to L-AA.
The preparation method of vitamin C oral disintegration tablet of the present invention prepares vitamin C mouth using common pressed-disc technique
Cavity disintegrating tablet.
Advantageous effect：The vitamin C oral disintegration tablet that the present invention is prepared is safe and stable, effective, and mouthfeel is good
Good, non-stimulated to oral mucosa, disintegrating property is good, and sliver is less prone in production.Preparation method operation letter provided by the invention
Single, production cost is low, and production efficiency is high, environmentally protective, is suitable for industrialized production.
Specific implementation mode
According to following embodiments, the present invention may be better understood.However, as it will be easily appreciated by one skilled in the art that real
It applies content described in example and is merely to illustrate the present invention, without sheet described in detail in claims should will not be limited
Invention.
Embodiment 1
Vitamin C preparation method：
(1) weigh 10g sweet tea powders cross 100~120 mesh sieve it is spare.
(2) it is clean that 80g acerola concentrates are weighed, sweet tea powder is added, are crushed using vibration atomizer low temperature interval：Per wheat-middlings
Broken 15 minutes, every minor tick 5 minutes recycled 5 times.
(3) step (2) crushed material is taken, is extracted with microwave negative pressure, extracts pressure 0.25MPa, temperature is 70 DEG C, at 360W
Extraction time 5min, continuous extraction 3 times, obtains extracting solution.
(4) extracting solution is subjected to ultrafiltration through hollow fiber filter membrane, obtains filtrate.
(5) after filtrate obtained by step (4) being carried out 50 DEG C of low-temperature reduced-pressure concentrations, through -35 DEG C of freeze-dryings to get vitamin
C。
Prescription：
132 parts of L-AA sodium, 44 parts of L-AA, 382 parts of D-sorbite, 150 parts of microcrystalline cellulose, citric acid
15 parts, 1.25 parts of silica 1,7.5 parts of magnesium stearate, 0.75 part of steviol glycoside, 7.5 parts of orange flavor.
Preparation process：
L-AA sodium, L-AA, D-sorbite, microcrystalline cellulose, citric acid, titanium dioxide are weighed by prescription
Silicon, magnesium stearate, steviol glycoside and orange flavor are uniformly mixed, and direct tablet compressing to obtain the final product.
Above-mentioned formula prepares 600 altogether, and tableting processes do not occur sliver, sticking situation, 6 volunteer's blind test main suit mouthfeels
Sweetness has lubrication sense but anacidity astringent sense.
Embodiment 2
Vitamin C preparation method：
(1) weigh 15g sweet tea powders cross 100~120 mesh sieve it is spare.
(2) it is clean that 100g acerola concentrates are weighed, sweet tea powder is added, are crushed using vibration atomizer low temperature interval：Every time
It crushes 10 minutes, every minor tick 5 minutes recycles 5 times.
(3) step (2) crushed material is taken, is extracted with microwave negative pressure, extracts pressure 0.20MPa, temperature is 80 DEG C, at 480W
Extraction time 3min, continuous extraction 2 times, obtains extracting solution.
(4) extracting solution is subjected to ultrafiltration through hollow fiber filter membrane, obtains filtrate.
(5) after filtrate obtained by step (4) being carried out 30 DEG C of low-temperature reduced-pressure concentrations, through -40 DEG C of freeze-dryings to get vitamin
C。
Prescription：
100 parts of L-AA sodium, 40 parts of L-AA, 360 parts of D-sorbite, 130 parts of microcrystalline cellulose, citric acid
10 parts, 0 part of silica 1,6 parts of magnesium stearate, 0.5 part of steviol glycoside, 6 parts of orange flavor.
Preparation process：
L-AA sodium, L-AA, D-sorbite, microcrystalline cellulose, citric acid, titanium dioxide are weighed by prescription
Silicon, magnesium stearate, steviol glycoside and orange flavor are uniformly mixed, and direct tablet compressing to obtain the final product.
Above-mentioned formula prepares 600 altogether, and tableting processes do not occur sliver, sticking situation, 6 volunteer's blind test main suit mouthfeels
Sweetness has lubrication sense but anacidity astringent sense.
Embodiment 3
Vitamin C preparation method：
(1) weigh 10g sweet tea powders cross 100~120 mesh sieve it is spare.
(2) it is clean that 40g acerola concentrates are weighed, sweet tea powder is added, are crushed using vibration atomizer low temperature interval：Per wheat-middlings
Broken 5 minutes, every minor tick 5 minutes recycled 5 times.
(3) step (2) crushed material is taken, is extracted with microwave negative pressure, extracts pressure 0.15MPa, temperature is 60 DEG C, at 100W
Extraction time 10min, continuous extraction 3 times, obtains extracting solution.
(4) extracting solution is subjected to ultrafiltration through hollow fiber filter membrane, obtains filtrate.
(5) after filtrate obtained by step (4) being carried out 60 DEG C of low-temperature reduced-pressure concentrations, through -20 DEG C of freeze-dryings to get vitamin
C。
Prescription：
150 parts of L-AA sodium, 50 parts of L-AA, 400 parts of D-sorbite, 180 parts of microcrystalline cellulose, citric acid
20 parts, 2 parts of silica 1,8 parts of magnesium stearate, 1 part of steviol glycoside, 8 parts of orange flavor.
Preparation process：
L-AA sodium, L-AA, D-sorbite, microcrystalline cellulose, citric acid, titanium dioxide are weighed by prescription
Silicon, magnesium stearate, steviol glycoside and orange flavor are uniformly mixed, and direct tablet compressing to obtain the final product.
Above-mentioned formula prepares 600 altogether, and tableting processes do not occur sliver, sticking situation, 6 volunteer's blind test main suit mouthfeels
Sweetness has lubrication sense but anacidity astringent sense.
Embodiment 4
Ascorbic preparation method is with reference to embodiment 1.
Prescription：
120 parts of L-AA sodium, 44 parts of L-AA, 380 parts of D-sorbite, 140 parts of microcrystalline cellulose, citric acid
12 parts, 0 part of silica 1,6 parts of magnesium stearate, 0.5 part of steviol glycoside, 6 parts of orange flavor.
Preparation process：
L-AA sodium, L-AA, D-sorbite, microcrystalline cellulose, citric acid, titanium dioxide are weighed by prescription
Silicon, magnesium stearate, steviol glycoside and orange flavor are uniformly mixed, and direct tablet compressing to obtain the final product.
Above-mentioned formula prepares 600 altogether, and tableting processes do not occur sliver, sticking situation, 6 volunteer's blind test main suit mouthfeels
Sweetness has lubrication sense but anacidity astringent sense.
Embodiment 5
Ascorbic preparation method is with reference to embodiment 2.
Prescription：
150 parts of L-AA sodium, 50 parts of L-AA, 390 parts of D-sorbite, 160 parts of microcrystalline cellulose, citric acid
18 parts, 2 parts of silica 1,8 parts of magnesium stearate, 1 part of steviol glycoside, 8 parts of orange flavor.
Preparation process：
L-AA sodium, L-AA, D-sorbite, microcrystalline cellulose, citric acid, titanium dioxide are weighed by prescription
Silicon, magnesium stearate, steviol glycoside and orange flavor are uniformly mixed, and direct tablet compressing to obtain the final product.
Above-mentioned formula prepares 600 altogether, and tableting processes do not occur sliver, sticking situation, 6 volunteer's blind test main suit mouthfeels
Sweetness has lubrication sense but anacidity astringent sense.
Embodiment 6
Ascorbic preparation method is with reference to embodiment 3.
Prescription：
130 parts of L-AA sodium, 44 parts of L-AA, 380 parts of D-sorbite, 140 parts of microcrystalline cellulose, citric acid
12 parts, 0 part of silica 1,6 parts of magnesium stearate, 0.5 part of steviol glycoside, 6 parts of orange flavor.
Preparation process：
L-AA sodium, L-AA, D-sorbite, microcrystalline cellulose, citric acid, titanium dioxide are weighed by prescription
Silicon, magnesium stearate, steviol glycoside and orange flavor are uniformly mixed, and direct tablet compressing to obtain the final product.
Above-mentioned formula prepares 600 altogether, and tableting processes do not occur sliver, sticking situation, 6 volunteer's blind test main suit mouthfeels
Sweetness has lubrication sense but anacidity astringent sense.
Embodiment 7
Ascorbic preparation method is with reference to embodiment 3.
Prescription：
135 parts of L-AA sodium, 50 parts of L-AA, 386 parts of D-sorbite, 160 parts of microcrystalline cellulose, citric acid
18 parts, 2 parts of silica 1,8 parts of magnesium stearate, 1 part of steviol glycoside, 8 parts of orange flavor.
Preparation process：
L-AA sodium, L-AA, D-sorbite, microcrystalline cellulose, citric acid, titanium dioxide are weighed by prescription
Silicon, magnesium stearate, steviol glycoside and orange flavor are uniformly mixed, and direct tablet compressing to obtain the final product.
Above-mentioned formula prepares 600 altogether, and tableting processes do not occur sliver, sticking situation, 6 volunteer's blind test main suit mouthfeels
Sweetness has lubrication sense but anacidity astringent sense.
8 hardness of embodiment, friability, disintegration time mensuration experiment
1, Determination of Hardness
Vitamin C oral disintegration tablet 10 is taken, uses YD-1 tablet hardness testers to measure tablet hardness respectively.
2, disintegration time mensuration
Vitamin C oral disintegration tablet 1 is taken, is placed in 10ml test tubes (test tube internal diameter is 13mm), 2ml is filled in test tube
Water, water temperature are 37 DEG C, and tablet should be disintegrated in 1 minute, be dispersed in water.Sieving is poured out, every time with water 2ml, rinse at twice
Test tube and sieve can all be less than the sieve of 710 ц m by aperture.6 are checked as stated above, should meet regulation.
3, friability measures
It is measured according to the tablet friability inspection technique of Chinese Pharmacopoeia.
The disintegration time limited of the vitamin C oral disintegration tablet prepared in embodiment 1-7, friability, tablet Determination of Hardness
It the results are shown in Table 1.
Table 1
| Hardness (N) | Friability | Disintegration time limited (second) | |
| Embodiment 1 | 22 | 0.1% | 8~13 |
| Embodiment 2 | 28 | 0.3% | 12~18 |
| Embodiment 3 | 29 | 0.2% | 11~18 |
| Embodiment 4 | 28 | 0.2% | 11~17 |
| Embodiment 5 | 29 | 0.2% | 11~18 |
| Embodiment 6 | 26 | 0.1% | 10~16 |
| Embodiment 7 | 27 | 0.1% | 10~16 |
As shown in Table 1, the vitamin C oral disintegration tablet that prepared by the present invention has good disintegrating property, can collapse rapidly
Solution, friability is small, and breakage is few, meets shipping storage requirement.
Claims (7)
1. a kind of vitamin C oral disintegration tablet, which is characterized in that it is mainly made of the component of following parts by weight：
100-150 parts of L-AA sodium, 40-50 parts of L-AA, 360-400 parts of D-sorbite, microcrystalline cellulose 130-
180 parts, 10-20 parts of citric acid, 0-12 parts of silica 1,6-8 parts of magnesium stearate, 0.5-1 parts of steviol glycoside, orange flavor 6-8
Part.
2. vitamin C oral disintegration tablet according to claim 1, which is characterized in that the L-AA is by following
Method is prepared：
(1) weigh 10~15g sweet tea powders cross 100~120 mesh sieve it is spare；
(2) 40~100g acerola concentrates are weighed, sweet tea powder is added, are crushed using vibration atomizer low temperature interval：5 are crushed every time
~25 minutes, every minor tick 4~6 minutes recycled 4~6 times；
(3) step (2) crushed material is taken, is extracted with microwave negative pressure, 0.15~0.25MPa of pressure is extracted, temperature is 60~80 DEG C,
100~500W lower extraction times, 1~10min continuously extracts 2~3 times, obtains extracting solution；
(4) extracting solution is subjected to ultrafiltration through hollow fiber filter membrane, obtains filtrate；
(5) after filtrate obtained by step (4) being carried out 30~60 DEG C of low-temperature reduced-pressures concentrations, through -20~-40 DEG C of freeze-dryings to get
L-AA.
3. vitamin C oral disintegration tablet according to claim 1, which is characterized in that it is mainly by the group of following parts by weight
Divide and is made：
120-150 parts of L-AA sodium, 44-50 parts of L-AA, 380-390 parts of D-sorbite, microcrystalline cellulose 140-
160 parts, 12-18 parts of citric acid, 0-12 parts of silica 1,6-8 parts of magnesium stearate, 0.5-1 parts of steviol glycoside, orange flavor 6-8
Part.
4. vitamin C oral disintegration tablet according to claim 1, which is characterized in that it is mainly by the group of following parts by weight
Divide and is made：
130-135 parts of L-AA sodium, 44-50 parts of L-AA, 380-386 parts of D-sorbite, microcrystalline cellulose 140-
160 parts, 12-18 parts of citric acid, 0-12 parts of silica 1,6-8 parts of magnesium stearate, 0.5-1 parts of steviol glycoside, orange flavor 6-8
Part.
5. vitamin C oral disintegration tablet according to claim 1, which is characterized in that it is mainly by the group of following parts by weight
Divide and is made：
132 parts of L-AA sodium, 44 parts of L-AA, 382 parts of D-sorbite, 150 parts of microcrystalline cellulose, citric acid 15
Part, 1.25 parts of silica 1,7.5 parts of magnesium stearate, 0.75 part of steviol glycoside, 7.5 parts of orange flavor.
6. vitamin C oral disintegration tablet according to claim 1, which is characterized in that the microcrystalline cellulose is from crystallite
Cellulose PH101, microcrystalline cellulose PH103 or microcrystalline cellulose PH301.
7. the preparation method of the vitamin C oral disintegration tablet described in claim 1-6 any one, which is characterized in that using general
Logical pressed-disc technique prepares vitamin C oral disintegration tablet.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810547788.6A CN108451914A (en) | 2018-05-31 | 2018-05-31 | A kind of vitamin C oral disintegration tablet |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201810547788.6A CN108451914A (en) | 2018-05-31 | 2018-05-31 | A kind of vitamin C oral disintegration tablet |
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| Publication Number | Publication Date |
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| CN108451914A true CN108451914A (en) | 2018-08-28 |
Family
ID=63215784
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| Application Number | Title | Priority Date | Filing Date |
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| CN201810547788.6A Pending CN108451914A (en) | 2018-05-31 | 2018-05-31 | A kind of vitamin C oral disintegration tablet |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111067105A (en) * | 2019-12-09 | 2020-04-28 | 安徽三九药业有限公司 | Vitamin C buccal tablet for enhancing immunity and preparation method thereof |
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2018
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| CN1775289A (en) * | 2004-11-15 | 2006-05-24 | 杭州民生药业集团有限公司 | Multi vitamin oral disintegrating tablet formulation and its preparing method |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111067105A (en) * | 2019-12-09 | 2020-04-28 | 安徽三九药业有限公司 | Vitamin C buccal tablet for enhancing immunity and preparation method thereof |
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