CN105287625B - A kind of Hydrotalcite composition of medicine tablet, preparation method and applications - Google Patents
A kind of Hydrotalcite composition of medicine tablet, preparation method and applications Download PDFInfo
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- CN105287625B CN105287625B CN201510889941.XA CN201510889941A CN105287625B CN 105287625 B CN105287625 B CN 105287625B CN 201510889941 A CN201510889941 A CN 201510889941A CN 105287625 B CN105287625 B CN 105287625B
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- hydrotalcite
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- stachyose
- lactose
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Abstract
There are Hydrotalcite medicinal composition tablets and preparation method capacity antacid and strength defoaming capacity, steady in a long-term simultaneously the object of the present invention is to provide a kind of.Wherein, the Hydrotalcite composition of medicine tablet is made of magnesium carbonate, activated dimethicone, polacrilin potassium, stachyose, microcrystalline cellulose, Sucralose, lactose, menthol and magnesium stearate.Pharmaceutical formulation provided by the invention and preparation method can dramatically increase the mixed mobility of supplementary material in control supplementary material partial size, and do not stick to one's teeth tooth after chewing, no grittiness, and fragrance is palatable, be suitble to industrialized production；And the simple process, cross contamination is few, and low energy consumption, reduces production cost.Importantly, the Hydrotalcite composition of medicine tablet obtained through the invention can effectively play a protective role to gastric mucosa, the healing quality of ulcer is improved, clinical effectiveness is also superior to commercially available hydrotalcite tablet kind.
Description
Technical field
The present invention relates to a kind of treatments for diseases such as hyperchlorhydria, gastritis, peptic ulcer, aerogastria and heartburns
Drug, in particular a kind of Hydrotalcite composition of medicine tablet, preparation method and applications.
Technical background
Hydrotalcite is a kind of antiacid, and has mucosa concurrently.Oral Hydrotalcite can quickly neutralize gastric acid, and
In conjunction with pepsin, cholic acid, lysolecithin, weaken the damage factor of gastric mucosa, at the same promote the synthesis of prostaglandin with
Release promotes mucosal blood flow, to reinforce the protective effect of gastric mucosa, is conducive to ulcer healing.Dimeticone
(Ddimethicone), chemical name is dimethylsiloxane polymer.Itself passes through and two almost without defoaming capacity
Silica after mixing evenly, activates the activated dimethicone for becoming superpower defoaming capacity after a certain period of time, in medicine at high temperature
It is upper to be used as defoaming agent, abdominal distension etc. caused by mitigating because of gas retention.
Summary of the invention
In order to overcome existing dosage form there are the drawbacks of, there is capacity antacid and strong simultaneously the object of the present invention is to provide a kind of
Power defoaming capacity, steady in a long-term Hydrotalcite medicinal composition tablets and preparation method.Wherein, the Hydrotalcite combination
Medicinal tablet is by magnesium carbonate, activated dimethicone, polacrilin potassium, stachyose, microcrystalline cellulose, Sucralose, lactose, peppermint
Brain and magnesium stearate composition.
The Hydrotalcite, polacrilin potassium, stachyose, microcrystalline cellulose, Sucralose, lactose and magnesium stearate grain
Degree is less than 200 microns.
The activated dimethicone is after dimeticone mixes in proportion with vapor phase method or precipitated silica, in 100-
Under the conditions of 150 DEG C, activated dimethicone made of heating reaction 0.5-5 hours.The weight of the silica and dimeticone
Amount is than being 0.5-5:1-10.
The Hydrotalcite, activated dimethicone, polacrilin potassium, stachyose, microcrystalline cellulose, Sucralose, lactose,
The weight ratio of menthol and magnesium stearate are as follows: 500-1000:50-150:50-200:50-250:100-200:1-5:200-500:
1-2:10-20.In specific application, 500-1000g containing Hydrotalcite, activated dimethicone in every 1000 preparation units
50-150g, polacrilin potassium 50-200g, stachyose 50-250g, microcrystalline cellulose 100-200g, Sucralose 1-5g, lactose
200-500g, menthol 1-2g and magnesium stearate 10-20g.
The preparation method of the Hydrotalcite composition of medicine tablet includes the following:
1) by Hydrotalcite, polacrilin potassium, stachyose, microcrystalline cellulose, Sucralose, lactose, menthol and tristearin
Powder of the granularity less than 200 microns is made in sour magnesium；
2) agitation and dilution in the activated dimethicone of recipe quantity is added in the lactose and microcrystalline cellulose for taking recipe quantity, then mistake
80 meshes obtain activated dimethicone dilution；
3) finally by Hydrotalcite, polacrilin potassium, activated dimethicone dilution, menthol, Sucralose, stearic acid
Magnesium, stachyose are added to the 3d motion mixer, and incorporation time 15-30 minutes to get total mixture；
4) total mixture direct tablet compressing is up to Hydrotalcite composition of medicine tablet.
The method have the benefit that: pharmaceutical formulation provided by the invention and preparation method are in control supplementary material partial size
The mixed mobility of supplementary material can be dramatically increased, do not stick to one's teeth tooth after chewing, no grittiness, and fragrance is palatable, is suitble to industrialization big
Production；And the simple process, cross contamination is few, and low energy consumption, reduces production cost.Importantly, through the invention
To Hydrotalcite composition of medicine tablet can effectively play a protective role to gastric mucosa, improve the healing quality of ulcer,
Clinical effectiveness is also superior to commercially available hydrotalcite tablet kind.
Specific embodiment
The preparation of 1 Hydrotalcite composition of medicine tablet of embodiment
1, weigh and take silica 5g, dimeticone 50g after evenly mixing, under the conditions of 115 DEG C, heat-activated 2 hours
Made of activated dimethicone.Supplementary material is weighed according to prescription 1.
Prescription 1
The first step weighs supplementary material according to the parameter of formula 1, and Hydrotalcite, polacrilin potassium, stachyose, crystallite is fine
That ties up element, Sucralose, lactose, menthol and magnesium stearate is processed into powder of the granularity less than 200 microns.
Second step takes the lactose of recipe quantity and microcrystalline cellulose that agitation and dilution in the activated dimethicone of recipe quantity is added,
Then it is spare that 80 meshes are crossed, finally by Hydrotalcite, polacrilin potassium, activated dimethicone dilution, menthol, trichlorine sugarcane
Sugar, magnesium stearate, stachyose are added to the 3d motion mixer, and incorporation time 15-30 minutes to get total mixture.
Third step is named as experimental group A by total mixture direct tablet compressing up to Hydrotalcite composition of medicine tablet.
2, medicinal material is weighed according to the weight of prescription 2 and prepares activated dimethicone, according to experimental group A Hydrotalcite composition of medicine
The preparation method of tablet is prepared Hydrotalcite composition of medicine tablet, is named as experimental group B.
Prescription 2
2, medicinal material is weighed according to the weight of prescription 3 and prepares activated dimethicone, according to experimental group A Hydrotalcite composition of medicine
The preparation method of tablet is prepared Hydrotalcite composition of medicine tablet, is named as experimental group C.
Prescription 3
Embodiment 2 detects experimental group A, B, C
1. Testing index
Appearance: white or class white film be should be
Disintegration time limited: referring to the 4th page 118 of version of Chinese Pharmacopoeia 2015, method label 0921；
3 antifoam performances: taking above-mentioned Hydrotalcite composition piece 1, sets finely ground in mortar, takes 2 clean 250ml amounts
Cylinder, the Qula for being separately added into 50ml1% lead to solution, finely ground medicinal powder are gently poured into a wherein graduated cylinder, graduated cylinder is sealed and buckles,
Same strength shaking 5 times, 1min counts out foam height, with that graduated cylinder of no added medication amount for 100%, is reduced with test sample
Foam volume, which calculates defoaming capacity, should be not less than 80%；
Weight differential: referring to the 4th page 4 of version of Chinese Pharmacopoeia 2015；
Microbial limit: referring to the 4th the 140-151 pages of version of Chinese Pharmacopoeia 2015；
Friability: referring to the 4th page 120 of version of Chinese Pharmacopoeia 2015；
Hydrotalcite relieving haperacidity power: new drug is become a full member the Western medicine part page 12 of standard the 48th.
2, assay
Dimeticone see 2015 two page 19 of version；
Hydrotalcite is shown in that new drug is become a full member the Western medicine part page 12 of standard the 48th.
Wherein, the specific as shown in table 1,2,3 of the testing result of experimental group A, B, C
The quality examination result of 1 experimental group A of table
The quality examination result of 2 experimental group B of table
The quality examination result of 3 experimental group C of table
The study on the stability of embodiment 3 experimental group A, B, C
Sample experiments group A, B, C is investigated to investigate within 36 months by long-term (condition: 25 ± 2 DEG C, RH60% ± 10%).It investigates
As a result as shown in table 4,5,6:
4 experimental group A sample stability of table investigates result
5 experimental group B sample stability of table investigates result
6 experimental group C sample study on the stability result of table
The result shows that 36 months long-term investigations, experimental group A, B, C indices are without significant change.
The activity of 4 Hydrotalcite medicinal composition tablets of embodiment is investigated
Pylorus ligation mouse 1. (Shay rat) model: Wistar male rat (weight 190g-220g) is divided into control group, reality
Group A, B, C group, positive controls 1 and positive controls 2 are tested, wherein commercially available hydrotalcite tablet (traditional Chinese medicines are administered in positive controls 1
Quasi- word H20153169), positive controls 2 are administered commercially available thiosugar aluminium flake (national drug standard H20057241) every group 6.It is wherein each
Group dosage is conversion Hydrotalcite bulk pharmaceutical chemicals and ulcerlmin bulk pharmaceutical chemicals 500mg/kgd, and totally 3 times, control group only gives salt water.
After last time is administered, each group ligatures pylorus, and gastric juice is collected after 4 hours and measures gland Gastric mucosal injury index, damage index
It is indicated with mucosa injury length (mm).Gastric juice is for measuring pepsin activity and gastric acidity.It is specific as shown in table 7.
Influence of the table 7 to the protective effect of pylorus ligation mouse gastric mucosa and to gastric acid, pepsin and gastric juice
P < 0.05 * compared with the control group；**P<0.001.
Absolute alcohol damage model: Wistar male rat (weight 190g-220g) be divided into control group, experimental group A, B, C,
Positive controls and alcohol group, wherein commercially available hydrotalcite tablet (national drug standard H20153169) is administered in positive controls 1, often
Group rat 6.Experimental group A, B, C, positive controls given low are conversion Hydrotalcite bulk pharmaceutical chemicals 500mg/kg.d, and totally 3
It is secondary.After last time administration 1 hour, experimental group A, B, C, positive controls and alcohol group gavage dehydrated alcohol, and control group is only given
Physiological saline.To rat is put to death after ethyl alcohol 1 hour, stomach is taken, measures mucosa injury index, stomach is protected in liquid nitrogen flash freezer, -70 DEG C of refrigerators
It deposits, awake reductase (QR) to be measured, the sweet skin-S- transferase (GSTs) of paddy moon bright, the sweet skin reductase (GR) of paddy moon bright, the sweet skin peroxidating of paddy moon bright
Object enzyme (GSH-PX) and lipid peroxidation product malonaldehyde (MDA) content.
Table 8 induces alcohol the protection of mucosal lesion, to the reduction of antioxidase and examining for lipoid peroxidization resistant
It examines
Note: P < 0.05 * compared with alcohol group；**P<0.001；With P < 0.001 the control group Bi compare ﹟ , ﹟ ﹟ of P < 0.05.
Hydrotalcite is antiacid, and the antacids containing aluminium generally has mucosa concurrently, and improves the healing matter of ulcer
Amount.Hydrotalcite tablet provided by the invention there is significant protection to make the gastric mucosa damage that pylorus ligation mouse and alcohol induce
With effect is better than commercially available Hydrotalcite tablet preparation and ulcerlmin tablet preparation.
Claims (2)
1. a kind of application of Hydrotalcite composition of medicine tablet in preparation treatment Gastroduodenal lesion drug；
The Hydrotalcite composition of medicine tablet is fine by Hydrotalcite, activated dimethicone, polacrilin potassium, stachyose, crystallite
Tie up element, Sucralose, lactose, menthol and magnesium stearate composition；
The Hydrotalcite, polacrilin potassium, stachyose, microcrystalline cellulose, Sucralose, the granularity of lactose and magnesium stearate are small
In 200 microns；
The activated dimethicone is after dimeticone mixes in proportion with vapor phase method or precipitated silica, in 100-150
Under the conditions of DEG C, activated dimethicone made of heating reaction 0.5-5 hours；
The weight ratio of silica and dimeticone is 0.5-5:1-10；
Wherein, Hydrotalcite, activated dimethicone, polacrilin potassium, stachyose, microcrystalline cellulose, Sucralose, lactose, thin
The weight ratio of lotus brain and magnesium stearate is 500-1000:50-150:50-200:50-250:100-200:1-5:200-500:1-
2:10-20。
2. application according to claim 1, which is characterized in that the preparation of the Hydrotalcite composition of medicine tablet includes such as
Under: 1) by Hydrotalcite, polacrilin potassium, stachyose, microcrystalline cellulose, Sucralose, lactose, menthol and magnesium stearate system
Powder at granularity less than 200 microns；2) lactose of recipe quantity and the activated dimethicone of microcrystalline cellulose addition recipe quantity are taken
Then middle agitation and dilution crosses 80 meshes and obtains activated dimethicone dilution；3) finally by Hydrotalcite, polacrilin potassium, work
Change dimeticone dilution, menthol, Sucralose, magnesium stearate, stachyose are added to the 3d motion mixer, incorporation time
15-30 minutes to get total mixture；4) total mixture direct tablet compressing is up to Hydrotalcite composition of medicine tablet.
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Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101797268A (en) * | 2010-03-11 | 2010-08-11 | 重庆健能医药开发有限公司 | Stable compound dimeticone hydrotalcite suspension |
| CN102151286A (en) * | 2010-12-13 | 2011-08-17 | 四川健能制药有限公司 | Hydrotalcite tablet and preparation method thereof |
| CN102532901A (en) * | 2010-12-21 | 2012-07-04 | 重庆北碚现代应用药物研究所 | Method for preparing simethicone |
-
2015
- 2015-12-04 CN CN201510889941.XA patent/CN105287625B/en active Active
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101797268A (en) * | 2010-03-11 | 2010-08-11 | 重庆健能医药开发有限公司 | Stable compound dimeticone hydrotalcite suspension |
| CN102151286A (en) * | 2010-12-13 | 2011-08-17 | 四川健能制药有限公司 | Hydrotalcite tablet and preparation method thereof |
| CN102532901A (en) * | 2010-12-21 | 2012-07-04 | 重庆北碚现代应用药物研究所 | Method for preparing simethicone |
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| CN105287625A (en) | 2016-02-03 |
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