CN107496373A - A kind of acotiamide hydrochloride hydrate composition capsule - Google Patents
A kind of acotiamide hydrochloride hydrate composition capsule Download PDFInfo
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- CN107496373A CN107496373A CN201710819528.5A CN201710819528A CN107496373A CN 107496373 A CN107496373 A CN 107496373A CN 201710819528 A CN201710819528 A CN 201710819528A CN 107496373 A CN107496373 A CN 107496373A
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- Prior art keywords
- hydrochloride hydrate
- acotiamide hydrochloride
- compritol
- ato
- sodium alginate
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
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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
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/425—Thiazoles
- A61K31/426—1,3-Thiazoles
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
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- Chemical & Material Sciences (AREA)
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- Pharmacology & Pharmacy (AREA)
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Abstract
The present invention relates to field of medicine preparations, specifically discloses a kind of acotiamide hydrochloride hydrate composition capsule.Acotiamide hydrochloride hydrate composition capsule of the present invention includes acotiamide hydrochloride hydrate, microcrystalline cellulose, starch, tyrosine, sodium alginate, Compritol 888 ATO.The preferably composition of acotiamide hydrochloride hydrate, microcrystalline cellulose, starch, tyrosine, sodium alginate, Compritol 888 ATO as acotiamide hydrochloride hydrate capsule of the invention, mutually synergy improves stability, mobility and the dissolution rate of acotiamide hydrochloride hydrate, hygroscopicity is reduced, is advantageous to the safe handling of clinical medicine and long-term storage.
Description
Technical field
The present invention relates to field of medicine preparations, and in particular to a kind of acotiamide hydrochloride hydrate composition capsule.
Background technology
Acotiamide hydrochloride hydrate, developed jointly by Japanese Ze Li new drugs Co., Ltd. and An Sitelaisi drugmakers, in
Take the lead on June 6th, 2013 listing in Japan, trade nameChemistry is entitled：N- [2- (double isopropylaminos) second
Base] -2- [(2- hydroxyls -4,5- dimethoxybenzoyl) amino] -4- thiazole carboxamides hydrochloride hydrates, molecular formula：
C21H30N4O5S·HCl·3H2O；Molecular weight：541.06, shown in its structure such as formula (I)：
It is global first functional dyspepsia FD medicine for treatment that hydrochloric acid Ah, which impersonates amine piece, mainly by suppressing acetyl courage
Alkali esterase works, and can promote WeiDongLi Capsule, improve stomach receiving obstacle, the expansion of enhancing stomach bottom.However, because hydrochloric acid Ah impersonates amine piece
For insoluble drug, the slightly soluble in water, almost do not dissolved in pH1.2 hydrochloric acid mediums, dissolution rate is slow, and the dissolution rate of medicine
The absorption of medicine is directly affected, causes bioavilability not high, medicine is influenceed and plays curative effect.
Generally improving drug dissolution method can start with terms of two：First, by crushing control raw material particle size or logical
The means such as micronizing are crossed to lift the dissolution rate of formulation products, but these physical operations add operational sequence, it will usually cause
The relevant material increase of raw material, crystal formation, moisture etc. change, and have impact on product quality.Second, in terms of preparation by formulation and technology come
Improve dissolution rate.Patent of invention CN105412026A by the range of supplementary product consumption improve silica dosage, to change
The dissolution of kind acotiamide hydrochloride hydrate tablet.Patent of invention CN104523686A proposes that the low possibility of acotiamide hydrochloride hydrate solubility is former
Because being that itself solubility is small, easily become sticky when being mixed with water so that solvent can not enter inside material, make dissolution mode from dissolving
Become corrosion, greatly reduce the solubility and dissolution rate of raw material.The patent by hydrochloric acid Ah by impersonating amine and hydrophily speed
Melt into point such as carbohydrate, alcohol carbohydrate is premixed, then with other auxiliary material mixing granulations, enable to enter dissolution medium during its chance water
Inside raw material, reach the purpose for improving dissolution rate.Also by using solid dispersions technique, height point can be made up to
Homogeneous state is dissipated, so as to ensure the absorption and utilization of made preparation.Solid dispersions, which have, dramatically increases insoluble drug
Dissolution rate, improve its bioavilability and postpone to absorb, reduce medication dose the features such as, as patent CN106344517A,
CN105919967A, but solid dispersion preparation preparation technology is complicated, requires higher to support, quality control is compared
It is difficult.
Due to the easy moisture absorption of acotiamide hydrochloride hydrate, its less stable, relevant material increase is very big under the conditions of hot and humid,
So the selection of drug ingedient and the selection of dosage and preparation method become particularly important.Drug ingedient chooses at random that also have can
Acotiamide hydrochloride hydrate capsule dissolubility variation, the increase of relevant material, moisture rising etc. can be caused, or even can not granulating.
The suitably species of preparation method and process conditions, filler, disintegrant, lubricant etc. and dosage and filling
Agent, disintegrant, the appropriate combination of lubricant are most important to the result of extraction of capsule, mobility, content uniformity and stability.Often
Filler has starch, lactose etc., and conventional disintegrant has microcrystalline cellulose, sodium carboxymethyl starch etc., conventional lubricant
There are talcum powder, magnesium stearate, silica, superfine silica gel powder, sodium stearyl fumarate, lauryl sodium sulfate etc..But how to lead to
Cross suitable prescription, technique obtains more excellent dissolution rate, improves its mobility and content uniformity, reduce its moisture,
Its stability is further improved, prior art does not all provide further prompting, and in view of this, spy proposes this invention.
It is contemplated that overcome the mobility of existing acotiamide hydrochloride hydrate capsule is bad, dissolution rate is low, content uniformity is obvious,
The problems such as hygroscopicity, gained acotiamide hydrochloride hydrate capsule stability is high, good fluidity, and content uniformity is low, and dissolution rate is high, and passes through
Experiment finds that its hygroscopicity significantly reduces, and substantially increases the security and validity of medication.
The content of the invention
In view of this, it is an object of the invention to provide a kind of acotiamide hydrochloride hydrate composition capsule so that the hydrochloric acid
Acotiamide capsule can improve the stability of acotiamide hydrochloride hydrate, mobility, reduce content uniformity and hygroscopicity, improve dissolution
Degree, greatly improve the security and validity of medication.
To achieve the above object, the present invention provides following technical scheme：
A kind of acotiamide hydrochloride hydrate composition capsule, the composition include acotiamide hydrochloride hydrate, microcrystalline cellulose, shallow lake
Powder, tyrosine, sodium alginate, Compritol 888 ATO.
Preferably, with weight, the composition includes：Acotiamide hydrochloride hydrate 25%-30%, crystallite are fine
Tie up plain 30%-35%, starch 22%-26%, tyrosine 0.1%-0.3%, sodium alginate 14%-18%, Compritol 888 ATO
0.4%-0.6%.
It is highly preferred that with weight, the composition includes：Acotiamide hydrochloride hydrate 27%, microcrystalline cellulose
32.5%th, starch 24%, tyrosine 0.2%, sodium alginate 15.8%, Compritol 888 ATO 0.5%.
It is highly preferred that the amount ratio of the Compritol 888 ATO and sodium alginate is 0.1:2.5-4.5.
Acotiamide hydrochloride amine composition of the present invention can be prepared according to any rational method of prior art.Ability
The prior art that field technique personnel grasp according to it, and by simple experiment, can prepare meet national drug quality completely
It is required that this composition.That is the realization of foregoing invention purpose can not also be limited by its preparation method.But in order to further
The quality of the composition is improved, present invention preferably provides following preparation method：
It is sweet that drug ingedient acotiamide hydrochloride hydrate, microcrystalline cellulose, starch, tyrosine, sodium alginate, behenic acid are crushed respectively
Grease, 80 mesh sieves are crossed, well mixed be sent into dry granulating machine is pelletized, 18 mesh whole grains, and capsule is filling.
Preferably, with weight, each Ingredients Weight percentage composition is：Acotiamide hydrochloride hydrate 25%-30%,
Microcrystalline cellulose 30%-35%, starch 22%-26%, tyrosine 0.1%-0.3%, sodium alginate 14%-18%, behenic acid
Glyceride 0.4%-0.6%.
It is highly preferred that with weight, each Ingredients Weight percentage composition is：Acotiamide hydrochloride hydrate 27%, crystallite
Cellulose 32.5%, starch 24%, tyrosine 0.2%, sodium alginate 15.8%, Compritol 888 ATO 0.5%.
It is highly preferred that the amount ratio of the Compritol 888 ATO and sodium alginate is 0.1:2.5-4.5.
It is easily tacky after acotiamide hydrochloride hydrate raw material moisture absorption, cause hardness to become big, cause disintegration difficult, dissolution rate is slack-off.
So if auxiliary material selects bad, easy moisture absorption, quality is unstable during causing finished product storage.Pharmaceutical composition is made
In, the generally auxiliary material of more likely few selection, and the stripping quantity of active component is bigger so can be with the reduction auxiliary material of maximum possible
Influence to active component, preparation technology is simplified, while reduce cost.Which but can specifically be reached from auxiliary material
Purpose is stated, it is necessary to which paying performing creative labour could realize, the present invention acotiamide hydrochloride hydrate composition prescription is carried out
Substantial amounts of screening, refers to experimental example 1, and the composition of the acotiamide hydrochloride amine composition of the present invention is finally determined.
Because the mobility of acotiamide hydrochloride hydrate and starch is poor, therefore the bad control of loading amount is caused, brought not to production
Just.The present inventor has found by substantial amounts of experiment screening：Sodium alginate cooks disintegrant, while adds Compritol 888 ATO and do and lubricate
Agent, it significantly improves mobility, ensure that content uniformity is small in large-scale production process, while finds that it can be improved by experiment
The dissolution rate of acotiamide hydrochloride hydrate capsule；In order to improve its stability in preparation process, a small amount of tyrosine is added, is made
Acotiamide hydrochloride hydrate good fluidity, content uniformity is small, and hygroscopicity significantly reduces, and dissolution rate and stability significantly improve.
Wherein the amount ratio of Compritol 888 ATO and sodium alginate has a great impact to the mobility and dissolution rate of medicine,
Experimental example 2 is Compritol 888 ATO, the dosage screening experiment of sodium alginate, when Compritol 888 ATO and the amount ratio of sodium alginate
Control is 0.1:During 2.5-4.5, its mobility is best, and content uniformity is low, and dissolution rate is high.Moisture absorption of the dosage of tyrosine to medicine
Property has a significant impact, and finds that it can significantly reduce the hygroscopicity of composition through overtesting.
For existing acotiamide hydrochloride hydrate capsule poor fluidity, dissolution rate and hygroscopicity are poor, stability is not high the defects of, this
Invention has considered the influence between various composition, the composition for optimizing acotiamide hydrochloride hydrate capsule is matched somebody with somebody by long-term further investigation
Side, acotiamide hydrochloride hydrate, microcrystalline cellulose, starch, tyrosine, sodium alginate, Compritol 888 ATO combination is selected to prepare hydrochloric acid
Acotiamide capsule, mutually synergy improves curative effect, and the good fluidity of the acotiamide hydrochloride hydrate capsule provided, loading amount
Difference is small, hygroscopicity significantly reduces, dissolution rate is high, stability is good, substantially increases the security and validity of medication.
Embodiment
The invention discloses a kind of acotiamide hydrochloride hydrate composition capsule, those skilled in the art can be used for reference in this paper
Hold, be suitably modified technological parameter realization.In particular, all similar replacements and change are to those skilled in the art
For be it will be apparent that they are considered as being included in the present invention.The method of the invention is entered by preferred embodiment
Description is gone, related personnel can substantially not depart from present invention, composition as described herein entered in spirit and scope
Row change is suitably changed with combining, to realize and using the technology of the present invention.
With reference to embodiment, the present invention is expanded on further.
The weight percentage (%) of embodiment 1-5 each components
| Embodiment 1 | Embodiment 2 | Embodiment 3 | Embodiment 4 | Embodiment 5 | |
| Acotiamide hydrochloride hydrate | 25 | 27 | 30 | 27.5 | 25.4 |
| Microcrystalline cellulose | 35 | 32.5 | 31.3 | 30 | 33 |
| Starch | 25.4 | 24 | 22 | 26 | 23 |
| Tyrosine | 0.1 | 0.2 | 0.3 | 0.1 | 0.2 |
| Sodium alginate | 14 | 15.8 | 16 | 15.8 | 18 |
| Compritol 888 ATO | 0.5 | 0.5 | 0.4 | 0.6 | 0.4 |
The preparation method of acotiamide hydrochloride hydrate capsule：Drug ingedient acotiamide hydrochloride hydrate, microcrystalline cellulose, shallow lake are crushed respectively
Powder, tyrosine, sodium alginate, Compritol 888 ATO, 80 mesh sieves are crossed, well mixed be sent into dry granulating machine is pelletized, and 18 mesh are whole
Grain, capsule are filling.
Test method：
1st, mobility-detected is tested：
The mobility of solid can not be expressed with single characteristic value, commonly use angle of repose (angle of repose) and represent.
Typically refer to the maximum angular that the free inclined-plane of powder accumulation horizon and horizontal plane are formed.Angle of repose is smaller, and frictional force is smaller, flowing
Property is better, it is considered that good fluidity during θ≤30 degree, the need for liquidity in production process can be met during θ≤40 degree.Powder
Mobility the weight differential of the preparations such as granule, capsule, tablet and normal operating are had a great influence.
Inventor uses injection method：Powder is slowly added into above funnel, the material spilt from funnel bottom is in level
The inclination angle of coniform accumulation body is formed on face.Determine 3 times altogether, average, the results are shown in Table 1.
2nd, content uniformity detects
Reference《Chinese Pharmacopoeia》The detection method detection about content uniformity, takes for trying under 2005 editions annex capsule items
Product 10, respectively accurately weighed weight pours out content (must not lose softgel shell), hard shell capsules softgel shell with small brush or other suitably
Apparatus is wiped only；Soft capsule shell is cleaned with ether equal solvent, and putting ventilation makes solvent wave to the greatest extent, respectively accurately weighed softgel shell weight,
Obtain the tolerant loading amount of every intragranular.(all labelled amounts are indicated every loading amount with certain component amount, should be with compared with sign loading amount
Average loading amount compares), content uniformity limit should must not be more than 2 within ± 10.0% beyond content uniformity limit.And
There must not be 1 one times of overrun.
3rd, dissolution rate detects
Dissolution determination method：By trial target and reference substance according to《Pharmacopoeia of People's Republic of China》Version two is attached within 2015
Record X C the second methods of method paddle method and investigate dissolution rate.Using 0.01N hydrochloric acid 900mL as dissolution medium, temperature is 37 DEG C, rotating speed 75r
Min-1, the medication amount in each testing sample is 30mg.Sampled using ultraviolet spectrophotometry after 60min carry out it is molten
Out-degree determines, and Detection wavelength 280nm, linear relationship is good in 5~25mgL-1, and the rate of recovery, Precision Experiment meet
Methodology requirement.
4th, draws moist test
According to the medicine draws moist test guideline of 2015 editions general rules of Chinese Pharmacopoeia 9103.
Specific test method is as follows：
Dry tool plug glass measuring cup (external diameter 50mm, a height of 15mm) is taken, suitable 25 are placed in experiment the previous day
(design temperature is 25 DEG C for DEG C of ± 1 DEG C thermostatic drier (placing ammonium chloride or ammonium sulfate saturated solution in bottom) or growth cabinet
± 1 DEG C, relative humidity is 80% ± 2%) in, accurately weighed weight (m1).
Take test sample appropriate, be laid in above-mentioned measuring cup, test sample thickness is about 1mm, accurately weighed weight (m2).
Measuring cup is open, and with bottle cap with being placed under the conditions of above-mentioned constant temperature and humidity 24 hours.
Cover measuring cup lid, accurately weighed weight (m3).
Percentage weight increase=(m3-m2)/(m2-m1) × 100%
Draw moist feature description with drawing defining for moist weightening
Deliquescence：Absorb enough moisture and form liquid.
It is great draw it is moist：Draw wet weightening and be not less than 15%.
Have draw it is moist：Draw wet weightening less than 15% but not less than 2%.
Slightly draw moist：Draw wet weightening less than 2% but not less than 0.2%.
Nothing is moist almost without drawing：Draw wet weightening and be less than 0.2%.
Experimental example 1：Prescription screening is tested
Due to the easy moisture absorption of acotiamide hydrochloride hydrate, to damp and hot unstable, therefore pay the utmost attention to dry granulation method preparation, prevent
Influence of the moisture agent temperature to supplementary material, specific preparation method are as follows：Supplementary material is crushed respectively, crosses 80 mesh sieves, it is well mixed to send
It is filling to enter granulation, 18 mesh whole grains, capsule in dry granulating machine.
Screening experiment overabundance of data, the important experimental data in part is only listed herein.Due to acotiamide hydrochloride hydrate and starch
Mobility is poor, therefore causes the bad control of loading amount, is made troubles to production.The present inventor publishes by substantial amounts of testing sieve
Existing, sodium alginate cooks disintegrant, while adds Compritol 888 ATO and do lubricant, and it significantly improves mobility, ensure that big
Content uniformity is small in production process, while finds that it can improve the dissolution rate of acotiamide hydrochloride hydrate capsule by experiment；Preparing
During in order to improve its stability, add a small amount of tyrosine, obtained acotiamide hydrochloride hydrate good fluidity, content uniformity
Small, hygroscopicity significantly reduces, and dissolution rate and stability significantly improve.
Experimental example 2：The dosage screening experiment of Compritol 888 ATO, sodium alginate
This experimental example is when preparing acotiamide hydrochloride hydrate capsule, and the dosage as Compritol 888 ATO, sodium alginate is sieved
Choosing experiment, controls each supplementary material weight percentage：Acotiamide hydrochloride hydrate 25%-30%, microcrystalline cellulose 30%-35%, form sediment
Powder 22%-26%, tyrosine 0.1%-0.3%, adjust Compritol 888 ATO on this basis, sodium alginate weight percent contains
Amount.
The dosage of disintegrant sodium alginate has a great influence to disintegration time and dissolution rate, and its dosage is too small, can not meet and collapses
Solution and the requirement of dissolution.Sodium alginate aqueous solution is the disintegrant of viscosity, and its dosage is bigger, and the speed of disintegration and dissolution is slower.
Therefore inventor passes through substantial amounts of experiment screening, selects its weight percentage to be advisable for 14%-18%.
The dosage screening experiment of the Compritol 888 ATO of table 2, sodium alginate
Method preparation is prepared as follows in above-mentioned prescription：Drug ingedient acotiamide hydrochloride hydrate, microcrystalline cellulose are crushed respectively
Element, starch, tyrosine, sodium alginate, Compritol 888 ATO, 80 mesh sieves are crossed, well mixed be sent into dry granulating machine is pelletized, and 18
Mesh whole grain, capsule are filling.
Screening experiment overabundance of data, only lists the important experimental data in part herein, and inventor passes through substantial amounts of experiment screening
It was found that the amount ratio of Compritol 888 ATO and sodium alginate has a great impact to the mobility and dissolution rate of medicine, work as behenyl
The amount ratio of acid glyceride and sodium alginate is controlled 0.1:During 2.5-4.5, its mobility is best, and content uniformity is low, dissolution rate
It is high.
Experimental example 3：Performance detection
According to acotiamide hydrochloride hydrate capsule prepared by prescription provided by the invention and preparation method with prior art hydrochloric acid Ah
Examine and be shown in Table 3 for the comparison of amine capsule performance：
The performance test results of table 3
As can be seen from the above table, dissolution rate height, the good fluidity of acotiamide hydrochloride hydrate capsule of the invention, content uniformity
Low, hygroscopicity significantly reduces, and its performance is significantly better than existing preparation acotiamide hydrochloride hydrate.
Experimental example 4：Accelerated test
The embodiment of the present invention 1,2 samples is taken to place 6 under conditions of being 75% ± 5% in 40 DEG C ± 2 DEG C of temperature, relative humidity
Individual month, respectively at the 1st, 2,3,6 the end of month sampling once, it is measured by stability high spot reviews project.Result of the test is shown in Table
4。
The accelerated test result of table 4
Identical experiment has been carried out to other embodiments of the invention, obtained and 1,2 similar result of the embodiment of the present invention；By
Experimental result can be seen that product of the embodiment of the present invention under conditions of 40 DEG C ± 2 DEG C of temperature, relative humidity are 75% ± 5%,
It is respectively provided with character, dissolution rate and about material etc. higher stability.
Embodiment 7：Long term test
It is respectively 25 DEG C in temperature to take the embodiment of the present invention 1, the sample of embodiment 2, and relative humidity is 60% ± 10% bar
Place 24 months under part, respectively at the 3rd, 6,9,12,18,24 the end of month sampling once, carried out by stability high spot reviews project
Measure.Result of the test is shown in Table 5.
The long-term test results of table 5
Identical experiment has been carried out to other embodiments of the invention, obtained similar to the embodiment of the present invention 1, embodiment 2
As a result；Product of the present invention is in 40 DEG C ± 2 DEG C of temperature, the condition that relative humidity is 75% ± 5% it can be seen from experimental result
Under, it is respectively provided with character, dissolution rate and about material etc. higher stability.
Claims (9)
1. a kind of acotiamide hydrochloride hydrate composition capsule, it is characterised in that it is fine that the composition includes acotiamide hydrochloride hydrate, crystallite
Tie up element, starch, tyrosine, sodium alginate, Compritol 888 ATO.
2. acotiamide hydrochloride hydrate composition capsule according to claim 1, it is characterised in that with weight,
The composition includes：Acotiamide hydrochloride hydrate 25%-30%, microcrystalline cellulose 30%-35%, starch 22%-26%, tyrosine
0.1%-0.3%, sodium alginate 14%-18%, Compritol 888 ATO 0.4%-0.6%.
3. acotiamide hydrochloride hydrate composition capsule according to claim 2, it is characterised in that with weight, institute
Stating composition includes：Acotiamide hydrochloride hydrate 27%, microcrystalline cellulose 32.5%, starch 24%, tyrosine 0.2%, sodium alginate
15.8%th, Compritol 888 ATO 0.5%.
4. acotiamide hydrochloride hydrate composition capsule according to claim 2, it is characterised in that the Compritol 888 ATO and sea
The amount ratio of mosanom is 0.1:2.5-4.5.
5. a kind of preparation method of acotiamide hydrochloride hydrate composition capsule, it is characterised in that comprise the following steps：
Drug ingedient acotiamide hydrochloride hydrate, microcrystalline cellulose, starch, tyrosine, sodium alginate, behenyl acid glycerol are crushed respectively
Ester, 80 mesh sieves are crossed, well mixed be sent into dry granulating machine is pelletized, 18 mesh whole grains, and capsule is filling.
6. preparation method according to claim 5, it is characterised in that with weight, each Ingredients Weight percentage
Content is：Acotiamide hydrochloride hydrate 25%-30%, microcrystalline cellulose 30%-35%, starch 22%-26%, tyrosine 0.1%-
0.3%th, sodium alginate 14%-18%, Compritol 888 ATO 0.4%-0.6%.
7. preparation method according to claim 6, it is characterised in that with weight, each Ingredients Weight percentage
Content is：Acotiamide hydrochloride hydrate 27%, microcrystalline cellulose 32.5%, starch 24%, tyrosine 0.2%, sodium alginate 15.8%,
Compritol 888 ATO 0.5%.
8. preparation method according to claim 6, it is characterised in that the dosage of the Compritol 888 ATO and sodium alginate
Than for 0.1:2.5-4.5.
9. acotiamide hydrochloride hydrate composition capsule prepared by preparation method described in claim 5-8 any one.
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| CN201710819528.5A CN107496373A (en) | 2017-09-12 | 2017-09-12 | A kind of acotiamide hydrochloride hydrate composition capsule |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110384670A (en) * | 2018-04-17 | 2019-10-29 | 北京泰德制药股份有限公司 | A kind of composition and preparation method thereof containing acotiamide hydrochloride hydrate |
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105919967A (en) * | 2016-06-12 | 2016-09-07 | 佛山市腾瑞医药科技有限公司 | Acotiamide hydrochloride preparation and application thereof |
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2017
- 2017-09-12 CN CN201710819528.5A patent/CN107496373A/en active Pending
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105919967A (en) * | 2016-06-12 | 2016-09-07 | 佛山市腾瑞医药科技有限公司 | Acotiamide hydrochloride preparation and application thereof |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110384670A (en) * | 2018-04-17 | 2019-10-29 | 北京泰德制药股份有限公司 | A kind of composition and preparation method thereof containing acotiamide hydrochloride hydrate |
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Application publication date: 20171222 |