CN110354093A - A kind of mosapride citrate pharmaceutical composition - Google Patents
A kind of mosapride citrate pharmaceutical composition Download PDFInfo
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Abstract
The invention discloses a kind of mosapride citrate pharmaceutical composition, the composition includes mosapride citrate, sustained release agent, diluent, glidant, lubricant etc..The composition rate of release is gentle, and burst effect will not occur, have good stability, and can improve the medication compliance of patient, and drug safety is high, and toxic side effect is small.
Description
Technical field
The present invention relates to the technical fields of pharmaceutical preparation, and in particular to a kind of pharmaceutical composition of mosapride citrate.
Background technique
Mosapride citrate (formula 1), -4 chloro- amino -5- chloro-2-ethoxy-N- [[4- (4- fluorine benzyl of chemical name (±)
Base) -2- morpholinyl] methyl] benzamide dihydrate citrate is selective serotonin 4 (5-HT4) receptor agonism
Agent promotes the release of acetylcholine by excited gastrointestinal tract cholinergic intrerneuron and the 5-HT4 receptor of myenteric nerve plexus,
To enhance gastrointestinal movement, improve the gastrointestinal symptom of functional dyspepsia FD patient, and does not influence the secretion of gastric acid.It is clinical
For functional dyspepsia FD with symptoms of digestive tract such as heartburn, belch, Nausea and vomiting, early satiety, big bellies；It can also be used for
The stomach dysfunction of gastroesophageal reflux disease, diabetic gastroparesis and part pacing stomach patient.
A variety of fast dissolving dosage forms of mosapride citrate, including tablet, capsule, dispersible tablet, mouth are developed both at home and abroad at present
Take solution, granule, oral disintegrating tablet etc..The quick releasing formulation pharmacokinetic studies result announced according to PMDA is it is found that this product half-life period
(t1/2) it is 2 hours, effective blood drug concentration could be maintained by needing to be administered daily 3 times, and compliance is poor, be unfavorable for the elderly etc.
The poor PATIENT POPULATION's medication of memory, while quick releasing formulation has apparent blood concentration peak value and low ebb value, side effect
Greatly.
The patent of Publication No. CN102335154A discloses a kind of Mosapride citrate sustained-release tablet, which has
12 hours slow releasing functions, the sustained release tablets are by mosapride citrate, slow-release material, diluent, adhesive, lubricant and packet
Clothing material composition, the dissolution of sustained-release tablets is reproducible from laboratory to mass production, by the study on the stability in June, release
Degree is held essentially constant.But the sustained release tablets chemical stability is bad, and related substance increases obvious in long-term placement process.
Authorization Notice No. is that the patent of CN103356498B discloses a kind of Mosapride citrate sustained-release tablet, the sustained release tablets
With 12 hours slow releasing functions, chemical stability was good.The sustained release tablets by mosapride citrate, slow-release material, stabilizer,
Adhesive, lubricant, coating material composition.According to PMDA IF (Interview Form) file announced it is found that the drug takes
Quick acting is needed after, reached peak at 0.8 ± 0.1 hour, but excessively slowly (1 is small for release in 1 hour before the sustained release tablets of above-mentioned patent
When only discharge 5~9%), 1 hour burst size is not enough to generate effective blood drug concentration, easily lead to worked after patient's medication it is slow,
It is unfavorable for the performance of drug effect.
The patent of Publication No. CN102548544A discloses drug that is a kind of while having quick-release characteristic and long-lasting nature
Composition.Preparation process is divided into the preparation with long-lasting nature particle and the preparation with quick-release characteristic particle, long-lasting nature
Grain preparation method is that binder solution is sprayed to active pharmaceutical ingredient, releases the control matrix and pharmaceutically acceptable carrier
It on mixture, and is coated twice, so that preparation has the slow-released part of long-lasting nature.Quick-release characteristic preparation method of granules is
To quick-release mixture spray adhesive solution to prepare immediate-release granules.The addition of excipient, disintegrating agent and lubricant has been prepared
Two kinds of particles in, tabletting be made with sustained release and quick-release characteristic product.The preparation process of the patent disclosure is cumbersome, reproducibility
Difference, energy consumption is high, is not inconsistent with energy-saving and environment-friendly main trend now, is also unfavorable for commercially producing.In addition the patented product is in alcohol
In the presence of in the case of, burst effect easily occurs, will lead to serious bad feedback.
It is above-mentioned it is an object of the invention to solve the problems, such as, provide a kind of gentle release, chemical property stabilization, without prominent
Release the citric acid that effect, preparation process are simple, can improve patient's medication compliance, improve drug safety, reducing toxic side effect
Mosapride composition.
Summary of the invention
The present invention provides a kind of mosapride citrate pharmaceutical composition, which is characterized in that composition includes sustained-release matrix
With the sustained release agent of sustained release component composition；
The sustained release agent be pharmaceutical composition weight 5%-85% (wt/wt), for example, it may be 5%, 6%, 7%,
8%, 9%, 10%, 11%, 12%, 13%, 14%, 15%, 16%, 17%, 18%, 19%, 20%, 21%, 22%,
23%, 24%, 25%, 26%, 27%, 28%, 29%, 30%, 31%, 32%, 33%, 34%, 35%, 36%, 37%,
38%, 39%, 40%, 41%, 42%, 43%, 44%, 45%, 46%, 47%, 48%, 49%, 50%, 51%, 52%,
53%, 54%, 55%, 56%, 57%, 58%, 59%, 60%, 61%, 62%, 63%, 64%, 65%, 66%, 67%,
68%, 69%, 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%,
83%, 84%, 85% etc.；
The sustained-release matrix includes one of xanthan gum, Compritol 888 ATO, chitosan, beeswax, Brazil wax etc.
Or it is a variety of；
The sustained release component is the compound of two or more material composition, and the compound includes hydroxy ethyl fiber
At least one of element, povidone, polyvinyl alcohol, the compound also include polyvinyl acetate, ethyl cellulose, acetic acid fibre
At least one of dimension element, stearic acid；
When the sustained release component is by two kinds of material compositions, weight ratio is (1-10): (10-1), for example, it may be 1:10,
1.5:10,2:10,2.5:10,3:10,3.5:10,4:10,4.5:10,5:10,5.5:10,6:10,6.5:10,7:10,7.5:
10,8:10,8.5:10,9:10,9.5:10,1:1,10:9.5,10:9,10:8.5,10:8,10:7.5,10:7,10:6.5,
10:6,10:5.5,10:5,10:4.5,10:4,10:3.5,10:3,10:2.5,10:2,10:1.5,10:1 etc.；
The weight ratio of the sustained-release matrix and sustained release component is (0.1-10): (10-0.1)；For example, it may be 0.1:10,
0.5:10,1:10,1.5:10,2:10,2.5:10,3:10,3.5:10,4:10,4.5:10,5:10,5.5:10,6:10,
6.5:10,7:10,7.5:10,8:10,8.5:10,9:10,9.5:10,1:1,10:9.5,10:9,10:8.5,10:8,10:
7.5,10:7,10:6.5,10:6,10:5.5,10:5,10:4.5,10:4,10:3.5,10:3,10:2.5,10:2,10:1.5,
10:1,10:0.5,10:0.1 etc.；
In described pharmaceutical composition, the component content of mosapride citrate is 5%-45%, for example, it may be 5%,
10%, 15%, 20%, 25%, 30%, 35%, 40%, 45% etc.；
Described pharmaceutical composition can be tablet, capsule, pulvis or dispersion；
It can also include diluent, glidant and lubrication other than sustained release agent and active constituent in described pharmaceutical composition
Agent etc.；
The diluent can be lactose, starch, pregelatinized starch, dextrin, microcrystalline cellulose, mannitol or calcium monohydrogen phosphate
One of or it is a variety of；Account for the 10-70% of pharmaceutical composition total weight；For example, it may be 10%, 15%, 20%, 25%,
30%, 35%, 40%, 45%, 50%, 55%, 60%, 65%, 70% etc.；
The glidant can be one of talcum powder, silica or a variety of；Account for the 0- of pharmaceutical composition total weight
5%, for example, it may be 0.01%, 0.1%, 0.5%, 1%, 1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%,
5%；
The lubricant can be magnesium stearate, stearic acid, sodium stearyl fumarate, hydrogenated vegetable oil, dodecyl sulphate
One of sodium is a variety of；Account for the 0-5% of pharmaceutical composition total weight；For example, it may be 0.01%, 0.1%, 0.5%, 1%,
1.5%, 2%, 2.5%, 3%, 3.5%, 4%, 4.5%, 5%；
In addition, the present invention provides a kind of preparation processes of mosapride citrate medicinal tablet:
1. supplementary material is pre-processed；
2. mosapride citrate is mixed with sustained release agent, diluent；
3. glidant mixing is added；
4. lubricant total mix is added；
5. by gained granulation；
6. the label of above-mentioned acquisition with Opadry solution spraying, is obtained film-coated tablet.
The release of mosapride citrate pharmaceutical composition prepared by the present invention is gentle, has good stability, no phenomenon of burst release,
The compliance and safety of patient medication can be effectively improved, preparation process is simple, low energy consumption, favorable reproducibility, is suitable for business metaplasia
It produces.
Detailed description of the invention
Fig. 1 is the blood concentration situation map of 1 prescription of embodiment different time in beagle dog body.
Specific embodiment
Below in conjunction with specific embodiment, embodiment of the present invention is described in detail.Following example is only used for
Illustrate the present invention, and should not be taken as limiting the scope of the invention.All technologies realized based on above content of the present invention are belonged to
The scope of the present invention.Auxiliary material in following embodiment can be replaced with pharmaceutically acceptable auxiliary material, or increased, reduced.
Embodiment 1
(1) prescription
| Ingredient | Accounting |
| Mosapride citrate | 20.21% |
| Xanthan gum | 18% |
| Polyvinyl acetate | 9% |
| Hydroxyethyl cellulose | 8% |
| Mannitol | 42.79% |
| Silica | 1% |
| Talcum powder | 1% |
(2) it prepares
Mosapride citrate is subjected to air-flow crushing processing, polyvinyl acetate and hydroxyethyl cellulose carry out wet process system
Grain is simultaneously dried, and hopper is added in treated mosapride citrate and wet granulation desciccate, xanthan gum, mannitol
Silica is added with 15rpm mixing 40min in mixing machine, and with 15rpm mixing 10min, talcum powder is added, mixes 5min, presses
Tabletting is carried out according to middle control content, is coated with Opadry.
Embodiment 2
(1) prescription
(2) it prepares
Mosapride citrate is subjected to air-flow crushing processing, polyvinyl acetate and povidone carry out at spray drying
Reason mixes treated mosapride citrate with spray drying products therefrom, Compritol 888 ATO, lactose addition hopper
Silica is added with 15rpm mixing 40min in machine, and with 15rpm mixing 10min, lauryl sodium sulfate, mixing is added
5min carries out tabletting according to middle control content, is coated with Opadry, weight gain 2%.
Embodiment 3
(1) prescription
(2) it prepares
Mosapride citrate is subjected to air-flow crushing processing, polyvinyl acetate and polyvinyl alcohol carry out at spray drying
Hopper mixing machine is added in treated mosapride citrate and spray drying products therefrom, chitosan, lactose by reason, with
Silica is added in 15rpm mixing 40min, and with 15rpm mixing 10min, magnesium stearate is added, 5min is mixed, according to middle control
Content carries out tabletting, is coated with Opadry, weight gain 2%.
Embodiment 4
(1) prescription
| Ingredient | Accounting |
| Mosapride citrate | 25% |
| Beeswax | 25% |
| Polyvinyl acetate | 6% |
| Povidone | 7% |
| Pregelatinized starch | 35% |
| Silica | 1% |
| Sodium stearyl fumarate | 1% |
(2) it prepares
Mosapride citrate is subjected to air-flow crushing processing, polyvinyl acetate and povidone carry out wet granulation and do
Dry, beeswax is heated in 80 DEG C of water-baths to be made to melt, and treated mosapride citrate is added, and stirring makes to be uniformly dispersed, to
Processing is pulverized and sieved after cooling, by wet granulation desciccate, the mosapride citrate to pulverize and sieve and wax material, pre- glue
Change starch and hopper mixing machine is added, with 15rpm mixing 40min, silica is added, with 15rpm mixing 10min, is added stearic
Fumaric acid sodium mixes 5min, carries out tabletting according to middle control content, is coated with Opadry.
Comparative example 1
(1) prescription
| Ingredient | Accounting |
| Mosapride citrate | 15% |
| Hydroxypropyl methylcellulose | 20% |
| Polyvinyl acetate | 10% |
| Lactose | 53% |
| Silica | 1% |
| Magnesium stearate | 1% |
(2) it prepares
Mosapride citrate is subjected to air-flow crushing processing, it will treated mosapride citrate and polyvinyl acetate
Hopper mixing machine is added in ester, hydroxypropyl methylcellulose, lactose, with 15rpm mixing 40min, silica is added, is mixed with 15rpm
Magnesium stearate is added in 10min, mixes 5min, carries out tabletting according to middle control content, is coated with Opadry, weight gain 2%.
Comparative example 2
(1) prescription
(2) it prepares
Mosapride citrate is subjected to air-flow crushing processing, polyvinyl acetate and polyvinyl alcohol are spray-dried,
Hopper mixing machine is added in treated mosapride citrate and Spray dried products, mannitol, with 15rpm mixing 40min,
Silica is added, with 15rpm mixing 10min, magnesium stearate is added, mixes 5min, carries out tabletting according to middle control content, uses Europe
Bar generation coating, weight gain 2%.
Product testing
One, study on the stability
Embodiment 1-4 sample, which is placed under acceleration environment, to be investigated, and 40 DEG C of temperature, it is as follows to investigate result for humidity 75%:
Two, release is investigated
1. drug release determination method:
Sample is taken, according to dissolution method (four annex of Chinese Pharmacopoeia version in 2015,0,931 second method), with 0.1mol/L
Hydrochloric acid solution 900ml is dissolution medium, and revolving speed is 75rpm per minute, operates according to methods, through 1,2,4,6,8,12 hour, takes solution
10ml, filtering, takes filtrate as test solution.0.1mol/L hydrochloric acid solution 10ml is supplemented simultaneously.Separately take citric acid Mo Shabi
Sharp reference substance, precision weigh 65mg, set in 100ml volumetric flask, and methanol dilution constant volume is added, it is molten to pipette 5ml with pipette precision
Liquid is added methanol dilution constant volume, pipettes 5ml solution into 10ml volumetric flask with pipette precision, add into 100ml volumetric flask
Enter methanol dilution constant volume, shake up, as reference substance solution.Above two solution is taken, is detected with HPLC, every is calculated and tires out
Product release, should meet regulation.
(1) release result is as follows:
2. alcohol burst release test:
Sample is taken, according under drug release determination item, to contain 0%, 5%, 20%, 40% alcohol in 0.1mol/L hydrochloric acid respectively
Solution is dissolution medium, in 15min, 30min, 45min, 60min, 90min, 120min, takes solution 10ml, and filtering takes filtrate
As test solution.Corresponding solution 10ml is supplemented simultaneously.Reference substance preparation method is the same as the preparation method one in drug release determination
It causes.Above two solution is taken, is detected with HPLC, every Accumulation dissolution is calculated, regulation should be met.
1 result of embodiment:
2 result of embodiment:
3 result of embodiment:
4 result of embodiment:
1 result of comparative example:
2 result of comparative example:
As can be seen from the test results, mosapride citrate composition property of the invention is stablized, and slow releasing function is good,
It is not influenced by alcohol content, phenomenon of burst release is not present, the compliance and safety of patient medication can be effectively improved.
Three, determination of plasma concentration in beagle dog
In order to study the slow release effect of this product, to the sample that beagle dog prepares to embodiment 1, different time is measured
The blood concentration of beagle dog, as a result as shown in following table and Fig. 1, this product discharges gently in beagle dog body as the result is shown, tool
There is good slow releasing function.
| Time/h | Blood concentration μ g/ml |
| 0 | 0 |
| 0.5 | 3.1 |
| 1 | 4.6 |
| 2 | 4.8 |
| 3 | 4.7 |
| 4 | 4.5 |
| 5 | 4.6 |
| 6 | 4.3 |
| 8 | 4.4 |
| 10 | 4.2 |
| 12 | 4.1 |
| 14 | 3.4 |
| 16 | 2.4 |
| 18 | 1.1 |
| 24 | 0.3 |
Claims (12)
1. a kind of mosapride citrate pharmaceutical composition, which is characterized in that the composition contains sustained release agent, the sustained release agent by
Sustained-release matrix and sustained release component form, and the sustained release component is the compound of two or more material composition.
2. pharmaceutical composition according to claim 1, which is characterized in that the sustained release agent is pharmaceutical composition total weight
5%-85%.
3. pharmaceutical composition according to claim 1, which is characterized in that the sustained release component include hydroxyethyl cellulose,
At least one of povidone, polyvinyl alcohol.
4. pharmaceutical composition according to claim 1, which is characterized in that the sustained release component also includes polyvinyl acetate
At least one of ester, ethyl cellulose, cellulose acetate, stearic acid.
5. pharmaceutical composition according to claim 1, which is characterized in that the sustained-release matrix includes xanthan gum, behenic acid
One of glyceride, chitosan, beeswax, Brazil wax etc. are a variety of.
6. pharmaceutical composition according to claim 1, which is characterized in that mosapride citrate is with 5%~45% amount
In the presence of with the total weight of pharmaceutical composition.
7. pharmaceutical composition according to claim 1, which is characterized in that the composition further includes dilution in addition to sustained release agent
Agent, glidant and lubricant.
8. pharmaceutical composition according to claim 7, which is characterized in that the diluent includes lactose, starch, pregelatinated
One of starch, dextrin, microcrystalline cellulose, mannitol or calcium monohydrogen phosphate are a variety of.
9. pharmaceutical composition according to claim 7, which is characterized in that the glidant includes talcum powder, silica
One of or it is a variety of.
10. pharmaceutical composition according to claim 7, which is characterized in that the lubricant includes magnesium stearate, tristearin
One of acid, sodium stearyl fumarate, hydrogenated vegetable oil, lauryl sodium sulfate are a variety of.
11. -10 described in any item pharmaceutical compositions according to claim 1, which is characterized in that composition can be tablet, glue
Capsule, pulvis or dispersion.
12. pharmaceutical composition according to claim 11, which is characterized in that when composition is tablet, stomach dissolution type can be used
Coating material coats the tablet.
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910698839.XA CN110354093B (en) | 2019-07-31 | 2019-07-31 | Mosapride citrate pharmaceutical composition |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201910698839.XA CN110354093B (en) | 2019-07-31 | 2019-07-31 | Mosapride citrate pharmaceutical composition |
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| CN110354093A true CN110354093A (en) | 2019-10-22 |
| CN110354093B CN110354093B (en) | 2021-09-17 |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111110645A (en) * | 2020-02-14 | 2020-05-08 | 齐齐哈尔医学院 | Mosapride citrate sustained release tablet and preparation method thereof |
Citations (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101011363A (en) * | 2005-09-26 | 2007-08-08 | 刘凤鸣 | Slow release tablet of amoxicillin |
| CN101816639A (en) * | 2010-01-15 | 2010-09-01 | 鲁南制药集团股份有限公司 | Tablets of mosapride citrate and preparation method thereof |
| KR20110055448A (en) * | 2009-11-17 | 2011-05-25 | 풍림무약주식회사 | Sustained release formulation containing mosapride as an active ingredient |
| CN102335154A (en) * | 2010-07-28 | 2012-02-01 | 重庆健能医药开发有限公司 | Mosapride citrate sustained-release tablet |
| CN103356498A (en) * | 2012-03-31 | 2013-10-23 | 四川健能制药有限公司 | Mosapride citrate dehydrate sustained release tablet |
| US20140099378A1 (en) * | 2012-10-10 | 2014-04-10 | Capricorn Pharma Inc. | Modified Release Formulations of Anti-Irritability Drugs |
| CN104274419A (en) * | 2013-07-10 | 2015-01-14 | 广东省中药研究所 | Trimetazidine hydrochloride sustained release tablet taking glyceryl behenate as framework material and preparation method of trimetazidine hydrochloride sustained release tablet |
| CN104622826A (en) * | 2015-03-02 | 2015-05-20 | 孙巧玲 | Mosapride citrate tablet and preparation method thereof |
| KR101587140B1 (en) * | 2013-12-26 | 2016-01-21 | 한국유나이티드제약 주식회사 | Capsule containing mini-tablets comprising mosapride citrate for sustained-releasing formulation improving gastrointestinal disease and preparing the method thereof |
| CN105287434A (en) * | 2009-03-18 | 2016-02-03 | 赢创罗姆有限公司 | Ethanol influence-resistant controlled-release medicine composition adopting coating containing neutral vinyl polymers and excipients |
| CN106214657A (en) * | 2016-09-06 | 2016-12-14 | 江苏豪森药业集团有限公司 | Thin membrane coated tablet of mosapride citrate and preparation method thereof |
| CN107456444A (en) * | 2017-08-14 | 2017-12-12 | 南京工业大学 | A kind of slow-release dry suspension of Mosapride and preparation method thereof |
| CN108653226A (en) * | 2013-03-15 | 2018-10-16 | 韩国联合制药株式会社 | The daily single administration sustained release preparation of Mosapride of pharmacology and clinical effect is provided |
-
2019
- 2019-07-31 CN CN201910698839.XA patent/CN110354093B/en active Active
Patent Citations (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101011363A (en) * | 2005-09-26 | 2007-08-08 | 刘凤鸣 | Slow release tablet of amoxicillin |
| CN105287434A (en) * | 2009-03-18 | 2016-02-03 | 赢创罗姆有限公司 | Ethanol influence-resistant controlled-release medicine composition adopting coating containing neutral vinyl polymers and excipients |
| KR20110055448A (en) * | 2009-11-17 | 2011-05-25 | 풍림무약주식회사 | Sustained release formulation containing mosapride as an active ingredient |
| CN101816639A (en) * | 2010-01-15 | 2010-09-01 | 鲁南制药集团股份有限公司 | Tablets of mosapride citrate and preparation method thereof |
| CN102335154A (en) * | 2010-07-28 | 2012-02-01 | 重庆健能医药开发有限公司 | Mosapride citrate sustained-release tablet |
| CN103356498A (en) * | 2012-03-31 | 2013-10-23 | 四川健能制药有限公司 | Mosapride citrate dehydrate sustained release tablet |
| US20140099378A1 (en) * | 2012-10-10 | 2014-04-10 | Capricorn Pharma Inc. | Modified Release Formulations of Anti-Irritability Drugs |
| CN108653226A (en) * | 2013-03-15 | 2018-10-16 | 韩国联合制药株式会社 | The daily single administration sustained release preparation of Mosapride of pharmacology and clinical effect is provided |
| CN104274419A (en) * | 2013-07-10 | 2015-01-14 | 广东省中药研究所 | Trimetazidine hydrochloride sustained release tablet taking glyceryl behenate as framework material and preparation method of trimetazidine hydrochloride sustained release tablet |
| KR101587140B1 (en) * | 2013-12-26 | 2016-01-21 | 한국유나이티드제약 주식회사 | Capsule containing mini-tablets comprising mosapride citrate for sustained-releasing formulation improving gastrointestinal disease and preparing the method thereof |
| CN104622826A (en) * | 2015-03-02 | 2015-05-20 | 孙巧玲 | Mosapride citrate tablet and preparation method thereof |
| CN106214657A (en) * | 2016-09-06 | 2016-12-14 | 江苏豪森药业集团有限公司 | Thin membrane coated tablet of mosapride citrate and preparation method thereof |
| CN107456444A (en) * | 2017-08-14 | 2017-12-12 | 南京工业大学 | A kind of slow-release dry suspension of Mosapride and preparation method thereof |
Non-Patent Citations (3)
| Title |
|---|
| HYE JIN KIM ET AL.,: "Formulation Optimization of Solid Dispersion of Mosapride", 《ARCH PHARM RES》 * |
| POJ KULVANICH ET AL.,: "Release characteristics of the matrices prepared from co-spray-dried powders of theophylline and ethylcellulose", 《DRUG DEV IND PHARM》 * |
| 李佳睿: "聚乙烯醇/壳聚糖医用缓释材料的研究", 《工程科技Ⅰ辑> * |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN111110645A (en) * | 2020-02-14 | 2020-05-08 | 齐齐哈尔医学院 | Mosapride citrate sustained release tablet and preparation method thereof |
| CN111110645B (en) * | 2020-02-14 | 2022-02-22 | 齐齐哈尔医学院 | Mosapride citrate sustained release tablet and preparation method thereof |
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