CN102657619A - Cimetidine instant granules and preparation method thereof - Google Patents
Cimetidine instant granules and preparation method thereof Download PDFInfo
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- CN102657619A CN102657619A CN2012101677015A CN201210167701A CN102657619A CN 102657619 A CN102657619 A CN 102657619A CN 2012101677015 A CN2012101677015 A CN 2012101677015A CN 201210167701 A CN201210167701 A CN 201210167701A CN 102657619 A CN102657619 A CN 102657619A
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- cimetidine
- product
- instant
- instant granular
- mixture
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- CCGSUNCLSOWKJO-UHFFFAOYSA-N cimetidine Chemical compound N#CNC(=N/C)\NCCSCC1=NC=N[C]1C CCGSUNCLSOWKJO-UHFFFAOYSA-N 0.000 title claims abstract description 35
- 229960001380 cimetidine Drugs 0.000 title claims abstract description 35
- 239000008187 granular material Substances 0.000 title abstract description 7
- 238000002360 preparation method Methods 0.000 title description 4
- 239000000546 pharmaceutical excipient Substances 0.000 claims abstract description 8
- 239000000203 mixture Substances 0.000 claims description 21
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 claims description 8
- 239000003795 chemical substances by application Substances 0.000 claims description 8
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 8
- 239000000080 wetting agent Substances 0.000 claims description 8
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 6
- UIIMBOGNXHQVGW-DEQYMQKBSA-M Sodium bicarbonate-14C Chemical compound [Na+].O[14C]([O-])=O UIIMBOGNXHQVGW-DEQYMQKBSA-M 0.000 claims description 6
- 238000001035 drying Methods 0.000 claims description 6
- BTCSSZJGUNDROE-UHFFFAOYSA-N gamma-aminobutyric acid Chemical compound NCCCC(O)=O BTCSSZJGUNDROE-UHFFFAOYSA-N 0.000 claims description 6
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 6
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 6
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 6
- 239000008213 purified water Substances 0.000 claims description 6
- 238000005550 wet granulation Methods 0.000 claims description 6
- -1 polyethylene Polymers 0.000 claims description 5
- FTLYMKDSHNWQKD-UHFFFAOYSA-N (2,4,5-trichlorophenyl)boronic acid Chemical compound OB(O)C1=CC(Cl)=C(Cl)C=C1Cl FTLYMKDSHNWQKD-UHFFFAOYSA-N 0.000 claims description 4
- 239000004471 Glycine Substances 0.000 claims description 4
- GUBGYTABKSRVRQ-QKKXKWKRSA-N Lactose Natural products OC[C@H]1O[C@@H](O[C@H]2[C@H](O)[C@@H](O)C(O)O[C@@H]2CO)[C@H](O)[C@@H](O)[C@H]1O GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 4
- 239000004698 Polyethylene Substances 0.000 claims description 4
- 229920002472 Starch Polymers 0.000 claims description 4
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims description 4
- 229930006000 Sucrose Natural products 0.000 claims description 4
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 claims description 4
- 239000008369 fruit flavor Substances 0.000 claims description 4
- 239000008101 lactose Substances 0.000 claims description 4
- 235000011090 malic acid Nutrition 0.000 claims description 4
- 229920000573 polyethylene Polymers 0.000 claims description 4
- HNJBEVLQSNELDL-UHFFFAOYSA-N pyrrolidin-2-one Chemical compound O=C1CCCN1 HNJBEVLQSNELDL-UHFFFAOYSA-N 0.000 claims description 4
- 229940085605 saccharin sodium Drugs 0.000 claims description 4
- 235000019698 starch Nutrition 0.000 claims description 4
- 239000005720 sucrose Substances 0.000 claims description 4
- 235000002906 tartaric acid Nutrition 0.000 claims description 4
- 239000011975 tartaric acid Substances 0.000 claims description 4
- OGNSCSPNOLGXSM-UHFFFAOYSA-N (+/-)-DABA Natural products NCCC(N)C(O)=O OGNSCSPNOLGXSM-UHFFFAOYSA-N 0.000 claims description 3
- BJEPYKJPYRNKOW-REOHCLBHSA-N (S)-malic acid Chemical compound OC(=O)[C@@H](O)CC(O)=O BJEPYKJPYRNKOW-REOHCLBHSA-N 0.000 claims description 3
- GUBGYTABKSRVRQ-XLOQQCSPSA-N Alpha-Lactose Chemical compound O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](CO)O[C@H](O)[C@H](O)[C@H]1O GUBGYTABKSRVRQ-XLOQQCSPSA-N 0.000 claims description 3
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 claims description 3
- 206010013786 Dry skin Diseases 0.000 claims description 3
- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 claims description 3
- 229960003692 gamma aminobutyric acid Drugs 0.000 claims description 3
- 229960002449 glycine Drugs 0.000 claims description 3
- 239000001630 malic acid Substances 0.000 claims description 3
- 238000000034 method Methods 0.000 claims description 3
- 229940093429 polyethylene glycol 6000 Drugs 0.000 claims description 3
- 239000002994 raw material Substances 0.000 claims description 3
- JXKPEJDQGNYQSM-UHFFFAOYSA-M sodium propionate Chemical group [Na+].CCC([O-])=O JXKPEJDQGNYQSM-UHFFFAOYSA-M 0.000 claims description 3
- 239000004324 sodium propionate Substances 0.000 claims description 3
- 229960003212 sodium propionate Drugs 0.000 claims description 3
- 235000010334 sodium propionate Nutrition 0.000 claims description 3
- 239000008107 starch Substances 0.000 claims description 3
- 229960001367 tartaric acid Drugs 0.000 claims description 3
- 238000002347 injection Methods 0.000 abstract description 6
- 239000007924 injection Substances 0.000 abstract description 6
- 241001465754 Metazoa Species 0.000 abstract description 5
- 230000001225 therapeutic effect Effects 0.000 abstract description 3
- 239000007884 disintegrant Substances 0.000 abstract 2
- 239000003906 humectant Substances 0.000 abstract 2
- 239000000470 constituent Substances 0.000 description 4
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 238000012856 packing Methods 0.000 description 3
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 2
- 241000287828 Gallus gallus Species 0.000 description 2
- 239000002202 Polyethylene glycol Substances 0.000 description 2
- 235000013330 chicken meat Nutrition 0.000 description 2
- 229920001223 polyethylene glycol Polymers 0.000 description 2
- PMZBHPUNQNKBOA-UHFFFAOYSA-N 5-methylbenzene-1,3-dicarboxylic acid Chemical compound CC1=CC(C(O)=O)=CC(C(O)=O)=C1 PMZBHPUNQNKBOA-UHFFFAOYSA-N 0.000 description 1
- 206010070814 Corrosive gastritis Diseases 0.000 description 1
- VEXZGXHMUGYJMC-UHFFFAOYSA-N Hydrochloric acid Chemical compound Cl VEXZGXHMUGYJMC-UHFFFAOYSA-N 0.000 description 1
- 206010022998 Irritability Diseases 0.000 description 1
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical group CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 1
- 206010046274 Upper gastrointestinal haemorrhage Diseases 0.000 description 1
- 239000002253 acid Substances 0.000 description 1
- 150000007513 acids Chemical class 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 239000003651 drinking water Substances 0.000 description 1
- 235000020188 drinking water Nutrition 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 210000004211 gastric acid Anatomy 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 125000002496 methyl group Chemical group [H]C([H])([H])* 0.000 description 1
- 230000009965 odorless effect Effects 0.000 description 1
- 235000019629 palatability Nutrition 0.000 description 1
- 229920000036 polyvinylpyrrolidone Polymers 0.000 description 1
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 230000002265 prevention Effects 0.000 description 1
- 125000002924 primary amino group Chemical group [H]N([H])* 0.000 description 1
- 230000001681 protective effect Effects 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 210000002784 stomach Anatomy 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 238000011287 therapeutic dose Methods 0.000 description 1
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- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
The invention relates to cimetidine instant granules comprising following mixed components, by weight, 10-20 parts of cimetidine, 30-40 parts of disintegrant, 20-40 parts of humectant, 2-10 parts of corrective and 10-20 parts of excipient. The cimetidine instant granules are prepared by mixing the cimetidine, the disintegrant, the humectant and the excipient. Evidenced by experiments, the cimetidine instant granules have the advantages of high stability, good taste, edible easiness for animals, convenience in utilization and good therapeutic effect, can be stored for a long time, and has effective amount higher than that of existing injection.
Description
Technical field
The present invention relates to cimetidine preparation of medicaments technical field, especially a kind of cimetidine instant granular and preparation method thereof.
Background technology
Cimetidine (N '-methyl-N "-[2 [[(5-methyl isophthalic acid H-imidazol-4 yl) methyl] sulfo-]-ethyl]-N-cyanoguanidines); white or off-white color crystalline powder; odorless almost, bitter in the mouth, it has the excretory effect of gastric acid inhibitory; the corrosive gastritis that causes because of chemical stimulation is had prevention and protective effect, bursts scorching and upper gastrointestinal hemorrhage also has obvious curative effects to the irritability stomach.
Cimetidine is prone to dissolve in methanol, in ethanol, dissolves, and dissolves slightly soluble in water in the isopropyl alcohol part omitted; In dilute hydrochloric acid, be prone to dissolve, cimetidine has the shortcoming of bitter in the mouth, palatability difference, and people invent out cimetidine inj through research; But its active constituent content only 0.4% when clinical use, needs a large amount of injections could satisfy the requirement of animal body; Inconvenience very, and multiple injection is prone to cause the stress of animal body, is unfavorable for treatment of diseases.
Summary of the invention
The objective of the invention is to overcome the deficiency of prior art, provide content high, easy to use a kind of cimetidine instant granular.
The technical scheme that the present invention takes is:
A kind of cimetidine instant granular is characterized in that: its raw material comprises blended by weight following component:
And said disintegrating agent is one or more the mixture in sucrose, lactose, the soluble starch.
And said wetting agent is sodium propionate, Gamma Amino Butyric Acid, glycine, tartaric acid, polyethylene than one or more the mixture in pyrrolidone, the polyethylene glycol 6000.
And said correctives is one or more the mixture in saccharin sodium, malic acid, sodium bicarbonate, the fruit flavors.
And said excipient is a microcrystalline Cellulose.
Another object of the present invention provides a kind of method for preparing of cimetidine instant granular, may further comprise the steps:
(1) cimetidine is mixed with disintegrating agent, pulverize the back and cross 80 mesh sieves;
(2) wetting agent is dissolved in purified water;
(3) with after correctives and the mixed with excipients, cross 80 mesh sieves, add in the product of step (1) mix homogeneously again;
(4) with the product of step (3) and the product mix homogeneously of step (2);
(5) wet granulation promptly makes finished product after 60～70 degrees centigrade of dryings then.
Advantage of the present invention and good effect are:
Among the present invention, cimetidine and disintegrating agent, wetting agent and correctives are mixed and made into instant granular, evidence, its stability is high; Can deposit the long period, mouthfeel is good, and animal is easy to eat; And content of effective is easy to use far above conventional injection liquid, and therapeutic effect is good.
The specific embodiment
Below in conjunction with embodiment, the present invention is further specified, following embodiment is illustrative, is not determinate, can not limit protection scope of the present invention with following embodiment.
A kind of cimetidine instant granular, its raw material comprise blended by weight following component:
Wherein, disintegrating agent is one or more the mixture in sucrose, lactose, the soluble starch.Wetting agent is sodium propionate, Gamma Amino Butyric Acid, glycine, tartaric acid, polyethylene than one or more the mixture in pyrrolidone, the polyethylene glycol 6000.Correctives is one or more the mixture in saccharin sodium, malic acid, sodium bicarbonate, the fruit flavors.Excipient is a microcrystalline Cellulose.
The method for preparing of above-mentioned cimetidine instant granular may further comprise the steps:
(1) cimetidine is mixed with disintegrating agent, pulverize the back and cross 80 mesh sieves;
(2) wetting agent is dissolved in purified water;
(3) with after correctives and the mixed with excipients, cross 80 mesh sieves, add in the product of step (1) mix homogeneously again;
(4) with the product of step (3) and the product mix homogeneously of step (2);
(5) wet granulation promptly makes finished product after 60～70 degrees centigrade of dryings then.
Embodiment 1
(1) 10 gram cimetidine is mixed with 40 gram sucrose, pulverize the back and cross 80 mesh sieves;
(2) 10 gram polyvinylpyrrolidones, 20 gram polyethylene glycol 6000s are dissolved in 20 milliliters of purified water;
(3) 5 gram sodium bicarbonate, 5 gram malic acids, 10 gram microcrystalline Cellulose are mixed after, cross 80 mesh sieves after, add in the product of step (1) mix homogeneously again;
(4) with the product of step (3) and the product mix homogeneously of step (2);
(5) wet granulation promptly makes finished product after drying, granulate, the packing.
The active constituent content of the cimetidine instant granular that makes is: 10%.
Embodiment 2
(1) 15 gram cimetidine is mixed with 35 gram soluble starches, pulverize the back and cross 80 mesh sieves;
(2) 20 gram tartaric acid, 10 gram polyethylene are dissolved in 20 milliliters of purified water than pyrrolidone;
(3) 5 gram sodium bicarbonate, 5 gram fruit flavors, 10 gram microcrystalline Cellulose are mixed after, cross 80 mesh sieves after, add in the product of step (1) mix homogeneously again;
(4) with the product of step (3) and the product mix homogeneously of step (2);
(5) wet granulation promptly makes finished product after drying, granulate, the packing.
The active constituent content of the cimetidine instant granular that makes is: 15%.
Embodiment 3
(1) 20 gram cimetidine is mixed with 38 gram lactose, pulverize the back and cross 80 mesh sieves;
(2) 10 gram glycine, 10 gram Gamma Amino Butyric Acids, 15 gram polyethylene glycol 6000s are dissolved in 25 milliliters of purified water;
(3) 5 gram sodium bicarbonate, 2 gram saccharin sodium, 10 gram microcrystalline Cellulose are mixed after, cross 80 mesh sieves after, add in the product of step (1) mix homogeneously again;
(4) with the product of step (3) and the product mix homogeneously of step (2);
(5) wet granulation promptly makes finished product after drying, granulate, the packing.
The active constituent content of the cimetidine instant granular that makes is: 20%.
Get the instant granular of 100 gram embodiment 1 or 2 or 3, melt in 300 jin of water, through drinking-water feeding chicken, its effective ingredient that contains satisfies the therapeutic dose of 6000 chickens, and conventional injection liquid needs the consumption of nearly twice just passable.
Below be the test of embodiment 1～3 stability, the result sees table 1:
Among the present invention, cimetidine and disintegrating agent, wetting agent and correctives are mixed and made into instant granular, evidence, its stability is high; Can deposit the long period, mouthfeel is good, and animal is easy to eat; And content of effective is easy to use far above conventional injection liquid, and therapeutic effect is good.
Claims (6)
1. cimetidine instant granular, it is characterized in that: its raw material comprises blended by weight following component:
2. a kind of cimetidine instant granular according to claim 1 is characterized in that: said disintegrating agent is one or more the mixture in sucrose, lactose, the soluble starch.
3. a kind of cimetidine instant granular according to claim 1 is characterized in that: said wetting agent is sodium propionate, Gamma Amino Butyric Acid, glycine, tartaric acid, polyethylene than one or more the mixture in pyrrolidone, the polyethylene glycol 6000.
4. a kind of cimetidine instant granular according to claim 1 is characterized in that: said correctives is one or more the mixture in saccharin sodium, malic acid, sodium bicarbonate, the fruit flavors.
5. a kind of cimetidine instant granular according to claim 1 is characterized in that: said excipient is a microcrystalline Cellulose.
6. one kind like claim 1 or 2 or 3 or the method for preparing of 4 or 5 described cimetidine instant granulars, it is characterized in that: may further comprise the steps:
(1) cimetidine is mixed with disintegrating agent, pulverize the back and cross 80 mesh sieves;
(2) wetting agent is dissolved in purified water;
(3) with after correctives and the mixed with excipients, cross 80 mesh sieves, add in the product of step (1) mix homogeneously again;
(4) with the product of step (3) and the product mix homogeneously of step (2);
(5) wet granulation promptly makes finished product after 60～70 degrees centigrade of dryings then.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210167701.5A CN102657619B (en) | 2012-05-25 | 2012-05-25 | Cimetidine instant granules and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210167701.5A CN102657619B (en) | 2012-05-25 | 2012-05-25 | Cimetidine instant granules and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN102657619A true CN102657619A (en) | 2012-09-12 |
| CN102657619B CN102657619B (en) | 2015-04-22 |
Family
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201210167701.5A Expired - Fee Related CN102657619B (en) | 2012-05-25 | 2012-05-25 | Cimetidine instant granules and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102657619B (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103933013A (en) * | 2014-05-04 | 2014-07-23 | 广东台城制药股份有限公司 | Cimetidine capsule and preparation method thereof |
| CN108078951A (en) * | 2018-02-07 | 2018-05-29 | 湖南博隽生物医药有限公司 | It is a kind of to be used to treat Cimetidine composition of stomach trouble and preparation method thereof |
Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1488345A (en) * | 2003-07-31 | 2004-04-14 | 雅来（佛山）制药有限公司 | Ranitidine hydrochloride capsule producing process |
| CN101305986A (en) * | 2007-05-14 | 2008-11-19 | 江苏润邦药业有限公司 | Lafutidine Tablet and its preparation method |
| CN101548953A (en) * | 2008-04-03 | 2009-10-07 | 上海医药工业研究院 | Medicine granule, preparation method thereof, and preparation containing same |
-
2012
- 2012-05-25 CN CN201210167701.5A patent/CN102657619B/en not_active Expired - Fee Related
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1488345A (en) * | 2003-07-31 | 2004-04-14 | 雅来（佛山）制药有限公司 | Ranitidine hydrochloride capsule producing process |
| CN101305986A (en) * | 2007-05-14 | 2008-11-19 | 江苏润邦药业有限公司 | Lafutidine Tablet and its preparation method |
| CN101548953A (en) * | 2008-04-03 | 2009-10-07 | 上海医药工业研究院 | Medicine granule, preparation method thereof, and preparation containing same |
Non-Patent Citations (1)
| Title |
|---|
| 贾燕等: "法莫替丁分散片的研制", 《中国医药工业杂志》 * |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103933013A (en) * | 2014-05-04 | 2014-07-23 | 广东台城制药股份有限公司 | Cimetidine capsule and preparation method thereof |
| CN103933013B (en) * | 2014-05-04 | 2014-12-10 | 广东台城制药股份有限公司 | Cimetidine capsule and preparation method thereof |
| CN108078951A (en) * | 2018-02-07 | 2018-05-29 | 湖南博隽生物医药有限公司 | It is a kind of to be used to treat Cimetidine composition of stomach trouble and preparation method thereof |
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|---|---|
| CN102657619B (en) | 2015-04-22 |
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