CN1299765C - Thymosin peptide oral tablet and its preparation method - Google Patents
Thymosin peptide oral tablet and its preparation method Download PDFInfo
- Publication number
- CN1299765C CN1299765C CNB2004100409289A CN200410040928A CN1299765C CN 1299765 C CN1299765 C CN 1299765C CN B2004100409289 A CNB2004100409289 A CN B2004100409289A CN 200410040928 A CN200410040928 A CN 200410040928A CN 1299765 C CN1299765 C CN 1299765C
- Authority
- CN
- China
- Prior art keywords
- thymosin
- buccal tablet
- preparation
- adjuvant
- tabletting
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
- 238000002360 preparation method Methods 0.000 title claims abstract description 17
- 108010046075 Thymosin Proteins 0.000 title claims description 43
- 239000007935 oral tablet Substances 0.000 title 1
- 229940096978 oral tablet Drugs 0.000 title 1
- 239000006189 buccal tablet Substances 0.000 claims abstract description 26
- 229940046011 buccal tablet Drugs 0.000 claims abstract description 22
- 239000000463 material Substances 0.000 claims abstract description 12
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 10
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims abstract description 10
- 239000002671 adjuvant Substances 0.000 claims abstract description 8
- FBPFZTCFMRRESA-FSIIMWSLSA-N D-Glucitol Natural products OC[C@H](O)[C@H](O)[C@@H](O)[C@H](O)CO FBPFZTCFMRRESA-FSIIMWSLSA-N 0.000 claims abstract description 7
- 229920002472 Starch Polymers 0.000 claims abstract description 7
- 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 abstract description 7
- 229930006000 Sucrose Natural products 0.000 claims abstract description 7
- 239000000600 sorbitol Substances 0.000 claims abstract description 7
- 239000008107 starch Substances 0.000 claims abstract description 7
- 235000019698 starch Nutrition 0.000 claims abstract description 7
- 239000005720 sucrose Substances 0.000 claims abstract description 7
- FBPFZTCFMRRESA-JGWLITMVSA-N D-glucitol Chemical compound OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-JGWLITMVSA-N 0.000 claims abstract description 5
- 235000019359 magnesium stearate Nutrition 0.000 claims abstract description 5
- 239000002994 raw material Substances 0.000 claims abstract description 5
- WLAMNBDJUVNPJU-UHFFFAOYSA-N 2-methylbutyric acid Chemical compound CCC(C)C(O)=O WLAMNBDJUVNPJU-UHFFFAOYSA-N 0.000 claims abstract description 3
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims abstract description 3
- 108010010803 Gelatin Proteins 0.000 claims abstract description 3
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 claims abstract description 3
- 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 abstract description 3
- 229930195725 Mannitol Natural products 0.000 claims abstract description 3
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims abstract description 3
- WQZGKKKJIJFFOK-VFUOTHLCSA-N beta-D-glucose Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-VFUOTHLCSA-N 0.000 claims abstract description 3
- 229940082484 carbomer-934 Drugs 0.000 claims abstract description 3
- 235000019441 ethanol Nutrition 0.000 claims abstract description 3
- 239000008273 gelatin Substances 0.000 claims abstract description 3
- 229920000159 gelatin Polymers 0.000 claims abstract description 3
- 235000019322 gelatine Nutrition 0.000 claims abstract description 3
- 235000011852 gelatine desserts Nutrition 0.000 claims abstract description 3
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims abstract description 3
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims abstract description 3
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims abstract description 3
- 229960003943 hypromellose Drugs 0.000 claims abstract description 3
- 239000008101 lactose Substances 0.000 claims abstract description 3
- 239000000594 mannitol Substances 0.000 claims abstract description 3
- 235000010355 mannitol Nutrition 0.000 claims abstract description 3
- 239000008108 microcrystalline cellulose Substances 0.000 claims abstract description 3
- 229940016286 microcrystalline cellulose Drugs 0.000 claims abstract description 3
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims abstract description 3
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims abstract description 3
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims abstract description 3
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims abstract description 3
- 102000007501 Thymosin Human genes 0.000 claims description 42
- LCJVIYPJPCBWKS-NXPQJCNCSA-N thymosin Chemical compound SC[C@@H](N)C(=O)N[C@H](CO)C(=O)N[C@H](CC(O)=O)C(=O)N[C@@H](C)C(=O)N[C@@H](C)C(=O)N[C@H](C(C)C)C(=O)N[C@H](CC(O)=O)C(=O)N[C@H](C(C)C)C(=O)N[C@H](CO)C(=O)N[C@H](CO)C(=O)N[C@H](CCC(O)=O)C(=O)N[C@H]([C@@H](C)CC)C(=O)N[C@H]([C@H](C)O)C(=O)N[C@H](C(C)C)C(=O)N[C@H](CCCCN)C(=O)N[C@H](CC(O)=O)C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N[C@H](CCC(O)=O)C(=O)N[C@H](CCCCN)C(=O)N[C@H](CCCCN)C(=O)N[C@H](CCC(O)=O)C(=O)N[C@H](C(C)C)C(=O)N[C@H](C(C)C)C(=O)N[C@H](CCC(O)=O)C(=O)N[C@H](CCC(O)=O)C(=O)N[C@@H](C)C(=O)N[C@H](CCC(O)=O)C(O)=O LCJVIYPJPCBWKS-NXPQJCNCSA-N 0.000 claims description 38
- 238000005303 weighing Methods 0.000 claims description 8
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 5
- 210000001541 thymus gland Anatomy 0.000 claims description 5
- 239000000843 powder Substances 0.000 claims description 4
- 239000007779 soft material Substances 0.000 claims description 4
- 239000004925 Acrylic resin Substances 0.000 claims description 3
- 239000001856 Ethyl cellulose Substances 0.000 claims description 3
- ZZSNKZQZMQGXPY-UHFFFAOYSA-N Ethyl cellulose Chemical compound CCOCC1OC(OC)C(OCC)C(OCC)C1OC1C(O)C(O)C(OC)C(CO)O1 ZZSNKZQZMQGXPY-UHFFFAOYSA-N 0.000 claims description 3
- 229920002301 cellulose acetate Polymers 0.000 claims description 3
- 239000003814 drug Substances 0.000 claims description 3
- 235000019325 ethyl cellulose Nutrition 0.000 claims description 3
- 229920001249 ethyl cellulose Polymers 0.000 claims description 3
- OBMZMSLWNNWEJA-XNCRXQDQSA-N C1=CC=2C(C[C@@H]3NC(=O)[C@@H](NC(=O)[C@H](NC(=O)N(CC#CCN(CCCC[C@H](NC(=O)[C@@H](CC4=CC=CC=C4)NC3=O)C(=O)N)CC=C)NC(=O)[C@@H](N)C)CC3=CNC4=C3C=CC=C4)C)=CNC=2C=C1 Chemical compound C1=CC=2C(C[C@@H]3NC(=O)[C@@H](NC(=O)[C@H](NC(=O)N(CC#CCN(CCCC[C@H](NC(=O)[C@@H](CC4=CC=CC=C4)NC3=O)C(=O)N)CC=C)NC(=O)[C@@H](N)C)CC3=CNC4=C3C=CC=C4)C)=CNC=2C=C1 OBMZMSLWNNWEJA-XNCRXQDQSA-N 0.000 claims description 2
- 102100028501 Galanin peptides Human genes 0.000 claims description 2
- 101710169265 Galanin peptides Proteins 0.000 claims description 2
- 101710176384 Peptide 1 Proteins 0.000 claims description 2
- 239000008103 glucose Substances 0.000 claims description 2
- 238000005469 granulation Methods 0.000 claims description 2
- 230000003179 granulation Effects 0.000 claims description 2
- 239000007787 solid Substances 0.000 claims description 2
- 108090000765 processed proteins & peptides Proteins 0.000 abstract description 7
- 230000002992 thymic effect Effects 0.000 abstract description 5
- 239000008121 dextrose Substances 0.000 abstract 1
- 229960004756 ethanol Drugs 0.000 abstract 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 3
- 201000010099 disease Diseases 0.000 description 2
- 239000008187 granular material Substances 0.000 description 2
- 238000002347 injection Methods 0.000 description 2
- 239000007924 injection Substances 0.000 description 2
- 238000000034 method Methods 0.000 description 2
- 239000000203 mixture Substances 0.000 description 2
- 206010028980 Neoplasm Diseases 0.000 description 1
- 108091005804 Peptidases Proteins 0.000 description 1
- 239000004365 Protease Substances 0.000 description 1
- 102100037486 Reverse transcriptase/ribonuclease H Human genes 0.000 description 1
- 210000001744 T-lymphocyte Anatomy 0.000 description 1
- 230000004071 biological effect Effects 0.000 description 1
- 230000001413 cellular effect Effects 0.000 description 1
- 230000007547 defect Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 230000001066 destructive effect Effects 0.000 description 1
- 238000001647 drug administration Methods 0.000 description 1
- 239000002662 enteric coated tablet Substances 0.000 description 1
- 239000000284 extract Substances 0.000 description 1
- 230000002496 gastric effect Effects 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 230000036737 immune function Effects 0.000 description 1
- 230000000968 intestinal effect Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 230000007774 longterm Effects 0.000 description 1
- 210000003205 muscle Anatomy 0.000 description 1
- 229920001184 polypeptide Polymers 0.000 description 1
- 102000004196 processed proteins & peptides Human genes 0.000 description 1
- 210000003296 saliva Anatomy 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
Landscapes
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention provides a new medicine-a buccal tablet of thymic peptide, which is prepared from 1 of thymic peptide and 0 to 450 of medical adjuvant material according to the parts of weight. Each buccal tablet of athymic peptide contains at least 2 mg of thymic peptide polypeptide. The medical adjuvant material comprises at least one of the raw materials of mannitol, microcrystalline cellulose, lactose, starch, polyvinylpyrrolidone, ethanol, hypromellose, carbomer 934, magnesium stearate, gelatin, sucrose, dextrose and sorbitol. The present invention also provides a preparation method for the buccal tablet of thymic peptide.
Description
Technical field:
The present invention and new drug---thymosin buccal tablet and preparation method thereof is relevant.
Background technology:
Thymosin is the medicine that extracts preparation from the animal thymus organ, and it is the mixture of the polypeptide composition of molecular weight 200～15000.Thymosin is used for various constitutionales or Secondary cases T cell defect disease, the disease disease that various cellular immune functions are low and the auxiliary treatment of tumor.Injection liquid of thymic peptide alpha 1 adopts injection muscles or intravenously administrable, uses inconvenience, and long-term prescription also causes suffering to the patient.The thymosin enteric coated tablet adopts the oral intestinal canal administration, and is unstable in gastrointestinal tract, easily destroyed by gastrointestinal protease, makes thymosin lose biological activity.
Summary of the invention:
The objective of the invention is provides a kind of convenient drug administration in order to overcome above deficiency, improves bioavailability, the thymosin buccal tablet that the whole body therapeutic effect is good.Another object of the present invention is for a kind of preparation method of thymosin buccal tablet is provided.
The object of the present invention is achieved like this:
Thymosin buccal tablet of the present invention is made by following raw material by weight:
Thymus peptide 1
Pharmaceutic adjuvant 0～450,
Thymus galanin peptide content is at least 2mg in the every above-mentioned thymosin buccal tablet.
Above-mentioned pharmaceutic adjuvant is a kind of in the following raw materials according at least:
Mannitol, microcrystalline Cellulose, lactose, starch, polyvinylpyrrolidone, ethanol, hypromellose, carbomer 934, magnesium stearate, gelatin, sucrose, glucose, sorbitol also can adopt other pharmaceutic adjuvant.
The preparation method of thymosin buccal tablet of the present invention comprises and gets solid adjuvant material, sieves with aperture 2.00～0.071mm medicine sieve, removes coarse powder, collects fine powder, takes by weighing thymosin, adjuvant, mixing in proportion, tabletting.
Take by weighing thymosin, adjuvant in the above-mentioned method in proportion, make soft material after the mixing, granulation, tabletting.
In the above-mentioned method behind the tabletting on the thymosin buccal tablet or below add the extexine of making by inert material, extexine is made by inert material, can prevent that saliva is to the destructive dissolving of tablet.
Above-mentioned inert material is polyacrylic resin or ethyl cellulose or cellulose acetate, also can adopt other inert material.
1000 thymosin buccal tablets of present embodiment 4 are made by the 70g thymosin.Every contains 30mg thymosin polypeptide.Its preparation method is: press recipe quantity weighing thymosin, with the flat stamping of φ 5.5mm.
Embodiment 5:
1000 thymosin buccal tablets of present embodiment 5 are made by 2g thymosin, 518g starch, 270g sucrose, 100g sorbitol, 12g magnesium stearate.Every contains 2mg thymosin polypeptide.Its preparation method is: press recipe quantity weighing thymosin, starch, sucrose, sorbitol mixing, with 200ml is that percent concentration is that 70% ethanol is made soft material, use the sieve series grain of aperture 1.3mm dry under 50 ℃ of temperature again, cross aperture 1.60mm mesh sieve granulate, with the scrobicula stamping of φ 12mm.
The foregoing description is that foregoing of the present invention is further described, but this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to the foregoing description.All technology that realizes based on foregoing all belong to protection scope of the present invention.
1000 thymosin buccal tablets of present embodiment 4 are made by the 70g thymosin.Every contains 30mg thymosin polypeptide.Its preparation method is: press recipe quantity weighing thymosin, with the flat stamping of φ 5.5mm.
Embodiment 5:
1000 thymosin buccal tablets of present embodiment 5 are made by 2g thymosin, 518g starch, 270g sucrose, 100g sorbitol, 12g magnesium stearate.Every contains 2mg thymosin polypeptide.Its preparation method is: press recipe quantity weighing thymosin, starch, sucrose, sorbitol mixing, with 200ml is that percent concentration is that 70% ethanol is made soft material, use the sieve series grain of aperture 1.3mm dry under 50 ℃ of temperature again, cross aperture 1.60mm mesh sieve granulate, with the scrobicula stamping of φ 12mm.
The foregoing description is that foregoing of the present invention is further described, but this should be interpreted as that the scope of the above-mentioned theme of the present invention only limits to the foregoing description.All technology that realizes based on foregoing all belong to protection scope of the present invention.
Claims (8)
1, thymosin buccal tablet is characterized in that being made by following raw material by weight:
Thymus peptide 1,
Pharmaceutic adjuvant 0～450,
Thymus galanin peptide content is at least 2mg in the every above-mentioned thymosin buccal tablet.
2, thymosin buccal tablet as claimed in claim 1 is characterized in that described pharmaceutic adjuvant is a kind of in the following raw materials according at least:
Mannitol, microcrystalline Cellulose, lactose, starch, polyvinylpyrrolidone, ethanol, hypromellose, carbomer 934, magnesium stearate, gelatin, sucrose, glucose, sorbitol.
3, the preparation method of thymosin buccal tablet as claimed in claim 1 or 2 is characterized in that comprising and gets solid adjuvant material, is that 2.00～0.071mm medicine sieve sieves with the aperture, removes coarse powder, collects fine powder, takes by weighing thymosin, adjuvant, mixing in proportion, tabletting.
4, the preparation method of thymosin buccal tablet as claimed in claim 3 is characterized in that taking by weighing thymosin, adjuvant in proportion, makes soft material after the mixing, granulation, tabletting.
5, the preparation method of thymosin buccal tablet as claimed in claim 3, it is characterized in that behind the tabletting on the thymosin buccal tablet or below add the extexine of making by inert material.
6, the preparation method of thymosin buccal tablet as claimed in claim 5 is characterized in that inert material is polyacrylic resin or ethyl cellulose or cellulose acetate.
7, the preparation method of thymosin buccal tablet as claimed in claim 4, it is characterized in that behind the tabletting on the thymosin buccal tablet or below add the extexine of making by inert material.
8, the preparation method of thymosin buccal tablet as claimed in claim 7 is characterized in that inert material is polyacrylic resin or ethyl cellulose or cellulose acetate.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100409289A CN1299765C (en) | 2004-10-29 | 2004-10-29 | Thymosin peptide oral tablet and its preparation method |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2004100409289A CN1299765C (en) | 2004-10-29 | 2004-10-29 | Thymosin peptide oral tablet and its preparation method |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1634566A CN1634566A (en) | 2005-07-06 |
| CN1299765C true CN1299765C (en) | 2007-02-14 |
Family
ID=34845886
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2004100409289A Expired - Fee Related CN1299765C (en) | 2004-10-29 | 2004-10-29 | Thymosin peptide oral tablet and its preparation method |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1299765C (en) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2007034264A1 (en) * | 2005-09-20 | 2007-03-29 | Arkema France | Process for preparing partial oxidation products of lower alcohols by direct oxidation of a lower alcohol and catalysts for use in that process |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2057537C1 (en) * | 1994-01-28 | 1996-04-10 | Московский эндокринный завод | Medicinal agent of immunomodulating action based on thymosine |
| CN1160583A (en) * | 1996-04-01 | 1997-10-01 | 杨清安 | Aphtha powder |
| CN1252992A (en) * | 1999-10-28 | 2000-05-17 | 东北制药厂 | Carboprost methyl ester preparation absorbable through oral mucosa and preparation method thereof |
| US20030031709A1 (en) * | 2001-08-01 | 2003-02-13 | Mann Morris A. | Compositions that facilitate absorption of peptides and methods related thereto |
| CN1524576A (en) * | 2003-02-24 | 2004-09-01 | 王金水 | Composite thymus peptide with immunoregulation function |
-
2004
- 2004-10-29 CN CNB2004100409289A patent/CN1299765C/en not_active Expired - Fee Related
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| RU2057537C1 (en) * | 1994-01-28 | 1996-04-10 | Московский эндокринный завод | Medicinal agent of immunomodulating action based on thymosine |
| CN1160583A (en) * | 1996-04-01 | 1997-10-01 | 杨清安 | Aphtha powder |
| CN1252992A (en) * | 1999-10-28 | 2000-05-17 | 东北制药厂 | Carboprost methyl ester preparation absorbable through oral mucosa and preparation method thereof |
| US20030031709A1 (en) * | 2001-08-01 | 2003-02-13 | Mann Morris A. | Compositions that facilitate absorption of peptides and methods related thereto |
| CN1524576A (en) * | 2003-02-24 | 2004-09-01 | 王金水 | Composite thymus peptide with immunoregulation function |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1634566A (en) | 2005-07-06 |
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