CN1562360A - Enteric-coated capsule of compound proteolytic enzyme - Google Patents
Enteric-coated capsule of compound proteolytic enzyme Download PDFInfo
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- CN1562360A CN1562360A CN 200410030650 CN200410030650A CN1562360A CN 1562360 A CN1562360 A CN 1562360A CN 200410030650 CN200410030650 CN 200410030650 CN 200410030650 A CN200410030650 A CN 200410030650A CN 1562360 A CN1562360 A CN 1562360A
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- bromelain
- enteric coated
- coated capsule
- trypsin
- chinese medicine
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- 239000002775 capsule Substances 0.000 title claims abstract description 54
- 108091005804 Peptidases Proteins 0.000 title claims abstract description 13
- 150000001875 compounds Chemical class 0.000 title claims description 18
- 102000035195 Peptidases Human genes 0.000 title abstract description 12
- 108010004032 Bromelains Proteins 0.000 claims abstract description 52
- 239000000284 extract Substances 0.000 claims abstract description 16
- JMGZEFIQIZZSBH-UHFFFAOYSA-N Bioquercetin Natural products CC1OC(OCC(O)C2OC(OC3=C(Oc4cc(O)cc(O)c4C3=O)c5ccc(O)c(O)c5)C(O)C2O)C(O)C(O)C1O JMGZEFIQIZZSBH-UHFFFAOYSA-N 0.000 claims abstract description 14
- IVTMALDHFAHOGL-UHFFFAOYSA-N eriodictyol 7-O-rutinoside Natural products OC1C(O)C(O)C(C)OC1OCC1C(O)C(O)C(O)C(OC=2C=C3C(C(C(O)=C(O3)C=3C=C(O)C(O)=CC=3)=O)=C(O)C=2)O1 IVTMALDHFAHOGL-UHFFFAOYSA-N 0.000 claims abstract description 14
- FDRQPMVGJOQVTL-UHFFFAOYSA-N quercetin rutinoside Natural products OC1C(O)C(O)C(CO)OC1OCC1C(O)C(O)C(O)C(OC=2C(C3=C(O)C=C(O)C=C3OC=2C=2C=C(O)C(O)=CC=2)=O)O1 FDRQPMVGJOQVTL-UHFFFAOYSA-N 0.000 claims abstract description 14
- 235000005493 rutin Nutrition 0.000 claims abstract description 14
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- 229960004555 rutoside Drugs 0.000 claims abstract description 14
- REFJWTPEDVJJIY-UHFFFAOYSA-N Quercetin Chemical compound C=1C(O)=CC(O)=C(C(C=2O)=O)C=1OC=2C1=CC=C(O)C(O)=C1 REFJWTPEDVJJIY-UHFFFAOYSA-N 0.000 claims abstract description 8
- 239000000463 material Substances 0.000 claims abstract description 8
- IKMDFBPHZNJCSN-UHFFFAOYSA-N Myricetin Chemical compound C=1C(O)=CC(O)=C(C(C=2O)=O)C=1OC=2C1=CC(O)=C(O)C(O)=C1 IKMDFBPHZNJCSN-UHFFFAOYSA-N 0.000 claims abstract description 5
- 239000013543 active substance Substances 0.000 claims abstract description 5
- PCOBUQBNVYZTBU-UHFFFAOYSA-N myricetin Natural products OC1=C(O)C(O)=CC(C=2OC3=CC(O)=C(O)C(O)=C3C(=O)C=2)=C1 PCOBUQBNVYZTBU-UHFFFAOYSA-N 0.000 claims abstract description 5
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- 235000005875 quercetin Nutrition 0.000 claims abstract description 4
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- 102100037486 Reverse transcriptase/ribonuclease H Human genes 0.000 claims 1
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- 239000002131 composite material Substances 0.000 abstract 1
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- 238000002360 preparation method Methods 0.000 description 12
- 238000000034 method Methods 0.000 description 9
- YMWUJEATGCHHMB-UHFFFAOYSA-N Dichloromethane Chemical compound ClCCl YMWUJEATGCHHMB-UHFFFAOYSA-N 0.000 description 6
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- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 description 4
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- 108010073385 Fibrin Proteins 0.000 description 2
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- OSGAYBCDTDRGGQ-UHFFFAOYSA-L calcium sulfate Chemical compound [Ca+2].[O-]S([O-])(=O)=O OSGAYBCDTDRGGQ-UHFFFAOYSA-L 0.000 description 2
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- 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 description 1
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- KDXKERNSBIXSRK-UHFFFAOYSA-N Lysine Natural products NCCCCC(N)C(O)=O KDXKERNSBIXSRK-UHFFFAOYSA-N 0.000 description 1
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- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Abstract
An enteric capsule of composite proteolytic enzyme is composed of the enteric shell and the core consisting of auxiliary and active substance which consists of trypsase, bromelin and the extract of Chinese-medicinal materials chosen from rutin, quercetin and myricetin.
Description
Technical field
The invention belongs to technical field of medicine, particularly a kind of by trypsin, bromelain and Chinese medicine extract, and the enteric coated capsule of the mixture of corresponding adjuvant composition.
Background technology
The anti-inflammatory effect of trypsin and bromelain is accepted extensively for medical educational circles, and has obtained great deal of experiment data and Clinical Laboratory.
Bromelain is a kind of proteolytic enzyme that extracts from Fructus Ananadis comosi, is cysteine proteinase, proteolysis can be become oligopeptide and aminoacid.The anti-inflammatory activity of bromelain shows as various physiological actions: bromelain can activate into fibrin-ferment with the fibrin proenzyme, improve the fibrin hydrolysis of inflammation part, thereby can stop kininogen to be converted into the kassinin kinin that kassinin kinin reduces inflammation part, immune complex in the degraded blood circulation, the Role in Plant Signal Transduction that stops born of the same parents to regulate kinases (ERK)-2 and p21 outward.
Trypsin is a kind of proteolytic enzyme that derives from Pancreas Sus domestica, it is a kind of serine protease, with serine and histidine residues is the avtive spot of hydrolysing activity, the peptide chain that constitutes of hydrolysis arginine or lysine optionally, digestion dissolving Denatured protein, but can not digest normal structure, because contain non-specific trypsininhibitory substance in the serum.Trypsin can make digestion such as pus, sputum, blood clot thinning, be easy to drain and get rid of, quicken wound surface and purify, promote granulation tissue new life, and do not damage normal structure or damage atomic (because of trypsininhibitory substance is arranged in the serum).In addition and antiinflammatory action arranged, be mainly used in pulmonary abscess, bronchitis etc. and make the thin easy expectoration of secretions, the detumescence of the local edema that ulcer, gangrene, traumatic damage, fistula etc. are produced, and the anti-inflammation detumescence of hematoma, dense swollen, arthritis, bursitis, thrombophlebitis, iridocyclitis, uveitis, mucositis etc.In addition, trypsin also has the blood vessel dilating effect, can improve the systemic circulation that comprises inflammation part, be of value to the absorption of alleviating contrafluxion and promoting other drug, can improve the systemic circulation that comprises inflammation part, be of value to the absorption of alleviating contrafluxion and promoting other medicines, thereby improve the curative effect of compatibe drug.Toxic and side effects is lower, and hepatic and renal function is not seen obvious influence yet.
Chinese Pharmacopoeia has been included multiple protein hydrolase medicines such as trypsin, Chymotrypsin, bromelain, the Phlogenzym that Germany Mucos company releases is to be the compound protein hydrolytic enzyme tablet of active component with trypsin, bromelain and rutin, bromelain 90mg wherein, trypsin 48mg, rutin 100mg.
From the present trypsin and the complex tablet of bromelain, a lot of deficiencies are arranged on preparation technology:
At first, the active component of enzyme of proteolysis medicine mainly is a proteolytic enzyme, and enzyme is a kind of protein, is easy to degeneration, to temperature, and pressure, various index requests such as humidity are very high.And necessary processes such as pressurization, heating and coating must cause the loss of Proteolytic enzyme enzyme activity among the preparation technology of tablet, and loss sometimes reaches more than 50%, and its inventory is also wanted corresponding raising.So not only to preparation technology, equipment proposes very high requirement, and improves cost of material.
Secondly,,, in quality testing and control procedure, must use various expensive proteolytic enzyme inhibitors, improve the difficulty and the cost of quality control because the multiple protein hydrolytic enzyme has same or analogous substrate for compound protein hydrolase medicine.
At last, the enteric coating of proteolytic enzyme tablet can influence the disintegrate of drug particles, is unfavorable for the performance of drug effect.
Summary of the invention
An object of the present invention is to propose a kind of compound protein hydrolase enteric coated capsule, for solving in preparation process the problem that the damage of tablet enzyme activity is serious.
Another purpose of the present invention is to propose a kind of compound protein hydrolase enteric coated capsule, for solving trypsin and bromelain complex tablet must use expensive enzyme inhibitor in preparation process problem.
Another object of the present invention is to propose a kind of compound protein hydrolase enteric coated capsule, it is serious both to have solved the enzyme activity damage in preparation process of trypsin and bromelain complex tablet, has solved the problem that must use expensive enzyme inhibitor in the mensuration process again.
For achieving the above object, to propose technical scheme as follows in the present invention:
A kind of compound protein hydrolase enteric coated capsule is characterized in that, is made of enteric coated capsule and the active substance and the mixture formed of corresponding auxiliary material of packing into wherein, and said active substance is trypsin, bromelain and Chinese medicine extract.
Said Chinese medicine extract can be rutin, Quercetin, and a kind of among the myricetin is preferably rutin.
The unit of activity of said bromelain can be 1-1, and 000,000 unit is preferably 10,000-500,000 unit.
Said tryptic total activity unit can be 1-1, and 000,000 unit is preferably 10,000-500,000 unit.
Said rutin can be the 1-1000 milligram, is preferably the 50-500 milligram.
The mixture that said trypsin and bromelain and Chinese medicine extract are formed can be powder, granule, microcapsule, microsphere.
The present invention also can be pressed into the trypsin sheet with independent the mixing with Chinese medicine extract and corresponding adjuvant of said trypsin, the independent mixing with Chinese medicine extract and corresponding adjuvant of bromelain is pressed into the bromelain sheet, pack in the said enteric coated capsule bromelain sheet and a trypsin sheet.
The present invention also can mix with Chinese medicine extract and corresponding adjuvant separately choosing a kind of in said trypsin and the bromelain wantonly, in the enteric coated capsule of packing into; Said another kind of protease mixes with corresponding adjuvant separately, in another enteric coated capsule of packing into.A said enteric coated capsule is according to a trypsin capsule and a bromelain capsulation.
The said granule of the present invention; microcapsule; microsphere (granule; microcapsule; microsphere preparation finishing back filled capsules) processing technology all can adopt traditional maturation process method; adjuvant wherein comprises diluent; lubricant; binding agent; coating materials etc. all can adopt general material; its consumption is as the criterion to fill full capsule according to the adjuvant that the preparation rule adopts; these contents are known technology (People's Health Publisher " pharmaceutics " in May, 2000; People's Health Publisher's " novel pharmaceutical formulation and new technique " in April, 1998); do not belong to the present invention's content required for protection, do not describe in detail at this.
The said enteric coated capsule of the present invention can be made into the capsule of 1-5 number, No. 0, No. 00, No. 000 various various dose, according to disease and drug effect, by manufacturer's use of arranging in pairs or groups flexibly.
The present invention also can be made into capsule No. 1, No. 2, No. 3, No. 4, No. 5, No. 0, No. 00, No. 000, is used for domestic animal and takes.
The invention has the advantages that:
According to first purpose of the present invention, dosage form of the present invention adopts capsule, technology is simple on the one hand, reduction is to the requirement of equipment, simultaneously, the technology of capsule preparations reduces the necessary tabletting of tablet technology, steps such as coating, also just reduced active loss, also just reduced dosage by its proteolytic enzyme that causes; Temperature, pressure, technological parameters such as humidity are more controlled, and preparation technology is simple, and cost reduces.Simultaneously, also avoided the influence of coating, more helped the performance of drug effect the granule disintegrate.
According to second purpose of the present invention, the present invention adopts single protease and corresponding adjuvant to press small pieces respectively to the capsular preparation that contains trypsin and bromelain, encapsulated then way, phase mutual interference when having avoided detecting between the multiple protein hydrolytic enzyme, avoid using expensive protease inhibitor, simultaneously, simplify assay method, reduced the difficulty and the cost of quality control.
According to the 3rd purpose of the present invention, the present invention with trypsin and bromelain respectively with corresponding adjuvant combined group resulting mixture, be respectively charged into capsule again.A trypsin and the compound enteric coated capsule of bromelain contains tryptic enteric coated capsule by one and an enteric coated capsule that contains bromelain is formed.Like this, both reduced the necessary tabletting of tablet technology, steps such as coating have also just reduced the active loss by its proteolytic enzyme that causes, have also just reduced dosage; Temperature, pressure, technological parameters such as humidity are more controlled, and preparation technology is simple, and cost reduces, and has also avoided the influence of coating to the granule disintegrate simultaneously, more helps the performance of drug effect; Phase mutual interference when having avoided again detecting between the multiple protein hydrolytic enzyme avoids using expensive protease inhibitor, simultaneously, simplifies assay method, has reduced the difficulty and the cost of quality control.
The specific embodiment
The present invention is further described by following examples, but these embodiment do not limit protection scope of the present invention.
Embodiment 1
Take by weighing each 10 gram of trypsin and bromelain, rutin 100 grams, microcrystalline Cellulose 100 grams, calcium sulfate 10 grams mix, mix three times after 80 order nylon mesh, after adding entry system soft material, cross 40 order nylon sieve series granules, dry naturally under the room temperature, in 30 ℃ of dryings 2 hours, cross 40 order nylon mesh granulate, fill enteric coated capsule then No. two, make 1000 altogether.This prescription contains trypsin 150,000 units, bromelain 110,000 units, rutin 100mg.The enzyme activity loss that this dosage form has avoided film-making agent technology to cause.
Embodiment 2
Take by weighing trypsin 30 grams and bromelain 50 grams, Quercetin 500 grams, starch 120, Pulvis Talci 2 grams are crossed 80 order nylon mesh, fill No. two enteric coated capsule, make 1000 altogether.This prescription contains trypsin 500,000 units, bromelain 500,000 units, Quercetin 500mg.
Embodiment 3
Take by weighing trypsin 1 gram and bromelain 10 grams respectively, rutin 100 grams, with trypsin and rutin and 10 gram microcrystalline Cellulose, 20 restrain the carboxymethyl starch sodium mixing is pressed into small pieces, makes 1000 altogether; With bromelain and 10 gram microcrystalline Cellulose, 20 gram carboxymethyl starch sodium mixing are pressed into small pieces, make 1000 altogether.With two kinds of small pieces enteric coated capsule of packing into No., make 1000 according to the method for each capsule dress a slice trypsin sheet and a slice bromelain sheet altogether.This prescription contains trypsin 20,000 units, bromelain 110,000 units, rutin 100mg.This dosage form has avoided using in the testing process expensive trypsin inhibitor.
Embodiment 4
Take by weighing each 1 gram of trypsin 30 grams and bromelain, myricetin 50 grams, compressibility Icing Sugar 90 grams, sucrose 30 grams, Polyethylene Glycol 30 grams are pulverized above material, cross 80 mesh sieves, mix homogeneously, polyvidone aqueous solution with 10% is granulated, and behind the vacuum drying, crosses 20 mesh sieve granulate; The granule of gained is with following solution enteric coated (EUDRAGITL30D-55 533 gram, polyethylene glycol 6000 type 16 grams, Pulvis Talci 16 grams, defoamer 1 gram, more than be dissolved in the 434 gram aqueous solutions), fill No. 1 conventional capsule after the enteric coated particles drying that makes, make 1000 altogether.This prescription contains trypsin 500,000 units, bromelain 10,000 units, myricetin 50mg.This dosage form avoids the film-making agent to cause to such an extent that enzyme activity loses.
Embodiment 5
Polymeric anhydride is dissolved in dichloromethane, take by weighing each 10 gram of trypsin and bromelain, rutin 100 grams, with rutin and bromelain mix homogeneously, respectively two kinds of powder are crushed to particle diameter less than 45um then, add respectively in the above-mentioned solution, mixture is added drop-wise in the silicone oil that contains anhydrous sorbitol mono fatty acid ester and dichloromethane, the microsphere that adds petroleum ether again and be stirred to two kinds of enzymes of capacity forms; The isolated by filtration microsphere is used petroleum ether, and vacuum drying spends the night; Promptly obtain trypsin microsphere and bromelain microsphere.Two kinds of microspheres of gained are filled No. 4 enteric coated capsulees, make 1000 two kinds of capsules respectively.Comprise a trypsin enteric coated capsule and a bromelain enteric coated capsule packing according to a compound trypsin and bromelain capsule.This dosage form had both avoided the film-making agent to cause the enzyme activity loss, had avoided using in the testing process expensive trypsin inhibitor again.
Embodiment 6
Take by weighing each 20 gram of trypsin and bromelain respectively, rutin 20 grams, with trypsin and rutin and starch 60, Pulvis Talci 1 gram is crossed 80 order nylon mesh, fills No. two enteric coated capsule; With bromelain and starch 60, Pulvis Talci 1 gram is crossed 80 order nylon mesh, fills No. two enteric coated capsule, makes 1000 two kinds of capsules respectively.Comprise a trypsin enteric coated capsule and a bromelain enteric coated capsule packing according to a trypsin and bromelain complex capsule.This scheme had both avoided the film-making agent to cause the enzyme activity loss, had avoided using in the testing process expensive trypsin inhibitor again.
Claims (8)
1, a kind of compound protein hydrolase enteric coated capsule is characterized in that, is made of enteric coated capsule and the active substance and the mixture formed of corresponding auxiliary material of packing into wherein, and said active substance is trypsin, bromelain and Chinese medicine extract.
2, compound protein hydrolase enteric coated capsule according to claim 1 is characterized in that said Chinese medicine extract is a rutin, Quercetin, and a kind of among the myricetin is preferably rutin.
3, compound protein hydrolase enteric coated capsule according to claim 1 is characterized in that the unit of activity of said bromelain is that the vigor of said bromelain is 1-1, and 000,000 unit is preferably 10,000-500,000 unit.
4, compound protein hydrolase enteric coated capsule as claimed in claim 1 is characterized in that, said tryptic vigor is 1-1, and 000,000 unit is preferably 10,000-500,000 unit.
5, as compound protein hydrolase enteric coated capsule as described in the claim 3, it is characterized in that said Chinese medicine extract amount is the 1-1000 milligram, is preferably the 50-500 milligram.
6, compound protein hydrolase enteric coated capsule according to claim 1 is characterized in that, the mixture that said trypsin or bromelain and Chinese medicine extract and corresponding auxiliary material are formed is powder, granule, microcapsule, microsphere.
7, compound protein hydrolase enteric coated capsule according to claim 1, it is characterized in that, the independent mixing with Chinese medicine extract and corresponding adjuvant of said trypsin is pressed into the trypsin sheet, the independent mixing with Chinese medicine extract and corresponding adjuvant of bromelain is pressed into the bromelain sheet, pack in the said enteric coated capsule bromelain sheet and a trypsin sheet.
8, compound protein hydrolase enteric coated capsule according to claim 1 is characterized in that, a kind of in optional said trypsin and the bromelain mixes with Chinese medicine extract and corresponding adjuvant separately, in the enteric coated capsule of packing into; Said another kind of protease mixes with corresponding adjuvant separately, in another enteric coated capsule of packing into.A said enteric coated capsule is according to a trypsin capsule and a bromelain capsulation.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410030650 CN1562360A (en) | 2004-04-02 | 2004-04-02 | Enteric-coated capsule of compound proteolytic enzyme |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410030650 CN1562360A (en) | 2004-04-02 | 2004-04-02 | Enteric-coated capsule of compound proteolytic enzyme |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN1562360A true CN1562360A (en) | 2005-01-12 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200410030650 Pending CN1562360A (en) | 2004-04-02 | 2004-04-02 | Enteric-coated capsule of compound proteolytic enzyme |
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| Country | Link |
|---|---|
| CN (1) | CN1562360A (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104762282A (en) * | 2015-04-03 | 2015-07-08 | 吴建中 | Polypeptide as well as phlogenzym tablet composition and application thereof |
| CN106215176A (en) * | 2016-08-22 | 2016-12-14 | 安徽瑞达健康产业投资有限公司 | A kind of efficiently antiinflammatory multienzyme compositions |
| CN107048341A (en) * | 2017-01-16 | 2017-08-18 | 星康桥医药科技（南京）有限公司 | A kind of application technology of enzyme and the medicine edible animal glue for which improving digestibility |
-
2004
- 2004-04-02 CN CN 200410030650 patent/CN1562360A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN104762282A (en) * | 2015-04-03 | 2015-07-08 | 吴建中 | Polypeptide as well as phlogenzym tablet composition and application thereof |
| CN106215176A (en) * | 2016-08-22 | 2016-12-14 | 安徽瑞达健康产业投资有限公司 | A kind of efficiently antiinflammatory multienzyme compositions |
| CN107048341A (en) * | 2017-01-16 | 2017-08-18 | 星康桥医药科技（南京）有限公司 | A kind of application technology of enzyme and the medicine edible animal glue for which improving digestibility |
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