CN1275647C - Application of neutral proteinase in preparing medicine for anorectal diseases and the medicine - Google Patents
Application of neutral proteinase in preparing medicine for anorectal diseases and the medicine Download PDFInfo
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- CN1275647C CN1275647C CN 03138879 CN03138879A CN1275647C CN 1275647 C CN1275647 C CN 1275647C CN 03138879 CN03138879 CN 03138879 CN 03138879 A CN03138879 A CN 03138879A CN 1275647 C CN1275647 C CN 1275647C
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- medicament
- medicine
- neutral protease
- neutral proteinase
- anus
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- 239000003814 drug Substances 0.000 title claims abstract description 47
- 101000693530 Staphylococcus aureus Staphylokinase Proteins 0.000 title abstract 5
- 208000015815 Rectal disease Diseases 0.000 title abstract 4
- 210000000436 anus Anatomy 0.000 claims abstract description 23
- 208000014617 hemorrhoid Diseases 0.000 claims abstract description 20
- 239000000829 suppository Substances 0.000 claims abstract description 11
- 206010009887 colitis Diseases 0.000 claims abstract description 9
- 208000004232 Enteritis Diseases 0.000 claims abstract description 5
- 206010036774 Proctitis Diseases 0.000 claims abstract description 5
- 108090000145 Bacillolysin Proteins 0.000 claims description 34
- 102000035092 Neutral proteases Human genes 0.000 claims description 34
- 108091005507 Neutral proteases Proteins 0.000 claims description 34
- 208000028774 intestinal disease Diseases 0.000 claims description 12
- 238000000576 coating method Methods 0.000 claims description 11
- 239000011248 coating agent Substances 0.000 claims description 10
- 208000037902 enteropathy Diseases 0.000 claims description 10
- 239000002671 adjuvant Substances 0.000 claims description 9
- 229940079593 drug Drugs 0.000 claims description 8
- 239000000463 material Substances 0.000 claims description 7
- 238000002360 preparation method Methods 0.000 claims description 7
- 239000002202 Polyethylene glycol Substances 0.000 claims description 5
- 229920001223 polyethylene glycol Polymers 0.000 claims description 5
- 239000004925 Acrylic resin 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
- 239000008101 lactose Substances 0.000 claims description 4
- 206010068172 Anal pruritus Diseases 0.000 claims description 3
- 208000009544 Pruritus Ani Diseases 0.000 claims description 3
- 229920000858 Cyclodextrin Polymers 0.000 claims description 2
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 claims description 2
- 230000001225 therapeutic effect Effects 0.000 abstract description 9
- 239000008280 blood Substances 0.000 abstract description 5
- 210000004369 blood Anatomy 0.000 abstract description 5
- 208000003251 Pruritus Diseases 0.000 abstract description 4
- 238000010579 first pass effect Methods 0.000 abstract description 3
- 231100000957 no side effect Toxicity 0.000 abstract description 3
- 239000002662 enteric coated tablet Substances 0.000 abstract 1
- 210000001035 gastrointestinal tract Anatomy 0.000 abstract 1
- 210000000936 intestine Anatomy 0.000 abstract 1
- 230000000638 stimulation Effects 0.000 abstract 1
- 210000002784 stomach Anatomy 0.000 abstract 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 8
- 102000004190 Enzymes Human genes 0.000 description 7
- 108090000790 Enzymes Proteins 0.000 description 7
- 208000032843 Hemorrhage Diseases 0.000 description 7
- 230000003203 everyday effect Effects 0.000 description 7
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- 238000011084 recovery Methods 0.000 description 7
- 208000035861 hematochezia Diseases 0.000 description 6
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- 238000010521 absorption reaction Methods 0.000 description 3
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- 210000001072 colon Anatomy 0.000 description 3
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- 238000003379 elimination reaction Methods 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 239000000284 extract Substances 0.000 description 3
- 239000012467 final product Substances 0.000 description 3
- 210000000664 rectum Anatomy 0.000 description 3
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- RZVAJINKPMORJF-UHFFFAOYSA-N Acetaminophen Chemical compound CC(=O)NC1=CC=C(O)C=C1 RZVAJINKPMORJF-UHFFFAOYSA-N 0.000 description 2
- 244000063299 Bacillus subtilis Species 0.000 description 2
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- 206010011224 Cough Diseases 0.000 description 1
- 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 description 1
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Landscapes
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
Abstract
The present invention belongs to the technical field of medicament and relates to a new purpose of neutral proteinase in preparing medicament for treating anorectal diseases and the medicament thereof. Neutral proteinase is used for preparing the medicament for treating anorectal diseases. The medicament comprises oral enteric coated tablets and external suppositories. The present invention provides the new purpose of the neutral proteinase and widens the application field of the neutral proteinase. The medicament belongs to positioning release medicament. The medicament can directly reach focus positions. Intestinal tracts and anuses have high blood medicament concentration for achieving therapeutic effects. The medicament has the advantages of no first pass effect, no stimulation to a stomach and an intestine, no side effect, safety, reliability, convenient use, exact therapeutic effects and good therapeutic effects, and is used for treating the anorectal diseases such as hemorrhoids, enteritis, colitis, rectitis, anus pruritus, etc. Particularly for the hemorrhoids, the medicament is clinically popularized and applied and has a wide market prospect.
Description
Technical field
The present invention relates to new purposes and the medicine of a kind of neutral protease, belong to medicine as preparation treatment anus, enteropathy medicine
Technical field.
Background technology
Hemorrhoid are commonly encountered diseases, so-called " ten people, nine hemorrhoid ", and with age growth sickness rate increases.It is the agglomerate that the cirso-by the upper and lower venous plexus of rectum causes, and therefore produce hemorrhage, the thrombosis agglomerate is deviate from the rectal cavity or outside the anus.Main clinical manifestation is: hemorrhage during (1) stool.Hemorrhage often be intermittence, with constipation, feces is stiff, times of defecation increases, drink and to eat irritable food etc. relevant.(2) the hemorrhoid piece is deviate from.Can reply voluntarily in early days, the later stage hemorrhoid have by the possibility of incarceration.(3) pain.The characteristics of external hemorrhoid are, patient often is local severe pain, defecation, sit, walk, cough etc. all can increase the weight of and be on tenterhooks.(4) pruritus.Chafe causes by casing slime outflow anus is outer.Along with the prolongation of disease time, produce local infection and complication thereof then, can not fully recover for a long time, directly influence patient's operate as normal and life.The misery that enteritis, colitis, proctitis etc. are brought to the patient also is the same.
At present, clinical Therapeutic Method commonly used: be careful in one's diet, keep free movement of the bowels, prevent to develop complications etc.; Clinical treatment there is no specific medicament, when being in a bad way, and excision and laser therapy, patient is very painful.
Summary of the invention
Technical problem to be solved by this invention is: new purposes and the corresponding medicine of a kind of neutral protease as preparation treatment anus, enteropathy medicine are provided, opened up the application of neutral protease, corresponding medicine has no side effect, and is safe and reliable, easy to use, therapeutic effect is good.
The present invention is used for the treatment of anus, enteropathy with neutral protease, that is: with the application of neutral protease as preparation treatment anus, enteropathy medicine.The metabolite that extracts in the fermentation liquid of bacillus subtilis (AS1.398).
Anus, intestinal diseases comprise hemorrhoid, enteritis, colitis, proctitis, pruritus ani etc.
Wherein:
Neutral protease can be the oral enteric sheet of neutral protease as preparation treatment anus, enteropathy medicine.
Enteric coatel tablets are made according to medical routine techniques and are got final product, and can add some corresponding auxiliary material etc., as being the oral enteric sheet that adjuvants such as neutral protease and lactose are made.
In order to make medicine can locate release, location absorption, the oral enteric sheet can be designed to coated tablet with coating method, oral enteric sheet, oral colon enteric coatel tablets etc. are arranged.
For enteric coatel tablets, can select for use coating materials such as OYP (Opadry), CAP (Cellulose Acetate Phthalate ester) or polyacrylic resin to make coated tablet.
For the colon enteric coatel tablets, can select for use coating materials such as cyclodextrin and polyacrylic resin to make coated tablet.
Neutral protease can also be the suppository of neutral protease as preparation treatment anus, enteropathy medicine, is medicine for external use.
Suppository is made according to medical routine techniques and is got final product, can add some corresponding auxiliary material etc., as being the suppository that adjuvants such as neutral protease and Polyethylene Glycol are made, the Polyethylene Glycol adjuvant is preferably selected the mixture of an amount of several different molecular weight polyethylene glycol for use.
Used adjuvant, coating material etc. among the present invention can also require according to the routine that medicine is made select to regulate to use, and processing technology requires to get final product according to the tablet of routine, the manufacturing technology of suppository.As: adjuvants such as neutral protease and an amount of lactose are mixed and made into granule, dry then, granulate, tabletting behind the mixing, coating is made the coating enteric coatel tablets again.With neutral protease and an amount of several different molecular weight polyethylene glycol mixture mixing, adopt hot melt to make suppository.
Principle of drug action:
(1) peak time is short, the blood drug level height.
This medicine has targeting, and the location discharges, locatees absorption in vivo.Through lesions position behind the drug release, no first pass effect, intestinal and anus blood drug level peaking, have rapid-action, the longer duration characteristics produce stronger pharmacological action to hemorrhoid and other intestinal, anal infection disease, have rapid-action, the longer duration characteristics have improved therapeutic index greatly.
(2) antiinflammatory, detumescence, pain relieving.
Neutral protease is the enzyme product that extracts from microorganism (metabolite that extracts the fermentation liquid of bacillus subtilis (AS1.398)), internal and external test show have good antiinflammatory, the repercussive pharmacological action, after this product is located in vivo and is discharged absorption, hemorrhoid and other intestinal, anal infection disease are produced antiinflammatory, analgesic pharmacological action, and its pharmacological action is better than general antibiotic and general analgesic.
(3) eliminate varicosis.
The cause of disease of hemorrhoid derives from the upper and lower venous plexus varicosis of rectum, thereby forms certain vein pressure, forms the vein bolt and since blood flow obstructed break hemorrhage, swell and ache.Internal and external test shows that neutral protease has good fibrinolytic effect, can remove the upper and lower venous plexus varicosis of rectum, and the dissolving vein is fastened, and reduces vein pressure, makes blood flow unimpeded, reaches the purpose of treatment.
(4) softening cicatrix, putrefaction-removing granulation-promoting.
Cicatrix that forms owing to phleborrhexis are hemorrhage or hemorrhoid piece cause breaking in daily routines very easily repeatedly, cause the dry and cracked no physiology elasticity of muscular tissue, and wound can not heal for a long time, and focus recurs again and again.The fibrinolytic effect of neutral protease can make the blood normal circulation, removes downright bad muscular tissue, makes cicatrix softening, and putrefaction-removing granulation-promoting impels wound healing.
The using method of medicine of the present invention:
Neutral protease oral enteric sheet: oral, be grown up each 2 (10mg/ sheets), every day 3 times, warm water delivery service before half an hour ante cibum; The child can be in the corresponding minimizing of its body weight ratio.Taking 5 days is a course of treatment.Anemia of pregnant woman and the forbidding of child below 12 years old.
Neutral protease oral colon delivery tablet: oral, be grown up each 2 (10mg/ sheets), every day 3 times, warm water delivery service before half an hour ante cibum; The child can be in the corresponding minimizing of its body weight ratio.Taking 5 days is a course of treatment.Anemia of pregnant woman and the forbidding of child below 12 years old.
Neutral protease suppository: anum administration, be grown up each 1 (10mg/ grain), every day 3 times.Using 5 days is a course of treatment.Anemia of pregnant woman and the forbidding of child below 12 years old.
The invention provides a kind of new purposes of neutral protease, widened the application of neutral protease.Medicine of the present invention belongs to the location and discharges medicine, directly arrives lesions position, intestinal and anus blood drug level height behind the drug release, reach therapeutic effect, and do not have first pass effect, to the gastrointestinal nonirritant, have no side effect, safe and reliable, easy to use, determined curative effect, therapeutic effect is good, can be used for treating disease, the especially hemorrhoid of anuses such as hemorrhoid, enteritis, colitis, proctitis, pruritus ani, intestinal aspect, can be applicable clinically, market prospect is wide.
The specific embodiment
The present invention is further illustrated below in conjunction with the test of embodiment and comparative.
Pharmaceutical dosage form: make tablet with neutral protease and lactose adjuvant, make coated tablet with the polyacrylic resin coating.
One, normal test situation
Therapeutic Method:
Neutral protease group (treatment group): oral neutral protease enteric coatel tablets (10mg/ sheet) are main, are grown up each 2, every day 3 times, warm water delivery service before half an hour ante cibum.
Anus portion paster group (matched group): commercially available paster, each 1 subsides of being grown up, every day 3 times.
Observational technique:
Observe the archorrhagia transference cure, nothings had blood in stool, redness disappears, no pruritus, no pain, walk, seat, found sense of discomfort and disappear; Stool is normal, and abdominal part, anus do not have distending pain.
Therapeutic outcome:
(1) hemorrhoid case group
Table 1: hemorrhage, have blood in stool, the difference of red and swollen, pain recovery time (my god)
| Group | X (meansigma methods) | S (standard deviation) | N (sample) |
| The treatment group | 5.18 | 3.28 | 19 |
| Matched group | 12.53 | 6.41 | 21 |
Illustrate: can obviously make hemorrhagely behind the neutral protein enzyme treatment, have blood in stool, redness, pain symptom recovers in advance.
Table 2: the comparison of varicosis elimination time (my god)
| Group | X | s | n |
| The treatment group | 14.12 | 5.56 | 21 |
| Matched group | 34.31 | 22.84 | 24 |
Illustrate: can remove varicosis rapidly behind the neutral protein enzyme treatment, recover in advance.
(2) chronic enteritis, the extensive case group of colitis:
Table 3: chronic enteritis, colitis recovery time is to relatively
| Group | X | s | n |
| The treatment group | 7.58 | 4.11 | 25 |
| Matched group | Invalid | - | 21 |
Illustrate: can make frank recovery in advance behind the neutral protein enzyme treatment.And matched group is invalid.
Two, double-blind trial situation
Therapeutic Method:
Neutral protease group (treatment group): oral neutral protease enteric coatel tablets (10mg/ sheet) are main, are grown up each 2, every day 3 times, warm water delivery service before half an hour ante cibum; The child can be in the corresponding minimizing of its body weight ratio.
Blank tablet group (matched group): oral starch sheet is main, is grown up each 2, every day 3 times.The child can be in the corresponding minimizing of its body weight ratio.
Observational technique:
Observe the archorrhagia transference cure, nothings had blood in stool, redness disappears, no pruritus, no pain, walk, seat, found sense of discomfort and disappear; Stool is normal, and abdominal part, anus do not have distending pain.
Therapeutic outcome:
(1) hemorrhoid case group
Table 4: hemorrhage, have blood in stool, the difference of red and swollen, pain recovery time (my god)
| Group | X (meansigma methods) | S (standard deviation) | N (sample) |
| The treatment group | 5.68 | 3.31 | 22 |
| Matched group | Invalid | 21 |
Illustrate: can obviously make hemorrhagely behind the neutral protein enzyme treatment, have blood in stool, redness, pain symptom recovers, and matched group is invalid.
Table 5: the comparison of varicosis elimination time (my god)
| Group | X | s | n |
| The treatment group | 15.02 | 6.16 | 24 |
| Matched group | Invalid | 23 |
Illustrate: can remove varicosis behind the neutral protein enzyme treatment, make glucose recovery, and matched group is invalid.
(2) chronic enteritis, the extensive case group of colitis:
Table 6: chronic enteritis, colitis recovery time is to relatively
| Group | X | s | n |
| The treatment group | 9.18 | 5.23 | 27 |
| Matched group | Invalid | - | 21 |
Illustrate: can make frank recovery in advance behind the neutral protein enzyme treatment.And matched group is invalid.
Neutral protease coated tablet and anus paster are selected in the case for the treatment of hemorrhoid and other intestinal, anal infection disease, no matter from the age, and state of an illness all similar, its comparative is reliable.Judge in elimination hemorrhoid symptom, eliminate varicosis, treat aspects such as other intestinal, anal infection disease from therapeutic outcome, the neutral protease group all is better than matched group, especially treatment hemorrhoid, releasing varicosis is had remarkable result.
Oppose than test with suppository of the present invention, the effect situation is basic identical.
Claims (10)
1, the AS1.398 neutral protease is as the application of preparation treatment anus, enteropathy medicine.
2, application according to claim 1 is characterized in that anus, intestinal diseases comprise hemorrhoid, enteritis, colitis, proctitis, pruritus ani.
3, a kind of medicine for the treatment of anus, enteropathy is characterized in that the oral enteric sheet for the AS1.398 neutral protease.
4, medicine according to claim 3 is characterized in that enteric coatel tablets are the oral enteric sheet that AS1.398 neutral protease and lactose adjuvant are made.
5,, it is characterized in that the oral enteric sheet is a coated tablet according to claim 3 or 4 described medicines.
6, medicine according to claim 5 is characterized in that coating is OYP or CAP material coating.
7, medicine according to claim 5 is characterized in that coating is cyclodextrin and polyacrylic resin material coating.
8, a kind of medicine for the treatment of anus, enteropathy is characterized in that the suppository for the AS1.398 neutral protease.
9, medicine according to claim 8 is characterized in that suppository is the suppository that AS1.398 neutral protease and adjuvant are made.
10, medicine according to claim 9 is characterized in that adjuvant is a Polyethylene Glycol.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03138879 CN1275647C (en) | 2003-08-06 | 2003-08-06 | Application of neutral proteinase in preparing medicine for anorectal diseases and the medicine |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 03138879 CN1275647C (en) | 2003-08-06 | 2003-08-06 | Application of neutral proteinase in preparing medicine for anorectal diseases and the medicine |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1486744A CN1486744A (en) | 2004-04-07 |
| CN1275647C true CN1275647C (en) | 2006-09-20 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 03138879 Expired - Lifetime CN1275647C (en) | 2003-08-06 | 2003-08-06 | Application of neutral proteinase in preparing medicine for anorectal diseases and the medicine |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1275647C (en) |
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2003
- 2003-08-06 CN CN 03138879 patent/CN1275647C/en not_active Expired - Lifetime
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| Publication number | Publication date |
|---|---|
| CN1486744A (en) | 2004-04-07 |
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