CN105770876B - Purposes of the ulinastatin in preparation treatment chronic prostatitis drug - Google Patents
Purposes of the ulinastatin in preparation treatment chronic prostatitis drug Download PDFInfo
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- CN105770876B CN105770876B CN201610374709.7A CN201610374709A CN105770876B CN 105770876 B CN105770876 B CN 105770876B CN 201610374709 A CN201610374709 A CN 201610374709A CN 105770876 B CN105770876 B CN 105770876B
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- ulinastatin
- chronic prostatitis
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- injection
- drug
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/55—Protease inhibitors
- A61K38/57—Protease inhibitors from animals; from humans
Abstract
The invention belongs to field of medicaments, and in particular to purposes of the ulinastatin in preparation treatment chronic prostatitis drug.Purposes of the ulinastatin provided by the invention in preparation treatment chronic prostatitis drug, it is found through experiment that, Ulinastatin injection can significantly reduce the prostate wet weight, volume and prostate index of chronic prostatitis rat, wherein the effect of high dose group is best, illustrates that ulinastatin provided by the invention has significant therapeutic effect to chronic prostatitis.Moreover, finding through prostata tissue pathological examination, ulinastatin can significantly improve the lesion tissue of chronic prostatitis, be more advantageous to the recovery of patients with chronic prostatitis.
Description
Technical field
The invention belongs to field of medicaments, and in particular to use of the ulinastatin in preparation treatment chronic prostatitis drug
On the way.
Background technique
Prostatitis is a kind of diseases of genito-urinary system that male adults are often suffered from, be clinically divided into acute prostatitis and
Two kinds of chronic prostatitis, wherein most commonly seen with chronic prostatitis.Chronic prostatitis is mainly in 18-45 years old man,
It is to urinate irritation and bladder genital area pain is the clinical syndrome mainly showed.The complicated multiplicity of its pathogenic factor, example
Such as: congestion of prostate, urine stimulation, cause pathogeny imcrobe infection, immunity reduce, allergy and sink into for a long time anxiety, depression, probably
Chronic prostatitis can be caused in the mood feared.
Often there are the bad diseases such as the positions such as waist sacrum, perineum, testis distending pain, urine retention, enuresis nocturna frequency in patients with chronic prostatitis
Shape also will affect the sexual function and fertility of patient, seriously affect the normal work and life of male compatriot.And chronic prostate
The scorching course of disease is slow, obstinate refractory, easily causes other complication such as chronic nephritis over the course for the treatment of, brings to patient heavy
Mental burden seriously endangers the health of male compatriot.
Currently, the Common drugs for the treatment of chronic prostatitis have antibiotic, anti-inflammatory agent, α receptor blocker, botanical medicine, exempt from
Epidemic disease inhibitor etc..But said medicine wholistic therapy effect is undesirable, and is easy to recur.Therefore, one kind is researched and developed out
Treatment chronic prostatitis effect is good, and therapeutic agent uneasy to recur is the problem of current urgent need to resolve.
Ulinastatin also known as human urine trypsin inhibitor (Human Urinary Trypsin Inhibitor, UTI),
It is the acidoglycoprotein being made of 143 amino acid isolated and purified from human urine, it is not only a kind of broad-spectrum protease
Inhibitor also has anti-inflammatory, antitumor and immunoregulatory effect.Currently, the clinical application of ulinastatin is mainly used for controlling
Treat the disease of acute pancreatitis, Hemorrhagic shock, CPR, antitumor and anti-Operative invasion etc..
With deepening continuously for modern study, the more and more purposes of ulinastatin are found.Chinese patent
CN101972471B discloses the purposes and its medicine group that ulinastatin is used to prepare treatment Autoimmune Encephalomyelitis drug
Close object；Chinese patent CN101954071B disclose ulinastatin as the purposes for preparing medicament for treating systemic lupus erythematosus and
Its pharmaceutical composition.But up to the present, not yet studies have found that ulinastatin is used to prepare treatment chronic prostatitis medicine
Purposes in object.
Summary of the invention
In order to solve in the prior art, to chronic prostatitis, there has been no the exact drug of therapeutic effect, the purpose of the present invention
It is to provide purposes of the ulinastatin in preparation treatment chronic prostatitis drug, provides one kind for patients with chronic prostatitis
New drug.
The present invention provides purposes of the ulinastatin in preparation treatment chronic prostatitis drug.
Further, the ulinastatin is freeze drying powder injection, and the carrier is glucose, sodium chloride, mannitol, lactose
With one of gelatin hydrolysate or its any mixture.
Further, the ulinastatin is injection, and the carrier is water for injection, glucose, sodium chloride and sweet dew
One of alcohol or its any mixture.
Further, the freeze drying powder injection also contains mannitol, dextran, gelatin hydrolysate, sodium citrate or sweet ammonia
Acid is used as additive.
Further, the injection also contains mannitol, sodium chloride or glucose as additive.
Ulinastatin injection provided by the invention is big to the chronic prostatitis built using 25% XIAOZHILING ZHUSHEYE
Mouse model has significant therapeutic effect.By measuring the prostate wet weight of chronic prostatitis rat, calculates its prostate and refer to
It counts, and measures the treatment of chronic prostatitis with indexs such as prostate volumes of drainage measurement chronic prostatitis rat
Situation.It is found through experiment that before Ulinastatin injection provided by the invention can significantly reduce chronic prostatitis rat
Prostate wet weigh, volume and prostate index have significant difference (p < 0.05) compared with model group, and with dosage
Increase, effect is better, and ulinastatin high dose group has extremely significant difference (p < 0.01) compared with model group.Meanwhile with
Injection Ceftriaxone Sodium group is compared, and the prostate that ulinastatin high dose group can significantly reduce chronic prostatitis rat is wet
Weight and prostate index have significant difference (p < 0.05), illustrate ulinastatin provided by the invention to chronic prostate
Inflammation has significant therapeutic effect.
Further, it is found through prostata tissue pathological examination, compared with model group, the low and middle dosage of ulinastatin
The prostatitis tissue pathologic change degree of group is between 0 grade and 1 grade, i.e. body of gland lumen slightly becomes smaller, and pleat is slightly reduced；It is pink in lumen
Color secretion is slightly reduced；Cell infiltration is dispersed on a small quantity；There is a small amount of proliferation of fibrous tissue；Extent of disease is less than 1/3.Wu Sita
The prostata tissue lesion of fourth high dose group is 0 grade, i.e. body of gland lumen has no obvious lesion, and body of gland is normal, and body of gland lumen is larger,
Pleat is more；There are a large amount of rediance secretion in lumen；Inflammatory cell is accidental or nothing；Without proliferation of fibrous tissue or accidental minute quantity
Proliferation of fibrous tissue.Illustrate that ulinastatin provided by the invention can significantly improve the lesion tissue of chronic prostatitis, more has
Conducive to the recovery of patients with chronic prostatitis.
In short, compared with prior art, technical solution provided by the invention has the advantage that
(1) purposes of the ulinastatin provided by the invention in preparation treatment chronic prostatitis drug, is chronic forefront
Adenositis patient provides a kind of new therapeutic agent, brings glad tidings for vast chronic prostatitis.
(2) purposes of the ulinastatin provided by the invention in preparation treatment chronic prostatitis drug, tests prove that
Ulinastatin has significant therapeutic effect to chronic prostatitis, and can effectively improve the disease of chronic prostatitis tissue
Become situation, is more advantageous to the rehabilitation of patients with chronic prostatitis.
Specific embodiment:
The following describes the present invention further through the description of specific embodiments, but it is to limit of the invention that this, which is not,
System, those skilled in the art's basic thought according to the present invention can make various modifications or improvements, but without departing from this
The basic thought of invention, is all within the scope of the present invention.
Embodiment 1, preparation ulinastatin freeze drying powder injection
100,000,000 unit of ulinastatin aqueous solution after taking filtration sterilization adds 20 grams of mannitol dissolutions, adjusts pH in
Property, 2000 milliliters are injected water to, adds sodium chloride to adjust isotonic, is sterile filtered, is sub-packed in 1000 cillin bottles, sterile
Under the conditions of freeze-drying to get.
Embodiment 2 prepares Ulinastatin injection
100,000,000 unit of ulinastatin aqueous solution after taking filtration sterilization adds 20 grams of mannitol dissolutions, adjusts pH in
Property, inject water to 2000 milliliters, add sodium chloride adjust it is isotonic, be sterile filtered, dispense in 1000 cillin bottles to get.
Embodiment 3 prepares Ulinastatin injection
100,000,000 unit of ulinastatin aqueous solution after taking filtration sterilization adds 20 grams of glucose dissolutions, adjusts pH in
Property, inject water to 2000 milliliters, add sodium chloride adjust it is isotonic, be sterile filtered, dispense in 1000 cillin bottles to get.
The influence test prostatitic on rat chronic of test example one, ulinastatin
1, subjects: choosing 72 SPF grades of male SD rats, and weight 280-300g is moved by Guangdong Province's medical experiment
Object center provides.
2, test material: Ulinastatin injection prepared by embodiment 2；It is moist to be purchased from Shandong for ceftriaxone sodium for injection
Pharmaceutical Co. Ltd, national drug standard H20056554；XIAOZHILING ZHUSHEYE is purchased from the double crane high-tech natural drug Limited Liabilities in Beijing
Company's production, lot number: 090808.
3, the foundation of chronic prostatitis animal model:
SD rat is randomly divided into 6 groups, every group 12, respectively control group, model group, Ceftriaxone Sodium group, Wu Sita
Fourth low dose group, ulinastatin middle dose group and ulinastatin high dose group.In addition to control group, remaining each group SD rat soap
Water is applied to abdomen and then shaves coat with blade, and the 2nd starts modeling, after 3.5% chloral hydrate anesthesia, in aseptic condition
Under, in the median abdominal incision about 2-3cm of rat, abdominal cavity of going directly, before proposing that bladder and two sides seminal vesicle, exposure invest on the inside of seminal vesicle
Column gland notopodium, bilateral are injected separately into 25% XIAOZHILING ZHUSHEYE 0.2ml, sew up the incision immediately.
4, test method:
Start to be administered within the 4th day after modeling, each group administration route is all made of tail vein injection method, and the dosage of each group is such as
Under:
Control group: isometric physiological saline is injected；
Model group: isometric physiological saline is injected；
Ceftriaxone Sodium group: the ceftriaxone injection of 0.1g/kg is injected；
Ulinastatin low dose group: Ulinastatin injection prepared by injection 50000 units/kg embodiment 2；
Ulinastatin middle dose group: Ulinastatin injection prepared by injection 150000 units/kg embodiment 2；
Ulinastatin high dose group: Ulinastatin injection prepared by injection 300000 units/kg embodiment 2；
It injects weekly 2 times, continuous 4 times are 1 course for the treatment of, by rat weight after 2 courses for the treatment of, put to death, take prostate, solved
Observation is cutd open, weighs prostate wet weight, calculates prostate index, prostate volume is measured with drainage, and with 10% Fu Er
Malin's solution is fixed, and is embedded, is sliced (5 μm of thickness), and HE dyeing carries out histopathological examination under light microscopic.
5, test result
5.1, influence of the ulinastatin to the prostate wet weight of chronic prostatitis rat, index and volume is as shown in table 1.
Test data of 1 ulinastatin of table to the prostate wet weight of chronic prostatitis rat, index and volume
| Group | Prostate wet weight (g) | Prostate index (g/100g weight) | Prostate volume (ml) |
| Control group | 0.58±0.07 | 0.22±0.02 | 0.59±0.08 |
| Model group | 0.97±0.12 | 0.38±0.04 | 0.98±0.13 |
| Ceftriaxone Sodium group | 0.74±0.09* | 0.30±0.03* | 0.75±0.10* |
| Ulinastatin low dose group | 0.75±0.10* | 0.31±0.03* | 0.76±0.10* |
| Ulinastatin middle dose group | 0.73±0.08* | 0.30±0.03* | 0.72±0.09* |
| Ulinastatin high dose group | 0.62±0.07**# | 0.27±0.02**# | 0.62±0.08** |
Note: compared with model group, * p < 0.05, * * p < 0.01；Compared with Ceftriaxone Sodium group, #P < 0.05.
As shown in Table 1, compared with model group, Ceftriaxone Sodium group and each ulinastatin administration group be can be significantly reduced slowly
Property prostatitis rat prostate wet weight, volume and prostate index, compared with model group have significant difference (p <
0.05), ulinastatin high dose group has extremely significant difference (p < 0.01) compared with model group.Ulinastatin high dose group
Compared with injecting Ceftriaxone Sodium group, it can significantly reduce the prostate wet weight of chronic prostatitis rat and prostate refers to
Number has significant difference (p < 0.05), illustrates that ulinastatin provided by the invention has chronic prostatitis and significantly controls
Therapeutic effect.
5.2, the results are shown in Table 2 for prostata tissue pathological examination.
The grade scale of prostata tissue lesion degree is judged, such as following table, series is higher, and lesion tissue is more serious.
2 chronic prostatitis histopathological examination result (n=12) of table
As shown in Table 2, compared with model group, the prostatitis tissue pathologic change degree of the low and middle dose group of ulinastatin exists
Between 0 grade and 1 grade, the prostata tissue lesion of ulinastatin high dose group is 0 grade, illustrates that ulinastatin provided by the invention can
To significantly improve the lesion tissue of chronic prostatitis, it is more advantageous to the recovery of patients with chronic prostatitis.
Claims (5)
1. purposes of the ulinastatin in preparation treatment chronic prostatitis drug.
2. purposes as described in claim 1, which is characterized in that the ulinastatin is freeze drying powder injection, and the carrier is Portugal
One of grape sugar, sodium chloride, mannitol, lactose and gelatin hydrolysate or its any mixture.
3. purposes as described in claim 1, which is characterized in that the ulinastatin is injection, and the carrier is injection
One of water, glucose, sodium chloride and mannitol or its any mixture.
4. purposes as claimed in claim 2, which is characterized in that the freeze drying powder injection also contains mannitol, dextran, water
Gelatin, sodium citrate or glycine are solved as additive.
5. purposes as claimed in claim 3, which is characterized in that the injection also contains mannitol, sodium chloride or glucose
As additive.
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| CN201610374709.7A CN105770876B (en) | 2016-05-30 | 2016-05-30 | Purposes of the ulinastatin in preparation treatment chronic prostatitis drug |
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| CN201610374709.7A CN105770876B (en) | 2016-05-30 | 2016-05-30 | Purposes of the ulinastatin in preparation treatment chronic prostatitis drug |
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| CN105770876A CN105770876A (en) | 2016-07-20 |
| CN105770876B true CN105770876B (en) | 2019-09-10 |
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Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101040977A (en) * | 2006-05-29 | 2007-09-26 | 成都地奥九泓制药厂 | Medicine for treating prostate disease and method for preparing same |
| CN101095948A (en) * | 2007-06-18 | 2008-01-02 | 广东天普生化医药股份有限公司 | Use of ulinastain in the preparing of treating and/or preventing sudden arrest of heart beat tritocerebrum damnification medicine |
| CN101381366A (en) * | 2004-02-25 | 2009-03-11 | 武田药品工业株式会社 | Benzimidazole derivative and its use as a ii receptor antagonist |
| CN105596302A (en) * | 2016-02-02 | 2016-05-25 | 广东天普生化医药股份有限公司 | Ulinastatin freeze-dried powder preparation and preparation method thereof |
-
2016
- 2016-05-30 CN CN201610374709.7A patent/CN105770876B/en active Active
Patent Citations (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101381366A (en) * | 2004-02-25 | 2009-03-11 | 武田药品工业株式会社 | Benzimidazole derivative and its use as a ii receptor antagonist |
| CN101040977A (en) * | 2006-05-29 | 2007-09-26 | 成都地奥九泓制药厂 | Medicine for treating prostate disease and method for preparing same |
| CN101095948A (en) * | 2007-06-18 | 2008-01-02 | 广东天普生化医药股份有限公司 | Use of ulinastain in the preparing of treating and/or preventing sudden arrest of heart beat tritocerebrum damnification medicine |
| CN105596302A (en) * | 2016-02-02 | 2016-05-25 | 广东天普生化医药股份有限公司 | Ulinastatin freeze-dried powder preparation and preparation method thereof |
Non-Patent Citations (1)
| Title |
|---|
| 乌司他丁药理药效及相关药品简介;youkaixian;《百度文库》;20120512;第1-40页 |
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