CN105770876A - Application of ulinastatin in preparing medicines for treating chronic prostatitis - Google Patents
Application of ulinastatin in preparing medicines for treating chronic prostatitis Download PDFInfo
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- CN105770876A CN105770876A CN201610374709.7A CN201610374709A CN105770876A CN 105770876 A CN105770876 A CN 105770876A CN 201610374709 A CN201610374709 A CN 201610374709A CN 105770876 A CN105770876 A CN 105770876A
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- ulinastatin
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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
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Abstract
The invention belongs to the field of medicines, and particularly relates to an application of ulinastatin in preparing medicines for treating chronic prostatitis.According to the application of ulinastatin in preparing the medicines for treating chronic prostatitis, experiments show that ulinastatin injection can remarkably reduce the prostate wet weight, size and prostate index of rats suffering chronic prostatitis, the effect of a high-dose group is best, and it shows that ulinastatin has a remarkable treatment effect on chronic prostatitis.Prostate tissue pathological examinations show that ulinastatin can remarkably improve the pathological changes of tissues of chronic prostatitis and is more beneficial for recovery of patients suffering chronic prostatitis.
Description
Technical field
The invention belongs to field of medicaments, be specifically related to ulinastatin purposes in preparation treatment chronic prostatitis medicine.
Background technology
Prostatitis is a kind of diseases of genito-urinary system that male adults is often suffered from, and is divided into acute prostatitis and chronic prostatitis two kinds clinically, wherein most commonly seen with chronic prostatitis.Chronic prostatitis is mainly in the man in 18-45 year, is the clinical syndrome to urinate irritation and bladder genital area pain is main manifestations.Its pathogenic factor complexity is various, for instance: the stimulation of congestion of prostate, urine, cause pathogeny imcrobe infection, immunity reduction, allergy and anxiety of sinking into for a long time, depression, frightened emotion all can cause chronic prostatitis.
Often there are the ill symptomses such as the position distending pains such as waist sacrum, perineum, testis, urine retention, nocturia frequency in patients with chronic prostatitis, also can affect sexual function and the fertility of patient, has a strong impact on normal operation and the life of male compatriot.And the chronic prostatitis course of disease is slow, obstinate refractory, over the course for the treatment of easily caused by other complication such as chronic nephritiss, bring heavy mental burden to patient, serious harm male compatriot's is healthy.
At present, the Common drugs treating chronic prostatitis has antibiotic, anti-inflammatory agent, α receptor blocking agent, plant amedica, immunosuppressant etc..But said medicine wholistic therapy effect is undesirable, and it is prone to recurrence.Therefore, researching and developing out one, to treat chronic prostatitis effective, and the medicine not easily recurred is the difficult problem currently needing solution badly.
Ulinastatin, have another name called human urine trypsin inhibitor (HumanUrinaryTrypsinInhibitor, UTI), it it is the acidoglycoprotein being made up of 143 aminoacid separating purification from human urine, it is not only a kind of broad-spectrum protease inhibitor, also has antiinflammatory, antitumor and immunoregulatory effect.At present, the clinical practice of ulinastatin is mainly used for the disease of the aspects such as treatment acute pancreatitis, shock, cardio-pulmonary resuscitation, antitumor and anti-Operative invasion.
Along with deepening continuously of modern study, the increasing purposes of ulinastatin is found.Chinese patent CN101972471B discloses ulinastatin for preparing purposes and the pharmaceutical composition thereof for the treatment of Autoimmune Encephalomyelitis medicine;Chinese patent CN101954071B discloses ulinastatin as purposes and the pharmaceutical composition thereof of preparing medicament for treating systemic lupus erythematosus.But, up to the present, not yet studies have found that ulinastatin is for preparing the purposes in treatment chronic prostatitis medicine.
Summary of the invention
In order to solve the medicine that chronic prostatitis not yet has in prior art therapeutic effect definite, it is an object of the invention to provide ulinastatin purposes in preparation treatment chronic prostatitis medicine, provide a kind of new medicine for patients with chronic prostatitis.
The invention provides ulinastatin purposes in preparation treatment chronic prostatitis medicine.
Further, described ulinastatin is lyophilized injectable powder, and described carrier is the one in glucose, sodium chloride, mannitol, lactose and gelatin hydrolysate or its any mixture.
Further, described ulinastatin is injection, and described carrier is the one in water for injection, glucose, sodium chloride and mannitol or its any mixture.
Further, described lyophilized injectable powder possibly together with mannitol, dextran, gelatin hydrolysate, sodium citrate or glycine as additive.
Further, described injection possibly together with mannitol, sodium chloride or glucose as additive.
The chronic prostatitis rat model adopting 25% XIAOZHILING ZHUSHEYE to build is had significant therapeutic effect by Ulinastatin injection provided by the invention.By measuring the prostate weight in wet base of chronic prostatitis rat, calculate its prostate index, and the index such as prostate volume measuring chronic prostatitis rat with drainage weighs the treatment situation of chronic prostatitis.Find through test, Ulinastatin injection provided by the invention can reduce the prostate weight in wet base of chronic prostatitis rat, volume and prostate index significantly, there is significant difference (p < 0.05) compared with model group, and along with the increase of dosage, its effect is more good, and ulinastatin high dose group has extremely significant difference (p < 0.01) compared with model group.Simultaneously, compared with injection ceftriaxone sodium group, ulinastatin high dose group can reduce prostate weight in wet base and the prostate index of chronic prostatitis rat significantly, there is significant difference (p < 0.05), illustrate that chronic prostatitis is had significant therapeutic effect by ulinastatin provided by the invention.
Further, finding through prostata tissue pathological examination, compared with model group, the prostatitis tissue pathologic change degree of the low and middle dosage group of ulinastatin is between 0 grade and 1 grade, and namely body of gland tube chamber slightly diminishes, and pleat slightly reduces;In tube chamber, pink secretions slightly reduces;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.The prostata tissue pathological changes of ulinastatin high dose group is 0 grade, and namely body of gland tube chamber has no obvious pathological changes, and body of gland is normal, and body of gland tube chamber is relatively big, and pleat is more;A large amount of rediance secretions is had in tube chamber;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, be more beneficial for the recovery of patients with chronic prostatitis.
In a word, compared with prior art, technical scheme provided by the invention has the advantage that
(1) ulinastatin provided by the invention purposes in preparation treatment chronic prostatitis medicine, provides a kind of new medicine for patients with chronic prostatitis, brings glad tidings for vast chronic prostatitis.
(2) ulinastatin provided by the invention purposes in preparation treatment chronic prostatitis medicine, tests prove that chronic prostatitis is had significant therapeutic effect by ulinastatin, and can effectively improve the pathological changes situation of chronic prostatitis tissue, it is more beneficial for the rehabilitation of patients with chronic prostatitis.
Detailed description of the invention:
Below by way of the description of detailed description of the invention, the invention will be further described, but this is not limitation of the present invention, those skilled in the art's basic thought according to the present invention, various modifications may be made or improves, but without departing from the basic thought of the present invention, all within the scope of the present invention.
Embodiment 1, prepare ulinastatin lyophilized injectable powder
Take ulinastatin aqueous solution 100,000,000 unit after filtration sterilization, add 20 grams of mannitol and dissolve, regulate pH to neutral, inject water to 2000 milliliters, add sodium chloride and regulate isotonic, aseptic filtration, it is sub-packed in 1000 cillin bottles, aseptically lyophilization, to obtain final product.
Embodiment 2, prepare Ulinastatin injection
Take ulinastatin aqueous solution 100,000,000 unit after filtration sterilization, add 20 grams of mannitol and dissolve, regulate pH to neutral, inject water to 2000 milliliters, add sodium chloride and regulate isotonic, aseptic filtration, in 1000 cillin bottles of subpackage, to obtain final product.
Embodiment 3, prepare Ulinastatin injection
Take ulinastatin aqueous solution 100,000,000 unit after filtration sterilization, add 20 grams of glucoses and dissolve, regulate pH to neutral, inject water to 2000 milliliters, add sodium chloride and regulate isotonic, aseptic filtration, in 1000 cillin bottles of subpackage, to obtain final product.
Test example one, ulinastatin are on the prostatitic impact test of rat chronic
1, subjects: choosing 72 SPF level male SD rats, body weight is 280-300g, Guangdong Medical Lab Animal Center provide.
2, test material: the Ulinastatin injection of embodiment 2 preparation;Ceftriaxone sodium for injection, is purchased from Shandong Runze Pharmaceutical Co., Ltd., the quasi-word H20056554 of traditional Chinese medicines;XIAOZHILING ZHUSHEYE, is purchased from Shuanghe High-Tech. Natural Medicine Co., Ltd., Beijing and produces, lot number: 090808.
3, the foundation of chronic prostatitis animal model:
SD rat is randomly divided into 6 groups, often group 12, respectively matched group, model group, ceftriaxone sodium group, ulinastatin low dose group, dosage group and ulinastatin high dose group in ulinastatin.Except matched group, all the other each group SD rats are applied in abdominal part with suds and then shave except by hair with blade, 2nd starts modeling, after the chloral hydrate anesthesia of 3.5%, under aseptic condition, median abdominal incision rat is about 2-3cm, through abdominal cavity, it is proposed to bladder and both sides seminal vesicle, exposes the prostate notopodium invested inside seminal vesicle, bilateral is injected separately into 25% XIAOZHILING ZHUSHEYE 0.2ml, sews up the incision immediately.
4, test method:
Within the 4th day after modeling, starting administration, each group route of administration all adopts tail vein injection method, and the dosage of each group is as follows:
Matched group: inject isopyknic normal saline;
Model group: inject isopyknic normal saline;
Ceftriaxone sodium group: the ceftriaxone injection of injection 0.1g/kg;
Ulinastatin low dose group: inject the Ulinastatin injection of embodiment 2 preparation of 50000 units/kg;
Dosage group in ulinastatin: inject the Ulinastatin injection of embodiment 2 preparation of 150000 units/kg;
Ulinastatin high dose group: inject the Ulinastatin injection of embodiment 2 preparation of 300000 units/kg;
Injection 2 times, are for continuous 4 times 1 course for the treatment of, by rat weight after 2 courses for the treatment of weekly, put to death, take prostate, carry out Anatomical Observation, weigh prostate weight in wet base, calculate prostate index, measure prostate volume with drainage, and fix with the formalin solution of 10%, embedding, section (thickness 5 μm), H E dyes, and carries out histopathological examination under light microscopic.
5, result of the test
5.1, ulinastatin is as shown in table 1 on the impact of the prostate weight in wet base of chronic prostatitis rat, index and volume.
Table 1 ulinastatin test data to the prostate weight in wet base of chronic prostatitis rat, index and volume
Group | Prostate weight in wet base (g) | Prostate index (g/100g body weight) | Prostate volume (ml) |
Matched 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* |
Dosage group in ulinastatin | 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 all can significantly reduce the prostate weight in wet base of chronic prostatitis rat, volume and prostate index, having significant difference (p < 0.05) compared with model group, ulinastatin high dose group has extremely significant difference (p < 0.01) compared with model group.Ulinastatin high dose group is compared with injection ceftriaxone sodium group, prostate weight in wet base and the prostate index of chronic prostatitis rat can be reduced significantly, there is significant difference (p < 0.05), illustrate that chronic prostatitis is had significant therapeutic effect by ulinastatin provided by the invention.
5.2, prostata tissue pathological examination result is as shown in table 2.
Passing judgment on the grade scale of prostata tissue lesion degree, such as following table, progression is more high, and lesion tissue is more serious.
Table 2 chronic prostatitis histopathological examination result (n=12)
As shown in Table 2, compared with model group, the prostatitis tissue pathologic change degree of the low and middle dosage group of ulinastatin is between 0 grade and 1 grade, the prostata tissue pathological changes of ulinastatin high dose group is 0 grade, illustrate that ulinastatin provided by the invention can significantly improve the lesion tissue of chronic prostatitis, be more beneficial for the recovery of patients with chronic prostatitis.
Claims (5)
1. ulinastatin purposes in preparation treatment chronic prostatitis medicine.
2. purposes as claimed in claim 1, it is characterised in that described ulinastatin is lyophilized injectable powder, and described carrier is the one in glucose, sodium chloride, mannitol, lactose and gelatin hydrolysate or its any mixture.
3. purposes as claimed in claim 1, it is characterised in that described ulinastatin is injection, and described carrier is the one in water for injection, glucose, sodium chloride and mannitol or its any mixture.
4. purposes as claimed in claim 2, it is characterised in that described lyophilized injectable powder possibly together with mannitol, dextran, gelatin hydrolysate, sodium citrate or glycine as additive.
5. purposes as claimed in claim 3, it is characterised in that described injection possibly together with mannitol, sodium chloride or glucose as additive.
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Citations (4)
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---|---|---|---|---|
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 |
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- 2016-05-30 CN CN201610374709.7A patent/CN105770876B/en active Active
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
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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 |
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YOUKAIXIAN: "乌司他丁药理药效及相关药品简介", 《百度文库》 * |
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