CN1562341A - Left ofloxacin and Pidotimod compound preparation - Google Patents
Left ofloxacin and Pidotimod compound preparation Download PDFInfo
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- CN1562341A CN1562341A CN 200410006239 CN200410006239A CN1562341A CN 1562341 A CN1562341 A CN 1562341A CN 200410006239 CN200410006239 CN 200410006239 CN 200410006239 A CN200410006239 A CN 200410006239A CN 1562341 A CN1562341 A CN 1562341A
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- 229960001163 pidotimod Drugs 0.000 title claims description 18
- 238000002360 preparation method Methods 0.000 title claims description 17
- -1 Pidotimod compound Chemical class 0.000 title claims description 10
- GSDSWSVVBLHKDQ-UHFFFAOYSA-N 9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid Chemical compound FC1=CC(C(C(C(O)=O)=C2)=O)=C3N2C(C)COC3=C1N1CCN(C)CC1 GSDSWSVVBLHKDQ-UHFFFAOYSA-N 0.000 title description 3
- 229960001699 ofloxacin Drugs 0.000 title description 3
- GSDSWSVVBLHKDQ-JTQLQIEISA-N Levofloxacin Chemical compound C([C@@H](N1C2=C(C(C(C(O)=O)=C1)=O)C=C1F)C)OC2=C1N1CCN(C)CC1 GSDSWSVVBLHKDQ-JTQLQIEISA-N 0.000 claims description 17
- 229960003376 levofloxacin Drugs 0.000 claims description 17
- UUTKICFRNVKFRG-WDSKDSINSA-N (4R)-3-[oxo-[(2S)-5-oxo-2-pyrrolidinyl]methyl]-4-thiazolidinecarboxylic acid Chemical compound OC(=O)[C@@H]1CSCN1C(=O)[C@H]1NC(=O)CC1 UUTKICFRNVKFRG-WDSKDSINSA-N 0.000 claims description 8
- 150000001875 compounds Chemical class 0.000 abstract description 8
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- 230000036039 immunity Effects 0.000 abstract description 6
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- 208000035143 Bacterial infection Diseases 0.000 description 5
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- 206010011224 Cough Diseases 0.000 description 4
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- 230000009798 acute exacerbation Effects 0.000 description 4
- 229940088710 antibiotic agent Drugs 0.000 description 4
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- 206010006458 Bronchitis chronic Diseases 0.000 description 3
- 239000003242 anti bacterial agent Substances 0.000 description 3
- 230000003115 biocidal effect Effects 0.000 description 3
- 208000007451 chronic bronchitis Diseases 0.000 description 3
- 238000000034 method Methods 0.000 description 3
- 230000002265 prevention Effects 0.000 description 3
- 208000000059 Dyspnea Diseases 0.000 description 2
- 206010013975 Dyspnoeas Diseases 0.000 description 2
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- 230000009471 action Effects 0.000 description 2
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- 208000020446 Cardiac disease Diseases 0.000 description 1
- 241000606153 Chlamydia trachomatis Species 0.000 description 1
- 208000035473 Communicable disease Diseases 0.000 description 1
- 108010054814 DNA Gyrase Proteins 0.000 description 1
- 206010061977 Genital infection female Diseases 0.000 description 1
- 206010058467 Lung neoplasm malignant Diseases 0.000 description 1
- 241000588653 Neisseria Species 0.000 description 1
- 206010034133 Pathogen resistance Diseases 0.000 description 1
- 210000000662 T-lymphocyte subset Anatomy 0.000 description 1
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- 230000010534 mechanism of action Effects 0.000 description 1
- 230000004060 metabolic process Effects 0.000 description 1
- 230000011278 mitosis Effects 0.000 description 1
- 210000000822 natural killer cell Anatomy 0.000 description 1
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- 229940071462 oralone Drugs 0.000 description 1
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- 201000007094 prostatitis Diseases 0.000 description 1
- 238000009613 pulmonary function test Methods 0.000 description 1
- LISFMEBWQUVKPJ-UHFFFAOYSA-N quinolin-2-ol Chemical compound C1=CC=C2NC(=O)C=CC2=C1 LISFMEBWQUVKPJ-UHFFFAOYSA-N 0.000 description 1
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- 230000001225 therapeutic effect Effects 0.000 description 1
- 230000002992 thymic effect Effects 0.000 description 1
- 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 description 1
- 210000001519 tissue Anatomy 0.000 description 1
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- 238000002562 urinalysis Methods 0.000 description 1
- 210000001635 urinary tract Anatomy 0.000 description 1
- 229960005486 vaccine Drugs 0.000 description 1
- 230000003519 ventilatory effect Effects 0.000 description 1
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- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
A compound medicine for exogenously killing pathogenic bacteria and endogenously improving immunity to treat bacterium-infections diseases is prepared from levoofloxacin and Piduomode.
Description
Technical field
The present invention relates to a kind of levofloxacin and pidotimod compound preparation, be used for the treatment of bacterial infection disease.
Background technology
Infectious disease is the problem that generally runs in the clinical position, and wherein about 80% infection all is by bacterial in the adult, relates to the outpatient service and the hospitalization patient of each clinical department.The directed toward bacteria sexuality is dyed clinical topmost means and is to use various antibiotic, makes the antibiotics product become the staple product of medical production field.But in recent years,, make the clinician in the process of treatment bacterial infection disease along with the antibiotics resistance problem is more serious, face still that a lot of complexity, intractable infection and repeatability infect etc. the puzzlement of problem.Because the cycle and the cost of exploitation antibiotics continue to increase, it is also unrealistic to search out the stronger antibiotic of renewal in a short time simultaneously.The immunology progress shows, the low problem of this class patient ubiquity self anti-infectious immunity level, the simple thorough removing that relies on exogenous antimicrobial drug to be not enough to reach fully pathogenic bacterium, and stay inducibly resistant hidden danger easily, if the strategy that can take therapeutic alliance to infect particularly utilizes suitable immunotherapy medicaments, by improving patient self anti-infectious immunity level, transferring body endogenous anti-infection ability, should be the best thinking of treatment bacterial infection.
Summary of the invention
The object of the present invention is to provide and a kind ofly can kill bacteria can regulate the compound preparation of patient's immunity again.
Technical solution of the present invention is: a kind of levofloxacin and pidotimod compound preparation, and it consists of:
Levofloxacin: 100-600mg
Pidotimod: 200-1600mg.
Principle of the present invention is as follows:
Levofloxacin is the laevoisomer form of ofloxacin, and its mechanism of action is to suppress the DNA gyrase, thereby synthesizing of blocking dna do not have significant difference between its MIC and the MBC, illustrates that it is a bactericidal antibiotic, and its antibacterial action is 2 times of ofloxacin.Representative as third generation quinolone antimicrobial, because antimicrobial spectrum is extensive, Gram-positive, negative bacterium all there is good antibacterial action, be applicable to diseases such as urethritis due to infection such as light, moderate respiratory system, urinary system, digestive system, skin soft tissue and the department of stomatology, department of otorhinolaryngology, ophthalmology, department of dermatologry and gonococcus, the chlamydia trachomatis, cervicitis, have wide applications.And because less, the determined curative effect of its side effect, moderate cost are well received, economical, societal benefits are remarkable, occupy the prostatitis that domestic antibacterials are used.
Pidotimod, commodity by name ten thousand are suitable peaceful, are a kind of immunomodulators of full chemosynthesis, and it can promote nonspecific immune reaction to promote specific immune response again.Can strengthen the activate the phagocytic capacity of macrophage and neutrophilic granulocyte, improve its chemotaxis; Activate natural killer cell; The former lymphopoiesis that causes of mitosis promoting, when making immunologic hypofunction the unbalance recovery of t lymphocyte subset group normal, be applicable to the treatment and the prevention of multiple infection such as lower respiratory tract, urinary system, gynecological infection.The clinical practice that exceedes 10 years abroad shows that with the antimicrobial drug use in conjunction acute exacerbation of bacterial infection being treated and recurred prevention has remarkable result.Can be used for the immune drug of anti-infective therapy with domestic existing other, compare as thymosin (comprising extrasin alpha, thymic peptide-5), vaccine, Chinese herbal medicine etc., ten thousand suitable rather have that constituent structure is clear and definite, purity is high, peroral dosage form is preserved, is portably used conveniently, safety is outstanding, untoward reaction is few, and produce effects is rapidly lasting, have advantages such as treatment and prevention dual function.
These two kinds of medicines adopt compound preparation treatment bacterial infection, except that the advantage that is had separately, also have following characteristics:
1. the scope of application is wider, and clinical each section common bacterial infects under the situation of treatment by rule of thumb, all can bring into play antibacterial action, can also control viral simultaneously and other see the generation of infecting due to the pathogen very much.
2. pharmacokinetics is close, and peak time (1-2 hour) and elimination half-life (4-5 hour) are approaching, all can extensively be distributed to each tissue, body fluid after the absorption.There is not the interaction between medicine in both, all drain through urinary tract in the original shape mode, and internal metabolism is few, no cumulative action, and safety is good.
3. pidotimod is with strong points to the castering action of whole body anti-infectious immunity system, and onset is rapid, can play a role in 3 to 5 days, cooperates the concordance that goes up mutually when having with levofloxacin in therapeutic process, satisfies the needs of clinical actute infection treatment.
4. the compound preparation treatment can be shortened the course of treatment and reduce recurrence, has drug effect economics advantage, also helps to reduce the bacterial resistance odds.
The specific embodiment:
A kind of levofloxacin of the present invention and pidotimod compound preparation, it consists of:
Levofloxacin: 100-600mg
Pidotimod: 200-1600mg
According to above-mentioned composition, add pharmaceutically acceptable additives again, make tablet form, oral one day twice, using 7 to 15 days continuously was a course of treatment.
Embodiment sees the following form:
Table 1 embodiment
Further specify beneficial effect of the present invention below by the curative effect report.
Levofloxacin and the treatment of pidotimod compound preparation are chronic
The clinical efficacy report of bronchitis acute exacerbation
[purpose] observation levofloxacin and pidotimod compound preparation are to the clinical efficacy of chronic bronchitis acute exacerbation
[method]
1. case is selected: 52 examples meet the patient of acute episode of chronic bronchitis diagnostic criteria, selected condition comprises previously annual morbidity repeatedly, with cough, expectoration or the symptom of panting, there are clear and definite X line and pulmonary function test index to change, have acute attack fervescence and blood abnormal features mutually.Selected patient got rid of the age greater than 70 years old, and serious ventilatory function obstacle (FEVI＜50% predicted value) is arranged, and merged pulmonary carcinoma, diabetes, bronchiectasis, severe cardiac disease of ZANG-organs etc.Wherein male 31 examples, women 21 examples, 58.5 years old mean age.All cases are divided into treatment group and matched group at random, and two groups of patient ages, sex and state of an illness are learned check p＞0.05 by statistics, have comparability.
2. Therapeutic Method: the treatment group gives levofloxacin and pidotimod compound preparation (compound preparation contains levofloxacin 200mg, pidotimod 800mg), and Bid is oral, continuous 15 days; Matched group gives levofloxacin, and 200mg Bid is oral, continuous 15 days.Two groups symptomatic treatment measure is identical
3. observation index: all patients examine and write down clinical process and assessment untoward reaction, clinical symptoms such as the body temperature before the record treatment, when one week of treatment and drug withdrawal, cough, expectoration difficulty.Detect neutrophilic granulocyte phagocytic index and phagocytic percentage, blood, routine urinalysis, hepatic and renal function when reaching drug withdrawal before the treatment.
4. statistical procedures: the enumeration data X 2 test, measurement data is checked with t, and p＜0.05 is as the standard that the significance,statistical meaning is arranged.
[result]
1. two groups of patient front and back cardinal symptoms change, and treatment group and matched group have significant difference (p＜0.05)
Cough situation of change before and after table 2 liang group patient's the treatment
| Treatment group (n=33) | Matched group (n=19) | ||||||
| Before the treatment (n) | Treat the 7th day (n) | Treat the 15th day (n) | Before the treatment (n) | Treat the 7th day (n) | Treat the 15th day (n) | ||
| Scoring | ??0 | 0 | 18 | 25 | 0 | 8 | 11 |
| ??1 | 7 | 11 | 7 | 1 | 5 | 6 | |
| ??2 | 21 | 3 | 1 | 15 | 4 | 2 | |
| ??3 | 5 | 1 | 3 | 2 | |||
Expectoration difficulty improvement situation before and after table 3 liang group patient's the treatment
| Treatment group (n=33) | Matched group (n=19) | ||||||
| Before the treatment (n) | Treat the 7th day (n) | Treat the 15th day (n) | Before the treatment (n) | Treat the 7th day (n) | Treat the 15th day (n) | ||
| Scoring | ??0 | 2 | 9 | ??25 | ??0 | ??4 | 11 |
| ??1 | 12 | 20 | ??5 | ??5 | ??9 | 5 | |
| ??2 | 16 | 4 | ??3 | ??13 | ??6 | 3 | |
| ??3 | 3 | ??1 | |||||
Dyspnea improves situation before and after table 4 liang group patient's the treatment
| Treatment group (n=33) | Matched group (n=19) | ||||||
| Before the treatment (n) | Treat the 7th day (n) | Treat the 15th day (n) | Before the treatment (n) | Treat the 7th day (n) | Treat the 15th day (n) | ||
| Scoring | ??0 | 7 | ??15 | 26 | 3 | 6 | ??13 |
| ??1 | 20 | ??16 | 7 | 10 | 11 | ??5 | |
| ??2 | 6 | ??2 | 0 | 6 | 2 | ??1 | |
2. two groups of patient treatment front and back lab index change
Peripheral blood leucocyte counting before and after the table 5 liang group patient
Improve situation with neutrophilic granulocyte percentage ratio
| Treatment group (n=33) | Matched group (n=19) | |||
| Before the treatment (X ± SD) | Treat the 15th day (X ± SD) | Before the treatment (X ± SD) | Treat the 15th day (X ± SD) | |
| Peripheral blood leucocyte counting (* 10 9) | ??8.2±3.9 | ??6.2±2.0 | ??8.2±2.7 | ??5.7±1.0 |
| Neutrophilic granulocyte percentage ratio (%) | ??66.2±11.2 | ??60.6± ????11.3 | ??76.0± ????10.8 | ??62.3± ????11.7 |
Neutrophilic granulocyte phagocytic index before and after the table 6 liang group patient
With neutrophilic granulocyte phagocytic percentage situation
| Treatment group (n=33) | Matched group (n=19) | |||
| Before the treatment (X ± SD) | Treat the 15th day (X ± SD) | Before the treatment (X ± SD) | Treat the 15th day (X ± SD) | |
| The neutrophilic granulocyte phagocytic index | ??0.95± ????0.47 | ??1.28±0.61 | ??1.41± ????0.43 | ??1.37± ????0.40 |
| Neutrophilic granulocyte phagocytic percentage (%) | ??43.47± ????15.55 | ??54.40± ????16.26 | ??54.47± ????6.69 | ??52.70± ????9.58 |
[conclusion]
By discovering, through 15 days treatment, two groups of patients' treatment finally all can obtain comparatively satisfied effect.But levofloxacin and pidotimod compound preparation treatment group can obviously be improved the symptom of chronic bronchitis acute exacerbation phase in a short time, as cough, expectoration difficulty and dyspnea, embodied significantly in average the 7th day and take a turn for the better, on average last till to have significant difference (p＜0.05) on the 10th day with contrast treatment group, illustrate that compound preparation has the effect of shortening the course of treatment.Simultaneously compare notable difference is also arranged on lab index for two groups, treatment group amynologic index improves more remarkable, particularly to the functions of neutrophils effect of being significantly improved, this also conforms to the pharmacological action of pidotimod composition in the compound preparation, proves that the raising of curative effect improves relevant with immune indexes really.Studies show that compound preparation was both directly killed pathogenic bacterium by levofloxacin from exogenous aspect, transfer endogenous anti-infectious immunity ability by pidotimod again and strengthen anti-infectious function to have the obvious synergistic effect, can be used for clinical anti-infective therapy.
Claims (1)
1, a kind of levofloxacin and pidotimod compound preparation is characterized in that it consists of:
Levofloxacin: 100-600mg
Pidotimod: 200-1600mg.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410006239 CN1232300C (en) | 2004-03-17 | 2004-03-17 | Left ofloxacin and Pidotimod compound preparation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200410006239 CN1232300C (en) | 2004-03-17 | 2004-03-17 | Left ofloxacin and Pidotimod compound preparation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1562341A true CN1562341A (en) | 2005-01-12 |
| CN1232300C CN1232300C (en) | 2005-12-21 |
Family
ID=34477641
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN 200410006239 Expired - Fee Related CN1232300C (en) | 2004-03-17 | 2004-03-17 | Left ofloxacin and Pidotimod compound preparation |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN1232300C (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100434076C (en) * | 2006-05-16 | 2008-11-19 | 邓文峰 | Compounding prepn. contg. cefteram pivoxil and pidotimod |
| CN104474526A (en) * | 2014-11-21 | 2015-04-01 | 成都乾坤动物药业有限公司 | Pharmaceutical composition for treating or/and preventing pet viral diseases and preparation method thereof |
-
2004
- 2004-03-17 CN CN 200410006239 patent/CN1232300C/en not_active Expired - Fee Related
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN100434076C (en) * | 2006-05-16 | 2008-11-19 | 邓文峰 | Compounding prepn. contg. cefteram pivoxil and pidotimod |
| CN104474526A (en) * | 2014-11-21 | 2015-04-01 | 成都乾坤动物药业有限公司 | Pharmaceutical composition for treating or/and preventing pet viral diseases and preparation method thereof |
Also Published As
| Publication number | Publication date |
|---|---|
| CN1232300C (en) | 2005-12-21 |
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Owner name: HAN ZHIQIANG Free format text: FORMER OWNER: TAIYANGSHI (TANGSHAN) PHARMACEUTICAL CO. LTD. Effective date: 20060324 |
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Assignee: Taiyangshi (Tangshan) Pharm Ind Co., Ltd. Assignor: Han Zhiqiang Contract fulfillment period: 2007.09.05 to 2024.01.16 Contract record no.: 2007990000066 Denomination of invention: A kind of compound preparation of levofloxacin and pidotimod Granted publication date: 20051221 License type: Exclusive license Record date: 20071012 |
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Assignee: Taiyangshi (Tangshan) Pharm Ind Co., Ltd. Assignor: Han Zhiqiang Contract fulfillment period: 2009.10.20 to 2014.10.19 Contract record no.: 2009990001300 Denomination of invention: A compound preparation of levofloxacin and Pi do Maude Granted publication date: 20051221 License type: General permission Record date: 20091130 Assignee: Taiyangshi (Tangshan) Pharm Ind Co., Ltd. Assignor: Han Zhiqiang Contract fulfillment period: 2009.12.16 to 2026.5.30 Contract record no.: 2009990001331 Denomination of invention: A compound preparation of levofloxacin and Pi do Maude Granted publication date: 20051221 License type: Exclusive license Record date: 20091217 |
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