CN101612152A - A kind of pharmaceutical composition that contains pidotimod and preparation method thereof - Google Patents
A kind of pharmaceutical composition that contains pidotimod and preparation method thereof Download PDFInfo
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- CN101612152A CN101612152A CN200810115387A CN200810115387A CN101612152A CN 101612152 A CN101612152 A CN 101612152A CN 200810115387 A CN200810115387 A CN 200810115387A CN 200810115387 A CN200810115387 A CN 200810115387A CN 101612152 A CN101612152 A CN 101612152A
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- pidotimod
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- antibacterials
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Abstract
The present invention is the compositions that is formed by pidotimod and any one antibacterials for a kind of pharmaceutical composition that contains pidotimod and preparation method thereof.Wherein antibacterials are beta-lactam (comprising penicillins, cephalo-type and atypia beta-lactam), aminoglycosides, polymyxins, Macrolide, lincomycin class, vancomycin, Tetracyclines, chloromycetin, the synthetic antimicrobial drug (comprises sulfonamides, quinolones, furans), in antifungal agent and the antiviral agents any one.The unit formulation consumption of pidotimod is 0.1-2g, preferred 0.4-0.8g.And the pharmaceutical dosage of antibacterials will be decided according to the dosage range of itself.The compositions of pidotimod and antibacterials both can directly be killed pathogenic bacterium from exogenous aspect by antibacterials, can transfer endogenous anti-infectious immunity ability by immunopotentiating agent again and strengthen anti-infectious function, had good synergism.
Description
Technical field
The present invention relates to a kind of pharmaceutical composition that contains pidotimod and preparation method thereof, belong to medical technical field.
Background technology
Pidotimod is an immunopotentiating agent, can promote nonspecific immune reaction to promote specific immune response again.Pidotimod can promote the activate the phagocytic capacity of macrophage and neutrophilic granulocyte, improves its chemotaxis; Activate natural killer cell; The former lymphopoiesis that causes of mitosis promoting, the helper T lymphocyte that reduces when making immunologic hypofunction (CD4+) raise with suppressor T lymphocyte (CD8+) ratio and recover normal; By stimulating interleukin-2 and gamma interferon to promote cell immune response.Although all showing pidotimod, zoopery and clinical experiment do not have directly antibiotic and antiviral activity; But by can bring into play the curative effect that significant treatment antibacterial (streptococcus pneumoniae, escherichia coli, bacillus pyocyaneus, Bacillus proteus etc.) fungus and virus (influenza virus, herpes simplex virus, myocarditis virus and mengo virus etc.) infect to the promotion of body's immunity.Can be used for last lower respiratory infection, otitis media, urinary system infection and gynecological infection that the downtrod patient of cellular immune function shows effect repeatedly.In order to reduce the number of times of acute attack, shorten the course of disease, alleviate the degree of outbreak; Antibiotic adjuvant drug when this product also can be used as actute infection.
Antibacterials refer to have killing or suppress a class medicine of microorganism that it comprises antibiotic and some chemical synthetic drugs, is a clinical scope of application big quasi drugs extensive, various in style, can treat by the infectious disease due to antibacterial, fungus, the virus etc.Chemical constitution and biological activity according to medicine, antibacterials are divided into following ten classes usually: beta-lactam (comprising penicillin, cephalo-type), aminoglycosides, Macrolide, polypeptide class, the lincomycin class, Tetracyclines, chloromycetin, the synthetic antimicrobial drug (comprises sulfonamides, quinolones, furans), antifungal agent and antiviral agents.Antibacterials mainly play a role by following approach: suppress cell wall synthetic, the permeability that increases cytoplasmic membrane, suppress nucleic acid synthetic, suppress the DNA of bacteria gyrase and suppress to rely on DNA the RNA polymerase, suppress synthetic and Profilin matter synthetic etc. of folic acid.
Immunopotentiating agent is the material that a class can improve autospecific immunity and nonspecific immune reaction, these materials can strengthen the organism antiviral, antibacterial, fungus and parasitic infection ability, use some responsive antimicrobial drugs if unite again, then both can directly kill pathogenic bacterium from exogenous aspect by antibacterials, can transfer endogenous anti-infectious immunity ability by immunopotentiating agent again and strengthen anti-infectious function, has good synergism, the scope of application is wider, clinical each section common bacterial infects 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.Present immunopotentiating agent pidotimod is widespread usage clinically, the clinician can adopt the in addition pidotimod therapeutic alliance again of suitable antibacterials according to the strain of patient infection, but, and bring a lot of discomforts to the patient often because the grasp of the dosage of use in conjunction is inaccurate.Use if the two is made compound preparation, will bring great convenience, improve the effective percentage of infectious disease treatment simultaneously to clinical practice with the proportioning of science.
Summary of the invention
The present invention is a kind of pharmaceutical composition that contains pidotimod, is to be the compositions that active component and pharmaceutically acceptable carrier form by pidotimod and any one antibacterials, and wherein the unit formulation consumption of pidotimod is 0.1-2g, preferred 0.4-0.8g.And the pharmaceutical dosage of antibacterials will be decided according to the dosage range of itself.
Described antibacterials can be selected from following any: beta-lactam (comprising penicillins, cephalo-type and atypia beta-lactam), aminoglycosides, polymyxins, Macrolide, lincomycin class, vancomycin, Tetracyclines, chloromycetin, the synthetic antimicrobial drug (comprises sulfonamides, quinolones, furans), in antifungal agent and the antiviral agents any one.Be preferably penicillins, cephalosporins, aminoglycosides, Tetracyclines, macrolide, quinolones, sulfonamides etc.Preferred in its penicillins, penicillin V, cloxacillin, amoxicillin, ampicillin, carboxylic Bian XiLin.Its cephalosporin apoplexy due to endogenous wind is preferred, cefalexin, cefaclor, ceftazidime, cefepime.Its Aminoglycoside apoplexy due to endogenous wind is preferred, streptomycin, gentamycin.Preferred in its Tetracyclines, tetracycline, oxytetracycline.Its macrocyclic lactone apoplexy due to endogenous wind is preferred, erythromycin, Roxithromycin.Preferred in its quinolones, ciprofloxacin, lomefloxacin.Preferred in its sulfonamides, sulfadiazine, sulfamethoxazole.
The present invention does not comprise following compositions: the special opinion of pidotimod+cephalo peopentyl ester, pidotimod+azithromycin, pidotimod+Moxifloxacin, pidotimod+prulifloxacin, pidotimod+levofloxacin compositions, pidotimod+Wannailuowei hydrochloride.
Arbitrary compositions of the present invention all can be made into compound oral administration preparation (comprising tablet, dispersible tablet, capsule, granule etc.) or injection.The compositions of pidotimod and antibacterials both can directly be killed pathogenic bacterium from exogenous aspect by antibacterials, can transfer endogenous anti-infectious immunity ability by immunopotentiating agent again and strengthen anti-infectious function, had good synergism.
The specific embodiment
Come the composite preparation of pidotimod of the present invention and any antibacterials done further specifying by following example, but be not limited in following example.
Embodiment 1 pidotimod and cloxacillin tablet
Prescription:
Preparation method:
Pidotimod, microcrystalline Cellulose are crossed 80 mesh sieves respectively, mix homogeneously, standby; It is an amount of that other gets 50% alcoholic solution, adds cloxacillin and make dissolving, and as binding agent system soft material, 24 mesh sieves are granulated with this solution, 50 ℃ of dryings, and 20 mesh sieve granulate add micropowder silica gel, CMS-Na, adopt suitable punch die compressed tablets behind the mix homogeneously, promptly.
If carry out coating for above-mentioned tablet, then obtain coated tablet, can be Film coated tablets, enteric coatel tablets etc.
In aforesaid operations, should note lucifuge.
Embodiment 2: pidotimod and roxithromycin capsules agent
Prescription:
Preparation method:
Pidotimod is all crossed 80 mesh sieves, behind the starch mix homogeneously, standby; It is an amount of that other gets 50% alcoholic solution, adds Roxithromycin and make dissolving, and as binding agent system soft material, 24 mesh sieves are granulated with this solution, 50 ℃ of dryings, and 20 mesh sieve granulate add magnesium stearate, mix homogeneously, packing, promptly.
Used capsule shells can be conventional capsule, also can be enteric coated capsule.
Above step should strict lucifuge be handled.
Embodiment 3: pidotimod and cefaclor soft capsule
Prescription:
Preparation method:
Cefaclor, pidotimod are dissolved among the PEG 400, add propylene glycol, stir, regulate content weight, compacting gets final product.
Embodiment 4: pidotimod and lomefloxacin drop pill
Prescription
Preparation method:
PEG 6000, stearic acid mix homogeneously post-heating to about 80 ℃, are made it complete fusion, add pidotimod, lomefloxacin, make it to melt, 80 ℃ of insulations, coolant are-5 ℃ of dimethicones, regulate the water dropper size, control the heavily about 210mg of every drop pill, drip system, filter, drying gets final product.
Embodiment 5: pidotimod and sulfamethoxazole oral cavity disintegration tablet
Prescription
Preparation method:
Pidotimod is crossed 80 mesh sieves, with xylitol, microcrystalline Cellulose mix homogeneously, standby; It is an amount of that other gets 50% alcoholic solution, adds sulfamethoxazole and make dissolving, and as binding agent system soft material, 24 mesh sieves are granulated with this solution, 50 ℃ of dryings, and 20 mesh sieve granulate, with aspartame, flavoring orange essence, PPVP mix homogeneously, tabletting gets final product.
Embodiment 6: pidotimod and penicillin V injection
Prescription
Preparation method:
Trometamol, sodium sulfite are dissolved in about 12000ml water for injection, add pidotimod, stir to make and dissolve fully; Other gets the about 5000ml of water for injection, adds penicillin V and makes it dissolving fully; Two liquid merge, and mix homogeneously adds 60 ℃ of absorption of 0.1% activated carbon adsorption 30min,, the 0.22um filtering with microporous membrane, fill, every 20ml, autoclaving, promptly.
Embodiment 7: pidotimod and mecobalamin lyophilized injectable powder
Prescription
Preparation method:
Trometamol, sodium sulfite, mannitol are dissolved in about 6000ml water for injection, add pidotimod, stir to make and dissolve fully; Other gets the about 2000ml of water for injection, adds ciprofloxacin and makes it dissolving fully; Two liquid merge, and mix homogeneously adds 60 ℃ of absorption of 0.1% activated carbon adsorption 30min,, the 0.22um filtering with microporous membrane, fill, every 10ml, medicinal liquid places freeze drying box, freezing 3～6 hours, makes temperature drop to one 35～-75 ℃; Distilled 6～18 hours for the first time, temperature rises to about-5 ℃; Distilled 2～8 hours for the second time, temperature rises to 25～50 ℃, takes out behind the vacuum gland, promptly.
Embodiment 8 evaluation of clinical curative effect
Below each test will further specify the curative effect of its compositions:
Test 1: erythromycin+pidotimod composition
Purpose: select erythromycin+pidotimod composition and erythromycin for treating sensitive organism pneumonia infection for use, and the controlled observation that carries out curative effect and untoward reaction.Method: select pneumonia patient 80 examples.Be divided into two groups at random, 40 examples adopt erythromycin+pidotimod composition, and are oral, and 600mg/ time, 3 times on the one, logotype 14 days; 40 examples adopt erythromycin, and are oral, and 300mg/ time, 3 times on the one, logotype 14 days.With the state of an illness and the variation of observed and recorded symptom, sign and the untoward reaction day by day in the course of treatment before the treatment of appropriate cards record patient, and before and after treatment, make relevant lab testing and take the photograph X line rabat, press curative effect judging standard relatively two groups curative effect and untoward reaction.The result: the cure rate (90%) of erythromycin+pidotimod composition group is apparently higher than erythromycin group (56.8%) (X
2=3.85, P＜0.05); Symptom, sign disappear very fast (P all＜0.05); And untoward reaction is obviously less, is 15%: 52.5% (X
2=12.58, P＜0.01).Conclusion: erythromycin+pidotimod composition treatment pneumonia good effect, short treating period, usage is easy, and untoward reaction is few, is worthy to be popularized.
Test 2: ampicillin+pidotimod composition
Purpose: safety and the effectiveness of estimating ampicillin+pidotimod composition and ampicillin capsule for treating respiratory tract and skin soft-tissue infection. method: use double blinding dual analog contrast method at random, treatment acute upper respiratory tract infection, skin soft-tissue infection.Ampicillin+pidotimod composition group, oral, 600mg/ time, 3 times on the one, the ampicillin group, oral, 300mg/ time, 3 times on the one, be 7～14 days the course of treatment.. the result: selected altogether qualified case 141 examples, ampicillin+pidotimod composition group 73 examples wherein, cure rate and effective percentage are respectively 81.2% and 91.8%; Matched group, ampicillin Capsules group 68 examples, cure rate and effective percentage are respectively 70.6% and 81.1%; Rate of adverse reactions ampicillin+pidotimod composition group is that 6.2% ampicillin Capsules group is 7.6%, and treatment group and matched group clinical efficacy and adverse effect all have significant difference, and the treatment group is more evident in efficacy than matched group.Conclusion: ampicillin+pidotimod composition is safer, the effective antibacterials of common acute bacterial respiratory tract infection of treatment and skin soft-tissue infection.
Test 3. ciprofloxacins+pidotimod composition
Purpose: estimate curative effect and safety that ciprofloxacin+pidotimod composition and ciprofloxacin contrast the treatment of urinary tract bacterial infection at random.Method: with the ciprofloxacin is contrast, adopts randomization open trial method, viewing test medicine ciprofloxacin+pidotimod composition group 61 examples, contrast medicine ciprofloxacin group 60 examples.The treatment group: oral, 800mg/ time, 2 times/day, matched group: oral, 400mg/ time, 2 days/time, be 14 days the course of treatment.The result: the clinical recovery rate of ciprofloxacin+pidotimod composition and ciprofloxacin treatment urinary system infection is respectively 90.2% and 81.3%, and effective percentage is respectively 96.1% and 85.0%, and bacteria clearance is respectively 94.3% and 82.2%.Learn check by statistics, above-mentioned two groups of result differences have significance (P＜0.05), and treatment group curative effect is better than matched group.Find from the 103 strain pathogenic bacterium drug sensitive test interpretations of result that are separated to, 93 strains (90.3%) pathogenic bacterium are to ciprofloxacin+pidotimod composition sensitivity, 81 strains (78.6%) pathogenic bacterium are to the ciprofloxacin sensitivity, and learning the difference of handling two groups by statistics has significance (0.021).Two medicine adverse reaction rates are respectively. (4.8%) with, (7.7%).Conclusion: ciprofloxacin+pidotimod composition is safely and effectively to the treatment of most gram positive bacterias, negative microbial urinary tract infection.
Claims (10)
1. the present invention is a kind of pharmaceutical composition that contains pidotimod, it is characterized in that: be to be the compositions that active component and pharmaceutically acceptable carrier form by pidotimod and any one antibacterials, wherein the unit formulation consumption of pidotimod is 0.1-2g, preferred 0.4-0.8g.
2. the described compositions of claim 1, it is characterized in that: its antibacterials are: beta-lactam (comprising penicillins, cephalo-type and atypia beta-lactam), aminoglycosides, polymyxins, Macrolide, the lincomycin class, vancomycin, Tetracyclines, chloromycetin, the synthetic antimicrobial drug (comprises sulfonamides, quinolones, furans), in antifungal agent and the antiviral agents any one.Be preferably in penicillins, cephalosporins, aminoglycosides, Tetracyclines, macrolide, quinolones, the sulfonamides any one.
3. the described compositions of claim 2 is characterized in that: preferred in its penicillins, and penicillin V, cloxacillin, amoxicillin, ampicillin, carboxylic Bian XiLin.
4. the described compositions of claim 2, it is characterized in that: its cephalosporin apoplexy due to endogenous wind is preferred, cefalexin, cefaclor, ceftazidime, cefepime.
5. the described compositions of claim 2, it is characterized in that: its Aminoglycoside apoplexy due to endogenous wind is preferred, streptomycin, gentamycin.
6. the described compositions of claim 2 is characterized in that: preferred in its Tetracyclines, and tetracycline, oxytetracycline.
7. the described compositions of claim 2, it is characterized in that: its macrocyclic lactone apoplexy due to endogenous wind is preferred, erythromycin, Roxithromycin.
8. the described compositions of claim 2 is characterized in that: preferred in its quinolones, and ciprofloxacin, lomefloxacin.
9. the described compositions of claim 2 is characterized in that: preferred in its sulfonamides, and sulfadiazine, sulfamethoxazole.
10. the described arbitrary compositions of claim 1～9 can be made into compound oral administration preparation (comprising tablet, dispersible tablet, capsule, granule) or injection.
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| Application Number | Priority Date | Filing Date | Title |
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| CN200810115387A CN101612152A (en) | 2008-06-23 | 2008-06-23 | A kind of pharmaceutical composition that contains pidotimod and preparation method thereof |
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| CN200810115387A CN101612152A (en) | 2008-06-23 | 2008-06-23 | A kind of pharmaceutical composition that contains pidotimod and preparation method thereof |
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Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101843580A (en) * | 2010-05-24 | 2010-09-29 | 南京威尔曼药物研究所 | Preparation method of pidotimod injection preparation |
| CN103127019A (en) * | 2013-03-22 | 2013-06-05 | 成都乾坤动物药业有限公司 | Florfenicol dispersible tablet as well as preparation method and application thereof |
| 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 |
| CN106580894A (en) * | 2016-11-28 | 2017-04-26 | 浙江仙琚制药股份有限公司 | Pidotimod orally disintegrating tablet and preparation method thereof |
| CN107137362A (en) * | 2017-05-25 | 2017-09-08 | 北京万鹏朗格医药科技有限公司 | A kind of injection Pidotimod lyophilized formulations and preparation method thereof |
-
2008
- 2008-06-23 CN CN200810115387A patent/CN101612152A/en active Pending
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101843580A (en) * | 2010-05-24 | 2010-09-29 | 南京威尔曼药物研究所 | Preparation method of pidotimod injection preparation |
| CN103127019A (en) * | 2013-03-22 | 2013-06-05 | 成都乾坤动物药业有限公司 | Florfenicol dispersible tablet as well as preparation method and application thereof |
| CN103127019B (en) * | 2013-03-22 | 2015-04-22 | 成都乾坤动物药业有限公司 | Florfenicol dispersible tablet as well as preparation method and application thereof |
| 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 |
| CN106580894A (en) * | 2016-11-28 | 2017-04-26 | 浙江仙琚制药股份有限公司 | Pidotimod orally disintegrating tablet and preparation method thereof |
| CN107137362A (en) * | 2017-05-25 | 2017-09-08 | 北京万鹏朗格医药科技有限公司 | A kind of injection Pidotimod lyophilized formulations and preparation method thereof |
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Open date: 20091230 |