CN105832730A - Cloxacillin sodium and clotrimazole composition and application thereof to biological medicines - Google Patents
Cloxacillin sodium and clotrimazole composition and application thereof to biological medicines Download PDFInfo
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- CN105832730A CN105832730A CN201610326712.1A CN201610326712A CN105832730A CN 105832730 A CN105832730 A CN 105832730A CN 201610326712 A CN201610326712 A CN 201610326712A CN 105832730 A CN105832730 A CN 105832730A
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- Prior art keywords
- clotrimazole
- cloxacillin sodium
- group
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- cloxacillin
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/425—Thiazoles
- A61K31/429—Thiazoles condensed with heterocyclic ring systems
- A61K31/43—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems
- A61K31/431—Compounds containing 4-thia-1-azabicyclo [3.2.0] heptane ring systems, i.e. compounds containing a ring system of the formula, e.g. penicillins, penems containing further heterocyclic rings, e.g. ticarcillin, azlocillin, oxacillin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4174—Arylalkylimidazoles, e.g. oxymetazolin, naphazoline, miconazole
Abstract
The invention discloses a cloxacillin sodium and clotrimazole composition and application thereof to biological medicines. The composition comprises cloxacillin sodium and clotrimazole, and the ratio of the weight part of cloxacillin sodium to the weight part of clotrimazole is (6-8):1. The composition comprises two clinically frequently-used chemical medicines including cloxacillin sodium and clotrimazole. It is shown through research that when cloxacillin sodium and clotrimazole are used in cooperation and meet a certain weight part ratio, the composition has an excellent treatment effect on the myocardial fibrosis caused by renal vascular hypertension and the acute lung injury and can be developed into medicines for treating the myocardial fibrosis caused by renal vascular hypertension and the acute lung injury.
Description
Technical field
The invention belongs to biomedicine field, relate to the old medicine newly use of Cloxacillin Sodium and clotrimazole, be specifically related to Cloxacillin Sodium
With the pharmaceutical composition of the clotrimazole new application in terms of medicine.
Background technology
Cloxacillin Sodium is semisynthetic penicillin, has acidproof, the feature of penicillin resistant enzyme, to GPC and Neisseria
Belong to and have antibacterial activity, staphylococcus (including staphylococcus aureus and CN-S) is produced the antibacterial of enzyme strain
Activity relatively OXA is strong, but is weak, to first to penicillin-susceptible staphylococcus and various streptococcic antibacterial action compared with penicillin
Oxygen XiLin resistant Staphylococcus species is invalid.
Clotrimazole is broad-spectrum antifungal medicine, multiple fungi especially Candida albicans is had preferable antibacterial action, its mechanism of action
It is the synthesis of suppression fungal cell membrane, and affects its metabolic process.
At present, there is not yet Cloxacillin Sodium or clotrimazole and renovascular hypertension and cause the relevant of myocardial fibrosis and ALI
Property report, this area research still belongs to blank.
Summary of the invention
It is an object of the invention to provide a kind of Cloxacillin Sodium and the pharmaceutical composition of clotrimazole and this pharmaceutical composition in treatment
Renovascular hypertension causes the new application in terms of myocardial fibrosis and ALI.
The above-mentioned purpose of the present invention is achieved by techniques below scheme:
A kind of pharmaceutical composition, comprises Cloxacillin Sodium and the weight of clotrimazole in Cloxacillin Sodium and clotrimazole, and said composition
The ratio of part is 6~8:1.
Further, described pharmaceutical composition comprise in Cloxacillin Sodium and clotrimazole, and said composition Cloxacillin Sodium and gram
The weight ratio of mould azoles is 7:1.
Further, described pharmaceutical composition comprise in Cloxacillin Sodium and clotrimazole, and said composition Cloxacillin Sodium and gram
The weight ratio of mould azoles is 6:1.
Further, described pharmaceutical composition comprise in Cloxacillin Sodium and clotrimazole, and said composition Cloxacillin Sodium and gram
The weight ratio of mould azoles is 8:1.
Aforementioned pharmaceutical compositions application in preparation treatment renovascular hypertension causes the medicine of myocardial fibrosis.
A kind of pharmaceutical preparation causing myocardial fibrosis for treating renovascular hypertension, including above-mentioned pharmaceutical composition, also wraps
Include pharmaceutically acceptable pharmaceutic adjuvant or carrier.
Further, described preparation is tablet, oral liquid, parenteral solution, aseptic powder injection, capsule or granule.
Aforementioned pharmaceutical compositions application in the medicine of preparation treatment ALI.
A kind of pharmaceutical preparation for treating ALI, including above-mentioned pharmaceutical composition, also includes pharmaceutically can accepting
Pharmaceutic adjuvant or carrier.
Further, described preparation is tablet, oral liquid, parenteral solution, aseptic powder injection, capsule or granule.
Advantages of the present invention:
Cloxacillin Sodium and the pharmaceutical composition of clotrimazole that the present invention provides contain the chemicals Cloxacillin that two kinds of clinics are conventional
Sodium and clotrimazole, present invention research shows: Cloxacillin Sodium and clotrimazole synergy and when meeting certain weight ratio,
Renovascular hypertension is caused myocardial fibrosis and ALI has excellent therapeutic action, treatment Renal vascular can be developed into
Property hypertension cause myocardial fibrosis and the medicine of ALI.
Detailed description of the invention
Further illustrate the essentiality content of the present invention below in conjunction with embodiment, but do not limit scope with this.To the greatest extent
The present invention is explained in detail by pipe with reference to preferred embodiment, it will be understood by those within the art that, can be to the present invention
Technical scheme modify or equivalent, without deviating from the spirit and scope of technical solution of the present invention.In following embodiment,
The ratio of Cloxacillin Sodium and clotrimazole is weight ratio.
Embodiment 1: renovascular hypertension is caused the therapeutic action of myocardial fibrosis
1, materials and methods
1.1 animal
Normal male SD rat (Traditional Chinese Medicine University Of Guangzhou's Experimental Animal Center provides), body weight 90~120g.
1.2 reagent and sample
Cloxacillin Sodium and clotrimazole are purchased from Nat'l Pharmaceutical & Biological Products Control Institute.Captopril: Changzhou pharmaceutical factory.
Prepared by 1.3 rat packets and model
Use classical arteria renalis clamp method.If postoperative blood pressure is more than 3 preoperative standard deviations and higher than 115mmHg, the most really
Cover half type is set up.Sham-operation group is only dissociated the arteria renalis, does not put silver brain clip.Renovascular hypertension in rats (RHR) is divided at random
Be 8 groups: sham-operation group, model control group, positive controls (captopril, 10mg/100g), Cloxacillin Sodium and gram
Mould azoles 7:1 group (20mg/100g), Cloxacillin Sodium and clotrimazole 6:1 group (20mg/100g), Cloxacillin Sodium and gram mould
Azoles 8:1 group (20mg/100g), Cloxacillin Sodium and clotrimazole 5:1 group (20mg/100g), Cloxacillin Sodium and clotrimazole
9:1 group (20mg/100g).Started in postoperative 5th week to be administered, continued treatment 8 weeks, put to death animal.Model control group: note
Penetrate with water 2ml/100g body weight gavage, every day 1 time.Other drug group: medicine body weight gavage, every day 1 time.Sham-operation group:
In addition to not pressing from both sides the arteria renalis, all identical with model group.
The measurement of 1.4 blood pressures
Using tail sleeve method, blood pressure instrument is rat computer blood pressure heart rate instrument (RBP-1 rat blood pressure instrument, China-Japan Friendship Hospital develops).
When the morning 9, measure the tail systolic arterial pressure under rat waking state, tie-in 3 times, average.
1.5 left ventricular mass (LVW), Left ventricular massindex (LVI=left ventricular mass/body weight) measure
Rat weight at the end of experiment, sacrificed by decapitation, take out heart, 4 DEG C of precooling normal saline flushing blood stains, filter paper blots weighs.
Removal atrium and big blood vessel at atrioventricular junction, remove right ventricular free wall, separates left ventricle and weighs, in this, as LVW,
And calculate LVW/BW.Putting in liquid nitrogen freezing immediately after ,-70 DEG C of preservations are to be measured.
1.6 collagen concentrations (Coll)
Nanjing is used to build up the hydroxyproline testing cassete mensuration Myocardial hydroxyproline concentration that Bioengineering Research Institute provides.Calculate hydroxyl dried meat
Histidine content, is then multiplied by 8.2, calculates collagen concentration.
1.7 statistical method
Experimental data mean ± standard deviation (x ± s) represents, application SPSS18.0 version statistical software carry out one-way analysis of variance and
T checks, statistically significant for difference with P < 0.05.
2, experimental result
2.1 impacts on renovascular hypertension (RHR) rat model Left ventricular massindex LVI
Comparing with Normal group, the Left ventricular massindex LVI of model control group rat raises;Compare with model control group,
Positive drug group, Cloxacillin Sodium and clotrimazole 7:1 group, 6:1 group and 8:1 group rat left ventricle ponderal index LVI significantly reduce (P
< 0.01 or P < 0.05);Comparing with model control group, Cloxacillin Sodium and clotrimazole 5:1 group, 9:1 group are without notable change (P
> 0.05).Result of the test is shown in Table 1.
2.2 impacts on renovascular hypertension rat model collagen level
Comparing with Normal group, the collagen level of model control group rat raises (P < 0.05).Compare with model control group,
Positive drug group, Cloxacillin Sodium and clotrimazole 7:1 group, 6:1 group and 8:1 group anti-rat collagen level significantly reduce (P < 0.01 or P
< 0.05);Comparing with model control group, Cloxacillin Sodium and clotrimazole 5:1 group, Cloxacillin Sodium and clotrimazole 9:1 group are without aobvious
Write change (P > 0.05).Result of the test is shown in Table 1.
Table 1 is on renovascular hypertension rat model Left ventricular massindex LVI and the impact of collagen (coll) level
Group | LVI(mg/g) | coll(mg/g.wet.wt) |
Sham-operation group | 1.81±0.32 | 2.21±0.32 |
Model control group | 2.42±0.28 | 2.62±0.67 |
Positive controls | 1.83±0.25 | 2.08±0.38 |
Cloxacillin Sodium and clotrimazole 6:1 group | 2.11±0.17 | 2.22±0.44 |
Cloxacillin Sodium and clotrimazole 8:1 group | 2.01±0.21 | 2.26±0.26 |
Cloxacillin Sodium and clotrimazole 7:1 group | 1.83±0.33 | 2.02±0.15 |
Cloxacillin Sodium and clotrimazole 5:1 group | 2.40±0.28 | 2.58±0.67 |
Cloxacillin Sodium and clotrimazole 9:1 group | 2.41±0.24 | 2.59±0.63 |
The principal cardiac pathological change that hypertension causes refers not only to the hypertrophy of cardiac muscle cell, but also includes myocardial fibrosis (MF)
With the structural change of coronary microvascular, research shows: thus cause cardiac dysfunction, piles up with Myocardial collagen network, interstitial weight
Build, form MF relevant.Modern study shows: RHR is the most typical animal model of research myocardial fibrosis.After surgery 4
The cardiac muscle performance in reactive fibreization of week RHR, then shows for 12 weeks after surgery in reparative fibrosis.
Result shows, can intervene by reducing the effect of collagen concentration when Cloxacillin Sodium and clotrimazole weight part ratio 6~8:1
The myocardial fibrosis of renovascular hypertension rat model, can be developed into treatment renovascular hypertension and causes the medicine of myocardial fibrosis.
Embodiment 2: the therapeutic action to ALI
1, materials and methods
1.1 animal
Healthy male cleaning grade SD rat, body weight 320-370g is selected (to be provided by Nanjing Military Command's hospital general's animal experimental center).
Animal feeding temperature (22 ± 1) DEG C, relative humidity 55%~65%, 12h periodicity of illumination aeration-drying environment in, use big
Mouse maintains material 1022 raising.
1.2 reagent and sample
Cloxacillin Sodium and clotrimazole are purchased from Nat'l Pharmaceutical & Biological Products Control Institute.Rat tumor necrosis factor-alpha (TNF-α), white
Cytokine-6 (IL-6), interleukin 10 (IL-10), enzyme linked immunosorbent assay (ELISA) detection kit is purchased from
Biosource International company of the U.S.;Rat HMGB1ELISA detection kit is purchased from Shino-Test company of Japan
Product.HMGB1 i.e. High mobility group box-1.
Prepared by 1.3 rat packets and model
Using cecal legation perforation method (CLP) to set up septicopyemia model, pre-operative anxiety 12h, with urethane (1250mg/kg)
Lumbar injection dosage is anaesthetized, and does the otch of a 2cm length along abdomen median line, enters abdomen and find caecum, blind with the ligation of 4-0 silk thread annular
Intestines root, a little to extruding ight soil after wearing 1 time at free-end with 18G syringe needle, send abdominal cavity back to, the most successively peritoneal suture and skin
Skin.Sham group is only cut open the belly, separates distal ileum, is closed abdomen operation.The postoperative physiological saline 1mL of hypodermic injection immediately supplements art
Middle fluid loss.Rat is randomly divided into 7 groups, often group 10, respectively sham-operation group (Sham group), model control group (CLP
Group), Cloxacillin Sodium and clotrimazole 7:1 group (20mg/100g), Cloxacillin Sodium and clotrimazole 6:1 group (20mg/100g),
Cloxacillin Sodium and clotrimazole 8:1 group (20mg/100g), Cloxacillin Sodium and clotrimazole 5:1 group (20mg/100g), chlorine
Azoles XiLin sodium and clotrimazole 9:1 group (20mg/100g).CLP+ medicine group is instant and 6h pneumoretroperitoneum injection drug respectively after CLP
Thing;Sham group is after sham-operation after instant and 6h, CLP group 0 and 6h abdominal cavity injecting normal saline 1mL respectively after CLP.
1.4 Testing index and method
Each treated animal all after CLP 24h take femoral vein blood 2mL, take serum-80 DEG C preservation after centrifugal 10min.Use ELISA
TNF-α, the level of HMGB1 and IL-10 in method detection serum.Additionally, detection lung tissue dry-wet weight ratios (W/D) after CLP 24h,
Activity of myeloperoxidase (MPO).
1.5 statistical method
Using SPSS19.0 statistical software to carry out statistical analysis, measurement data represents with mean ± standard deviation (x ± s), compares between many groups
Relatively using one-way analysis of variance, P < 0.05 is that difference is statistically significant.
2, experimental result
2.1 on septicopyemia rat TNF-α, the impact of HMGB1 and IL-10 level
Comparing with Sham group, CLP substantially increases Plasma TNF-α, HMGB1 and IL-10 level.Compare with model control group,
Cloxacillin Sodium and clotrimazole 7:1 group, 6:1 group and 8:1 group Plasma TNF-α, HMGB1 and IL-10 level substantially reduce (P
< 0.01 or P < 0.05);Compare with model control group, Cloxacillin Sodium and clotrimazole 5:1 group, 9:1 group Plasma TNF-α,
HMGB1 and IL-10 level is without notable change (P > 0.05).Result see table.
2.2 on septicopyemia lung tissue of rats W/D and the impact of MPO activity
Comparing with Sham group, CLP substantially increases lung tissue W/D and MPO activity, (P < 0.05).With model control group
Relatively, Cloxacillin Sodium and clotrimazole 7:1 group, 6:1 group and 8:1 group lung tissue W/D and MPO activity substantially reduce (P <
0.01 or P < 0.05);Compare with model control group, Cloxacillin Sodium and clotrimazole 5:1 group, Cloxacillin Sodium and clotrimazole 9:1
Group is without notable change (P > 0.05).Result see table.
The above results shows, can significantly reduce the lung that septicopyemia causes when Cloxacillin Sodium and clotrimazole weight part ratio 6~8:1
Damage, can develop into the medicine for the treatment of ALI.
Embodiment 3: the preparation of tablet
Prepare the composition of Cloxacillin Sodium and clotrimazole, and utilize organic acid such as tartaric acid or citric acid or formic acid or second two
The salt that acid etc., inorganic acid example hydrochloric acid or sulfuric acid or phosphoric acid are made, conventional ratio adds excipient pelletizing press sheet.
Embodiment 4: the preparation of oral liquid
Prepare the composition of Cloxacillin Sodium and clotrimazole, and utilize organic acid such as tartaric acid or citric acid or formic acid or second two
The salt that acid etc., inorganic acid example hydrochloric acid or sulfuric acid or phosphoric acid are made, oral liquid preparation method makes oral liquid routinely.
Embodiment 5: the preparation of parenteral solution
Prepare the composition of Cloxacillin Sodium and clotrimazole, and utilize organic acid such as tartaric acid or citric acid or formic acid or second two
The salt that acid etc., inorganic acid example hydrochloric acid or sulfuric acid or phosphoric acid are made, injects routinely and uses water, and essence filter, injection is made in embedding sterilizing
Liquid.Research finds, pH scope is when 6.2~6.4, and in accelerated test and long term test, parenteral solution remains clarification.PH is low
During in 6.2 or higher than 6.4, long-term March precipitation occurs under normal temperature condition, and shaking cannot be redissolved.
Embodiment 6: the preparation of aseptic powder injection
Prepare the composition of Cloxacillin Sodium and clotrimazole, and utilize organic acid such as tartaric acid or citric acid or formic acid or second two
The salt that acid etc., inorganic acid example hydrochloric acid or sulfuric acid or phosphoric acid are made, is dissolved in sterile water for injection, and stirring makes molten, with aseptic
Suction funnel filters, more aseptic essence filter, is sub-packed in ampoule, and after frozen drying, aseptic sealing by fusing obtains powder-injection.
Embodiment 7: capsule or the preparation of granule
Prepare the composition of Cloxacillin Sodium and clotrimazole, and utilize organic acid such as tartaric acid or citric acid or formic acid or second two
The salt that acid etc., inorganic acid example hydrochloric acid or sulfuric acid or phosphoric acid are made, ratio adds excipient routinely, makes capsule or granule.
The effect of above-described embodiment indicates that the essentiality content of the present invention, but does not limit protection scope of the present invention with this.
It will be understood by those within the art that, technical scheme can be modified or equivalent, and not take off
Essence and protection domain from technical solution of the present invention.
Claims (10)
1. a pharmaceutical composition, it is characterised in that: comprise Cloxacillin Sodium in Cloxacillin Sodium and clotrimazole, and said composition
It is 6~8:1 with the weight ratio of clotrimazole.
Pharmaceutical composition the most according to claim 1, it is characterised in that: comprise Cloxacillin Sodium and clotrimazole, and this group
In compound, the weight ratio of Cloxacillin Sodium and clotrimazole is 7:1.
Pharmaceutical composition the most according to claim 1, it is characterised in that: comprise Cloxacillin Sodium and clotrimazole, and this group
In compound, the weight ratio of Cloxacillin Sodium and clotrimazole is 6:1.
Pharmaceutical composition the most according to claim 1, it is characterised in that: comprise Cloxacillin Sodium and clotrimazole, and this group
In compound, the weight ratio of Cloxacillin Sodium and clotrimazole is 8:1.
5. the arbitrary described pharmaceutical composition of Claims 1 to 4 causes the medicine of myocardial fibrosis at preparation treatment renovascular hypertension
In application.
6. the pharmaceutical preparation causing myocardial fibrosis for treating renovascular hypertension, it is characterised in that: include claim
1~4 arbitrary described pharmaceutical compositions, also include pharmaceutically acceptable pharmaceutic adjuvant or carrier.
Pharmaceutical preparation the most according to claim 6, it is characterised in that: described preparation be tablet, oral liquid, parenteral solution,
Aseptic powder injection, capsule or granule.
8. Claims 1 to 4 arbitrary described pharmaceutical composition application in the medicine of preparation treatment ALI.
9. the pharmaceutical preparation being used for treating ALI, it is characterised in that: include the arbitrary described medicine of Claims 1 to 4
Compositions, also includes pharmaceutically acceptable pharmaceutic adjuvant or carrier.
Pharmaceutical preparation the most according to claim 9, it is characterised in that: described preparation be tablet, oral liquid, parenteral solution,
Aseptic powder injection, capsule or granule.
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