CN104274404A - Compound doxycycline antibacterial medicine - Google Patents
Compound doxycycline antibacterial medicine Download PDFInfo
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- CN104274404A CN104274404A CN201410560755.7A CN201410560755A CN104274404A CN 104274404 A CN104274404 A CN 104274404A CN 201410560755 A CN201410560755 A CN 201410560755A CN 104274404 A CN104274404 A CN 104274404A
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Abstract
The invention belongs to the technical field of medicines, and provides a compound doxycycline antibacterial medicine. The effective component of the medicine prepared from astragalus membranaceus aqueous extract and doxycycline is an oil-in-water type nano-emulsion, and the nano-emulsion is prepared from the following components in parts by weight: 1-20 parts of an astragalus membranaceus aqueous extract, 15-40 parts of a surfactant, 1-20 parts of co-surfactant, 1-25 parts of doxycycline, 1-20 parts of oil and 20-70 parts of distilled water. The nano-emulsion has the advantages of uniformly distribution, transparent system, high stability, relatively low surface tension, excellent mobility and convenience in taking, can be quickly swallowed by reticuloendothelial cells after being administrated, so that the medicine can quickly take effect, constant plasma concentration and pharmacological effect can be maintained, the bioavailability of the medicine can be improved, the drug effect can be enhanced, the using amount and using frequency of the medicine can be reduced.
Description
Technical field
The invention belongs to medical art, be specifically related to a kind of compound recipe doxycycline antibacterials.
Background technology
Doxycycline, another name: doxycycline (Doxycycline), doxycycline, long-acting terramycin, is mainly used in treating responsive microbial respiratory tract, urinary tract and biliary tract infection.Antimicrobial spectrum is substantially identical with tetracycline, oxytetracycline, and the inside and outside antimicrbial power of body all comparatively tetracycline is strong.Microorganism has close cross resistance to this product and tetracycline, oxytetracycline etc.Oral absorption is good.Be mainly used in responsive gram positive bacteria and upper respiratory tract infection, tonsillitis, biliary tract infection, lymphadenitis, cellulitis, senile chronic bronchitis etc. caused by gram negative bacilli, be also used for the treatment of typhus fever, Qiang's parasitosis, mycoplasma pneumonia etc.Also can be used for treating cholera, or for preventing pernicious malaria and leptospiral infection.
Radix Astragali water extract is the water extract of the root of leguminous plant Radix Astagali, and be brown color or pale powder, effective ingredient is astragaloside and astragalus polysaccharides, has enhancing immunity, strengthens energy, resisting fatigue, mutation, protects the liver, suppresses the effect of osteoclast.Astragalus polysaccharides has blood fat reducing, namely reduces the effect of cholesterol and triglyceride, high density lipoprotein increasing; Can prevention and therapy cardiovascular and cerebrovascular disease, as atherosclerosis, coronary artery pathological changes, peripheral angiopathy and hyperlipemia etc.Astragaloside has the effect significantly reducing blood glucose, glycolated hemoglobin and urine protein, the AGEs in renal cortex and serum can be reduced, display astragaloside has antioxidation, and has inhibitory action to aldose reductase, suppresses proliferation of mesangial cells in addition, alleviates the effect of renal hypertrophy.In astragaloside, add suitable adjuvant, can be made into oral formulations, for prevention and therapy diabetic nephropathy.
At present, the use of doxycycline is comparatively general, and its common dosage forms has tablet, capsule etc.Although oral doxycycline can by gastrointestinal absorption, absorb not exclusively, and due to the dissolution rate of medicine slow, bioavailability is poor.And the effect of Radix Astragali water extract is comparatively slow, it is unsatisfactory to be used alone effect.
Summary of the invention
Object of the present invention aims to provide a kind of compound recipe doxycycline antibacterials.
Based on above-mentioned purpose, the present invention takes following technical scheme:
A kind of compound recipe doxycycline antibacterials, its effective ingredient is Radix Astragali water extract and doxycycline.
Preferably, compound recipe doxycycline antibacterials dosage form is oil-in-water type nano-emulsion.
Preferred further, nano-emulsion weight portion consists of: Radix Astragali water extract 1 ~ 20 part, 15 ~ 40 parts, surfactant, cosurfactant 1 ~ 20 part, doxycycline 1 ~ 25 part, oil 1 ~ 20 part, distilled water 20 ~ 70 parts.
Preferred further, the weight portion of above-mentioned nano-emulsion consists of: Radix Astragali water extract 1 ~ 12 part, 15 ~ 35 parts, surfactant, cosurfactant 1 ~ 12 part, doxycycline 1 ~ 18 part, oil 5 ~ 15 parts, distilled water 25 ~ 65 parts.
Preferred further, the weight portion of above-mentioned nano-emulsion consists of: Radix Astragali water extract 6.3 parts, 28 parts, surfactant, cosurfactant 4 parts, doxycycline 8.2 parts, oil 14 parts, distilled water 39.5 parts.
Preferably, surfactant be in polyoxyl 40 hydrogenated castor oil (RH40), castor oil polyoxyethylene ether 40 (EL40), Tween 80 or PLURONICS F87 any one or with the mixture of span80.
Preferably, cosurfactant is selected from ethanol, 1,2-PD, PEG400 and glycerol.
Preferably, grease separation is from soybean oil, cinnamic aldehyde, Ethyl formate, ethyl oleate, fatty glyceride, Oleum Ricini, Oleum Brassicae campestris, linoleic acid, ethyl n-butyrate., isopropyl myristate, ethyl acetate and oleic acid.
Preferred further, oil is isopropyl myristate.
Nano-emulsion of the present invention is obtained by following steps: get doxycycline, surfactant and cosurfactant, stir, then slowly instillation contains the aqueous solution of Radix Astragali water extract wherein, along with the increase of Radix Astragali water extract aqueous solution, system stickiness increases, when the amount adding Radix Astragali water extract aqueous solution makes system become oil-in-water type nano-emulsion from Water-In-Oil, system viscosity is thinning from the state of most thickness, and namely what now produce is water white compound recipe doxycycline antibacterials nano-emulsion.The present invention can be made into after making nano-emulsion oral liquid directly take, also can through encapsulated or through process such as lyophilized powder technology.
Radix Astragali water extract is the root extract of leguminous plant Radix Astagali, extracts by the following method: astragalus root is after cleaning, drying, pulverizing, 10 times of water gagings, ebuillition of heated extracts 2-3 time, each 1.5-3 hour, filter, merging filtrate, is condensed into extractum, leaves standstill after cooling, precipitate with ethanol, centrifugal disgorging, then remove protein, phlegmatic temperament constituents with mixed solvent, obtain Radix Astragali water extract.
Nano-emulsion (nanoemulsion) is also known as microemulsion (microemulsion), formed by water, oil, surfactant and cosurfactant etc. are spontaneous, particle diameter is Thermodynamically stable, the isotropism of 1 ~ 100nm, transparent or semitransparent homodisperse system.In general, nano-emulsion is divided into three types, i.e. oil-in-water type nano-emulsion (O/W), water-in-oil type nanoemulsion (W/O) and bicontinuous nano-emulsion (B.C).Nano-emulsion has the unrivaled advantage of other preparations many: 1. for isotropic transparency liquid, belongs to thermodynamically metastable fixed system, through pressure sterilizing or centrifugally can not make it layering; 2. technique is simple, and preparation process does not need special installation, can spontaneously be formed, and nano-emulsion particle diameter is generally 1 ~ 100nm; 3. viscosity is low, can reduce pain during injection; 4. there is slow release and targeting; 5. improve the dissolubility of medicine, reduce medicine enzymolysis in vivo, can be formed the protective effect of medicine and improve the absorption of gastrointestinal tract to medicine, improving the bioavailability of medicine.
The present invention adds bland cosurfactant except hydrotropy effect in medicine, cosurfactant is mainly in order to the hydrophile-lipophile balance value (HLB) of adjustment form surface-active agent, oil water interfacial tension is reduced further, increase profit and the rigidity of limitans, cosurfactant is incorporated in interfacial film, promote the formation of radius of curvature very membranelle, expand the newborn district area of nano-emulsion.
Compound recipe doxycycline nano-emulsion provided by the invention passes through oral administration, drastically increase the dissolubility of doxycycline, reduce medicine first pass effect in vivo, promote the gastrointestinal absorption of doxycycline, and novelty water soluble drug and fat-soluble medicine are organically combined, improve the treatment ability of medicine.Doxycycline is fat-soluble, and human body is to the transhipment of medicine and absorb extremely difficult, and nano-emulsion substrate provides good dissolving environment for doxycycline, can through Lymphatic time oral, overcomes first pass effect and molecule by barrier during gastrointestinal tract.By adding doxycycline, also improving the antibacterial ability of Radix Astragali water extract on the other hand, making antibacterial more stable, better effects if.
The present invention has the following advantages:
1. nanoemulsion medicine particle diameter of the present invention is between 20.3 ~ 55.5nm, and mean diameter is 38.4nm, is to add surfactant and cosurfactant in doxycycline, is titrated to even, transparent nano-emulsion system with the distilled water being dissolved with Radix Astragali water extract.
2. nano-emulsion of the present invention is evenly distributed, system is transparent, good stability, have lower surface tension, have good mobility, taking convenience.
3. engulfed by reticuloendothelial cell rapidly after nano-emulsion administration of the present invention, make medicine rapid-onset, and maintain constant blood drug level and pharmacodynamics effect, improve the bioavailability of medicine, enhancing drug effect, the consumption reducing medicine and access times.
4. simple, the efficacy stability of nano-emulsion preparation method of the present invention, power consumption are low.
Accompanying drawing explanation
Fig. 1 is the nano-emulsion transmission electron microscope photo of the embodiment of the present invention 7;
Fig. 2 is the nano-emulsion granularmetric analysis of the embodiment of the present invention 7.
Detailed description of the invention
Below in conjunction with specific embodiment, the present invention is described in further details:
embodiment 1
A kind of compound recipe doxycycline antibacterials, its dosage form is nano-emulsion, and the weight portion of nano-emulsion consists of: Radix Astragali water extract is 5.3 parts, castor oil polyoxyethylene ether 40(surfactant) 28 parts, ethanol (cosurfactant) 3 parts, doxycycline 7.2 parts, isopropyl myristate (oil) 14 parts, distilled water 42.5 parts.
Accurately take castor oil polyoxyethylene ether 40 28g, ethanol 3g, doxycycline 7.2g, isopropyl myristate 14g stirs under room temperature (25 DEG C) condition, then slowly instillation is dissolved with the distilled water of Radix Astragali water extract wherein, along with the increase of Radix Astragali water extract aqueous solution, system stickiness increases, when the amount adding Radix Astragali water extract aqueous solution makes system become oil-in-water type nano-emulsion from Water-In-Oil, system viscosity is thinning from the state of most thickness, namely what now produce is water white compound recipe doxycycline nano-emulsion, now add the amount 42.5g of water, Radix Astragali water extract is 5.3g.
embodiment 2
A kind of compound recipe doxycycline antibacterials, its dosage form is nano-emulsion, the weight portion of nano-emulsion consists of: Radix Astragali water extract is 6.8 parts, castor oil polyoxyethylene ether 40(surfactant) 25 parts, 1,2-PD (cosurfactant) 10 parts, doxycycline 4.5 parts, ethyl oleate (oil) 10 parts, distilled water 43.7 parts.
Its preparation method is with reference to embodiment 1.
embodiment 3
A kind of compound recipe doxycycline antibacterials, its dosage form is nano-emulsion, and the weight portion of nano-emulsion consists of: Radix Astragali water extract is 4.5 parts, polyoxyl 40 hydrogenated castor oil (surfactant) 30 parts, glycerol (cosurfactant) 11 parts, doxycycline 5.5 parts, linoleic acid (oil) 13 parts, distilled water 36 parts.
Its preparation method is with reference to embodiment 1.
embodiment 4
A kind of compound recipe doxycycline antibacterials, its dosage form is nano-emulsion, and the weight portion of nano-emulsion consists of: Radix Astragali water extract is 8.5 parts, polyoxyl 40 hydrogenated castor oil (surfactant) 25 parts, ethanol (cosurfactant) 5 parts, doxycycline 5 parts, ethyl n-butyrate. (oil) 11 parts, distilled water 56.5 parts.
Its preparation method is with reference to embodiment 1.
embodiment 5
A kind of compound recipe doxycycline antibacterials, its dosage form is nano-emulsion, and the weight portion of nano-emulsion consists of: Radix Astragali water extract is 5 parts, Tween 80 (surfactant) 28 parts, glycerol (cosurfactant) 4 parts, doxycycline 7 parts, oleic acid (oil) 15 parts, distilled water 41 parts.
Its preparation method is with reference to embodiment 1.
embodiment 6
A kind of compound recipe doxycycline antibacterials, its dosage form is nano-emulsion, and the weight portion of nano-emulsion consists of: Radix Astragali water extract is 7 parts, Tween 80 (surfactant) 25 parts, PEG400 (cosurfactant) 3 parts, doxycycline 7.5 parts, ethyl acetate (oil) 12 parts, distilled water 45.5 parts.
Its preparation method is with reference to embodiment 1.
embodiment 7
A kind of compound recipe doxycycline antibacterials, its dosage form is nano-emulsion, and the weight portion of nano-emulsion consists of: Radix Astragali water extract is 6.3 parts, PLURONICS F87 (surfactant) 28 parts, PEG400 (cosurfactant) 4 parts, doxycycline 8.2 parts, isopropyl myristate (oil) 14 parts, distilled water 39 parts.
Its preparation method is with reference to embodiment 1.
embodiment 8
A kind of compound recipe doxycycline antibacterials, its dosage form is nano-emulsion, and the weight portion of nano-emulsion consists of: Radix Astragali water extract is 1 part, PLURONICS F87 (surfactant) 15 parts, ethanol (cosurfactant) 5 parts, doxycycline 4 parts, Ethyl formate (oil) 8 parts, distilled water 67 parts.
Its preparation method is with reference to embodiment 1.
embodiment 9
A kind of compound recipe doxycycline antibacterials, its dosage form is nano-emulsion, and the weight portion of nano-emulsion consists of: Radix Astragali water extract is 20 parts, Tween 80 (surfactant) 27 parts, PEG400 (cosurfactant) 3 parts, doxycycline 4 parts, isopropyl myristate (oil) 5 parts, distilled water 41 parts.
Its preparation method is with reference to embodiment 1.
embodiment 10
A kind of compound recipe doxycycline antibacterials, its dosage form is nano-emulsion, and the weight portion of nano-emulsion consists of: Radix Astragali water extract is 12 parts, castor oil polyoxyethylene ether 40(surfactant) 35 parts, glycerol (cosurfactant) 1 part, doxycycline 1 part, linoleic acid (oil) 1 part, distilled water 50 parts.
Its preparation method is with reference to embodiment 1.
embodiment 11 test example
11.1 granularmetric analyses
Observe embodiment 1-10 sample under transmission electron microscope, find that drop is that class is spherical, good dispersion, without adhesion.Fig. 1 is the transmission electron microscope photo of the compound recipe doxycycline antibacterials nano-emulsion to embodiment 7, the sample of embodiment 7 detects through Malvern Particle Size Analyzer, testing result as shown in Figure 2, as can be seen from the figure, nano-emulsion particle diameter is mainly distributed between 20.3 ~ 55.5nm, and mean diameter is 38.4nm.
stability analysis
The nano-emulsion product of Example 1-10 carries out the stability that centrifugal test, photo-stability testing, temperature stability test etc. observe compound recipe doxycycline nano-emulsion of the present invention respectively, confirms whether the present invention has the wild effects such as layering, muddiness or crystal precipitation.
high speed centrifugation is tested
Get the sample for preparing in right amount in centrifuge tube, with centrifugal 10 min of the rotating speed of 15 000r/min, after centrifugal test, each embodiment sample is observed, find that each embodiment sample still keeps centrifugal front clear, have no the wild effects such as layering, muddiness or crystal precipitation.
photo-stability testing
The each embodiment sample prepared in right amount is loaded in water white transparency vial, sealing, be positioned over 10d under normal lighting conditions, observe respectively at 1d, 2d, 4d, 6d, 8d, 10d sampling.Result shows, in 10d viewing duration, each embodiment sample all keeps clear, has no the wild effects such as layering, muddiness or crystal precipitation.
temperature stability test
Get each embodiment sample, each embodiment sample divides three parts, loads in colourless transparent glass bottle, sealing, each point of sample is positioned over 4 DEG C, under room temperature (25 DEG C) and 40 DEG C of three kinds of temperature conditions, keeps sample and investigate 30d, every 5d sampling observation.Result shows, each embodiment sample all keeps clear under three kinds of temperature conditions, has no the wild effects such as layering, muddiness or crystal precipitation.
long-term stable experiment
Get each embodiment sample, each embodiment sample divides three parts, load in Brown Glass Brown glass bottles and jars only, sealing, be placed in (25 ± 2) DEG C, relative humidity (60 ± 5) % condition lower 12 months, sample respectively at when 0,3,6,9 and 12 months, investigate character and the changes of contents of nano-emulsion, based on the expiration date of drug measuring method of regression analysis, calculate the effect duration of compound recipe doxycycline nano-emulsion.Result of the test shows, under long term test condition, the outward appearance of compound recipe doxycycline nano-emulsion keeps clear and bright, homogeneous always, has no the phenomenons such as layering, complexion changed, flocculation and breakdown of emulsion; Radix Astragali water extract in system and doxycycline content extend in time and reduce gradually, the equation of linear regression that its content-time changing curve provides, and the effect duration calculating compound recipe doxycycline nano-emulsion is 33.15 months (with time short person for standard).
toxicity test
With commercially available Radix Astragali water extract tablet for contrast agents, acute toxicity test is carried out according to new drug nonphosphorylated neurofilament H method, repeated dose toxicity test, genetic toxicity test (comprising Ames test, Micronuclei In The Mouse Bone Marrow test, the test of In vitro culture mammalian cell chromosome mutation), reproductive toxicity test (General Reproductiv e Toxicity Assessment, sensitive period to teratogenic agent toxicity test, perinatal toxicity are tested), carcinogenic test, immunotoxicity test and Local irritation study, result of the test is as follows:
This product is to Mouse Acute Toxicity experiment conclusion: contrast with commercially available Radix Astragali water extract tablet, compound recipe doxycycline nano-emulsion does not occur measuring interior untoward reaction and death.
The Salmonella reversion test of product of the present invention, the result of the genetic toxicity test such as mouse inbred strain and testis chromosomal aberration test are feminine gender.
The result that rat 30d feeds product of the present invention shows: contrast with commercially available Radix Astragali water extract tablet, within experimental period, in the metering of compound recipe doxycycline nano-emulsion, each test group of animals growth promoter is good, the indexs such as body weight, food ration, routine blood test, blood biochemistry, organ coefficient are all within normal range, and histopathologic examination is no abnormality seen also.
This product long term toxicity test conclusion: contrast with commercially available Radix Astragali water extract tablet, within experimental period, in the metering of compound recipe doxycycline nano-emulsion, this medicine has no rat untoward reaction for three months at continuous gastric infusion, every Index for examination is all within normal range, and its main organs of pathologic finding and target organ are showed no the toxic pathological change that this guiding drug rises.
Claims (9)
1. compound recipe doxycycline antibacterials, is characterized in that, its effective ingredient is Radix Astragali water extract and doxycycline.
2. compound recipe doxycycline antibacterials according to claim 1, is characterized in that, the dosage form of described antibacterials is oil-in-water type nano-emulsion.
3. compound recipe doxycycline antibacterials according to claim 2, it is characterized in that, described nano-emulsion weight portion consists of: Radix Astragali water extract 1 ~ 20 part, 15 ~ 40 parts, surfactant, cosurfactant 1 ~ 20 part, doxycycline 1 ~ 25 part, oil 1 ~ 20 part, distilled water 20 ~ 70 parts.
4. compound recipe doxycycline antibacterials according to claim 3, it is characterized in that, described nano-emulsion weight portion consists of: Radix Astragali water extract 1 ~ 12 part, 15 ~ 35 parts, surfactant, cosurfactant 1 ~ 12 part, doxycycline 1 ~ 18 part, oil 5 ~ 15 parts, distilled water 25 ~ 65 parts.
5. compound recipe doxycycline antibacterials according to claim 4, it is characterized in that, described nano-emulsion weight portion consists of: Radix Astragali water extract 6.3 parts, 28 parts, surfactant, cosurfactant 4 parts, doxycycline 8.2 parts, oil 14 parts, distilled water 39.5 parts.
6. according to the arbitrary described compound recipe doxycycline antibacterials of claim 3-5, it is characterized in that, described surfactant be in polyoxyl 40 hydrogenated castor oil, castor oil polyoxyethylene ether 40, Tween 80 or PLURONICS F87 any one or with the mixture of span80.
7., according to the arbitrary described compound recipe doxycycline antibacterials of claim 3-5, it is characterized in that, described cosurfactant is selected from ethanol, 1,2-PD, PEG400 and glycerol.
8. according to the arbitrary described compound recipe doxycycline antibacterials of claim 3-5, it is characterized in that, described grease separation is from soybean oil, cinnamic aldehyde, Ethyl formate, ethyl oleate, fatty glyceride, Oleum Ricini, Oleum Brassicae campestris, linoleic acid, ethyl n-butyrate., isopropyl myristate, ethyl acetate and oleic acid.
9. compound recipe doxycycline antibacterials according to claim 8, is characterized in that, described oil is isopropyl myristate.
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| CN201410560755.7A CN104274404A (en) | 2014-10-21 | 2014-10-21 | Compound doxycycline antibacterial medicine |
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| CN201410560755.7A CN104274404A (en) | 2014-10-21 | 2014-10-21 | Compound doxycycline antibacterial medicine |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104940132A (en) * | 2015-06-05 | 2015-09-30 | 河南牧翔动物药业有限公司 | Berberine sulfate oral liquid and preparation method thereof |
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| CN102895245A (en) * | 2012-10-30 | 2013-01-30 | 河南牧翔动物药业有限公司 | Compound trimethoprim and doxycycline hydrochloride nanoemulsion preparation and preparation method thereof |
| CN103202846A (en) * | 2013-04-09 | 2013-07-17 | 黑龙江省汇丰动物保健品有限公司 | Veterinary enrofloxacin hydrochloride and doxycycline hydrochloride nano emulsion and preparation method thereof |
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- 2014-10-21 CN CN201410560755.7A patent/CN104274404A/en active Pending
Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN102144967A (en) * | 2010-04-23 | 2011-08-10 | 镇江威特药业有限责任公司 | Veterinary long-acting compound doxycycline injection and preparation method thereof |
| CN102895245A (en) * | 2012-10-30 | 2013-01-30 | 河南牧翔动物药业有限公司 | Compound trimethoprim and doxycycline hydrochloride nanoemulsion preparation and preparation method thereof |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| CN104940132A (en) * | 2015-06-05 | 2015-09-30 | 河南牧翔动物药业有限公司 | Berberine sulfate oral liquid and preparation method thereof |
| CN104940132B (en) * | 2015-06-05 | 2018-02-27 | 河南牧翔动物药业有限公司 | A kind of berberine sulfate oral liquid and preparation method thereof |
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Application publication date: 20150114 |