CN103494929A - Houttuynia cordata injectable in situ gel as well as preparation method thereof - Google Patents
Houttuynia cordata injectable in situ gel as well as preparation method thereof Download PDFInfo
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Abstract
The invention belongs to the field of animal pharmaceutical preparations, and relates to houttuynia cordata injectable in situ gel as well as a preparation method thereof. The in situ gel comprises the following components in parts by weight: 40.0-75.0 parts of fresh Houttuynia cordata distillate, 16.5-29.5 parts of poloxamer 407 (P407), 0.5-11.5 parts of poloxamer 188 (P188), 0.02-11.0 parts of a high molecular retardant, 0.1-10.0 parts of a solubilizing stabilizer and 0.01-3.0 parts of a preservative. The obtained preparation per milliliter is equivalent to 6.0-10.0g of a fresh product of a crude drug. The preparation provided by the invention is a liquid freely flowing at room temperature, forms a semisolid gel after being given by intramuscular injection or subcutaneous injection, and can continuously and stably release drugs, so that the in situ gel is just given once in a course of treatment. The in situ gel has the advantages of simple preparation, stable property, convenient administration, definite curative effect, strong animal adaptability and the like. The preparation provided by the invention has wide pharmacological effects such as antibacterial effect, antivirus effect, anti-inflammatory effect and immunoregulation, and is applicable to preventing and treating diseases of animals such as pigs, cattle, sheep, dogs and cats.
Description
Technical field
The invention belongs to the medicine for animal formulation art, relate to a kind of situ-gel and preparation method thereof for houttuynia injection with suitable phase transition temperature.
Technical background
Herba Houttuyniae belongs to the antipyretic and antidotal type Chinese herbal medicine, containing the various active composition, and as volatile oils such as capric acid acetaldehyde, myrcenes, the flavonoids such as quercitrin, rutin, the organic acids such as Palmic acid, Aristolochic Acid, also have water soluble polysaccharide, sterols, cordarine and inorganic salt etc.Modern pharmacology studies have shown that, the pharmacological action widely such as that Herba Houttuyniae has is antibiotic, antiviral, antiinflammatory, enhancing immunity and diuresis, hemostasis, calmness, analgesia.
Studies show that, Herba Houttuyniae has obvious inhibitory action to staphylococcus aureus, hemophilus influenza, micrococcus catarrhalis, Diplococcus pneumoniae, Candida albicans etc., and escherichia coli, dysentery bacterium, Bacillus typhi are also had to stronger inhibitory action.Herba Houttuyniae to effects such as Asia A type virus, influenza virus, hemorrhagic fever viruss significantly.Herba Houttuyniae can strengthen leukocytic phagocytic activity, and the Promote immunity globulin generates, and significantly improves the ratio of periphery blood T lymphocyte, participates in adjusting the neutrophilic granulocyte oxidizing process, improves the neutrophilic granulocyte fungicidal effectiveness.Herba Houttuyniae has stronger antiinflammatory action, can significantly suppress the inflammatory mediators such as PGB, SRS-A discharges, reduce the early stage blood capillary of inflammation hyperfunction, swelling due to inhibition Oleum Tiglii, dimethylbenzene etc., capillary permeability increase, can also obviously reduce the release of the inflammatory cytokines such as TNF-α, IL-1 β, hinder the expansion of cascade of response of inflammation.
Herba Houttuyniae is extensive use in livestock and poultry disease control and prevention.The feed additive of doing as usual, can obviously reduce the generation of pig lung plague, influenza and typhoid fever etc.; Bright careless Direct-fed can be prevented and treated piglet pujos blancos; The diseases such as houttuyfonate injection swine paratyphoid, influenza, asthma, high fever syndrome, pulmonary infection and sow urinary system infection, successful.Herba Houttuyniae can be used for preventing and treating puckery and urinary tract infection of enteritis, gastritis, bacillary dysentery, leptospirosis, hematuria, the urine of cattle and sheep etc., and to the cattle chronic metritis, goat chronic cervicitis, pelvic inflammatory disease etc. also have good curative effect.House pet is clinical, its control canine distemper commonly used, canine viral pneumonia etc.
Product forms for animals and the specification of Herba Houttuyniae approved have: 1. Herba Houttuyniae injectio, and specification: 2mL is equivalent to crude drug in whole 4g, and 5mL is equivalent to crude drug in whole 10g, and 10mL is equivalent to crude drug in whole 20g, and 50mL is equivalent to crude drug in whole 100g; 2. Herba Houttuyniae end; 9. the Herba Ephedrae Herba Houttuyniae is loose.
The reported dosage form of Herba Houttuyniae still has: tablet, buccal tablet, granule, superfine powder, spray, decoct, eye drop, nasal drop etc.Have no the report of houttuynia injection by the situ-gel dosage form.
Oneself disclosed relevant dosage form patent of Herba Houttuyniae has: the microemulsion injection of Herba Houttuyniae oil enteric coated capsule, compound houttuynia cordata capsule, Herba Houttuyniae Chinese medicine decoction, compound Houttuynia cordata mixture, FUFANG YUXINGCAO DIWAN, houttuynia cordata freeze-dried powder needle for injections, Herba Houttuyniae extract, compound houttuynin lotion, cordate houttuynia eye drops, heartleaf houttuynia herb extract feed additive, be used for the treatment of the compound Houttuynia cordata injection of canine paratyphoid etc.Have no report and the publication of houttuynia injection with situ-gel.
Injection-type situ-gel (injectable in situ gel) is by medicine and polymer dissolution or is suspended in suitable solvent, local subcutaneous injection or intramuscular injection, polymer gelling and form semisolid or solid drugs storage storehouse under the medicine-feeding part physiological condition.Medicine slowly discharges along with the continuous corrosion of gel, degraded, and follow the universal law that medicine spreads, dissolves from gel, there is the release cycle that extends, reduce administration number of times and reduce the advantage such as adverse effect, overcome the shortcoming of emulsion, liposome, microsphere and micelle, the misery of avoiding implant to operate on while implanting.The injection-type situ-gel is according to its gelling mechanism, divide thermosensitive in situ gel, ion-sensitive gel, the responsive gel of pH etc., wherein, only mat variations in temperature and gelling of thermosensitive in situ gel, can be more widely applicable for the numerous tissues of health, organ or tract, and other all need specific physiological condition or extrinsic factor to trigger gelling.
After temperature sensitive type in-situ gel (thermosensitive in situ gel) refers to that macromolecular material is with the liquid condition administration, at agents area, thermal stimulus is produced to response, the reversible conversion of dispersity or conformation occurs, and forms the drug depot gel of semi-solid.Mainly with poloxamer, be host material, wherein ripe with poloxamer188 (P407) and PLURONICS F87 (P188) research application.Certain density P407 aqueous solution has the solidifying character of special reverse hot glue, is liquid during low temperature, become gel after being elevated to uniform temperature, and the gelation temperature of solution increases and reduces with P407 concentration in system.Add P188 in system, can improve the gelation temperature of solution, adjust ratio and the concentration of P407 and P188, can obtain desirable gelation temperature; Coordinate again suitable macromolecule blocker, adjust viscosity, mechanical strength and the corrosion speed of system solution, can reach suitable drug release time again.It is low that the injection temperature sensing in situ gel rubber that the poloxamer of take is matrix composition has toxicity, zest is little, good biocompatibility, the advantage that external rheological charactristics is good, its prepare simple, easy to use, the mucous membrane tissue affinity is strong, the holdup time is long, in pharmaceutical preparation, being widely used, is the study hotspot in sustained-release preparation field in recent years.
In the animal diseases control process, selecting suitable administering mode, guarantee to suffer from poultry and take in enough doses, is the prerequisite that reaches the expection prevention effect.The regular injection preparation, often need repetition administration for several times a course for the treatment of, and frequent injection and Baoding animal are both time-consuming bothersome, easily cause again Animal stress to increase the weight of on the contrary the state of an illness, even cause new disease, affect curative effect of medication and prognosis of disease.Medicine is with the administration of injection situ-gel, and single administration can maintain the effective blood drug concentration of long period, and can keep the blood drug level of relative stable state, be conducive to better bring into play drug effect, improve compliance, reduce administration number of times, reduce adverse effect, increase economic efficiency.
Summary of the invention
The objective of the invention is the deficiency for the existing special livestock formulation administration of Herba Houttuyniae, a kind of houttuynia injection situ-gel is provided.
Another object of the present invention is to provide the preparation method of this houttuynia injection with situ-gel.
Purpose of the present invention can be achieved through the following technical solutions:
The houttuynia injection situ-gel, comprise following component: fresh Herba Houttuyniae distillate 40.0-75.0 weight portion, P40716.5-29.5 weight portion, P1880.5-11.5 weight portion, macromolecule blocker 0.02-11.0 weight portion, solubilising stabilizing agent 0.1-10.0 weight portion, antiseptic 0.01-3.0 weight portion, every milliliter, preparation is equivalent to the new fresh goods 6.0-10.0g of crude drug in whole.
Described gel-type vehicle be selected from poloxamer 108,124,188,237,338,407 any one or multiple; Preferred poloxamer188 16.5-29.5 weight portion, PLURONICS F87 0.5-11.5 weight portion.
Described macromolecule blocker be selected from polyvinyl alcohol, polyvidone, methylcellulose, hydroxypropyl emthylcellulose, hydroxyethyl-cellulose, hydroxypropyl cellulose, sodium carboxymethyl cellulose, carbomer, hyaluronic acid, chitosan, carboxymethyl chitosan, sodium alginate etc. any one or multiple; Preferably carboxymethyl cellulose sodium 0.04-0.75 weight portion or hydroxypropyl emthylcellulose 0.03-0.7 weight portion.
The agent of described solubilising stabilizing agent be selected from glycerol, tween 20, Tween-60, tween 80, propylene glycol, n-butyl alcohol, isopropyl alcohol, isobutanol, Polyethylene Glycol etc. any one or multiple; Preferred tween 80 0.1-4.0 weight portion.
Described antiseptic be selected from oxybenzene esters, chlorobutanol, benzyl alcohol, chlorhexidine acetate, benzalkonium bromide, potassium sorbate, thimerosal etc. any one or multiple; Preferred benzyl alcohol 0.5-2.0 weight portion.
Described houttuynia injection comprises following steps by the preparation method of situ-gel: (a) get the fresh Herba Houttuyniae of recipe quantity, steam distillation prepares distillate; (b) solubilising stabilizing agent and antiseptic are joined in the Herba Houttuyniae distillate, with water for injection, be diluted to debita spissitudo; (c) gel-type vehicle of recipe quantity and the macromolecule blocker selected are sprinkling upon on above-mentioned Herba Houttuyniae solution, 4 ℃ of left and right cold preservation 24h, clarify, without agglomerate, finely dispersed solution, 0.22 μ m microporous filter membrane filtration again; (d) by (c) gained solution water for injection standardize solution, mix, obtain.
The invention has the advantages that:
The present invention utilizes responsive to temperature character and the combination of different model poloxamer of poloxamer aqueous solution, prepared the houttuynia injection situ-gel with suitable phase transition temperature, it is existed with liquid condition at ambient temperature, when intramuscular injection or subcutaneous injection administration, form gel in injection site.It is slow that made houttuynia injection is compared release with situ-gel and conventional Herba Houttuyniae injectio, and blood drug level is steady, and efficiency time extends greatly; Macromolecular material physiological compatibility used is good, and zest is low, safe.Houttuynia injection of the present invention is simple by situ-gel preparation technology, and drug administration by injection is convenient, reduces administration number of times, improves the animal compliance, can better bring into play the effect of Herba Houttuyniae.
The accompanying drawing explanation
The external release curve of situ-gel for houttuynia injection
The specific embodiment
Embodiment 1:
Situ-gel for houttuynia injection (every 1mL is equivalent to the new fresh goods 6.0g of crude drug in whole)
Prescription
Preparation method: (a) get the fresh Herba Houttuyniae of recipe quantity, with the standby distillate of vapor distillation legal system; (b) tween 80 of recipe quantity, benzyl alcohol are joined in above-mentioned Herba Houttuyniae distillate, with water for injection, be diluted to debita spissitudo; (c) gel-type vehicle of recipe quantity and sodium carboxymethyl cellulose are sprinkling upon on above-mentioned Herba Houttuyniae solution, 4 ℃ of left and right cold preservations are spent the night again, and are clarified, without agglomerate, finely dispersed solution, and 0.22 μ m microporous filter membrane filters; (d) (c) used to the water for injection standardize solution, stir, obtain.
Prepared situ-gel is carried out to external performance evaluation, comprise the mensuration of gelation temperature, gelling time, thermal reversibility, release, viscosity, pH value etc.Projects assay method is as follows, and its measurement result is in Table 1, and release in vitro the results are shown in accompanying drawing.
Gelling temp is measured (adopting the test tube roll back method) and is got gel solution 3～4mL of being stored in refrigerator to test tube, and thermometer is inserted in gel solution.Test tube is placed in to water-bath (the water-bath liquid level exceeds test tube content gel solution 3cm), slowly heats up, heating rate is about every 1min～2min and raises 1 ℃.Test tube is tilted 90 °, and the temperature when observed content thing does not flow is defined as gelation temperature.Each sample determination 3 times, result is got its meansigma methods.
Gelling time is measured 25 ℃ of situ-gel solution and is placed 0.5h, is placed in the test tube the insulation that are preheated to 37 ℃, records transformation time.
Thermal reversibility is measured gel is heated to specified temp (30,35,40,45,50,55,60,70 ℃), then slowly cool to room temperature, can be regarded as Heating Cyclic one time, check is until gel no longer possesses Thermo-sensitive or composition changes, still have Thermo-sensitive if repeat 10 times, note is done cycle-index>10.
The accurate 10mL in-situ gel preparation of drawing of drug release determination, be placed in the flat tool plug scale test tube of having weighed in advance, then row is weighed.This test tube is placed in to the water bath with thermostatic control agitator balance 10min of 37.3 ± 0.2 ℃, makes polymer solution be completed into gel.Carefully add 37 ℃ of 5mL buffer (pH7.4 through preheating, containing SDS0.5%, as release medium) in, water bath with thermostatic control vibration (95 times/min), respectively 15,40,60min, 1.33,2,3,5,8,12,24,48,60,72,84,96,104,120h inclines immediately and whole release medium, the container surfaces externally and internally is blotted with filter paper, weighing record, then be reentered into balance 10min in the water bath with thermostatic control agitator rapidly, then supplement release medium 5mL.Repeatable operation like this, until off-test.
Viscosity measurement is used Rotary Viscosimeter to measure the viscosity of the lower gel of room temperature (25 ℃).
PH value is measured with acidometer and is measured the pH value under situ-gel solution room temperature.
Embodiment 2:
Situ-gel for houttuynia injection (every 1mL is equivalent to the new fresh goods 8.0g of crude drug in whole)
Prescription
Preparation method: (a) get the fresh Herba Houttuyniae of recipe quantity, with the standby distillate of vapor distillation legal system; (b) tween 80 of recipe quantity, chlorobutanol are joined in the Herba Houttuyniae distillate, with water for injection, be diluted to debita spissitudo; (c) gel-type vehicle of recipe quantity and polyvidone are sprinkling upon on the above-mentioned Herba Houttuyniae solution water surface, 4 ℃ of left and right cold preservations are spent the night again, and are clarified, without agglomerate, finely dispersed solution, and 0.22 μ m microporous filter membrane filters; (d) (c) used to the water for injection standardize solution, stir, obtain.External method of evaluating performance, with implementing 1, the results are shown in Table 1, and release in vitro the results are shown in accompanying drawing.
Embodiment 3:
Situ-gel for houttuynia injection (every 1mL is equivalent to the new fresh goods 8.0g of crude drug in whole)
Prescription
Preparation method: (a) get the fresh Herba Houttuyniae of recipe quantity, with the standby distillate of vapor distillation legal system; (b) tween 80 of recipe quantity, benzyl alcohol are joined in the Herba Houttuyniae distillate, with water for injection, be diluted to debita spissitudo; (c) gel-type vehicle of recipe quantity, sodium carboxymethyl cellulose and polyvidone are sprinkling upon on the above-mentioned Herba Houttuyniae solution water surface, 4 ℃ of left and right cold preservations are spent the night again, and are clarified, without agglomerate, finely dispersed solution, and 0.22. μ m microporous filter membrane filters; (d) (c) used to the water for injection standardize solution, stir, obtain.External method of evaluating performance, with implementing 1, the results are shown in Table 1, and release in vitro the results are shown in accompanying drawing.
Embodiment 4:
Situ-gel for houttuynia injection (every 1mL is equivalent to the new fresh goods 10.0g of crude drug in whole)
Prescription
Preparation method: (a) get the fresh Herba Houttuyniae of recipe quantity, with the standby distillate of vapor distillation legal system; (b) tween 80 of recipe quantity, chlorobutanol are joined in the Herba Houttuyniae distillate, with water for injection, be diluted to debita spissitudo; (c) gel-type vehicle of recipe quantity and hydroxypropyl emthylcellulose are sprinkling upon on the above-mentioned Herba Houttuyniae solution water surface, 4 ℃ of left and right cold preservations are spent the night again, and are clarified, without agglomerate, finely dispersed solution, and 0.22 μ m microporous filter membrane filters; (d) (c) used to the water for injection standardize solution, stir, obtain.The in-vitro evaluation method, with implementing 1, the results are shown in Table 1, and release in vitro the results are shown in accompanying drawing.
Embodiment 5:
Situ-gel for houttuynia injection (every 1mL is equivalent to the new fresh goods 10.0g of crude drug in whole)
Prescription
Preparation method: (a) get the fresh Herba Houttuyniae of recipe quantity, with the standby distillate of vapor distillation legal system; (b) tween 80 of recipe quantity, chlorobutanol are joined in the Herba Houttuyniae distillate, with water for injection, be diluted to debita spissitudo; (c) gel-type vehicle of recipe quantity, sodium carboxymethyl cellulose and sodium alginate are sprinkling upon on the above-mentioned Herba Houttuyniae solution water surface, 4 ℃ of left and right cold preservations are spent the night again, and are clarified, without agglomerate, finely dispersed solution, and 0.22 μ m microporous filter membrane filters; (d) (c) used to the water for injection standardize solution, stir, obtain.
Concrete preparation method and in-vitro evaluation method are with implementing 1.The results are shown in Table 1, release in vitro the results are shown in accompanying drawing.
The external performance evaluation of situ-gel for table 1 houttuynia injection
Claims (6)
1. prepare a kind of houttuynia injection situ-gel with suitable phase transition temperature, it is characterized in that comprising following component: fresh Herba Houttuyniae distillate 40.0-75.0 weight portion, P40716.5-29.5 weight portion, P1880.5-11.5 weight portion, macromolecule blocker 0.02-11.0 weight portion, solubilising stabilizing agent 0.1-10.0 weight portion, antiseptic 0.01-3.0 weight portion, in preparation, every milliliter is equivalent to the new fresh goods 6.0-10.0 gram of crude drug in whole.This gel has suitable phase transition temperature, can with liquid condition, exist at ambient temperature, forms solid or semi-solid gel after administration in body.
2. a kind of houttuynia injection situ-gel with suitable phase transition temperature according to claim 1, it is characterized in that in described preparation, thermosensitive hydrogel substrate is selected from poloxamer188 and PLURONICS F87, wherein poloxamer188 accounts for the 16.5-29.5 weight portion, and PLURONICS F87 accounts for the 0.5-11.5 weight portion.Regulate the two consumption and can control the phase transition temperature of said preparation between 32 ℃-37 ℃.
3. a kind of houttuynia injection situ-gel with suitable phase transition temperature according to claim 1, it is characterized in that macromolecule blocker in described preparation be selected from polyvinyl alcohol, polyvidone, methylcellulose, hydroxypropyl emthylcellulose, hydroxyethyl-cellulose, hydroxypropyl cellulose, sodium carboxymethyl cellulose, carbomer, hyaluronic acid, chitosan, carboxymethyl chitosan, sodium alginate etc. any one or multiple; Preferred preferably carboxymethyl cellulose sodium 0.04-0.75 weight portion or hydroxypropyl emthylcellulose 0.03-0.7 weight portion.
4. a kind of Radix Isatidis injection situ-gel with suitable phase transition temperature according to claim 1, it is characterized in that the solubilising stabilizing agent agent described in described preparation be selected from glycerol, tween 20, Tween-60, tween 80, propylene glycol, n-butyl alcohol, isopropyl alcohol, isobutanol, Polyethylene Glycol etc. any one or multiple; Preferred tween 80 0.1-4.0 weight portion.
5. a kind of houttuynia injection situ-gel with suitable phase transition temperature according to claim 1, it is characterized in that antiseptic in described preparation be selected from oxybenzene esters, chlorobutanol, benzyl alcohol, chlorhexidine acetate, benzalkonium bromide, potassium sorbate, thimerosal etc. any one or multiple; Preferred benzyl alcohol 0.5-2.0 weight portion.
6. the preparation method of situ-gel for a kind of houttuynia injection with suitable phase transition temperature according to claim 1, it is characterized in that comprising following steps: (a) get the fresh Herba Houttuyniae of recipe quantity, steam distillation prepares distillate; (b) solubilising stabilizing agent and antiseptic are joined in the Herba Houttuyniae distillate, with water for injection, be diluted to debita spissitudo; (c) gel-type vehicle of recipe quantity and the macromolecule blocker selected are sprinkling upon on above-mentioned Herba Houttuyniae solution, 4 ℃ of left and right cold preservation 24h, clarify, without agglomerate, finely dispersed solution, 0.22 μ m microporous filter membrane filtration again; (d) by (c) gained solution water for injection standardize solution, mix, obtain.
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| CN105232450A (en) * | 2015-11-17 | 2016-01-13 | 南京多普特兽药研发有限公司 | Rifaximin-containing in-situ gel for breast injection and preparation method of rifaximin-containing in-situ gel |
| CN109288914A (en) * | 2017-07-24 | 2019-02-01 | 复旦大学 | Purposes of the cordate houttuynia total flavones in the drug of preparation prevention and treatment viral pneumonia |
| CN116370543A (en) * | 2023-04-20 | 2023-07-04 | 南京同仁堂药业有限责任公司 | Cattle yellow detoxification tablet and preparation method thereof |
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| CN116370543A (en) * | 2023-04-20 | 2023-07-04 | 南京同仁堂药业有限责任公司 | Cattle yellow detoxification tablet and preparation method thereof |
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Application publication date: 20140108 |