CN100418528C - Heat-sensitive gel containing matrine alkaloid and its preparing method - Google Patents
Heat-sensitive gel containing matrine alkaloid and its preparing method Download PDFInfo
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- CN100418528C CN100418528C CNB2006100242218A CN200610024221A CN100418528C CN 100418528 C CN100418528 C CN 100418528C CN B2006100242218 A CNB2006100242218 A CN B2006100242218A CN 200610024221 A CN200610024221 A CN 200610024221A CN 100418528 C CN100418528 C CN 100418528C
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- sensitive gel
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Abstract
The present invention relates to a heat sensitive gel containing matrine alkaloid and a preparing method thereof. The preparation is composed of matrine alkaloid, hypromellose, poloxamer 407, phosphate buffer solution with a pH value from 5.0 to 7.0, glycerol and preservative. The heat sensitive gel preparation of the present invention is sensitive to temperature, and forms fluxible liquid at the normal temperature. When the temperature approaches body temperature from 28 DEG C to 33 DEG C, reversibility phase change occurs, and the gel is formed. The heat sensitive gel can be conveniently and effectively applied to vaginas, mucous membranes of external genitalia, skin or eye regions.
Description
Technical field
The present invention relates to a kind of thermal sensitive gel that contains matrine alkaloid, being specifically related to a kind of is active component with the matrine alkaloid, the Pharmaceutical composition that contains poloxamer 407, said composition has heat-sensitive gel, can be applied to human bodies such as vagina, eye, external genitalia mucosa and common skin.The invention still further relates to the preparation method of this heat-sensitive gel preparation.
Background technology
Matrine alkaloid is the alkaloid that a class has matridinde-15-ketonize architectural feature, it mainly is the natural product of separation and Extraction from plant Radix Sophorae Flavescentis and Herba Sophorae alopecuroidis, comprise total alkaloids position (abbreviation Radix Sophorae Flavescentis total alkaloids) and the monomeric compound that purification obtains from Radix Sophorae Flavescentis total alkaloids, as matrine, oxymatrine, sophoridine, aloperine, sophocarpine, sophoramine, sophoranol alkali, N-oxysophocarpine.Effects such as that matrine alkaloid has mostly is antibiotic, antiinflammatory, antiviral, analgesia, antipruritic, parasite killing.Wherein matrine, oxymatrine, kurarinone (oxymatrine that contains a small amount of sophocarpine) are extensive use of in clinical practice.
Matrine alkaloid can be used for diseases such as dermatosis, gynecological and men and women's sexually transmitted disease (STD) clinically, at present widely used is that the external preparation of active pharmaceutical ingredient is generally solution and vaginal suppository with the matrine alkaloid, and conventional dosage forms exists affected part and lacks, is unfavorable for that effective ingredient plays a role or uses defectives such as inconvenience, patient's poor compliance action time when reality is used.Chinese invention patent application 02157376.X and Chinese invention patent ZL03119731.0 have pointed out oxymatrine purposes in preparation skin antipruritic agent medicine for curing sexual disease respectively.The disclosed external preparation of above-mentioned patent documentation is liniment and lotion, is solution.Chinese invention patent application 200410040106.0 discloses a kind of vagina membrane of Radix Sophorae Flavescentis total alkaloids, need the medicine film be filled in the vagina deep with finger when this membrane uses, and is very inconvenient, patient's poor compliance.Chinese invention patent ZL02135793.5 discloses a kind of matrine vaginal gel, and this vaginal preparation is easy to use, and its water-soluble base can pollution clothes yet.But as ordinary gel, its inherent defective is arranged, i.e. gel viscosity control difficulty, if gel viscosity is less, its site of administration very fast can Yin Shengli secretions dilution and flow out external; If viscosity is bigger, difficulty when then using is unfavorable for disperseing at affected part.
Relevant is that the thermal sensitive gel of active pharmaceutical ingredient does not appear in the newspapers as yet with the matrine alkaloid.
Summary of the invention
The object of the invention is to provide a kind of thermal sensitive gel that contains matrine alkaloid, and said preparation is active pharmaceutical ingredient with the matrine alkaloid, is adjuvant with hypromellose, poloxamer 407 etc., has the phase transition temperature near body temperature.Another object of the present invention is to provide the preparation method of this thermal sensitive gel.
By weight, thermal sensitive gel of the present invention is composed as follows:
Matrine alkaloid 0.5%-10%
Hypromellose 0.5%-1.0%
Poloxamer 407 18%-25%
PH is the phosphate buffer 56%-72% of 5.0-7.0
Glycerol 8%-12%
Antiseptic 0.05-0.3%
In the above-mentioned prescription, matrine alkaloid is the alkaloid with matridinde-15-ketonize architectural feature, comprises Radix Sophorae Flavescentis total alkaloids (the total alkaloids position of separation and Extraction from plant Radix Sophorae Flavescentis and Herba Sophorae alopecuroidis), matrine, oxymatrine, sophoridine, aloperine, sophocarpine, sophoramine, sophoranol alkali, N-oxysophocarpine, kurarinone etc.Wherein preferred Radix Sophorae Flavescentis total alkaloids, matrine, oxymatrine or kurarinone.Matrine alkaloid can be bought or adopt conventional method to extract and prepare by market, and the preferable amount of matrine alkaloid is 1.0%-2.5%w/w.
PH is that the compound method of the phosphate buffer of 5.0-7.0 is: the pH value of sodium dihydrogen phosphate of regulating 0.2mol/L with sodium hydroxide test solution (get the 4.3g sodium hydroxide and add 100ml water promptly) is to required pH value.For the preparation that vagina is used, preferred pH is the phosphate buffer of 5.0-6.0, and wherein optimal choice pH is 5.0 phosphate buffer; For the preparation that use at other positions, preferred pH is the phosphate buffer of 6.0-7.0.
The mixture of mixture, sorbic acid and the p-Hydroxybenzoate ethyl ester of antiseptic employing sorbic acid, p-Hydroxybenzoate methyl ester, p-Hydroxybenzoate ethyl ester, hydroxybenzoate propyl ester, sorbic acid and p-Hydroxybenzoate methyl ester or the mixture of sorbic acid and p-Hydroxybenzoate propyl ester.
The present invention discovers, under control specific matrine alkaloid solution concentration and pH condition, the dissolving order of each component of the present composition is set the temperature-sensitive character that can optimize poloxamer 407 solution, and the solution that finally makes poloxamer 407 concentration be low to moderate 18%w/w also has the heat-sensitive gel near the phase transition temperature of body temperature.
The characteristics of the preparation method of heat-sensitive gel preparation of the present invention are that matrine alkaloid was dissolved in the phosphate buffer that pH value is 5.0-7.0 before poloxamer 407, if after poloxamer 407 is dissolved in phosphate buffer, add matrine alkaloid, then can make prepared chemical compound lose temperature-sensitive character.Specifically comprise the steps: to take by weighing each component according to formula proportion, at first matrine alkaloid is added in the phosphate buffer that pH value is 5.0-7.0 and dissolve, add hypromellose dissolving back then and add poloxamer 407, add glycerol and antiseptic dissolving after the dissolving promptly.
Thermal sensitive gel of the present invention can be applied to human bodies such as vagina, eye, external genitalia mucosa and common skin.The packing of above thermal sensitive gel is selected: for the thermal sensitive gel that vagina is used, select to adopt disposable aluminum pipe, plastic tube, plastic bottle and the vagina injector with conduit of single dose, pack.Use more convenient health.For the thermal sensitive gel that men and women's vulvar mucous membrane is used or general skin is used, select common aluminum pipe, mould the pipe multiple-unit container, also can adopt the spray bottle packing of pressing or extruding, wherein the spray bottle packing more can be brought into play the advantage of the thermal sensitive gel of the present invention's announcement: be liquid under the room temperature, can atomize, droplet becomes viscid semi-solid gel rapidly under temperature influence.For gel for eye use, then need to be packaged in the eye drop Packaging Bottle of sterilization.
Beneficial effect
1, the present invention has adopted the dissolving order of concentration and pH condition and each component of specific matrine alkaloid, improved the temperature-sensitive character of poloxamer 407 solution, resulting heat-sensitive gel preparation has the reversible mutual commentaries on classics characteristic of liquid/gel takes place under suitable temperature conditions responsive to temperature.Heat-sensitive gel preparation of the present invention is low viscous flowable liquids shape at normal temperatures, and the reversibility phase transformation takes place near 28-33 ℃ of body temperature the time, form high viscosity, immobilising gel, can be applied to vagina, external genitalia mucosa, skin and eye easily and effectively.
2, the present composition has good heat-sensitive gel, and medication is convenient, improves patient's compliance, and medicine closely contacts with the site of administration mucosa simultaneously, and prolong drug is in the holdup time of affected part, thereby reaches the purpose of enhancing therapeutic effect.
3, the volatile oil heat-sensitive gel of the present invention preparation is easy to clean, and does not have greasy feeling, with after pollution clothes not.
The specific embodiment
The present invention is further elaborated below in conjunction with specific embodiment, but do not limit the present invention.
Poloxamer 407 is available from Nanjing WeiEr chemical engineering Co., Ltd among the following embodiment.The compound method of the phosphate buffer of pH5.0-7.0: the pH value of regulating the sodium dihydrogen phosphate of 0.2mol/L with sodium hydroxide test solution (get the 4.3g sodium hydroxide and add 100ml water promptly) extremely sets value.
The vagina of embodiment 1 unit dose package is with thermal sensitive gel (specification 2g/ props up, 1000)
Prescription: component title consumption (g)
Matrine 50
Hypromellose 17.46
Poloxamer 407 362
PH5.0 phosphate buffer 1 368
Glycerol 200
Sorbic acid 2
Methyl parahydroxybenzoate 2
According to prescription, take by weighing each component, in the pH5.0 phosphate buffer, add matrine, stirring and dissolving.In gained solution, add hypromellose dissolving back and add poloxamer 407 stirring and dissolving, add sorbic acid, methyl parahydroxybenzoate and glycerol dissolving at last promptly.With each unit formulation 2g, be sub-packed in the disposable vaginal injector, add outer package.Inject in intravaginal during use.
The external genitalia mucosa of embodiment 2 multiple-unit containers is with thermal sensitive gel (specification 5g/ props up, 1000)
Prescription: component title consumption (g)
Oxymatrine 125
Hypromellose 45
Poloxamer 407 950
PH6.0 phosphate buffer 3320
Glycerol 550
Sorbic acid 10
According to prescription, take by weighing each component, in the pH6.0 phosphate buffer, add oxymatrine, stirring and dissolving.In gained solution, add hypromellose dissolving back and add poloxamer 407 stirring and dissolving, add the dissolving of sorbic acid and glycerol at last promptly.With each unit formulation 5g, be sub-packed in spray bottle.Pressing spraying affected part during use.
The vagina of embodiment 3 unit dose packages is with thermal sensitive gel (specification 5g/ props up, 1000)
Prescription: component title consumption (g)
Oxymatrine 100
Hypromellose 45
Poloxamer 407 900
PH5.5 phosphate buffer 3545
Glycerol 400
Sorbic acid 10
According to prescription, take by weighing each component, in the pH5.5 phosphate buffer, add oxymatrine, stirring and dissolving.In gained solution, add hypromellose dissolving back and add poloxamer 407 stirring and dissolving, add the dissolving of sorbic acid and glycerol at last promptly.With each unit formulation 5g, be sub-packed in the disposable vaginal injector, add outer package.Inject in intravaginal during use.
The external preparation for skin thermal sensitive gel of embodiment 4 multiple-unit containers (specification 20g/ props up, 1000)
Prescription: component title consumption (g)
Radix Sophorae Flavescentis total alkaloids 320
Hypromellose 200
Poloxamer 407 4100
PH6.0 phosphate buffer 1 2960
Glycerol 2400
Propyl p-hydroxybenzoate 20
According to prescription, take by weighing each component, in the pH6.0 phosphate buffer, add Radix Sophorae Flavescentis total alkaloids, stirring and dissolving.In gained solution, add hypromellose dissolving back and add poloxamer 407 stirring and dissolving, add the dissolving of propyl p-hydroxybenzoate and glycerol at last promptly.With each unit formulation 20g, be sub-packed in spray bottle.Pressing sparges the affected part during use.
The eye of embodiment 5 multiple-unit containers is with thermal sensitive gel (specification 2g/ props up, 1000)
Prescription: component title consumption (g)
Oxymatrine 50
Hypromellose 12
Poloxamer 407 360
PH6.8 phosphate buffer 1 416
Glycerol 160
Methyl parahydroxybenzoate 2
According to prescription, take by weighing each component, in the pH6.8 phosphate buffer, add oxymatrine, stirring and dissolving.In gained solution, add hypromellose dissolving back and add poloxamer 407 stirring and dissolving, add the dissolving of methyl parahydroxybenzoate and glycerol at last promptly.With each unit formulation 2g, be sub-packed in the eye drop plastic bottle.Splash into eye during use.
The vagina of embodiment 6 unit dose packages is with thermal sensitive gel (specification 5g/ props up, 1000)
Prescription: component title consumption (g)
Kurarinone 25
Hypromellose 45
Poloxamer 407 920
PH5.5 phosphate buffer 3600
Glycerol 400
Sorbic acid 10
According to prescription, take by weighing each component, in the pH5.5 phosphate buffer, add kurarinone, stirring and dissolving.In gained solution, add hypromellose dissolving back and add poloxamer 407 stirring and dissolving, add the dissolving of sorbic acid and glycerol at last promptly.With each unit formulation 5g, be sub-packed in the disposable vaginal injector, add outer package.Inject in intravaginal during use.
The external preparation for skin thermal sensitive gel of embodiment 7 multiple-unit containers (specification 5g/ props up, 1000)
Prescription: component title consumption (g)
Radix Sophorae Flavescentis total alkaloids 500
Hypromellose 25.5
Poloxamer 407 1250
PH6.0 phosphate buffer 2822
Glycerol 400
Ethylparaben 2.5
According to prescription, take by weighing each component, in the pH6.0 phosphate buffer, add Radix Sophorae Flavescentis total alkaloids, stirring and dissolving.In gained solution, add hypromellose dissolving back and add poloxamer 407 stirring and dissolving, add the dissolving of ethylparaben and glycerol at last promptly.With each unit formulation 5g, be sub-packed in the Plastic paste tube.Smear a little during use in the affected part.
The phase transition temperature of embodiment 8 thermal sensitive gels of the present invention is measured
Specimen: according to the thermal sensitive gel of described prescription of embodiment 1-7 and method preparation.
Phase transition temperature assay method: with thermal sensitive gel sample 5g, put in the 10ml test tube, put in the water-bath of controllable temperature the built-in thermometer of test tube, working sample temperature, regulate the water bath with thermostatic control temperature, make sample temperature from 25 ℃, 1 ℃ of every rising kept 2 minutes, whether observation sample change into from flowable liquid can not mobile gel immediately, and the phase transition temperature that is of this phase transformation takes place.After undergoing phase transition, take out and put under the room temperature to observe whether revert to liquid, judge whether phase transformation is reversible.
Test result is as shown in the table:
Test result shows: the reversibility phase transformation takes place in thermal sensitive gel of the present invention near 28-33 ℃ of body temperature the time, wherein skin and external genitalia are lower with the phase transition temperature of thermal sensitive gel (embodiment 2,4 and 7), it is 28 ℃, and vagina and eye are higher with the phase transition temperature of thermal sensitive gel (embodiment 1,3,5 and 6), reach 31-33 ℃, this is to be fit to the body temperature distribution situation.
Claims (5)
1. thermal sensitive gel that contains matrine alkaloid, by weight, it consists of:
Matrine alkaloid 0.5%-10%
Hypromellose 0.5%-1.0%
Poloxamer 407 18%-25%
PH is the phosphate buffer 56%-72% of 5.0-7.0
Glycerol 8%-12%
Antiseptic 0.05-0.3%
Wherein antiseptic is the mixture of mixture, sorbic acid and p-Hydroxybenzoate ethyl ester of sorbic acid, p-Hydroxybenzoate methyl ester, p-Hydroxybenzoate ethyl ester, hydroxybenzoate propyl ester, sorbic acid and p-Hydroxybenzoate methyl ester or the mixture of sorbic acid and p-Hydroxybenzoate propyl ester.
2. the thermal sensitive gel that contains matrine alkaloid according to claim 1, wherein matrine alkaloid is Radix Sophorae Flavescentis total alkaloids, matrine, oxymatrine or kurarinone.
3. the thermal sensitive gel that contains matrine alkaloid according to claim 1 and 2 is characterized in that by weight, and the content of matrine alkaloid is 1.0%-2.5%, and pH is that the content of the phosphate buffer of 5.0-7.0 is 64.8%-72%.
4. the described preparation method that contains the thermal sensitive gel of matrine alkaloid of claim 1, it is characterized in that may further comprise the steps: at first matrine alkaloid is added in the phosphate buffer that pH value is 5.0-7.0 and dissolve, add hypromellose dissolving back then and add poloxamer 407, add glycerol and antiseptic dissolving after the dissolving promptly.
The described thermal sensitive gel that contains matrine alkaloid of claim 1 the preparation vagina with thermal sensitive gel, eye with thermal sensitive gel, external genitalia mucosa with thermal sensitive gel and common skin with the application in the thermal sensitive gel.
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| CNB2006100242218A CN100418528C (en) | 2006-02-28 | 2006-02-28 | Heat-sensitive gel containing matrine alkaloid and its preparing method |
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| CNB2006100242218A CN100418528C (en) | 2006-02-28 | 2006-02-28 | Heat-sensitive gel containing matrine alkaloid and its preparing method |
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| CN100418528C true CN100418528C (en) | 2008-09-17 |
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Cited By (1)
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|---|---|---|---|---|
| US9884049B2 (en) | 2014-07-14 | 2018-02-06 | Orion Biotechnology Canada Ltd. | Microbicidal composition comprising an octoxynol and a quinolizidine alkaloid compound or a source thereof |
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Assignee: Qili Pharmaceutical Co., Ltd., Haikou Assignor: Shanghai Huatuo Medicine Sci-Tech Development Co., Ltd. Contract fulfillment period: 2008.9.20 to 2014.9.20 Contract record no.: 2008460000008 Denomination of invention: Heat-sensitive gel containing matrine alkaloid and its preparing method Granted publication date: 20080917 License type: Exclusive license Record date: 20081101 |
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