CN107982281A - Ophthalmically acceptable semisolid preparation of Chinese medicine composition and preparation method thereof - Google Patents
Ophthalmically acceptable semisolid preparation of Chinese medicine composition and preparation method thereof Download PDFInfo
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Abstract
The invention discloses a kind of ophthalmically acceptable semisolid preparation of Chinese medicine composition, including Chinese medicine composition and auxiliary material, the component and parts by weight of the Chinese medicine composition are 90 110 parts of calamine, 0.5 1.5 parts of muscone, 25 35 parts of borneol, 46 parts of coral, 0.5 1.5 parts of bear gall, 46 parts of amber, 0.5 1.5 parts of pearl, 24 parts of cinnabar, 68 parts of borax;The ophthalmically acceptable semisolid preparation of Chinese medicine composition includes gel for eye and Eye ointments, and the auxiliary material of the gel for eye is made of pharmaceutically acceptable hydrophilic gel matrix and carrier, and the auxiliary material of the Eye ointments is made of pharmaceutically acceptable oleaginous base.The present invention is using ophthalmically acceptable semisolid preparation of Chinese medicine composition of said components and preparation method thereof, and stability is high, irritation is small, good patient compliance.
Description
Technical field
The present invention relates to eye medicinal technical field, more particularly to a kind of ophthalmically acceptable semisolid preparation of Chinese medicine composition and its
Preparation method.
Background technology
Eyes are the more fragile organs of human body, and according to statistics, eye-drops preparations ophthalmic solution accounts for more than 60%, because of its use
Convenient, easily formula, compliance are well easily received by many patients, but are goed deep into biopharmacy and pharmacokinetics
Research, it is found that conventional eye drop solutions have the ocular drug holdup time is short, bioavilability is low etc., only less than 5% medicine
Thing reaches intraocular by cornea and plays a role, and leverages the therapeutic effect of dosing eyes.
Gel delivery system refers to that the latex stiff of homogeneous, suspension or emulsion-type is made with that can form the auxiliary material of gel for medicine
Liquid or semisolid.Topical gels agent category individual event decentralized system, there is water gelling agent and point of oil phase gelling agent, aqueous gel
The main matrix of agent is generally by water, glycerine or propane diols and cellulose derivative, carbomer and alginate, tragacanth, bright
Glue, starch are formed;The main matrix of oil-base gel agent is by atoleine and polyoxyethylene or fat oil and colloidal silicon or aluminium soap, zinc
Soap is formed.
Traditional Chinese medicine ophthalmology application it is unique and raise property, Taurus medicament for the eyes is traditional Chinese medicine recipe, is called " Taurus in history
Eight treasures (choice ingredients of certain special dishes) medicament for the eyes ", is made of mineral matter, bear gall, muscone, borneol, coral etc..Late Ming & early Qing is started from, more than 300 years existing
History, obtains Chinese illness in eye specific drug title, persons suffering from ocular disorders first choice brand, national non-material cultural heritage, treatment epidemic conjunctivitis, eye
The outer drop illness in eye such as red rotten, sand holes, tearing against wind and nebula is dazzled, clinical efficacy is notable.But it is powder, in use, with small glass rod
Dip in medicinal powder and be applied to eye, inconvenient for use, poor compliance.Chinese patent CN101579393A disclose a kind of Chinese medicine eye-drops preparations and
Its preparation process, gel-type vehicle is mentioned in the inside includes hypromellose, sodium carboxymethylcellulose, methylcellulose, ethyl
Cellulose, carbomer, record according to relevant information and related experiment are shown, sodium carboxymethylcellulose in the ophthalmic gel base,
Hypromellose has incompatibility with calamine, and methylcellulose and ethyl cellulose dosage are higher, and using effect is poor.
The content of the invention
The object of the present invention is to provide ophthalmically acceptable semisolid preparation of a kind of Chinese medicine composition and preparation method thereof, stability is high,
Irritation is small, good patient compliance.
To achieve the above object, the present invention provides a kind of ophthalmically acceptable semisolid preparation of Chinese medicine composition, including Chinese traditional medicine composition
Thing and auxiliary material, the component and parts by weight of the Chinese medicine composition are 90-110 parts of calamine, 0.5-1.5 parts of muscone, ice
25-35 parts of piece, 4-6 parts of coral, 0.5-1.5 parts of bear gall, 4-6 parts of amber, 0.5-1.5 parts of pearl, 2-4 parts of cinnabar, borax 6-8
Part;
The ophthalmically acceptable semisolid preparation of Chinese medicine composition includes gel for eye and Eye ointments, the gel for eye it is auxiliary
Material is made of pharmaceutically acceptable hydrophilic gel matrix and carrier, and the auxiliary material of the Eye ointments is by pharmaceutically acceptable oil
Matrix forms;
The Chinese herb medicine eye semisolid preparation is for treating epidemic conjunctivitis, eye dazzles red rotten, sand holes, tearing against wind and nebula
Outer drop illness in eye.
Preferably, the component of the Chinese medicine composition and parts by weight are 100 parts of calamine, 1 part of muscone, borneol 30
Part, 5 parts of coral, 1 part of bear gall, 5 parts of amber, 1 part of pearl, 3 parts of cinnabar, 7 parts of borax.
Preferably, the hydrophilic gel matrix is carbomer, in hydroxyethyl cellulose, methylcellulose, poloxamer
One or more kinds of mixtures, but not include hypromellose, sodium carboxymethylcellulose;
The carrier is solubilizer, isotonic regulator, preservative, pH adjusting agent;
The oleaginous base is vaseline, liquid paraffin, lanolin;
The solubilizer is Tween-80, one or more kinds of in PLURONICS F87, Crodaret
Mixture;
The mixture that the isotonic regulator is glycerine, one or more kinds of in propane diols, sorbierite;
The preservative be it is a kind of in chloreresol, methyl hydroxybenzoate, the third fat of oxybenzene, thimerosal, benzalkonium chloride, sodium benzoate or
More than one mixture;
The pH adjusting agent is mixture one or more kinds of in sodium hydroxide, triethanolamine, sodium acid carbonate etc..
Preferably, the component of the gel for eye and dosage are:Chinese medicine composition 300-900mg, hydrophilic gel base
Matter 50-200mg, solubilizer 0-300mg, isotonic regulator 5-300mg, preservative 0-10mg, then add pH adjusting agent and adjust
Solution acid alkalinity, adds water to 10g.
Preferably, the component of the gel for eye and dosage are Chinese medicine composition 400mg, hydrophilic gel matrix
90mg, solubilizer 20mg, isotonic regulator 150mg, preservative 1mg, then add pH adjusting agent and adjust solution acid alkalinity, add water
To 10g.
Preferably, the component of the Eye ointments and dosage are Chinese medicine composition 0.4-2g, vaseline 1-9g, liquid paraffin 0-
1g, lanolin 0.06-1g.
Preferably, the component of the Eye ointments and dosage are Chinese medicine composition 0.4g, vaseline 3.4g, liquid paraffin
0.06g, lanolin 0.14g.
The preparation method of gel for eye, comprises the steps of in the ophthalmically acceptable semisolid preparation of the Chinese medicine composition:
(1) by calamine, borneol, coral, muscone, bear gall, amber, pearl, cinnabar, borax this nine tastes medicine difference powder
It is broken, the medicinal powder of each component is then weighed respectively;
(2) medicinal powder of muscone, bear gall is mixed, then with other seven flavor medicine powder facing-ups of step (1), sieved, to obtain the final product
Chinese medicine composition;
(3) water, hydrophilic gel matrix are added in beaker, room temperature is swollen overnight naturally, after stirring evenly, obtains gel
Vehicle solution is spare;
(4) isotonic regulator, solubilizer, preservative and Chinese medicine composition are added in beaker, is dissolved in water, fills medicinal powder
Share in the benefit it is wet, be uniformly dispersed, obtain solution a;
(5) add in the solution a that step (4) obtains, grind by several times in the gel vehicle solution for obtaining step (3)
Or stir evenly;
(6) it is 6-9 to add pH adjusting agent and adjust pH, grinds or stirs evenly, and is uniformly mixed after adding gauge water, sampling
Carry out quality testing, dispensed after qualified, to obtain the final product.
The preparation method of gel for eye, comprises the steps of in the ophthalmically acceptable semisolid preparation of the Chinese medicine composition:
(1) by calamine, borneol, coral, muscone, bear gall, amber, pearl, cinnabar, borax this nine tastes medicine difference powder
It is broken, the medicinal powder of each component is weighed respectively, it is stand-by;
(2) muscone, bear gall powder are mixed, then with other seven flavor medicine powder facing-ups of step (1), sieved, after qualified,
It is stand-by up to Chinese medicine composition;
(3) water, hydrophilic gel matrix are added in beaker, room temperature is swollen overnight, stirs evenly, obtain gel blank naturally
Matrix solution, adds pH adjusting agent, stirring, obtains solution a, spare;
(4) isotonic regulator, solubilizer, preservative and Chinese medicine composition are taken, be dissolved in water facing-up, obtains solution b, makes medicine
Powder is fully soaked and is uniformly dispersed;
(5) the solution a for obtaining step (3) is added in the solution b in step (4) by several times, is ground or is stirred evenly;
(6) add gauge water, after uniform, sampling carries out quality testing, is dispensed after qualified, to obtain the final product.
The preparation method of Eye ointments, comprises the steps of in the ophthalmically acceptable semisolid preparation of the Chinese medicine composition:
(1) by calamine, borneol, coral, muscone, bear gall, amber, pearl, cinnabar, borax this nine tastes medicine difference powder
It is broken, the medicinal powder of each component is weighed respectively, it is stand-by;
(2) muscone, bear gall powder are mixed, it is then qualified with other seven flavor medicine powder facing-ups in step (1), sieving
Afterwards, it is stand-by up to Chinese medicine composition;
(3) it will be put into cold liquid paraffin, stir evenly after the Chinese medicine composition obtained in step (2) sterilizing, filtration;Again plus
Enter into the vaseline and lanolin for having sterilized, filtering and being cooled to about 50 DEG C, stir evenly, make solidification, to obtain the final product.
Therefore, for the present invention using ophthalmically acceptable semisolid preparation of above-mentioned Chinese medicine composition and preparation method thereof, stability is high, stimulates
The small, good patient compliance of property.
Below by embodiment, technical scheme is described in further detail.
Embodiment
Embodiments of the present invention are described further below.
Embodiment one
A kind of ophthalmically acceptable semisolid preparation of Chinese medicine composition includes gel for eye and Eye ointments, Chinese herb medicine eye semisolid preparation
For treating epidemic conjunctivitis, eye dazzle the outer drop illness in eye of red rotten, sand holes, tearing against wind and nebula.The present invention by stability test,
Prove that indices meet regulation in 24 months at room temperature.The present invention proves that this product irritation is small, suitable by irritation test
It is strong with property.The physicochemical character of invention formulation product:This product is the semisolid preparation of light red brown.Invention formulation product it is excellent
Point:Patient's compliance is improved, and medicinal part affinity is strong, the holdup time is long, toxic side effect is small.
The ophthalmically acceptable semisolid preparation of Chinese medicine composition includes Chinese medicine composition and auxiliary material, the component and parts by weight of Chinese medicine composition
Number is 90-110 parts of calamine, 0.5-1.5 parts of muscone, 25-35 parts of borneol, 4-6 parts of coral, 0.5-1.5 parts of bear gall, amber
4-6 parts, 0.5-1.5 parts of pearl, 2-4 parts of cinnabar, 6-8 parts of borax.
The auxiliary material of gel for eye is made of pharmaceutically acceptable hydrophilic gel matrix and carrier, the auxiliary material of Eye ointments by
Pharmaceutically acceptable oleaginous base composition;The viscosity of gel for eye is reduced with the increase of shear rate, is had well
Rheological property.Prepared gel for eye viscosity is reduced with the increase of shear rate, in pseudoplastic fluid volume property, with eye
Physiology is adapted, and when patient blinks, produces a shearing force, gel viscosity declines, is easy to absorb, will not cause eye not
Suitable, after blink, gel viscosity recovers, and does not influence its holdup time in eye.
Hydrophilic gel matrix is one kind or one in carbomer, hydroxyethyl cellulose, methylcellulose, poloxamer etc.
Kind thing mixed above, but do not include hypromellose, sodium carboxymethylcellulose, this two kinds of common ophthalmic gel bases, with
Mineral matter has incompatibility, can produce infusible precipitate.
Carrier is solubilizer, isotonic regulator, preservative, pH adjusting agent;
Oleaginous base is vaseline, liquid paraffin, lanolin;
Solubilizer mixes for the one or more in Tween-80, PLURONICS F87, Crodaret etc.
Compound, wherein it is preferred that Tween-80;
Isotonic regulator is glycerine, one or more kinds of mixtures in propane diols, sorbierite, wherein preferably glycerine;
Preservative is chloreresol, methyl hydroxybenzoate, the third fat of oxybenzene, thimerosal, benzalkonium chloride, one kind in sodium benzoate or one
Kind thing mixed above;
PH adjusting agent is one or more kinds of mixtures in sodium hydroxide, triethanolamine, sodium acid carbonate etc., wherein excellent
Select sodium hydroxide.
The component and dosage of gel for eye be:Chinese medicine composition 300-900mg, hydrophilic matrix 50-200mg, solubilising
Agent 0-300mg, isotonic regulator 5-300mg, preservative 0-10mg, appropriate pH adjusting agent, adds water to 10g.
The component and dosage of Eye ointments are Chinese medicine composition 0.4-2g, vaseline 1-9g, liquid paraffin 0-1g, lanolin
0.06-1g, is made paste 2-10g.
The preparation method of gel for eye, comprises the steps of:
(1) by calamine, borneol, coral, muscone, bear gall, amber, pearl, cinnabar, borax this nine tastes medicine difference powder
It is broken, the medicinal powder of each component is then weighed respectively;
(2) medicinal powder of muscone, bear gall is mixed, then with other seven flavor medicine powder facing-ups of step (1), sieved, to obtain the final product
Chinese medicine composition;
(3) water, hydrophilic gel matrix are added in beaker, room temperature is swollen overnight naturally, after stirring evenly, obtains gel
Vehicle solution is spare;
(4) isotonic regulator, solubilizer, preservative and Chinese medicine composition are added, is dissolved in water, medicinal powder is fully soaked,
It is uniformly dispersed, obtains solution a;
(5) add in the solution a that step (4) obtains, grind by several times in the gel vehicle solution for obtaining step (3)
Or stir evenly;
(6) it is 6-9 to add sodium hydroxide solution and adjust pH, grinds or stirs evenly, and is uniformly mixed after adding gauge water,
Sampling carries out quality testing, is dispensed after qualified, to obtain the final product.
The preparation method of Eye ointments, comprises the steps of:
(1) by calamine, borneol, coral, muscone, bear gall, amber, pearl, cinnabar, borax this nine tastes medicine difference powder
It is broken, the medicinal powder of each component is weighed respectively, it is stand-by;
(2) muscone, bear gall powder are mixed, it is then qualified with other seven flavor medicine powder facing-ups in step (1), sieving
Afterwards, it is stand-by up to Chinese medicine composition;
(3) in the liquid paraffin that will be let cool after the Chinese medicine composition obtained in step (2) sterilizing, filtration, stir evenly, add
Into the vaseline and lanolin for having sterilized, filtering and being cooled to about 50 DEG C, stir evenly, make solidification, to obtain the final product.
Embodiment two
The component and parts by weight of Chinese medicine composition for 100 parts of calamine, 1 part of muscone, 30 parts of borneol, 5 parts of coral,
1 part of bear gall, 5 parts of amber, 1 part of pearl, 3 parts of cinnabar, 7 parts of borax.
The component and dosage of gel for eye are Chinese medicine composition 400mg, hydrophilic matrix 90mg, solubilizer 20mg, etc.
Conditioning agent 150mg is oozed, preservative 1mg, appropriate pH adjusting agent, adds water to 10g.
The component and dosage of Eye ointments are Chinese medicine composition 0.4g, vaseline 3.4g, liquid paraffin 0.06g, lanolin
0.14g, is made paste 4g.
The preparation method of gel for eye, comprises the steps of:
(1) by calamine, borneol, coral, muscone, bear gall, amber, pearl, cinnabar, borax this nine tastes medicine difference powder
It is broken, the medicinal powder of each component is weighed respectively, it is stand-by;
(2) muscone, bear gall powder are mixed, then with other seven flavor medicine powder facing-ups of step (1), sieved, after qualified,
It is stand-by up to Chinese medicine composition;
(3) water, hydrophilic gel matrix are added in beaker, room temperature is swollen overnight, stirs evenly, obtain gel blank naturally
Matrix solution, adds sodium hydroxide solution, stirring, obtains solution a, spare;
(4) isotonic regulator, solubilizer, preservative and Chinese medicine composition are taken, be dissolved in water facing-up, obtains solution b, makes medicine
Powder is fully soaked and is uniformly dispersed;
(5) the solution a for obtaining step (3) is added in the solution b in step (4) by several times, is ground or is stirred evenly;
(6) add gauge water, after uniform, sampling carries out quality testing, is dispensed after qualified, to obtain the final product.
Embodiment three
The component and proportioning of Chinese medicine composition be:Pearl 0.26g, muscone 0.26g, bear gall 0.26g, cinnabar 0.82g,
Coral 1.31g, amber 1.31g, borax 1.80g, borneol 7.80g, calamine (forge) 26.18g
The component of gel for eye use and proportioning are Chinese medicine composition impalpable powder 40g, carbomer9349g, Tween-80 2g, glycerine
15g, benzalkonium chloride 0.1g, appropriate pH adjusting agent, water for injection add to 1000g, make 100 altogether.
The preparation method of gel for eye use:
(1) the nine taste medicine such as calamine (forging), borneol, coral, muscone, bear gall is respectively crushed into impalpable powder, claims respectively
The medicinal powder of each recipe quantity is taken, it is stand-by;
(2) muscone, bear gall powder are mixed, with other seven flavor medicine powder facing-ups, crosses 200 mesh sieves, always taken after mixed 20min
Sample is examined, and it is qualified to examine, stand-by up to Chinese medicine composition impalpable powder;
(3) water for injection is measured in beaker, adds the carbomer of recipe quantity934, room temperature is swollen naturally to be stayed overnight, get Ka Bo
Nurse solution for standby;
(4) recipe quantity glycerine, Tween-80, preservative are weighed, respectively plus after the dissolving of a small amount of water, mixed solution is matched somebody with somebody with medicinal powder
Grind, obtain lapping liquid a, medicinal powder is fully soaked and is uniformly dispersed;
(5) carbomer solution is added in the lapping liquid a that step (4) obtains by several times, grinding is uniform;
(6) it is 7-8 to add suitable 10% sodium hydroxide solution and adjust pH, and grinding is uniform, adds water for injection and supplies body
Product, grinds well, and sampling carries out quality testing, is dispensed after qualified, to obtain the final product.
Example IV
The component and dosage of gel for eye use are Chinese medicine composition impalpable powder 40g, carbomer94010g, Tween-80 2g, glycerine
15g, benzalkonium chloride 0.1g, appropriate pH adjusting agent, water for injection add to 1000g, make 100 altogether.
The preparation method of gel for eye use:
(1) the nine taste medicine such as calamine (forging), borneol, coral, muscone, bear gall is respectively crushed into impalpable powder, claims respectively
The medicinal powder of each recipe quantity is taken, it is stand-by;
(2) muscone, bear gall powder are mixed, with other seven flavor medicine powder facing-ups, crosses 200 mesh sieves, always taken after mixed 20min
Sample is examined, and it is qualified to examine, stand-by up to Chinese medicine composition impalpable powder;
(3) water for injection is measured in beaker, adds the carbomer of recipe quantity940, room temperature is swollen naturally to be stayed overnight, get Ka Bo
Nurse solution for standby;
(4) recipe quantity glycerine, Tween-80, preservative are weighed, respectively plus after the dissolving of a small amount of water, mixed solution is matched somebody with somebody with medicinal powder
Grind, the lapping liquid a of acquisition, makes medicinal powder fully soak and be uniformly dispersed;
(5) carbomer solution is added to step (4) by several times to obtain in lapping liquid a, grinding is uniform;
(6) it is 7-8 to add suitable 10% sodium hydroxide solution and adjust pH, and grinding is uniform, adds water for injection and supplies body
Product, grinds well, and sampling carries out quality testing, is dispensed after qualified, to obtain the final product.
Embodiment five
The component and proportioning of gel for eye use are Chinese medicine composition impalpable powder 40g, carbomer93420g, Tween-80 2g, glycerine
15g, benzalkonium chloride 0.1g, appropriate pH adjusting agent, water for injection add to 1000g, make 100 altogether.
The preparation method of gel for eye use:
(1) the nine taste medicine such as calamine (forging), borneol, coral, muscone, bear gall is respectively crushed into impalpable powder, claims respectively
The medicinal powder of each recipe quantity is taken, it is stand-by;
(2) muscone, bear gall powder are mixed, with other seven flavor medicine powder facing-ups, crosses 200 mesh sieves, always taken after mixed 20min
Sample is examined, and it is qualified to examine, stand-by up to Chinese medicine composition impalpable powder;
(3) water for injection is measured in beaker, adds the carbomer of recipe quantity934, room temperature is swollen naturally to be stayed overnight, get Ka Bo
Nurse solution for standby;
(4) recipe quantity glycerine, Tween-80, preservative are weighed, respectively plus after the dissolving of a small amount of water, mixed solution is matched somebody with somebody with medicinal powder
Grind, obtain lapping liquid, medicinal powder is fully soaked and is uniformly dispersed;
(5) carbomer solution is added in the lapping liquid that step (4) obtains by several times, grinding is uniform;
(6) it is 7-8 to add suitable 10% sodium hydroxide solution and adjust pH, and grinding is uniform, adds water for injection and supplies body
Product, grinds well, and sampling carries out quality testing, is dispensed after qualified, to obtain the final product.
Embodiment six
The component and proportioning of gel for eye use are Chinese medicine composition impalpable powder 40g, carbomer9345g, hydroxyethyl cellulose 5g,
Glycerine 16.5g, benzalkonium chloride 0.1g, appropriate pH adjusting agent, water for injection add to 1000g, make 100 altogether.
The preparation method of gel for eye use:
(1) the nine taste medicine such as calamine (forging), borneol, coral, muscone, bear gall is respectively crushed into impalpable powder, claims respectively
The medicinal powder of each recipe quantity is taken, it is stand-by;
(2) muscone, bear gall powder are mixed, with other seven flavor medicine powder facing-ups, crosses 200 mesh sieves, always taken after mixed 20min
Sample is examined, and it is qualified to examine, stand-by up to Chinese medicine composition impalpable powder;
(3) water for injection is measured in beaker, adds the carbomer of recipe quantity934, room temperature is swollen naturally to be stayed overnight, get Ka Bo
Nurse solution for standby;
(4) water for injection is measured in beaker, adds the hydroxyethyl cellulose of recipe quantity, and room temperature is swollen overnight, obtains naturally
Hydroxyethyl cellulose solution is spare;
(5) weigh recipe quantity glycerine, Tween-80 and preservative to be dissolved with a small amount of water respectively, mixed solution and medicinal powder facing-up,
Lapping liquid a is obtained, medicinal powder is fully soaked, is uniformly dispersed;
(6) hydroxyethyl cellulose solution is stirred evenly, added by several times in the lapping liquid a that step (5) obtains, grinding is equal
It is even, obtain lapping liquid b;
(7) carbomer solution is stirred evenly, adds appropriate 10% sodium hydroxide solution, stir evenly, obtain transparent blank
Gel, adds in the lapping liquid b that step (6) obtains, stirs evenly;
(8) add water for injection and supply volume, grind well, sampling carries out quality testing, is dispensed after qualified, to obtain the final product.
Embodiment seven
The component and proportioning of gel for eye use are Chinese medicine composition impalpable powder 40g, carbomer9346g, hydroxyethyl cellulose 3g,
Glycerine 16.5g, Tween-80 2g, benzalkonium chloride 0.1g, appropriate pH adjusting agent, water for injection add to 1000g, make 100 altogether.
The preparation method of gel for eye use:
(1) the nine taste medicine such as calamine (forging), borneol, coral, muscone, bear gall is respectively crushed into impalpable powder, claims respectively
The medicinal powder of each recipe quantity is taken, it is stand-by;
(2) muscone, bear gall powder are mixed, with other seven flavor medicine powder facing-ups, crosses 200 mesh sieves, always taken after mixed 20min
Sample is examined, and it is qualified to examine, stand-by up to Chinese medicine composition impalpable powder;
(3) water for injection is measured in beaker, adds the carbomer of recipe quantity934, room temperature is swollen naturally to be stayed overnight, get Ka Bo
Nurse solution for standby;
(4) water for injection is measured in beaker, adds the hydroxyethyl cellulose of recipe quantity, and room temperature is swollen overnight, obtains naturally
Hydroxyethyl cellulose solution is spare;
(5) weigh recipe quantity glycerine, Tween-80 and preservative to be dissolved with a small amount of water respectively, mixed solution and medicinal powder facing-up,
Medicinal powder is fully soaked, be uniformly dispersed;
(6) hydroxyethyl cellulose solution is stirred evenly, added by several times in the lapping liquid that step (5) obtains, grinding is uniform;
(7) carbomer solution is stirred evenly, adds appropriate 10% sodium hydroxide solution, stir evenly, obtain transparent blank
Gel, adds in the lapping liquid that step (6) obtains, stirs evenly;
(8) add water for injection and supply volume, grind well, sampling carries out quality testing, is dispensed after qualified, to obtain the final product.
Embodiment eight
The component and proportioning of gel for eye use are Chinese medicine composition impalpable powder 40g, carbomer9806g, hydroxyethyl cellulose 4g,
Glycerine 13.3g, Tween-80 1g, benzalkonium chloride 0.1g, appropriate pH adjusting agent, water for injection add to 1000g, make 100 altogether.
The preparation method of gel for eye use:
(1) the nine taste medicine such as calamine (forging), borneol, coral, muscone, bear gall is respectively crushed into impalpable powder, claims respectively
The medicinal powder of each recipe quantity is taken, it is stand-by;
(2) muscone, bear gall powder are mixed, with other seven flavor medicine powder facing-ups, crosses 200 mesh sieves, always taken after mixed 20min
Sample is examined, and it is qualified to examine, stand-by up to Chinese medicine composition impalpable powder;
(3) water for injection is measured in beaker, adds the carbomer of recipe quantity980, room temperature is swollen naturally to be stayed overnight, get Ka Bo
Nurse solution for standby;
(4) water for injection is measured in beaker, adds the hydroxyethyl cellulose of recipe quantity, and room temperature is swollen overnight, obtains naturally
Hydroxyethyl cellulose solution is spare;
(5) weigh recipe quantity glycerine, Tween-80 and preservative to be dissolved with a small amount of water respectively, mixed solution and medicinal powder facing-up,
The lapping liquid a of acquisition, makes medicinal powder fully soak, is uniformly dispersed;
(6) hydroxyethyl cellulose solution is stirred evenly, added by several times in the lapping liquid a that step (5) obtains, grinding is equal
It is even, the lapping liquid b of acquisition;
(7) carbomer solution is stirred evenly, adds appropriate 10% sodium hydroxide solution, stir evenly, obtain transparent blank
Gel, adds in the lapping liquid b that step (6) obtains, stirs evenly;
(8) add water for injection and supply volume, grind well, sampling carries out quality testing, is dispensed after qualified, to obtain the final product.
Embodiment nine
The component and proportioning of gel for eye use are Chinese medicine composition impalpable powder 40g, AA-1 polycarbophil 4.5g, hydroxy ethyl fiber
Plain 3.3g, glycerine 16.5g, Tween-80 2g, benzalkonium chloride 0.1g, appropriate pH adjusting agent, water for injection add to 1000g, altogether system
100.
The preparation method of gel for eye use:
(1) the nine taste medicine such as calamine (forging), borneol, coral, muscone, bear gall is respectively crushed into impalpable powder, claims respectively
The medicinal powder of each recipe quantity is taken, it is stand-by;
(2) muscone, bear gall powder are mixed, with other seven flavor medicine powder facing-ups, crosses 200 mesh sieves, always taken after mixed 20min
Sample is examined, and it is qualified to examine, stand-by up to Chinese medicine composition impalpable powder;
(3) water for injection is measured in beaker, adds the AA-1 polycarbophils of recipe quantity, and room temperature is swollen overnight, obtains naturally
Carbomer solution is spare;
(4) water for injection is measured in beaker, adds the hydroxyethyl cellulose of recipe quantity, and room temperature is swollen overnight, obtains naturally
Hydroxyethyl cellulose solution is spare;
(5) weigh recipe quantity glycerine, Tween-80 and preservative to be dissolved with a small amount of water respectively, mixed solution and medicinal powder facing-up,
The lapping liquid a of acquisition, makes medicinal powder fully soak, is uniformly dispersed;
(6) hydroxyethyl cellulose solution is stirred evenly, added by several times in the lapping liquid a that step (5) obtains, grinding is equal
It is even, the lapping liquid b of acquisition;
(7) carbomer solution is stirred evenly, adds appropriate 10% sodium hydroxide solution, stir evenly, obtain transparent blank
Gel, adds in step (6) in lapping liquid b, stirs evenly;
(8) add water for injection and supply volume, grind well, sampling carries out quality testing, is dispensed after qualified, to obtain the final product.
Gel for eye long-term stable experiment is shown in Table 1
Gel for eye use stability test result prepared by 1 embodiment of the present invention nine of table
Embodiment ten
The component and proportioning of Eye ointments are Chinese medicine composition impalpable powder 40g, vaseline 340g, liquid paraffin 6g, lanolin
14g, make 100 altogether, 4g/ branch.
The preparation method of Eye ointments:
(1) the nine taste medicine such as calamine (forging), borneol, coral, muscone, bear gall is respectively crushed into impalpable powder, claims respectively
The medicinal powder of each recipe quantity is taken, it is stand-by;
(2) muscone, bear gall powder are mixed, with other seven flavor medicine powder facing-ups, crosses 200 mesh sieves, always taken after mixed 20min
Sample is examined, and it is qualified to examine, stand-by up to Chinese medicine composition impalpable powder;
(3) by matrix heating and melting, after filtering, sterilizing, is cooled to 50 DEG C;
(4) Chinese medicine composition impalpable powder is added in sterilizing liquid paraffin, stirred evenly, then add to sterilizing vaseline and lanolin
In, stir evenly, make solidification, be made, to obtain the final product.
Eye ointments long-term stable experiment is shown in Table 2
Eye ointments stability test result prepared by 2 embodiment of the present invention ten of table
Therefore, for the present invention using ophthalmically acceptable semisolid preparation of above-mentioned Chinese medicine composition and preparation method thereof, stability is high, stimulates
The small, good patient compliance of property.
Finally it should be noted that:The above embodiments are merely illustrative of the technical solutions of the present invention rather than is limited,
Although the present invention is described in detail with reference to preferred embodiments, it will be understood by those of ordinary skill in the art that:Its according to
So can be to technical scheme technical scheme is modified or replaced equivalently, and these modifications or equivalent substitution cannot also make to repair
Technical solution after changing departs from the spirit and scope of technical solution of the present invention.
Claims (10)
- A kind of 1. ophthalmically acceptable semisolid preparation of Chinese medicine composition, it is characterised in that:Including Chinese medicine composition and auxiliary material, the Chinese medicine group The component and parts by weight of compound for 90-110 parts of calamine, 0.5-1.5 parts of muscone, 25-35 parts of borneol, 4-6 parts of coral, 0.5-1.5 parts of bear gall, 4-6 parts of amber, 0.5-1.5 parts of pearl, 2-4 parts of cinnabar, 6-8 parts of borax;The ophthalmically acceptable semisolid preparation of Chinese medicine composition includes gel for eye and Eye ointments, the auxiliary material of the gel for eye by Pharmaceutically acceptable hydrophilic gel matrix and carrier composition, the auxiliary material of the Eye ointments is by pharmaceutically acceptable oleaginous base Composition;The Chinese herb medicine eye semisolid preparation is used to treating epidemic conjunctivitis, eye dazzles the outer drop of red rotten, sand holes, tearing against wind and nebula Illness in eye.
- A kind of 2. ophthalmically acceptable semisolid preparation of Chinese medicine composition according to claim 1, it is characterised in that:The Chinese traditional medicine composition The component and parts by weight of thing for 100 parts of calamine, 1 part of muscone, 30 parts of borneol, 5 parts of coral, 1 part of bear gall, 5 parts of amber, 1 part of pearl, 3 parts of cinnabar, 7 parts of borax.
- A kind of 3. ophthalmically acceptable semisolid preparation of Chinese medicine composition according to claim 1, it is characterised in that:The hydrophily is coagulated Gel matrix is carbomer, one or more kinds of mixtures in hydroxyethyl cellulose, methylcellulose, poloxamer, but Do not include hypromellose, sodium carboxymethylcellulose;The carrier is solubilizer, isotonic regulator, preservative, pH adjusting agent;The oleaginous base is vaseline, liquid paraffin, lanolin;The mixing that the solubilizer is Tween-80, one or more kinds of in PLURONICS F87, Crodaret Thing;The mixture that the isotonic regulator is glycerine, one or more kinds of in propane diols, sorbierite;The preservative is a kind of or a kind of in chloreresol, methyl hydroxybenzoate, the third fat of oxybenzene, thimerosal, benzalkonium chloride, sodium benzoate Mixture above;The pH adjusting agent is mixture one or more kinds of in sodium hydroxide, triethanolamine, sodium acid carbonate etc..
- A kind of 4. ophthalmically acceptable semisolid preparation of Chinese medicine composition according to claim 3, it is characterised in that:The gel for eye use The component and dosage of agent be:Chinese medicine composition 300-900mg, hydrophilic gel matrix 50-200mg, solubilizer 0-300mg, etc. Conditioning agent 5-300mg, preservative 0-10mg are oozed, pH adjusting agent is then added and adjusts solution acid alkalinity, add water to 10g.
- A kind of 5. ophthalmically acceptable semisolid preparation of Chinese medicine composition according to claim 3, it is characterised in that:The gel for eye use The component and dosage of agent are Chinese medicine composition 400mg, hydrophilic gel matrix 90mg, solubilizer 20mg, isotonic regulator 150mg, preservative 1mg, then add pH adjusting agent and adjust solution acid alkalinity, add water to 10g.
- A kind of 6. ophthalmically acceptable semisolid preparation of Chinese medicine composition according to claim 3, it is characterised in that:The Eye ointments Component and dosage are Chinese medicine composition 0.4-2g, vaseline 1-9g, liquid paraffin 0-1g, lanolin 0.06-1g.
- A kind of 7. ophthalmically acceptable semisolid preparation of Chinese medicine composition according to claim 3, it is characterised in that:The Eye ointments Component and dosage are Chinese medicine composition 0.4g, vaseline 3.4g, liquid paraffin 0.06g, lanolin 0.14g.
- 8. the preparation method of gel for eye in the ophthalmically acceptable semisolid preparation of Chinese medicine composition according to claim 3, it is special Sign is, comprises the steps of:(1) calamine, borneol, coral, muscone, bear gall, amber, pearl, cinnabar, borax this nine tastes medicine are crushed respectively, Then the medicinal powder of each component is weighed respectively;(2) medicinal powder of muscone, bear gall is mixed, then with other seven flavor medicine powder facing-ups of step (1), sieved, up to Chinese medicine Composition;(3) water, hydrophilic gel matrix are added in beaker, room temperature is swollen overnight naturally, after stirring evenly, obtains gel blank Matrix solution is spare;(4) isotonic regulator, solubilizer, preservative and Chinese medicine composition are added in beaker, is dissolved in water, medicinal powder is fully moistened It is wet, be uniformly dispersed, obtain solution a;(5) added by several times in the gel vehicle solution for obtaining step (3) in the solution a that step (4) obtains, grind or stir Mix uniformly;(6) it is 6-9 to add pH adjusting agent and adjust pH, grinds or stirs evenly, and is uniformly mixed after adding gauge water, sampling carries out Quality testing, dispenses, after qualified to obtain the final product.
- 9. the preparation method of gel for eye in the ophthalmically acceptable semisolid preparation of Chinese medicine composition according to claim 3, it is special Sign is, comprises the steps of:(1) calamine, borneol, coral, muscone, bear gall, amber, pearl, cinnabar, borax this nine tastes medicine are crushed respectively, The medicinal powder of each component is weighed respectively, it is stand-by;(2) muscone, bear gall powder are mixed, then with other seven flavor medicine powder facing-ups of step (1), sieved, after qualified, to obtain the final product Chinese medicine composition, it is stand-by;(3) water, hydrophilic gel matrix are added in beaker, room temperature is swollen overnight, stirs evenly, obtain gel bare substrate naturally Solution, adds pH adjusting agent, stirring, obtains solution a, spare;(4) isotonic regulator, solubilizer, preservative and Chinese medicine composition are taken, be dissolved in water facing-up, obtains solution b, fills medicinal powder Share in the benefit wet and be uniformly dispersed;(5) the solution a for obtaining step (3) is added in the solution b in step (4) by several times, is ground or is stirred evenly;(6) add gauge water, after uniform, sampling carries out quality testing, is dispensed after qualified, to obtain the final product.
- 10. the preparation method of Eye ointments, its feature exist in the ophthalmically acceptable semisolid preparation of Chinese medicine composition according to claim 3 In comprising the steps of:(1) calamine, borneol, coral, muscone, bear gall, amber, pearl, cinnabar, borax this nine tastes medicine are crushed respectively, The medicinal powder of each component is weighed respectively, it is stand-by;(2) muscone, bear gall powder are mixed, then with other seven flavor medicine powder facing-ups in step (1), sieved, after qualified, i.e., Chinese medicine composition is obtained, it is stand-by;(3) it will be put into cold liquid paraffin, stir evenly after the Chinese medicine composition obtained in step (2) sterilizing, filtration;It is then added to It has been sterilized that, filtered and be cooled in about 50 DEG C of vaseline and lanolin, stirred evenly, make solidification, to obtain the final product.
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