CN101716243A - Qingkailing gelling agent for eyes and preparation method thereof - Google Patents
Qingkailing gelling agent for eyes and preparation method thereof Download PDFInfo
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- CN101716243A CN101716243A CN200910256028A CN200910256028A CN101716243A CN 101716243 A CN101716243 A CN 101716243A CN 200910256028 A CN200910256028 A CN 200910256028A CN 200910256028 A CN200910256028 A CN 200910256028A CN 101716243 A CN101716243 A CN 101716243A
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Abstract
The invention relates to a qingkailing gelling agent for eyes and a preparation method thereof. The invention provides a local medicine for treating the inflammatory eye diseases such as the conjunctivitis, the keratitis, the iritis, the endophthalmitis and the like. The used auxiliary materials comprise a gel substrate, an osmotic pressure regulator, a bacteriostatic agent, a pH regulator and the like. In the invention, the medicament form of the medicine of qingkailing is enriched by optimizing the auxiliary materials and improving the process, a mode of local administration is adopted, as a result, the medicine directly reaches an acting position, the effective medicine concentration in eyes is increased, the administration dose is small, sothe adverse reaction caused by venous administration is effectively avoided.
Description
Technical field
The invention belongs to field of traditional Chinese, be specifically related to a kind of medicine for the treatment of ophthalmic diseases, the invention still further relates to QINGKAILING gel for eye use and preparation method thereof.
Background technology
QINKAILING ZHUSHEYE is the compound Chinese medicinal preparation of developing on the basis of name side " cow-bezoar bolus for resurrection " in ancient times; " QINGKAILING " has multiple dosage form at present; as injection, freeze-dried powder, granule, tablet, oral liquid etc., Main Ingredients and Appearance is cholic acid, Concha Margaritifera powder, Hyodeoxycholic Acid, Fructus Gardeniae, Cornu Bubali powder, Radix Isatidis, baicalin, Flos Lonicerae.Its function cures mainly and is heat-clearing and toxic substances removing, eleminating phlegm and freeing channels, consciousness and resuscitation restoring.Be used for calentura, coma, apoplectic hemiplegia, the obnubilation patient sees above-mentioned patient as acute hepatitis, upper respiratory tract infection, pneumonia, cerebral thrombosis, cerebral hemorrhage.Modern pharmacology studies have shown that the main effective ingredient of QINKAILING ZHUSHEYE is jasminoidin, baicalin, hyocholic acid, Concha Margaritifera etc., has microcirculation improvement, analgesic, calm, antiviral, antibacterial action, can suppress the growth of virus replication and various pathogens.We find that QINKAILING ZHUSHEYE also has better therapeutical effect to struvite oculopathy such as conjunctivitis, keratitis, iritis, endophthalmitis etc. in secular clinical practice.The clinical adverse of QINKAILING ZHUSHEYE intravenously administrable happens occasionally, and seriously restricts its extensive use in clinical.Diluted by the tear in the conjunctival sac immediately behind the common eye drop eye drip, and discharge from lacrimal passage very soon, action time is of short duration, is that the gel of substrate is as pharmaceutical carrier and adopt the high molecular weight hydrophilic polymer, the gel for eye that is prepared into has effectively solved the problems referred to above.
Summary of the invention
The objective of the invention is " QINKAILING ZHUSHEYE " prescription medical material, the Qingkailing gelling agent for eyes that adopts specific method for making to make is with the untoward reaction of avoiding QINKAILING ZHUSHEYE with satisfy the demand of clinical ophthalmology local application.
An object of the present invention is to provide a kind of QINGKAILING eye-gel preparation, the QINGKAILING ophthalmic preparation comprises situ-gel, the responsive gel of PH, thermosensitive in situ gel, ion-sensitive gel, and said preparation is better to multiple treatment of eye disorders effect.
Another object of the present invention provides a kind of preparation method of QINGKAILING gel for eye use, and the ophthalmic preparation of this method preparation plays slow releasing function, the bioavailability height.
For achieving the above object, the present invention is realized by following technical scheme:
The prescription of QINGKAILING gel for eye use:
13 parts of cholic acid
200 parts of Concha Margaritiferas
15 parts of Hyodeoxycholic Acid
100 parts of Fructus Gardeniaes
100 parts of Cornu Bubalis
800 parts of Radix Isatidis
20 parts of baicalins
80 parts of Flos Loniceraes
Gel-type vehicle 0.5-20 part
Osmotic pressure regulator 0.001-1 part
Antibacterial 0.001-1 part
PH regulator 0.001-1 part
Pure water or water for injection are an amount of
QINGKAILING gel for eye use 1000g or ml
Gel-type vehicle of the present invention is one or more a mixture of poloxamer, card pool nurse, polyvinyl alcohol, polyvidone, sodium carboxymethyl cellulose, chitosan, methylcellulose, hydroxyethyl-cellulose, hyaluronic acid, hyaluronate sodium, hyaluronic acid sodium, Polyethylene Glycol, hypromellose etc.
Osmotic pressure regulator of the present invention is wherein one or more a mixture such as sodium chloride, potassium chloride, glucose, Borax, boric acid, mannitol, glycerol.
Antibacterial of the present invention is to one or more mixture wherein such as hydroxyl Ethyl formate, phenoxyethanol, oxybenzene esters, sorbic acid, chlorobutanol.
PH regulator of the present invention is wherein one or more the mixture of Borax, boric acid, sodium dihydrogen phosphate, sodium hydroxide, triethylamine, sodium hydrogen phosphate, acetic acid, sodium acetate, hydrochloric acid, citric acid, sodium citrate etc.
Eye-gel preparation of the present invention is by active ingredient and suitable substrate, PH regulator, osmotic pressure agent of making gel, compositions such as antiseptic.
The following example only is used for illustrating the present invention, has no to limit the meaning of protection domain of the present invention.
Embodiment 1:
Prescription:
Cholic acid 13g
Concha Margaritifera 200g
Hyodeoxycholic Acid 15g
Fructus Gardeniae 100g
Cornu Bubali 100g
Radix Isatidis 800g
Baicalin 20g
Flos Lonicerae 80g
Card pool nurse 1g
Sodium chloride or potassium chloride 0.5g
Ethylparaben 0.5g
The PH regulator is an amount of
Pure water or water for injection are an amount of
QINGKAILING gel for eye use 1000g
Method for making:
(1) Radix Isatidis 800g decocts with water 2 times, and each 1 hour, collecting decoction filtered, and filtrate is concentrated into 200ml, adds ethanol and makes and contain the alcohol amount and reach 60%, and cold preservation filters, and filtrate recycling ethanol adds water, and cold preservation is standby.
(2) Fructus Gardeniae 100g decocts with water 2 times, and 1 hour for the first time, 0.5 hour for the second time, collecting decoction, filtrate is concentrated into 25ml, adds ethanol and makes and contain the alcohol amount and reach 60%, and cold preservation filters, and filtrate recycling ethanol adds water, and cold preservation is standby.
(3) Flos Lonicerae 80g decocts with water 2 times, each 0.5 hour, collecting decoction filters, and filtrate is concentrated into 60ml, add ethanol and make and contain alcohol amount and reach 75%, filter, filtrate is regulated pH value to 8.0, ethanol is reclaimed in cold preservation, adds ethanol again and makes and contain the alcohol amount and reach 85%, cold preservation filters filtrate recycling ethanol, add water, cold preservation is standby.
(4) Cornu Bubali powder 100g uses barium hydroxide solution; Concha Margaritifera powder 200g with respectively hydrolysis 7-9 hour of sulphuric acid, filters, and merging filtrate is regulated pH value to 3.5-4.0, filters, and filtrate adds ethanol to be made and contain the alcohol amount and reach 60%, and cold preservation filters, filtrate recycling ethanol, and cold preservation is standby.
(5) Fructus Gardeniae liquid, Radix Isatidis liquid and Cornu Bubali, Concha Margaritifera hydrolysis mixed liquor are merged after, be added in 75% alcoholic solution of cholic acid 13g, Hyodeoxycholic Acid 15g, mixing adds ethanol and makes and contain the alcohol amount and reach 75%, regulate pH value to 7.0, cold preservation filters, filtrate recycling ethanol adds water, and cold preservation is standby.
(6) baicalin 20g with the dissolving of pure water or water for injection, transfers pH value to 7.5, adds Flos Lonicerae extractive solution, and mixing merges with above-mentioned each reserve liquid, mixing, and add the injection water to 500ml, and again after charcoal treatment, cold preservation, standby as storing solution.
(7) under aseptic technique, take by weighing carbomer 10.0g and add a small amount of pure water or water for injection profit rise (at least 12 hours) earlier, add alkali (as sodium hydroxide, triethylamine etc.) and regulate pH to neutral, make substrate form sticky, even gel, ripening, add alkali again and regulate pH, form transparent gel-type vehicle to neutral
(8) the QINGKAILING storing solution with above-mentioned steps joins in the gel-type vehicle, stirs, and adds sodium chloride or potassium chloride, ethylparaben, PH regulator, add pure water or water for injection to 1000g, mix homogeneously, sterilization, packing promptly gets the QINGKAILING gel for eye use.
Gained QINGKAILING gel for eye use is yellow translucent, and the pH value scope is: 6-8, the osmotic pressure scope is: 300～400mosmol, the viscosity scope is: 45～75mPa.s.
Embodiment 2:
Prescription:
Cholic acid 13g
Concha Margaritifera 200g
Hyodeoxycholic Acid 15g
Fructus Gardeniae 100g
Cornu Bubali 100g
Radix Isatidis 800g
Baicalin 20g
Flos Lonicerae 80g
Hypromellose 5g
Glycerol 10g
Ethylparaben 0.5g
Triethylamine is an amount of
Pure water or water for injection are an amount of
QINGKAILING gel for eye use 1000g
Method for making:
(1) Radix Isatidis 800g decocts with water 2 times, and each 1 hour, collecting decoction filtered, and filtrate is concentrated into 200ml, adds ethanol and makes and contain the alcohol amount and reach 60%, and cold preservation filters, and filtrate recycling ethanol adds water, and cold preservation is standby.
(2) Fructus Gardeniae 100g decocts with water 2 times, and 1 hour for the first time, 0.5 hour for the second time, collecting decoction, filtrate is concentrated into 25ml, adds ethanol and makes and contain the alcohol amount and reach 60%, and cold preservation filters, and filtrate recycling ethanol adds water, and cold preservation is standby.
(3) Flos Lonicerae 80g decocts with water 2 times, each 0.5 hour, collecting decoction filters, and filtrate is concentrated into 60ml, add ethanol and make and contain alcohol amount and reach 75%, filter, filtrate is regulated pH value to 8.0, ethanol is reclaimed in cold preservation, adds ethanol again and makes and contain the alcohol amount and reach 85%, cold preservation filters filtrate recycling ethanol, add water, cold preservation is standby.
(4) Cornu Bubali powder 100g uses barium hydroxide solution; Concha Margaritifera powder 200g with respectively hydrolysis 7-9 hour of sulphuric acid, filters, and merging filtrate is regulated pH value to 3.5-4.0, filters, and filtrate adds ethanol to be made and contain the alcohol amount and reach 60%, and cold preservation filters, filtrate recycling ethanol, and cold preservation is standby.
(5) Fructus Gardeniae liquid, Radix Isatidis liquid and Cornu Bubali, Concha Margaritifera hydrolysis mixed liquor are merged after, be added in 75% alcoholic solution of cholic acid 13g, Hyodeoxycholic Acid 15g, mixing adds ethanol and makes and contain the alcohol amount and reach 75%, regulate pH value to 7.0, cold preservation filters, filtrate recycling ethanol adds water, and cold preservation is standby.
(6) baicalin 20g with the dissolving of pure water or water for injection, transfers pH value to 7.5, adds Flos Lonicerae extractive solution, and mixing merges with above-mentioned each reserve liquid, mixing, and add the injection water to 500ml, and again after charcoal treatment, cold preservation, standby as storing solution.
(7) A: under aseptic technique, take by weighing hypromellose 5.0g, rising with the solvent profit earlier, (solvent can be the aqueous solution of water or medicine, profit can adopt room temperature profit to rise or substrate directly be joined moisten in the solution of uniform temperature and rise when rising), the substrate profit rises and finishes, stir evenly, form gel-type vehicle.
B: under aseptic technique, take by weighing hypromellose 5.0g, the glycerol of adding 10%～20%, grind evenly, placed 30 minutes, adding solvent profit rises, and (solvent can be the aqueous solution of water or medicine, profit can adopt room temperature profit to rise or substrate directly be joined moisten in the solution of uniform temperature and rise when rising), the substrate profit rises and finishes, and stirs evenly, and forms gel-type vehicle.
(8) the QINGKAILING storing solution with above-mentioned steps joins in the gel-type vehicle, stirs, and glycerol, ethylparaben, PH regulator are added pure water or water for injection to 1000g, mix homogeneously, and sterilization, packing promptly gets the QINGKAILING gel for eye use.
Gained QINGKAILING gel for eye use is yellow translucent, and the pH value scope is: 6-8, the osmotic pressure scope is: 300～400mosmol, the viscosity scope is: 45～75mPa.s.
Embodiment 3:
Prescription:
Cholic acid 13g
Concha Margaritifera 200g
Hyodeoxycholic Acid 15g
Fructus Gardeniae 100g
Cornu Bubali 100g
Radix Isatidis 800g
Baicalin 20g
Flos Lonicerae 80g
Chitosan 25g
Glycerol 100mg
Propylene glycol 50mg
Triethylamine 10mg
Pure water or water for injection are an amount of
QINGKAILING gel for eye use 1000g
Method for making:
(1) Radix Isatidis 800g decocts with water 2 times, and each 1 hour, collecting decoction filtered, and filtrate is concentrated into 200ml, adds ethanol and makes and contain the alcohol amount and reach 60%, and cold preservation filters, and filtrate recycling ethanol adds water, and cold preservation is standby.
(2) Fructus Gardeniae 100g decocts with water 2 times, and 1 hour for the first time, 0.5 hour for the second time, collecting decoction, filtrate is concentrated into 25ml, adds ethanol and makes and contain the alcohol amount and reach 60%, and cold preservation filters, and filtrate recycling ethanol adds water, and cold preservation is standby.
(3) Flos Lonicerae 80g decocts with water 2 times, each 0.5 hour, collecting decoction filters, and filtrate is concentrated into 60ml, add ethanol and make and contain alcohol amount and reach 75%, filter, filtrate is regulated pH value to 8.0, ethanol is reclaimed in cold preservation, adds ethanol again and makes and contain the alcohol amount and reach 85%, cold preservation filters filtrate recycling ethanol, add water, cold preservation is standby.
(4) Cornu Bubali powder 100g uses barium hydroxide solution; Concha Margaritifera powder 200g with respectively hydrolysis 7-9 hour of sulphuric acid, filters, and merging filtrate is regulated pH value to 3.5-4.0, filters, and filtrate adds ethanol to be made and contain the alcohol amount and reach 60%, and cold preservation filters, filtrate recycling ethanol, and cold preservation is standby.
(5) Fructus Gardeniae liquid, Radix Isatidis liquid and Cornu Bubali, Concha Margaritifera hydrolysis mixed liquor are merged after, be added in 75% alcoholic solution of cholic acid 13g, Hyodeoxycholic Acid 15g, mixing adds ethanol and makes and contain the alcohol amount and reach 75%, regulate pH value to 7.0, cold preservation filters, filtrate recycling ethanol adds water, and cold preservation is standby.
(6) baicalin 20g with the dissolving of pure water or water for injection, transfers pH value to 7.5, adds Flos Lonicerae extractive solution, and mixing merges with above-mentioned each reserve liquid, mixing, and add the injection water to 500ml, and again after charcoal treatment, cold preservation, standby as storing solution.
(7) under aseptic technique, take by weighing the chitosan 25g of 90% deacetylation, add appropriate amount of purified water or water for injection and glacial acetic acid respectively, stirring at room makes dissolving, and swelling is spent the night, and forms clear gel substrate.
(8) the QINGKAILING storing solution with above-mentioned steps joins in the gel-type vehicle, stirs, add propylene glycol 5.0mg and glycerol 5.0mg mixing successively after, drip triethanolamine 1.0mg, add pure water or water for injection to 1000g, mix homogeneously, sterilization, packing promptly gets the QINGKAILING gel for eye use.
Gained QINGKAILING gel for eye use is yellow translucent, and the pH value scope is: 6-8, the osmotic pressure scope is: 300～400mosmol, the viscosity scope is: 45～75mPa.s.
Claims (6)
1. Qingkailing gelling agent for eyes, its active component is made up of with different proportionings cholic acid, Hyodeoxycholic Acid, baicalin, Fructus Gardeniae, Radix Isatidis, Flos Lonicerae, Cornu Bubali, Concha Margaritifera.It is characterized in that: the acceptable material of medicine that contains at least a formation gel.
2. according to the gel of claim 1, the prescription of its gel is:
13 parts of cholic acid
200 parts of Concha Margaritiferas
15 parts of Hyodeoxycholic Acid
100 parts of Fructus Gardeniaes
100 parts of Cornu Bubalis
800 parts of Radix Isatidis
20 parts of baicalins
80 parts of Flos Loniceraes
Gel-type vehicle 0.5-20 part
Osmotic pressure regulator 0.001-1 part
Antibacterial 0.001-1 part
PH regulator 0.001-1 part
Pure water or water for injection are an amount of
QINGKAILING gel for eye use 1000g or ml
3. according to the gel of claim 1, its characteristics are that prepared gel is applied to the various diseases associated with inflammation of ophthalmology.
4. according to the preparation method of claim 1,2 described gels, be characterized in: the QINGKAILING gel is in preparation process, the QINGKAILING crude drug through handling, is made the herbal extract or the extract of QINGKAILING gel for eye use, and the ratio of extracting liquid volume and medical material weight is 1000: 100-10000.
5. according to the preparation method of claim 1,2,3 described gels, be characterised in that adjuvants such as adding gel-type vehicle, PH regulator, osmotic pressure regulator make:
(a) gel-type vehicle is one or more a mixture of poloxamer, card pool nurse, polyvinyl alcohol, polyvidone, sodium carboxymethyl cellulose, chitosan, methylcellulose, hydroxyethyl-cellulose, hyaluronic acid, hyaluronate sodium, hyaluronic acid sodium, Polyethylene Glycol, hypromellose etc.;
(b) osmotic pressure regulator is wherein one or more a mixture such as sodium chloride, potassium chloride, glucose, Borax, boric acid, mannitol, glycerol;
(c) antibacterial is to one or more mixture wherein such as hydroxyl Ethyl formate, phenoxyethanol, oxybenzene esters, sorbic acid, chlorobutanol;
(d) the PH regulator is wherein one or more the mixture of Borax, boric acid, sodium dihydrogen phosphate, sodium hydroxide, triethylamine, sodium hydrogen phosphate, acetic acid, sodium acetate, hydrochloric acid, citric acid, sodium citrate etc.;
(e) preferred hydroxy methocel, its model is 30000～90000mpas, concentration is 0.2%-1.5%;
(f) regulating PH is 5-9;
(g) the osmotic pressure scope is: 200～500mosmol;
(h) viscosity is: 45～75mPa.s.
6. according to the preparation method of the described gel of claim 1-5, may further comprise the steps:
(1) Radix Isatidis decocts with water 2 times, and each 1 hour, collecting decoction filtered, and filtrate is concentrated into 200ml, adds ethanol and makes and contain the alcohol amount and reach 60%, and cold preservation filters, and filtrate recycling ethanol adds water, and cold preservation is standby;
(2) Fructus Gardeniae decocts with water 2 times, and 1 hour for the first time, 0.5 hour for the second time, collecting decoction, filtrate is concentrated into 25ml, adds ethanol and makes and contain the alcohol amount and reach 60%, and cold preservation filters, and filtrate recycling ethanol adds water, and cold preservation is standby;
(3) Flos Lonicerae decocts with water 2 times, and each 0.5 hour, collecting decoction, filter, filtrate is concentrated into 60ml, adds ethanol and makes and contain the alcohol amount and reach 75%, filter, filtrate is regulated pH value to 8.0, cold preservation, reclaim ethanol, add ethanol again and make and contain the alcohol amount and reach 85%, cold preservation, filter, filtrate recycling ethanol adds water, and cold preservation is standby;
(4) Cornu Bubali powder barium hydroxide solution, Concha Margaritifera powder filters with respectively hydrolysis 7-9 hour of sulphuric acid, and merging filtrate is regulated pH value to 3.5-4.0, filters, and filtrate adds ethanol to be made and contains the alcohol amount and reach 60%, and cold preservation filters, filtrate recycling ethanol, cold preservation is standby;
(5) Fructus Gardeniae liquid, Radix Isatidis liquid and Cornu Bubali, Concha Margaritifera hydrolysis mixed liquor are merged after, be added in 75% alcoholic solution of cholic acid, Hyodeoxycholic Acid, mixing adds ethanol and makes and contain the alcohol amount and reach 75%, regulate pH value to 7.0, cold preservation filters, filtrate recycling ethanol adds water, and cold preservation is standby;
(6) baicalin dissolves with water for injection, transfers pH value to 7.5, adds Flos Lonicerae extractive solution, and mixing merges with above-mentioned each reserve liquid, mixing, and add the injection water to 500ml, and again after charcoal treatment, cold preservation, standby as storing solution;
(7) get gel-type vehicle, after adding appropriate amount of purified water or water for injection dissolving are expanded, add osmotic pressure regulator, antibacterial again, heating makes it dissolving, adds the PH regulator again, makes solution be neutrality;
(8) the QINGKAILING storing solution with above-mentioned steps joins in the gel-type vehicle, stirs, and mix homogeneously is added pure water or water for injection to 1000g, sterilization, and packing promptly gets the QINGKAILING gel for eye use.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910256028A CN101716243A (en) | 2009-12-21 | 2009-12-21 | Qingkailing gelling agent for eyes and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200910256028A CN101716243A (en) | 2009-12-21 | 2009-12-21 | Qingkailing gelling agent for eyes and preparation method thereof |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101716243A true CN101716243A (en) | 2010-06-02 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200910256028A Pending CN101716243A (en) | 2009-12-21 | 2009-12-21 | Qingkailing gelling agent for eyes and preparation method thereof |
Country Status (1)
| Country | Link |
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| CN (1) | CN101716243A (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103070948A (en) * | 2012-11-07 | 2013-05-01 | 山东施尔明眼科医院 | Pharmaceutical composition for treating eye diseases and preparation method |
| CN103520227A (en) * | 2013-10-09 | 2014-01-22 | 南京农业大学 | Injectable Isatis Root in-situ gel, and preparation method thereof |
-
2009
- 2009-12-21 CN CN200910256028A patent/CN101716243A/en active Pending
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103070948A (en) * | 2012-11-07 | 2013-05-01 | 山东施尔明眼科医院 | Pharmaceutical composition for treating eye diseases and preparation method |
| CN103070948B (en) * | 2012-11-07 | 2014-12-03 | 山东施尔明眼科医院 | Pharmaceutical composition for treating eye diseases and preparation method |
| CN103520227A (en) * | 2013-10-09 | 2014-01-22 | 南京农业大学 | Injectable Isatis Root in-situ gel, and preparation method thereof |
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Application publication date: 20100602 |