阅读说明：本技术 一种中药组合物眼用半固体制剂及其制备方法 (A Chinese medicinal composition semi-solid preparation for eye use, and its preparation method ) 是由 郝秋实 孙立霞 方夏琴 于 2017-12-08 设计创作，主要内容包括：本发明公开了一种中药组合物眼用半固体制剂,所述中药组合物的组分和重量份数为炉甘石90～110份、人工麝香0.5～1.5份、冰片25～35份、珊瑚4～6份、熊胆0.5～1.5份、琥珀4～6份、珍珠0.5～1.5份、朱砂2～4份、硼砂6～8份；所述中药组合物眼用半固体制剂包括眼用凝胶剂和眼膏剂,所述眼用凝胶剂的辅料由药物可接受的亲水性凝胶基质和载体组成,所述眼膏剂的辅料由药物可接受的油脂性基质组成。本发明采用上述组分的中药组合物眼用半固体制剂及其制备方法,稳定性高、刺激性小、患者顺应性好。(The invention discloses a semi-solid preparation of a traditional Chinese medicine composition for eyes, which comprises, by weight, 90-110 parts of calamine, 0.5-1.5 parts of artificial musk, 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 and 6-8 parts of borax; the traditional Chinese medicine composition ophthalmic semisolid preparation comprises an ophthalmic gel and an ophthalmic ointment, wherein an auxiliary material of the ophthalmic gel consists of a pharmaceutically acceptable hydrophilic gel matrix and a carrier, and an auxiliary material of the ophthalmic ointment consists of a pharmaceutically acceptable oleaginous matrix. The traditional Chinese medicine composition ophthalmic semisolid preparation adopting the components and the preparation method thereof have the advantages of high stability, small irritation and good patient compliance.)

1. A traditional Chinese medicine composition is characterized in that: the traditional Chinese medicine composition comprises, by weight, 90-110 parts of calamine, 0.5-1.5 parts of artificial musk, 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 and 6-8 parts of borax.

2. The traditional Chinese medicine composition according to claim 1, wherein: the traditional Chinese medicine composition comprises, by weight, 100 parts of calamine, 1 part of artificial musk, 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 and 7 parts of borax.

3. The ophthalmic semisolid preparation of the traditional Chinese medicine composition prepared from the traditional Chinese medicine composition according to claim 1, which is characterized in that: the traditional Chinese medicine composition ophthalmic semisolid preparation comprises an ophthalmic gel and an ophthalmic ointment.

4. The ophthalmic semisolid preparation of a traditional Chinese medicine composition according to claim 3, which is characterized in that: the ophthalmic gel comprises the following components in parts by weight: the traditional Chinese medicine composition comprises 900mg of the traditional Chinese medicine composition, 50-200mg of the hydrophilic gel matrix, 0-300mg of the solubilizer, 5-300mg of the isotonic regulator and 0-10mg of the preservative, then the pH regulator is added to regulate the pH value of the solution, and the water is added to 10 g.

5. The ophthalmic semisolid preparation of a traditional Chinese medicine composition according to claim 3, which is characterized in that: the components and the dosage of the ophthalmic gel are 400mg of the traditional Chinese medicine composition, 90mg of the hydrophilic gel matrix, 20mg of the solubilizer, 150mg of the isotonic regulator and 1mg of the preservative, then the pH regulator is added to regulate the pH value of the solution, and water is added to 10 g.

6. The ophthalmic semisolid preparation of a traditional Chinese medicine composition according to claim 3, which is characterized in that: the components and the dosage of the eye ointment are 0.4 to 2g of traditional Chinese medicine composition, 1 to 9g of vaseline, 0 to 1g of liquid paraffin and 0.06 to 1g of lanolin.

7. The ophthalmic semi-solid preparation of the traditional Chinese medicine composition according to claim 3, wherein the components and the dosage of the eye ointment are 0.4g of the traditional Chinese medicine composition, 3.4g of vaseline, 0.06g of liquid paraffin and 0.14g of lanolin.

8. The ophthalmic semisolid preparation of the traditional Chinese medicine composition according to claim 3, wherein the preparation method of the ophthalmic gel comprises the following steps:

(1) respectively pulverizing Galamina, Borneolum Syntheticum, Corallium japonicum Kishinouye, Moschus, fel Ursi, Succinum, Margarita, Cinnabaris, and Borax, and respectively weighing the medicinal powders;

(2) mixing the powders of artificial Moschus and fel Ursi, grinding with the rest powders of the above seven materials in step (1), and sieving to obtain Chinese medicinal composition;

(3) adding water and a hydrophilic gel matrix into a beaker, naturally swelling at normal temperature overnight, and uniformly stirring to obtain a gel blank matrix solution for later use;

(4) adding an isotonic regulator, a solubilizer, a preservative and a traditional Chinese medicine composition into a beaker, adding water for dissolving, and fully wetting and uniformly dispersing the medicinal powder to obtain a solution a;

(5) adding the gel blank matrix solution obtained in the step (3) into the solution a obtained in the step (4) in a plurality of times, and grinding or uniformly stirring;

(6) adding pH regulator to adjust pH to 6-9, grinding or stirring, adding quantitative water, mixing, sampling, quality testing, and packaging.

9. The ophthalmic semisolid preparation of the traditional Chinese medicine composition according to claim 3, wherein the preparation method of the ophthalmic gel comprises the following steps:

(1) respectively pulverizing Galamina, Borneolum Syntheticum, Corallium japonicum Kishinouye, Moschus, fel Ursi, Succinum, Margarita, Cinnabaris, and Borax, and respectively weighing the medicinal powders;

(2) mixing artificial Moschus and fel Ursi powder, grinding with the rest seven medicinal powders in step (1), sieving, and making into Chinese medicinal composition;

(3) adding water and a hydrophilic gel matrix into a beaker, naturally swelling at normal temperature overnight, uniformly stirring to obtain a gel blank matrix solution, adding a pH regulator, and stirring to obtain a solution a for later use;

(4) dissolving isoosmotic adjusting agent, solubilizer, antiseptic and Chinese medicinal composition in water, and grinding to obtain solution b for thoroughly moistening and uniformly dispersing medicinal powder;

(5) adding the solution a obtained in the step (3) into the solution b obtained in the step (4) for several times, and grinding or uniformly stirring;

(6) adding quantitative water, homogenizing, sampling, performing quality detection, and packaging.

10. The ophthalmic semi-solid preparation of the traditional Chinese medicine composition according to claim 3, wherein the preparation method of the eye ointment comprises the following steps:

(1) respectively pulverizing Galamina, Borneolum Syntheticum, Corallium japonicum Kishinouye, Moschus, fel Ursi, Succinum, Margarita, Cinnabaris, and Borax, and respectively weighing the medicinal powders;

(2) mixing artificial Moschus and fel Ursi powder, grinding with the rest seven medicinal powders in step (1), sieving, and making into Chinese medicinal composition;

(3) sterilizing and filtering the traditional Chinese medicine composition obtained in the step (2), then putting the traditional Chinese medicine composition into cold liquid paraffin, and uniformly stirring; adding into sterilized vaseline and lanoline cooled to 50 deg.C, stirring, and coagulating.

Technical Field

The invention relates to the technical field of ophthalmic medicines, in particular to an ophthalmic semisolid preparation of a traditional Chinese medicine composition and a preparation method thereof.

Background

The eye is a fragile organ of a human body, statistics shows that the eye preparation solution type eye drops account for more than 60 percent, are convenient to use, easy to formulate and good in compliance and are easily accepted by a large number of patients, but with the intensive study of biopharmaceutics and pharmacokinetics, the problems of short residence time of eye medicines, low bioavailability and the like of the conventional eye drops are found, only less than 5 percent of medicines reach the eye through a cornea to play a role, and the treatment effect of eye administration is greatly influenced.

The gel administration system refers to that the medicine and auxiliary materials capable of forming gel are prepared into thick liquid or semisolid of emulsion in a uniform, suspension or emulsion form. Topical gel belongs to single-phase dispersion system, and comprises aqueous gel and oil phase gel, wherein the main matrix of the aqueous gel generally comprises water, glycerol or propylene glycol and cellulose derivative, carbomer and alginate, tragacanth, gelatin, and starch; the main matrix of the oily gel consists of liquid paraffin, polyoxyethylene or fatty oil, colloidal silica or aluminum soap and zinc soap.

The application of the traditional Chinese medicine in ophthalmology has uniqueness and recuperation, the Jinniu eye medicine is a famous formula of the traditional Chinese medicine, has a history of being named as 'Jinniu Babao eye medicine', and consists of mineral substances, bear gall, artificial musk, borneol, coral and the like. The Chinese medicine has been obtained for more than three hundred years from the beginning of Ming dynasty, has a specific medicine name for treating eye diseases in China, is a preferred brand for eye disease patients, is a national non-material cultural heritage, and has obvious clinical curative effect on treating exopathic eye diseases such as fulminant conjunctivitis, trachoma, epiphora induced by wind, veillancy nebula and the like. However, the powder is used, and when the powder is used, a small glass rod is used for dipping the powder and coating the powder on eyes, so that the use is inconvenient and the compliance is poor. Chinese patent CN101579393A discloses a traditional Chinese medicine ophthalmic preparation and its preparation process, wherein gel matrix comprises hydroxypropyl methylcellulose, sodium carboxymethylcellulose, methylcellulose, ethylcellulose and carbomer, according to the record of related data and related experiments, the sodium carboxymethylcellulose, hydroxypropyl methylcellulose and calamine in the ophthalmic gel matrix have incompatibility, and the dosage of methylcellulose and ethylcellulose is higher, and the using effect is poor.

Disclosure of Invention

The invention aims to provide a traditional Chinese medicine composition ophthalmic semisolid preparation and a preparation method thereof, which have the advantages of high stability, small irritation and good patient compliance.

In order to realize the purpose, the invention provides a traditional Chinese medicine composition, which comprises 90-110 parts of calamine, 0.5-1.5 parts of artificial musk, 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 and 6-8 parts of borax by weight;

preferably, the traditional Chinese medicine composition comprises, by weight, 100 parts of calamine, 1 part of artificial musk, 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 and 7 parts of borax.

The invention provides a traditional Chinese medicine composition ophthalmic semisolid preparation prepared from the traditional Chinese medicine composition, and the traditional Chinese medicine composition ophthalmic semisolid preparation comprises an ophthalmic gel and an ophthalmic ointment.

Preferably, the ophthalmic gel comprises the following components in percentage by weight: the traditional Chinese medicine composition comprises 900mg of the traditional Chinese medicine composition, 50-200mg of the hydrophilic gel matrix, 0-300mg of the solubilizer, 5-300mg of the isotonic regulator and 0-10mg of the preservative, then the pH regulator is added to regulate the pH value of the solution, and the water is added to 10 g.

More preferably, the components and the dosage of the ophthalmic gel are 400mg of the traditional Chinese medicine composition, 90mg of the hydrophilic gel matrix, 20mg of the solubilizer, 150mg of the isotonic regulator and 1mg of the preservative, then the pH regulator is added to regulate the pH value of the solution, and the water is added to 10 g.

Preferably, the components and the dosage of the eye ointment are 0.4 to 2g of the traditional Chinese medicine composition, 1 to 9g of vaseline, 0 to 1g of liquid paraffin and 0.06 to 1g of lanolin.

More preferably, the components and the dosage of the eye ointment are 0.4g of traditional Chinese medicine composition, 3.4g of vaseline, 0.06g of liquid paraffin and 0.14g of lanolin.

The invention provides a preparation method of the traditional Chinese medicine composition ophthalmic gel, which comprises the following steps:

(1) respectively pulverizing Galamina, Borneolum Syntheticum, Corallium japonicum Kishinouye, Moschus, fel Ursi, Succinum, Margarita, Cinnabaris, and Borax, and respectively weighing the medicinal powders;

(2) mixing the powders of artificial Moschus and fel Ursi, grinding with the rest powders of the above seven materials in step (1), and sieving to obtain Chinese medicinal composition;

(3) adding water and a hydrophilic gel matrix into a beaker, naturally swelling at normal temperature overnight, and uniformly stirring to obtain a gel blank matrix solution for later use;

(4) adding an isotonic regulator, a solubilizer, a preservative and a traditional Chinese medicine composition into a beaker, adding water for dissolving, and fully wetting and uniformly dispersing the medicinal powder to obtain a solution a;

(5) adding the gel blank matrix solution obtained in the step (3) into the solution a obtained in the step (4) in a plurality of times, and grinding or uniformly stirring;

(6) adding pH regulator to adjust pH to 6-9, grinding or stirring, adding quantitative water, mixing, sampling, quality testing, and packaging.

The invention also provides another preparation method of the traditional Chinese medicine composition ophthalmic gel, which comprises the following steps:

(1) respectively pulverizing Galamina, Borneolum Syntheticum, Corallium japonicum Kishinouye, Moschus, fel Ursi, Succinum, Margarita, Cinnabaris, and Borax, and respectively weighing the medicinal powders;

(2) mixing artificial Moschus and fel Ursi powder, grinding with the rest seven medicinal powders in step (1), sieving, and making into Chinese medicinal composition;

(3) adding water and a hydrophilic gel matrix into a beaker, naturally swelling at normal temperature overnight, uniformly stirring to obtain a gel blank matrix solution, adding a pH regulator, and stirring to obtain a solution a for later use;

(4) dissolving isoosmotic adjusting agent, solubilizer, antiseptic and Chinese medicinal composition in water, and grinding to obtain solution b for thoroughly moistening and uniformly dispersing medicinal powder;

(5) adding the solution a obtained in the step (3) into the solution b obtained in the step (4) for several times, and grinding or uniformly stirring;

(6) adding quantitative water, homogenizing, sampling, performing quality detection, and packaging.

The invention provides a preparation method of the traditional Chinese medicine composition eye ointment, which comprises the following steps:

(1) respectively pulverizing Galamina, Borneolum Syntheticum, Corallium japonicum Kishinouye, Moschus, fel Ursi, Succinum, Margarita, Cinnabaris, and Borax, and respectively weighing the medicinal powders;

(2) mixing artificial Moschus and fel Ursi powder, grinding with the rest seven medicinal powders in step (1), sieving, and making into Chinese medicinal composition;

(3) sterilizing and filtering the traditional Chinese medicine composition obtained in the step (2), then putting the traditional Chinese medicine composition into cold liquid paraffin, and uniformly stirring; adding into sterilized vaseline and lanoline cooled to 50 deg.C, stirring, and coagulating.

Therefore, the ophthalmic semisolid preparation of the traditional Chinese medicine composition and the preparation method thereof have the advantages of high stability, small irritation and good patient compliance.

The technical solution of the present invention is further described in detail by the following examples.

Detailed Description

The invention provides a traditional Chinese medicine composition, which preferably comprises, by weight, 90-110 parts of calamine, 0.5-1.5 parts of artificial musk, 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 and 6-8 parts of borax; more preferably 100 parts of calamine, 1 part of artificial musk, 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 and 7 parts of borax. In the present invention, all the raw material components are commercially available products well known to those skilled in the art unless otherwise specified.

The invention provides a traditional Chinese medicine composition ophthalmic semisolid preparation prepared from the traditional Chinese medicine composition, and the traditional Chinese medicine composition ophthalmic semisolid preparation comprises an ophthalmic gel and an ophthalmic ointment. The auxiliary material of the ophthalmic gel consists of a pharmaceutically acceptable hydrophilic gel matrix and a carrier, and the auxiliary material of the eye ointment consists of a pharmaceutically acceptable oleaginous matrix.

The hydrophilic gel matrix is one or a mixture of more than one of carbomer, hydroxyethyl cellulose, methylcellulose and poloxamer, but does not comprise hydroxypropyl methylcellulose and sodium carboxymethylcellulose; the carrier is a solubilizer, an isotonic regulator, a preservative and a pH regulator; the oleaginous base is vaseline, liquid paraffin, and lanolin; the solubilizer is one or a mixture of more than one of tween-80, poloxamer 188 and polyoxyethylene hydrogenated castor oil; the isoosmotic adjusting agent is one or a mixture of more than one of glycerol, propylene glycol and sorbitol; the antiseptic is one or more of chlorocresol, methyl hydroxybenzoate, propyl hydroxybenzoate, thimerosal, benzalkonium chloride, and sodium benzoate; the pH regulator is one or more of sodium hydroxide, triethanolamine, sodium bicarbonate, etc.

In the present invention, the components and the dosage of the ophthalmic gel are preferably as follows: the traditional Chinese medicine composition comprises 900mg of the traditional Chinese medicine composition, 50-200mg of the hydrophilic gel matrix, 0-300mg of the solubilizer, 5-300mg of the isotonic regulator and 0-10mg of the preservative, then the pH regulator is added to regulate the pH value of the solution, and water is added to 10 g; more preferably 400mg of the traditional Chinese medicine composition, 90mg of the hydrophilic gel matrix, 20mg of the solubilizer, 150mg of the isotonic regulator and 1mg of the preservative, then the pH regulator is added to regulate the pH value of the solution, and water is added to 10 g.

In the invention, the components and the dosage of the eye ointment are preferably 0.4g of traditional Chinese medicine composition, 3.4g of vaseline, 0.06g of liquid paraffin and 0.14g of lanolin.

The invention provides a preparation method of the traditional Chinese medicine composition ophthalmic gel, which comprises the following steps:

(1) respectively pulverizing Galamina, Borneolum Syntheticum, Corallium japonicum Kishinouye, Moschus, fel Ursi, Succinum, Margarita, Cinnabaris, and Borax, and respectively weighing the medicinal powders;

(2) mixing the powders of artificial Moschus and fel Ursi, grinding with the rest powders of the above seven materials in step (1), and sieving to obtain Chinese medicinal composition;

(3) adding water and a hydrophilic gel matrix into a beaker, naturally swelling at normal temperature overnight, and uniformly stirring to obtain a gel blank matrix solution for later use;

(4) adding an isotonic regulator, a solubilizer, a preservative and a traditional Chinese medicine composition into a beaker, adding water for dissolving, and fully wetting and uniformly dispersing the medicinal powder to obtain a solution a;

(5) adding the gel blank matrix solution obtained in the step (3) into the solution a obtained in the step (4) in a plurality of times, and grinding or uniformly stirring;

(6) adding pH regulator to adjust pH to 6-9, grinding or stirring, adding quantitative water, mixing, sampling, quality testing, and packaging.

The invention provides another preparation method of the traditional Chinese medicine composition ophthalmic gel, which comprises the following steps:

(1) respectively pulverizing Galamina, Borneolum Syntheticum, Corallium japonicum Kishinouye, Moschus, fel Ursi, Succinum, Margarita, Cinnabaris, and Borax, and respectively weighing the medicinal powders;

(2) mixing artificial Moschus and fel Ursi powder, grinding with the rest seven medicinal powders in step (1), sieving, and making into Chinese medicinal composition;

(3) adding water and a hydrophilic gel matrix into a beaker, naturally swelling at normal temperature overnight, uniformly stirring to obtain a gel blank matrix solution, adding a pH regulator, and stirring to obtain a solution a for later use;

(4) dissolving isoosmotic adjusting agent, solubilizer, antiseptic and Chinese medicinal composition in water, and grinding to obtain solution b for thoroughly moistening and uniformly dispersing medicinal powder;

(5) adding the solution a obtained in the step (3) into the solution b obtained in the step (4) for several times, and grinding or uniformly stirring;

(6) adding quantitative water, homogenizing, sampling, performing quality detection, and packaging.

The invention also provides a preparation method of the traditional Chinese medicine composition eye ointment, which comprises the following steps:

(1) respectively pulverizing Galamina, Borneolum Syntheticum, Corallium japonicum Kishinouye, Moschus, fel Ursi, Succinum, Margarita, Cinnabaris, and Borax, and respectively weighing the medicinal powders;

(2) mixing artificial Moschus and fel Ursi powder, grinding with the rest seven medicinal powders in step (1), sieving, and making into Chinese medicinal composition;

(3) sterilizing and filtering the traditional Chinese medicine composition obtained in the step (2), then putting the traditional Chinese medicine composition into cold liquid paraffin, and uniformly stirring; adding into sterilized vaseline and lanoline cooled to 50 deg.C, stirring, and coagulating

The invention also provides application of the semi-solid preparation of the traditional Chinese medicine composition in treating exopathic eye diseases such as fulminant fire eyes, red and rotten eyes, trachoma, lacrimation against wind and nebula.

The technical solution of the present invention will be clearly and completely described below with reference to the embodiments of the present invention. It is to be understood that the described embodiments are merely exemplary of the invention, and not restrictive of the full scope of the invention. All other embodiments, which can be derived by a person skilled in the art from the embodiments given herein without making any creative effort, shall fall within the protection scope of the present invention.

Example one

A Chinese medicinal composition, YAN ZHU SHE YU ZHI JI (ophthalmic semisolid preparation), comprises ophthalmic gel and eye ointment, and can be used for treating acute conjunctivitis, conjunctival congestion, trachoma, epiphora induced by wind, and nebula. The stability test proves that all indexes meet the regulations within 24 months at room temperature. The irritation test proves that the product has small irritation and strong applicability. The preparation product of the invention has the following physical and chemical properties: the product is a light reddish brown semisolid preparation. The preparation product of the invention has the advantages that: improves the compliance of patients, has strong affinity with medicinal parts, long retention time and small toxic and side effects.

The traditional Chinese medicine composition semi-solid preparation for eyes comprises 90-110 parts of calamine, 0.5-1.5 parts of artificial musk, 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 and 6-8 parts of borax.

The auxiliary material of the ophthalmic gel consists of a pharmaceutically acceptable hydrophilic gel matrix and a carrier, and the auxiliary material of the eye ointment consists of a pharmaceutically acceptable oleaginous matrix; the viscosity of the ophthalmic gel decreases with increasing shear rate, having good rheological properties. The viscosity of the prepared ophthalmic gel is reduced along with the increase of the shearing speed, the ophthalmic gel has pseudoplastic fluid property, is adaptive to the physiology of eyes, generates shearing force when a patient blinks, is easy to absorb, can not cause discomfort of the eyes, recovers after the blinking is finished, and does not influence the retention time of the ophthalmic gel in the eyes.

The hydrophilic gel matrix is one or more of carbomer, hydroxyethyl cellulose, methylcellulose, poloxamer, etc., but does not include hydroxypropyl methylcellulose and sodium carboxymethylcellulose, and the two common ophthalmic gel matrices have incompatibility with mineral substances and can generate insoluble precipitate.

The carrier is solubilizer, isotonic regulator, preservative and pH regulator;

the oleaginous base is vaseline, liquid paraffin, and lanoline;

the solubilizer is one or more of tween-80, poloxamer 188, polyoxyethylene hydrogenated castor oil, etc., preferably tween-80;

the isoosmotic adjusting agent is one or more of glycerol, propylene glycol and sorbitol, preferably glycerol;

the antiseptic is one or more of chlorocresol, methyl hydroxybenzoate, propyl hydroxybenzoate, thimerosal, benzalkonium chloride, and sodium benzoate;

the pH regulator is one or more of sodium hydroxide, triethanolamine, and sodium bicarbonate, preferably sodium hydroxide.

The ophthalmic gel comprises the following components in parts by weight: the traditional Chinese medicine composition comprises 900mg of the traditional Chinese medicine composition, 50-200mg of the hydrophilic matrix, 0-300mg of the solubilizer, 5-300mg of the isotonic regulator, 0-10mg of the preservative and a proper amount of the pH regulator, and water is added until 10 g.

The components and dosage of the eye ointment are 0.4-2g of traditional Chinese medicine composition, 1-9g of vaseline, 0-1g of liquid paraffin and 0.06-1g of lanolin, and the eye ointment is prepared into 2-10g of ointment.

The preparation method of the ophthalmic gel comprises the following steps:

(1) respectively pulverizing Galamina, Borneolum Syntheticum, Corallium japonicum Kishinouye, Moschus, fel Ursi, Succinum, Margarita, Cinnabaris, and Borax, and respectively weighing the medicinal powders;

(2) mixing the powders of artificial Moschus and fel Ursi, grinding with the rest powders of the above seven materials in step (1), and sieving to obtain Chinese medicinal composition;

(3) adding water and a hydrophilic gel matrix into a beaker, naturally swelling at normal temperature overnight, and uniformly stirring to obtain a gel blank matrix solution for later use;

(4) adding an isotonic regulator, a solubilizer, a preservative and a traditional Chinese medicine composition, adding water for dissolving, fully wetting and uniformly dispersing the medicinal powder to obtain a solution a;

(5) adding the gel blank matrix solution obtained in the step (3) into the solution a obtained in the step (4) in a plurality of times, and grinding or uniformly stirring;

(6) adding sodium hydroxide solution to adjust pH to 6-9, grinding or stirring, adding quantitative water, mixing, sampling, quality testing, and packaging.

The preparation method of the eye ointment comprises the following steps:

(1) respectively pulverizing Galamina, Borneolum Syntheticum, Corallium japonicum Kishinouye, Moschus, fel Ursi, Succinum, Margarita, Cinnabaris, and Borax, and respectively weighing the medicinal powders;

(2) mixing artificial Moschus and fel Ursi powder, grinding with the rest seven medicinal powders in step (1), sieving, and making into Chinese medicinal composition;

(3) sterilizing and filtering the Chinese medicinal composition obtained in the step (2), then placing the Chinese medicinal composition into cold liquid paraffin, stirring uniformly, adding the mixture into vaseline and lanolin which are sterilized, filtered and cooled to about 50 ℃, stirring uniformly, and solidifying to obtain the Chinese medicinal composition.

Example two

The traditional Chinese medicine composition comprises, by weight, 100 parts of calamine, 1 part of artificial musk, 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 and 7 parts of borax.

The components and dosage of the ophthalmic gel are 400mg of the traditional Chinese medicine composition, 90mg of the hydrophilic matrix, 20mg of the solubilizer, 150mg of the isotonic regulator, 1mg of the preservative and a proper amount of the pH regulator, and the water is added to 10 g.

The components and dosage of the eye ointment are 0.4g of traditional Chinese medicine composition, 3.4g of vaseline, 0.06g of liquid paraffin and 0.14g of lanolin, and the eye ointment is prepared into 4g of ointment.

The preparation method of the ophthalmic gel comprises the following steps:

(1) respectively pulverizing Galamina, Borneolum Syntheticum, Corallium japonicum Kishinouye, Moschus, fel Ursi, Succinum, Margarita, Cinnabaris, and Borax, and respectively weighing the medicinal powders;

(2) mixing artificial Moschus and fel Ursi powder, grinding with the rest seven medicinal powders in step (1), sieving, and making into Chinese medicinal composition;

(3) adding water and a hydrophilic gel matrix into a beaker, naturally swelling at normal temperature overnight, uniformly stirring to obtain a gel blank matrix solution, adding a sodium hydroxide solution, and stirring to obtain a solution a for later use;

(4) dissolving isoosmotic adjusting agent, solubilizer, antiseptic and Chinese medicinal composition in water, and grinding to obtain solution b for thoroughly moistening and uniformly dispersing medicinal powder;

(5) adding the solution a obtained in the step (3) into the solution b obtained in the step (4) for several times, and grinding or uniformly stirring;

(6) adding quantitative water, homogenizing, sampling, performing quality detection, and packaging.

EXAMPLE III

The traditional Chinese medicine composition comprises the following components in parts by weight: 0.26g of pearl, 0.26g of artificial musk, 0.26g of bear gall, 0.82g of cinnabar, 1.31g of coral, 1.31g of amber, 1.80g of borax, 7.80g of borneol and 26.18g of calcined calamine

The components and the mixture ratio of the ophthalmic gel are 40g of superfine powder of the traditional Chinese medicine composition, 9349g of carbomer, 802g of tween, 15g of glycerol, 0.1g of benzalkonium chloride and a proper amount of pH regulator, and the ophthalmic gel is prepared into 100 pieces by adding 1000g of water for injection.

The preparation method of the ophthalmic gel comprises the following steps:

(1) respectively pulverizing Galamina (preparata), Borneolum Syntheticum, Corallium japonicum Kishinouye, artificial Moschus, and fel Ursi into fine powder, and respectively weighing medicinal powder;

(2) mixing artificial Moschus and fel Ursi powder, grinding with other seven medicinal powders, sieving with 200 mesh sieve, mixing for 20min, sampling, and inspecting to obtain superfine powder;

(3) measuring injection water in a beaker, adding the carbomer 934 in a prescription amount, and naturally swelling at normal temperature overnight to obtain a carbomer solution for later use;

(4) weighing the glycerol, the tween-80 and the preservative in the prescription amount, respectively adding a small amount of water to dissolve, and then mixing the mixed solution and the medicinal powder and grinding to obtain grinding fluid a, so that the medicinal powder is fully wetted and uniformly dispersed;

(5) adding carbomer solution into the grinding liquid a obtained in the step (4) in batches, and uniformly grinding;

(6) adding appropriate amount of 10% sodium hydroxide solution to adjust pH to 7-8, grinding, adding injectable water to make up volume, grinding, sampling for quality detection, and packaging.

Example four

The components and dosage of the ophthalmic gel are 40g of superfine powder of the traditional Chinese medicine composition, 94010g of carbomer, 802g of tween-802, 15g of glycerol, 0.1g of benzalkonium chloride, a proper amount of pH regulator and 1000g of water for injection, and 100 pieces are prepared in total.

The preparation method of the ophthalmic gel comprises the following steps:

(1) respectively pulverizing Galamina (preparata), Borneolum Syntheticum, Corallium japonicum Kishinouye, artificial Moschus, and fel Ursi into fine powder, and respectively weighing medicinal powder;

(2) mixing artificial Moschus and fel Ursi powder, grinding with other seven medicinal powders, sieving with 200 mesh sieve, mixing for 20min, sampling, and inspecting to obtain superfine powder;

(3) measuring injection water in a beaker, adding the formula amount of carbomer 940, and naturally swelling at normal temperature overnight to obtain carbomer solution for later use;

(4) weighing the glycerol, the tween-80 and the preservative in the prescription amount, respectively adding a small amount of water to dissolve, and then mixing the mixed solution and the medicinal powder to grind to obtain grinding fluid a, so that the medicinal powder is fully wetted and uniformly dispersed;

(5) adding carbomer solution into the grinding fluid a obtained in the step (4) in several times, and uniformly grinding;

(6) adding appropriate amount of 10% sodium hydroxide solution to adjust pH to 7-8, grinding, adding injectable water to make up volume, grinding, sampling for quality detection, and packaging.

EXAMPLE five

The components and the mixture ratio of the ophthalmic gel are 40g of superfine powder of the traditional Chinese medicine composition, 93420g of carbomer, 802g of tween, 15g of glycerol, 0.1g of benzalkonium chloride, a proper amount of pH regulator and 1000g of water for injection, and 100 pieces are prepared in total.

The preparation method of the ophthalmic gel comprises the following steps:

(1) respectively pulverizing Galamina (preparata), Borneolum Syntheticum, Corallium japonicum Kishinouye, artificial Moschus, and fel Ursi into fine powder, and respectively weighing medicinal powder;

(2) mixing artificial Moschus and fel Ursi powder, grinding with other seven medicinal powders, sieving with 200 mesh sieve, mixing for 20min, sampling, and inspecting to obtain superfine powder;

(3) measuring injection water in a beaker, adding the carbomer 934 in a prescription amount, and naturally swelling at normal temperature overnight to obtain a carbomer solution for later use;

(4) weighing the glycerol, the tween-80 and the preservative in the prescription amount, respectively adding a small amount of water to dissolve, mixing the mixed solution and the medicinal powder, and grinding to obtain grinding fluid, so that the medicinal powder is fully wetted and uniformly dispersed;

(5) adding carbomer solution into the grinding fluid obtained in the step (4) in several times, and uniformly grinding;

(6) adding appropriate amount of 10% sodium hydroxide solution to adjust pH to 7-8, grinding, adding injectable water to make up volume, grinding, sampling for quality detection, and packaging.

EXAMPLE six

The ophthalmic gel comprises 40g of superfine powder of Chinese medicinal composition, 9345g of carbomer, 5g of hydroxyethyl cellulose, 16.5g of glycerol, 0.1g of benzalkonium chloride, a proper amount of pH regulator, and 1000g of water for injection, and is prepared into 100 pieces.

The preparation method of the ophthalmic gel comprises the following steps:

(1) respectively pulverizing Galamina (preparata), Borneolum Syntheticum, Corallium japonicum Kishinouye, artificial Moschus, and fel Ursi into fine powder, and respectively weighing medicinal powder;

(2) mixing artificial Moschus and fel Ursi powder, grinding with other seven medicinal powders, sieving with 200 mesh sieve, mixing for 20min, sampling, and inspecting to obtain superfine powder;

(3) measuring injection water in a beaker, adding the carbomer 934 in a prescription amount, and naturally swelling at normal temperature overnight to obtain a carbomer solution for later use;

(4) measuring injection water into a beaker, adding the hydroxyethyl cellulose in a prescription amount, and naturally swelling at normal temperature overnight to obtain a hydroxyethyl cellulose solution for later use;

(5) weighing the glycerol, the tween-80 and the preservative with the prescription amount, respectively dissolving with a small amount of water, and mixing and grinding the mixed solution and the medicinal powder to obtain grinding fluid a, so that the medicinal powder is fully wetted and uniformly dispersed;

(6) uniformly stirring the hydroxyethyl cellulose solution, adding the hydroxyethyl cellulose solution into the grinding fluid a obtained in the step (5) for several times, and uniformly grinding to obtain grinding fluid b;

(7) uniformly stirring carbomer solution, adding a proper amount of 10% sodium hydroxide solution, uniformly stirring to obtain transparent blank gel, adding the transparent blank gel into the grinding fluid b obtained in the step (6), and uniformly stirring;

(8) adding water for injection to complement volume, grinding, sampling, performing quality detection, and packaging after qualification.

EXAMPLE seven

The ophthalmic gel comprises 40g of superfine powder of Chinese medicinal composition, 9346g of carbomer, 3g of hydroxyethyl cellulose, 16.5g of glycerol, 802g of tween-802, 0.1g of benzalkonium chloride, a proper amount of pH regulator, and 1000g of water for injection, and is prepared into 100 pieces.

The preparation method of the ophthalmic gel comprises the following steps:

(1) respectively pulverizing Galamina (preparata), Borneolum Syntheticum, Corallium japonicum Kishinouye, artificial Moschus, and fel Ursi into fine powder, and respectively weighing medicinal powder;

(2) mixing artificial Moschus and fel Ursi powder, grinding with other seven medicinal powders, sieving with 200 mesh sieve, mixing for 20min, sampling, and inspecting to obtain superfine powder;

(3) measuring injection water in a beaker, adding the carbomer 934 in a prescription amount, and naturally swelling at normal temperature overnight to obtain a carbomer solution for later use;

(4) measuring injection water into a beaker, adding the hydroxyethyl cellulose in a prescription amount, and naturally swelling at normal temperature overnight to obtain a hydroxyethyl cellulose solution for later use;

(5) weighing the glycerol, the tween-80 and the preservative with the prescription amount, respectively dissolving with a small amount of water, and grinding the mixed solution and the medicinal powder to fully wet and uniformly disperse the medicinal powder;

(6) uniformly stirring the hydroxyethyl cellulose solution, adding the hydroxyethyl cellulose solution into the grinding liquid obtained in the step (5) for several times, and uniformly grinding;

(7) uniformly stirring carbomer solution, adding a proper amount of 10% sodium hydroxide solution, uniformly stirring to obtain transparent blank gel, adding into the grinding fluid obtained in the step (6), and uniformly stirring;

(8) adding water for injection to complement volume, grinding, sampling, performing quality detection, and packaging after qualification.

Example eight

The components and the mixture ratio of the ophthalmic gel are 40g of superfine powder of the traditional Chinese medicine composition, 9806g of carbomer, 4g of hydroxyethyl cellulose, 13.3g of glycerol, 801g of tween-801, 0.1g of benzalkonium chloride, a proper amount of pH regulator and 1000g of water for injection, and 100 pieces are prepared in total.

The preparation method of the ophthalmic gel comprises the following steps:

(1) respectively pulverizing Galamina (preparata), Borneolum Syntheticum, Corallium japonicum Kishinouye, artificial Moschus, and fel Ursi into fine powder, and respectively weighing medicinal powder;

(2) mixing artificial Moschus and fel Ursi powder, grinding with other seven medicinal powders, sieving with 200 mesh sieve, mixing for 20min, sampling, and inspecting to obtain superfine powder;

(3) measuring injection water into a beaker, adding the carbomer 980 in a prescription amount, and naturally swelling at normal temperature overnight to obtain a carbomer solution for later use;

(4) measuring injection water into a beaker, adding the hydroxyethyl cellulose in a prescription amount, and naturally swelling at normal temperature overnight to obtain a hydroxyethyl cellulose solution for later use;

(5) weighing the glycerol, the tween-80 and the preservative with the prescription amount, respectively dissolving with a small amount of water, and mixing and grinding the mixed solution and the medicinal powder to obtain grinding fluid a, so that the medicinal powder is fully wetted and uniformly dispersed;

(6) uniformly stirring the hydroxyethyl cellulose solution, adding the hydroxyethyl cellulose solution into the grinding fluid a obtained in the step (5) for several times, and uniformly grinding to obtain grinding fluid b;

(7) uniformly stirring carbomer solution, adding a proper amount of 10% sodium hydroxide solution, uniformly stirring to obtain transparent blank gel, adding the transparent blank gel into the grinding fluid b obtained in the step (6), and uniformly stirring;

(8) adding water for injection to complement volume, grinding, sampling, performing quality detection, and packaging after qualification.

Example nine

The components and the mixture ratio of the ophthalmic gel are 40g of superfine powder of the traditional Chinese medicine composition, 4.5g of AA-1 polycarbophil, 3.3g of hydroxyethyl cellulose, 16.5g of glycerol, 802g of Tween-802 g, 0.1g of benzalkonium chloride and a proper amount of pH regulator, and the total amount is 100.

The preparation method of the ophthalmic gel comprises the following steps:

(1) respectively pulverizing Galamina (preparata), Borneolum Syntheticum, Corallium japonicum Kishinouye, artificial Moschus, and fel Ursi into fine powder, and respectively weighing medicinal powder;

(2) mixing artificial Moschus and fel Ursi powder, grinding with other seven medicinal powders, sieving with 200 mesh sieve, mixing for 20min, sampling, and inspecting to obtain superfine powder;

(3) measuring injection water in a beaker, adding the AA-1 polycarbophil in a prescription amount, and naturally swelling at normal temperature overnight to obtain a carbomer solution for later use;

(4) measuring injection water into a beaker, adding the hydroxyethyl cellulose in a prescription amount, and naturally swelling at normal temperature overnight to obtain a hydroxyethyl cellulose solution for later use;

(5) weighing the glycerol, the tween-80 and the preservative with the prescription amount, respectively dissolving with a small amount of water, and mixing and grinding the mixed solution and the medicinal powder to obtain grinding fluid a, so that the medicinal powder is fully wetted and uniformly dispersed;

(6) uniformly stirring the hydroxyethyl cellulose solution, adding the hydroxyethyl cellulose solution into the grinding fluid a obtained in the step (5) for several times, and uniformly grinding to obtain grinding fluid b;

(7) uniformly stirring carbomer solution, adding a proper amount of 10% sodium hydroxide solution, uniformly stirring to obtain transparent blank gel, adding into the grinding liquid b in the step (6), and uniformly stirring;

(8) adding water for injection to complement volume, grinding, sampling, performing quality detection, and packaging after qualification.

The long-term stability test of the ophthalmic gel is shown in Table 1

TABLE 1 stability test results for ophthalmic gels prepared in example nine of the present invention

Example ten

The components and the mixture ratio of the eye ointment are 40g of superfine powder of the traditional Chinese medicine composition, 340g of vaseline, 6g of liquid paraffin, 14g of lanolin, 100 pieces in total and 4g per piece.

The preparation method of the eye ointment comprises the following steps:

(1) respectively pulverizing Galamina (preparata), Borneolum Syntheticum, Corallium japonicum Kishinouye, artificial Moschus, and fel Ursi into fine powder, and respectively weighing medicinal powder;

(2) mixing artificial Moschus and fel Ursi powder, grinding with other seven medicinal powders, sieving with 200 mesh sieve, mixing for 20min, sampling, and inspecting to obtain superfine powder;

(3) heating and melting the matrix, filtering, sterilizing, and cooling to 50 deg.C;

(4) adding the superfine powder into sterilized liquid paraffin, stirring, adding into sterilized vaseline and lanoline, stirring, and coagulating.

The long-term stability test of the eye ointment is shown in Table 2

Table 2 stability test results of eye ointments prepared in example ten of the present invention

Therefore, the ophthalmic semisolid preparation of the traditional Chinese medicine composition and the preparation method thereof have the advantages of high stability, small irritation and good patient compliance.

Finally, it should be noted that: the above embodiments are only for illustrating the technical solutions of the present invention and not for limiting the same, and although the present invention is described in detail with reference to the preferred embodiments, those of ordinary skill in the art should understand that: modifications and equivalents may be made to the invention without departing from the spirit and scope of the invention.