CN101057860A - Eye drops and preparing method thereof - Google Patents
Eye drops and preparing method thereof Download PDFInfo
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- CN101057860A CN101057860A CN 200710106035 CN200710106035A CN101057860A CN 101057860 A CN101057860 A CN 101057860A CN 200710106035 CN200710106035 CN 200710106035 CN 200710106035 A CN200710106035 A CN 200710106035A CN 101057860 A CN101057860 A CN 101057860A
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Abstract
The invention discloses an eye drop and its preparing process, wherein each 1000 ml of the eye drop comprises right amount of ophthalmologically usable adjuvant, vitamin B6 0. 06-3. 0g, taurine 0. 12-6. 0g, sodium hyaluronate 0-3. 0g. The invention also provides the process for preparing the eye drop.
Description
[technical field]
The invention belongs to technical field of Chinese medicines, be specifically related to a kind of eye drops and preparation method thereof.
[background technology]
Taurine is a kind of special aminoacid, is the requisite a kind of nutrient of human body, and the marvellous effect of balance health is arranged.Also have a large amount of taurines in the human eye retina, so supplementation of taurine is also most important for people's eyes.Eye's cornea has self-repairing capability, promptly is subjected to some when injury when cornea, can self-regeneration.Mostly contain taurine in the medicament for the eyes, exactly in order to strengthen the self-repairing capability of cornea, the antagonism ophthalmic.This shows that daily supplementation of taurine can be promoted the self-repairing capability of eyes cornea, the prevention ophthalmic diseases.
The hydrochlorate of vitamin B6 is the crystallization or the crystalline powder of white or off-white color, and it is the phosphoric acid Vitamin B6 in erythrocyte, and the coenzyme that the latter can not lack as body can participate in aminoacid, the homergy of carbohydrate and fat.Vitamin B6 also participates in the reaction that tryptophan is converted into nicotinic acid 5-hydroxy tryptamine in addition.And can stimulate leukocytic growth, be to form the hemoglobin desired material.As when lacking vitamin B6 and pantothenic acid, can cause blurred vision.
Hyaluronate sodium is a kind of important effect, spontaneous biopolymer, mucopolysaccharide that the disaccharide unit of being made up of N-acetylglucosamine and D-D-Glucuronic acid sodium salt repeats to form of having in many parts of human body.The most important characteristic of sodium hyaluronate solution is a viscoelasticity; This characteristic shows as, and is in the time of the hyaluronate sodium eye drip, different in the process neutralization performance in a short time of nictation.Nictation, shearforce is arranged the molecule of hyaluronate sodium mutually in solution.As a result, sodium hyaluronate solution shows as elastic and low viscosity relatively, and is distributed on the surface of cornea easily.
Taurine, hyaluronate sodium and vitamin B6 all are the common drugs of ophthalmic remedy, but do not have document and product openly to provide the rational proportion and the prescription of this three's combination at present.
[summary of the invention]
The object of the present invention is to provide a kind of eye drops, and provide the rational proportion of the most rational taurine, hyaluronate sodium and vitamin B6 three combination and the eye drops under the prescription.
Eye drops of the present invention comprises medicinal eye drop and eye sterilizing article.
Particularly per 1000 milliliters of eye drops of the present invention contain: the available pharmaceutic adjuvant of ophthalmology, vitamin B6 0.06-3.0 gram, taurine 0.12-6.0 gram, hyaluronate sodium 0.06-3.0 gram.
Preferably, per 1000 milliliters of described eye drops contain: the available pharmaceutic adjuvant of ophthalmology, vitamin B6 0.1-1.0 gram, taurine 0.2-1.5 gram, hyaluronate sodium 0.1-1.0 gram.
Preferred, per 1000 milliliters of described eye drops contain: the available pharmaceutic adjuvant of ophthalmology, vitamin B6 0.3-0.5 gram, taurine 0.5-1.5 gram, hyaluronate sodium 0.3-0.5 gram.
Most preferred, per 1000 milliliters of described eye drops contain: the available pharmaceutic adjuvant of ophthalmology, vitamin B6 0.33 gram, taurine 0.67 gram, hyaluronate sodium 0.33 gram.
Eye drops of the present invention comprises medicinal eye drop and eye sterilizing article.
Another object of the present invention is to provide the preparation method of eye drops.The preparation method of above-mentioned eye drops is: hyaluronate sodium is dissolved in water for injection earlier, regulates the pH value scope to 4.0-9.0, add the available pharmaceutic adjuvant of vitamin and taurine and ophthalmology again, make eye drops.
Preferred above-mentioned preparation method is: hyaluronate sodium is dissolved in water for injection earlier, regulates the pH value scope to 5.0-8.5, add the available pharmaceutic adjuvant of vitamin and taurine and ophthalmology again, make eye drops.
Preferred above-mentioned preparation method is: hyaluronate sodium is dissolved in water for injection earlier, regulates the pH value scope to 6.0-8.5, add the available pharmaceutic adjuvant of vitamin and taurine and ophthalmology again, make eye drops.
Most preferred above-mentioned preparation method is: hyaluronate sodium is dissolved in water for injection earlier, regulates the pH value scope to 7.0-7.2, add the available pharmaceutic adjuvant of vitamin and taurine and ophthalmology again, make eye drops.
The present invention has remarkable result for improving the tired sense organ of experimenter, and the stability of eye drops of the present invention is better, especially can keep the stability of taurine, and this is that prior art can not be instructed.
[specific embodiment]
Following embodiment and experimental example further describe the present invention, but described embodiment and experimental example only are used to illustrate the present invention rather than restriction the present invention.Compare with the sample of reference examples, the stability of eye drops of the present invention is better, especially can keep the stability of taurine, and this all is that prior art can not be instructed.
Embodiment 1
Prescription: vitamin B6 0.33 gram taurine 0.67 gram hyaluronate sodium 0.33 gram
Methyl hydroxybenzoate 0.3 gram sodium chloride 75.0 gram waters for injection are an amount of
Method for making: with 600 milliliters of water for injection heated and boiled, be cooled to 80 ℃, add hyaluronate sodium; be cooled to 60 ℃ while stirring; the adjusting pH value is 7.0-7.2, in addition taurine and vitamin B6 is added dropwise in the above solution while stirring, stirs more than 30 minutes; add sodium chloride and methyl hydroxybenzoate while hot; be stirred to whole dissolvings, after the filtrate temperature is reduced to 40 ℃, cross microporous filter membrane (0.22 μ m) and filter; add the injection water again and supply weight to 1000 milliliter, promptly aseptic subpackaged.
Embodiment 2
Prescription: vitamin B6 0.1 gram taurine 0.2 gram hyaluronate sodium 0.1 gram
Methyl hydroxybenzoate 0.3 gram sodium chloride 73.0 gram waters for injection are an amount of
Method for making: with 600 milliliters of water for injection heated and boiled, be cooled to 80 ℃, add hyaluronate sodium; be cooled to 60 ℃ while stirring; the adjusting pH value is 4.8-5.0, in addition taurine and vitamin B6 is added dropwise in the above solution while stirring, stirs more than 30 minutes; add sodium chloride and methyl hydroxybenzoate while hot; be stirred to whole dissolvings, after the filtrate temperature is reduced to 40 ℃, cross microporous filter membrane (0.22 μ m) and filter; add the injection water again and supply weight to 1000 milliliter, promptly aseptic subpackaged.
Embodiment 3
Prescription: vitamin B6 1.0 gram taurines 1.5 gram hyaluronate sodiums 1.0 grams
Methyl hydroxybenzoate 0.3 gram sodium chloride 70.0 gram waters for injection are an amount of
Method for making: with 600 milliliters of water for injection heated and boiled, be cooled to 80 ℃, add hyaluronate sodium; be cooled to 60 ℃ while stirring; the adjusting pH value is 7.1-7.4, in addition taurine and vitamin B6 is added dropwise in the above solution while stirring, stirs more than 30 minutes; add sodium chloride and methyl hydroxybenzoate while hot; be stirred to whole dissolvings, after the filtrate temperature is reduced to 40 ℃, cross microporous filter membrane (0.22 μ m) and filter; add the injection water again and supply weight to 1000 milliliter, promptly aseptic subpackaged.
Embodiment 4
Prescription: vitamin B6 3.0 gram taurines 6.0 gram hyaluronate sodiums 3.0 grams
Methyl hydroxybenzoate 0.3 gram sodium chloride 65.0 gram waters for injection are an amount of
Method for making: with 600 milliliters of water for injection heated and boiled, be cooled to 80 ℃, add hyaluronate sodium; be cooled to 60 ℃ while stirring; the adjusting pH value is 6.0-6.2, in addition taurine and vitamin B6 is added dropwise in the above solution while stirring, stirs more than 30 minutes; add sodium chloride and methyl hydroxybenzoate while hot; be stirred to whole dissolvings, after the filtrate temperature is reduced to 40 ℃, cross microporous filter membrane (0.22 μ m) and filter; add the injection water again and supply weight to 1000 milliliter, promptly aseptic subpackaged.
Embodiment 5
Prescription: vitamin B6 3.0 gram taurines 6.0 gram hyaluronate sodiums 3.0 grams
Methyl hydroxybenzoate 0.3 gram sodium chloride 62.5 gram waters for injection are an amount of
Method for making: with 600 milliliters of water for injection heated and boiled, be cooled to 80 ℃, add hyaluronate sodium; be cooled to 60 ℃ while stirring; the adjusting pH value is 4.8-5.0, in addition taurine and vitamin B6 is added dropwise in the above solution while stirring, stirs more than 30 minutes; add sodium chloride and methyl hydroxybenzoate while hot; be stirred to whole dissolvings, after the filtrate temperature is reduced to 40 ℃, cross microporous filter membrane (0.22 μ m) and filter; add the injection water again and supply weight to 1000 milliliter, promptly aseptic subpackaged.
Embodiment 6
Prescription: vitamin B6 0.06 gram taurine 0.12 gram hyaluronate sodium 0.06 gram
Methyl hydroxybenzoate 0.3 gram sodium chloride 75.0 gram waters for injection are an amount of
Method for making: with 600 milliliters of water for injection heated and boiled, be cooled to 80 ℃, add hyaluronate sodium; be cooled to 60 ℃ while stirring; the adjusting pH value is 7.8-8.5, in addition taurine and vitamin B6 is added dropwise in the above solution while stirring, stirs more than 30 minutes; add sodium chloride and methyl hydroxybenzoate while hot; be stirred to whole dissolvings, after the filtrate temperature is reduced to 40 ℃, cross microporous filter membrane (0.22 μ m) and filter; add the injection water again and supply weight to 1000 milliliter, promptly aseptic subpackaged.
Reference examples 1
Prescription: vitamin B6 0.33 gram taurine 0.67 gram methyl hydroxybenzoate 0.3 gram
Sodium chloride 75.5 gram waters for injection are an amount of
Method for making: with 500 milliliters of water for injection heated and boiled; be cooled to 80 ℃; adding taurine and vitamin B6 is added dropwise in the above solution while stirring; stir more than 30 minutes, add sodium chloride and methyl hydroxybenzoate while hot, be stirred to whole dissolvings; after the filtrate temperature is reduced to 40 ℃; cross microporous filter membrane (0.22 μ m) and filter, add the injection water again and supply weight to 1000 milliliter, promptly aseptic subpackaged.
Reference examples 2
Prescription: vitamin B6 0.1 gram hyaluronate sodium 0.1 gram methyl hydroxybenzoate 0.3 gram
Sodium chloride 73.3 gram waters for injection are an amount of
Method for making: with 600 milliliters of water for injection heated and boiled, be cooled to 80 ℃, add hyaluronate sodium, be cooled to 60 ℃ while stirring, the adjusting pH value is 3.8-4.0, in addition vitamin B6 is added dropwise in the above solution while stirring, stirs more than 30 minutes, add sodium chloride and methyl hydroxybenzoate while hot, be stirred to whole dissolvings, after the filtrate temperature is reduced to 40 ℃, cross microporous filter membrane (0.22 μ m) and filter, add the injection water again and supply weight to 1000 milliliter, promptly aseptic subpackaged.
Reference examples 3
Prescription: taurine 1.5 gram hyaluronate sodiums 1.0 gram methyl hydroxybenzoate 0.3 gram
Sodium chloride 70.0 gram waters for injection are an amount of
Method for making: with 600 milliliters of water for injection heated and boiled, be cooled to 80 ℃, add hyaluronate sodium; be cooled to 60 ℃ while stirring; the adjusting pH value is 3.1-3.4, in addition taurine is added dropwise in the above solution while stirring, stirs more than 30 minutes; add sodium chloride and methyl hydroxybenzoate while hot; be stirred to whole dissolvings, after the filtrate temperature is reduced to 40 ℃, cross microporous filter membrane (0.22 μ m) and filter; add the injection water again and supply weight to 1000 milliliter, promptly aseptic subpackaged.
Reference examples 4
Prescription: vitamin B6 0.05 gram taurine 0.1 gram hyaluronate sodium 0.05 gram
Methyl hydroxybenzoate 0.3 gram sodium chloride 78.0 gram waters for injection are an amount of
Method for making: with 600 milliliters of water for injection heated and boiled, be cooled to 80 ℃, add hyaluronate sodium; be cooled to 60 ℃ while stirring; the adjusting pH value is 3.0-4.2, in addition taurine and vitamin B6 is added dropwise in the above solution while stirring, stirs more than 30 minutes; add sodium chloride and methyl hydroxybenzoate while hot; be stirred to whole dissolvings, after the filtrate temperature is reduced to 40 ℃, cross microporous filter membrane (0.22 μ m) and filter; add the injection water again and supply weight to 1000 milliliter, promptly aseptic subpackaged.
Reference examples 5
Prescription: vitamin B6 4.0 gram taurines 8.0 gram hyaluronate sodiums 4.0 grams
Methyl hydroxybenzoate 0.3 gram sodium chloride 58.5 gram waters for injection are an amount of
Method for making: with 600 milliliters of water for injection heated and boiled, be cooled to 80 ℃, add hyaluronate sodium; be cooled to 60 ℃ while stirring; the adjusting pH value is 4.8-5.0, in addition taurine and vitamin B6 is added dropwise in the above solution while stirring, stirs more than 30 minutes; add sodium chloride and methyl hydroxybenzoate while hot; be stirred to whole dissolvings, after the filtrate temperature is reduced to 40 ℃, cross microporous filter membrane (0.22 μ m) and filter; add the injection water again and supply weight to 1000 milliliter, promptly aseptic subpackaged.
Reference examples 6
Prescription: vitamin B6 0.06 gram taurine 0.12 gram hyaluronate sodium 0.06 gram
Methyl hydroxybenzoate 0.3 gram sodium chloride 75.0 gram waters for injection are an amount of
Method for making: with 600 milliliters of water for injection heated and boiled, be cooled to 80 ℃, add hyaluronate sodium; be cooled to 60 ℃ while stirring; the adjusting pH value is 3.8-4.1, in addition taurine and vitamin B6 is added dropwise in the above solution while stirring, stirs more than 30 minutes; add sodium chloride and methyl hydroxybenzoate while hot; be stirred to whole dissolvings, after the filtrate temperature is reduced to 40 ℃, cross microporous filter membrane (0.22 μ m) and filter; add the injection water again and supply weight to 1000 milliliter, promptly aseptic subpackaged.
Experimental example 1-the present invention is to women's white-collar job personnel's comfort test
1. physical data: there are eyestrain women white-collar job personnel totally 60 people in subjective readme, average 27.9 soil 6.3 years old, and computation time every day was divided into 6 groups at random between to 8 to 10 hours, every group 10 people.
2. experimental technique: clean both hands, head is steeved, and left hand thumb and forefinger draw back palpebra inferior respectively, and the right hand drips 1 in the general 1-2 of a distance eyes centimetre place far away, does not close one's eyes, rapidly face is looked underground, blinking gently.The grading of comfort level is divided into: as snug as a bug in a rug, comfortable, do not have difference, uncomfortable, very uncomfortable, be difficult to stand, the experimenter according to self the impression fill in.
Experimental group 1: embodiment 1 each 1 in experimenter's left eye and right eye, reference examples 1 by turns after half an hour is filled in the comfort level scale.
Experimental group 2: embodiment 2 each 1 in experimenter's left eye and right eye, reference examples 2 by turns after half an hour is filled in the comfort level scale.
Experimental group 3: embodiment 3 each 1 in experimenter's left eye and right eye, reference examples 3 by turns after half an hour is filled in the comfort level scale.
Experimental group 4: embodiment 4 each 1 in experimenter's left eye and right eye, reference examples 4 by turns after half an hour is filled in the comfort level scale.
Experimental group 5: embodiment 5 each 1 in experimenter's left eye and right eye, reference examples 5 by turns after half an hour is filled in the comfort level scale.
Experimental group 6: embodiment 6 each 1 in experimenter's left eye and right eye, reference examples 6 by turns after half an hour is filled in the comfort level scale.
The concrete data of experiment see Table 1.
Table 1 the present invention and reference substance are for the statistics of eyes comfort level
The experimenter | Accumulated number | |||||
Comfort level | As snug as a bug in a rug | Comfortable | There is not difference | Uncomfortable | Very uncomfortable | Be difficult to stand |
Embodiment 1 | 5 | 3 | 2 | 0 | 0 | 0 |
Reference examples 1 | 0 | 2 | 5 | 3 | 0 | 0 |
Embodiment 2 | 3 | 2 | 4 | 1 | 0 | 0 |
Reference examples 2 | 1 | 2 | 2 | 5 | 0 | 0 |
Embodiment 3 | 3 | 4 | 3 | 0 | 0 | 0 |
Reference examples 3 | 1 | 4 | 4 | 1 | 0 | 0 |
Embodiment 4 | 3 | 3 | 3 | 1 | 0 | 0 |
Reference examples 4 | 1 | 5 | 4 | 0 | 0 | 0 |
Embodiment 5 | 3 | 3 | 3 | 1 | 0 | 0 |
Reference examples 5 | 1 | 2 | 5 | 2 | 0 | 0 |
Embodiment 6 | 3 | 4 | 3 | 0 | 0 | 0 |
Reference examples 6 | 1 | 2 | 5 | 2 | 0 | 0 |
Above description of test, the present invention has remarkable result for improving the tired sense organ of experimenter.
The test of experimental example 2-eye drops stability of the present invention
1. test method: the sample of getting each embodiment 1-6 and reference examples 1-6 places 40 ℃ calorstat to place 15 months, respectively at the content of taurine and vitamin B6 in 0 month, 6 months, 15 months sampling and measuring samples.
2. assay method: each composition in the sample is measured according to high performance liquid chromatography (two appendix V of Chinese Pharmacopoeia version in 2005 D).
3. result processing method: measure taurine and vitamin B6 amount in the sample of each embodiment and reference examples in order to last method, calculate every bottle in the average absolute content of each composition.With 0 month absolute content was the relative percentage composition of benchmark 100%, with the absolute content of 6 months or 15 months absolute content divided by 0 month, was the relative percentage composition (%) with 6 months or 15 months.
5. result of the test: the sample of each embodiment and reference examples places 40 ℃ calorstat to place 15 months, and taurine and the vitamin B6 relative percentage composition in the time of 6 months, 15 months the results are shown in Table 2.
The sample of table 2 embodiment and reference examples is at 40 ℃ of * June, 15 months relative percentage composition (%) of 40 ℃ of *
Sample | Content of taurine changes | The vitamin B6 changes of contents | ||
40 ℃ of * June (%) | 40 ℃ of * 15 months (%) | 40 ℃ of * June (%) | 40 ℃ of * 15 months (%) | |
Embodiment 1 | 98.6 | 95.4 | 99.5 | 98.2 |
Embodiment 2 | 96.7 | 95.1 | 96.7 | 96.2 |
Embodiment 3 | 95.0 | 94.0 | 97.5 | 95.5 |
Embodiment 4 | 96.4 | 94.7 | 98.3 | 96.7 |
Embodiment 5 | 97.1 | 95.5 | 97.1 | 95.1 |
Embodiment 6 | 97.9 | 93.8 | 98.1 | 97.3 |
Reference examples 1 | 95.9 | 91.1 | 97.5 | 96.2 |
Reference examples 2 | 94.1 | 90.4 | 97.7 | 96.9 |
Reference examples 3 | 95.1 | 90.5 | 97.8 | 96.5 |
Reference examples 4 | 94.7 | 92.7 | 98.9 | 97.7 |
Reference examples 5 | 92.1 | 90.1 | 98.9 | 96.1 |
Reference examples 6 | 93.9 | 89.8 | 98.8 | 97.9 |
As seen the result compares with the sample of reference examples from table, and the stability of eye drops of the present invention is better, especially can keep the stability of taurine, and this is that prior art can not be instructed.
Claims (9)
1. an eye drops is characterized in that per 1000 milliliters of described eye drops contain: the available pharmaceutic adjuvant of ophthalmology, vitamin B6 0.06-3.0 gram, taurine 0.12-6.0 gram, hyaluronate sodium 0.06-3.0 gram.
2. according to the described eye drops of claim 1, it is characterized in that per 1000 milliliters of described eye drops contain: the available pharmaceutic adjuvant of ophthalmology, vitamin B6 0.1-1.0 gram, taurine 0.2-1.5 gram, hyaluronate sodium 0.1-1.0 gram.
3. according to the described eye drops of claim 2, it is characterized in that per 1000 milliliters of described eye drops contain: the available pharmaceutic adjuvant of ophthalmology, vitamin B6 0.3-0.5 gram, taurine 0.5-1.5 gram, hyaluronate sodium 0.3-0.5 gram.
4 according to the described eye drops of claim 3, it is characterized in that per 1000 milliliters of described eye drops contain: the available pharmaceutic adjuvant of ophthalmology, vitamin B6 0.33 gram, taurine 0.67 gram, hyaluronate sodium 0.33 gram.
5. according to the arbitrary described eye drops of claim 1-4, it is characterized in that described eye drops is medicinal eye drop.
6. according to the arbitrary described eye drops of claim 1-4, it is characterized in that described eye drops is the eye sterilizing article.
7. the preparation method of the arbitrary described eye drops of claim 1-6 is characterized in that, hyaluronate sodium is dissolved in water for injection earlier, regulates the pH value scope to 4.0-9.0, adds the available pharmaceutic adjuvant of vitamin and taurine and ophthalmology again, makes eye drops.
8. according to the preparation method of the described eye drops of claim 7, it is characterized in that described adjusting pH value scope is 5.0-8.5.
9. the preparation method of described eye drops according to Claim 8 is characterized in that described adjusting pH value scope is 7.0-7.2.
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CN105663160A (en) * | 2016-04-14 | 2016-06-15 | 齐齐哈尔市前进医药有限责任公司 | Eye element eye drops and preparation method thereof |
CN106176806A (en) * | 2016-08-29 | 2016-12-07 | 安徽艾珂尔制药有限公司 | A kind of Kanamycin sulfate eye drops and preparation method thereof |
CN106214460A (en) * | 2016-09-18 | 2016-12-14 | 成都测迪森生物科技有限公司 | A kind of eye syringe |
CN106265797A (en) * | 2016-09-18 | 2017-01-04 | 成都测迪森生物科技有限公司 | A kind of collyrium |
CN107028973A (en) * | 2017-05-12 | 2017-08-11 | 浙江工贸职业技术学院 | Eye drops for relieving asthenopia and preparation method thereof |
CN111617031A (en) * | 2020-06-25 | 2020-09-04 | 长春生物制品研究所有限责任公司 | Stable recombinant human interferon alpha 1b eye drops and production method thereof |
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2007
- 2007-05-30 CN CN 200710106035 patent/CN101057860A/en active Pending
Cited By (6)
Publication number | Priority date | Publication date | Assignee | Title |
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CN105663160A (en) * | 2016-04-14 | 2016-06-15 | 齐齐哈尔市前进医药有限责任公司 | Eye element eye drops and preparation method thereof |
CN106176806A (en) * | 2016-08-29 | 2016-12-07 | 安徽艾珂尔制药有限公司 | A kind of Kanamycin sulfate eye drops and preparation method thereof |
CN106214460A (en) * | 2016-09-18 | 2016-12-14 | 成都测迪森生物科技有限公司 | A kind of eye syringe |
CN106265797A (en) * | 2016-09-18 | 2017-01-04 | 成都测迪森生物科技有限公司 | A kind of collyrium |
CN107028973A (en) * | 2017-05-12 | 2017-08-11 | 浙江工贸职业技术学院 | Eye drops for relieving asthenopia and preparation method thereof |
CN111617031A (en) * | 2020-06-25 | 2020-09-04 | 长春生物制品研究所有限责任公司 | Stable recombinant human interferon alpha 1b eye drops and production method thereof |
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