CN101181252B - Chloromycetin eyedrops with long shelf-life and preparation method thereof - Google Patents
Chloromycetin eyedrops with long shelf-life and preparation method thereof Download PDFInfo
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- CN101181252B CN101181252B CN2007101908292A CN200710190829A CN101181252B CN 101181252 B CN101181252 B CN 101181252B CN 2007101908292 A CN2007101908292 A CN 2007101908292A CN 200710190829 A CN200710190829 A CN 200710190829A CN 101181252 B CN101181252 B CN 101181252B
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- eye drop
- chloromycetin
- chloramphenicol eye
- chloramphenicol
- long
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- WIIZWVCIJKGZOK-RKDXNWHRSA-N chloramphenicol Chemical compound ClC(Cl)C(=O)N[C@H](CO)[C@H](O)C1=CC=C([N+]([O-])=O)C=C1 WIIZWVCIJKGZOK-RKDXNWHRSA-N 0.000 title claims abstract description 100
- 239000003889 eye drop Substances 0.000 title claims abstract description 50
- 238000002360 preparation method Methods 0.000 title claims abstract description 15
- 229940097572 chloromycetin Drugs 0.000 title claims description 52
- 229940012356 eye drops Drugs 0.000 title 1
- 229960005091 chloramphenicol Drugs 0.000 claims abstract description 48
- 125000000687 hydroquinonyl group Chemical group C1(O)=C(C=C(O)C=C1)* 0.000 claims description 15
- 230000000694 effects Effects 0.000 claims description 14
- 239000003795 chemical substances by application Substances 0.000 claims description 13
- 239000000243 solution Substances 0.000 claims description 10
- 230000000844 anti-bacterial effect Effects 0.000 claims description 8
- 239000006196 drop Substances 0.000 claims description 8
- CIWBSHSKHKDKBQ-JLAZNSOCSA-N Ascorbic acid Chemical compound OC[C@H](O)[C@H]1OC(=O)C(O)=C1O CIWBSHSKHKDKBQ-JLAZNSOCSA-N 0.000 claims description 6
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 claims description 6
- 239000002671 adjuvant Substances 0.000 claims description 6
- 239000000872 buffer Substances 0.000 claims description 6
- 239000012467 final product Substances 0.000 claims description 6
- 239000002738 chelating agent Substances 0.000 claims description 5
- ZGTMUACCHSMWAC-UHFFFAOYSA-L EDTA disodium salt (anhydrous) Chemical group [Na+].[Na+].OC(=O)CN(CC([O-])=O)CCN(CC(O)=O)CC([O-])=O ZGTMUACCHSMWAC-UHFFFAOYSA-L 0.000 claims description 4
- 229910052751 metal Inorganic materials 0.000 claims description 4
- 239000002184 metal Substances 0.000 claims description 4
- QELSKZZBTMNZEB-UHFFFAOYSA-N propylparaben Chemical compound CCCOC(=O)C1=CC=C(O)C=C1 QELSKZZBTMNZEB-UHFFFAOYSA-N 0.000 claims description 4
- ZZZCUOFIHGPKAK-UHFFFAOYSA-N D-erythro-ascorbic acid Natural products OCC1OC(=O)C(O)=C1O ZZZCUOFIHGPKAK-UHFFFAOYSA-N 0.000 claims description 3
- 229930003268 Vitamin C Natural products 0.000 claims description 3
- 238000007872 degassing Methods 0.000 claims description 3
- 238000000855 fermentation Methods 0.000 claims description 3
- 230000004151 fermentation Effects 0.000 claims description 3
- 239000000203 mixture Substances 0.000 claims description 3
- 229910052757 nitrogen Inorganic materials 0.000 claims description 3
- 238000003756 stirring Methods 0.000 claims description 3
- 235000019154 vitamin C Nutrition 0.000 claims description 3
- 239000011718 vitamin C Substances 0.000 claims description 3
- 229960002233 benzalkonium bromide Drugs 0.000 claims description 2
- KHSLHYAUZSPBIU-UHFFFAOYSA-M benzododecinium bromide Chemical compound [Br-].CCCCCCCCCCCC[N+](C)(C)CC1=CC=CC=C1 KHSLHYAUZSPBIU-UHFFFAOYSA-M 0.000 claims description 2
- 229960001617 ethyl hydroxybenzoate Drugs 0.000 claims description 2
- NUVBSKCKDOMJSU-UHFFFAOYSA-N ethylparaben Chemical compound CCOC(=O)C1=CC=C(O)C=C1 NUVBSKCKDOMJSU-UHFFFAOYSA-N 0.000 claims description 2
- LXCFILQKKLGQFO-UHFFFAOYSA-N methylparaben Chemical compound COC(=O)C1=CC=C(O)C=C1 LXCFILQKKLGQFO-UHFFFAOYSA-N 0.000 claims description 2
- GYCKQBWUSACYIF-UHFFFAOYSA-N o-hydroxybenzoic acid ethyl ester Natural products CCOC(=O)C1=CC=CC=C1O GYCKQBWUSACYIF-UHFFFAOYSA-N 0.000 claims description 2
- 239000004405 propyl p-hydroxybenzoate Substances 0.000 claims description 2
- 235000010232 propyl p-hydroxybenzoate Nutrition 0.000 claims description 2
- 229960003415 propylparaben Drugs 0.000 claims description 2
- RTKIYNMVFMVABJ-UHFFFAOYSA-L thimerosal Chemical compound [Na+].CC[Hg]SC1=CC=CC=C1C([O-])=O RTKIYNMVFMVABJ-UHFFFAOYSA-L 0.000 claims description 2
- 229940033663 thimerosal Drugs 0.000 claims description 2
- 238000000034 method Methods 0.000 abstract description 9
- 238000004519 manufacturing process Methods 0.000 abstract description 4
- 239000007853 buffer solution Substances 0.000 abstract description 2
- BGNXCDMCOKJUMV-UHFFFAOYSA-N Tert-Butylhydroquinone Chemical compound CC(C)(C)C1=CC(O)=CC=C1O BGNXCDMCOKJUMV-UHFFFAOYSA-N 0.000 abstract 1
- 238000007789 sealing Methods 0.000 abstract 1
- 239000004250 tert-Butylhydroquinone Substances 0.000 abstract 1
- 235000019281 tert-butylhydroquinone Nutrition 0.000 abstract 1
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 24
- 239000003814 drug Substances 0.000 description 15
- BXRFQSNOROATLV-UHFFFAOYSA-N 4-nitrobenzaldehyde Chemical compound [O-][N+](=O)C1=CC=C(C=O)C=C1 BXRFQSNOROATLV-UHFFFAOYSA-N 0.000 description 12
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 description 12
- 229940079593 drug Drugs 0.000 description 11
- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 6
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 6
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 6
- 239000006187 pill Substances 0.000 description 4
- 229910021538 borax Inorganic materials 0.000 description 3
- KGBXLFKZBHKPEV-UHFFFAOYSA-N boric acid Chemical compound OB(O)O KGBXLFKZBHKPEV-UHFFFAOYSA-N 0.000 description 3
- 239000004327 boric acid Substances 0.000 description 3
- 238000005516 engineering process Methods 0.000 description 3
- 150000003254 radicals Chemical class 0.000 description 3
- 239000011780 sodium chloride Substances 0.000 description 3
- 239000004328 sodium tetraborate Substances 0.000 description 3
- 235000010339 sodium tetraborate Nutrition 0.000 description 3
- JXTHNDFMNIQAHM-UHFFFAOYSA-N dichloroacetic acid Chemical compound OC(=O)C(Cl)Cl JXTHNDFMNIQAHM-UHFFFAOYSA-N 0.000 description 2
- 239000008187 granular material Substances 0.000 description 2
- YWIVKILSMZOHHF-QJZPQSOGSA-N sodium;(2s,3s,4s,5r,6r)-6-[(2s,3r,4r,5s,6r)-3-acetamido-2-[(2s,3s,4r,5r,6r)-6-[(2r,3r,4r,5s,6r)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2- Chemical compound [Na+].CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 YWIVKILSMZOHHF-QJZPQSOGSA-N 0.000 description 2
- 241000894006 Bacteria Species 0.000 description 1
- 206010010741 Conjunctivitis Diseases 0.000 description 1
- 150000001408 amides Chemical class 0.000 description 1
- 239000003963 antioxidant agent Substances 0.000 description 1
- 230000003078 antioxidant effect Effects 0.000 description 1
- 235000006708 antioxidants Nutrition 0.000 description 1
- 239000007864 aqueous solution Substances 0.000 description 1
- 230000033228 biological regulation Effects 0.000 description 1
- 238000000354 decomposition reaction Methods 0.000 description 1
- 238000006731 degradation reaction Methods 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 229960005215 dichloroacetic acid Drugs 0.000 description 1
- 230000008030 elimination Effects 0.000 description 1
- 238000003379 elimination reaction Methods 0.000 description 1
- 208000030533 eye disease Diseases 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 230000007062 hydrolysis Effects 0.000 description 1
- 238000006460 hydrolysis reaction Methods 0.000 description 1
- 206010023332 keratitis Diseases 0.000 description 1
- 239000002075 main ingredient Substances 0.000 description 1
- 230000014759 maintenance of location Effects 0.000 description 1
- 229910021645 metal ion Inorganic materials 0.000 description 1
- 125000002924 primary amino group Chemical group [H]N([H])* 0.000 description 1
- 102000004169 proteins and genes Human genes 0.000 description 1
- 108090000623 proteins and genes Proteins 0.000 description 1
- 238000007348 radical reaction Methods 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 241000894007 species Species 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000003826 tablet Substances 0.000 description 1
- 229930003231 vitamin Natural products 0.000 description 1
- 239000011782 vitamin Substances 0.000 description 1
- 235000013343 vitamin Nutrition 0.000 description 1
- 229940088594 vitamin Drugs 0.000 description 1
- 150000003722 vitamin derivatives Chemical class 0.000 description 1
Landscapes
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
The invention discloses a chloramphenicol eye drop with long validity period, including chloramphenicol and buffer solution and the eye drop contains the tert-butyl hydroquinone with the weight concentration of 0.01 to 0.05 percent. The chloramphenicol eye drop of the invention can not only be prepared according to the existing processing technique, but can also be prepared according to the following method: the preparation method of the invention includes preparation process and filling-sealing process. Compared with the prior art, the guarantee period of the invention can achieve more than 2years, which is conducive to the production, sales and usage of the chloramphenicol eye drop, so the invention has great benefits for the creation of a conservation-oriented society.
Description
Technical field
The invention belongs to Chloramphenicol Eye Drop and preparation method thereof, belong to Chloramphenicol Eye Drop that contains tertiary butylated hydroquinone (TBHQ) and preparation method thereof especially.
Background technology
Chloramphenicol Eye Drop is a kind of eye medicine commonly used, be " two medicines that recorded of Chinese pharmacopoeia version in 2005, once as the use of on market, circulating of OTC Class A medicine, its Main Ingredients and Appearance is chloromycetin, buffer, antibacterial, water, also have in Chloramphenicol Eye Drop, to add hyaluronic acid sodium, glycerol, improve retention time at eye to strengthen viscosity.The common shelf-life of medicine is 2 years, and the shelf-life of Chloramphenicol Eye Drop can only reach 8-12 month, this is owing to chloromycetin in the Chloramphenicol Eye Drop resolves into the chloromycetin glycol easily, paranitrobenzaldehyde, chloromycetin glycol and paranitrobenzaldehyde have stronger zest to eyes, influence patient's use, therefore " in the Chinese pharmacopoeia version in 2005, content to chloromycetin glycol in the Chloramphenicol Eye Drop and paranitrobenzaldehyde has all been made regulation, be that the content of chloromycetin glycol must not be and is higher than 8% of drug content, the content of paranitrobenzaldehyde must not be higher than 0.5% of drug content.
Chinese patent CN1872038A has introduced drop pill type eye drip fluid of chloramphenicol and preparation method thereof, it isolates chloromycetin and aqueous solution by principal agent chloromycetin being prepared into drop pill, thereby reach the purpose that prolongs expiration date of drug, but because the dissolubility of chloromycetin in water is slightly soluble, above-mentioned medicine in use, must jolting just can make the chloromycetin dissolving for a long time, therefore be unfavorable for patient's use.
Chinese patent CN1163266C discloses a kind of collyrium for the treatment of conjunctivitis and keratitis oculopathy, it steps new protein stabiliser and alpha-interferon by adding in Chloramphenicol Eye Drop, improved it to golden Portugal bacterium, colibacillary sterilizing rate, but the shelf-life of the said goods can only reach 1 year.
Summary of the invention
Technical problem to be solved by this invention provides long Chloramphenicol Eye Drop of effect duration and preparation method thereof.
The technical scheme of technical solution problem of the present invention is: the Chloramphenicol Eye Drop that effect duration is long comprises that containing weight concentration in chloromycetin, buffer, the eye drop is the 0.01-0.05% tertiary butylated hydroquinone.
Containing weight concentration in the preferred Chloramphenicol Eye Drop is the 0.02-0.05% tertiary butylated hydroquinone.
For the ability of the removing free radical that strengthens tertiary butylated hydroquinone, the concentration of can also gaining in weight is the vitamin C of 0.01-0.05%.
In order to strengthen the dissolubility in buffer of tertiary butylated hydroquinone, can also in Chloramphenicol Eye Drop, add glycerol.
Because be subjected to the influence of each metal ion species easily in the process for preparation, so also can add metal chelating agent in Chloramphenicol Eye Drop, described metal chelating agent is EDTA-2Na, a kind of or several mixture of disodium edetate.
Described chloromycetin also can be made into drop pill, tablet, granule form.
Described chloromycetin is the chloromycetin of explained hereafter by fermentation.
Described ph value of buffer solution is 6-6.5.
Also can add antibacterial in the Chloramphenicol Eye Drop, described antibacterial is one or more a mixture of methyl hydroxybenzoate, ethyl hydroxybenzoate, propylparaben.
Described antibacterial can also be benzalkonium bromide, thimerosal.
Chloramphenicol Eye Drop can also add hyaluronic acid sodium.
Chloramphenicol Eye Drop of the present invention promptly can be prepared according to existing manufacturing technique, also can be prepared by following method, and following method is preferable.
Preparation method of the present invention comprises preparation process, embedding operation:
Described preparation process is:
Earlier the adjuvant except that chloromycetin is dropped in the reactor; after treating various adjuvant dissolvings; be to be not less than 10 minutes with ultrasonic degas under the condition of ten thousand hertz of 2-5 with solution in frequency; after treating the solution degassing fully; add principal agent chloromycetin; under nitrogen protection,, be cooled to room temperature and get final product in 30-50 ℃ of stirring 30-60 minute.
Described embedding operation is: drop into reactor from principal agent chloromycetin and pick up counting, the embedding time must not be above 5 hours.
It has been generally acknowledged that pH value when Chloramphenicol Eye Drop is 7 when following, main degradation reaction is an amide hydrolysis, generates amino substance and dichloroacetic acid.When adjusting the buffer agent consumption, make pH drop to 5.8 by original 6.4, the stability of Chloramphenicol Eye Drop is improved.
The applicant thinks, the dominant response that Chloramphenicol Eye Drop decomposes in water is a radical reaction, by in Chloramphenicol Eye Drop, increasing tertiary butylated hydroquinone, and tertiary butylated hydroquinone is an antioxidant, effect with free radical in the very strong removing solution, by elimination, reach the effect duration of improving Chloramphenicol Eye Drop, the purpose of shelf-life to free radical in the Chloramphenicol Eye Drop.
Usage and dosage: external.Eye drip, each 1-2 drips 3-5 time on the one.
The present invention compared with prior art, the shelf-life can reach more than 2 years, helped the producing and selling and the use of Chloramphenicol Eye Drop, and the society that creates economizing type is had very big benefit.
The specific embodiment:
Below in conjunction with embodiment the present invention is described in detail.
The detection method of content of chloromycetin, chloromycetin glycol, paranitrobenzaldehyde is for " the 778th page method is tested in two ones of the Chinese pharmacopoeia versions in 2005 in of the present invention.
Accelerated test of the present invention is: during whole accelerated tests, all that embodiment is made sample is placed in the baking oven of 40 ± 2 ℃ of temperature.1 month of accelerated test is equivalent to 3 months of normal room temperature.
Described tertiary butylated hydroquinone is to buy on the market.
Embodiment 1:
Extracting chloromycetin 2.5 grams, boric acid 1.5 grams, Borax 0.5 gram, sodium chloride 6.5 grams, tertiary butylated hydroquinone 0.1 gram, water is added to 1000 milliliters and gets final product, and the solution pH value is 6.2.
Embodiment 2:
Extracting chloromycetin 2.5 grams, boric acid 1.5 grams, Borax 0.5 gram, sodium chloride 6.5 grams, tertiary butylated hydroquinone 0.3 gram, water is added to 1000 milliliters and gets final product.
Embodiment 3:
Extracting chloromycetin 2.5 grams, boric acid 1.5 grams, Borax 0.5 gram, sodium chloride 6.5 grams, tertiary butylated hydroquinone 0.5 gram, water is added to 1000 milliliters and gets final product.
Embodiment 1 result is as shown in table 1:
Table 1:
| Quickened 4 months | Quickened 8 months | Quickened 12 months | |
| Chloromycetin drug content (%) | 98.9 | 90.7 | 81.5 |
| Chloromycetin glycol content (%) | Do not have | 7.6 | 10.7 |
| Paranitrobenzaldehyde content (%) | Do not have | 0.3 | 2.3 |
Embodiment 2 results are as shown in table 2:
Table 2:
| Quickened 4 months | Quickened 8 months | Quickened 12 months | |
| Chloromycetin drug content (%) | 99.7 | 91.6 | 82.6 |
| Chloromycetin glycol content (%) | Do not have | 7.6 | 9.2 |
| Paranitrobenzaldehyde content (%) | Do not have | 0.3 | 1.9 |
Embodiment 3 results are as shown in table 3:
Table 3:
| Quickened 4 months | Quickened 8 months | Quickened 12 months | |
| Chloromycetin drug content (%) | 96.9 | 92.4 | 82.9 |
| Chloromycetin glycol content (%) | Do not have | 7.4 | 9.1 |
| Paranitrobenzaldehyde content (%) | Do not have | 0.3 | 1.8 |
Embodiment 1-3 shows that tertiary butylated hydroquinone content all can be realized the present invention when 0.01-0.05%.
Embodiment 4:
Except that the concentration of gaining in weight was 0.03% vitamin C, all the other were identical with embodiment 2.
Embodiment 4 results are as shown in table 4:
Table 4:
| Quickened 4 months | Quickened 8 months | Quickened 12 months | |
| Chloromycetin drug content (%) | 98.6 | 93.2 | 84.3 |
| Chloromycetin glycol content (%) | Do not have | 7.2 | 8.8 |
| Paranitrobenzaldehyde content (%) | Do not have | 0.3 | 1.8 |
Embodiment 4 explanation, weight concentration are the stability that 0.03% vitamin can improve the Chloramphenicol Eye Drop that contains tertiary butylated hydroquinone.
Embodiment 5:
Except that adding the EDTA-2Na in Chloramphenicol Eye Drop, all the other are identical with embodiment 4.
Embodiment 5 results are as shown in table 5:
Table 5:
| Quickened 4 months | Quickened 8 months | Quickened 12 months | |
| Chloromycetin drug content (%) | 100.5 | 94.6 | 86.8 |
| Chloromycetin glycol content (%) | Do not have | 7.0 | 8.5 |
| Paranitrobenzaldehyde content (%) | Do not have | 0.2 | 1.8 |
In solution, add the stability that chelating agent can improve Chloramphenicol Eye Drop.
Embodiment 6:
Except that being that all the other are identical with embodiment 5 chloromycetin produced of fermentation technology at the used principal agent chloromycetin of Chloramphenicol Eye Drop.
Embodiment 6 results are as shown in table 6:
Table 6:
| Quickened 4 months | Quickened 8 months | Quickened 12 months | |
| Chloromycetin drug content (%) | 99.4 | 95.8 | 87.8 |
| Chloromycetin glycol content (%) | Do not have | 6.5 | 8.0 |
| Paranitrobenzaldehyde content (%) | Do not have | 0.2 | 1.0 |
Embodiment 7:
Except that principal agent being made the granule that contains chloromycetin 0.25 gram, all the other are identical with embodiment 6.
Embodiment 8:
Except that principal agent being made the tablet that contains chloromycetin 0.25 gram, all the other are identical with embodiment 6.
Embodiment 9:
Except that principal agent being made the drop pill that contains chloromycetin 0.25 gram, all the other are identical with embodiment 6.
Embodiment 7-9 is difficult for oxidized decomposition, so its shelf-life can also prolong because principal agent chloromycetin wraps in solid or the semisolid.
Embodiment 10:
Removing production process is:
Earlier adjuvant except that chloromycetin is dropped in the reactor, treat various adjuvants dissolvings after, be under 40,000 hertz the condition with ultrasonic degas 30 minutes with solution in frequency; after treating the solution degassing fully; add principal agent chloromycetin, under nitrogen protection,, be cooled to room temperature and get final product in 40 ℃ of stirrings 60 minutes.Drop into reactor from principal agent chloromycetin and pick up counting, the embedding time is 3.5 hours, and outer, all the other are identical with embodiment 6.
Embodiment 10 results are as shown in table 7:
Table 7:
| Quickened 4 months | Quickened 8 months | Quickened 12 months | |
| Chloromycetin drug content (%) | 97.6 | 94.5 | 91.2 |
| Chloromycetin glycol content (%) | Do not have | 6.2 | 7.5 |
| Paranitrobenzaldehyde content (%) | Do not have | 0.1 | 0.8 |
Embodiment 10 explanation, the described production technology of the application of the invention can improve the stability of Chloramphenicol Eye Drop.
In conjunction with the embodiments the present invention has been carried out exemplary description above; obviously specific implementation of the present invention is not subjected to the restriction of aforesaid way; as long as adopted the improvement of the various unsubstantialities that method of the present invention design and technical scheme carry out; or design of the present invention and technical scheme are directly applied to other occasion without improving, all within protection scope of the present invention.
Claims (9)
- Effect duration long Chloramphenicol Eye Drop, comprise chloromycetin, buffer, it is characterized in that: containing weight concentration in the eye drop is the 0.01-0.05% tertiary butylated hydroquinone.
- 2. the Chloramphenicol Eye Drop that effect duration according to claim 1 is long, it is characterized in that: containing weight concentration in the Chloramphenicol Eye Drop is the 0.02-0.05% tertiary butylated hydroquinone.
- 3. the Chloramphenicol Eye Drop that effect duration according to claim 1 is long is characterized in that: contain the vitamin C that weight concentration is 0.01-0.05% in the Chloramphenicol Eye Drop.
- 4. the Chloramphenicol Eye Drop that effect duration according to claim 1 is long, it is characterized in that: add metal chelating agent in Chloramphenicol Eye Drop, described metal chelating agent is a disodium edetate.
- 5. the Chloramphenicol Eye Drop that effect duration according to claim 1 is long is characterized in that: described chloromycetin is the chloromycetin of explained hereafter by fermentation.
- 6. the Chloramphenicol Eye Drop that effect duration according to claim 1 is long, it is characterized in that: the pH value of described buffer is 6-6.5.
- 7. the Chloramphenicol Eye Drop that effect duration according to claim 1 is long is characterized in that: add antibacterial in Chloramphenicol Eye Drop, described antibacterial is one or more a mixture of methyl hydroxybenzoate, ethyl hydroxybenzoate, propylparaben.
- 8. the Chloramphenicol Eye Drop that effect duration according to claim 1 is long, it is characterized in that: add antibacterial in Chloramphenicol Eye Drop, described antibacterial is a benzalkonium bromide, thimerosal.
- 9. the preparation method of the Chloramphenicol Eye Drop that effect duration according to claim 1 is long is characterized in that: comprise preparation process, embedding operation:Described preparation process is:Earlier the adjuvant except that chloromycetin is dropped in the reactor, after treating various adjuvant dissolvings, be to be not less than 10 minutes with ultrasonic degas under the condition of ten thousand hertz of 2-5 with solution in frequency, after treating the solution degassing fully, add principal agent chloromycetin, under nitrogen protection,, be cooled to room temperature and get final product in 30-50 ℃ of stirring 30-60 minute;Described embedding operation is: drop into reactor from principal agent chloromycetin and pick up counting, the embedding time must not be above 5 hours.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2007101908292A CN101181252B (en) | 2007-11-30 | 2007-11-30 | Chloromycetin eyedrops with long shelf-life and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN2007101908292A CN101181252B (en) | 2007-11-30 | 2007-11-30 | Chloromycetin eyedrops with long shelf-life and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN101181252A CN101181252A (en) | 2008-05-21 |
| CN101181252B true CN101181252B (en) | 2010-06-02 |
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| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2007101908292A Expired - Fee Related CN101181252B (en) | 2007-11-30 | 2007-11-30 | Chloromycetin eyedrops with long shelf-life and preparation method thereof |
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| Country | Link |
|---|---|
| CN (1) | CN101181252B (en) |
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2007
- 2007-11-30 CN CN2007101908292A patent/CN101181252B/en not_active Expired - Fee Related
Non-Patent Citations (2)
| Title |
|---|
| 陈国广等.氯霉素滴眼液的稳定性及其处方工艺的改进.华西药学杂志21 5.2006,21(5),443-445. |
| 陈国广等.氯霉素滴眼液的稳定性及其处方工艺的改进.华西药学杂志21 5.2006,21(5),443-445. * |
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| Publication number | Publication date |
|---|---|
| CN101181252A (en) | 2008-05-21 |
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