CN1742742A - Amikacin paste and preparing method and use - Google Patents
Amikacin paste and preparing method and use Download PDFInfo
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- CN1742742A CN1742742A CN 200510105892 CN200510105892A CN1742742A CN 1742742 A CN1742742 A CN 1742742A CN 200510105892 CN200510105892 CN 200510105892 CN 200510105892 A CN200510105892 A CN 200510105892A CN 1742742 A CN1742742 A CN 1742742A
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- amikacin
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Abstract
The present invention relates to an amikacin ointment, including medicinal active component which is amikacin or its medicinal salt and medicinal auxiliary material containing greasiness matrix and water-soluble matrix. Its composition includes (by wt%) 0.05%-5% of amikacin or its medicinal salt, optimum is 0.25%, 25%-50% of greasiness matrix, 5%-20% of water-soluble matrix, and the rest is distilled water.
Description
Technical field:
The invention belongs to field of medicaments, relate to a kind of amikacin paste and its production and application.
Background technology:
Amikacin (Kanamycin A Sulfate) claims Likacin, amikacin, amikacin, A Mikaxin etc. again, is the antibiotic of semisynthetic aminoglycoside, amino hydroxyl butyryl chain is introduced the streptamine part of kanamycin A molecule and gets.Its pharmaceutical salts, commonly used is sulfate, i.e. amikacin sulfate.
Skin is subjected to wound can cause infection, causes the main sensitive organism of trauma infection contamination that staphylococcus aureus (clinical infection rate 50%～60%), citric acid bacillus (clinical infection rate 10%～15%), escherichia coli (clinical infection rate 5%～10%), clayey Serratieae (clinical infection rate 5%～10%) etc. are arranged.The antimicrobial spectrum of amikacin is similar to gentamycin, and part bacterial strain negative to escherichia coli, Pseudomonas aeruginosa, indole and positive Bacillus proteus, klebsiella spp, acinetobacter calcoaceticus, citrobacter and serratia marcecens and enterobacteria has good antibacterial action.For tubercule bacillus, atypical mycobacterium and staphylococcus aureus (produce enzyme and do not produce the enzyme strain) good antibacterial action is arranged also.Other gram positive coccus (comprising streptococcus faecalis), anaerobe, rickettsia, fungus and virus are all insensitive to this product.
Amikacin is mainly used in the trauma infection contamination disease that Pseudomonas aeruginosa, Bacillus proteus, escherichia coli and staphylococcus aureus etc. cause.
But because the biological half-life of amikacin is short, clinical consumption is big, and has ear, nephrotoxicity, and therefore restriction is widely used clinically.
Disclose amikacin, lincomycin and dexamethasone injection among the Chinese patent application publication number CN1123143A, be used for the treatment of psoriasis as active component; Disclose amikacin sulfate and clobetasol propionate among the Chinese patent application publication number CN1231179A as active component, be mixed with liquid or unguentum, be used for the treatment of " tinea pedis " tinea, the tinea manuum, tinea pedis, tinea etc.; Also disclosed a kind ofly among the CN1449743A, be used for the treatment of the trauma infection contamination disease with the spray of Aminoglycoside antibiotics as active component; The 9th the 1st phase of volume of " Jiangsu pharmacy and clinical research " calendar year 2001 has also disclosed the amikacin sulfate eye drop; " animal medicine progress " 2004 the 25th the 6th phases of volume have also disclosed the liposomal amikacin preparation.Have the lotion (being the aqueous solution of amikacin) of amikacin at present on the market, be used for responsive microbial severe trauma and infect.In prior art, do not see the report that amikacin paste agent and preparation process thereof are arranged, also not seeing has relevant product.
Summary of the invention:
The present invention develops the ointment formulation of a kind of amikacin or its pharmaceutical salts by form improvement and prescription design, compare with existing lotion, not only use and carry aspect convenient, but also have advantages such as skin nonirritants.Especially, amikacin paste of the present invention aspect heat-resisting, freezing test, has more unexpected stability.The present invention has not only overcome the defective of amikacin external preparation in the prior art, has also enriched the amikacin preparation type, has more commercial Application and exploitation value.
The purpose of this invention is to provide a kind of amikacin paste preparation and preparation method thereof, be used for the treatment of the trauma infection contamination disease that Pseudomonas aeruginosa, Bacillus proteus, escherichia coli and staphylococcus aureus etc. cause, by external and topical, farthest bring into play drug effect, and the toxic and side effects of minimizing amikacin, thereby finish the present invention.
For realizing above-mentioned goal of the invention, the present invention adopts following technical scheme:
A kind of amikacin paste, comprise active constituents of medicine and pharmaceutic adjuvant, described active constituents of medicine is amikacin (Kanamycin A Sulfate) or its pharmaceutical salts, described pharmaceutic adjuvant is greasing base and water-soluble base, it is characterized in that, the percentage by weight of each component is in the ointment: amikacin or its pharmaceutical salts 0.05%～5%, preferred percentage by weight is 0.25%, the ointment base weight ratio is 95%～99.95%, wherein greasing base 25%～50%, water-soluble base 5%～20%, surplus are distilled water, and the percentage by weight sum of each component is 100%.
Wherein, described greasing base is selected from one or more in stearic acid, glyceryl monostearate, paraffin, liquid paraffin, white vaseline, lanoline, hexadecanol, octadecanol, span series, Cera Flava, the animal and plant fat;
Wherein, described water-soluble base is selected from one or more in glycerol, propylene glycol, sorbitol, peregal 20, Polyethylene Glycol series, tween series, sodium lauryl sulphate, dimethyl sulfoxide, the triethanolamine.
Above-mentioned described span series is meant Arlacel-60, Arlacel-40 or Arlacel-20;
Above-mentioned described Polyethylene Glycol series is meant PEG400, cetomacrogol 1000, polyethylene glycol 1500, Macrogol 3000 or Macrogol 4000;
Above-mentioned described tween series is meant tween 80, Tween-65, Tween-40 or tween 20.
Amikacin paste of the present invention can also contain antiseptic.Described antiseptic is selected from parabens, chlorocresol, ethylparaben, chlorobutanol, sorbic acid, benzalkonium chloride or benzalkonium bromide; Be preferably ethyl hydroxybenzoate.
Amikacin pharmaceutical salts of the present invention is preferably amikacin sulfate.
The present invention also provides the preparation method of above-mentioned amikacin paste, and comprise following steps: (a) get amikacin or its pharmaceutical salts, water is that solvent makes dissolving; (b) greasing base of aseptic process is become to split under 75～80 ℃ the temperature, fusion also stirs; (c) water-soluble base of aseptic process is become to split under 75～80 ℃ the temperature, stir and make dissolving and mix homogeneously; (d) (b) joined in synthermal (c), stirring makes fully emulsified; (e) (a) added in (d), and stir natural cooling.
Amikacin paste of the present invention can be used for treating infectious disease.Described infectious disease, for example infectious disease that can cause for Pseudomonas aeruginosa, Bacillus proteus, escherichia coli or staphylococcus aureus etc.
Amikacin paste of the present invention, finished product uniform and smooth, good stability, high safety, curative effect height, be easy to the washing; Ointment preparation method of the present invention, easy, the constant product quality of technology is suitable for suitability for industrialized production.
The specific embodiment
The present invention is further described by the following examples or explanation.Described embodiment only is in order to explain or to illustrate, is not that claim protection domain of the present invention is limited.
Embodiment 1
Prescription:
Amikacin 2.5g
Glyceryl monostearate 150g
White vaseline 100g
Liquid paraffin 90g
Arlacel-60 30g
Ethyl hydroxybenzoate 1g
Glycerol 100g
Tween 80 35g
Distilled water adds to 1000g
Preparation method: get amikacin, with the suitable quantity of water dissolving, standby; Water-soluble base glycerol, ethyl hydroxybenzoate, tween 80, the distilled water of aseptic process are put in the container, and water-bath is stirred down for 75～80 ℃ and is made dissolving and mix homogeneously; With greasing base glyceryl monostearate, white vaseline, liquid paraffin, the sorbester p18 of aseptic process are put in another container 75～80 ℃ of following fusions of water-bath, and mix homogeneously; The greasing base of mixing is slowly joined in the synthermal water-soluble base, under same temperature conditions, stir in the same direction, make it fully emulsified; Add the aqueous solution of amikacin again, stir, natural cooling.
Embodiment 2
Prescription:
Amikacin 2.5g
Stearic acid 80g
Hexadecanol 60g
Liquid paraffin 100g
White vaseline 100g
Arlacel-60 10g
Ethyl hydroxybenzoate 1g
Glycerol 60g
Peregal 20 25g
Distilled water adds to 1000g
Preparation method: with embodiment 1.
Embodiment 3
Prescription:
Amikacin 2.5g
Stearic acid 180g
White vaseline 180g
Glyceryl monostearate 10g
Ethyl hydroxybenzoate 1g
Glycerol 60g
Peregal 20 30g
Distilled water adds to 1000g
Preparation method: with embodiment 1.
Embodiment 4
Prescription:
Amikacin 2.5g
Hexadecanol 120g
Liquid paraffin 60g
White vaseline 150g
Ethyl hydroxybenzoate 1g
Glycerol 60g
Sodium lauryl sulphate 10g
Distilled water adds to 1000g
Preparation method: with embodiment 1.
Embodiment 5
Prescription:
Amikacin 2.5g
Glyceryl monostearate 40g
Stearic acid 120g
White vaseline 50g
Liquid paraffin 70g
Ethylparaben 1g
Glycerol 100g
Triethanolamine 20ml
Distilled water adds to 1000g
Preparation method: with embodiment 1.
Embodiment 6: thermostability, freezing test
Get the sample of being developed, place respectively at 55 ℃ of constant temperature and reached-15 ℃ of placements 24 hours in 6 hours, should not have oil-water separation (lamination), liquefaction or coarsening phenomenon.
Show by result of the test, amikacin paste of the present invention, by thermostability, freezing test, sample does not all have the oil-water separation phenomenon, and the result sees Table 1 and table 2 respectively.
Table 1 heat-resistance test result
| Sample | Liquefaction phenomenon | Lamination | Change color |
| Embodiment 1 | There is not liquefaction | No layering | Invariant color |
| Embodiment 2 | There is not liquefaction | No layering | Invariant color |
| Embodiment 3 | There is not liquefaction | No layering | Invariant color |
| Embodiment 4 | There is not liquefaction | No layering | Invariant color |
| Embodiment 5 | There is not liquefaction | No layering | Invariant color |
Table 2 freezing test result
Embodiment 7: stability test
| Sample | Alligatoring | Dehydration | Variable color |
| Embodiment 1 | Do not have | Do not have | Invariant color |
| Embodiment 2 | Do not have | Do not have | Invariant color |
| Embodiment 3 | Do not have | Do not have | Invariant color |
| Embodiment 4 | Do not have | Do not have | Invariant color |
| Embodiment 5 | Do not have | Do not have | Invariant color |
To the sample of being developed keep sample for a long time respectively the test and accelerated test.
Sample thief, with reference to Chinese Pharmacopoeia two appendix of version in 2000 " medicine stability test guideline ", press commercially available back, the test that keeps sample for a long time (places 25 ℃ ± 2 ℃, relative humidity 60% ± 10%) place under the condition, and respectively at 3,6,9,12 months sample analysis, and (30 ℃ ± 2 ℃ of accelerated tests, relative humidity 75% ± 10%) place under the condition, and respectively at 1,2,3,6 the end of month sample analysis.Aspects such as main character from sample, uniformity, oil-water separation phenomenon (having or not layering), content are investigated, and the result is table 3 and 4 respectively.
The table 3 amikacin paste of the present invention result of the test that keeps sample for a long time
| Sample | Time (moon) | Character | Uniformity | Have or not layering | Content (%) |
| Embodiment 1 | 0 | Off-white color | Uniform and smooth | No layering | 99.0 |
| 3 | Off-white color | Uniform and smooth | No layering | 98.5 | |
| 6 | Off-white color | Uniform and smooth | No layering | 99.2 | |
| 9 | Off-white color | Uniform and smooth | No layering | 99.5 | |
| 12 | Off-white color | Uniform and smooth | No layering | 98.6 | |
| Embodiment 2 | 0 | Off-white color | Uniform and smooth | No layering | 99.2 |
| 3 | Off-white color | Uniform and smooth | No layering | 98.4 | |
| 6 | Off-white color | Uniform and smooth | No layering | 98.7 | |
| 9 | Off-white color | Uniform and smooth | No layering | 98.6 | |
| 12 | Off-white color | Uniform and smooth | No layering | 98.3 |
| Embodiment 3 | 0 | Off-white color | Uniform and smooth | No layering | 98.2 |
| 3 | Off-white color | Uniform and smooth | No layering | 98.4 | |
| 6 | Off-white color | Uniform and smooth | No layering | 97.6 | |
| 9 | Off-white color | Uniform and smooth | No layering | 98.0 | |
| 12 | Off-white color | Uniform and smooth | No layering | 97.5 | |
| Embodiment 4 | 0 | Off-white color | Uniform and smooth | No layering | 97.8 |
| 3 | Off-white color | Uniform and smooth | No layering | 97.5 | |
| 6 | Off-white color | Uniform and smooth | No layering | 97.9 | |
| 9 | Off-white color | Uniform and smooth | No layering | 98.2 | |
| 12 | Off-white color | Uniform and smooth | No layering | 97.4 | |
| Embodiment 5 | 0 | Off-white color | Uniform and smooth | No layering | 98.5 |
| 3 | Off-white color | Uniform and smooth | No layering | 98.0 | |
| 6 | Off-white color | Uniform and smooth | No layering | 97.6 | |
| 9 | Off-white color | Uniform and smooth | No layering | 97.4 | |
| 12 | Off-white color | Uniform and smooth | No layering | 97.7 |
Table 4 ointment accelerated test of the present invention result
| Sample | Time (moon) | Character | Uniformity | Have or not layering | Content (%) |
| Embodiment 1 | 0 | Off-white color | Uniform and smooth | No layering | 99.0 |
| 1 | Off-white color | Uniform and smooth | No layering | 98.6 | |
| 2 | Off-white color | Uniform and smooth | No layering | 98.4 | |
| 3 | Off-white color | Uniform and smooth | No layering | 99.1 | |
| 6 | Off-white color | Uniform and smooth | No layering | 98.1 | |
| Embodiment 2 | 0 | Off-white color | Uniform and smooth | No layering | 99.2 |
| 1 | Off-white color | Uniform and smooth | No layering | 98.8 | |
| 2 | Off-white color | Uniform and smooth | No layering | 98.5 | |
| 3 | Off-white color | Uniform and smooth | No layering | 98.3 | |
| 6 | Off-white color | Uniform and smooth | No layering | 98.6 | |
| Embodiment 3 | 0 | Off-white color | Uniform and smooth | No layering | 98.2 |
| 1 | Off-white color | Uniform and smooth | No layering | 98.0 |
| 2 | Off-white color | Uniform and smooth | No layering | 97.5 | |
| 3 | Off-white color | Uniform and smooth | No layering | 97.7 | |
| 6 | Off-white color | Uniform and smooth | No layering | 97.3 | |
| Embodiment 4 | 0 | Off-white color | Uniform and smooth | No layering | 97.8 |
| 1 | Off-white color | Uniform and smooth | No layering | 97.3 | |
| 2 | Off-white color | Uniform and smooth | No layering | 97.0 | |
| 3 | Off-white color | Uniform and smooth | No layering | 98.1 | |
| 6 | Off-white color | Uniform and smooth | No layering | 96.9 | |
| Embodiment 5 | 0 | Off-white color | Uniform and smooth | No layering | 98.5 |
| 1 | Off-white color | Uniform and smooth | No layering | 98.1 | |
| 2 | Off-white color | Uniform and smooth | No layering | 97.8 | |
| 3 | Off-white color | Uniform and smooth | No layering | 97.6 | |
| 6 | Off-white color | Uniform and smooth | No layering | 98.7 |
Shown that by result of the test amikacin paste of the present invention is in keep sample for a long time test and accelerated test are investigated, sample is stable, the appearance character uniform and smooth, and no lamination, content has no significant change.This shows that ointment of the present invention is reliable and stable.
With the sample that the present invention developed, the skin bit of the breakage of partial smearing rat does not see that the part has erythema or edema to form, and the result shows that amikacin paste of the present invention does not have obvious local irritation reaction and anaphylaxis.
Claims (9)
1. amikacin paste, comprise active constituents of medicine and pharmaceutic adjuvant, described active constituents of medicine is amikacin (Kanamycin A Sulfate) or its pharmaceutical salts, described pharmaceutic adjuvant is greasing base and water-soluble base, it is characterized in that, the percentage by weight of each component is in the ointment: amikacin or its pharmaceutical salts 0.05%～5%, preferred 0.25%, greasing base 25%～50%, water-soluble base 5%～20%, surplus is a distilled water, the percentage by weight sum of each component is 100%, wherein, described greasing base is selected from stearic acid, glyceryl monostearate, paraffin, liquid paraffin, white vaseline, lanoline, hexadecanol, octadecanol, span series, Cera Flava, in the animal and plant fat one or more; Described water-soluble base is selected from one or more in glycerol, propylene glycol, sorbitol, peregal 20, Polyethylene Glycol series, tween series, sodium lauryl sulphate, dimethyl sulfoxide, the triethanolamine.
2. amikacin paste according to claim 1, wherein said span series is meant Arlacel-60,40 or 20; Polyethylene Glycol series is meant PEG400,1000,1500,3000 or 4000; Tween series is meant tween 80,65,40 or 20.
3. amikacin paste according to claim 1 and 2 wherein can also contain antiseptic.
4. amikacin paste according to claim 3, wherein said antiseptic is selected from parabens, chlorocresol, chlorobutanol, sorbic acid, benzalkonium chloride or benzalkonium bromide; Be preferably ethyl hydroxybenzoate.
5. according to each described amikacin paste of claim 1-4, wherein said amikacin pharmaceutical salts is an amikacin sulfate.
6. amikacin paste according to claim 1, the weight of each component is in the ointment: amikacin 2.5g, stearic acid 80g, hexadecanol 60g, liquid paraffin 100g, white vaseline 100g, Arlacel-60 10g, ethyl hydroxybenzoate 1g, glycerol 60g, peregal 2025g, adding distil water to total amount is 1000g; Perhaps, the weight of each component is in the ointment: amikacin 2.5g, and glyceryl monostearate 150g, white vaseline 100g, liquid paraffin 90g, Arlacel-60 30g, ethyl hydroxybenzoate 1g, glycerol 100g, tween 80 35g, adding distil water to total amount is 1000g; Perhaps, the weight of each component is in the ointment: amikacin 2.5g, and stearic acid 180g, white vaseline 180g, glyceryl monostearate 10g, ethyl hydroxybenzoate 1g, glycerol 60g, peregal 20 30g, adding distil water to total amount is 1000g; Perhaps, the weight of each component is in the ointment: amikacin 2.5g, and hexadecanol 120g, liquid paraffin 60g, white vaseline 150g, ethyl hydroxybenzoate 1g, glycerol 60g, sodium lauryl sulphate 10g, adding distil water to total amount is 1000g; Perhaps, the weight of each component is in the ointment: amikacin 2.5g, and glyceryl monostearate 40g, stearic acid 120g, white vaseline 50g, liquid paraffin 70g, ethyl hydroxybenzoate 1g, glycerol 100g, triethanolamine 20ml, adding distil water to total amount is 1000g.
7. method for preparing each described amikacin paste of claim 1-6, it comprises following steps: (a) get amikacin or its pharmaceutical salts, water is that solvent makes dissolving; (b) greasing base of aseptic process is become to split under 75～80 ℃ the temperature, fusion also stirs; (c) water-soluble base of aseptic process is become to split under 75～80 ℃ the temperature, stir and make dissolving and mix homogeneously; (d) (b) joined in synthermal (c), stirring makes fully emulsified; (e) (a) added in (d), and stir natural cooling.
8. each described amikacin paste of claim 1-6 is used for preparing the application of treatment trauma infection contamination disease medicament.
9. application according to claim 8, wherein said trauma infection contamination disease is the trauma infection contamination disease that Pseudomonas aeruginosa, Bacillus proteus, escherichia coli or staphylococcus aureus etc. cause.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005101058922A CN100421670C (en) | 2005-10-09 | 2005-10-09 | Amikacin paste and preparing method and use |
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| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005101058922A CN100421670C (en) | 2005-10-09 | 2005-10-09 | Amikacin paste and preparing method and use |
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| Publication Number | Publication Date |
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| CN1742742A true CN1742742A (en) | 2006-03-08 |
| CN100421670C CN100421670C (en) | 2008-10-01 |
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Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101972264A (en) * | 2010-10-13 | 2011-02-16 | 南京泽恒医药技术开发有限公司 | Method for preparing miconazole nitrate-and hydrocortisone-containing medicinal cream |
| CN103933051A (en) * | 2014-05-12 | 2014-07-23 | 广东台城制药股份有限公司 | Triamcinolone acetonide acetat and preparation method thereof |
| CN106309353A (en) * | 2015-06-19 | 2017-01-11 | 江苏吉贝尔药业股份有限公司 | Ointment used for treating psoriasis and preparation method thereof |
-
2005
- 2005-10-09 CN CNB2005101058922A patent/CN100421670C/en not_active Expired - Fee Related
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN101972264A (en) * | 2010-10-13 | 2011-02-16 | 南京泽恒医药技术开发有限公司 | Method for preparing miconazole nitrate-and hydrocortisone-containing medicinal cream |
| CN103933051A (en) * | 2014-05-12 | 2014-07-23 | 广东台城制药股份有限公司 | Triamcinolone acetonide acetat and preparation method thereof |
| CN106309353A (en) * | 2015-06-19 | 2017-01-11 | 江苏吉贝尔药业股份有限公司 | Ointment used for treating psoriasis and preparation method thereof |
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| Publication number | Publication date |
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| CN100421670C (en) | 2008-10-01 |
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Granted publication date: 20081001 Termination date: 20091109 |