CN102204931A - Amiotide eye drop containing composite bacteriostatic agent - Google Patents
Amiotide eye drop containing composite bacteriostatic agent Download PDFInfo
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- CN102204931A CN102204931A CN2011101392868A CN201110139286A CN102204931A CN 102204931 A CN102204931 A CN 102204931A CN 2011101392868 A CN2011101392868 A CN 2011101392868A CN 201110139286 A CN201110139286 A CN 201110139286A CN 102204931 A CN102204931 A CN 102204931A
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Abstract
The invention discloses an amiotide eye drop containing a composite bacteriostatic agent. The composite bacteriostatic agent is phydroxybenzoate ester and phenethyl alcohol, wherein the concentration of the phydroxybenzoate ester is 0.1 to 0.4g/L; the concentration of the phenethyl alcohol is 4 to 5ml/L; and the phydroxybenzoate ester is one of or a mixture of more than two of methyl parahydroxybenzoate, ethyl p-hydroxybenzoate, propyl p-hydroxybenzoate and butyl p-hydroxybenzoate. Through the combined collaborative bacteriostatic action of the phydroxybenzoate ester and the phenethyl alcohol, the amiotide eye drop can improve the bacteriostatic activity, enhances the microbial contamination resistance, expands the antibacterial spectrum and has relatively high inhabitation effect on gram-negative bacterium, gram-positive bacterium and fungi. The potency assay of the bacteriostatic agent proves that the amiotide eye drop completely accords with the rule of a bacteriostatic agent efficacy test method guiding principle, which is the appendix of 'China Pharmacopeia 2000 (vol. II)', and the safety and the efficiency of the amiotide eye drop can satisfy clinical needs.
Description
Technical field
The present invention relates to a kind of ammonia iodine peptide eye drop that contains the compound recipe antibacterial.
Background technology
Senile cataract is the very general disease of old people.Data shows according to statistics, and in the Chinese cataract patient, 50～59 years old patient accounts for 60%, 60～69 years old patient and account for the prevalence of patient more than 80%, 70 years old then above 90%.In treatment early-stage senile cataractous numerous medicines, ammonia iodine peptide eye drop is an eye drop commonly used, and is evident in efficacy and frequency of utilization is high.At present commercially available ammonia iodine peptide eye drop is a kind ofly to extract the biochemical preparation that forms by pig whole eyeball and thyroid through pancreatin and mycoprotein enzyme hydrolysis, contain (what play a major role are Is) such as 18 seed amino acids, polypeptide, nucleotide and various trace elements such as organic iodine and glutamic acid, cystine, glycine, day propylhomoserin, winter propylhomoserin, lysines, contained antibacterial is P-hydroxybenzoic acid class and gentamycin sulfate in the component of this eye drop.
Guo Haoshui finds that under study for action gentamycin sulfate belongs to the aminoglycoside class, toxic and side effects such as nephrotoxicity, ototoxicity, neuromuscular toxicity and anaphylaxis are arranged, some toxic and side effects or even irreversible (" gentamycin toxicity and prevention ", theory of medicine and practice, 1995,8 (8): 377).This point also clearly marks in the capsular explanation of commercially available gentamycin sulfate, and gram negative bacilli significantly increases the gentamycin persister in recent years.Scholars such as Luo Mingsheng, Gao Tianhui, Song Minxian think that the main effect of parabens is to stop fungus growth, and its fungistatic effect to gram negative bacteria is relatively poor relatively.Phenethanol has significant bacteriostasis to gram negative bacteria, and can mould fungus inhibition, to bacillus pyocyaneus have preferably bacteriostasis (" Chinese pharmaceutic adjuvant ", Beijing, Chemical Industry Press, 2006:137).
Antibacterial is added in the eye drop and uses, and its objective is to prevent preparation contingent microbial contamination and breeding in normal storage and use.And " Chinese Pharmacopoeia 2010 version two ones ", Beijing, Chinese Medicine science and technology publishing house, 2010: also increased antibacterial appendix 215-216) newly and renderd a service the guideline of checking, it is that test organisms carries out the antibacterial efficacy determinations that the regulation eye drop needs with Pseudomonas aeruginosa, escherichia coli, staphylococcus aureus, Candida albicans, aspergillus niger.Therefore, in its kind of the antibacterial of using in the eye drop and the working concentration scope thereof, tackle above-mentioned five kinds of bacterium and all play effective inhibitory action.
As seen, there is drug safety hidden danger in the antibacterial of commercially available ammonia iodine peptide eye drop, can't meet clinical needs, and therefore, how filtering out suitable antibacterial has become the technical barrier that solution is badly in need of in this area.
Summary of the invention
The object of the present invention is to provide a kind of ammonia iodine peptide eye drop that contains the compound recipe antibacterial, wherein the compound recipe antibacterial is parabens and phenethanol, gram positive bacteria, gram negative bacteria and other fungus all there are bacteriostasis preferably, safe and effective.
The technical solution used in the present invention is:
A kind of ammonia iodine peptide eye drop that contains the compound recipe antibacterial, it is characterized in that described compound recipe antibacterial is parabens and phenethanol, in containing the ammonia iodine peptide eye drop of compound recipe antibacterial, (preferred 0.15～0.3g/L), described phenethanol concentration is 4～5ml/L to described parabens concentration 0.1～0.4g/L; Described parabens is one or more the mixing in methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate and the butyl p-hydroxybenzoate.
Further, the described ammonia iodine peptide eye drop that contains the compound recipe antibacterial of this law, every 1000ml ammonia iodine peptide eye drop is made up of following component: the thyroid extract, the eyeball extract, parabens 0.1～0.4g (preferred 0.15～0.3g), phenethanol 4～5ml, ethanol 1～4ml, the sodium hydroxide solution that is used to regulate ammonia iodine peptide eye drop pH value to 5.5～7.0 is an amount of, and surplus is a water for injection; Described thyroid extract is the extract that mammiferous thyroid obtains through pancreatin, neutral proteinase hydrolysis under heating condition successively, described eyeball extract is the extract that mammiferous eyeball obtains through pancreatin, neutral proteinase hydrolysis under heating condition successively, the consumption of described thyroid extract is counted 0.025～0.045g with the content of organic iodine wherein, and the consumption of described eyeball extract is counted 35～50g with its total solids content; Described mammal is preferably pig, cattle or sheep.
The organic iodine that contains in the described thyroid extract, it is the distinctive and bonded I of aminoacid in the thyroid extract, can detect organic iodine percentage composition in the thyroid extract by titrimetry, and calculate the consumption of thyroid extract, i.e. organic iodine percentage composition in the consumption/thyroid extract of required organic iodine in thyroid extract consumption=ammonia iodine peptide eye drop according to the organic iodine percentage composition.
This is the known computational methods of those skilled in the art, and those skilled in the art all can calculate each raw material consumption voluntarily according to prescription.
Preferably, the described prescription that contains the ammonia iodine peptide eye drop of compound recipe antibacterial is: contain the thyroid extract in every 1000ml ammonia iodine peptide eye drop, the eyeball extract, ethylparaben 0.3g, phenethanol 5ml, ethanol 3ml, the sodium hydroxide solution that is used for regulator solution pH value to 6.0 is an amount of, the consumption of thyroid extract is counted 0.035g with the content of organic iodine wherein, and the consumption of eyeball extract is counted 38g with its total solids content, and all the other are water for injection.
Preferably, the described prescription that contains the ammonia iodine peptide eye drop of compound recipe antibacterial is: contain the thyroid extract in every 1000ml ammonia iodine peptide eye drop, the eyeball extract, propyl p-hydroxybenzoate 0.2g, phenethanol 5ml, ethanol 2ml, the sodium hydroxide solution that is used for regulator solution pH value to 6.0 is an amount of, the consumption of thyroid extract is counted 0.035g with the content of organic iodine wherein, and the consumption of eyeball extract is counted 38g with its total solids content, and all the other are water for injection.
Preferably, the described prescription that contains the ammonia iodine peptide eye drop of compound recipe antibacterial is: contain the thyroid extract in every 1000ml ammonia iodine peptide eye drop, the eyeball extract, propyl p-hydroxybenzoate 0.3g, phenethanol 4ml, ethanol 3ml, the sodium hydroxide solution that is used for regulator solution pH value to 6.5 is an amount of, the consumption of thyroid extract is counted 0.035g with the content of organic iodine wherein, and the consumption of eyeball extract is counted 38g with its total solids content, and all the other are water for injection.
Thyroid extract of the present invention can extract by the following method and obtain: getting the mammal thyroid is raw material, described mammal is pig, cattle or sheep, mix with purified water raw material chopping back, and to regulate pH value with 10% sodium hydroxide solution be 8.0～10.0, stir, use pancreatin hydrolysis 2～6 hours (preferred 4 hours) down at 40～50 ℃ earlier; Use neutral proteinase hydrolysis 2～6 hours (preferred 4 hours) down at 45～55 ℃ again, reaction finishes the centrifugal removal residue of afterreaction liquid, get supernatant add ethanol to alcoholic acid final concentration be 75%, remove precipitation, the gained clear liquid filters, filtrate decompression concentrates, and obtains solid content and be 20～40%, the thyroid extract of organic iodine content 0.1～0.3%; The consumption of described purified water is 2～3 times of raw materials quality, and the consumption of described pancreatin is 1～3% of a raw materials quality, and described neutral protein enzyme dosage is 0.1～0.3% of a raw materials quality.
Eyeball extract of the present invention extracts by the following method and obtains: getting the mammal eyeball is raw material, described mammal is pig, cattle or sheep, mix with purified water raw material chopping back, and to regulate pH value with 10% sodium hydroxide solution be 8.5～10.0, stir, use pancreatin hydrolysis 2～6 hours (preferred 4 hours) down at 40～50 ℃ earlier; Use neutral proteinase hydrolysis 2～6 hours (preferred 4 hours) down at 45～55 ℃ again, reaction finishes the centrifugal removal residue of afterreaction liquid, get supernatant add ethanol to alcoholic acid final concentration be 75%, remove precipitation, the gained clear liquid filters, filtrate decompression concentrates, and obtains solid content and be 20～30% eyeball extract; The consumption of described purified water is 2～3 times of raw materials quality, and the consumption of described pancreatin is 1～3% of a raw materials quality, and described consumption is 0.1～0.3% of a raw materials quality.
More than be the known extracting method of those skilled in the art, be usually used in the preparation of ammonia iodine peptide eye drop.
The ammonia iodine peptide eye drop that contains the compound recipe antibacterial of the present invention can prepare by the following method: take by weighing parabens according to recipe quantity, phenethanol, ethanol, dissolve back and thyroid extract and eyeball extract mixing fully, add the injection water near recipe quantity (be generally recipe quantity 90%), add while stirring between 4% sodium hydroxide solution regulator solution pH value to 5.5～7.0, the active carbon that gained solution adds solution quality 0.2% is used for the solution decolouring, be heated to 100 ℃, stirred 10～20 minutes, add the injection water at last to recipe quantity, stir, be cooled to room temperature, aseptic filtration, sterile filling promptly gets the described ammonia iodine peptide eye drop that contains the compound recipe antibacterial.
In order to keep the stable acid-base value of medicine, help improving the product stability of ammonia iodine peptide eye drop, guarantee the product curative effect, minimizing is to the zest of eye, compliance when the increase patient uses, with sodium hydroxide solution regulator solution pH value to 5.5～7.0, be preferably 5.8～6.8 in the ammonia iodine peptide eye drop of the present invention.
The present invention is directed to problems such as toxic and side effects that antibacterial in the commercially available ammonia iodine peptide eye drop exists and antimicrobial spectrum be not wide, do not adding on the basis that gentamycin sulfate uses, the antibacterial of eye drop is screened.Compatibility test by prescription, screening is suitable for the antibacterial with this kind eye drop system, again its inhibitory effect is studied, the result shows, in the typical concentrations scope of antibacterial, list can't reach the effect that suppresses gram negative bacteria, gram positive bacteria, fungus simultaneously with a kind of antibacterial in eye drop.Therefore, need one group of compound preservative of screening to be used for this eye drop.Show that from the The selection result of compound preservative parabens and phenethanol coupling can enlarge scope of restraining fungi, strengthen bacteriostatic activity, gram negative bacteria, gram positive bacteria, fungus are all had good inhibitory effect.
Meanwhile, the compound preservative that filters out is carried out the investigation of inhibitory effect demonstration test, the result shows parabens and phenethanol coupling as compound preservative, meets the regulation of " Chinese Pharmacopoeia 2010 version two ones " appendix fully, and is safe and effective.
The present invention has following advantage:
A kind of ammonia iodine peptide eye drop that contains the compound recipe antibacterial provided by the invention, collaborative antibacterial by parabens and phenethanol coupling, improve bacteriostatic activity, strengthen the antimicrobial pollution capacity, enlarge antimicrobial spectrum, gram negative bacteria, gram positive bacteria, fungus are all had better inhibitory action; And meet " Chinese Pharmacopoeia 2010 version two ones " appendix regulation fully through antibacterial potency test checking, its safety and effective performance meet clinical needs.
The specific embodiment
The present invention will be further described below in conjunction with embodiment, but protection scope of the present invention is not limited thereto.
Preparation method of extract is in the following example:
1. thyroid extract: get the 125g pig thyroid gland, chopping drops into the reactor that the 250g purified water is housed, and regulates feed liquid to pH8.5 with 10% sodium hydroxide solution, stir, earlier at 45 ℃ down with total 2g pancreatin hydrolysis 4 hours; Again 50 ℃ down with amounting to 0.2g neutral proteinase hydrolysis 4 hours, centrifugal removal residue, getting supernatant, to add ethanol to final concentration be 75%, removes precipitation, clear liquid filters, filtrate decompression concentrates, and obtains the extract 60g of organic iodine content 0.1%, solid content 20%.
2. thyroid extract: get the 125g pig thyroid gland, chopping drops into the reactor that the 250g purified water is housed, and regulates feed liquid to pH8.5 with 10% sodium hydroxide solution, stir, earlier at 45 ℃ down with total 2g pancreatin hydrolysis 4 hours; Again 50 ℃ down with amounting to 0.2g neutral proteinase hydrolysis 4 hours, centrifugal removal residue, getting supernatant, to add ethanol to final concentration be 75%, removes precipitation, clear liquid filters, filtrate decompression concentrates, and obtains the extract 30g of organic iodine content 0.2%, solid content 40%.
3. eyeball preparation method of extract: get 125g Oculus sus domestica ball, chopping drops into the reactor that the 250g purified water is housed, and regulates feed liquid to pH8.5 with 10% sodium hydroxide solution, stir, earlier at 45 ℃ down with total 2g pancreatin hydrolysis 4 hours; Again 50 ℃ down with amounting to 0.2g neutral proteinase hydrolysis 4 hours, centrifugal removal residue, getting supernatant, to add ethanol to final concentration be 75%, removes precipitation, clear liquid filters, filtrate decompression concentrates, and obtains the extract 45g of solid content 20%.
As stated above doing several times as the raw material of embodiment more.
4. eyeball preparation method of extract: get 125g Oculus sus domestica ball, chopping drops into the reactor that the 250g purified water is housed, and regulates feed liquid to pH8.5 with 10% sodium hydroxide solution, stir, earlier at 45 ℃ down with total 2g pancreatin hydrolysis 4 hours; Again 50 ℃ down with amounting to 0.2g neutral proteinase hydrolysis 4 hours, centrifugal removal residue, getting supernatant, to add ethanol to final concentration be 75%, removes precipitation, clear liquid filters, filtrate decompression concentrates, and obtains the extract 30g of solid content 30%.
As stated above doing several times as the raw material of embodiment more.
Embodiment 1
Get thyroid extract (containing organic iodine 0.2%, solid content 40%) 17.5g and eyeball extract (solid content 30%) 126.6g, in the beaker that has high input; Get ethylparaben 0.3g, phenethanol 5.0ml adds ethanol 3ml, stirs it is dissolved fully, in the beaker that has high input; Add the injection water to 900ml, add 4% sodium hydroxide solution regulator solution pH value to 6.0 while stirring; The active carbon that adds 2g is used for the solution decolouring, and heating keeps 100 ℃, stirs 10 minutes.Add the injection water and measure to 1000ml, stir, be cooled to room temperature; Aseptic filtration, sterile filling promptly obtains ammonia iodine peptide eye drop.
Embodiment 2
Get thyroid extract (containing organic iodine 0.1%, solid content 20%) 35g and eyeball extract (solid content 20%) 190g, in the beaker that has high input; Get propyl p-hydroxybenzoate 0.2g, phenethanol 5.0ml adds ethanol 2ml, stirs it is dissolved fully, in the beaker that has high input; Add the injection water to 900ml, add 4% sodium hydroxide solution regulator solution pH value to 6.0 while stirring; The active carbon that adds 2g is used for the solution decolouring, and heating keeps 100 ℃, stirs 20 minutes.Add the injection water and measure to 1000ml, stir, be cooled to room temperature; Aseptic filtration, sterile filling promptly obtains ammonia iodine peptide eye drop.
Embodiment 3
Get thyroid extract (containing organic iodine 0.1%, solid content 20%) 35g and eyeball extract (solid content 20%) 190g, in the beaker that has high input; Get propyl p-hydroxybenzoate 0.3g, phenethanol 4.0ml adds ethanol 3ml, stirs it is dissolved fully, in the beaker that has high input; Add the injection water to 900ml, add 4% sodium hydroxide solution regulator solution pH value to 6.5 while stirring; The active carbon that adds 2g is used for the solution decolouring, and heating keeps 100 ℃, stirs 20 minutes.Add the injection water and measure to 1000ml, stir, be cooled to room temperature; Aseptic filtration, sterile filling promptly obtains ammonia iodine peptide eye drop.
Embodiment 4 the present invention are used for the prescription screening of the antibacterial of ammonia iodine peptide eye drop
Take by weighing an amount of benzalkonium chloride, benzalkonium bromide, chlorhexidine, epsilon-polylysine, methyl parahydroxybenzoate, ethyl ester, propyl ester, month silicic acid monoglyceride respectively, phenethanol makes its content be respectively 0.05%, 0.05%, 0.02%, 0.1%, 0.1%, 0.04%, 0.03%, 0.1%, 0.5% to the blank eye drop of the ammonia iodine peptide of the not bacteriostatic agent of having prepared.Place, observe the ammonia iodine peptide solution that has added antibacterial and whether clarify, and compare with its aqueous solution.The result is as follows:
The experimental result of the incompatibility of table 1 antibacterial prescription screening
The blank eye drop of the ammonia iodine peptide of described not bacteriostatic agent is prepared by the following method: get thyroid extract (containing organic iodine 0.1%, total solid 20%) 35g and eyeball extract (containing total solid 20%) 190g, in the beaker that has high input; Add the injection water to 900ml, add 4% sodium hydroxide solution regulator solution pH value to 6.0 while stirring; The active carbon that adds 2g is used for the solution decolouring, and heating keeps 100 ℃, stirs 20 minutes.Add the injection water and measure to 1000ml, stir, be cooled to room temperature; Aseptic filtration, sterile filling promptly obtains the not blank eye drop of ammonia iodine peptide of bacteriostatic agent.
Embodiment 5 the present invention are used for the fungistatic effect of the antibacterial of ammonia iodine peptide eye drop and investigate
With escherichia coli, staphylococcus aureus, Pseudomonas aeruginosa, Candida albicans, aspergillus niger is test organisms, adopts nephelometry, investigates the fungistatic effect of antibacterial.
The preparation of bacteria suspension: escherichia coli, staphylococcus aureus, Pseudomonas aeruginosa are seeded under aseptic condition respectively in the 10ml nutrient broth medium, 35 ℃, cultivate 24h.Bacteria suspension dilutes with physiological saline solution, makes bacterial concentration reach 10
6Cfu/ml.Candida albicans is seeded under aseptic condition in the 10ml improvement Martin fluid medium, 25 ℃, cultivates 48h.Bacteria suspension dilutes with physiological saline solution, makes bacterial concentration reach 10
6Cfu/ml.Aspergillus niger is seeded under aseptic condition in the improvement Martin agar culture medium, and 25 ℃, cultivate 5d,, and make and contain spore count 10 the spore eluting with the physiological saline solution that contains 0.05% polyoxyethylene sorbitan monoleate
6The spore suspension of cfu/ml.
The preparation of test liquid: take by weighing p-Hydroxybenzoate 0.2g and title (amount) respectively and get p-Hydroxybenzoate 0.2g, phenethanol 5ml, be dissolved in the 100ml nutrient broth medium, use for escherichia coli, staphylococcus aureus, Pseudomonas aeruginosa test.Take by weighing p-Hydroxybenzoate 0.2g and title (amount) respectively and get p-Hydroxybenzoate 0.2g, phenethanol 5ml,, be dissolved in the 100ml improvement Martin fluid medium, use for Candida albicans, aspergillus niger test.Get the 10ml test liquid to test tube, autoclaving.Each test bacterium is established two pipe test liquids, and establishes one group of control tube.Under the aseptic condition, every test tube adds bacteria suspension 0.2ml.35 ℃ of escherichia colis, staphylococcus aureus, Pseudomonas aeruginosa are cultivated 24h, and 25 ℃ of Candida albicans, aspergillus nigers are cultivated 48h.Whether solution is clarified in the observation test tube.Experimental result is as follows:
The fungistatic effect of table 2 antibacterial is investigated the result
Annotate: the long bacterium of "+" expression, the not long bacterium of "-" expression
By table 2 data as can be known, it is wide inadequately that the compound preservative of p-Hydroxybenzoate and phenethanol coupling has solved commercially available ammonia iodine peptide eye drop antimicrobial spectrum, the problem that bacteriostatic activity is not high.
Embodiment 6 the present invention are used for the inhibitory effect checking of the antibacterial of ammonia iodine peptide eye drop
Antibacterial according to " Chinese Pharmacopoeia 2010 version two ones " appendix regulation is renderd a service the inspection technique guideline, and the ammonia iodine peptide eye drop that the embodiment of the invention 1 to embodiment 3 is prepared carries out the inhibitory effect demonstration test.
Result of the test is as follows:
Table 3 embodiment 1 inhibitory effect test organisms is counted decline 1g value
Table 4 embodiment 2 inhibitory effect test organismss are counted decline 1g value
Table 5 embodiment 3 inhibitory effect test organismss are counted decline 1g value
As can be known, antibacterial: 7 days bacterium numbers descend and are no less than 1.01g from table 3-table 5, and 14 days bacterium numbers descend and are no less than 3.01g, and the bacterium number did not increase in 14 days to 28 days; Fungus: with the initial value ratio, the bacterium number did not increase in 7 days, 14 days, 28 days; The result meets eye drop antibacterial inhibitory effect criterion, therefore eye drop provided by the invention contains the compound preservative of p-Hydroxybenzoate and phenethanol coupling, meet " Chinese Pharmacopoeia 2010 version two ones " antibacterial and render a service the regulation of inspection technique guideline, antibacterial energetic, safe and effective.
Claims (9)
1. ammonia iodine peptide eye drop that contains the compound recipe antibacterial, it is characterized in that described compound recipe antibacterial is parabens and phenethanol, in containing the ammonia iodine peptide eye drop of compound recipe antibacterial, described parabens concentration 0.1～0.4g/L, described phenethanol concentration is 4～5ml/L; Described parabens is one or more the mixing in methyl parahydroxybenzoate, ethylparaben, propyl p-hydroxybenzoate and the butyl p-hydroxybenzoate.
2. the ammonia iodine peptide eye drop that contains the compound recipe antibacterial as claimed in claim 1, it is characterized in that, every 1000ml ammonia iodine peptide eye drop is made up of following component: the thyroid extract, the eyeball extract, parabens 0.1～0.4g, phenethanol 4～5ml, ethanol 1～4ml, be used to regulate the sodium hydroxide solution of ammonia iodine peptide eye drop pH value to 5.5～7.0, surplus is a water for injection; Described thyroid extract is the extract that mammiferous thyroid obtains through pancreatin, neutral proteinase hydrolysis successively, described eyeball extract is the extract that mammiferous eyeball obtains through pancreatin, neutral proteinase hydrolysis successively, the consumption of described thyroid extract is counted 0.025～0.045g with the content of organic iodine wherein, and the consumption of described eyeball extract is counted 35～50g with its total solids content.
3. the ammonia iodine peptide eye drop that contains the compound recipe antibacterial as claimed in claim 2 is characterized in that described mammal is pig, cattle or sheep.
4. the ammonia iodine peptide eye drop that contains the compound recipe antibacterial as claimed in claim 2, it is characterized in that, contain the thyroid extract, eyeball extract, ethylparaben 0.3g in every 1000ml ammonia iodine peptide eye drop, phenethanol 5ml, ethanol 3ml is used for the sodium hydroxide solution of regulator solution pH value to 6.0, and the consumption of thyroid extract is counted 0.035g with the content of organic iodine wherein, the consumption of eyeball extract is counted 38g with its total solids content, and all the other are water for injection.
5. the ammonia iodine peptide eye drop that contains the compound recipe antibacterial as claimed in claim 2, it is characterized in that, contain the thyroid extract, eyeball extract, propyl p-hydroxybenzoate 0.2g in every 1000ml ammonia iodine peptide eye drop, phenethanol 5ml, ethanol 2ml is used for the sodium hydroxide solution of regulator solution pH value to 6.0, and the consumption of thyroid extract is counted 0.035g with the content of organic iodine wherein, the consumption of eyeball extract is counted 38g with its total solids content, and all the other are water for injection.
6. the ammonia iodine peptide eye drop that contains the compound recipe antibacterial as claimed in claim 2, it is characterized in that, contain the thyroid extract, eyeball extract, propyl p-hydroxybenzoate 0.3g in every 1000ml ammonia iodine peptide eye drop, phenethanol 4ml, ethanol 3ml is used for the sodium hydroxide solution of regulator solution pH value to 6.5, and the consumption of thyroid extract is counted 0.035g with the content of organic iodine wherein, the consumption of eyeball extract is counted 38g with its total solids content, and all the other are water for injection.
7. as the described ammonia iodine peptide eye drop that contains the compound recipe antibacterial of claim 2～6, it is characterized in that described thyroid extract extracts by the following method obtains: getting the mammal thyroid is raw material, described mammal is pig, cattle or sheep, mix with purified water raw material chopping back, and to regulate pH value with 10% sodium hydroxide solution be 8.5～10.0, stir, use pancreatin hydrolysis 2～6 hours down at 40～50 ℃ earlier; Use neutral proteinase hydrolysis 2～6 hours down at 45～55 ℃ again, reaction finishes the centrifugal removal residue of afterreaction liquid, get supernatant add ethanol to alcoholic acid final concentration be 75%, remove precipitation, the gained clear liquid filters, filtrate decompression concentrates, and obtains solid content and be 20～40%, the thyroid extract of organic iodine content 0.1～0.3%; The consumption of described purified water is 2～3 times of raw materials quality, and the consumption of described pancreatin is 1～3% of a raw materials quality, and the consumption of described neutral protease is 0.1～0.3% of a raw materials quality.
8. as the described ammonia iodine peptide eye drop that contains the compound recipe antibacterial of claim 2～6, it is characterized in that described eyeball extract extracts by the following method obtains: getting the mammal eyeball is raw material, described mammal is pig, cattle or sheep, mix with purified water raw material chopping back, and to regulate pH value with 10% sodium hydroxide solution be 8.5～10.0, stir, use pancreatin hydrolysis 2～6 hours down at 40～50 ℃ earlier; Again 45～55 ℃ down with neutral proteinase hydrolysis 2～6 hours, reaction finishes the centrifugal removal residue of afterreaction liquid, getting supernatant, to add ethanol to alcoholic acid final concentration be 75%, remove precipitation, the gained clear liquid filters, and filtrate decompression concentrates, and obtains solid content and be 20～30% eyeball extract; The consumption of described purified water is 2～3 times of raw materials quality, and the consumption of described pancreatin is 1～3% of a raw materials quality, and the consumption of described neutral protease is 0.1～0.3% of a raw materials quality.
9. as the described ammonia iodine peptide eye drop that contains the compound recipe antibacterial of claim 2～6, it is characterized in that ammonia iodine peptide eye drop prepares by the following method: take by weighing parabens according to recipe quantity, phenethanol, ethanol, dissolve back and thyroid extract and eyeball extract mixing fully, add the injection water to 90% of recipe quantity, add while stirring between 4% sodium hydroxide solution regulator solution pH value to 5.5～7.0, the active carbon that gained solution adds solution quality 0.2% is used for the solution decolouring, be heated to 100 ℃, stirred 10～20 minutes, add the injection water at last to recipe quantity, stir, be cooled to room temperature, aseptic filtration, sterile filling promptly gets the described ammonia iodine peptide eye drop that contains the compound recipe antibacterial.
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| WO2018223080A1 (en) * | 2017-06-02 | 2018-12-06 | Zurex Pharma, Inc. | Low-alcohol and sterilizable antimicrobial compositions and use thereof |
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