CN1965857A - Eye drop of povidone iodine and preparation process thereof - Google Patents
Eye drop of povidone iodine and preparation process thereof Download PDFInfo
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- CN1965857A CN1965857A CN 200610124977 CN200610124977A CN1965857A CN 1965857 A CN1965857 A CN 1965857A CN 200610124977 CN200610124977 CN 200610124977 CN 200610124977 A CN200610124977 A CN 200610124977A CN 1965857 A CN1965857 A CN 1965857A
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- povidone iodine
- eye drop
- regulator
- osmotic pressure
- eye
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Abstract
The invention relates to a polyketone iodine eyedrops, and relative production, wherein it adds polyketone iodine into osmotic pressure adjuster, stabilizer, and pH adjuster to be dissolved, and using pH adjuster to realize constant volume; pH adjuster at 100 volume units contain 0.1-0.5 units of polyketone iodine, 0.35-0.65 osmotic pressure adjuster mass units, stabilizer at 0.05 mass units; the pH of osmotic pressure adjuster is 6.0-6.8. The invention can treat kinds of ceratitis, with high safety but no side effect.
Description
Technical field
The invention belongs to the medicine of treatment oculopathy, being specifically related to a kind of is the eye drop of principal agent with the povidone iodine.
Background technology
Povidone iodine has been widely used in clinical disinfectant for external use, and the povidone iodine major function is anticorrosion for sterilization.2005 editions second one of Chinese Pharmacopoeia records.Chinese patent discloses multiple povidone iodine external agent, and as 93111431.4 disclosed ointment, it can not be directly used in eye; As the disclosed foaming agent of povidone iodine of CN03143440.1, it can not be directly used in eye.Now there is not document openly whether povidone iodine can be used for the treatment of ocular disease as yet, whether eye is had negative interaction.
Summary of the invention
The object of the present invention is to provide that a kind of treatment is viral, bacillary, fungal keratitis (ulcer) and eye (before comprising operation) disinfectant eye drop of povidone iodine and preparation method, to address the above problem.
The technical scheme that realizes one of the object of the invention is: eye drop of povidone iodine, it is made up of povidone iodine and osmotic pressure regulator, PH regulator, stabilizing agent, the povidone iodine that wherein contains 0.1～0.5 weight portion in the PH regulator of 100 parts by volume, 0.35 the osmotic pressure regulator of～0.65 weight portion, 0.05 the stabilizing agent of weight portion, the PH of eye drop of povidone iodine are 6.0～6.8.
Described PH regulator adopts phosphate buffer, and PH is 5.91-8.04.
Described stabilizing agent adopts potassium iodate.
Described osmotic pressure regulator adopts sodium chloride.
Two the technical scheme that realizes the object of the invention is: the preparation method of eye drop of povidone iodine, and it is with principal agent composition povidone iodine, adds osmotic pressure regulator, stabilizing agent, with the dissolving of PH regulator, with PH regulator standardize solution; The povidone iodine that wherein contains 0.1～0.5 weight portion in the PH regulator of 100 parts by volume, the osmotic pressure regulator of 0.35～0.65 weight portion, the stabilizing agent of 0.05 weight portion, the PH of eye drop of povidone iodine are 6.0～6.8.
That eye drop of povidone iodine can be treated is viral, bacillary, fungal keratitis (ulcer) and eye (before comprising operation) sterilization have significant curative effect, and safety, reliable, have no side effect.Its preparation method is simple, and is stable.
The specific embodiment
Embodiment 1
Povidone iodine 0.1g
Potassium iodate 0.05g
Sodium chloride 0.6g
Phosphate buffer PH is 6.5 100ml
Above-mentioned principal agent povidone iodine is added a certain amount of phosphate buffer dissolving, after adding sodium chloride, potassium iodate dissolving respectively successively, add phosphate buffer to capacity 100ml, aseptic envelope is irritated in a certain size, in the sealed container of specification, promptly produce eye drop of povidone iodine, the PH of eye drop of povidone iodine is 6.5.
Embodiment 2
Povidone iodine 0.25g
Potassium iodate 0.05g
Sodium chloride 0.6g
Phosphate buffer PH is 6.5 100ml
Preparation as stated above, the PH of eye drop of povidone iodine is (6.5).
Embodiment 3
Povidone iodine 0.5g
Potassium iodate 0.05g
Sodium chloride 0.6g
Phosphate buffer PH is 6.5 100ml
Preparation as stated above, the PH of eye drop of povidone iodine is (6.5).
Embodiment 4
Povidone iodine 0.3g
Potassium iodate 0.05g
Sodium chloride 0.35g
Phosphate buffer PH is 6.5 100ml
Preparation as stated above, the PH of eye drop of povidone iodine is (6.5).
It is as follows that the eye drop of povidone iodine pharmacological toxicology is learned result of study:
1, pharmacodynamic study result:
Eye drop of povidone iodine is to the therapeutic test of rabbit staphylococcus aureus keratitis:
Get 20 N/R big ear white rabbit of animal eyes, body weight 2.0-2.5kg, male and female dual-purpose.After Animal Anesthesia, splash into 0.1ml (3 * 10 at the cornea and the conjunctiva layer place of every eye
9/ ml) staphylococcus aureus is caused eye keratitis.Keratitis model success after 24 hours.Be divided into 4 groups then at random, every group of each 5 animals, totally 10 eyes.The 1st group is physiology saline control group, dosage 0.2ml/ eye, every day the secondary eye drip, after each medication closed 40 seconds; The 2nd group is levofloxacin (0.3%) group, dosage 0.2ml/ eye, every day the secondary eye drip, after each medication closed 40 seconds; The 3rd group is 0.5% eye drop of povidone iodine group, dosage 0.2ml/ eye, every day the secondary eye drip, after each medication closed 40 seconds, subsequently with normal saline flushing to colourless; The 4th group is 0.5% eye drop of povidone iodine group, dosage 0.1ml/ eye, every day the secondary eye drip, after each medication closed 40 seconds, subsequently with normal saline flushing to colourless; Each organizes every day with continuous 7 days of same dose and method.Each ulcer symptom variation in every day each group of observed and recorded, and therapeutic effect marked, the results are shown in Table 2.And in administration after 7 days, rotate 3 circles gently at the corneal ulcer place with sterile saline moistening cotton swab, and be inoculated in then on the bouillon agar plate, cultivated 48 hours under 37 ℃ of conditions, judge and cultivate the yin and yang attribute result.The results are shown in Table 3
Table 2 0.5% eye drop of povidone iodine is treated appraisal result to rabbit staphylococcus aureus keratitis:
| The experiment group | The normal saline group | Levofloxacin eye drop group | Eye drop of povidone iodine group 0.2ml/ only | Eye drop of povidone iodine group 0.1ml/ only organizes | |
| Scoring | |||||
| 1 day 2 days 3 days 4 days 5 days 6 days 7 days 8 days | 3.5±0.4 3.7±0.3 3.4±0.3 3.3±0.3 3.0±0.5 2.9±0.6 3.0±0.4 3.0±0.3 | 1.8±0.4* 0.8±0.3* 0.3±0.2* 0.1±0.2* 0.0±0.1* 0* 0* 0* | 1.7±0.5* 0.7±0.4* 0.3±0.2* 0.1±0.1* 0.0±0.1* 0* 0* 0* | 1.9±0.4* 0.8±0.3* 0.3±0.2* 0.1±0.1* 0.0±0.1* 0* 0* 0* | |
*Compare with the normal saline group P＜0.001
Table 3 0.5% eye drop of povidone iodine treatment back lagophthalmos secretions bacteria cultivation results:
| Group | Eye number (only) | Antibacterial detects number positive (only) | |
| Before the treatment | After the treatment | ||
| Normal saline group levofloxacin eye drop group eye drop of povidone iodine group (0.2ml/ only) eye drop of povidone iodine group (0.1ml/ only) | 10 10 10 10 | 10 10 10 10 | 10 0 * 0 * 0 * |
* compare with the normal saline group P＜0.001
From table 2, visible eye drop of povidone iodine treatment staphylococcus aureus causes keratitis and promptly produced the obvious treatment effect in 24 hours among 3 results, and the performance of cornea inflammation is gone down, and medication reached healing after 4 days, therefore can be used as treatment bacterial keratitis medicine.
2, safety research zest research as a result:
The 0.1%-0.5% eye drop of povidone iodine is disposable to splash in the rabbit conjunctival capsule, closes and closes 40 seconds, and with normal saline flushing, the result does not see irritative response.
As seen povidone iodine eye drop external curing of the present invention is viral, bacillary, fungal keratitis (ulcer) and eye (before comprising operation) sterilization has significant curative effect, and safety, reliable, have no side effect.
Claims (8)
1, a kind of eye drop of povidone iodine, it is made up of povidone iodine and osmotic pressure regulator, PH regulator, stabilizing agent.The povidone iodine that wherein contains 0.1～0.5 weight portion in the PH regulator of 100 parts by volume, the osmotic pressure regulator of 0.35～0.65 weight portion, the stabilizing agent of 0.05 weight portion, the PH of eye drop of povidone iodine are 6.0～6.8.。
2, eye drop of povidone iodine according to claim 1 is characterized in that: described PH regulator adopts phosphate buffer, and PH is 5.91-8.04.
3, eye drop of povidone iodine according to claim 1 is characterized in that: described stabilizing agent adopts potassium iodate.
4, eye drop of povidone iodine according to claim 1 is characterized in that: described osmotic pressure regulator adopts sodium chloride.
5, a kind of preparation method of eye drop of povidone iodine, it is with principal agent composition povidone iodine, adds osmotic pressure regulator, stabilizing agent, the dissolving of PH regulator, with PH regulator standardize solution; The povidone iodine that wherein contains 0.1～0.5 weight portion in the PH regulator of 100 parts by volume, the osmotic pressure regulator of 0.35～0.65 weight portion, the stabilizing agent of 0.05 weight portion, the PH of eye drop of povidone iodine are 6.0～6.8.。
6, as the preparation method of eye drop of povidone iodine as described in the claim 5, it is characterized in that: described PH regulator adopts phosphate buffer, and PH is 5.91-8.04.
7, as the preparation method of eye drop of povidone iodine as described in the claim 5, it is characterized in that: described stabilizing agent adopts potassium iodate.
8, as the preparation method of eye drop of povidone iodine as described in the claim 5, it is characterized in that: described osmotic pressure regulator adopts sodium chloride.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610124977 CN1965857A (en) | 2006-11-09 | 2006-11-09 | Eye drop of povidone iodine and preparation process thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN 200610124977 CN1965857A (en) | 2006-11-09 | 2006-11-09 | Eye drop of povidone iodine and preparation process thereof |
Publications (1)
| Publication Number | Publication Date |
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| CN1965857A true CN1965857A (en) | 2007-05-23 |
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| CN 200610124977 Pending CN1965857A (en) | 2006-11-09 | 2006-11-09 | Eye drop of povidone iodine and preparation process thereof |
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Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8765724B2 (en) | 2006-03-14 | 2014-07-01 | Cls Pharmaceuticals, Inc. | Methods of using ophthalmic compositions comprising povidone-iodine |
| CN107412215A (en) * | 2017-08-15 | 2017-12-01 | 樊长春 | A kind of eye drops and preparation method thereof |
| CN110151686A (en) * | 2018-04-13 | 2019-08-23 | 山东虎力机械有限公司 | With flushing liquor and preparation method thereof after a kind of ophthalmologic operation |
| CN110559175A (en) * | 2019-08-27 | 2019-12-13 | 陈文龙 | conjunctival sac disinfection solution and using method and device thereof |
| CN110799179A (en) * | 2017-07-04 | 2020-02-14 | 富陆凯米有限责任公司 | Solid composition comprising iodine reagent and sodium chloride with improved water solubility and antiviral and antibacterial composition for eye, oral cavity, nasal cavity or inhalation comprising aqueous solution thereof |
| CN114608746A (en) * | 2022-03-08 | 2022-06-10 | 三门峡市眼科医院 | In-vitro pig anterior ocular segment perfusion and culture model and application thereof |
-
2006
- 2006-11-09 CN CN 200610124977 patent/CN1965857A/en active Pending
Cited By (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US8765724B2 (en) | 2006-03-14 | 2014-07-01 | Cls Pharmaceuticals, Inc. | Methods of using ophthalmic compositions comprising povidone-iodine |
| US10849928B2 (en) | 2006-03-14 | 2020-12-01 | Clarus Cls Holdings, Llc | Methods of using ophthalmic compositions comprising povidone-iodine |
| CN110799179A (en) * | 2017-07-04 | 2020-02-14 | 富陆凯米有限责任公司 | Solid composition comprising iodine reagent and sodium chloride with improved water solubility and antiviral and antibacterial composition for eye, oral cavity, nasal cavity or inhalation comprising aqueous solution thereof |
| CN107412215A (en) * | 2017-08-15 | 2017-12-01 | 樊长春 | A kind of eye drops and preparation method thereof |
| CN110151686A (en) * | 2018-04-13 | 2019-08-23 | 山东虎力机械有限公司 | With flushing liquor and preparation method thereof after a kind of ophthalmologic operation |
| CN110151686B (en) * | 2018-04-13 | 2021-08-03 | 葛强 | Ophthalmologic postoperative flushing fluid and preparation method thereof |
| CN110559175A (en) * | 2019-08-27 | 2019-12-13 | 陈文龙 | conjunctival sac disinfection solution and using method and device thereof |
| CN114608746A (en) * | 2022-03-08 | 2022-06-10 | 三门峡市眼科医院 | In-vitro pig anterior ocular segment perfusion and culture model and application thereof |
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