CN104983786A - Polyvinyl alcohol composition - Google Patents
Polyvinyl alcohol composition Download PDFInfo
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- CN104983786A CN104983786A CN201510411146.XA CN201510411146A CN104983786A CN 104983786 A CN104983786 A CN 104983786A CN 201510411146 A CN201510411146 A CN 201510411146A CN 104983786 A CN104983786 A CN 104983786A
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Abstract
The invention relates to the field of ophthalmic drugs, in particular to a polyvinyl alcohol composition, which is mainly prepared by following raw materials in parts by weight: 8-15 parts of polyvinyl alcohol, 0.1-0.5 part of polyvinylpyrrolidone, 0.5-5 parts of xanthan gum and 0.5-3 parts of nonionic surfactant. According to the polyvinyl alcohol composition, the polyvinyl alcohol, polyvinylpyrrolidone, xanthan gum and nonionic surfactant are specifically selected for match usage, a moisturizing action is enhanced, action time thereof in eyes is prolonged, healing of corneal epithelial cells is better promoted, an epithelial cell barrier is recovered, a treatment effect is improved, a finally obtained preparation is stable in performance and high in use comfortable level, and has obvious treatment effect for dry eyes, eyestrain and the like. In the preparation process, respective raw materials are directly mixed in water, and matched with one another, and the defect that polyvinylpyrrolidone is easily caked is overcome.
Description
Technical field
The present invention relates to eye medicinal field, in particular to a kind of polyvinyl alcohol compositions.
Background technology
Existing polyvinyl alcohol eye drop, mainly contain polyvinyl alcohol, polyvinylpyrrolidone, sodium chloride and water for injection to mix, as a kind of lubricant for preventing or treat the irritations such as eye is dry and astringent, foreign body sensation, eyestrain or improving the dry symptom of eye.Because this polyvinyl alcohol eye drop does not add antiseptic, antibacterial etc., behind Kaifeng, need disposable being finished, this adds increased cost, be also unfavorable for that consumer uses.
In addition, owing to the addition of polyvinylpyrrolidone in this product, in production technology, polyvinylpyrrolidone raw material easily produces caking, must stir and slowly add during dissolving, then continues stirring until and dissolve completely, therefore, mixing time and cost of labor is added.In addition, the action effect of this eye drop need to promote.
In view of this, special proposition the present invention.
Summary of the invention
The object of the present invention is to provide a kind of polyvinyl alcohol compositions, the ophthalmic preparation that described polyvinyl alcohol compositions is made, stability, extended shelf-life, can significant prolongation action time after said preparation uses, and promotes the healing of corneal epithelial cell, recover epithelial cell barriers, improve curative effect; Also there is the advantages such as comfort level is high, nonirritant, use safety, and prepare easy, cost-saving.
In order to realize above-mentioned purpose of the present invention, spy by the following technical solutions:
A kind of polyvinyl alcohol compositions, makes primarily of following raw material, by weight, and polyvinyl alcohol 8-15 part, polyvinylpyrrolidone 0.1-0.5 part, xanthan gum 0.5-5 part, non-ionic surface active agent 0.5-3 part.
Polyvinyl alcohol compositions provided by the invention, specific select polyvinyl alcohol, polyvinylpyrrolidone, xanthan gum and non-ionic surface active agent with the use of, strengthen wetting action, extend its action time in eyes, better promote the healing of corneal epithelial cell, recover epithelial cell barriers, improve curative effect, the preparation stable performance finally obtained, comfort is high, and, eyestrain dry and astringent to eye etc. is evident in efficacy.And in preparation process, each raw material is directly mixed in water, cooperatively interact between each raw material, overcome the defect that polyvinylpyrrolidone easily produces caking.
In order to strengthen the collaborative reinforced effects between each composition, preferably, by weight, polyvinyl alcohol 10-12 part, polyvinylpyrrolidone 0.2-0.4 part, xanthan gum 1-3 part, non-ionic surface active agent 1-2 part.
Preferably, described non-ionic surface active agent is one or both in aliphatic alcohol ester, sucrose ester.Verify through test of many times, non-ionic surface active agent select in aliphatic alcohol ester, sucrose ester one or both, the compatibility of medicine that polyvinyl alcohol compositions makes and ocular tissue can be increased, and, have the effect of better bacteriostasis antibiosis, each composition cooperatively interacts, and extends the preservation time of preparation, behind medicine Kaifeng, all can use in 10 days.
Preferably, described composition also comprises Borneolum Syntheticum, and by weight, described Borneolum Syntheticum is 0.1-0.5 part.By adding Borneolum Syntheticum, energy is increasing action effect significantly, and increases the comfortableness in use procedure.
More preferably, by weight, described Borneolum Syntheticum is 0.2-0.3 part.
Further, described composition also comprises Olibanum and Radix Sophorae Flavescentis, and by weight, described Olibanum is 5-20 part, and described Radix Sophorae Flavescentis is 3-10 part.Olibanum and Radix Sophorae Flavescentis cooperatively interact, and not only have extraordinary effect to inflamed eyes, the blood streak, swelling and pruritus, and extend the holding time of Kaifeng medicine further.
In order to strengthen the mutually collaborative effect strengthened of Olibanum and Radix Sophorae Flavescentis, preferably, by weight, described Olibanum is 8-15 part, and described Radix Sophorae Flavescentis is 5-8 part.
In order to meet the demand of public use, polyvinyl alcohol compositions can make various dosage form, and further, described raw material also comprises the adjuvant described polyvinyl alcohol compositions being made various dosage form;
Described dosage form comprises any one in eye drop, collyrium, eye ointment, gel for eye use, eye micropill.The preparation of various dosage form is conventionally prepared.
Preferably, the dosage form of described polyvinyl alcohol compositions is eye drop, and described raw material also comprises isotonic agent and pH adjusting agent;
Described eye drop is made by following steps:
Polyvinyl alcohol, polyvinylpyrrolidone, xanthan gum and non-ionic surface active agent are added to respectively in water for injection, mixing, obtains the first mixed liquor;
If containing Borneolum Syntheticum, then add in the first mixed liquor, mixing, obtains the second mixed liquor;
If containing Olibanum and Radix Sophorae Flavescentis, described Olibanum and Radix Sophorae Flavescentis add in the second mixed liquor with the form of extracting solution;
Then add isotonic agent and pH adjusting agent, the osmotic pressure of adjustment solution is 300-310mOsm/L, and pH value is 6.5-7.5, obtains the 3rd mixed liquor;
By subpackage after described 3rd mixed liquor filtration sterilization;
Wherein, by weight, the consumption of described water for injection is 150-300 part.
The present invention is by progressively adding each composition, and obtained eye drop uniform component, uses comfortable, evident in efficacy.
Wherein, isotonic agent is any one or more in sodium chloride, potassium chloride, boric acid, sodium sulfate, potassium sulfate, Chile saltpeter, potassium nitrate, sodium acetate, mannitol, glycerol, propylene glycol, glucose.
Isotonic agent is the standard meeting ophthalmic preparation to polyvinyl alcohol compositions be made osmotic pressure.According to the present invention, osmotic pressure regulator use amount in the formulation can change because of many factors, as osmotic pressure regulator type and intensity thereof, prescription forms, the physics and chemistry stability etc. of medicine and preparation, those skilled in the art understand, the target osmotic pressure that the use amount of this osmotic pressure regulator can easily desirably regulate is determined, such as when the target osmotic pressure of hope be with body fluid substantially isotonic or slightly high ooze, being mixed with most material particularly after all formulation ingredients than water, before preparation standardize solution (to final weight and/or volume), with the osmotic pressure regulator of Sq, osmotic pressure adjustment is carried out to preparation, easily can determine osmotic pressure regulator concrete consumption in the formulation thus.
PH adjusting agent is any one or more in sodium dihydrogen phosphate, sodium hydrogen phosphate, potassium dihydrogen phosphate, dipotassium hydrogen phosphate, acetic acid, sodium acetate, citric acid, sodium citrate, tartaric acid, sodium tartrate, sodium carbonate, potassium carbonate, sodium bicarbonate, potassium bicarbonate, sodium hydroxide, potassium hydroxide, hydrochloric acid, phosphoric acid.
PH adjusting agent is the standard meeting ophthalmic preparation to polyvinyl alcohol compositions be made acid-base value.PH value regulator use amount in the formulation changes because of many factors, as pH value regulator type and intensity thereof, prescription forms, the physics and chemistry stability etc. of medicine and preparation, those skilled in the art understand, the target ph that the amount of this pH value regulator in inventive gel agent can easily desirably regulate is determined, such as when the target ph of hope is 6.5-7.5, being mixed with most material particularly after all formulation ingredients than water, before preparation standardize solution (to final weight and/or volume), by the pH value regulator of Sq, pH value adjustment is carried out to preparation, easily can determine pH value regulator concrete consumption in the formulation thus.
Preferably, described 3rd mixed liquor also comprised before filtration sterilization: by the 3rd mixed liquor ultrasound wave 10-30min obtained, and ultrasound wave power used is 5-10W.
Find through test, before filtration sterilization, mixed liquor is carried out ultrasound wave with specific power, add the curative effect of eye drop, and more importantly, increase the comfortableness of eye drop use.
Compared with prior art, beneficial effect of the present invention is:
(1) polyvinyl alcohol compositions provided by the invention, specific select polyvinyl alcohol, polyvinylpyrrolidone, xanthan gum and non-ionic surface active agent with the use of, strengthen wetting action, extend its action time in eyes, the healing of better promotion corneal epithelial cell, recovers epithelial cell barriers, the preparation stable performance obtained, comfort is high, and, eyestrain dry and astringent to eye etc. is evident in efficacy.
(2) the present invention is also specific selects one or both in aliphatic alcohol ester, sucrose ester as non-ionic surface active agent, the compatibility of medicine that polyvinyl alcohol compositions makes and ocular tissue can be increased, and, there is the effect of better bacteriostasis antibiosis, each composition cooperatively interacts, extend the preservation time of preparation, behind medicine Kaifeng, all can use in 10 days.
(3) the present invention is by adding Borneolum Syntheticum, increasing action effect, and increases the comfortableness in use procedure.
(4) the present invention also added Olibanum and Radix Sophorae Flavescentis, and Olibanum and Radix Sophorae Flavescentis cooperatively interact, and not only has extraordinary effect to inflamed eyes, the blood streak, swelling and pruritus, and extends the holding time of Kaifeng medicine further.
(5) each raw material provided by the invention cooperatively interacts, and overcomes polyvinylpyrrolidone easily produces caking defect when preparing aqueous solution.
(6) the present invention is in the process preparing eye drop, add the step of mixed liquor first being carried out to ultrasonic Treatment, and then carry out filtration sterilization, which not only adds the curative effect of eye drop, and the more important thing is the comfortableness significantly increasing eye drop and use.
Detailed description of the invention
Below in conjunction with embodiment, embodiment of the present invention are described in detail, but it will be understood to those of skill in the art that the following example only for illustration of the present invention, and should not be considered as limiting the scope of the invention.Unreceipted actual conditions person in embodiment, the condition of conveniently conditioned disjunction manufacturer suggestion is carried out.Agents useful for same or the unreceipted production firm person of instrument, being can by the conventional products of commercially available acquisition.
Embodiment 1
Polyvinyl alcohol compositions is made eye drop, and concrete steps are as follows:
Add in 150ml water for injection respectively by polyvinyl alcohol 8g, polyvinylpyrrolidone 0.1g, xanthan gum 0.5g and aliphatic alcohol ester 0.5g, mixing, obtains the first mixed liquor;
Then add sodium chloride and sodium dihydrogen phosphate, the osmotic pressure of adjustment solution is 300mOsm/L, and pH value is 7.5, obtains target mixed liquor;
By subpackage after target mixed liquor filtration sterilization.
Group 2: by the target mixed liquor ultrasound wave 30min obtained, ultrasound wave power used is 5W; Then subpackage after filtration sterilization is carried out.
Embodiment 2
Polyvinyl alcohol compositions is made eye drop, and concrete steps are as follows:
Add in 200ml water for injection respectively by polyvinyl alcohol 15g, polyvinylpyrrolidone 0.5g, xanthan gum 5g and sucrose ester 3g, mixing, obtains the first mixed liquor;
Then add sodium sulfate and sodium hydrogen phosphate, the osmotic pressure of adjustment solution is 310mOsm/L, and pH value is 7.2, obtains target mixed liquor;
Group 1: by subpackage after described target mixed liquor filtration sterilization.
Group 2: by the target mixed liquor ultrasound wave 10min obtained, ultrasound wave power used is 10W; Then subpackage after filtration sterilization is carried out.
Embodiment 3
Polyvinyl alcohol compositions is made eye drop, and concrete steps are as follows:
Add in 170ml water for injection respectively by polyvinyl alcohol 10g, polyvinylpyrrolidone 0.2g, xanthan gum 1g, aliphatic alcohol ester 0.5g and sucrose ester 0.5g, mixing, obtains the first mixed liquor;
Then add potassium nitrate and potassium carbonate, the osmotic pressure of adjustment solution is 305mOsm/L, and pH value is 7.0, obtains target mixed liquor;
Group 1: by subpackage after described target mixed liquor filtration sterilization.
Group 2: by the target mixed liquor ultrasound wave 25min obtained, ultrasound wave power used is 7W; Then subpackage after filtration sterilization is carried out.
Embodiment 4
Polyvinyl alcohol compositions is made eye drop, and concrete steps are as follows:
Add in 150ml water for injection respectively by polyvinyl alcohol 12g, polyvinylpyrrolidone 0.4g, xanthan gum 3g, aliphatic alcohol ester 1.5g and sucrose ester 0.5g, mixing, obtains the first mixed liquor;
Then add glucose, sodium chloride and acetic acid, the osmotic pressure of adjustment solution is 300mOsm/L, and pH value is 6.7, obtains target mixed liquor;
Group 1: by subpackage after described target mixed liquor filtration sterilization.
Group 2: by the target mixed liquor ultrasound wave 20min obtained, ultrasound wave power used is 8W; Then subpackage after filtration sterilization is carried out.
Embodiment 5
Polyvinyl alcohol compositions is made eye drop, and concrete steps are as follows:
Add in 200ml water for injection respectively by polyvinyl alcohol 8g, polyvinylpyrrolidone 0.1g, xanthan gum 0.5g and aliphatic alcohol ester 0.5g, mixing, obtains the first mixed liquor;
In the first mixed liquor, add Borneolum Syntheticum 0.1g, mixing, obtains the second mixed liquor;
Then add sodium chloride and sodium dihydrogen phosphate, the osmotic pressure of adjustment solution is 300mOsm/L, and pH value is 7.5, obtains the 3rd mixed liquor;
Group 1: by subpackage after the 3rd mixed liquor filtration sterilization.
Group 2: by the 3rd mixed liquor ultrasound wave 30min obtained, ultrasound wave power used is 5W; Then subpackage after filtration sterilization is carried out.
Embodiment 6
Polyvinyl alcohol compositions is made eye drop, and concrete steps are as follows:
Add in 300ml water for injection respectively by polyvinyl alcohol 15g, polyvinylpyrrolidone 0.5g, xanthan gum 5g and sucrose ester 3g, mixing, obtains the first mixed liquor;
In the first mixed liquor, add Borneolum Syntheticum 0.3g, mixing, obtains the second mixed liquor;
Then add sodium sulfate and sodium hydrogen phosphate, the osmotic pressure of adjustment solution is 310mOsm/L, and pH value is 7.2, obtains the 3rd mixed liquor;
Group 1: by subpackage after the 3rd mixed liquor filtration sterilization.
Group 2: by the 3rd mixed liquor ultrasound wave 10min obtained, ultrasound wave power used is 10W; Then subpackage after filtration sterilization is carried out.
Embodiment 7
Polyvinyl alcohol compositions is made eye drop, and concrete steps are as follows:
Add in 250ml water for injection respectively by polyvinyl alcohol 9g, polyvinylpyrrolidone 0.3g, xanthan gum 2g and aliphatic alcohol ester 1g and sucrose ester 0.5g, mixing, obtains the first mixed liquor;
In the first mixed liquor, add Borneolum Syntheticum 0.2g, mixing, obtains the second mixed liquor;
Then add isotonic agent sodium acetate, mannitol, glycerol and pH adjusting agent citric acid, sodium citrate, the osmotic pressure of adjustment solution is 310mOsm/L, and pH value is 7.0, obtains the 3rd mixed liquor;
Group 1: by subpackage after the 3rd mixed liquor filtration sterilization.
Group 2: by the 3rd mixed liquor ultrasound wave 20min obtained, ultrasound wave power used is 8W; Then subpackage after filtration sterilization is carried out.
Embodiment 8
Polyvinyl alcohol compositions is made eye drop, and concrete steps are as follows:
Get Olibanum 5g, Radix Sophorae Flavescentis is 3g, uses water for injection distillation extraction, obtains extracting solution 50ml;
Add in 150ml water for injection respectively by polyvinyl alcohol 10g, polyvinylpyrrolidone 0.3g, xanthan gum 1g and aliphatic alcohol ester 1g, mixing, obtains the first mixed liquor;
Extracting solution and the first mixed liquor are mixed, then add isotonic agent potassium chloride, glucose and pH adjusting agent phosphoric acid, the osmotic pressure of adjustment solution is 300mOsm/L, and pH value is 6.5, obtains the second mixed liquor;
Group 1: by subpackage after the second mixed liquor filtration sterilization.
Group 2: by the second mixed liquor ultrasound wave 20min obtained, ultrasound wave power used is 8W; Then subpackage after filtration sterilization is carried out.
Embodiment 9
Polyvinyl alcohol compositions is made eye drop, and concrete steps are as follows:
Get Olibanum 8g, Radix Sophorae Flavescentis is 5g, uses water for injection distillation extraction, obtains extracting solution 50ml;
Add in 150ml water for injection respectively by polyvinyl alcohol 12g, polyvinylpyrrolidone 0.4g, xanthan gum 3g and sucrose ester 1.5g, mixing, obtains the first mixed liquor;
Extracting solution and the first mixed liquor are mixed, then add sodium chloride and sodium bicarbonate, the osmotic pressure of adjustment solution is 300mOsm/L, and pH value is 7.2, obtains the second mixed liquor;
Group 1: by subpackage after the second mixed liquor filtration sterilization.
Group 2: by the second mixed liquor ultrasound wave 15min obtained, ultrasound wave power used is 10W; Then subpackage after filtration sterilization is carried out.
Embodiment 10
Polyvinyl alcohol compositions is made eye drop, and concrete steps are as follows:
Get Olibanum 20g, Radix Sophorae Flavescentis is 10g, uses water for injection distillation extraction, obtains extracting solution 100ml;
Add in 150ml water for injection respectively by polyvinyl alcohol 15g, polyvinylpyrrolidone 0.5g, xanthan gum 5g and aliphatic alcohol ester 1g, mixing, obtains the first mixed liquor;
In the first mixed liquor, add Borneolum Syntheticum 0.3g, mixing, obtains the second mixed liquor;
Extracting solution and the second mixed liquor are mixed, then add isotonic agent sodium acetate, glycerol and pH adjusting agent potassium hydroxide, the osmotic pressure of adjustment solution is 305mOsm/L, and pH value is 7.5, obtains the 3rd mixed liquor;
Group 1: by subpackage after the 3rd mixed liquor filtration sterilization.
Group 2: by the 3rd mixed liquor ultrasound wave 10min obtained, ultrasound wave power used is 10W; Then subpackage after filtration sterilization is carried out.
Embodiment 11
Polyvinyl alcohol compositions is made eye drop, and concrete steps are as follows:
Get Olibanum 15g, Radix Sophorae Flavescentis is 8g, uses water for injection distillation extraction, obtains extracting solution 50ml;
Add in 150ml water for injection respectively by polyvinyl alcohol 10g, polyvinylpyrrolidone 0.4g, xanthan gum 3g and sucrose ester 1g, mixing, obtains the first mixed liquor;
In the first mixed liquor, add Borneolum Syntheticum 0.2g, mixing, obtains the second mixed liquor;
Extracting solution and the second mixed liquor are mixed, then add sodium chloride and sodium bicarbonate, the osmotic pressure of adjustment solution is 305mOsm/L, and pH value is 7.0, obtains the 3rd mixed liquor;
Group 1: by subpackage after the 3rd mixed liquor filtration sterilization.
Group 2: by the 3rd mixed liquor ultrasound wave 20min obtained, ultrasound wave power used is 7W; Then subpackage after filtration sterilization is carried out.
Embodiment 12
Polyvinyl alcohol compositions is made eye drop, and concrete steps are as follows:
Get Olibanum 8g, Radix Sophorae Flavescentis is 5g, uses water for injection distillation extraction, obtains extracting solution 50ml;
Add in 150ml water for injection respectively by polyvinyl alcohol 10g, polyvinylpyrrolidone 0.3g, xanthan gum 2g and aliphatic alcohol ester 1g, sucrose ester 1g, mixing, obtains the first mixed liquor;
In the first mixed liquor, add Borneolum Syntheticum 0.3g, mixing, obtains the second mixed liquor;
Extracting solution and the second mixed liquor are mixed, then add potassium chloride and tartaric acid, the osmotic pressure of adjustment solution is 305mOsm/L, and pH value is 6.8, obtains the 3rd mixed liquor;
Group 1: by subpackage after the 3rd mixed liquor filtration sterilization.
Group 2: by the 3rd mixed liquor ultrasound wave 20min obtained, ultrasound wave power used is 6W; Then subpackage after filtration sterilization is carried out.
Experimental example 1
The eye drop that embodiment 1-12 is obtained carries out eye irritant test.Specific as follows:
The 2.2-2.4kg large ear white race rabbit of regular grade is adopted to test, the rabbit selected is healthy, adult, the non-stimulated symptom of eye, cornea zero defect, conjunctiva not damaged, eye drop the present invention obtained directly instills in the eye of right side, left side eye does not process in contrast, every animal consumption is 0.1ml at every turn, every day 1 time, after 6 hours, observe the impact of corneal, iris and conjunctiva, continue titration 10 days.Often organize use 3 rabbit.
Find in process of the test, eye drop provided by the invention all without impact, shows as eyes non-stimulated on the cornea of rabbit, iris and conjunctiva.
Experimental example 2
Eye drop fill group 1 in embodiment 1-12 and group 2 obtained is in colourless plastic bottle, and correspondence markings is sample 1-24 respectively, as test group; Meanwhile, with commercially available disposable polyvinyl alcohol eye drop as a control group.Broken a seal under room temperature environment by bottled eye drop in test group and matched group respectively, after opening, ooze 1 drop of liquid, bottle stopper of then screwing on, repeats, and opens 5 every day, continues 30 days altogether.Respectively at the 5th day, the 10th day, the 15th day, the 20th day, the 25th day, within the 30th day, observe the outward appearance of different eye drop, measure aseptic condition and carry out centrifugal test (500r/min).Result is as shown in table 1.
The detected status of the different eye drop of table 1
Note: "-" be not for detect.
As can be seen from Table 1, matched group is made up of polyvinyl alcohol, polyvinylpyrrolidone, sodium chloride and water for injection, and behind Kaifeng, easy pollution microbes, needs disposable being finished, can not preserve; Eye drop provided by the invention, the eye drop room temperature resting period containing polyvinyl alcohol, polyvinylpyrrolidone, xanthan gum and sucrose ester and/or aliphatic alcohol ester reaches 10 days; After with the addition of Olibanum and Radix Sophorae Flavescentis, the eye drop resting period behind Kaifeng reaches 25 days, obviously extends the product holding time behind Kaifeng.
In addition, room temperature is also placed the sample 8-12 that the sample 1-7 of 10 days and room temperature places 25 days and is determined pH by the present invention, and pH value is all within the scope of 6.5-7.5.Respectively room temperature is placed the test that sample 13-24 that the sample 1-12 of 10 days and room temperature places 25 days carries out in experimental example 1, result shows, all on the cornea of rabbit, iris and conjunctiva without impact, show as eyes non-stimulated.
Experimental example 3
The eye drop that embodiment 1-12 is obtained is used for clinical trial.Random selecting 1300 eyes are dry and astringent, hold fatigable patient, are divided into 26 groups, and front 24 groups are test group, respectively corresponding test group 1-24, the test group 1-24 corresponding eye drops using group 1 and group 2 in embodiment 1-12 obtained respectively; Group 25 is the 1 polyvinyl alcohol eye drop using Xindong Shengji Co., Ltd. to produce as a control group, and group 26 2 uses normal saline as a control group.Drip 4 every day, use after 10 days, statistics effect.Effect is divided into recovery from illness, effective and invalid, wherein, fully recovers for ocular tissue observes normal, and the dry and astringent and fatigue symptom of eye disappears; Effectively significantly improve for ocular tissue, the dry and astringent and fatigue symptom of eye obviously alleviates; Invalid is that ocular tissue and eye symptom are without significant change.Concrete outcome is as shown in table 2.
The effect of dry and astringent, the easy fatigue symptom of table 2 pair eyes
| Group | Recovery from illness number | Effective number | Invalid number |
| Test group 1 | 43 | 7 | 0 |
| Test group 2 | 44 | 6 | 0 |
| Test group 3 | 43 | 7 | 0 |
| Test group 4 | 44 | 6 | 0 |
| Test group 5 | 45 | 5 | 0 |
| Test group 6 | 45 | 5 | 0 |
| Test group 7 | 45 | 5 | 0 |
| Test group 8 | 46 | 4 | 0 |
| Test group 9 | 46 | 4 | 0 |
| Test group 10 | 46 | 4 | 0 |
| Test group 11 | 46 | 4 | 0 |
| Test group 12 | 47 | 3 | 0 |
| Test group 13 | 47 | 3 | 0 |
| Test group 14 | 47 | 3 | 0 |
| Test group 15 | 47 | 3 | 0 |
| Test group 16 | 47 | 3 | 0 |
| Test group 17 | 48 | 2 | 0 |
| Test group 18 | 49 | 1 | 0 |
| Test group 19 | 50 | 0 | 0 |
| Test group 20 | 50 | 0 | 0 |
| Test group 21 | 50 | 0 | 0 |
| Test group 22 | 50 | 0 | 0 |
| Test group 23 | 50 | 0 | 0 |
| Test group 24 | 50 | 0 | 0 |
| Matched group 1 | 35 | 15 | 0 |
| Matched group 2 | 0 | 10 | 40 |
As can be seen from Table 1, eye drop provided by the invention is dry and astringent to eyes, it is evident in efficacy to hold fatigable patient, wherein, after adding Borneolum Syntheticum, can increasing action effect, and improve the use susceptibility of client; After adding Olibanum and this two tastes Chinese medicine ingredients of Radix Sophorae Flavescentis, both interact, the epithelial damage of repairing corneal, recover epithelial cell barriers, have better curative effect; In addition, through the group of ultrasonic Treatment in preparation process, the comfort level that client uses obviously increases, if comfort level full marks are the words of 10 points, the eye drop not carrying out ultrasonic Treatment must be divided into 7 points, and 10 points must be divided into through the eye drop of ultrasonic Treatment, matched group 1 must be divided into 7 points, and a little through the better efficacy of the eye drop of ultrasonic Treatment.Eye drop action effect provided by the invention is apparently higher than commercially available prod, and patient's comfort obviously increases.
Experimental example 4
The eye drop that embodiment 1-12 is obtained is used for clinical trial.Random selecting 950 inflamed eyes or the blood streak or swelling, and with the patient of pruritus, be divided into 19 groups at random, the eye drops that front 16 group corresponding test group 1-16, test group 1-16 correspondences use group 1 and group 2 in embodiment 2-3,5-6,8-9,10-11 obtained; Group 17 is the 1 polyvinyl alcohol eye drop using Xindong Shengji Co., Ltd. to produce as a control group; Group 19 2 request for utilization CN200410035918.6 as a control group, the eye drop that embodiment 4 obtains with embodiment 2; Group 19 3 uses normal saline as a control group.Drip 4 every day, use after 10 days, statistics effect.Effect is divided into recovery from illness, effective and invalid, wherein, fully recovers for ocular tissue observes normal, and swelling or the blood streak and pruritis disappear; Effectively significantly improve for ocular tissue, swelling or the blood streak and pruritis obviously alleviate; Invalid is that ocular tissue and eye symptom are without significant change.Concrete outcome is as shown in table 3.
Table 3 therapeutic effect
| Group | Recovery from illness number | Effective number | Invalid number |
| Test group 1 | 32 | 14 | 4 |
| Test group 2 | 33 | 13 | 4 |
| Test group 3 | 33 | 12 | 5 |
| Test group 4 | 33 | 13 | 4 |
| Test group 5 | 34 | 12 | 4 |
| Test group 6 | 34 | 13 | 3 |
| Test group 7 | 34 | 13 | 3 |
| Test group 8 | 35 | 11 | 4 |
| Test group 9 | 43 | 7 | 0 |
| Test group 10 | 45 | 5 | 0 |
| Test group 11 | 43 | 7 | 0 |
| Test group 12 | 44 | 6 | 0 |
| Test group 13 | 45 | 5 | 0 |
| Test group 14 | 46 | 4 | 0 |
| Test group 15 | 46 | 4 | 0 |
| Test group 16 | 47 | 3 | 0 |
| Matched group 1 | 20 | 15 | 15 |
| Matched group 2 | 26 | 19 | 5 |
| Matched group 3 | 0 | 3 | 47 |
As can be seen from Table 3, eye drop provided by the invention, time mainly containing polyvinyl alcohol, polyvinylpyrrolidone, xanthan gum and non-ionic surface active agent, to inflamed eyes or the blood streak or swelling, and be not fine with patient's curative effect of pruritus, because this eye drop has good performance of keeping humidity and repairs the effect of damage, but not fine to the effect of swelling, the blood streak and pruritus; But after adding Olibanum and this two tastes Chinese medicine ingredients of Radix Sophorae Flavescentis, both interact, and have extraordinary blood circulation promoting and blood stasis dispelling, detumescence and promoting granulation and antipruritic effect, to the Be very effective of swelling, the blood streak and pruritus; In addition, through the group of ultrasonic Treatment in preparation process, the comfort level that client uses obviously increases, if comfort level full marks are the words of 10 points, the eye drop not carrying out ultrasonic Treatment must be divided into 7 points, and 10 points must be divided into through the eye drop of ultrasonic Treatment, matched group 1 must be divided into 7 points, and a little through the better efficacy of the eye drop of ultrasonic Treatment.Eye drop action effect provided by the invention is apparently higher than commercially available prod, and patient's comfort obviously increases.
Although illustrate and describe the present invention with specific embodiment, however it will be appreciated that can to make when not deviating from the spirit and scope of the present invention many other change and amendment.Therefore, this means to comprise all such changes and modifications belonged in the scope of the invention in the following claims.
Claims (10)
1. a polyvinyl alcohol compositions, is characterized in that, makes primarily of following raw material, by weight, and polyvinyl alcohol 8-15 part, polyvinylpyrrolidone 0.1-0.5 part, xanthan gum 0.5-5 part, non-ionic surface active agent 0.5-3 part.
2. polyvinyl alcohol compositions according to claim 1, is characterized in that, by weight, and polyvinyl alcohol 10-12 part, polyvinylpyrrolidone 0.2-0.4 part, xanthan gum 1-3 part, non-ionic surface active agent 1-2 part.
3. polyvinyl alcohol compositions according to claim 1, is characterized in that, described non-ionic surface active agent is one or both in aliphatic alcohol ester, sucrose ester.
4. polyvinyl alcohol compositions according to claim 1, is characterized in that, described raw material also comprises Borneolum Syntheticum, and by weight, described Borneolum Syntheticum is 0.1-0.5 part.
5. polyvinyl alcohol compositions according to claim 4, is characterized in that, by weight, described Borneolum Syntheticum is 0.2-0.3 part.
6. polyvinyl alcohol compositions according to claim 1, is characterized in that, described raw material also comprises Olibanum and Radix Sophorae Flavescentis, and by weight, described Olibanum is 5-20 part, and described Radix Sophorae Flavescentis is 3-10 part.
7. polyvinyl alcohol compositions according to claim 6, is characterized in that, by weight, described Olibanum is 8-15 part, and described Radix Sophorae Flavescentis is 5-8 part.
8. the polyvinyl alcohol compositions according to any one of claim 1-7, is characterized in that, described raw material also comprises the adjuvant described polyvinyl alcohol compositions being made various dosage form;
Described dosage form comprises any one in eye drop, collyrium, eye ointment, gel for eye use, eye micropill.
9. polyvinyl alcohol compositions according to claim 8, is characterized in that, the dosage form of described polyvinyl alcohol compositions is eye drop, and described raw material also comprises isotonic agent and pH adjusting agent;
Described eye drop is made by following steps:
Polyvinyl alcohol, polyvinylpyrrolidone, xanthan gum and non-ionic surface active agent are added to respectively in water for injection, mixing, obtains the first mixed liquor;
If containing Borneolum Syntheticum, then add in the first mixed liquor, mixing, obtains the second mixed liquor;
If containing Olibanum and Radix Sophorae Flavescentis, described Olibanum and Radix Sophorae Flavescentis add in the second mixed liquor with the form of extracting solution;
Then add isotonic agent and pH adjusting agent, the osmotic pressure of adjustment solution is 300-310mOsm/L, and pH value is 6.5-7.5, obtains the 3rd mixed liquor;
By subpackage after described 3rd mixed liquor filtration sterilization;
Wherein, by weight, the consumption of described water for injection is 150-300 part.
10. polyvinyl alcohol compositions according to claim 9, is characterized in that, described 3rd mixed liquor also comprised before filtration sterilization: by the 3rd mixed liquor ultrasound wave 10-30min obtained, and ultrasound wave power used is 5-10W.
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