CN104983786B - Polyvinyl alcohol composition - Google Patents
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- CN104983786B CN104983786B CN201510411146.XA CN201510411146A CN104983786B CN 104983786 B CN104983786 B CN 104983786B CN 201510411146 A CN201510411146 A CN 201510411146A CN 104983786 B CN104983786 B CN 104983786B
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Abstract
The invention relates to the field of ophthalmic medicines, and in particular relates to a polyvinyl alcohol composition which is mainly prepared from the following raw materials, 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 a nonionic surfactant. The polyvinyl alcohol composition provided by the invention specifically selects polyvinyl alcohol, polyvinylpyrrolidone, xanthan gum and nonionic surfactant for matching use, so that the moistening effect is enhanced, the acting time of the polyvinyl alcohol composition in eyes is prolonged, the healing of corneal epithelial cells is better promoted, the epithelial cell barrier is recovered, the curative effect is improved, and the finally obtained preparation has stable performance and high use comfort and has obvious curative effects on dry eyes, eye fatigue and the like. In addition, in the preparation process, all the raw materials are directly mixed in water and are matched with each other, so that the defect that polyvinylpyrrolidone is easy to agglomerate is overcome.
Description
Technical Field
The invention relates to the field of ophthalmic medicines, and in particular relates to a polyvinyl alcohol composition.
Background
The existing polyvinyl alcohol eye drops are mainly prepared by mixing polyvinyl alcohol, polyvinylpyrrolidone, sodium chloride and water for injection, and are used as a lubricant for preventing or treating stimulation symptoms such as dry eyes, foreign body sensation, asthenopia and the like or improving dryness symptoms of eyes. Because the polyvinyl alcohol eye drops are not added with preservatives, antibacterial agents and the like, the polyvinyl alcohol eye drops need to be used up at one time after being unsealed, the cost is increased, and the polyvinyl alcohol eye drops are not beneficial to consumers to use.
In addition, because the polyvinylpyrrolidone is added into the product, the polyvinylpyrrolidone raw material is easy to agglomerate in the production process, and the polyvinylpyrrolidone raw material must be slowly added while stirring during dissolution and then continuously stirred until the polyvinylpyrrolidone raw material is completely dissolved, so that the blending time and the labor cost are increased. In addition, the action effect of the eye drops is still to be improved.
In view of the above, the present invention is particularly proposed.
Disclosure of Invention
The invention aims to provide a polyvinyl alcohol composition, an eye preparation prepared from the polyvinyl alcohol composition has stable performance and prolonged shelf life, and the preparation can remarkably prolong the action time, promote the healing of corneal epithelial cells, recover epithelial cell barriers and improve the curative effect after being used; also has the advantages of high comfort, no irritation, safe use, simple preparation and cost saving.
In order to achieve the above purpose of the present invention, the following technical solutions are adopted:
a polyvinyl alcohol composition is mainly prepared from 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 by weight.
The polyvinyl alcohol composition provided by the invention specifically selects polyvinyl alcohol, polyvinylpyrrolidone, xanthan gum and nonionic surfactant for matching use, so that the moistening effect is enhanced, the acting time of the polyvinyl alcohol composition in eyes is prolonged, the healing of corneal epithelial cells is better promoted, the epithelial cell barrier is recovered, the curative effect is improved, and the finally obtained preparation has stable performance and high use comfort and has obvious curative effects on dry eyes, eye fatigue and the like. In addition, in the preparation process, all the raw materials are directly mixed in water and are matched with each other, so that the defect that polyvinylpyrrolidone is easy to agglomerate is overcome.
In order to enhance the synergistic enhancement effect among the components, preferably, the components comprise 10 to 12 parts by weight of polyvinyl alcohol, 0.2 to 0.4 part by weight of polyvinylpyrrolidone, 1 to 3 parts by weight of xanthan gum and 1 to 2 parts by weight of nonionic surfactant.
Preferably, the nonionic surfactant is one or two of fatty alcohol ester and sucrose ester. Multiple tests prove that the nonionic surfactant is one or two of fatty alcohol ester and sucrose ester, so that the compatibility of the medicament prepared from the polyvinyl alcohol composition with eye tissues can be improved, better antibacterial and bacteriostatic effects are achieved, the components are matched with each other, the storage time of the preparation is prolonged, and the medicament can be used within 10 days after the seal is opened.
Preferably, the components also comprise 0.1-0.5 part of borneol by weight. By adding borneol, the effect can be obviously improved, and the comfort in the use process is improved.
More preferably, the borneol is 0.2-0.3 part by weight.
Further, the components also comprise 5-20 parts of frankincense and 3-10 parts of radix sophorae flavescentis by weight. The frankincense and the radix sophorae flavescentis are matched with each other, so that the eye ointment has a good effect on redness and swelling, blood streak, swelling and itching of eyes, and the storage time of the unsealing medicine is further prolonged.
In order to enhance the synergistic enhancement effect of the frankincense and the radix sophorae flavescentis, preferably, the frankincense is 8-15 parts by weight, and the radix sophorae flavescentis is 5-8 parts by weight.
In order to meet the requirements of the public, the polyvinyl alcohol composition can be prepared into various dosage forms, and further, the raw materials also comprise auxiliary materials for preparing the polyvinyl alcohol composition into various dosage forms;
the preparation formulation comprises any one of eye drops, eye lotion, eye ointment, eye gel and eye pellets. The preparation of various dosage forms can be prepared according to the conventional method.
Preferably, the dosage form of the polyvinyl alcohol composition is eye drops, and the raw materials further comprise an isotonic agent and a pH regulator;
the eye drops are prepared by the following steps:
respectively adding polyvinyl alcohol, polyvinylpyrrolidone, xanthan gum and a nonionic surfactant into water for injection, and uniformly mixing to obtain a first mixed solution;
if the borneol is contained, adding the borneol into the first mixed solution, and uniformly mixing to obtain a second mixed solution;
if containing frankincense and radix sophorae flavescentis, the frankincense and the radix sophorae flavescentis are added into the second mixed solution in the form of extracting solution;
then adding an isotonic agent and a pH regulator, adjusting the osmotic pressure of the solution to 300-310mOsm/L and the pH value to 6.5-7.5 to obtain a third mixed solution;
filtering and sterilizing the third mixed solution, and packaging;
wherein the amount of the water for injection is 150-300 parts by weight.
The eye drops prepared by gradually adding the components have uniform components, comfortable use and obvious curative effect.
Wherein the isotonic agent is one or more of sodium chloride, potassium chloride, boric acid, sodium sulfate, potassium sulfate, sodium nitrate, potassium nitrate, sodium acetate, mannitol, glycerol, propylene glycol, and glucose.
The isotonic agent is used for preparing the polyvinyl alcohol composition into an osmotic pressure meeting the standard of the ophthalmic preparation. The amount of osmolyte used in a formulation according to the present invention will vary depending on a number of factors, such as the type of osmolyte and its strength, the formulation composition, the physical and chemical stability of the drug and the formulation, etc., and it will be understood by those skilled in the art that the amount of osmolyte used can be readily determined in accordance with the desired target osmotic pressure to be adjusted, for example, in the case where the desired target osmotic pressure is substantially isotonic or slightly hypertonic with body fluids, by osmolyte adjusting the formulation with an appropriate amount of osmolyte after mixing most of the materials, especially all the formulation ingredients except water, before the formulation is brought to volume (to final weight and/or volume), whereby the specific amount of osmolyte used in the formulation can be readily determined.
The pH regulator is one or more of sodium dihydrogen phosphate, disodium 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, and phosphoric acid.
The pH regulator is used for preparing the polyvinyl alcohol composition into a pH value which meets the standard of the ophthalmic preparation. The amount of pH modifying agent used in the formulation will vary depending upon a number of factors, such as the type of pH modifying agent and its strength, formulation composition, physical and chemical stability of the drug and formulation, etc., and it will be understood by those skilled in the art that the amount of pH modifying agent in the gel of the present invention can be readily determined in accordance with the desired target pH to be adjusted, for example, in the case of a desired target pH of 6.5 to 7.5, by adjusting the pH of the formulation with an appropriate amount of pH modifying agent after mixing most of the materials, particularly all of the formulation ingredients except water, and prior to bringing the formulation to volume (to final weight and/or volume), and thereby readily determining the specific amount of pH modifying agent to be used in the formulation.
Preferably, the third mixed solution further comprises, before filter sterilization: and performing ultrasonic treatment on the obtained third mixed solution for 10-30min, wherein the power of the ultrasonic treatment is 5-10W.
It is found through experiments that the mixed solution is subjected to ultrasonic wave with specific power before filtration and sterilization, so that the curative effect of the eye drops is improved, and more importantly, the use comfort of the eye drops is improved.
Compared with the prior art, the invention has the beneficial effects that:
(1) the polyvinyl alcohol composition provided by the invention specifically selects polyvinyl alcohol, polyvinylpyrrolidone, xanthan gum and nonionic surfactant for matching use, so that the moistening effect is enhanced, the acting time of the polyvinyl alcohol composition in eyes is prolonged, the healing of corneal epithelial cells is better promoted, the epithelial cell barrier is recovered, and the obtained preparation has stable performance and high use comfort level and has obvious curative effects on dry eyes, eye fatigue and the like.
(2) The invention also specifically selects one or two of fatty alcohol ester and sucrose ester as nonionic surfactant, can increase the compatibility of the medicament prepared from the polyvinyl alcohol composition with eye tissues, has better antibacterial and bacteriostatic effects, and can prolong the preservation time of the preparation by matching the components, and the medicament can be used within 10 days after the seal is opened.
(3) The borneol is added to improve the action effect and the comfort in the use process.
(4) The invention also adds frankincense and radix sophorae flavescentis which are matched with each other, so that the invention has good effects on redness and swelling, blood streak, swelling and itching of eyes, and further prolongs the storage time of the unsealing medicine.
(5) The raw materials provided by the invention are matched with each other, so that the defect that the polyvinylpyrrolidone is easy to agglomerate when being used for preparing the aqueous solution is overcome.
(6) In the process of preparing the eye drops, the invention adds the step of firstly carrying out ultrasonic treatment on the mixed solution and then carrying out filtration and sterilization, thereby not only increasing the curative effect of the eye drops, but also obviously increasing the use comfort of the eye drops.
Detailed Description
Embodiments of the present invention will be described in detail below with reference to examples, but it will be understood by those skilled in the art that the following examples are only illustrative of the present invention and should not be construed as limiting the scope of the present invention. The examples, in which specific conditions are not specified, were conducted under conventional conditions or conditions recommended by the manufacturer. The reagents or instruments used are not indicated by the manufacturer, and are all conventional products commercially available.
Example 1
The polyvinyl alcohol composition is prepared into eye drops, and the specific steps are as follows:
respectively adding 8g of polyvinyl alcohol, 0.1g of polyvinylpyrrolidone, 0.5g of xanthan gum and 0.5g of fatty alcohol ester into 150ml of water for injection, and uniformly mixing to obtain a first mixed solution;
then adding sodium chloride and sodium dihydrogen phosphate, adjusting the osmotic pressure of the solution to 300mOsm/L and the pH value to 7.5 to obtain a target mixed solution;
filtering the target mixture, sterilizing, and packaging.
Group 2: performing ultrasonic treatment on the obtained target mixed solution for 30min, wherein the power of the ultrasonic treatment is 5W; then filtering, sterilizing and packaging.
Example 2
The polyvinyl alcohol composition is prepared into eye drops, and the specific steps are as follows:
respectively adding 15g of polyvinyl alcohol, 0.5g of polyvinylpyrrolidone, 5g of xanthan gum and 3g of sucrose ester into 200ml of water for injection, and uniformly mixing to obtain a first mixed solution;
then adding sodium sulfate and disodium hydrogen phosphate, adjusting the osmotic pressure of the solution to 310mOsm/L and the pH value to 7.2 to obtain a target mixed solution;
group 1: and (3) filtering and sterilizing the target mixed solution, and packaging.
Group 2: performing ultrasonic treatment on the obtained target mixed solution for 10min, wherein the power of the ultrasonic treatment is 10W; then filtering, sterilizing and packaging.
Example 3
The polyvinyl alcohol composition is prepared into eye drops, and the specific steps are as follows:
respectively adding 10g of polyvinyl alcohol, 0.2g of polyvinylpyrrolidone, 1g of xanthan gum, 0.5g of fatty alcohol ester and 0.5g of sucrose ester into 170ml of water for injection, and uniformly mixing to obtain a first mixed solution;
then adding potassium nitrate and potassium carbonate, and adjusting the osmotic pressure of the solution to 305mOsm/L and the pH value to 7.0 to obtain a target mixed solution;
group 1: and (3) filtering and sterilizing the target mixed solution, and packaging.
Group 2: performing ultrasonic treatment on the obtained target mixed solution for 25min, wherein the power of the ultrasonic treatment is 7W; then filtering, sterilizing and packaging.
Example 4
The polyvinyl alcohol composition is prepared into eye drops, and the specific steps are as follows:
respectively adding 12g of polyvinyl alcohol, 0.4g of polyvinylpyrrolidone, 3g of xanthan gum, 1.5g of fatty alcohol ester and 0.5g of sucrose ester into 150ml of water for injection, and uniformly mixing to obtain a first mixed solution;
then adding glucose, sodium chloride and acetic acid, adjusting the osmotic pressure of the solution to 300mOsm/L and the pH value to 6.7 to obtain a target mixed solution;
group 1: and (3) filtering and sterilizing the target mixed solution, and packaging.
Group 2: performing ultrasonic treatment on the obtained target mixed solution for 20min, wherein the power of the ultrasonic treatment is 8W; then filtering, sterilizing and packaging.
Example 5
The polyvinyl alcohol composition is prepared into eye drops, and the specific steps are as follows:
respectively adding 8g of polyvinyl alcohol, 0.1g of polyvinylpyrrolidone, 0.5g of xanthan gum and 0.5g of fatty alcohol ester into 200ml of water for injection, and uniformly mixing to obtain a first mixed solution;
adding 0.1g of borneol into the first mixed solution, and uniformly mixing to obtain a second mixed solution;
then adding sodium chloride and sodium dihydrogen phosphate, adjusting the osmotic pressure of the solution to 300mOsm/L and the pH value to 7.5 to obtain a third mixed solution;
group 1: filtering and sterilizing the third mixed solution, and packaging.
Group 2: performing ultrasonic treatment on the obtained third mixed solution for 30min, wherein the power of the ultrasonic treatment is 5W; then filtering, sterilizing and packaging.
Example 6
The polyvinyl alcohol composition is prepared into eye drops, and the specific steps are as follows:
respectively adding 15g of polyvinyl alcohol, 0.5g of polyvinylpyrrolidone, 5g of xanthan gum and 3g of sucrose ester into 300ml of water for injection, and uniformly mixing to obtain a first mixed solution;
adding 0.3g of borneol into the first mixed solution, and uniformly mixing to obtain a second mixed solution;
then adding sodium sulfate and disodium hydrogen phosphate, adjusting the osmotic pressure of the solution to 310mOsm/L and the pH value to 7.2, and obtaining a third mixed solution;
group 1: filtering and sterilizing the third mixed solution, and packaging.
Group 2: performing ultrasonic treatment on the obtained third mixed solution for 10min, wherein the power of the ultrasonic treatment is 10W; then filtering, sterilizing and packaging.
Example 7
The polyvinyl alcohol composition is prepared into eye drops, and the specific steps are as follows:
respectively adding 9g of polyvinyl alcohol, 0.3g of polyvinylpyrrolidone, 2g of xanthan gum, 1g of fatty alcohol ester and 0.5g of sucrose ester into 250ml of water for injection, and uniformly mixing to obtain a first mixed solution;
adding 0.2g of borneol into the first mixed solution, and uniformly mixing to obtain a second mixed solution;
then adding sodium acetate, mannitol, glycerol as isotonic agent, citric acid as pH regulator, and sodium citrate, adjusting osmotic pressure of the solution to 310mOsm/L and pH value to 7.0 to obtain a third mixed solution;
group 1: filtering and sterilizing the third mixed solution, and packaging.
Group 2: performing ultrasonic treatment on the obtained third mixed solution for 20min, wherein the power of the ultrasonic treatment is 8W; then filtering, sterilizing and packaging.
Example 8
The polyvinyl alcohol composition is prepared into eye drops, and the specific steps are as follows:
distilling 5g of frankincense and 3g of radix sophorae flavescentis with water for injection to obtain 50ml of extracting solution;
respectively adding 10g of polyvinyl alcohol, 0.3g of polyvinylpyrrolidone, 1g of xanthan gum and 1g of fatty alcohol ester into 150ml of water for injection, and uniformly mixing to obtain a first mixed solution;
mixing the extract with the first mixed solution, adding potassium chloride, glucose and phosphoric acid as pH regulator, and adjusting osmotic pressure to 300mOsm/L and pH to 6.5 to obtain a second mixed solution;
group 1: filtering and sterilizing the second mixed solution, and packaging.
Group 2: performing ultrasonic treatment on the obtained second mixed solution for 20min, wherein the power of the ultrasonic treatment is 8W; then filtering, sterilizing and packaging.
Example 9
The polyvinyl alcohol composition is prepared into eye drops, and the specific steps are as follows:
distilling 8g of frankincense and 5g of radix sophorae flavescentis with water for injection to obtain 50ml of extracting solution;
respectively adding 12g of polyvinyl alcohol, 0.4g of polyvinylpyrrolidone, 3g of xanthan gum and 1.5g of sucrose ester into 150ml of water for injection, and uniformly mixing to obtain a first mixed solution;
mixing the extract with the first mixed solution, adding sodium chloride and sodium bicarbonate, adjusting osmotic pressure of the solution to 300mOsm/L, and adjusting pH to 7.2 to obtain a second mixed solution;
group 1: filtering and sterilizing the second mixed solution, and packaging.
Group 2: performing ultrasonic treatment on the obtained second mixed solution for 15min, wherein the power of the ultrasonic treatment is 10W; then filtering, sterilizing and packaging.
Example 10
The polyvinyl alcohol composition is prepared into eye drops, and the specific steps are as follows:
distilling 20g of frankincense and 10g of radix sophorae flavescentis with water for injection to obtain 100ml of extracting solution;
respectively adding 15g of polyvinyl alcohol, 0.5g of polyvinylpyrrolidone, 5g of xanthan gum and 1g of fatty alcohol ester into 150ml of water for injection, and uniformly mixing to obtain a first mixed solution;
adding 0.3g of borneol into the first mixed solution, and uniformly mixing to obtain a second mixed solution;
mixing the extract with the second mixed solution, adding sodium acetate, glycerol and potassium hydroxide as isotonic agent, adjusting osmotic pressure to 305mOsm/L and pH to 7.5 to obtain a third mixed solution;
group 1: filtering and sterilizing the third mixed solution, and packaging.
Group 2: performing ultrasonic treatment on the obtained third mixed solution for 10min, wherein the power of the ultrasonic treatment is 10W; then filtering, sterilizing and packaging.
Example 11
The polyvinyl alcohol composition is prepared into eye drops, and the specific steps are as follows:
distilling 15g of frankincense and 8g of radix sophorae flavescentis with water for injection to obtain 50ml of extracting solution;
respectively adding 10g of polyvinyl alcohol, 0.4g of polyvinylpyrrolidone, 3g of xanthan gum and 1g of sucrose ester into 150ml of water for injection, and uniformly mixing to obtain a first mixed solution;
adding 0.2g of borneol into the first mixed solution, and uniformly mixing to obtain a second mixed solution;
mixing the extract with the second mixed solution, adding sodium chloride and sodium bicarbonate, adjusting osmotic pressure of the solution to 305mOsm/L, and adjusting pH to 7.0 to obtain a third mixed solution;
group 1: filtering and sterilizing the third mixed solution, and packaging.
Group 2: performing ultrasonic treatment on the obtained third mixed solution for 20min, wherein the power of the ultrasonic treatment is 7W; then filtering, sterilizing and packaging.
Example 12
The polyvinyl alcohol composition is prepared into eye drops, and the specific steps are as follows:
distilling 8g of frankincense and 5g of radix sophorae flavescentis with water for injection to obtain 50ml of extracting solution;
respectively adding 10g of polyvinyl alcohol, 0.3g of polyvinylpyrrolidone, 2g of xanthan gum, 1g of fatty alcohol ester and 1g of sucrose ester into 150ml of water for injection, and uniformly mixing to obtain a first mixed solution;
adding 0.3g of borneol into the first mixed solution, and uniformly mixing to obtain a second mixed solution;
mixing the extract with the second mixed solution, adding potassium chloride and tartaric acid, adjusting osmotic pressure of the solution to 305mOsm/L and pH value to 6.8 to obtain a third mixed solution;
group 1: filtering and sterilizing the third mixed solution, and packaging.
Group 2: performing ultrasonic treatment on the obtained third mixed solution for 20min, wherein the power of the ultrasonic treatment is 6W; then filtering, sterilizing and packaging.
Experimental example 1
Eye drops prepared in examples 1 to 12 were subjected to eye irritation test. The method comprises the following specific steps:
the common-grade 2.2-2.4kg of big-ear white rabbits are adopted for testing, the selected rabbits are healthy, adult, have no irritation symptom to eyes, have no defect on cornea and have no damage to conjunctiva, the eye drops prepared by the invention are directly dripped into the right side eye, the left side eye is not treated as a control, the dosage of each animal is 0.1ml each time, 1 time per day, the influence on the cornea, iris and conjunctiva is observed after 6 hours, and the titration is continued for 10 days. 3 rabbits were used per group.
In the test process, the eye drops provided by the invention have no influence on the cornea, iris and conjunctiva of rabbits, and show no stimulation to eyes.
Experimental example 2
The eye drops prepared in groups 1 and 2 of examples 1 to 12 were filled in colorless plastic bottles, and the bottles were labeled as samples 1 to 24, respectively, and used as test groups; meanwhile, commercially available disposable polyvinyl alcohol eye drops were used as a control. The bottled eye drops in the test group and the control group are respectively unsealed at room temperature, 1 drop of liquid is dripped after the bottled eye drops are opened, then the bottle stopper is screwed on, and the operation is repeated, and the bottled eye drops are opened 5 times a day for 30 days. The appearance of the different eye drops was observed on day 5, day 10, day 15, day 20, day 25 and day 30, and the sterility and the centrifugation test (500r/min) were measured. The results are shown in Table 1.
TABLE 1 examination of different eye drops
Note: "-" is not detected.
As can be seen from Table 1, the control group is prepared from polyvinyl alcohol, polyvinylpyrrolidone, sodium chloride and water for injection, and is easy to pollute mixed bacteria after being unsealed, needs to be used up at one time and cannot be stored; the eye drops provided by the invention contain polyvinyl alcohol, polyvinylpyrrolidone, xanthan gum and sucrose ester and/or fatty alcohol ester, and the storage time of the eye drops at room temperature reaches 10 days; after the frankincense and the radix sophorae flavescentis are added, the storage time of the unsealed eye drops reaches 25 days, and the storage time of the unsealed product is obviously prolonged.
In addition, the pH values of samples 1-7 which are placed for 10 days at normal temperature and samples 8-12 which are placed for 25 days at normal temperature are measured, and the pH values are in the range of 6.5-7.5. The results of the experiments in experimental example 1 were obtained by subjecting samples 1 to 12, which were left at room temperature for 10 days, and samples 13 to 24, which were left at room temperature for 25 days, to the tests in experimental example 1, and the results showed that none of them affected the cornea, iris and conjunctiva of rabbits, showing no irritation to eyes.
Experimental example 3
The eye drops prepared in examples 1 to 12 were used in clinical trials. 1300 patients with dry eyes and easy fatigue are randomly selected and evenly divided into 26 groups, the first 24 groups are test groups and respectively correspond to the test groups 1-24, and the test groups 1-24 respectively correspond to the eye drops prepared by the groups 1 and 2 in the examples 1-12; as a control group 1, polyvinyl alcohol eye drops manufactured by Xindong Bio-technology Co., Ltd were used in group 25, and as a control group 2, physiological saline was used in group 26. The effect was counted after 4 drops per day for 10 days. The effects are divided into recovery, significant effect and ineffectiveness, wherein the recovery refers to normal observation of eye tissues and disappearance of eye dryness and fatigue symptoms; the obvious effect is that the eye tissue is obviously improved, and the dry and astringent eye and fatigue symptoms are obviously relieved; the failure was no apparent change in ocular tissue and ocular symptoms. Specific results are shown in table 2.
TABLE 2 Effect on dry eyes and fatigue
| Group of | The number of healed people | Number of effective people | Number of invalid persons |
| 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 |
| Control group 1 | 35 | 15 | 0 |
| Control group 2 | 0 | 10 | 40 |
As can be seen from the table 1, the eye drops provided by the invention have obvious curative effect on patients with dry eyes and easy fatigue, wherein after the borneol is added, the action effect can be increased, and the use sensitivity of customers is improved; after the frankincense and the radix sophorae flavescentis are added, the frankincense and the radix sophorae flavescentis interact with each other to repair damage of corneal epithelial cells and restore epithelial cell barriers, so that the medicine has a better curative effect; in addition, the comfort level of the eye drops subjected to ultrasonic treatment in the preparation process is obviously improved for customers, if the comfort level is fully divided into 10 minutes, the eye drops not subjected to ultrasonic treatment are divided into 7 minutes, the eye drops subjected to ultrasonic treatment are divided into 10 minutes, the eye drops subjected to ultrasonic treatment are divided into 7 minutes compared with the control group 1, and the curative effect of the eye drops subjected to ultrasonic treatment is better. The eye drops provided by the invention have obviously higher effect than the products sold on the market, and the use comfort of patients is obviously improved.
Experimental example 4
The eye drops prepared in examples 1 to 12 were used in clinical trials. 950 patients with redness or swelling of eyes and itching were randomly selected and divided into 19 groups, the first 16 groups corresponded to test groups 1-16, test groups 1-16 corresponded to eye drops prepared by using groups 1 and 2 of examples 2-3, 5-6, 8-9, and 10-11; group 17 used as a control group 1 polyvinyl alcohol eye drops manufactured by Xindong biotechnology, Inc.; group 19 used as control group 2 the eye drops prepared in example 2 of example 4 under application No. CN 200410035918.6; group 19 used as control group 3 was saline. The effect was counted after 4 drops per day for 10 days. The effects are divided into healing, significant effect and ineffective effect, wherein the healing is that the eye tissue is observed normally, and swelling or blood streak and pruritus symptoms disappear; the obvious effects are that the eye tissues are obviously improved, and the symptoms of swelling or blood streak and pruritus are obviously relieved; the failure was no apparent change in ocular tissue and ocular symptoms. Specific results are shown in table 3.
TABLE 3 therapeutic Effect
| Group of | The number of healed people | Number of effective people | Number of invalid persons |
| 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 |
| Control group 1 | 20 | 15 | 15 |
| Control group 2 | 26 | 19 | 5 |
| Control group 3 | 0 | 3 | 47 |
As can be seen from table 3, when the eye drops provided by the present invention mainly contain polyvinyl alcohol, polyvinylpyrrolidone, xanthan gum and nonionic surfactant, the eye drops have not very good therapeutic effects on the red swelling or bloody streak or swelling of eyes and patients with pruritus, because the eye drops have very good moisture retention and damage repairing effects, but have not very good effects on the swelling, bloody streak and pruritus; after the frankincense and the radix sophorae flavescentis are added, the two traditional Chinese medicine components interact with each other, so that the frankincense and the radix sophorae flavescentis have very good effects of activating blood circulation to dissipate blood stasis, eliminating swelling and promoting tissue regeneration and relieving itching, and have obvious effects on swelling, blood streak and pruritus; in addition, the comfort level of the eye drops subjected to ultrasonic treatment in the preparation process is obviously improved for customers, if the comfort level is fully divided into 10 minutes, the eye drops not subjected to ultrasonic treatment are divided into 7 minutes, the eye drops subjected to ultrasonic treatment are divided into 10 minutes, the eye drops subjected to ultrasonic treatment are divided into 7 minutes compared with the control group 1, and the curative effect of the eye drops subjected to ultrasonic treatment is better. The eye drops provided by the invention have obviously higher effect than the products sold on the market, and the use comfort of patients is obviously improved.
While particular embodiments of the present invention have been illustrated and described, it would be obvious that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is therefore intended to cover in the appended claims all such changes and modifications that are within the scope of this invention.
Claims (4)
1. The polyvinyl alcohol composition is characterized by being prepared from the following raw materials, by weight, 8-15 parts of polyvinyl alcohol, 0.1-0.5 part of polyvinylpyrrolidone, 0.5-5 parts of xanthan gum, 0.5-3 parts of a non-ionic surfactant, 0.1-0.5 part of borneol, 5-20 parts of frankincense, 3-10 parts of radix sophorae flavescentis, 150 parts of water for injection, 300 parts of an isotonic agent and a pH regulator;
the dosage form of the polyvinyl alcohol composition is eye drops;
the nonionic surfactant is one or two of fatty alcohol ester and sucrose ester;
the eye drops are prepared by the following steps:
respectively adding polyvinyl alcohol, polyvinylpyrrolidone, xanthan gum and a nonionic surfactant into water for injection, and uniformly mixing to obtain a first mixed solution;
adding borneol into the first mixed solution, and uniformly mixing to obtain a second mixed solution;
adding the frankincense and the radix sophorae flavescentis into the second mixed solution in the form of extracting solution; then, adding an isotonic agent and a pH regulator, and adjusting the osmotic pressure of the solution to 300-310mOsm/L and the pH value to 6.5-7.5 to obtain a third mixed solution;
performing ultrasonic treatment on the obtained third mixed solution for 10-30min, wherein the power of the ultrasonic treatment is 5-10W;
filtering and sterilizing the third mixed solution, and packaging.
2. The polyvinyl alcohol composition according to claim 1, wherein the polyvinyl alcohol composition comprises, by weight, 10 to 12 parts of polyvinyl alcohol, 0.2 to 0.4 part of polyvinylpyrrolidone, 1 to 3 parts of xanthan gum, and 1 to 2 parts of a nonionic surfactant.
3. The polyvinyl alcohol composition according to claim 1, wherein the amount of the borneol is 0.2 to 0.3 part by weight.
4. The polyvinyl alcohol composition as claimed in claim 1, wherein the amount of the olibanum is 8-15 parts and the amount of the sophora flavescens is 5-8 parts by weight.
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| CN101049307A (en) * | 2006-04-07 | 2007-10-10 | 沈阳海普科技有限公司 | Matrine eye drip liquid, and producing method |
| CN101264053A (en) * | 2008-05-13 | 2008-09-17 | 赖福平 | Oxybuprocaine hydrochloride eye drops and preparation thereof |
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