CN102961399A - Sodium chloride eye drops and preparation method thereof - Google Patents

Sodium chloride eye drops and preparation method thereof Download PDF

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CN102961399A
CN102961399A CN2012104921529A CN201210492152A CN102961399A CN 102961399 A CN102961399 A CN 102961399A CN 2012104921529 A CN2012104921529 A CN 2012104921529A CN 201210492152 A CN201210492152 A CN 201210492152A CN 102961399 A CN102961399 A CN 102961399A
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eye drop
sodium chloride
injection
water
hypromellose
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CN102961399B (en
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杨亚军
徐亮
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Ningxia Kang Ya pharmaceutical Limited by Share Ltd
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KANGYA PHARMACEUTICAL INDUSTRY Co Ltd NINGXIA
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Abstract

The invention provides sodium chloride eye drops containing hydroxypropyl methylcellulose and a preparation method of the sodium chloride eye drops. The eye drops comprise sodium chloride, hydroxypropyl methylcellulose and water for injection, and a bacteriostatic agent and an acid-base regulator can be added. The eye drops have the following prescription and amount based on 100ml: 0.45-0.75g of sodium chloride, 0.03-0.06g of hydroxypropyl methylcellulose, a pH buffer system and the water for injection. The eye drops are long-lasting in function, obvious in effect of treating xerophthalmia, safe and small in side effect.

Description

Sodium chloride eye drop and preparation method thereof
Technical field
The present invention relates to a kind of sodium chloride eye drop and preparation method thereof, especially relate to the sodium chloride eye drop that contains hypromellose, belong to field of pharmaceutical preparations.
Background technology
Xerophthalmia is a kind of common ophthalmic diseases; be again the angle conjunctival xerosis; refer to that tear matter that any reason causes or amount are unusual or kinetics is unusual, cause tear film stability decline, and with ophthalmic uncomfortable and (or) general name of the various diseases of eye table organization characteristics of lesion.Along with TV play, computer etc. is widely used in human daily life, aged tendency of population increases gradually in recent years, and the incidence rate of xerophthalmia rises year by year, badly influences the normal development of teenager vision and the usefulness eye health of middle-aged and elderly people.
The primary treatment measure of xerophthalmia is to replenish tear, i.e. local humidity and the lubricating ability of using the artificial tears to improve ocular surface.
External artificial tears has tens of kinds more than, generally by the ingredients that contains some inorganic salts and high molecular polymer and stimulate lacrimal secretion.But most artificial tearss are unstable to the effect for the treatment of of dry eye, and the persistent period is short, and the domestic adjuvant such as antibacterial that contains has certain toxic action to eye table epithelium more.At present, commercially available eye drop antibacterial mostly is benzalkonium chloride, and it can destroy the tight connecting band between corneal epithelial cell, the cornea permeability is increased, can also be combined with the lipid film of corneal epithelial cell film, cell membrane be increased the permeability of water and various ions, and reduce artificial tears's curative effect.
In recent years, though the existing eye drop that can increase moistening effect on the market, such as: sodium hyaluronate eye drops or contain the eye drop of hyaluronic acid sodium, but hyaluronic acid sodium is unstable under light, heat, easily degraded, long preservation at room temperature, simultaneously, hyaluronic acid sodium is a kind of biomacromolecule mucopolysaccharide, easy contaminated long bacterium.In view of the defective of above eye drop, be necessary to develop a kind of steady quality, can play long-acting moisturizing again, easing eyes is dry and astringent, simultaneously, the eye drop that side effect is again little.
Summary of the invention
The object of the invention is exactly to solve the defective that prior art exists, and provides a kind of steady quality, long-acting moisturizing, the eye drop that side effect is little.The sodium chloride eye drop that contains hypromellose provided by the invention just can overcome the above problems well.
The object of the present invention is to provide a kind of sodium chloride eye drop that contains hypromellose.
Another object of the present invention is to provide the preparation method of the sodium chloride eye drop that contains hypromellose.
The present invention relates to a kind of sodium chloride eye drop that contains hypromellose, it is characterized in that, described eye drop contains sodium chloride 0.45~0.75g in 100ml, hypromellose 0.03~0.06g, pH buffer system, water for injection.
Above-mentioned pH buffer system is preferably boric acid and Borax, and its consumption is respectively 0.53g and 0.05g.
The present invention relates to a kind of sodium chloride eye drop that contains hypromellose, it is characterized in that, described eye drop contains sodium chloride 0.55g in 100ml, hypromellose 0.05g, boric acid 0.53g, Borax 0.05g, water for injection.
The above-mentioned sodium chloride eye drop that contains hypromellose also contains acid-base modifier, so that the pH value of final solution is 6.0~8.5, and preferred 6.5~7.5.
Above-mentioned acid-base modifier is selected from: one or more of hydrochloric acid, citric acid, sodium hydroxide, potassium hydroxide and sodium citrate.
Preferably, the above-mentioned sodium chloride eye drop that contains hypromellose also contains antibacterial, and its content is 0.01g~0.5g
Above-mentioned antibacterial is selected from: one or more of chlorobutanol, thimerosal, sorbic acid, benzalkonium chloride, methyl hydroxybenzoate, ethyl hydroxybenzoate, propyl hydroxybenzoate and butyl hydroxybenzoate, and preferred ethyl hydroxybenzoate, its consumption is 0.03g.
Select hypromellose and sodium chloride to be used among the present invention, make eye drop have extraordinary moistening effect, the weight proportion of preferred hypromellose and sodium chloride is: 3: 55~6: 55
Preparation method of the present invention is characterized in that, the method may further comprise the steps:
(1) in advance that the hypromellose adding of recipe quantity is an amount of The water for injection dissolvingFor subsequent use.
(2) take by weighing respectively sodium chloride, antibacterial, boric acid and the Borax of recipe quantity, each adds an amount of water for injection, sterilizes after mixing.
(3) antibacterial after the sterilization in the above-mentioned steps (2) is for subsequent use after with an amount of water for injection heating for dissolving.
(4) sodium chloride after the sterilization in the above-mentioned steps (2), boric acid, Borax are added in the antibacterial solution of placing room temperature in the above-mentioned steps (3), stir and make dissolving, mix homogeneously.
(5) with the solution mix homogeneously in step (1) and (4), add residue water for injection and mix homogeneously.
(6) regulate medicinal liquid pH value to 6.5~7.5 with potassium hydroxide or the 0.1mol/L hydrochloric acid solution of 0.1mol/L, with 0.22 μ m filter membrane the medicinal liquid for preparing is carried out aseptic filtration, take a sample to check after filtration finishes appearance character, pH value, qualified rear fill.
Because the utilization of technique scheme, the present invention compared with prior art has the following advantages:
(1) but contain hypromellose the sodium chloride eye drop long period stick to the corneal epithelium surface, play keeping the skin wet and protective effect, and meet the osmotic pressure of human body tear, viscosity and electrolyte concentration etc.
(2) the pH scope of general eye drop is all 6~8, and it is uncomfortable that too high (pH is greater than 9) or excessively low (pH is less than 5) can make eye produce.Therefore, the pH that determines eye drop is: 6.5~7.5.The present invention adopts boric acid and Borax buffer system, can keep the pH of medicinal liquid at 6.5-7.5, and borate also has certain bacteriostasis simultaneously.
(3) eye drop steady quality of the present invention is fit at normal temperatures long preservation.
The specific embodiment:
Embodiment 1:
In 100ml, the preparation eye drop contains:
Sodium chloride 0.55g, hypromellose 0.03g, boric acid 0.53g, Borax 0.05g, ethyl hydroxybenzoate 0.03g, water for injection.
Preparation method may further comprise the steps:
(1) gets in advance the 0.05g hypromellose and join in an amount of water for injection, dissolve for subsequent use.
(2) take by weighing respectively sodium chloride 0.55g, ethyl hydroxybenzoate 0.03g, boric acid 0.53g and Borax 0.05g, each adds an amount of water for injection, stirs to make and puts into high-pressure sterilizing pot (121 ℃, 30 minutes) in the mix homogeneously rear-mounted triangular beaker and sterilize.
(3) with the ethyl hydroxybenzoate after the above-mentioned sterilization with an amount of water for injection heating for dissolving.
(4) sodium chloride after the above-mentioned sterilization, boric acid, Borax are added in the ethyl hydroxybenzoate solution of the placement room temperature in above-mentioned (3), stir and make dissolving, mix homogeneously.
(5) with the solution mix homogeneously in step (1) and (4), add residue water for injection and mix homogeneously.
(6) regulate medicinal liquid pH value to 6.5~7.5 with potassium hydroxide or the 0.1mol/L hydrochloric acid solution of 0.1mol/L, with 0.22 μ m filter membrane the medicinal liquid for preparing is carried out aseptic filtration, take a sample to check after filter finishing appearance character, pH value, osmotic pressure, visible foreign matters, qualified rear fill.
Embodiment 2:
In 100ml, the preparation eye drop contains:
Sodium chloride 0.55g, hypromellose 0.05g, boric acid 0.53g, Borax 0.05g, ethyl hydroxybenzoate 0.03g, water for injection.
Its preparation method is with above-mentioned embodiment 1.
Embodiment 3:
In 100ml, the preparation eye drop contains:
Sodium chloride 0.55g, hypromellose 0.06g, boric acid 0.53g, Borax 0.05g, ethyl hydroxybenzoate 0.03g, water for injection.
Its preparation method is with above-mentioned embodiment 1.
Each embodiment sample and the eye drop that does not add the blank of hypromellose and be added with hyaluronate sodium are carried out the test of moisturizing rate, and result of the test is as follows:
The moisturizing rate of different wetting agents is with the variation of standing time
Figure BSA00000812666200041
For guaranteeing steady quality of the present invention, safety, so carried out medicine stability test (accelerating and long term test).Test example is as follows:
One, accelerated test
1.40 ℃ ± 2 ℃, relative humidity RH75% ± 5%, result of the test is as follows:
Figure BSA00000812666200042
2.40 ℃ ± 2 ℃, relative humidity 25% ± 5%, result of the test is as follows:
Figure BSA00000812666200052
Two, long term test
1.25 ℃ ± 2 ℃, relative humidity 60% ± 10%, result of the test is as follows:
Figure BSA00000812666200053
2.25 ℃ ± 2 ℃, relative humidity 40% ± 5%, result of the test is as follows:
Figure BSA00000812666200071
Three, conclusion
The sample that the present invention produces with embodiment is in 40 ℃ ± 2 ℃, relative humidity 75% ± 5%, and 40 ℃ ± 2 ℃, to place 6 months under relative humidity 25% ± 5% condition, indices is good, conforms to quality requirements.In 25 ℃ ± 2 ℃, relative humidity 60% ± 10%, 25 ℃ ± 2 ℃, to place 2 years under relative humidity 40% ± 5% condition, significant change does not all occur in outward appearance, pH, viscosity, sodium chloride content and ethyl hydroxybenzoate content, conforms to quality requirements.

Claims (9)

1. a sodium chloride eye drop that contains hypromellose is characterized in that, described eye drop contains sodium chloride 0.45~0.75g in 100ml, hypromellose 0.03~0.06g, pH buffer system, water for injection.
2. eye drop according to claim 1 is characterized in that, the pH buffer system is boric acid and Borax.
3. eye drop according to claim 1, the weight proportion that it is characterized in that hypromellose and sodium chloride is 3: 55~6: 55.
4. eye drop according to claim 1 is characterized in that, described eye drop contains sodium chloride 0.55g in 100ml, hypromellose 0.05g, boric acid 0.53g, Borax 0.05g, water for injection.
5. the described eye drop of any one is characterized in that also containing acid-base modifier according to claim 1-4, so that the pH value of final solution is 6.0~8.5, and preferred 6.5~7.5.
6. eye drop according to claim 5, described acid-base modifier is selected from one or more of hydrochloric acid, citric acid, sodium hydroxide, potassium hydroxide and sodium citrate.
7. eye drop according to claim 6 is characterized in that it also contains antibacterial, and its content is 0.01g~0.5g.
8. eye drop according to claim 7 is characterized in that described antibacterial is selected from the one or more combination of chlorobutanol, thimerosal, sorbic acid, benzalkonium chloride, methyl hydroxybenzoate, ethyl hydroxybenzoate, propyl hydroxybenzoate and butyl hydroxybenzoate, preferred ethyl hydroxybenzoate.
9. the preparation method of described eye drop according to claim 8 is characterized in that the method may further comprise the steps:
(1) in advance that the hypromellose adding of recipe quantity is an amount of The water for injection dissolvingFor subsequent use.
(2) take by weighing respectively sodium chloride, antibacterial, boric acid and the Borax of recipe quantity, each adds an amount of water for injection, sterilizes after mixing.
(3) antibacterial after the sterilization in the above-mentioned steps (2) is for subsequent use after with an amount of water for injection heating for dissolving.
(4) sodium chloride after the sterilization in the above-mentioned steps (2), boric acid, Borax are added in the antibacterial solution of placing room temperature in the above-mentioned steps (3), stir and make dissolving, mix homogeneously.
(5) with the solution mix homogeneously in step (1) and (4), add residue water for injection and mix homogeneously.
(6) regulate medicinal liquid pH value to 6.5~7.5 with potassium hydroxide or the 0.1mol/L hydrochloric acid solution of 0.1mol/L, with 0.22 μ m filter membrane the medicinal liquid for preparing is carried out aseptic filtration, take a sample to check after filtration finishes appearance character, pH value, qualified rear fill.
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Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109439469A (en) * 2018-12-27 2019-03-08 江苏海伦隐形眼镜有限公司 A kind of dissolving method of cellulose, cellulose-containing clear transparent solutions and its application
CN114848670A (en) * 2022-05-26 2022-08-05 青岛博益特生物材料股份有限公司 Eye drops and preparation method thereof
CN115093486A (en) * 2022-07-13 2022-09-23 上海卫康光学眼镜有限公司 Hydroxypropyl methylcellulose HPMC (hydroxy propyl methyl cellulose) dissolving method
CN115702879A (en) * 2021-08-06 2023-02-17 成都康弘药业集团股份有限公司 Eye drops of atropine sulfate

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102100693A (en) * 2009-12-16 2011-06-22 沈阳兴齐制药有限公司 Artificial tears including carnosine and preparation method thereof
CN102188368A (en) * 2011-04-15 2011-09-21 苏州太湖美药业有限公司 Preparation technology of compound sodium chloride eye drop solution
CN102283805A (en) * 2011-06-29 2011-12-21 扬子江药业集团有限公司 Method for preparing eye drops containing non-ionic cellulose derivatives

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102100693A (en) * 2009-12-16 2011-06-22 沈阳兴齐制药有限公司 Artificial tears including carnosine and preparation method thereof
CN102188368A (en) * 2011-04-15 2011-09-21 苏州太湖美药业有限公司 Preparation technology of compound sodium chloride eye drop solution
CN102283805A (en) * 2011-06-29 2011-12-21 扬子江药业集团有限公司 Method for preparing eye drops containing non-ionic cellulose derivatives

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN109439469A (en) * 2018-12-27 2019-03-08 江苏海伦隐形眼镜有限公司 A kind of dissolving method of cellulose, cellulose-containing clear transparent solutions and its application
CN115702879A (en) * 2021-08-06 2023-02-17 成都康弘药业集团股份有限公司 Eye drops of atropine sulfate
CN114848670A (en) * 2022-05-26 2022-08-05 青岛博益特生物材料股份有限公司 Eye drops and preparation method thereof
CN115093486A (en) * 2022-07-13 2022-09-23 上海卫康光学眼镜有限公司 Hydroxypropyl methylcellulose HPMC (hydroxy propyl methyl cellulose) dissolving method

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Address after: 750002 the Ningxia Hui Autonomous Region street, Jinfeng District, Yinchuan City Fu Ning Lane No. 57

Patentee after: Ningxia Kang Ya pharmaceutical Limited by Share Ltd

Address before: 750002 No. 6 road, hi tech Industrial Development Zone, the Ningxia Hui Autonomous Region, Yinchuan

Patentee before: Kangya Pharmaceutical Industry Co., Ltd., Ningxia