CN102961399B - Sodium chloride eye drops and preparation method thereof - Google Patents
Sodium chloride eye drops and preparation method thereof Download PDFInfo
- Publication number
- CN102961399B CN102961399B CN201210492152.9A CN201210492152A CN102961399B CN 102961399 B CN102961399 B CN 102961399B CN 201210492152 A CN201210492152 A CN 201210492152A CN 102961399 B CN102961399 B CN 102961399B
- Authority
- CN
- China
- Prior art keywords
- sodium chloride
- eye drop
- eye drops
- hypromellose
- injection
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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
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 angle conjunctival xerosis; refer to that tear matter that any reason causes or amount are abnormal or kinetics is abnormal, cause tear film stability to decline, and with the general name of the various diseases of ophthalmic uncomfortable and (or) eye table organization characteristics of lesion.The daily life that is widely used in recent years the mankind along with TV play, computer etc., aged tendency of population increases gradually, and the incidence rate of xerophthalmia rises year by year, badly influences the normal development of teenager vision and the use eye health of middle-aged and elderly people.
The primary treatment measure of xerophthalmia is to supplement tear, i.e. local humidity and the lubricating ability that uses artificial tears to improve ocular surface.
External artificial tears has tens of kinds more than, generally by the ingredients containing some inorganic salts and high molecular polymer and stimulation 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 contains the adjuvants such as antibacterial domestic more, and eye table epithelium is had to certain toxic action.At present, commercially available eye drop antibacterial mostly is benzalkonium chloride, and it can destroy the tight connecting band between corneal epithelial cell, 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 market, as: sodium hyaluronate eye drops or the eye drop containing hyaluronic acid sodium, but hyaluronic acid sodium is unstable under light, heat, easily degraded, should not at room temperature preserve, simultaneously for a long time, hyaluronic acid sodium is a kind of biomacromolecule mucopolysaccharide, easy contaminated long bacterium.In view of the defect of above eye drop, be necessary to develop a kind of steady quality, can play again long-acting moisturizing, easing eyes is dry and astringent, meanwhile, the eye drop that side effect is again little.
Summary of the invention
The object of the invention is exactly to solve the defect that prior art exists, and provides a kind of steady quality, long-acting moisturizing, the eye drop that side effect is little.Sodium chloride eye drop containing 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 containing hypromellose, it is characterized in that, described eye drop, in 100ml, contains sodium chloride 0.45～0.75g, 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 containing hypromellose, it is characterized in that, described eye drop, in 100ml, contains sodium chloride 0.55g, hypromellose 0.05g, boric acid 0.53g, Borax 0.05g, water for injection.
The above-mentioned sodium chloride eye drop containing hypromellose also contains acid-base modifier, and the pH value that makes final solution is 6.0～8.5, and preferably 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 containing 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 preferably ethyl hydroxybenzoate, its consumption is 0.03g.
In the present invention, select hypromellose and sodium chloride to be used in conjunction with, make eye drop have extraordinary moistening effect, preferably the weight proportion of hypromellose and sodium chloride is: 3: 55～6: 55
Preparation method of the present invention, is characterized in that, the method comprises the following steps:
(1) in advance the hypromellose of recipe quantity is added in right amount
water for injection dissolvesfor subsequent use.
(2) take respectively sodium chloride, antibacterial, boric acid and the Borax of recipe quantity, respectively add appropriate water for injection, after being uniformly mixed, carry out sterilizing.
(3) by the antibacterial after sterilizing in above-mentioned steps (2) with for subsequent use after appropriate water for injection heating for dissolving.
(4) sodium chloride, boric acid, Borax after sterilizing in above-mentioned steps (2) are added in the antibacterial solution of placing room temperature in above-mentioned steps (3), be stirred to dissolve mix homogeneously.
(5), by the solution mix homogeneously in step (1) and (4), add residue water for injection mix homogeneously.
(6) regulate medicinal liquid pH value to 6.5～7.5 with the potassium hydroxide of 0.1mol/L or 0.1mol/L hydrochloric acid solution, the medicinal liquid preparing is carried out to aseptic filtration, after filtration finishes, take a sample to check appearance character, pH value, qualified rear fill with 0.22 μ m filter membrane.
Due to the utilization of technique scheme, the present invention compared with prior art has the following advantages:
(1) can the long period containing the sodium chloride eye drop of hypromellose stick to corneal epithelium surface, play and keep 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 too 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 maintain 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 applicable to preserving for a long time at normal temperatures.
Detailed description of the invention:
Embodiment 1:
In 100ml, prepare eye drop and contain:
Sodium chloride 0.55g, hypromellose 0.03g, boric acid 0.53g, Borax 0.05g, ethyl hydroxybenzoate 0.03g, water for injection.
Preparation method comprises the following steps:
(1) get in advance 0.05g hypromellose and join in appropriate water for injection, dissolve for subsequent use.
(2) take respectively sodium chloride 0.55g, ethyl hydroxybenzoate 0.03g, boric acid 0.53g and Borax 0.05g, respectively add appropriate water for injection, stirring makes to put into high-pressure sterilizing pot (121 DEG C, 30 minutes) in mix homogeneously rear-mounted triangular beaker and carries out sterilizing.
(3) by appropriate water for injection heating for dissolving for the ethyl hydroxybenzoate after above-mentioned sterilizing.
(4) sodium chloride after above-mentioned sterilizing, boric acid, Borax are added in the ethyl hydroxybenzoate solution of the placement room temperature in above-mentioned (3), be stirred to dissolve mix homogeneously.
(5), by the solution mix homogeneously in step (1) and (4), add residue water for injection 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, the medicinal liquid preparing is carried out to aseptic filtration with 0.22 μ m filter membrane, after filtration finishes, take a sample to check appearance character, pH value, osmotic pressure, visible foreign matters, qualified rear fill.
Embodiment 2:
In 100ml, prepare eye drop and contain:
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-described embodiment 1.
Embodiment 3:
In 100ml, prepare eye drop and contain:
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-described 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 to 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
For ensureing steady quality of the present invention, safety, therefore carried out medicine stability test (accelerating and long term test).Test example is as follows:
One, accelerated test
1.40 DEG C ± 2 DEG C, relative humidity RH75% ± 5%, result of the test is as follows:
2.40 DEG C ± 2 DEG C, relative humidity 25% ± 5%, result of the test is as follows:
Two, long term test
1.25 DEG C ± 2 DEG C, relative humidity 60% ± 10%, result of the test is as follows:
2.25 DEG C ± 2 DEG C, relative humidity 40% ± 5%, result of the test is as follows:
Three, conclusion
The present invention with embodiment produce sample in 40 DEG C ± 2 DEG C, relative humidity 75% ± 5%, 40 DEG C ± 2 DEG C, under relative humidity 25% ± 5% condition, place 6 months, indices is good, conforms to quality requirements.In 25 DEG C ± 2 DEG C, relative humidity 60% ± 10%, 25 DEG C ± 2 DEG C, under relative humidity 40% ± 5% condition, place 2 years, all there is not significant change in outward appearance, pH, viscosity, sodium chloride content and ethyl hydroxybenzoate content, conforms to quality requirements.
Claims (3)
1. the sodium chloride eye drop containing hypromellose, it is characterized in that, described eye drop is in 100ml, it is by sodium chloride 0.45～0.75g, hypromellose 0.03～0.06g, 0.01g～0.5g ethyl hydroxybenzoate, pH buffer system, water for injection and acid-base modifier composition, wherein the weight proportion of hypromellose and sodium chloride is 3: 55～6: 55, the pH value of eye drop is 6.5～7.5.
2. eye drop according to claim 1, is characterized in that, pH buffer system is boric acid and Borax.
3. eye drop according to claim 1, is characterized in that, described eye drop is in 100ml, and it is by sodium chloride 0.55g, hypromellose 0.06g, boric acid 0.53g, Borax 0.05g, ethyl hydroxybenzoate 0.03g, water for injection and acid-base modifier composition.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210492152.9A CN102961399B (en) | 2012-11-28 | 2012-11-28 | Sodium chloride eye drops and preparation method thereof |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201210492152.9A CN102961399B (en) | 2012-11-28 | 2012-11-28 | Sodium chloride eye drops and preparation method thereof |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN102961399A CN102961399A (en) | 2013-03-13 |
| CN102961399B true CN102961399B (en) | 2014-09-10 |
Family
ID=47792018
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201210492152.9A Active CN102961399B (en) | 2012-11-28 | 2012-11-28 | Sodium chloride eye drops and preparation method thereof |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN102961399B (en) |
Families Citing this family (3)
| 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 |
| CN114848670B (en) * | 2022-05-26 | 2023-06-02 | 青岛博益特生物材料股份有限公司 | Eye drop 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 |
Citations (3)
| 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 |
-
2012
- 2012-11-28 CN CN201210492152.9A patent/CN102961399B/en active Active
Patent Citations (3)
| 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 |
Also Published As
| Publication number | Publication date |
|---|---|
| CN102961399A (en) | 2013-03-13 |
Similar Documents
| Publication | Publication Date | Title |
|---|---|---|
| NO20240132A1 (en) | Ophthalmic compositions and methods for treating eyes | |
| CN101405009B (en) | Ophthalmic composition comprising xanthan gum and glucose | |
| WO2006112029A1 (en) | Ophthalmic composition | |
| CN104981234A (en) | Artificial tears comprising sodium hyaluronate and carboxymethylcellulose | |
| JP2009515921A (en) | Pharmaceutical composition free of dexpantenol, calcium ions and phosphate, and the use of calcium chelators and ophthalmically compatible viscosity modifiers | |
| WO2008001872A1 (en) | Ophthalmic composition containing alginic acid or salt thereof | |
| CN102961399B (en) | Sodium chloride eye drops and preparation method thereof | |
| CN110974970A (en) | Compound pharmaceutical composition eye drops, preparation method and application thereof | |
| EP4279063A2 (en) | Ophthalmic pharmaceutical composition, preparation method therefor and application thereof | |
| JP2017066065A (en) | Ophthalmic composition | |
| CN112190542B (en) | Aqueous in-situ gel ophthalmic preparation for treating xerophthalmia | |
| US9351991B2 (en) | Hypertonic dextran solution and methods of treating and preventing recurrent corneal erosion | |
| JP2017190348A (en) | Aqueous ophthalmic composition | |
| CN112426405A (en) | Pharmaceutical composition for preventing and controlling myopia development, eye drops and preparation method and application thereof | |
| CN101396333A (en) | Eye in-situ gel of chiral anti-glaucoma medicine L-3alpha alkyla acyloxy-6belta alkyla acyloxy tropane and preparation method thereof | |
| CN102512467A (en) | Ophthalmic preparation of panax notoginseng saponins and preparation method thereof | |
| CN103720641A (en) | Taurine-containing ophthalmic in-vivo gel preparation and preparation method thereof | |
| CN105232454A (en) | High-fidelity chitosan sodium hyaluronate eye drops and preparation method thereof | |
| CN102579492A (en) | Sodium hyaluronate eyedrop containing deproteinized calf blood extractive and preparation method thereof | |
| CN102188368A (en) | Preparation technology of compound sodium chloride eye drop solution | |
| CN101579357A (en) | Ready-to-use fel ursi ophthalmic gel | |
| CN107802597B (en) | Sodium hyaluronate composition and preparation method and application thereof | |
| CN104622800A (en) | Bendazac lysine eye drop and preparation method thereof | |
| EP2800573B1 (en) | Ophthalmic composition | |
| CN102973594B (en) | A kind of ophthalmic preparation and preparation method containing oxygen microcapsule |
Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| C06 | Publication | ||
| PB01 | Publication | ||
| C10 | Entry into substantive examination | ||
| SE01 | Entry into force of request for substantive examination | ||
| C14 | Grant of patent or utility model | ||
| GR01 | Patent grant | ||
| CP03 | Change of name, title or address | ||
| CP03 | Change of name, title or address |
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 |