CN100370971C - Phacolysin eye medicinal formulation - Google Patents
Phacolysin eye medicinal formulation Download PDFInfo
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- CN100370971C CN100370971C CNB2005101235734A CN200510123573A CN100370971C CN 100370971 C CN100370971 C CN 100370971C CN B2005101235734 A CNB2005101235734 A CN B2005101235734A CN 200510123573 A CN200510123573 A CN 200510123573A CN 100370971 C CN100370971 C CN 100370971C
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Abstract
The present invention relates to an ophthalmic medicine preparation of phacolysin. The preparation is the ophthalmic medicine preparation formed by that the active component phacolysin and a solvent are separated, and is formed by that the medicinal active component phacolysin is made into an independent solid preparation and is separated from the solvent; when packaged, the solid preparation and the solvent are separately packaged, and then are together put into a big packaging box so that both the solid preparation and solvent exist in one packaging box; when the ophthalmic medicine preparation of phacolysin is used, the solid preparation is dissolved into the solvent, and the ophthalmic medicine preparation is prepared only in case that the ophthalmic medicine preparation needs to be used so as to perform the function of stabilizing the preparation.
Description
Technical field:
The present invention relates to a kind of eye medicinal preparation, particularly relate to a kind of eye medicinal preparation of phacolin.
Background technology:
Phacolin, English name: Phacolin, chemical name is: 5,12-dihydro-5,7,12,14-four nitrogen pentacenes 2,9-sodium disulfonate.
Structural formula is:
Molecular formula: C
18H
10N
4Na
2O
6S
2
Molecular weight: 488.41
Phacolin is the albuminolysis zymoexciter, the effect that has activator protein to decompose, as eye drop, can prevent cataract, porous is in crystalline lens behind the phacolin eye drip, makes the albuminolysis of degeneration and is absorbed, and it is transparent to have a crystalline lens of keeping, improve the metabolism of ocular tissue, can stop the development of the cataract state of an illness.
Existing phacolin product adopts the solution prescription, owing to wherein added some cosolvents, stabilizing agent is that product has certain zest, and this easily decomposes in water owing to phacolin simultaneously, causes product stability not high, has influenced the quality of product.
The invention provides and a kind of the active constituents of medicine phacolin is made independently solid preparation, open with the separated from solvent of dissolution method Kelin, packing has solved the problems referred to above respectively.
Summary of the invention:
The invention provides the discrete eye medicinal preparation of a kind of active component and solvent, said preparation is that the active constituents of medicine phacolin is made independently solid preparation, with separated from solvent, during packing solid preparation and solvent are separately packed, together be put in the big packing box again, making to have in the packing box promptly has solid preparation, solvent is also arranged, during use solid preparation is dissolved in the solvent, now with the current, played the effect of stabilization formulations.
Eye medicinal preparation of the present invention, wherein said solid preparation can be a dry powder doses, can be tablet, also can be granule.Its active component is a phacolin, can add suitable adjuvant when said preparation needs, and plays and supports and the hydrotropy effect.These adjuvants can be conventional, but have preferred.
The preferred solid preparation of the present invention is a tablet, and its prescription is composed as follows:
1, prescription
| Per 10,000 consumptions | |
| Phacolin | 15g |
| Filler (taurine) | 800～1000g |
| Boric acid | 100～200g |
| Ethanol | 100ml |
| Water for injection | 70ml |
2, technology
(1) pulverizes: phacolin, filler, boric acid pulverize separately are crossed 60～100 mesh sieves;
(2) get ethanol, add the injection water and make it be diluted to 40%～60% ethanol liquid, as binding agent;
(3) mixed: as to follow the example of in Kelin, filler, the boric acid adding mixer-granulator mixed.Do earlier and mixed 8～15 minutes, added the binding agent wet mixing then 2～5 minutes, make soft material;
(4) granulate: soft material is crossed the sieve series grain 10～No. 14;
(5) drying: 40～75 ℃, dry 3～8 hours;
(6) granulate: cross the sieve granulate after drying is finished 12～No. 16;
(7) total mixing: 5～20 minutes;
(8) tabletting;
(9) aluminium-plastic bubble plate packing tablet, 1 slice/.
Eye medicinal preparation of the present invention, wherein said solvent is used to dissolve solid preparation of the present invention, and its requirement is, and dissolving is fast, and capacity is little, has no side effect.Described solvent is made up of water basically, adds some osmotic pressure regulators in case of necessity, buffer agent, and antiseptic etc. also can add thickening agent.
Solvent of the present invention, it is composed as follows preferably to fill a prescription:
1, prescription
| Per 10,000 consumptions | |
| Buffer system (phosphate-buffered system or borate buffer system) | 180～1100g |
| Osmotic pressure regulator (sodium chloride/glucose) | 243～297g |
| Antiseptic (merthiolate or oxybenzene esters or benzalkonium bromide or benzalkonium chloride or benzene oxygen alcohols) | 2～60g |
| Thickening agent (hyaluronate sodium or hypromellose or 30 POVIDONE K 30 BP/USP 30 or cellulose and derivant thereof) | 100～300g |
| Water for injection adds to | 100L |
2, technology
(1) water for injection 20L, the dissolving antiseptic filters in the adding dilute preparing tank with the titanium rod;
(2) water for injection 20L, dissolving hyaluronate sodium or other thickening agent add dilute preparing tank;
(3) water for injection 20L, dissolving buffer system and osmotic pressure regulator filter in the adding dilute preparing tank with the titanium rod;
(4) in dilute preparing tank, add the injection water to 100L, attemperation: 22 ± 4 ℃, stirred 20～25 minutes;
(5) 0.22,0.45 μ m nuclepore membrane filter filters;
(6) circulation is 10 minutes;
(7) fill, 10ml/ props up;
(8) outer package: 1+solvent of dress one+aluminum-plastic packaged tablet of description is 1 in every capsule, box/case in 1/capsule * 10 capsules/middle box * 20.
The most preferred prescription composition of solvent wherein of the present invention is listed in the embodiment of the invention.
Preparation of the present invention, preferred packaged combination is solid preparation and the 10ml solvent that contains the 1.5mg active component.
Owing to adopt technology of the present invention, stability of drug is improved greatly, the placement cycle reaches 2 years, and now with the current, makes medicament keep fresh.
Preparation of the present invention, its prescription is formed a large amount of screenings of process and is obtained, optimization process has also been passed through in its preparation, makes to reach best, reaches optimization for making, the inventor has done a large amount of work, passed through comparative experiments, screening experiment, and through zoopery, clinical experiment confirms that preparation of the present invention compared with prior art has outstanding substantive specific and obvious improvement.
Medicament of the present invention is easy to absorb, and formulation method is simple, and effect is good, few side effects, and good absorbing, the comfort level height, nonirritant shows the feedback after relevant crowd's use, is subjected to people's welcome deeply.
The specific embodiment:
Further specify the present invention by the following examples, but not as limitation of the present invention.
Embodiment 1
1, tablet formulation
| Per 10,000 consumptions | |
| Phacolin | 15g |
| Filler (taurine) | 1000g |
| Boric acid | 200g |
| Ethanol | 100ml |
| Water for injection | 70ml |
2, technology
(1) pulverizes: phacolin, filler, boric acid pulverize separately are crossed 60～100 mesh sieves;
(2) get ethanol, add the injection water and make it be diluted to 40%～60% ethanol liquid, as binding agent;
(3) mixed: as to follow the example of in Kelin, filler, the boric acid adding mixer-granulator mixed.Do earlier and mixed 8～15 minutes, added the binding agent wet mixing then 2～5 minutes, make soft material;
(4) granulate: soft material is crossed the sieve series grain 10～No. 14;
(5) drying: 40～75 ℃, dry 3～8 hours;
(6) granulate: cross the sieve granulate after drying is finished 12～No. 16;
(7) total mixing: 5～20 minutes;
(8) tabletting;
(9) aluminium-plastic bubble plate packing tablet, 1 slice/.
Solvent formula:
3, prescription
| Per 10,000 consumptions | |
| Phosphate-buffered system | 1100g |
| Osmotic pressure regulator (glucose/sodium chloride) | 297g |
| Merthiolate | 60g |
| Hyaluronate sodium | 300g |
| Water for injection adds to | 100L |
4, technology
(1) water for injection 20L, the dissolving antiseptic filters in the adding dilute preparing tank with the titanium rod;
(2) water for injection 20L, dissolving hyaluronate sodium or other thickening agent add dilute preparing tank;
(3) water for injection 20L, dissolving buffer system and osmotic pressure regulator filter in the adding dilute preparing tank with the titanium rod;
(4) in dilute preparing tank, add the injection water to 100L, attemperation: 22 ± 4 ℃, stirred 20～25 minutes;
(5) 0.22,0.45 μ m nuclepore membrane filter filters;
(6) circulation is 10 minutes;
(7) fill, 10ml/ props up;
Outer package: 1+solvent of dress one+aluminum-plastic packaged tablet of description is 1 in every capsule, box/case in 1/capsule * 10 capsules/middle box * 20.
Embodiment 2
Solvent formula
| Per 10,000 consumptions | |
| The borate buffer system | 180g |
| Osmotic pressure regulator (sodium chloride/glucose) | 243g |
| Benzalkonium bromide | 2g |
| Hypromellose | 100g |
| Water for injection adds to | 100L |
Preparation method is identical with embodiment 1.
Claims (2)
1. the eye medicinal preparation of a phacolin, it is characterized in that, the active component phacolin is made independently solid preparation, with separated from solvent, during packing solid preparation and solvent are separately packed, together be put in the big packing box, making in the packing box promptly has solid preparation, and solvent is also arranged again, during use solid preparation is dissolved in the solvent, now with the current, wherein said solid preparation is a tablet, and its prescription is composed as follows:
Described solvent is an aqueous solution, and its prescription is composed as follows:
Wherein said buffer system is phosphate-buffered system or borate buffer system, wherein said osmotic pressure regulator is sodium chloride or glucose, wherein said antiseptic is merthiolate, oxybenzene esters, benzalkonium bromide, benzalkonium chloride or benzene oxygen alcohols, and wherein said thickening agent is hyaluronate sodium, hypromellose, 30 POVIDONE K 30 BP/USP 30 or cellulose.
2. the pharmaceutical preparation of claim 1 is characterized in that, solvent is packaged into 10ml/ and props up, and every of solid preparation contains 1.5mg active component phacolin.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005101235734A CN100370971C (en) | 2005-11-21 | 2005-11-21 | Phacolysin eye medicinal formulation |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CNB2005101235734A CN100370971C (en) | 2005-11-21 | 2005-11-21 | Phacolysin eye medicinal formulation |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1775206A CN1775206A (en) | 2006-05-24 |
| CN100370971C true CN100370971C (en) | 2008-02-27 |
Family
ID=36765007
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB2005101235734A Active CN100370971C (en) | 2005-11-21 | 2005-11-21 | Phacolysin eye medicinal formulation |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN100370971C (en) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN102579185B (en) * | 2012-04-06 | 2014-12-10 | 成都华神生物技术有限责任公司 | Eye-drop device and application method thereof |
| CN107028889A (en) * | 2017-04-20 | 2017-08-11 | 吴广印 | One kind meets water unstable material separation preparation and preparation method thereof |
-
2005
- 2005-11-21 CN CNB2005101235734A patent/CN100370971C/en active Active
Non-Patent Citations (5)
| Title |
|---|
| 国家药品标准化学药品地方标准上升国家标准第八册. 国家药典委员会，109，化学工业出版社. 2002 * |
| 法可林滴眼液的稳定性研究. 吴伟，唐细兰，何梅凤，陈茂玲.中国药房，第15卷第1期. 2004 * |
| 白内障发病机制及预防治疗的研究进展. 陈莺.眼科新进展，第25卷第2期. 2005 * |
| 白内障药物治疗研究进展. 徐蔚.上海铁道大学学报，第20卷第11期. 1999 * |
| 药剂学. 毕殿洲，278-279、282-285，人民卫生出版社. 2001 * |
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| Publication number | Publication date |
|---|---|
| CN1775206A (en) | 2006-05-24 |
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Address after: 430040, Hubei, Wuhan Lake East and West Silver Lake office, gold and silver, 2 Hunan Street Patentee after: Wujing Pharmacy Co., Ltd. Wuhan Address before: 430040, No. five, 1 King Road, Xin Qiao hi tech Industrial Park, Dongxihu, Hubei, Wuhan Patentee before: Wujing Pharmacy Co., Ltd. Wuhan |