CN105726515A - Sildenafil oral membrane for pets and preparation method thereof - Google Patents
Sildenafil oral membrane for pets and preparation method thereof Download PDFInfo
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- CN105726515A CN105726515A CN201510565612.XA CN201510565612A CN105726515A CN 105726515 A CN105726515 A CN 105726515A CN 201510565612 A CN201510565612 A CN 201510565612A CN 105726515 A CN105726515 A CN 105726515A
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Abstract
The invention belongs to the technical field of medicines and discloses a sildenafil oral membrane for pets and a preparation method thereof. The sildenafil oral membrane includes sildenafil raw material drug, and a membrane forming material, a disintegrating agent, a plasticizer and a flavoring agent. The disintegrating agent is preferably selected from carboxymethyl starch sodium; the membrane forming material is preferably a mixture of PVA, starch and poloxamer; the plasticizer is preferably selected from glycerol; and the flavoring agent is preferably selected from mannitol. The preparation method comprises the steps of precisely weighing the PVA, the starch, the carboxymethyl starch sodium, the mannitol, the glycerol, the poloxamer and the sildenafil, dissolving the components in solvents including proper amounts of alcohol, water and the like to completely and uniformly mixing the components, removing bubbles from the solution, forming a membrane with the solution in a coating manner and drying the membrane, and removing the membrane, cutting the membrane into required specification, and packaging and sterilizing the membrane to prepare the sildenafil oral membrane. Compared with other veterinary medicine preparations, the oral membrane is low in cost and has quick treatment effect, and can be used as a first choice for first-aid of pets.
Description
Technical field
The invention belongs to pharmaceutical technology field, be specifically related to a kind of house pet sldenafil pelliculae pro cavo oris and preparation method thereof.
Background technology
Sldenafil is a kind of specific phosphodiesterase enzyme-5 inhibitor, in recent years, the therapeutical effect of heart disease pulmonary hypertension is gradually paid attention to by it for everybody, research shows that it realizes diastole pulmonary vascular smooth muscle mainly through nitric oxide pathway, reduce the effect of pulmonary vascular resistance, significantly improve vascular endothelial function, improve Pulmonic symptom.
In recent years, the hobby of toy is increased by the raising of people's lives level and people, and the house pet quantity in family is continuously increased.But, domestic cityization is serious, and pet activity amount reduces, the heart disease incidence rate causing house pet significantly raises, and more frighteningly, China is on the low side to house pet medication attention degree, especially when house pet first aid, market lacking related drugs, especially lacking can not the active remedy of intravenous injection first aid.
Summary of the invention
It is an object of the invention to solve the market vacancy to house pet first aid or house pet acute cardiac episode medicine for treatment.
Sldenafil pelliculae pro cavo oris is a kind of new drug delivery system, medicine carrying membrane, and its size, shape, thickness are similar to stamp, is placed on house pet Sublingual, can rapid solution, release medicine in saliva.Compared with conventional pharmaceutical dosage forms, pelliculae pro cavo oris has following characteristics: medicine can directly be absorbed into blood by direct oral cavity mucosa, accelerates infiltration rate, improves animal organism availability;It is easy to the treatment to house pet.
For these reasons, the present invention is through experimentation, sldenafil, PVA, starch, plasticizer, disintegrating agent and flavoring agent are prepared film former, optimization experiment again through preparation technology, determining the preparation technology of " sldenafil pelliculae pro cavo oris ", this preparation technology has the advantages such as good stability, impurity level be low.
Described disintegrating agent selects dried starch, carboxymethyl starch sodium, cross-linked pvp a kind of or both mixture, it is preferable that carboxymethyl starch sodium;
Described filmogen selects one or more mixture of HPMC, PVA, gelatin, arabic gum, poloxamer, starch, dextrin, sodium carboxymethyl cellulose, it is preferable that the mixture of PVA, starch and poloxamer;
One or more mixture in glycerol, propylene glycol, ethylene glycol selected by described plasticizer, it is preferable that glycerol;
One or more mixture in mannitol, essence, sucrose, maltose, xylitol selected by described flavoring agent, it is preferable that mannitol;
The preparation method that invention also provides above-mentioned sldenafil pelliculae pro cavo oris, specifically includes procedure below:
(1) precision weighs PVA, adds water and makes dissolving at 95 DEG C, keeps 2 hours at 95 DEG C, puts to room temperature when solution is clarified completely, as solution I, standby;
(2) weigh starch, carboxymethyl starch sodium, mannitol, indigo etc., add water and dissolve mixing in right amount, as solution II, standby;
(3) weigh PLURONICS F87 and sldenafil, with ethanol in proper amount dissolve, and add glycerol carry out dissolve mixing, as solution III, standby;
(4) solution III it is slowly added into solution II and is stirred continuously so that it is being thoroughly mixed uniformly, and remove the bubble in solution, as solution IV, standby;
(5) solution I it is slowly added into solution IV and is stirred continuously so that it is being thoroughly mixed uniformly, and remove the bubble in solution, as solution V, standby;
(6) by solution V film on request, dry:
(7) demoulding, cuts into required specification on request by prepared thin film, packaging, sterilizing, thus obtaining the product sldenafil pelliculae pro cavo oris.
Sldenafil pelliculae pro cavo oris pliability obtained by the present invention is good, appearance uniform, and dissolved in oral cavity is fast, absorbs rapidly.
Sldenafil pelliculae pro cavo oris of the present invention has the advantage that supplementary product consumption is few, production cost is low simultaneously;Preparation technology is simple, it is easy to industrialized production, and no dust pollution, and house pet acute heart disease and first aid using medicine compliance is high.
Detailed description of the invention
The present invention is further elaborated by following example, but the scope of the present invention is not limited to following embodiment.Therefore, under the method premise of the present invention, the simple modifications of the present invention is belonged to the scope of protection of present invention.
Embodiment 1
Every containing sldenafil 5mg, its prescription is:
Its preparation method is:
(1) precision weighs PVA, adds water and makes dissolving at 95 DEG C, keeps 2 hours at 95 DEG C, puts to room temperature when solution is clarified completely, as solution I, standby;
(2) weigh starch, add water and dissolve mixing in right amount, as solution II, standby;
(3) weigh PLURONICS F87 and sldenafil, with ethanol in proper amount dissolve, and add glycerol carry out dissolve mixing, as solution III, standby;
(4) solution III it is slowly added into solution II and is stirred continuously so that it is being thoroughly mixed uniformly, and remove the bubble in solution, as solution IV, standby;
(5) solution I it is slowly added into solution IV and is stirred continuously so that it is being thoroughly mixed uniformly, and remove the bubble in solution, as solution V, standby;
(6) by solution V film on request, dry;
(7) demoulding, cuts into required specification on request by prepared thin film, packaging, sterilizing, thus obtaining the product sldenafil pelliculae pro cavo oris.
Evaluate: outward appearance is poor, and water quantities is many, and film-strength is poor, and mouthfeel is poor.
Embodiment 2
Every containing sldenafil 5mg, its prescription is:
(1) precision weighs PVA, adds water and makes dissolving at 95 DEG C, keeps 2 hours at 95 DEG C, puts to room temperature when solution is clarified completely, as solution I, standby;
(2) weigh carboxymethyl starch sodium, cross-linked pvp, mannitol, add water and dissolve mixing in right amount, as solution II, standby;
(3) weigh PLURONICS F87 and sldenafil, with ethanol in proper amount dissolve, and add glycerol carry out dissolve mixing, as solution III, standby;
(4) solution III it is slowly added into solution II and is stirred continuously so that it is being thoroughly mixed uniformly, and remove the bubble in solution, as solution IV, standby;
(5) solution I it is slowly added into solution IV and is stirred continuously so that it is being thoroughly mixed uniformly, and remove the bubble in solution, as solution V, standby;
(6) by solution V film on request, dry;
(7) demoulding, cuts into required specification on request by prepared thin film, packaging, sterilizing, thus obtaining the product sldenafil pelliculae pro cavo oris.
Evaluate: appearance uniform, dissolved in oral cavity is poor.
Embodiment 3
Every containing sldenafil 5mg, its prescription is:
Its preparation method is:
(1) precision weighs PVA, adds water and makes dissolving at 95 DEG C, keeps 2 hours at 95 DEG C, puts to room temperature when solution is clarified completely, as solution I, standby;
(2) weigh starch, carboxymethyl starch sodium, cross-linked pvp, mannitol, add water and dissolve mixing in right amount, as solution II, standby;
(3) weigh PLURONICS F87 and sldenafil, with ethanol in proper amount dissolve, and add glycerol carry out dissolve mixing, as solution III, standby;
(4) solution III it is slowly added into solution II and is stirred continuously so that it is being thoroughly mixed uniformly, and remove the bubble in solution, as solution IV, standby;
(5) solution I it is slowly added into solution IV and is stirred continuously so that it is being thoroughly mixed uniformly, and remove the bubble in solution, as solution V, standby;
(6) by solution V film on request, dry;
(7) demoulding, cuts into required specification on request by prepared thin film, packaging, sterilizing, thus obtaining the product sldenafil pelliculae pro cavo oris.
Evaluating: appearance uniform, dissolved in oral cavity is better, and film-strength is general.
Embodiment 4
Every containing sldenafil 5mg, its prescription is:
Its preparation method is:
(1) precision weighs PVA, adds water and makes dissolving at 95 DEG C, keeps 2 hours at 95 DEG C, puts to room temperature when solution is clarified completely, as solution I, standby;
(2) weigh starch, sodium carboxymethyl cellulose, carboxymethyl starch sodium, mannitol, indigo, add water and dissolve mixing in right amount, as solution II, standby;
(3) weigh PLURONICS F87 and sldenafil, with ethanol in proper amount dissolve, and add glycerol carry out dissolve mixing, as solution III, standby;
(4) solution III it is slowly added into solution II and is stirred continuously so that it is being thoroughly mixed uniformly, and remove the bubble in solution, as solution IV, standby;
(5) solution I it is slowly added into solution IV and is stirred continuously so that it is being thoroughly mixed uniformly, and remove the bubble in solution, as solution V, standby;
(6) by solution V film on request, dry;
(7) demoulding, cuts into required specification on request by prepared thin film, packaging, sterilizing, thus obtaining the product sldenafil pelliculae pro cavo oris.
Evaluating: appearance uniform, dissolved in oral cavity is better, and film-strength is better.
Embodiment 5
Every containing sldenafil 5mg, its prescription is:
Its preparation method is:
(1) precision weighs PVA, adds water and makes dissolving at 95 DEG C, keeps 2 hours at 95 DEG C, puts to room temperature when solution is clarified completely, as solution I, standby;
(2) weigh starch, carboxymethyl starch sodium, mannitol, add water and dissolve mixing in right amount, as solution II, standby;
(3) weigh PLURONICS F87 and sldenafil, with ethanol in proper amount dissolve, and add glycerol carry out dissolve mixing, as solution III, standby;
(4) solution III it is slowly added into solution II and is stirred continuously so that it is being thoroughly mixed uniformly, and remove the bubble in solution, as solution IV, standby;
(5) solution I it is slowly added into solution IV and is stirred continuously so that it is being thoroughly mixed uniformly, and remove the bubble in solution, as solution V, standby;
(6) by solution V film on request, dry;
(7) demoulding, cuts into required specification on request by prepared thin film, packaging, sterilizing, thus obtaining the product sldenafil pelliculae pro cavo oris.
Evaluating: appearance uniform, color and luster is consistent, and film-strength is good, fast in dissolved in oral cavity speed, free from extraneous odour.
Claims (6)
1. a house pet sldenafil pelliculae pro cavo oris, it is characterised in that comprise sldenafil crude drug and filmogen, disintegrating agent, plasticizer and flavoring agent.
2. sldenafil pelliculae pro cavo oris according to claim 1, it is characterised in that disintegrating agent selects dried starch, carboxymethyl starch sodium, cross-linked pvp a kind of or both mixture, it is preferable that carboxymethyl starch sodium.
3. sldenafil pelliculae pro cavo oris according to claim 1, it is characterized in that filmogen selects one or more mixture of HPMC, PVA, gelatin, arabic gum, poloxamer, starch, dextrin, sodium carboxymethyl cellulose, it is preferable that the mixture of PVA, starch and poloxamer.
4. sldenafil pelliculae pro cavo oris according to claim 1, it is characterised in that one or more mixture in glycerol, propylene glycol, ethylene glycol selected by plasticizer, it is preferable that glycerol.
5. sldenafil pelliculae pro cavo oris according to claim 1, it is characterised in that one or more mixture in mannitol, essence, sucrose, maltose, xylitol selected by flavoring agent, it is preferable that mannitol.
6. the preparation method of sldenafil membrane according to claim 1, it is characterised in that: precision weighs PVA, adds water and makes dissolving at 95 DEG C, keeps 2 hours at 95 DEG C, puts to room temperature when solution is clarified completely, as solution I, standby;Weigh starch, carboxymethyl starch sodium, mannitol etc., add water and dissolve mixing in right amount, as solution II, standby;Weigh PLURONICS F87 and sldenafil, with ethanol in proper amount dissolve, and add glycerol carry out dissolve mixing, as solution III, standby;Solution III it is slowly added into solution II and is stirred continuously so that it is being thoroughly mixed uniformly, and remove the bubble in solution, as solution IV, standby;Solution I it is slowly added into solution IV and is stirred continuously so that it is being thoroughly mixed uniformly, and remove the bubble in solution, as solution V, standby;By solution V film on request, dry;Demoulding, cuts into required specification on request by prepared thin film, packaging, sterilizing, thus obtaining the product sldenafil pelliculae pro cavo oris.
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CN201510565612.XA CN105726515A (en) | 2015-09-09 | 2015-09-09 | Sildenafil oral membrane for pets and preparation method thereof |
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Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103340842A (en) * | 2013-07-08 | 2013-10-09 | 天津市聚星康华医药科技有限公司 | Nimodipine film agent for oral cavities and preparation method of nimodipine film agent |
CN103989661A (en) * | 2014-05-26 | 2014-08-20 | 苏州大学 | Sildenafil oral instant membrane and preparation method thereof |
CN104586820A (en) * | 2015-01-13 | 2015-05-06 | 齐鲁制药有限公司 | Sildenafil rapidly disintegrating film composition with high drug loading capacity |
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Patent Citations (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN103340842A (en) * | 2013-07-08 | 2013-10-09 | 天津市聚星康华医药科技有限公司 | Nimodipine film agent for oral cavities and preparation method of nimodipine film agent |
CN103989661A (en) * | 2014-05-26 | 2014-08-20 | 苏州大学 | Sildenafil oral instant membrane and preparation method thereof |
CN104586820A (en) * | 2015-01-13 | 2015-05-06 | 齐鲁制药有限公司 | Sildenafil rapidly disintegrating film composition with high drug loading capacity |
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