CN104971063A - Medicinal composition containing tadalafil, and preparation method thereof - Google Patents
Medicinal composition containing tadalafil, and preparation method thereof Download PDFInfo
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- CN104971063A CN104971063A CN201510335079.8A CN201510335079A CN104971063A CN 104971063 A CN104971063 A CN 104971063A CN 201510335079 A CN201510335079 A CN 201510335079A CN 104971063 A CN104971063 A CN 104971063A
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Abstract
The invention discloses a medicinal composition containing tadalafil, and a preparation method thereof, and belongs to the pharmaceutical field. The medicinal composition is used for treating male sexual disfunction. Tadalafil is reasonably combined with a trace element zinc, and pharmaceutically acceptable auxiliary materials, such as a plasticizer, a film forming material, a filler, a disintegrating agent, an adhesive, a lubricant, a solubilizer and a stabilizer are added to prepare an oral pellicle, a chewing tablet, an oral solution and various oral dosage forms for clinic application.
Description
Technical field
The invention belongs to pharmaceutical field, relate to a kind of pharmaceutical composition containing tadanafil and preparation method thereof.
Background technology
Generally speaking, male sexual disorder refers to that male is in the double teacher of the sexual activitys such as libido, erection, sexual intercourse, orgasm, ejaculation, and wherein certain stage or several stage or all stage occur abnormal and affect sexual activity and normally carry out.The most common male sexual disorder is that erection and ejaculation are abnormal.The patient suffering from this type of disease often very large, the sense of personal worth of stress and will power is subject to very large injury, therefore easily cause that goodwill as between spouses is inharmonious, the breakdown of a family and then impact society stable, oneself causes the great attention of International Medical circle.
Tadanafil (Tadalafi1) is a kind of reversible, selectivity phosphodiesterase-5(PDE-5) inhibitor, treatment male erectile dysfunction (ED) is developed by Li Lai company, its mechanism of action is that tadanafil can strengthen nitric oxide (NO) under sexual stimulus as PDE-5 selective depressant and discharge the erection physiological reaction caused, and research proves that NO is the main medium causing corpus cavernosal smooth muscle to relax and erect.This medicine is in Nikkei FDA approval listing November 23 in 2003, in clinical practice, find after listing that it also has certain curative effect in treatment other sexual dysfunctions of male or infertility, as the lower urinary tract symptom etc. caused by the motility of sperm of infertility male, hyperplasia of prostate can be improved.
Zinc is trace element necessary in a kind of human body, research shows that zinc not only participates in the metabolism of DNA, RNA, protein, saccharide, lipid, vitamin, mineral in animal body, also relevant with activity with the function of insulin, glucagon, prostaglandin, gonadal hormone etc.In males, zinc is mainly distributed in testis, epididymis and prostate and seminal fluid, especially the highest with Zn content in seminal fluid, can reach more than 100 times of content in blood plasma.In addition, zinc is pituitary gonadotropic hormone and the indispensable material of interstitial cell synthetic androgen, also scalable male hormone metabolism, thus affects testicualr development and spermatogenesis.Research shows, seminiferous tubule atrophy, degeneration during zinc deficiency, and tube wall is thinning, subside, impaired, and germ cell number reduces, and spermatogenesis is obstructed and even stops, and interstitial cell quantity reduces.Visible, zinc and male's sexual closely related, and can treatment male sexual disorder in play synergism with tadanafil.
Through the retrieval of patent and scientific and technical literature, there is not yet the relevant report of the compound preparation that tadanafil and trace element zinc form.
The invention is intended to provide a kind of new compound preparation be made up of tadanafil and trace element zinc, be used for the treatment of male sexual disorder, both collaborative uses are better than being used alone effect.
Summary of the invention
The compound preparation that the object of the present invention is to provide a kind of tadanafil and trace element zinc to form, is used for the treatment of male sexual disorder.The present invention is oral formulations, facilitates patient to take.
Compound preparation of the present invention, comprises the pharmaceutically acceptable adjuvant such as tadanafil, trace element zinc and plasticizer, filmogen, filler, disintegrating agent, binding agent, lubricant, solubilizing agent, stabilizing agent.
Compound preparation of the present invention, wherein tadanafil can be its active substance itself, also can be its pharmaceutically acceptable salt, preferred tadanafil; The source of trace element zinc can be its pharmaceutically acceptable salt, preferred zinc gluconate.
Compound preparation of the present invention, wherein the weight ratio of tadanafil and trace element zinc two kinds of active component is 2.5 ~ 20:0.5 ~ 3(W/W).
Compound preparation of the present invention is oral formulations, and preferred dosage form is oral instant membrane, chewable tablet and oral liquid.
The formula of oral instant membrane of the present invention is composed as follows:
| Composition | Consumption/(unit: g, 1000 amounts) |
| Tadanafil | 2.5～20 |
| Zinc | 0.5～3 |
| Plasticizer | 3～20 |
| Filler | 10～12 |
| Filmogen | 10～15 |
| Sweeting agent | 1～2.5 |
| Aromatic | In right amount |
| Water | In right amount |
Wherein said plasticizer includes but not limited to glycerol, propylene glycol and Polyethylene Glycol.
Described filler includes but not limited to any combination of sorbitol and maltodextrin, mannitol and dextrin, lactose and microcrystalline Cellulose and pregelatinized Starch and sodium carboxymethyl cellulose.
Described filmogen includes but not limited to hydroxypropyl methylcellulose, hydroxypropyl cellulose, IR and polyvidone.
Described sweeting agent includes but not limited to aspartame, sucralose, stevioside and glycyrrhizin.
The formula of chewable tablet of the present invention is composed as follows:
| Composition | Consumption/(unit: g, 1000 amounts) |
| Tadanafil | 2.5～20 |
| Zinc | 0.5～3 |
| Filler | 240～280 |
| Binding agent | 10～20 |
| Disintegrating agent | 8～12 |
| Lubricant | 10～15 |
| Sweeting agent | 5～10 |
| Aromatic | In right amount |
Wherein said filler includes but not limited to any combination of maltodextrin and sorbitol, pregelatinized Starch and mannitol, microcrystalline Cellulose and xylitol, beta-schardinger dextrin-and erythritol.
Described binding agent includes but not limited to hydroxypropyl methylcellulose, methylcellulose, starch and polyvidone.
Described disintegrating agent includes but not limited to carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone and low-substituted hydroxypropyl cellulose.
Described lubricant includes but not limited to one or both combinations in micropowder silica gel, magnesium stearate, Pulvis Talci and castor oil hydrogenated.
Described sweeting agent includes but not limited to aspartame, stevioside and sucralose.
The formula of oral liquid of the present invention is composed as follows:
| Composition | Consumption/(unit: g; 10mL/ bottle, 1000 bottles of amounts) |
| Tadanafil | 2.5～20 |
| Zinc | 0.5～3 |
| Solubilizing agent | 125～1600 |
| Filler | 4000～7000 |
| Sweeting agent | 1～1.5 |
| Stabilizing agent | 5～10 |
| Aromatic | In right amount |
| Water | In right amount |
Wherein said solubilizing agent includes but not limited to propylene glycol, glycerol and Polyethylene Glycol.
Described filler includes but not limited to sorbitol, mannitol, simple syrup and xylitol.
Described sweeting agent includes but not limited to sweetener, aspartame, glycyrrhizin and sucralose.
Described stabilizing agent includes but not limited to sodium benzoate, ethyl hydroxybenzoate, glycyrrhizic acid dipotassium and sodium citrate.
Detailed description of the invention
The present invention is further elaborated by following examples, but scope of the present invention is not limited to these embodiments.So, under method prerequisite of the present invention, all the scope of protection of present invention is belonged to simple modifications of the present invention.
the preparation method of described oral instant membrane:
embodiment 1
Prescription (1000 amounts):
| Composition | Consumption/g |
| Tadanafil | 2.5 |
| Zinc citrate | 5 |
| Glycerol | 3 |
| Sorbitol | 5 |
| Hydroxypropyl methylcellulose | 10 |
| Maltodextrin | 5 |
| Aspartame | 2.5 |
| Mint Essence | 2.5 |
| Purified water | 100 |
Preparation technology:
(1) each supplementary material is taken by above-mentioned prescription;
(2) by the glycerol moistening of tadanafil and zinc citrate, add hydroxypropyl methylcellulose, sorbitol, maltodextrin, aspartame and water, be placed to completely swelling after stirring;
(3) add essence, stir;
(4) film, dry, demoulding and get final product.
embodiment 2
Prescription (1000 amounts):
| Composition | Consumption/g |
| Tadanafil | 5 |
| Zinc glycinate | 5 |
| Propylene glycol | 5 |
| Mannitol | 5 |
| Hydroxypropyl cellulose | 10 |
| Dextrin | 6 |
| Sucralose | 1 |
| Citron essence | 2 |
| Purified water | 100 |
Preparation technology:
(1) each supplementary material is taken by above-mentioned prescription;
(2) by the propylene glycol moistening of tadanafil and zinc glycinate, add hydroxypropyl cellulose, mannitol, dextrin, sucralose and water, be placed to completely swelling after stirring;
(3) add essence, stir;
(4) film, dry, demoulding and get final product.
embodiment 3
Prescription (1000 amounts):
| Composition | Consumption/g |
| Tadanafil | 10 |
| Zinc gluconate | 15 |
| Polyethylene Glycol | 10 |
| Lactose | 5 |
| IR | 15 |
| Microcrystalline Cellulose | 6 |
| Stevioside | 1 |
| Apple essence | 2 |
| Purified water | 100 |
Preparation technology:
(1) each supplementary material is taken by above-mentioned prescription;
(2) by the Polyethylene Glycol moistening of tadanafil and zinc gluconate, add IR, lactose, microcrystalline Cellulose, stevioside and water, be placed to completely swelling after stirring;
(3) add essence, stir;
(4) film, dry, demoulding and get final product.
embodiment 4
Prescription (1000 amounts):
| Composition | Consumption/g |
| Tadanafil | 20 |
| Zinc gluconate | 20 |
| Glycerol | 20 |
| Pregelatinized Starch | 10 |
| Polyvidone | 15 |
| Sodium carboxymethyl cellulose | 2 |
| Glycyrrhizin | 1 |
| Flavoring pineapple essence | 2 |
| Purified water | 120 |
Preparation technology:
(1) each supplementary material is taken by above-mentioned prescription;
(2) by the glycerol moistening of tadanafil and zinc gluconate, add polyvidone, pregelatinized Starch, sodium carboxymethyl cellulose, glycyrrhizin and water, be placed to completely swelling after stirring;
(3) add essence, stir;
(4) film, dry, demoulding and get final product.
Product dissolves the assay method in time limit: test sample 6 medicine films of preparing of Example 1-4 respectively, and adopt disintegration time mensuration method (Chinese Pharmacopoeia version in 2010 two annex X A) to measure respectively, each medicine film all should all dissolve and pass through screen cloth in 3 minutes.
The method of test-meal experiment: by 5 healthy volunteer's test-meal tadanafil zinc oral instant membranes, everyone takes a slice, when not drinking water, the solution time behind oral cavity put in record, and evaluate mouthfeel, and standards of grading are: 0 point: without bitterness, mouthfeel is excellent, 1 point: have slight taste, good mouthfeel, 2 points: bitterness is more obvious, mouthfeel is general, 3 points: have strong bitterness, mouthfeel is poor, and concrete result (meansigma methods) refers to following table.
| Embodiment is numbered | 1 | 2 | 3 | 4 |
| Mouth feel score (dividing) | 0 | 0 | 0 | 0 |
| Oral cavity is dissolved the time limit (second) | 28 | 36 | 33 | 30 |
the preparation method of described chewable tablet:
embodiment 5
Prescription (1000 amounts):
| Composition | Consumption/g |
| Tadanafil | 2.5 |
| Zinc lactate | 9 |
| Maltodextrin | 200 |
| Sorbitol | 40 |
| Mint Essence | 5 |
| Aspartame | 10 |
| Hydroxypropyl methylcellulose | 10 |
| Carboxymethyl starch sodium | 8 |
| Micropowder silica gel | 10 |
| Magnesium stearate | 5 |
Preparation technology:
(1) each supplementary material is taken by above-mentioned prescription;
(2) by after tadanafil, zinc lactate, sorbitol, aspartame, maltodextrin, hydroxypropyl methylcellulose, carboxymethyl starch sodium mix homogeneously, add water soft material processed;
(3) granulation, drying;
(4) essence, micropowder silica gel, magnesium stearate mix homogeneously is added after granulate again, tabletting and get final product.
embodiment 6
Prescription (1000 amounts):
| Composition | Consumption/g |
| Tadanafil | 5 |
| Zinc gluconate | 15 |
| Pregelatinized Starch | 200 |
| Mannitol | 40 |
| Citron essence | 5 |
| Stevioside | 5 |
| Methylcellulose | 15 |
| Cross-linked carboxymethyl fiber acid sodium | 10 |
| Micropowder silica gel | 10 |
| Pulvis Talci | 5 |
Preparation technology:
(1) each supplementary material is taken by above-mentioned prescription;
(2) by after Da Lafei, zinc gluconate, mannitol, stevioside, pregelatinized Starch, methylcellulose, cross-linking sodium carboxymethyl cellulose mix homogeneously, add water soft material processed;
(3) granulation, drying;
(4) essence, micropowder silica gel, Pulvis Talci mix homogeneously is added after granulate again, tabletting and get final product.
embodiment 7
Prescription (1000 amounts):
| Composition | Consumption/g |
| Tadanafil | 10 |
| Zinc citrate | 2 |
| Microcrystalline Cellulose | 200 |
| Xylitol | 60 |
| Apple essence | 5 |
| Sucralose | 5 |
| Starch | 20 |
| Polyvinylpolypyrrolidone | 12 |
| Castor oil hydrogenated | 10 |
Preparation technology:
(1) each supplementary material is taken by above-mentioned prescription;
(2) by after tadanafil, zinc citrate, microcrystalline Cellulose, xylitol, polyvinylpolypyrrolidone, starch, sucralose mix homogeneously, add water soft material processed;
(3) granulation, drying;
(4) essence, castor oil hydrogenated mix homogeneously is added after granulate again, tabletting and get final product.
embodiment 8
Prescription (1000 amounts):
| Composition | Consumption/g |
| Tadanafil | 20 |
| Zinc gluconate | 20 |
| Beta-schardinger dextrin- | 240 |
| Erythritol | 40 |
| Grape essence | 5 |
| Sucralose | 6 |
| Polyvidone | 12 |
| Low-substituted hydroxypropyl cellulose | 8 |
| Magnesium stearate | 10 |
Preparation technology:
(1) each supplementary material is taken by above-mentioned prescription;
(2) by after tadanafil, zinc gluconate, beta-schardinger dextrin-, polyvidone, erythritol, sucralose, low-substituted hydroxypropyl cellulose mix homogeneously, add water soft material processed;
(3) granulation, drying;
(4) essence, castor oil hydrogenated mix homogeneously is added after granulate again, tabletting and get final product.
By the equal smooth in appearance of chewable tablet prepared by embodiment 5 ~ 8, hardness is moderate, and good mouthfeel.
the preparation method of described oral liquid:
embodiment 9
Prescription (10mL/ bottle amounts to 1000 bottles):
| Composition | Consumption/g |
| Tadanafil | 2.5 |
| Zinc citrate | 5 |
| Propylene glycol | 125 |
| Sorbitol | 4000 |
| Mint Essence | 5 |
| Sodium benzoate | 10 |
| Steviosin | 1 |
| Purified water | In right amount |
Preparation technology:
(1) each supplementary material is taken by above-mentioned prescription;
(2) tadanafil, zinc citrate propylene glycol are disperseed;
(3) add suitable quantity of water to dissolve, then add sorbitol, stevioside, essence and sodium benzoate and stir, filter;
(4) regulate pH to 5 ~ 8, the polishing water yield, stirs evenly and get final product.
embodiment 10
Prescription (10mL/ bottle amounts to 1000 bottles):
| Composition | Consumption/g |
| Tadanafil | 5 |
| Zinc gluconate | 12 |
| Glycerol | 300 |
| Mannitol | 5000 |
| Citron essence | 5 |
| Ethyl hydroxybenzoate | 5 |
| Aspartame | 1.5 |
| Purified water | In right amount |
Preparation technology:
(1) each supplementary material is taken by above-mentioned prescription;
(2) tadanafil, zinc gluconate glycerol are disperseed;
(3) add suitable quantity of water to dissolve, then add mannitol, aspartame, essence and ethyl hydroxybenzoate and stir, filter;
(4) regulate pH to 5 ~ 8, the polishing water yield, stirs evenly and get final product.
embodiment 11
Prescription (10mL/ bottle amounts to 1000 bottles):
| Composition | Consumption/g |
| Tadanafil | 10 |
| Zinc lactate | 10 |
| Polyethylene Glycol | 700 |
| Simple syrup | 6000 |
| Refrigerant essence | 5 |
| Glycyrrhizic acid dipotassium | 5 |
| Glycyrrhizin | 1 |
| Purified water | In right amount |
Preparation technology:
(1) each supplementary material is taken by above-mentioned prescription;
(2) tadanafil, zinc lactate Polyethylene Glycol are disperseed;
(3) add suitable quantity of water to dissolve, then add simple syrup, glycyrrhizin, essence and glycyrrhizic acid dipotassium and stir, filter;
(4) regulate pH to 5 ~ 8, the polishing water yield, stirs evenly and get final product.
embodiment 12
Prescription (10mL/ bottle amounts to 1000 bottles):
| Composition | Consumption/g |
| Tadanafil | 20 |
| Zinc glycinate | 5 |
| Glycerol | 1600 |
| Xylitol | 7000 |
| Flavoring pineapple essence | 5 |
| Sodium citrate | 10 |
| Sucralose | 1 |
| Purified water | In right amount |
Preparation technology:
(1) each supplementary material is taken by above-mentioned prescription;
(2) tadanafil, zinc glycinate glycerol are disperseed;
(3) add suitable quantity of water to dissolve, then add xylitol, sucralose, essence and sodium citrate and stir, filter;
(4) regulate pH to 5 ~ 8, the polishing water yield, stirs evenly and get final product.
The oral liquid prepared by embodiment 9 ~ 12 is settled solution, and good mouthfeel.
Claims (9)
1. the pharmaceutical composition containing tadanafil, it is characterized in that: described compositions is using tadanafil and trace element zinc as active constituents of medicine, and wherein the weight ratio of tadanafil and trace element two kinds of active component is 2.5 ~ 20:0.5 ~ 3(W/W).
2. pharmaceutical composition according to claim 1, is characterized in that: described tadanafil can be active component itself, also can be its pharmaceutically acceptable salt, wherein preferred tadanafil; The source of described trace element zinc can be its pharmaceutically acceptable salt, preferred zinc gluconate.
3. pharmaceutical composition according to claim 1, is characterized in that: be made up of the pharmaceutically acceptable adjuvant such as tadanafil, trace element zinc and plasticizer, filmogen, filler, disintegrating agent, binding agent, lubricant, solubilizing agent, stabilizing agent.
4. pharmaceutical composition according to claim 3, is characterized in that: be any oral formulations.
5. pharmaceutical composition according to claim 4, is characterized in that: can be the solid preparation such as oral instant membrane, chewable tablet and oral liquid.
6. pharmaceutical composition according to claim 5, is characterized in that: the formula of described oral instant membrane is composed as follows:
Wherein said plasticizer includes but not limited to glycerol, propylene glycol and Polyethylene Glycol; Described filler includes but not limited to any combination of sorbitol and maltodextrin, mannitol and dextrin, lactose and microcrystalline Cellulose and pregelatinized Starch and sodium carboxymethyl cellulose; Described filmogen includes but not limited to hydroxypropyl methylcellulose, hydroxypropyl cellulose, IR and polyvidone; Described sweeting agent includes but not limited to aspartame, sucralose, stevioside and glycyrrhizin.
7. pharmaceutical composition according to claim 5, is characterized in that: the formula of described chewable tablet is composed as follows:
Wherein said filler includes but not limited to any combination of maltodextrin and sorbitol, pregelatinized Starch and mannitol, microcrystalline Cellulose and xylitol, beta-schardinger dextrin-and erythritol; Described binding agent includes but not limited to hydroxypropyl methylcellulose, methylcellulose, starch and polyvidone; Described disintegrating agent includes but not limited to carboxymethyl starch sodium, cross-linking sodium carboxymethyl cellulose, polyvinylpolypyrrolidone and low-substituted hydroxypropyl cellulose; Described lubricant includes but not limited to one or both combinations in micropowder silica gel, magnesium stearate, Pulvis Talci and castor oil hydrogenated; Described sweeting agent includes but not limited to aspartame, stevioside and sucralose.
8. pharmaceutical composition according to claim 5, is characterized in that: the formula of described oral liquid is composed as follows:
Wherein said solubilizing agent includes but not limited to propylene glycol, glycerol and Polyethylene Glycol; Described filler includes but not limited to sorbitol, mannitol, simple syrup and xylitol; Described sweeting agent includes but not limited to sweetener, aspartame, glycyrrhizin and sucralose; Described stabilizing agent includes but not limited to sodium benzoate, ethyl hydroxybenzoate, glycyrrhizic acid dipotassium and sodium citrate.
9. the purposes of pharmaceutical composition according to claim 1 in preparation treatment male sexual disorder.
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| Application Number | Priority Date | Filing Date | Title |
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| CN201510335079.8A CN104971063A (en) | 2015-06-17 | 2015-06-17 | Medicinal composition containing tadalafil, and preparation method thereof |
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| CN201510335079.8A CN104971063A (en) | 2015-06-17 | 2015-06-17 | Medicinal composition containing tadalafil, and preparation method thereof |
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| CN201510335079.8A Pending CN104971063A (en) | 2015-06-17 | 2015-06-17 | Medicinal composition containing tadalafil, and preparation method thereof |
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
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| CN110638768A (en) * | 2019-10-25 | 2020-01-03 | 株洲千金药业股份有限公司 | Preparation method of medicine for treating male erectile dysfunction |
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| US20020094988A1 (en) * | 1999-05-14 | 2002-07-18 | Robert Hines | Method of treating erectile dysfunction |
| CN101623252A (en) * | 2008-07-09 | 2010-01-13 | 北京德众万全药物技术开发有限公司 | Sertraline hydrochloride oral liquid and preparation method thereof |
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Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN110638768A (en) * | 2019-10-25 | 2020-01-03 | 株洲千金药业股份有限公司 | Preparation method of medicine for treating male erectile dysfunction |
| CN110638768B (en) * | 2019-10-25 | 2024-04-16 | 株洲千金药业股份有限公司 | Preparation method of medicine for treating male erectile dysfunction |
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Application publication date: 20151014 |