CN101524531A - Preparation and application of pharmaceutical composition containing collagen and isosorbide mononitrate - Google Patents
Preparation and application of pharmaceutical composition containing collagen and isosorbide mononitrate Download PDFInfo
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- CN101524531A CN101524531A CN200810026588A CN200810026588A CN101524531A CN 101524531 A CN101524531 A CN 101524531A CN 200810026588 A CN200810026588 A CN 200810026588A CN 200810026588 A CN200810026588 A CN 200810026588A CN 101524531 A CN101524531 A CN 101524531A
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- isosorbide mononitrate
- impotence
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- collagen protein
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Abstract
The invention discloses a pharmaceutical composition for treating impotence and frigidity. Penis cavernous tissue of an impotence patient has obvious pathological changes, and the pathological damages are possibly related to ischemia and hypoxia in local tissues and lack of collagen. Therefore, local application of small molecular collagen absorbed through skin is helpful for improving the toughness of penile tissues as well as the elasticity and the tensility of the tissues; the main pharmacological actions of isosorbide mononitrate include relaxing smooth muscles and expanding peripheral blood vessels, and local application can ensure cavernous hyperaemia and penile erection; combined local application of collagen and isosorbide mononitrate only requires small doses and almost has no side effects of oral drugs; isosorbide mononitrate does not arouse sexual desire and just assists a patient in restoring normal erection function when sexual excitement appears; moreover, the drug composition also has remarkable curative effects of improving female frigidity, thereby providing a novel choice for treating the impotence and the frigidity.
Description
[technical field]
The present invention relates to medical technical field, is a kind of pharmaceutical composition for the treatment of sexual impotence and hyposexuality.
[background technology]
Sexual impotence is a kind of symptom common, the most serious in the male sexual disorder, and pathogenesis is still not fully aware of at present.The cause of disease according to sexual impotence takes place can be divided into psychological, organic.Report that according to foreign literature impotence patient accounts for the 37-42% of male sexual disorder, domestic sampling survey shows that the people of 10-20% has the sexual impotence phenomenon in the adult male.Sexual impotence is the key factor that influences people's physical and mental health, family harmony and social stability.Traditional view thinks, sexual impotence is mainly caused by psychology and spirituality factor, thereby clinical treatment biases toward the psychotherapy, to the then not attention of some organic impotence patient of needs operation or Drug therapy.
Abroad impotence patient penile tissue cell ultrastructure is studied, find that impotence patient cavernous body of penis smooth muscle cell has significant pathological change, smooth muscle cell and neurocyte atrophy, quantity reduce, interstitial fibers hamartoplasia, and this may be the key factor that causes sexual impotence.Therefore research and understand the pathological change of smooth muscle cell in various sexual impotence in the erectile tissue has crucial meaning to the Clinics and Practices of sexual impotence.
Corpus cavernosum tissue mainly is made of blood vessel, nerve, smooth muscle cell, stroma etc.The girder that smooth muscle cell and collagen fiber and elastic fibers are formed is woven into netted in length and breadth, wherein contains abundant blood vessel, and there is the squamous epithelium small pieces of cloth used for patches on the mesh plane, forms blood sinus.Blood sinus is led to mutually and is directly communicated with arteriovenous.The intravital smooth muscle cell diastole of sponge can enlarge the blood sinus space, makes blood resides wherein, the intrinsic pressure raising of blood sinus.Vein under the albuginea penis is produced bigger pressure block its blood backflow, make erection.
The impotence patient corpus cavernosum tissue has tangible pathological change, and wherein smooth muscle cell and neurocyte atrophy, quantity reduce, and interstitial fibers hamartoplasia is the most obvious, and this pathological lesion may lack relevant with local organization hypoxic-ischemic and collagen protein.
Collagen protein is the extremely important structural protein of connective tissue, plays the function that supports organ, protection body, is the flexible principal element of organ that decision comprises penis.Collagen protein and vasodilation are united use and had not only been improved the toughness of tissue but also can make penis full fast, impotence treatment is had rapid-action, the effect of effect stability.
The molecular weight of common collagen protein does not wait to millions of at hundreds of thousands, and absorption rate is not high.The collagen protein product generally adopts the compound protease technology for hydrolyzing, and molecular weight improves greatly 3000Da left and right sides human absorptivity and utilization rate, and bioavailability can reach more than 95%.
Isosorbide mononitrate (ISMN) is the main bioactive metabolites matter of Dilatrate-SR, and is the same with other organic nitrates, and main pharmacological is relaxing smooth muscle and blood vessel dilating.ISMN discharges nitrogen oxide (NO), NO is identical with the endothelium relaxing factor, can activate guanylate cyclase and make the cyclic guanylic acid (cGPM) in the smooth muscle cell increase vascular smooth muscle relaxation, peripheral arterial and venectasia, isosorbide mononitrate is stronger to the venous dilating effect.Topical application makes spongy body hyperemia, erection.
Though the Viagra curative effect is more reliable, costs an arm and a leg, and side effect is arranged, as headache, flush, the change of temporary visual color, blurred vision etc.These side effect are directly related to the effect of whole body blood vessel with oral drugs.The simple vasodilation class medicine that uses, further expansion is lax to make the cavernous veins of penis hole, and life-time service needs the bigger drug dose could the full once again spongy body that progressively increases of peripheral blood, along with the side effect of the increasing whole body of drug dose is also increasing.
And the local toughness of using the micromolecular collagen Transdermal absorption to help to strengthen penile tissue strengthens elasticity and the tension force organized.Associating isosorbide mononitrate part uses that not only dosage is little, and the side effect that does not almost have oral drugs and brought.Isosorbide mononitrate itself can not cause libido, just when sex drive occurring, helps the patient to recover normal erection function.The pharmaceutical composition of collagen protein and isosorbide mononitrate provides new selection for treating sexual impotence and hyposexuality.
The incidence rate of bibliographical information female sexual disorder is roughly between 35-60%, wherein hyposexuality and orgasm hypofunction are the most general, the local use of isosorbide mononitrate can make female sex organs congested excited equally, the collagen protein local absorption helps the elastic effect of vagina that recovers again, recover vitality, also safe and effective to the low treatment of female libido.
Toxicological test:
1. acute toxicity
The disposable administration result of isosorbide mononitrate LD50 (mg/kg body weight) is as follows:
2. long term toxicity/subacute toxicity
The rat long term toxicity test shows free of toxic effects.Mutagenesis and carcinogenecity do not find all that in the research of multinomial vivo and vitro mutagenicity test it has mutagenicity.The research of rat long term test does not find that it has carcinogenic probability yet.The genotoxicity aspect does not see that isosorbide mononitrate has teratogenesis at animal embryo, in utero reach in the research of postnatal development condition.
Each present dosage form indication of isosorbide mononitrate all is cardiovascular disease, collagen protein and isosorbide mononitrate the pharmaceutical composition at home and abroad application of sexual impotence or hyposexuality indication do not appear in the newspapers and relevant patent, and this pharmaceutical composition has vast market prospect.
Component and content are by weight percentage in the prescription of this pharmaceutical composition: collagen protein 1%, isosorbide mononitrate 0.025 ‰-0.25 ‰ also comprise pharmaceutically acceptable substrate, solubilizing agent, wetting agent and adjuvant in the prescription.Described adjuvant is carbomer, lauryl alcohol sodium sulphate, micropowder silica gel, glycerol, propylene glycol, ethyl acetate, ethanol, triethylamine, laurocapram, stearic acid, stearyl alcohol, vaseline, liquid Paraffin, Polyethylene Glycol, tween 80 etc.Pharmaceutical composition can be prepared into pharmaceutical dosage forms such as liniment, gel, ointment, suppository, effervescent tablet.
[summary of the invention]
Collagen protein 1%, isosorbide mononitrate 0.025 ‰-0.25 ‰, all the other are substrate, bulking agent and adjuvant commonly used in the medicine.Described adjuvant is carbomer, lauryl alcohol sodium sulphate, micropowder silica gel, glycerol, propylene glycol, ethyl acetate, ethanol, triethylamine, laurocapram, stearic acid, stearyl alcohol, vaseline, liquid Paraffin, Polyethylene Glycol, tween 80 etc.Pharmaceutical composition can be prepared into pharmaceutical dosage forms such as liniment, gel, ointment, suppository, effervescent tablet.
The objective of the invention is to realize by following manner:
Embodiment 1: the liniment prescription g of unit
Collagen protein 10
Isosorbide mononitrate 0.025
Glycerol 50
Laurocapram 10
Ethanol 100
Deionized water 830
Regulate pH value 5.5 with reagent such as lactic acid and promptly obtain liniment of the present invention, by inserting in the bottle after the known technology preparation, sealing gets final product.
Embodiment 2: gel formula: the g of unit
Collagen protein 10
Isosorbide mononitrate 0.025
Glycerol 50
Laurocapram 10
Carbomer 10
Deionized water 920
Method for making:
1. get carbomer 10 grams were added in the 500ml water natural swelling 24 hours, stir evenly stand-by.
2. collagen protein 10g, isosorbide mononitrate 0.025g, glycerol 50g, laurocapram 100g are standby.
3. the above-mentioned solution with gained is added in the stand-by carbomer solution, through fully stirring, makes it to become gel.Adding deionized water in this gel, to make described gel gross weight be 1000g, regulates pH value 5.5 with reagent such as lactic acid, promptly obtains gel preparation of the present invention, and by inserting in the container after the known technology preparation, sealing gets final product.
Embodiment 3: paste ingredient: the g of unit
Isosorbide mononitrate 10
Stearic acid 60
Stearyl alcohol 60
Vaseline 60
Liquid Paraffin 84
Polyethylene Glycol 40
Tween 80 44
Glycerol 300
Deionized water 342
Method for making:
1. with oil phase substance, after promptly stearic acid 60g, stearyl alcohol 60g, vaseline 60g, liquid Paraffin 84g mix, heat 40-80 ℃ and dissolve.
2. with aqueous phase substance, after promptly glycerol 300g, Polyethylene Glycol 40g, tween 80 44g, water 342g mix, be heated to 40-80 ~ C.
With oil, the biphase material of water at 80 ℃ of following mix homogeneously, be cooled to room temperature after, add isosorbide mononitrate 10g, mix homogeneously promptly gets ointment.
Claims (8)
1. treat the pharmaceutical composition of sexual impotence and hyposexuality, it is characterized in that: component is collagen protein and isosorbide mononitrate, is used for the treatment of sexual impotence and hyposexuality.
2. according to the pharmaceutical composition of claim 1 described treatment sexual impotence and hyposexuality, it is characterized in that: component and content are collagen protein 1%, isosorbide mononitrate 0.025 ‰-0.25 ‰ by weight percentage in the composite formula.
3. according to the pharmaceutical composition of the requirement of claim 2 preparation, it is characterized in that: the molecular weight of collagen protein is about 3000Da.
4. according to the pharmaceutical composition of the requirement of claim 2 preparation, it is characterized in that: component and content are collagen protein 1%, isosorbide mononitrate 0.025 ‰-0.25 ‰ by weight percentage in the composite formula.All the other are substrate, solubilizing agent and adjuvant commonly used in the medicine.
5. according to the pharmaceutical composition of the requirement of claim 4 preparation, it is characterized in that: described adjuvant is carbomer, lauryl alcohol sodium sulphate, micropowder silica gel, glycerol, propylene glycol, ethyl acetate, ethanol, triethylamine, laurocapram, stearic acid, stearyl alcohol, vaseline, liquid Paraffin, Polyethylene Glycol, tween 80 etc.
6. pharmaceutical composition according to claim 1 is characterized in that: pharmaceutical composition can be prepared into pharmaceutical dosage forms such as liniment, gel, ointment, suppository, effervescent tablet.
7. preparation of pharmaceutical compositions method as claimed in claim 4 is characterized in that: the dosage form pH value 5.5 of liniment, gel, ointment, suppository.
8. pharmaceutical composition as claimed in claim 4 is applicable to that impotence and female libido are low.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200810026588A CN101524531A (en) | 2008-03-04 | 2008-03-04 | Preparation and application of pharmaceutical composition containing collagen and isosorbide mononitrate |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN200810026588A CN101524531A (en) | 2008-03-04 | 2008-03-04 | Preparation and application of pharmaceutical composition containing collagen and isosorbide mononitrate |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CN101524531A true CN101524531A (en) | 2009-09-09 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN200810026588A Pending CN101524531A (en) | 2008-03-04 | 2008-03-04 | Preparation and application of pharmaceutical composition containing collagen and isosorbide mononitrate |
Country Status (1)
| Country | Link |
|---|---|
| CN (1) | CN101524531A (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107320463A (en) * | 2017-07-10 | 2017-11-07 | 徐静 | A kind of slow-release transdermal patch containing Isosorbide Mononitrate and its application |
-
2008
- 2008-03-04 CN CN200810026588A patent/CN101524531A/en active Pending
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN107320463A (en) * | 2017-07-10 | 2017-11-07 | 徐静 | A kind of slow-release transdermal patch containing Isosorbide Mononitrate and its application |
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| Date | Code | Title | Description |
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| C06 | Publication | ||
| PB01 | Publication | ||
| C02 | Deemed withdrawal of patent application after publication (patent law 2001) | ||
| WD01 | Invention patent application deemed withdrawn after publication |
Open date: 20090909 |